Attached files
file | filename |
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EX-32 - MICROMET, INC. | v192452_ex32.htm |
EX-10.2 - MICROMET, INC. | v192452_ex10-2.htm |
EX-31.1 - MICROMET, INC. | v192452_ex31-1.htm |
EX-31.2 - MICROMET, INC. | v192452_ex31-2.htm |
10-Q - MICROMET, INC. | v192452_10q.htm |
BI
Contract Number: [***]
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Execution
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Micromet
Contract Number: [***]
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COLLABORATION
AND LICENSE AGREEMENT
This
Collaboration and License Agreement (the “Agreement”) is made and
entered into effective as of May 5, 2010 (the “Effective Date”), by and
between Micromet
AG, having its principal place of business at Staffelseestrasse 2, 81477
Munich, Germany (VAT-ID No.: DE811666912) (“Micromet”), and Boehringer
Ingelheim International GmbH, having its principal place of business at
Binger Str. 173, 55216 Ingelheim, Germany (VAT-ID No: DE 811138149) (“BI”). Micromet and
BI each may be referred to herein individually as a “Party,” or collectively as the
“Parties.”
Recitals
A. Micromet
has developed a proprietary platform for the discovery, research, and
development of BiTE®
antibodies, which may have applications in the treatment of cancer and other
diseases.
B. BI
is a global pharmaceutical company with experience in the research, development
and commercialization of pharmaceutical products.
C. Micromet
and BI desire to collaborate on the research and development of one or more
products comprising a BiTE antibody binding to a specific target, and to have BI
further develop, manufacture and commercialize such products on a worldwide
basis (including, in the case of commercialization in the U.S., through a
co-promotion arrangement with Micromet).
In
consideration of the foregoing premises and the mutual promises and covenants
contained herein, the receipt and sufficiency of which are hereby acknowledged,
the Parties hereby agree as follows:
Agreement
1.
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Definitions
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When used
in this Agreement, capitalized terms will have the meanings as defined below and
throughout the Agreement.
1.1 “Affiliate” means an entity
that, directly or indirectly, through one or more intermediaries, controls, is
controlled by, or is under common control with a Party. For purposes
of this definition only, “control” and, with correlative meanings, the terms
“controlled by” and “under common control with” means (a) the possession,
directly or indirectly, of the power to direct the management or policies of an
entity, whether through the ownership of voting securities, contract rights,
voting rights, corporate governance or otherwise, or (b) the ownership, directly
or indirectly, of more than 50% of the voting securities or other ownership
interest of an entity; provided, that if local law
restricts foreign ownership, control will be established by direct or indirect
ownership of the maximum ownership percentage that may, under such local law, be
owned by foreign interests.
1.2 “Antibody” means a molecule
comprising two (2) or more immunoglobulin variable domains or parts of such
domains.
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1.3 “Applicable Law” means the
laws, rules, and regulations, including any statutes, rules, regulations,
guidelines, or other requirements (including Good Manufacturing Practices (GMP),
Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), collectively
referred to as “GxP”), that may be in effect from time to time and apply to the
development, manufacture, registration, and marketing of a Product in the
countries of the Territory, including any such statutes, rules, regulations,
guidelines, or other requirements of the FDA or the EMA.
1.4 “ [***] Technology”
has the meaning as defined in Section 6.2.2
1.5 “ [***] Technology”
means, in respect of any [***] or [***] , any
Patent or Know-How conceived or generated solely by employees, agents or Service
Providers of BI or its Affiliates or sublicensees and that results
from [***] performed under this Agreement, including
the [***] for [***] , with respect to such
Lead [***] or [***] ; for the sake of clarity,
the subject matter of such Patents or Know How may include (but not be limited
to) [***] methods, methods
for [***] and [***] and [***]
, methods for [***]
, [***] including [***] , methods
of [***] and [***] methods
associated therewith of or for
such [***] or [***] .
1.6 “ [***] Technology”
means any Patent or Know-How that is conceived or generated solely by employees,
agents or Service Providers [***] or its Affiliates or
sublicensees in connection and accordance with the research, development or
Commercialization of Products under this Agreement, but excluding (i)
any [***] Technology, (ii)
any [***] Technology, and (iii) any Patent or Know-How
that is conceived or generated following
the [***] of [***] hereunder.
1.7 “BI Indemnitee” has the meaning
as defined in Section 14.2.
1.8 “ [***] Technology”
means any [***] Technology other than
the [***] Technology.
1.9 “ [***] Technology”
means any [***] Technology listed on Exhibit L item 1 and
2a.
1.10 “ [***] Technology”
means any Patent or Know-How that (a) is Controlled
by [***] or its Affiliates during the Term, and (b)
is [***] for
the [***] or [***] of
a [***] , but excluding any [***] Technology
and [***] Technology. A list of Patents in
the [***] Technology, filed as of the Effective Date, that
claim or cover [***] and [***] to
such [***] as well as
the [***] of [***] to [***] is
listed on Exhibit
L and Know-How comprising the [***] Technology is
referenced on Exhibit
L.
1.11 “
[***] Activities” means
the activities to be performed by [***] or its [***] regarding the [***] of a
[***] and/or [***] , [***] [***] of an appropriate [***] including [***] and
[***] [***] for [***] and [***] , [***] of [***] supporting [***] , [***] of a
[***] as well as [***] and [***] .
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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1.12 “BiTE Antibody” means any
bi-specific, single-chain Antibody binding to the [***] of
T cells.
1.13 “ [***] Antibody”
means any bi-specific single-chain polypeptide containing (a)
a [***] Antibody binding to
the [***] of T cells, and (b)
a [***] Antibody binding to a [***]
.
1.14 “BLA” means a Biologics License
Application, supplemental Biologics License Application, or similar application
filed or to be filed with the FDA, or a comparable application in jurisdictions
outside the United States of America, including a marketing approval application
filed or to be filed with the EMA.
1.15 “Breaching Party” has the
meaning as defined in Section 12.2.1.
1.16 “Business Day” means any
weekday that is not a legal holiday in the states of Rheinland-Pfalz and
Bavaria, Germany and is not a day on which banking institutions in such states
are required by law or regulation to be closed.
1.17 “Calendar Quarter” means any
one of the four three-month time periods in any calendar year commencing on
January 1, April 1, July 1 and October 1 of such year.
1.18 “Change of Control” means with respect to
any Party (the “Acquired
Entity”) (a) any sale, exchange, transfer, or issuance to or acquisition
by one or more Third Parties of shares representing more than fifty percent
(50%) of the aggregate ordinary voting power entitled to vote for the election
of directors represented by the issued and outstanding stock of the Acquired
Entity or any Affiliate that directly or indirectly controls the Acquired Entity
(whether by sale or merger, but excluding the issuance of shares in financing
transactions), whether such sale, exchange, transfer, issuance or acquisition is
made directly or indirectly, beneficially or of record or in one transaction or
a series of related transactions; (b) a merger or consolidation under applicable
law of the Acquired Entity with a Third Party in which the shareholders of the
Acquired Entity or any Affiliate that directly or indirectly controls the
Acquired Entity immediately prior to such merger or consolidation do not
continue to hold immediately following the closing of such merger or
consolidation at least fifty percent (50%) of the aggregate ordinary voting
power entitled to vote for the election of directors represented by the issued
and outstanding stock of the entity surviving or resulting from such
consolidation; or (c) a sale or other disposition of all or substantially all of
the assets of the Acquired Entity to one (1) or more Third Parties in one
transaction or a series of related transactions.
1.19 “Co-Chair” has the meaning as
defined in Section 2.1.1.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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1.20 “Co-Promotion Agreement” has
the meaning as defined in Section 4.5.1.
1.21 “Co-Promotion Term” has the
meaning as defined in Section 4.5.1.
1.22 “Collaboration Target” means
the whole or fragments and [***] of [***] ,
identified by the [***] entry
name [***] and accession number [***] , with
the amino acid sequence as set out in Exhibit
A.
1.23 “Commercialization” means the
pre-launch scientific communication and study activities conducted for a Product
prior to obtaining Marketing Approval, including early access programs, the
manufacture for commercial sale, and the marketing, promotion, advertising,
selling and distribution of a Product after Marketing Approval has been
obtained, including any Phase IV trials and risk evaluation and mitigation
strategies (REMS) or equivalent obligations imposed by any Regulatory Authority,
including the FDA. The term “Commercialize” has a
correlative meaning.
1.24 “Commercially Reasonable
Efforts” means the carrying out of obligations or tasks by a Party in a
sustained manner using a level of efforts in good faith consistent with the
reasonable best practices of pharmaceutical companies with comparable size and
business activities of the respective Party, and the exercise of prudent
scientific and business judgment for the development and commercialization of a
pharmaceutical product having similar market potential as a Product at a similar
stage of its product life, taking into account all relevant matters such as the
prospects of or actual establishment of the Product in the marketplace, the
competitiveness of the marketplace, the proprietary position of the Product, the
regulatory status involved, the pricing and launching strategy and the relative
safety and efficacy of the Product. Without limiting the foregoing,
Commercially Reasonable Efforts requires, with respect to a task or obligation
to be performed under this Agreement, that the Party: (a) within a reasonable
time assign responsibility for such obligation to specific employee(s) who are
held accountable for progress and monitor such progress on an on-going basis,
(b) set and consistently seek to achieve specific, meaningful and measurable
objectives for carrying out such tasks and obligations, and (c) consistently
make and implement decisions and allocate resources designed to advance progress
with respect to such tasks or obligations.
1.25 “Competing Product” has the
meaning as defined in Section 7.9.1.
1.26 “Confidential Information” has the meaning as
defined in Section 10.1.
1.27 “Contract Manager” has the
meaning as defined in Section 2.3.
1.28 “Control” means, with respect
to a Party and any Patent, Know-How, or other intellectual property right, that
a Party owns or has a license to such Patent, Know-How or intellectual property
right and has the ability to grant to the other Party a license or a sublicense
(as applicable) to such Patent, Know-How or intellectual property right on the
terms and conditions set forth herein without violating the terms of any
agreement or other arrangement with any Third Party existing at the time such
Party would be required hereunder to grant to the other Party such access,
license or sublicense. The term “Controlled” has a correlative
meaning.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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1.29 “Cost Overrun” has the meaning as
defined in Section 8.2.4.
1.30 “Development Candidate” means a
Lead Candidate which has been designated as a Development Candidate by the JSC
and approved by BI for start of pre-clinical development pursuant to Section
3.1.5.
1.31 “Development Candidate
Criteria” means the criteria for selecting a Development Candidate as set
forth on Exhibit
N to this Agreement, as may be modified by the Parties jointly in
writing.
1.32 “Development Plan” means the
plan for the preclinical and clinical development of a Development Candidate as
further defined in Section 3.2.1, as may be amended in accordance with this
Agreement. The initial Development Plan is part of the Initial R&D Plan (as
defined in Section 1.52).
1.33 “Disclosing Party” has the meaning as
defined in Section 10.1.
1.34 “Dispute” has the meaning as
defined in Section 17.4.2.
1.35 “EMA” means the European
Medicines Agency, or any successor agency thereto.
1.36 “Executive Officer” means (a)
in the case of Micromet, the [***] of Micromet; and (b) in
the case of BI, depending on the actual status of the Product,
the [***] responsible for [***] or
the [***] responsible for [***] ; or, in each
case, such individual’s nominated designee with direct-reporting responsibility,
who must be a member of the Party’s senior management with appropriate
decision-making authority, but who is not a Contract Manager or a member of the
JSC or any JPT.
1.37 “ [***] ” has the meaning as
defined in Section 3.3.3.
1.38 “FDA” means the United States
Food and Drug Administration, or any successor agency thereto.
1.39 “Field” means
the [***] , [***] , [***] ,
and [***] of [***] and [***] and [***]
.
1.40 “First Commercial Sale” means
the first sale to a Third Party of a Product in a country after Marketing
Approval has been obtained for such country or, as the case may be, for part of
a country such as a province.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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1.41 “FTE” means the equivalent of a
total of [***] hours per year of work carried out by a
qualified employee of a Party in connection with the performance of an activity
under this Agreement. In the case that any personnel of a Party who
works partially on an activity under this Agreement and partially on other work,
then the full-time equivalent to be attributed to such individual’s work
hereunder will be equal to the percentage of such individual’s total work time
that such individual spent working on such activity under this
Agreement. FTE work will not include the work
of [***] or [***] .
1.42 “FTE Rate” means, initially, €
[***] per FTE, which amount is fully burdened and includes without
limitation, for each FTE, laboratory supplies and equipment (excluding in each
case items provided for separately under the Research Plan or Development Plan),
equipment maintenance costs, utilities, waste removal, travel expenses, and a
pro rata allocation of general and administrative expenses. Starting
on [***] , and on every [***] thereafter during
the Term, the FTE Rate
will [***] by [***] equal to
the [***] of the previous [***] in
the [***] ( [***] ) since the
last [***] .
1.43 “ [***] Competition”
means and shall be deemed to [***] in
a [***] in the [***] with respect to
a [***] if and for so long as in [***] : (a)
one or more [***] Products (other than
a [***] Product authorized or sold
by [***] or its Affiliates or by
a [***] under a [***] or
any [***] granted by [***] or its
Affiliate and provided in all cases that [***] or its
Affiliates do not have a [***] in
such [***] Product) are available for [***] ,
and (b) the [***] of the
corresponding [***] in
such [***] during
the [***] have [***] by either (i)
in [***] at least [***] from
the [***] in the [***] or (ii)
in [***] of the [***] , at
least [***] from the [***] in
such [***] . As used in this Agreement, the “ [***] ” of
a [***] in a [***] will mean
the [***] of such [***] in
such [***] during
the [***] immediately preceding the [***] of
the first [***] Product in such [***]
.
1.44 “ [***] Product”
shall mean, with respect to a particular [***] and a
particular [***] , any [***] product (other
than the [***] ) that (a) is
a [***] or [***] ”
or [***] to
a [***] and [***] in
an [***] and [***] of [***] as
such [***] and (b) for which
a [***] has [***] (based upon
then-current Applicable Laws
governing [***] of [***] )
whose [***] for [***] relies [***] (but
not [***] ) on [***] generated
by [***] or [***] .
1.45 “GLP Toxicology Study” means a
preclinical study performed in accordance with good laboratory practice (GLP)
(a) in which the Product is administered to animals in order to assess its
toxicity, and (b) that is required for the Regulatory Filing of an IND and/or
BLA.
1.46 “Governmental Authority” means
any supranational, national, federal, state, local, municipal,
quasi-governmental or other authority of any nature (including any governmental
division, subdivision, department, agency, bureau, branch, office, commission,
council, court or other tribunal) exercising executive, legislative or judicial
governmental powers.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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1.47 “IND” means an Investigational
New Drug Application filed or to be filed with the FDA, and the equivalent
application in jurisdictions outside the United States of America, including
“Investigational Medicinal Product Dossier” filed or to be filed with the
national Regulatory Authorities in Europe.
1.48 “Indemnification Claim Notice”
has the meaning as defined in Section 14.3.
1.49 “Indemnified Party” has the meaning as
defined in Section 14.3.
1.50 “Indemnifying Party” has the meaning as
defined in Section 14.3.
1.51 “Indemnitees” has the meaning as
defined in Section 14.3.
1.52
“Initial R&D
Plan” consists of the initial
Research Plan (as defined in Section 1.95) and the initial Development Plan (as
defined in Section 1.32) as of the Effective Date and is attached as Exhibit
C.
1.53 “JCPT” means the Joint
Commercialization Project Team.
1.54 “JDPT” means the Joint
Development Project Team.
1.55 “ [***] Technology”
means any Patent or Know-How (a) that is conceived or
generated [***] by employees, agents, or Service Providers
of [***] or their respective Affiliates in connection and
accordance with the research, development or Commercialization of Products under
this Agreement, or (b) that is conceived or
generated [***] by employees, agents, or Service Providers
of [***] or their respective Affiliates in connection and
accordance with the research, development or Commercialization of Products under
this Agreement and to the extent [***] or the
full [***] of
any [***] or [***] .
1.56 “JPT” has the meaning as
defined in Section 2.2.1.
1.57 “JPT Leader” has the meaning as
defined in Section 2.2.1.
1.58 “JRPT” means the Joint Research
Project Team.
1.59 “JSC” has the meaning as
defined in Section 2.1.1.
1.60 “Know-How” means (a) any
scientific or technical information, results and data of any type whatsoever, in
any tangible or intangible form whatsoever, that is not in the public domain or
otherwise publicly known, including databases, practices, methods, techniques,
specifications, formulations, formulae, protein sequences, DNA sequences,
knowledge, know-how, skill, experience, test data including pharmacological,
medicinal chemistry, biological, chemical, biochemical, toxicological and
clinical test data, analytical and quality control data, stability data, studies
and procedures, and manufacturing process and development information, results
and data, and (b) any biological, chemical, or physical materials that are not
in the public domain or otherwise available to the public; all to the extent not
claimed or disclosed in a Patent.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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1.61 “Lead Candidate” means a BiTE
Antibody binding to the Collaboration Target (whether or not such BiTE Antibody
contains a [***] ) which has been generated by Micromet and which is
proposed by the JRPT to (a) further characterize
by [***] studies, and
(b) [***] and [***] at BI
for [***] .
1.62
“Licensed
Technology” means the [***] Technology, [***]
Technology, [***] Technology, [***] rights and interest
in [***] Technology, any [***] Technology that was
generated by employees, agents or Service Providers of Micromet and that is
owned solely by Micromet, any [***] Technology that is acquired or
licensed by [***] during the Term and that is included in Licensed
Technology pursuant to Section [***] , and any [***]
Technology that is included in Licensed Technology pursuant to Section
[***] .
1.63 “Losses” has the meaning as
defined in Section 14.1.
1.64 “Major Market” means each of
the [***] , the [***] , [***]
, [***] , [***]
, [***] and [***] .
1.65 “Marketing Approval” means the
approval of a BLA, and
any [***] and [***] to the extent
required by Applicable Law prior to the sale of a Product in a
country.
1.66 “ [***] Collaboration
Expenses” means those costs and expenses incurred
by [***] after [***] directly in
connection with
the [***] or [***] of
a [***] in accordance with this Agreement
(including [***] work,
developing [***] for [***] of [***]
, conducting [***] activities and
supporting [***] of a [***] , preparation
of [***] as well as
of [***] with [***] relating to
a [***] , ensuring [***] with [***]
, [***] and w [***] and
reviewing [***] and [***] ) as agreed by the
Parties and pursuant to
the [***] or [***] Plan (it being
understood that activities conducted prior to [***] are
described in the [***] ), as follows:
(a)
[***] associated with the [***] of
any [***] or [***] performed
for [***] by a [***] in accordance
with the Research Plan and Development Plan (and for clarity are not otherwise
included as part of the [***] ); and
(b)
[***] .
Any cost
and expenses incurred by [***] in
the [***] of activities under the Research Plan or
Development Plan due
to [***] to [***] such activities in
accordance with [***] (including, by way of
example, [***] such activities with [***] )
shall
be [***] from [***] Collaboration
Expenses. Micromet will consult with BI through the relevant JPT
prior to [***] . For the avoidance of
doubt, [***] will not include
in [***] the costs of any [***] and
not used for activities under the Research Plan or Development Plan, subject to
Section 3.1.3.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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1.67 “ [***] Technology”
means any Patent or Know-How conceived or generated solely by employees, agents
or Service Providers of [***] or its Affiliates in
connection and accordance with the research, development or Commercialization of
Products under this Agreement, but
excluding [***] Technology.
1.68 “
[***] Collaborator” means any Third Party generating,
developing or commercializing a product containing or comprising
a [***] alone or in collaboration
with [***] under a license to Patents Controlled
by [***] , but excluding any Third
Party [***] as a [***] for research,
development or Commercialization activities (including, by way of
example, [***] , [***] or [***]
).
1.69 “ [***] Product”
means, with respect to a particular country or territory, a product containing
or comprising a [***] generated, developed or
commercialized by a [***] alone or in collaboration
with [***] in such country or territory under a license to
Patents Controlled by [***] .
1.70 “ [***] Technology”
means any Patent or Know-How that (a) is conceived or generated by employees,
agents or Service Providers of a [***] or its Affiliates,
either solely or jointly with employees, agents or Service Providers
of [***] or its Affiliates, (b) is Controlled
by [***] , and (c) is [***] for
the [***] or [***] of
a [***] .
1.71 “ [***] FTE Costs”
means, for all [***] performed
by [***] in accordance with
the [***] or the [***] , as applicable, the
product of (a) the number of FTEs used by [***] for such
research and development activity as set forth in
the [***] and evidenced by appropriate means and (b) the
FTE Rate as defined in Section 1.42. For the avoidance of doubt, the activity of
contract personnel will be charged as Out-of-Pocket Costs as specified in the
applicable [***] or [***] .
1.72 “Micromet Indemnitee” has the meaning as
defined in Section 14.1.
1.73 “ [***] Technology”
means any Patent or Know-How that (a)
is [***] Technology, [***] Technology
or [***] Technology, (b) is owned or otherwise Controlled
by [***] after the Effective Date, and (c)
is [***] for
the [***] or [***] of
a [***] . Notwithstanding,
if [***] is subject of a Change in Control with a Third
Party, the Patents and Know-How owned or Controlled by such Third Party (whether
such Third Party becomes the assignee of this Agreement or if such Third Party
remains an Affiliate of [***] ), will be automatically excluded from
the definition of [***] Technology.
1.74 “Micromet Marks” means the
Micromet and BiTE platform names and logos as set forth in Exhibit
M.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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1.75 “ [***] Technology”
means any Patent or Know-How that (a) is licensed from a Third Party
to [***] as of the Effective Date, and (b)
is [***] for
the [***] or [***] of
a [***] , including the Patents Controlled
by [***] pursuant to the [***] .
1.76 “ [***] Technology”
means any Patent or Know-How that (a) is owned by [***] as
of the Effective Date, and (b)
is [***] for [***] or [***] of
a [***] , including the Patents listed on Exhibit
D.
1.77 “ [***] Product” means, with respect
to a [***] or [***] , a product that comprises
a [***] and [***] by [***] to
bind to a target other than the [***] and
further [***] and [***] in
such [***] or [***] by [***] or
using Third Parties [***] (including, by way of
example, [***] , [***] or [***]
). For the avoidance of doubt, a [***] Product
shall not include any [***]
, [***] or [***] with
a [***] .
1.78 “Net Sales” means the gross
amount invoiced by BI, its Affiliates, and any of their sublicensees (each a
“Selling Party”) for
sales of a Product to any Third Party (and in all cases amounts actually
received to the extent not invoiced), less any (a) normal and customary trade,
cash, and quantity discounts actually allowed, including chargebacks, compulsory
rebates, reimbursements, or similar payments granted or given to wholesalers or
other distributors, buying groups, health care insurance carriers or other
institutions; (b) amounts allowed for returned or defective product; (c)
insurance and transportation charges to the extent included in the invoiced
amount; and (d) custom duties, VAT, sales taxes or other governmental charges
paid in connection with such sales (but excluding what is commonly known as
income taxes). Any of the deductions listed above that involved a
payment by a Selling Party will be taken as a deduction in the Calendar Quarter
during which the payment is actually made by such entity. Net Sales
shall not include any Product provided by BI for no consideration, or for
reimbursement of manufacturing costs only, for (i) use in clinical trials, (ii)
use in research or for other non-commercial uses, or (iii) use as part of a
compassionate use or similar program. Any amounts received on account
of transfers of a Product between Selling Parties will be excluded from the
calculation of Net Sales, and Net Sales will be calculated based on the final
sale of such transferred Product by a Selling Party to any Third
Party. If a Selling Party receives non-cash consideration for a
Product sold or otherwise transferred to a Third Party, Net Sales for such sale
or transfer will be determined based on the average of the Net Sales prices
charged to other Third Parties in respect of cash sales of such Product during
the applicable reporting period. A sale of a Product is deemed to
occur upon invoicing. If any discounts or other deductions are made
in connection with sales of the Product that are bundled or sold together with
other products of BI, its Affiliates or sublicensees, in no event will the
discount applied to the Product exceed the discount applied to other products of
BI, its Affiliates or sublicensees in such arrangement based upon the respective
list prices of the Product and such other products prior to applying the
discount. For the avoidance of doubt, in countries where BI Commercializes a
Product using the services of Third Party distributors (recognized agents), BI
sales to such distributors are considered sales of a Product for the purpose of
this definition.
***
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has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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1.79 “Non-Breaching Party” has the meaning as
defined in Section 12.2.1.
1.80 “Out-of-Pocket Costs” means
costs and expenses paid to Third Parties (or payable to Third Parties and
accrued in accordance with IAS/IFRS (or GAAP for the U.S.)) by Micromet and/or
its Affiliates, if applicable.
1.81 “Patent” means (a) any patent
and patent application in any country or supranational jurisdiction, and (b) any
provisional, substitution, division, continuation, continuation in part,
reissue, renewal, registration, confirmation, reexamination, extension,
supplementary protection certificate and the like, of any such patent or patent
application.
1.82 “Patent Challenge” has the meaning as
defined in Section 6.5.1.
1.83 “Person” means a natural
person, corporation, partnership, trust, joint venture, limited liability
company, Regulatory Authority or any other entity or organization.
1.84 “Phase 1 Trial” means a
clinical trial of a pharmaceutical product on healthy subjects or patients
designed with the primary purpose of determining safety, metabolism and
pharmacokinetic properties and clinical pharmacology of such product as and to
the extent defined for the United States in 21 C.F.R. § 312.21(a), or its
successor regulation, or the equivalent regulation in any
other country, including the Phase 1 part of any clinical trial that
is a combination Phase 1 Trial and Phase 2 Trial.
1.85 “Phase 2 Trial” means a
clinical trial of a pharmaceutical product on patients designed to
determine the safe and effective dose range in the proposed therapeutic
indication as and to the extent defined for the United States in 21 C.F.R. §
312.21(b), or its successor regulation, or the equivalent regulation in any
other country.
1.86 “Phase 3 Trial” means a
clinical trial of a pharmaceutical product on patients designed to (a) establish
that a drug is safe and efficacious for its intended use; (b) define warnings,
precautions and adverse reactions that are associated with the drug in the
dosage range to be prescribed; and (c) support a Marketing Approval of such
drug, as and to the extent defined for the United States in 21 C.F.R. §
312.21(c), or its successor regulation, or the equivalent
regulation in any other country.
1.87 “Pivotal Trial” means (a) a
Phase 3 Trial, or (b) a Phase 2 Trial, or a combination Phase 2 Trial and Phase
3 Trial for which the relevant Regulatory Authority has determined that the data
generated in such trial could be sufficient, depending on its outcome, to
support a Marketing Approval for such pharmaceutical product.
1.88 “Product” means any product or
product candidate comprising a BiTE Antibody binding to the Collaboration Target
that is generated and/or developed pursuant to this Agreement.
***
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has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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1.89 “Program Transfer” has the meaning as
defined in Section 13.1.
1.90 “Receiving Party” has the meaning as
defined in Section 10.1.
1.91 “Recovery” has the meaning as
defined in Section 6.4.2(d).
1.92 “Regulatory Authority” means,
in a particular country or jurisdiction, any Governmental Authority involved in
granting approval to market or sell a Product, including any pricing and
reimbursement approvals, in such country or jurisdiction, including the FDA, the
EMA, and any Governmental Authority equivalent to and performing some or all of
the functions the FDA or EMA in the applicable jurisdiction.
1.93 “Regulatory Exclusivity” means
any exclusive marketing rights or data exclusivity rights conferred by any
Regulatory Authority with respect to the Product other than a Patent right in
the Territory.
1.94 “Regulatory Filing” means any
submission or application made with a Regulatory Authority, including any IND or
BLA, that has been accepted for filing pursuant to the procedures of such
authority.
1.95 “Research Plan” means the plan
for the generation and identification of Development Candidate(s) as further
defined in Section 3.1.1, as may be amended in accordance with Section 3.1.2.
The initial Research Plan is part of the Initial R&D Plan (as defined in
Section 1.52).
1.96 “ROW Territory” means all
countries in the Territory other than the U.S.
1.97 “Sales Participation Payment”
has the meaning as defined in Section 8.4.3, as may
be [***] in accordance with Section 8.4.4, 8.4.5 or Exhibit
G.
1.98 “Sales Participation Term”
meaning as defined in Section 8.4.3.
1.99 “Service Provider” has the meaning as
defined in Section 3.6.
1.100 “Term” has the meaning as
defined in Section 12.1.
1.101 “Territory” means all countries
of the world.
1.102 “Third Party” means any entity
other than Micromet, BI or their respective Affiliates.
1.103 “Third Party Claim” has the meaning as
defined in Section 14.1.
***
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Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
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1.104 “ [***] ” means any of the
pre-existing agreements of [***] as of the Effective Date
listed in Exhibit
E.
1.105 “U.S.” means the fifty (50)
states of the United States of America, any new states added after the Effective
Date, and the District of Columbia.
1.106 “ [***] Date” means
the then-current date of expected [***] for a Product in
the [***] in the [***] as determined
in accordance with then-current [***] .
1.107 “U.S. Commercialization Plan”
means a comprehensive plan for the strategy for the commercial launch of the
Product in the U.S. that describes the pre-launch, launch and subsequent
Commercialization activities for the Product (including, if available,
advertising, education, planning, marketing, sales force training and
allocation, distribution, pricing, and reimbursement), with the
Parties [***] in the [***] of
the [***] in the U.S.
1.108 “Valid Claim” means (a)
an [***] of an [***] that has not
(i) expired or been canceled, (ii) been declared invalid by a decision of a
court or other appropriate body of competent jurisdiction, from which no appeal
is or can be taken, (iii) been admitted to be invalid or unenforceable through
reissue, disclaimer or otherwise, or (iv) been abandoned or disclaimed; and (b)
a claim included in a [***] that
is [***] and that has not been (i) canceled, (ii)
withdrawn from consideration, (iii) finally determined to be unallowable by the
applicable Governmental Authority (from which no appeal is or can be taken), or
(iv) abandoned or disclaimed; provided, however, that if a
claim of a patent application has been pending for more
than [***] ( [***] ) [***] from the
filing date of such patent application in the applicable country within the
Territory, such claim will not constitute a Valid Claim for the purposes of this
Agreement unless and until a Patent issues with such claim.
2.
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Collaboration
Governance
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2.1 Joint
Steering Committee.
2.1.1 Establishment of Joint Steering
Committee. The Parties will establish a joint steering
committee (the “JSC”)
within thirty (30) days of the Effective Date, to oversee the research,
development and Commercialization of the Product(s) and the activities to be
performed by the JPTs under this Agreement. The JSC will be in place
until (i) the expiration of the [***] , or (ii)
the [***] of the [***] in the
first [***] , whichever is longer. The Parties anticipate
that the JSC will manage the collaboration in a cooperative and transparent
manner, in accordance with the principles and procedures described in this
Agreement. Each Party will appoint three (3) employees with senior
level and decision making authority and expertise to serve as their
representatives on the JSC. From time to time, on written notice to
the other Party, Micromet and BI each may substitute any of its representatives
on the JSC. Each Party will designate one of its members of the JSC
as the “Co-Chair.” Subject
to the provisions of this Section 2, the JSC will establish its own procedural
rules for its operation.
***
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has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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2.1.2 Tasks of the
JSC. The JSC will have the power only to:
(a) review,
amend and govern the overall strategies for research, development, regulatory
activities, and Commercialization for the Product(s);
(b) nominate
Lead Candidates as proposed by the JRPT;
(c) amend
the Development Candidate Criteria (including the various data sets upon which
such criteria will be based), and recommend the actual selection of a
Development Candidate;
(d) oversee
the conduct of the development, manufacture and Commercialization of the
Products under this Agreement;
(e) monitor
the activities and performance of the JPTs;
(f) review
and approve in writing any updates or amendments to the Research Plan,
Development Plan, and U.S. Commercialization Plan, including the budget
for [***] Collaboration Expenses;
(g) monitor
the progress of and coordinate the activities undertaken pursuant to the
Research Plan, Development Plan, and US. Commercialization Plan;
(h) oversee
the progress of the key Commercialization activities as outlined in BI’s ROW
Commercialization Plan; and
(i) take
such other actions as are expressly delegated to the JSC in this
Agreement. The JSC will not have any power to amend this Agreement
and will have only such powers as are specifically delegated to it under this
Agreement.
2.1.3 JSC Meetings. The
JSC will meet twice every calendar year, unless otherwise agreed by the
Parties. Meetings may be held in person or by means of
telecommunication (telephone, video, or web conferences); provided, however, that at least one
meeting per year will be held in person. The JSC may meet more
frequently by agreement of the Co-Chairs. The Co-Chair of a Party,
alternating with the Co-Chair of the other Party, will be responsible for
organizing the meetings of the JSC and for distributing the agenda of the
meetings. The organizing Co-Chair will include on the agenda any item
within the scope of the responsibility of the JSC that is requested to be
included by any member of the JSC, and will distribute the agenda to the JSC no
less than two (2) weeks before the meeting. Any materials or presentations to be
used in a JSC meeting will be distributed reasonably in advance of the
meeting. Each Party may, in its discretion, invite non-voting
employees, consultants or advisors (which consultants and advisors will be under
an obligation of confidentiality no less stringent than the terms set forth in
Section 10) to attend any meeting of the JSC.
***
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has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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2.1.4 Meeting
Minutes. The Co-Chair who organized the JSC meeting (or his or
her designee) will aim to prepare the meeting minutes within fifteen (15)
Business Days after each meeting, and will send it to all members of the JSC for
review and approval. Minutes will be deemed approved unless any
member of the JSC objects to the accuracy of such minutes by providing written
notice to the other members of the JSC within fifteen (15) Business Days of
receipt of the minutes. In the event of any such objection that is
not resolved by mutual agreement of the Co-Chairs, such minutes will be amended
to reflect such unresolved objection.
2.1.5 Decision
Making.
(a) The
JSC will take action on matters within its power by unanimous consent of the
members of the JSC, with each Party having a single vote, irrespective of the
number of JSC members in attendance at a meeting, or by a written resolution
signed by the Co-Chairs.
(b) If
the JSC is unable to reach unanimous consent on a particular matter relating to
either (i) the desired response to a [***] , as described in Section
8.2.4 or (ii) any [***] to be performed
by [***] that would be adversely affected by
the [***] caused by
the [***] described in Section 2.1.5(c) below, in each
case within [***] ( [***]
) [***] after the matter has been submitted to the JSC for
resolution, then the Co-Chair representing [***] will have
the authority to [***] a [***] on
the matter in lieu of [***] of the [***]
.
(c) If
the JSC is unable to reach unanimous consent on a particular matter, then the
matter will be escalated, by written notice, to the respective Executive
Officers of each Party. The Executive Officers of each Party (or their
respective designees) will meet at least once in person to discuss such matter,
if not otherwise agreed on, and use their good faith efforts to resolve the
unresolved matter within [***] ( [***]
) [***] after the matter has been escalated by written
notice to the Executive Officers. If the Executive Officers (or their
designees) cannot reach agreement on how to resolve such matter within
the [***] ( [***] ) [***] time
period, then (i) for matters relating to the [***] of
a [***] , to
the [***] of [***] in support of
an [***] for a [***] ,
to [***] to [***] an [***] for
a [***] , to [***] by [***] , or to
the [***] or [***] of
a [***] following [***] , the Executive Officer
of [***] (or the designee) will have the authority
to [***] a [***] [***] on
the matter in lieu of the [***] of the [***] ,
and (ii) for matters relating to [***] performed
by [***] , but not related to [***] , the Executive
Officer of [***] (or the designee) will have the authority
to make a [***] on the matter in lieu of
the [***] of the [***] .
***
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has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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(d) Notwithstanding
the terms of Section 2.1.5(c), the Executive Officer
of [***] will not have the authority to make
a [***] that would
(i) [***] the [***] ,
(ii) [***] the [***] of [***] of [***]
, or [***] or [***] obligations
under the [***] (except for the right to request
additional research activities in accordance with Section 3.1.2),
or [***] in a manner inconsistent with
the [***] of [***] set forth in
Sections 3.1.3, 3.2.3 or 4, as applicable, or
(iii) [***] any [***] or [***] or
amendment thereto during the [***] ( [***]
) [***] following the [***] that
materially [***] the [***] of
the [***] or [***] from that
described in the [***] attached as [***] . Notwithstanding the
terms of Section 2.1.5(c), the Executive Officer
of [***] will not have the authority
to [***] the [***] of [***] of [***]
, or [***] or [***] obligations
under the [***] or [***] in a manner
inconsistent with
the [***] of [***] set forth in
Sections 3.1.3, 3.2.3 or 4, as applicable.
(e) Notwithstanding
the terms of Sections 2.1.5(b), (c) and (d) above, if the matter concerns a
dispute regarding the interpretation of this Agreement, the performance or
alleged nonperformance of a Party’s obligations under this Agreement, or any
other alleged breach of this Agreement, such matter will be resolved in
accordance with the terms of Section 17.4. The JSC and Project Teams
shall each perform its responsibilities and make decisions (including any
decisions made by an Executive Officer of a Party pursuant to Section
2.1.5) under this Agreement based on the principles of prompt and
diligent development and Commercialization of Product in the Territory
consistent with Commercially Reasonable Efforts.
2.2 Joint
Project Teams.
2.2.1 Establishment of Joint Project
Teams. The Parties will establish a number of joint project
teams (each, a “Joint Project
Team” or “JPT”)
to oversee the research, development and Commercialization of Products
hereunder: the Joint Research Project Team (“JRPT”), Joint Development
Project Team (“JDPT”)
and Joint Commercialization Project Team (“JCPT”). Additional
information regarding each of the JPTs is set forth in Exhibit
B. Each Party will designate two (2) of its members on a
particular JPT as the core members thereof and will designate one of its core
members as the “JPT Leader.” The JPT Leaders will be the primary
points of contact for the other Party for all matters relating to the activities
overseen by the applicable JPT. From time to time, on written notice
to the other Party, Micromet and BI each may substitute any of its
representatives on a JPT. Upon dissolution of the JSC in accordance
with Sections 2.1.1, 4.5.3 (Change of Control) or 13.6 (a) (Material Breach) the
JPTs will automatically be disbanded.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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2.2.2 Formation and Tasks of the
JPTs. The Parties will establish each JPT described in Exhibit B at the time
indicated therein. Each JPT will have only such powers as are
specifically delegated to it by the JSC or the terms of this Agreement,
including Exhibit
B. No JPT will have any power to amend this Agreement or to
make decisions assigned to the JSC.
2.2.3 JPT Meetings. Each
JPT will meet in plenum
or in subgroups as often as required for the expeditious performance of the
Research Plan, Development Plan or U.S. Commercialization
Plan. Meetings may be held in person or by means of telecommunication
(telephone, video, or web conferences) in the frequency according to Exhibit B;
provided, however, that at least two
meetings per year will be held in person. The JPT Leaders will be
responsible for establishing the meeting schedule, and will alternate in
organizing the meetings of the applicable JPT. The JPT Leader organizing a JPT
meeting will be responsible for distributing the agenda of the
meeting. The organizing JPT Leader will include on the agenda any
item within the scope of the responsibility of the applicable JPT that is
requested to be included by any member of such JPT, and will aim to distribute
the agenda to such JPT no less than one (1) week before the meeting. Each Party
may, in its discretion, invite non-voting employees, consultants or advisors
(which consultants and advisors will be under an obligation of confidentiality
no less stringent than the terms set forth in Section 10) to attend any meeting
of a JPT.
2.2.4 Meeting
Minutes. The JPT Leader who organized a JPT meeting (or his or
her designee) will aim to prepare the meeting minutes within fifteen (15)
Business Days after each meeting, and will send it to all members of the
applicable JPT for review and approval. Minutes will be deemed
approved unless any member of such JPT objects to the accuracy of such minutes
by providing written notice to the other members of such JPT within fifteen (15)
Business Days of receipt of the minutes. In the event of any such
objection that is not resolved by mutual agreement of the applicable JPT
Leaders, such minutes will be amended to reflect such unresolved
objection.
2.2.5 Activities; Reports. Each JPT will serve as
the forum for the Parties to update each other regarding ongoing research,
development or Commercialization activities, as applicable. Each
Party will provide the relevant JPT with reports describing the results of such
Party’s activities completed pursuant to each work package in the Research Plan
and Development Plan (except that, with respect
to [***] Activities performed by BI, only summary reports
will be provided). Each JPT shall review the plans, data, results and
reports, in reasonable detail and summary, generated since the previous meeting
and shall discuss future work packages and potential amendments of the
respective plan.
***
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has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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2.2.6 Decision
Making. Each JPT will agree on proposals and recommendations
to the JSC on all matters within the responsibility of such JPT by unanimous
consent, with each Party having a single vote, irrespective of the number of JPT
members in attendance at a meeting, or by a written resolution signed by the
applicable JPT Leaders. All proposals and recommendations of a JPT
will be submitted for approval by the JSC. If a JPT is unable to
reach unanimous consent on a particular matter, such matter will be submitted to
the JSC for resolution in accordance with Section 2.1.5.
2.3 Contract
Managers. Each of the Parties will appoint a single individual
to monitor and facilitate the performance of this Agreement (each a “Contract
Manager”). Each Party may change its designated Contract
Manager from time to time upon written notice to the other Party. The
Contract Managers will serve as the initial point of contact with respect to any
contractual matters between the Parties relating to this Agreement, including
any disputes.
3.
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Product
Research and Development
|
3.1 Research
Plan.
3.1.1 Scope. The Research
Plan will be designed to produce BiTE Antibodies that fulfill the required
Development Candidate Criteria for selection of at least one (1) such BiTE
Antibody as a Development Candidate. The Research Plan will include
(i) a budget of [***] Collaboration Expenses to be
incurred pursuant to the Research Plan specified in the activity list on a
quarterly and overall basis, (ii) a summary of work packages listing the
activities of each Party, and (iii) a project overview relating to timelines as
a Gantt-chart. The Research Plan will set specific objectives and
timelines for carrying out the activities described therein. The Parties agree
that the BiTE Antibodies to be developed under this Agreement may be based on
Micromet’s
new [***] and [***] Version [***]
, as well as
BI’s [***] or [***] under this
Agreement.
3.1.2 Initial Research
Plan. The initial Research Plan for the initial Product
covering the period from the Effective Date through
the [***] of the [***] is part of
the Initial R&D Plan. The Initial R&D Plan, and any
amendments thereto, will be divided into pre-defined work
packages. The Initial R&D Plan as agreed by the Parties is based
on the [***] for development of a Product with
a [***] including [***] of such
Product with a [***] in an [***]
. Prior to the Effective Date both Parties
have [***] other [***] for [***] including
a [***] to [***] and/or a
Product [***] a [***] . In the
Initial R&D Plan certain decision points are included at which the
respective JPT shall decide on the above
mentioned [***] and may eventually propose amendments of
the then-current Research Plan or Development Plan to the JSC for
approval. During the performance of the Research Plan, the JRPT will
periodically review and propose amendments to the Research Plan, for approval by
the JSC, to reflect the progress achieved and the further development activities
to be undertaken by the Parties in the research of potential Product candidates,
but not less than once every year in conjunction with the required resources and
program review cycle. In addition, BI may request that Micromet
perform additional research activities that BI believes
are [***] in support of [***] for
the Product, and Micromet will use reasonable efforts to perform such activities
under the Research Plan subject to the availability of resources to perform such
activities and the terms of Section 3.3. The Parties agree that, as
of the Effective Date, the Initial R&D Plan includes
the [***] that the Parties anticipate will be necessary
for the [***] of a [***]
. Nevertheless, each Party acknowledges and agrees that the research
program described in the Initial R&D Plan is subject to various technical
and scientific risks, and that neither Party guarantees that
any [***] will result from the performance of such
program.
***
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has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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3.1.3 Allocation of Responsibilities;
Performance. Under the Research Plan, Micromet will be
primarily responsible for conducting the generation and optimization of BiTE
Antibodies binding to the Collaboration Target, as well as
certain [***] activities and manufacture of
certain [***] . Each Party will perform the work packages
set forth in the Research Plan. In each JRPT meeting the data and
results generated since the previous meeting will be reviewed and
discussed. Based on the data and results, the JRPT will mutually
agree whether the planned work packages of the Research Plan require amendment,
to be proposed to the JSC. If the JSC decides to cancel certain work
packages set forth in the Research Plan to be conducted by Micromet less
than [***] ( [***] ) [***] before
the planned start of the respective work packages, then to the extent Micromet
is not able to [***] the applicable [***]
, [***] Collaboration Expenses will be deemed to include
the [***] associated
with [***] (excluding however
any [***] at Micromet only providing support
for [***] ) for a period of up to [***] ( [***]
) [***] following such cancellation.
3.1.4 Lead Candidate
Nomination. Prior to or following completion of the relevant
activities described in the Research Plan and the JRPT’s good faith
determination that it has identified one or more suitable potential Lead
Candidates, then the JRPT will promptly propose to the JSC BiTE Antibodies
generated within the scope of the Research Plan for the JSC’s review and
nomination of one or more Lead Candidates. Within thirty (30) days
after submission by the JRPT of the potential Lead Candidates, the JSC will
formally decide on the nomination of one or more of such BiTE Antibodies as Lead
Candidate(s) and will propose these Lead Candidates to [***] . If the
JSC does not approve any of the proposed Lead Candidates as Lead Candidates
or [***] within thirty (30) days, the JSC
or [***] will, within thirty (30) days, specify additional
research activities for the generation or selection of more desirable BiTE
Antibodies and the Parties will amend the Research Plan to reflect any such
activities. Thereafter, the Parties will use Commercially Reasonable
Efforts to conduct such activities, subject to the terms of Section 3.3.3 below.
Following such nomination, the Parties will perform the applicable activities
set forth in the Research Plan with respect to such Lead
Candidate(s).
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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3.1.5 Development Candidate
Selection. Prior to or following completion of the relevant
activities in the Research Plan and the JRPT’s determination that it has
identified one or more suitable potential Development Candidates, the JRPT will
promptly propose to the JSC one or more Lead Candidates for the JSC’s review and
selection of at least one Development Candidate. Within thirty (30) days after
submission by the JRPT of the potential Development Candidate(s), the JSC
(subject to [***] [***] under
Section [***] ) will formally recommend one or more of such potential
Development Candidate(s) to [***] for start of
pre-clinical development and further development as a
Product. [***] shall decide upon the selection of the
proposed Development Candidate in accordance with [***] , however no
later than sixty (60) days after the JSC recommendation. If the JSC
does not recommend a Development Candidate to [***] for
start of pre-clinical development or if [***] does not
approve such start of pre-clinical development within the applicable timeframes
described above, then the JSC or [***] , as applicable, will
undertake one of the other decisions described in this Section
3.1.5. If at least one of the proposed Development
Candidates [***] , then the JSC will be obligated to recommend,
and [***] will be obligated to approve, a BiTE Antibody as
the Development Candidate, such BiTE Antibody not necessarily to be the above
mentioned Development Candidate [***] . If none of the
proposed Development Candidates [***] , then the JSC will, within
thirty (30) days after the submission of such proposed Development Candidate(s)
to the JSC, either (a) formally recommend one of such proposed Development
Candidates as a Development Candidate anyway to [***] for
start of pre-clinical development, or (b) not approve any of the proposed
Development Candidates as the Development Candidate, in which case the JSC
shall, within thirty (30) days after its meeting, specify additional research
and development activities for the generation or selection of more desirable
BiTE Antibodies and the Parties will amend the Research Plan to reflect any such
activities (thereafter, the Parties will use Commercially Reasonable Efforts to
conduct such activities, subject to the terms of Section 3.3.3
below). If [***] does not approve any of the
Development Candidates recommended by the JSC as the Development Candidate, then
either (i) [***] will, within thirty (30) days
after [***] , specify additional research and development activities
for the generation or selection of more desirable BiTE Antibodies and the
Parties will amend the Research Plan to reflect any such activities (thereafter,
the Parties will use Commercially Reasonable Efforts to conduct such activities,
subject to the terms of Section 3.3.3 below), or (ii) if no such activities are
specified by [***] within thirty (30) days after the
respective decision, then [***] will have the right to
terminate this Agreement pursuant to Section 12.4.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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3.2 Development
Plan.
3.2.1 Scope. The
Development Plan will be designed to accomplish the filing of the first IND for
a Product, and the filing of BLAs and the receipt of Marketing Approval for a
Product in the Major Markets. The Development Plan will include (i) a
budget of [***] Collaboration Expenses to be incurred
pursuant to the Development Plan specified in the activity list on a quarterly
and overall basis (for so long as Micromet is conducting work packages under
such Development Plan), (ii) a summary of work packages listing the activities
of each Party, and (iii) a project overview specifying the planned timelines as
a Gantt-chart. The Development Plan will set specific objectives and timelines
for carrying out development activities sufficient in scope and quality to
progress the development of a Product towards Marketing Approval within
timelines and using standards customary in the biopharmaceutical industry for
Products at a similar stage of development and with similar market
potential.
3.2.2 Initial Development
Plan. The initial Development Plan for the initial Product
covering the period from [***] of
the [***] through the first [***] of
an [***] is part of the Initial R&D
Plan. The Initial R&D Plan, and any amendments thereto, will be
divided into work packages. The JDPT will periodically review and
propose amendments to the Development Plan, for approval by the JSC, to reflect
the progress achieved and the further development activities to be undertaken by
the Parties in the development of a Product, but not less than once every
year. Notwithstanding the foregoing, the Parties agree that, as of
the Effective Date, the Initial R&D Plan includes
the [***] that the
Parties [***] will be necessary for
the [***] and [***] of
the [***] for an [***] for
a [***] . Nevertheless, each Party acknowledges and agrees that the
development program described in the Initial R&D Plan and following
amendments thereto is subject to various technical and scientific risks, and
that neither Party guarantees that any [***] of
an [***] for a [***] , any filing
of [***] or
the [***] of [***] for
a [***] will result from the performance of such
program.
3.2.3 Allocation of
Responsibilities. Each Development Plan will reflect the
following allocation of responsibilities:
(a) [***] ; [***] .
Micromet will be primarily responsible for conducting [***]
testing in [***] for Products. Micromet will be
responsible for the development of [***] for use with each
Product and the performance
of [***] during [***] testing. Upon
transfer of these [***] to BI, BI will be responsible for
conducting [***] during [***] in [***] and [***]
.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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(b)
[***] and [***] .
(i) BI
or its designee will be responsible
for [***] and [***] ,
further [***] and the [***] of
any [***] used in
the [***] for [***] or [***] use,
and the [***] and [***] of
the [***] for [***] , [***] ,
and [***] throughout the world. In addition, BI
may conduct certain [***] as deemed necessary by
BI.
(ii) BI
will be responsible for contracting with any Third Party Service Provider, if
used, for the [***] of [***] for use
under this Agreement (including
any [***] activities). If BI proposes to use
any such Service Provider, BI will inform Micromet through the JDPT and JSC
regarding the selection and qualification of the [***] .
(iii) If
BI will [***] and [***] to Micromet
for the performance of [***] , if any, the Parties
will [***] a [***] describing
the [***] of each Party relating
to [***] and [***] of
the [***] , which agreement hereby is incorporated in and made part
of this Agreement by reference.
(c) [***] . After
completion of the activities set forth in the Development Plan that are
reasonably required for the initiation of [***] of
the [***] , [***] will use Commercially
Reasonable Efforts to initiate such studies according to the Development
Plan.
(d) Clinical
Development. [***] will draft, in collaboration
with [***] , the clinical protocols for trials using the Product, for
review by the JDPT and approval by the JSC. The Parties will
collaborate with respect to any [***] and
associated [***] . BI will be responsible for the
Regulatory Filing of INDs for Products and the performance of all clinical
trials of Products. BI will provide the JDPT with summaries of
clinical trial data, updates regarding the monitoring of the trials, and reports
regarding the review and assessment of safety and efficacy
data. Micromet may, at their cost and discretion, attend the meetings
with the data review committee and the drug safety monitoring board for the
various clinical trials.
(e) IND Filing. After
completion of the activities set forth in the [***] , the JDPT will
propose the Regulatory Filing of INDs for Products to the JSC for review and
confirmation (subject, in any case, to each Party’s internal processes regarding
the approval of such Regulatory Filings). The JSC (subject
to [***] right under Section [***] ) will
recommend to [***] an IND for a Product to be filed in a
Major Market. [***] shall decide upon the IND filing
in accordance with [***] , however no later than sixty (60) days
after the JSC confirmation. If the JSC does not recommend such a
Regulatory Filing for an IND to [***] , then within thirty (30) days
of such determination, the JSC shall specify additional pre-clinical activities
for the generation of such regulatory package, in which case the Parties will
amend the Development Plan to reflect any such activities.
If [***] does not approve the Regulatory Filing
recommended by the JSC, then either (i) [***] will, within
sixty (60) days, specify additional pre-clinical activities for the generation
of such regulatory package, in which case the Parties will amend the Development
Plan to reflect any such activities, or (ii) [***] will
have the right to terminate this Agreement pursuant to Section
12.4.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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3.3 Research
and Development Expenses.
3.3.1 Prior to [***]
.
[***] will [***] and [***] incurred
in the performance of the work packages outlined in the then-current Research
Plan and then-current Development Plan up to and including
the [***] of the [***] for
a [***] , subject to Section 3.3.3 below.
3.3.2 Following [***]
. After the [***] of
the [***] for a [***]
, [***] will bear all costs incurred
by [***] in the performance of work packages under the
Development Plan. The [***] for
any [***] incurred by [***] pursuant
to the Development Plan is described in Section 8.2.
3.3.3 Reimbursement of [***]
. Notwithstanding anything to the contrary in this Agreement, if the
total [***] incurred by Micromet
hereunder [***] equivalent to
the [***] of
(i) [***] for [***] and
(ii) [***] of [***] (€ [***] ) (such
amount, the “ [***] ”),
then the amount of [***] will
be [***] in accordance with the terms of Section
8.2.
3.4 Diligence.
3.4.1 By
Micromet. Micromet will use Commercially Reasonable Efforts to
generate BiTE Antibodies binding to the Collaboration Target and to perform the
activities assigned to it in the Research Plan and Development
Plan. All efforts of Micromet’s Affiliates and Micromet’s Service
Providers will be considered efforts of Micromet for the purpose of determining
Micromet’s compliance with its obligations under this Section
3.4.1.
3.4.2 By BI. BI will use
Commercially Reasonable Efforts to develop at least one (1) Development
Candidate selected pursuant to this Agreement (including, without limitation, by
funding the development program for such Development Candidate) as a Product, to
perform the activities assigned to it in the Research Plan and Development Plan,
and to obtain Marketing Approval for at least one (1) Product in at least one
indication in each Major Market. All efforts of BI’s Affiliates and
sublicensees, and their respective Service Providers, will be considered efforts
of BI for the purpose of determining BI’s compliance with its obligations under
this Section 3.4.2.
3.5 Reports. The JPTs
will provide regular reports to the JSC detailing the Parties’ research and
development activities under the Research Plan or Development Plan, as
applicable, and the results of such activities.
***
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has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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3.6 Use of Service
Providers. Each Party may perform any of its obligations under
the Research Plan or Development Plan through Third Party service providers such
as contract research organizations, consultants or other independent contractors
(each a “Service
Provider”). The Party engaging a Service Provider will be
responsible for conducting such qualification audits as may be required under
GxP regulations prior to the engagement of such Service
Provider. Each Party will inform the other Party of the identity of,
and the nature of services provided by the Service Providers used by such
Party. The Party using a Service Provider will remain responsible to
the other Party for the work performed by the Service Provider. Each
Party will ensure that such Service Providers are bound in writing by
obligations of confidentiality and non-use regarding Confidential Information
that are substantially the same as or more stringent than those undertaken by
the Parties pursuant to Section 10 hereof, the provisions on intellectual
property ownership hereunder and that the agreement with such Service Providers
contains customary terms providing for the assignment to such Party of all
intellectual property developed in the course of performing the services for
such Party.
4.
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Commercialization
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4.1 Commercialization in the
Territory. Subject to Micromet’s U.S. co-promotion rights
described below, BI will be responsible at its costs for all aspects of the
Commercialization of Products in the Field in the Territory, including (a)
marketing and promotion; (b) booking sales and distribution and performance of
related services; (c) handling all aspects of order processing, invoicing and
collection, inventory and receivables; (d) providing customer support, including
handling medical queries, and performing other related functions; and (e)
ensuring that its practices and procedures comply with Applicable Laws relating
to the Commercialization of the Product in the Field and the
Territory.
4.1.1 Co-Promotion in
U.S. BI and Micromet will have the rights and responsibilities
for co-promoting the Products in the U.S. in the Field in accordance with this
Agreement and the U.S. Commercialization Plan, as provided in this Section 4;
provided, however,
that, during the Co-Promotion Term, the terms of the Co-Promotion Agreement will
apply to the Parties’ co-promotion of the Product in the
U.S. [***] will be responsible for supporting the
sales functions of [***] (including, without limitation,
by providing Product samples, if any, promotional materials, sales force
training, and the like). [***] will
bear [***] costs related to the Commercialization of
Products in the U.S., except that [***] will
bear [***] incurred in connection with its activities
according to the U.S. Commercialization Plan, including
its [***] of [***] in the U.S. under
the Co-Promotion Agreement.
4.1.2 Ex-U.S.
Commercialization. BI will be solely responsible for and bear
all costs and expenses associated with the Commercialization of Products outside
the U.S.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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4.2 Commercialization
Plans.
4.2.1 For the U.S. BI
will provide Micromet with an initial overview of estimated Commercialization
activities in the U.S., containing such information as reasonably necessary for
Micromet to evaluate whether to opt out of its co-promotion right pursuant to
Section 4.5.2 (including, by way of example, information regarding the target
markets, anticipated detailing efforts and allocations, etc.), at
least [***] ( [***] ) [***] prior to
the then-current date of expected Marketing Approval for a Product in the
U.S. After Micromet has indicated to BI that it does not want to
opt-out of the co-promotion in U.S. according to Section 4.5.2, the Parties will
enter into good faith negotiations on the Co-Promotion Agreement drafted by BI
according to Section 4.5.1. After execution of the Co-Promotion
Agreement BI will provide a more detailed U.S. Commercialization Plan, which
will be further discussed by the JCPT and approved by the JSC sufficiently prior
to the U.S. Approval Date. Such detailed U.S. Commercialization Plan
will contain such information as the JSC believes necessary for the successful
commercial launch of such Product in the U.S. in the Field in each of the
applicable indications and will generally conform to the level of detail
utilized by the Parties in preparation of their own product commercialization
plans. The U.S. Commercialization Plan will be deemed Confidential
Information of both Parties, and each Party will use such U.S. Commercialization
Plan only to the extent necessary to carry out its Commercialization activities
for the Product. From time to time as reasonably necessary, the JSC
will update the U.S. Commercialization Plan (it being understood that BI will be
primarily responsible for generating such draft updates for review and approval
by the JSC).
4.2.2 For the ROW Territory. With
respect to the countries in the ROW Territory where BI, directly or indirectly,
Commercializes the Product, BI will provide to the JSC for review, but not
approval, a summary plan that describes the launch and subsequent
Commercialization activities for the Product (the “ROW Commercialization Plan”),
and any significant amendments or updates thereto.
4.2.3 Manufacturing. [***] or
its designee will be responsible for the manufacturing of any Product for
commercial use, and the manufacturing and fill & finish of the Product for
commercial supply throughout the
world. If [***] is co [***] .
and [***] are used, then (a) the Parties will cooperate
through the JCPT to manage the supply of [***] and related
distribution issues with respect to the U.S., and (b) the Parties
will [***] describing the [***] of
each Party relating
to [***] and [***] of
the [***] , which agreement hereby is incorporated in and made part
of this Agreement by reference.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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4.3 Diligence in
Commercialization. BI will use Commercially Reasonable Efforts
to Commercialize at least one (1) Product in each Major Market and in the
following countries: [***] and [***] (it
being understood that, during the Co-Promotion Term, promotion in the U.S. will
be conducted jointly with Micromet, as described in Section
4.1.1). All efforts of BI’s Affiliates and sublicensees, and their
respective Service Providers, will be considered efforts of BI for the purpose
of determining BI’s compliance with its obligations under this Section
4.3.
4.4 Branding,
Trademarks, Trade Dress, and Logos.
4.4.1 Product Marks. BI
will solely own, and will be solely responsible for selecting, the trademark
used to identify any Product that will be Commercialized in the Territory
pursuant to this Agreement. BI will oversee the filing, prosecution
and maintenance of all trademark registrations for a Product in the Territory,
and BI will be responsible for the payment of any and all costs relating to such
filing, prosecution, and maintenance. Except as described in Section
4.4.2, BI will have sole responsibility for, and will be the sole owner of, all
trade dress, logos, slogans, and designs used on and in connection with any
Product that will be Commercialized in the Territory pursuant to this
Agreement.
4.4.2 Micromet Marks. To
the extent allowable by Applicable Law, (i) Product packaging, promotional
materials and Product labeling for use in the U.S. and (ii) certain promotional
materials for the Product for use in the ROW Territory will carry, in an
appropriate location, the Micromet Marks, subject to BI’s reasonable approval of
the size, position and location thereof. BI acknowledges Micromet's
exclusive ownership of the Micromet Marks and agrees not to take any action
inconsistent with such ownership. BI will not use any Micromet Marks
in a way that would adversely affect its value or use any trademark confusingly
similar to any Micromet Marks in connection with any products (including the
Product). For the avoidance of doubt, the use of the pre-fix “BI” and
of the term “micro”, either alone or as a word fragment, shall not be deemed to
be confusingly similar to any Micromet Marks. BI will comply with reasonable
trademark usage guidelines provided by Micromet from time to time to maintain
the goodwill and value of the Micromet Marks, it being understood that BI will
retain the final say regarding the size and placement of such marks on Product
packaging, promotional materials and labeling.
4.5 Co-Promotion in the
U.S.
4.5.1 Co-Promotion
Agreement. Micromet will have a right to co-promote the
Product in the U.S. jointly with BI pursuant to a co-promotion agreement
describing the co-promotion activities of the Parties for the Product (the
“Co-Promotion
Agreement”) subject to and in accordance with the terms outlined in Exhibit G. The
Parties will negotiate the Co-Promotion Agreement including an initial summary
of the U.S. Commercialization Plan to be executed at
least [***] ( [***] ) [***] prior to
the [***] , with the procedures described in Exhibit K applying to
any failure by the Parties to agree on the terms of such separate agreement
within [***] ( [***]
) [***] following the start of such
negotiations. The “Co-Promotion Term” will be set
forth in the Co-Promotion Agreement and will commence upon execution of the
Co-Promotion Agreement and will continue as long as the Co-Promotion Agreement
remains effective, but in no event longer than the Sales Participation
Term.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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4.5.2 Opt-Out. At the
latest [***] ( [***] ) [***] prior to the
then-current date of [***] for a Product in the U.S. in
accordance with the then-current Development Plan, Micromet may opt-out of the
co-promotion of Products in the U.S. upon written notice to BI. Upon
the exercise of such opt-out right or Micromet’s termination of the Co-Promotion
Agreement as described on Exhibit G, (i) the
Parties will have no obligation to enter into a Co-Promotion Agreement, (ii) the
applicable Sales Participation Payment [***] set forth in
Section [***] , (iii) BI will be solely responsible for and bear all
costs and expenses associated with the Commercialization of Products throughout
the Territory during the Term in accordance with a single Commercialization Plan
as communicated to the JSC, and (iv) the JCPT, if formed, will be
disbanded. For clarity, Micromet will not have the right to opt back
in to co-promotion following the exercise of the opt-out right.
4.5.3 [***] Option upon
a [***] . In the event
that [***] undergoes a [***]
, [***] may elect to [***] right
to [***] Products [***] n
the [***] upon written notice to [***]
. [***] right under this Section 4.5.3 will
terminate [***] ( [***]
) [***] after [***] receives written
notice by [***] of the [***] of
such [***] . Following the exercise of such right and on
the effective date of such [***] , (i) the Parties will
either [***] [***] , if one has
been [***] , or will otherwise have [***] to
enter into a [***] , (ii) the [***] set forth
in Section [***] [***] ,
(iii) [***] will be solely responsible for and bear all
costs and expenses associated with
the [***] of [***] during the Term
in accordance with a single [***] approved by
the [***] , and (iv) the [***] will
be [***] . The [***] will include a
similar provision allowing [***] to exercise
its [***] of the [***] following
a [***] of [***] within
the [***] ( [***] ) [***] -period described
above with the effective date of such [***] not later
than [***] ( [***]
) [***] following [***] election and
as indicated in the [***] notice.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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5.
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Regulatory
Matters
|
5.1 Regulatory
Filings. Unless the JSC determines otherwise, BI will be
responsible at its expense for the preparation, filing, prosecution and
maintenance of any Regulatory Filings for clinical trials of Products and will
be the sponsor of such trials. BI will cooperate and collaborate with
Micromet through the JDPT and the JSC in conducting its activities under this
Section 5, including, where practicable, and upon request by Micromet, by
providing advance drafts of proposed Regulatory Filings to the JDPT members with
sufficient lead time for review and discussion in the JDPT (but excluding any
such filings, or portions thereof, relating to Chemistry, Manufacturing and
Controls (CMC)); provided, that BI may submit
any Regulatory Filing without awaiting Micromet’s review
comments. Micromet will assist BI, as may be reasonably necessary, in
the preparation of Regulatory Filings, including providing necessary documents
or other materials required by Applicable Law. BI, as the sponsor of
the clinical trials of the Product performed pursuant to this Agreement, will be
responsible for and control, as required by Applicable Law, the performance of
such clinical trial, including but not limited to any decisions relating to the
safety of any subjects participating in such clinical trial.
5.2 Communications and Meetings with
Regulatory Authorities. BI will be solely responsible for any
communications with the Regulatory Authorities occurring or required in
connection with obtaining or maintaining any Regulatory Filings or Marketing
Approvals for a Product. Until the First Commercial Sale in a
particular Major Market, BI will promptly provide Micromet with copies of key
written or electronic correspondence received from Regulatory Authorities in
such Major Market relating to a Product, and will provide Micromet with a
reasonable opportunity to provide comments on any responses to such Regulatory
Authorities. In addition, BI will promptly notify Micromet in writing
and in advance of any meeting with any Regulatory Authority in the U.S. or the
EU relating to a Product, and Micromet may, at its own expense, or BI may
request, at BI’s expense, to have two employees or consultants (including one
representative from Micromet’s clinical team and one from its regulatory team)
participate in such meeting as an observer. Upon request by Micromet
and where practicable, BI shall provide advance drafts of any presentations or
other materials to be used by BI in a meeting with Regulatory Authorities in the
Major Markets regarding Products to the JDPT members with sufficient lead time
for review and discussion in the JDPT; provided, that BI may use any
presentations or other materials without awaiting Micromet’s
review.
5.3 Clinical Safety and Pharmacovigilance
Matters. BI will be responsible for handling, recording and
reporting of adverse events arising in the development of the Product, and will
follow its established standard operating procedures for implementing the
requirements under Applicable Law. BI will establish and maintain the
clinical safety database for Products, and will provide Micromet, upon request,
with regular reports listing adverse events in such database related to the
Product pursuant to a separate “Pharmacovigilance Agreement” to be agreed by the
Parties describing the details, contact persons and processes for such
reports. Based on Micromet’s experiences in the development of other
BiTE Antibodies, Micromet will keep BI regularly informed via the JDPT on any
safety events known to Micromet that may reasonably be expected with the
Products, taking into account the T cell engaging mode of action, the biology of
the Collaboration Target, the specific disease and other relevant
factors.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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5.4 Audits
and Inspections.
5.4.1 Each
Party will perform such internal audits and external audits of its Service
Providers as required by Applicable Laws. BI will have the right, at
its own cost, to conduct such audits of Micromet’s facilities, records, and
Service Providers as is required under Applicable Laws
or [***] (which shall be reasonable and consistent with
industry practices and with respect to which [***] will
duly inform [***] prior to any such audit
during [***] research and development of Products
hereunder), taking into account the then-current development stage of the
Product, to assure BI’s compliance with GxP regulations in the development of a
Product; provided,
however, that such audits of Micromet or its Service Providers will be
conducted not less than [***] ( [***]
) [***] advance notice during regular business hours, and
may not be conducted more than once in
any [***] period. Micromet and or its Service
Providers will correct the findings of any such audit in accordance with
standard industry practice. The Parties agree and acknowledge that as
of the Effective Date [***] is
not [***] to perform any activities that
would [***] the [***] described
above.
5.4.2 Each
Party will inform the other Party without delay of any inspections its
facilities or records relating to the development or manufacture of a Product
that are planned to be performed by any Regulatory Authorities. The
Party to be inspected will take all reasonable measures in accordance with
standard industry practice to prepare for such inspections.
5.5 Recalls and Voluntary
Withdrawals. If either Party becomes aware of information
relating to any Product that indicates that a unit or batch of Product may not
conform to the specifications thereof, or that potential adulteration,
misbranding, and/or other issues have arisen that relate to the safety or
efficacy of such released Products, it will promptly notify the other Party
thereof in writing. BI will have the
right, [***] to control any Product recall, field
correction, or withdrawal of any Product in the Territory; provided, however, that BI
will promptly notify Micromet of any recall
action [***] being considered, and where practicable,
reasonable consider and incorporate the views of Micromet prior to taking any
such recall action.
5.6 Records. All
activities performed by or on behalf of a Party under the Research Plan or
Development Plan will be completely and accurately recorded, in sufficient
detail and in good scientific manner. Each Party will maintain, or
cause to be maintained, for at least [***] ( [***] ) years
after the termination of this Agreement, or for such longer period as may be
required by Applicable Law, complete and accurate records of its respective
development activities with respect to a Product, including the drug master
file, Product recalls, and other records made in connection with or filed with
any Regulatory Authority. As part of keeping the records, each Party shall
ensure that all of its personnel and all of its agents that are involved in the
research and/or development will keep accurate laboratory notebooks, which
laboratory notebooks: (i) shall be duly signed, dated and witnessed; and (ii)
shall be created and maintained in accordance with its standard operating
procedures that would be sufficient to allow for said laboratory notebooks to be
used in any proceedings before the United States Patent and Trademark Office or
U.S. courts, in order to establish the date of invention for any inventions in
accordance with United States patent laws.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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6.
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Intellectual
Property Matters
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6.1 Inventorship. Inventorship
with respect to any invention or discovery that is or may be patentable made
pursuant to activities conducted pursuant to this Agreement will be determined
in accordance with United States rules of inventorship, it being understood that
the Parties may be subject to local laws relating to the compensation of
inventors.
6.2 Ownership.
6.2.1 Default Rules. Micromet will
own all right, title and interest in and to
any [***] Technology, [***] Technology, [***] Technology,
and Micromet’s rights and interest
in [***] Technology. BI will own all right,
title and interest in and to
any [***] Technology, [***] Technology, [***] Technology
and BI’s rights and interest
in [***] Technology. Micromet and BI will
each [***] an [***] in
any [***] Technology, without obligation to account to the
other for the exploitation thereof or to seek consent of the other for the grant
of any licenses under or the enforcement
of [***] Technology except as expressly limited by the
terms of this Agreement. Each Party will take all necessary and
proper acts, and will cause its and its Affiliates’ employees, agents and
Service Providers to take such necessary and proper acts, to effect the
ownership provisions provided in this Section 6.2.
6.2.2 Following [***]
. After [***] of
the [***] for a [***] in
a [***] will, upon [***] written
request, [***] (or its designated Affiliate or
sublicensee) all of [***] rights and interest in any
Patents within the [***] Technology to the
extent [***] the [***] or
the [***] of such [***] (such assigned Patents,
collectively, the “
[***] Technology”). [***] will
reimburse [***] for all reasonable and documented expenses
incurred by [***] in connection with [***]
. The Parties will cooperate regarding the method, timing and
implementation of such [***] .
6.3 Filing,
Prosecution and Maintenance of Patents.
6.3.1 [***] Technology; [***] Technology. Subject
to the terms of this Section 6, Micromet will file, prosecute, defend and
maintain (including the filing of any extension or supplementary protection
certificate) at its costs any Patents claiming inventions or discoveries that
are part of the [***] Technology
and [***] Technology in its discretion and in accordance
with its business practices. Micromet will provide BI with an update
of the filing, prosecution and maintenance status for each of the Patents within
the [***] Technology on
a [***] basis, and will use Commercially Reasonable
Efforts to consult with and cooperate with BI with respect to such filing,
prosecution and maintenance, including providing BI with drafts of proposed
material filings (to the extent of any claims that cover the composition or use
of the Product) to allow BI a reasonable opportunity for review and comment
before such filings are due. Micromet will give reasonable
consideration to any suggestions or recommendations of BI concerning the
preparation, filing, prosecution, defense and maintenance of the Patents within
the [***] Technology, to the extent of any claims that
cover the composition or use of the Product. Micromet will file and
maintain the Patents within the [***] Technology,
at [***] and [***] , in
the [***] specified in [***]
. Micromet will file and maintain the Patents within
the [***] Technology in
such [***] as BI may request in writing,
at [***] and [***] . If Micromet
decides to finally abandon the prosecution of any Patent within
the [***] Technology that [***] to
the [***] or a [***] , then it will inform BI
thereof in writing with sufficient advance notice to reasonably enable BI
to [***] the [***] or [***] of
such Patent(s), [***] . If
BI [***] to [***] the [***] or [***] of
such
Patent(s), [***] will [***] such
Patent(s) [***] .
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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6.3.2 [***] Technology; [***] Technology; [***] Technology. BI
will have the right to file, prosecute, defend and maintain (including the
filing of any extension or supplementary protection certificate) at its costs
any Patents claiming inventions or discoveries that are part of
the [***] Technology, [***] Technology
or, after their [***] to [***] ,
the [***] Technology; provided, that any such
activities with respect to the [***] Technology will be
performed by an [***] reasonably acceptable
to [***] and [***] . BI will
reasonably inform Micromet and consult with Micromet regarding the filing,
prosecution, defense and maintenance of such Patents (including in any case, an
update at least one per calendar quarter) and will give reasonable consideration
to any suggestions or recommendations of Micromet concerning the preparation,
filing, prosecution, defense and maintenance of such Patents to the extent
generally applicable to [***] ; provided, that BI will be
obligated to implement any such comments from Micromet that, in Micromet’s
reasonable determination, are necessary to avoid a detrimental effect on the
prosecution, issuance and validity of Patents that are part
of [***] Technology
or [***] Licensed Technology. If BI decides to finally
abandon the prosecution of Patent within
the [***] Technology
or [***] Technology
that [***] to [***] , then it will inform
Micromet thereof in writing with sufficient advance notice to reasonably enable
Micromet
to [***] the [***] or [***] of
such Patent(s), [***] . If
Micromet [***] to [***] the [***] or [***] of
such
Patent(s), [***] will [***] such
Patent(s) to [***] .
6.3.3 [***] Technology. With
respect to inventions or discoveries within
the [***] Technology, the Parties will discuss and decide
on a case-by-case basis which Party will file, prosecute, defend and maintain
Patents claiming such inventions or discoveries. Subject to such
discussion and decision, Micromet will bear such responsibility with respect to
Patents within [***] Technology primarily related
to [***] , and BI will bear such responsibility with respect to
Patents within [***] Technology primarily related to
a [***] . Any such filing, prosecution and maintenance
(including the filing of any extension or supplementary protection certificate),
will be made in both Parties’ name. The Parties
will [***] the [***] of [***] associated
with the filing, prosecuting and maintaining the Patents within
the [***] Technology in
the [***] set forth on [***] ; with respect
to any other [***]
, [***] will [***] such [***]
. The filing Party will reasonably inform the other Party and consult
with the other Party with respect to such activities (including
the [***] of [***] and
contemplated [***] ) and, to the extent possible, will undertake the
filing, prosecution and defense of any Patents
within [***] Technology in a way that will not be
detrimental to the prosecution, issuance and validity of Patents that are part
of [***] Technology
or [***] [***] Technology, or the
development or Commercialization of a Product.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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6.3.4 [***] Technology.
Subject to the terms of this Section 6, BI will file, prosecute, defend and
maintain (including the filing of any extension or supplementary protection
certificate) at its costs any Patents claiming inventions or discoveries that
are part of the [***] Technology and
that [***] or [***] the [***] or
any [***] in its discretion and in accordance with its
business practices. Notwithstanding the foregoing, with respect to
the [***] described on [***] , BI will: (i)
provide Micromet with a copy of such [***] promptly after
the Effective Date, (ii) reasonably inform and consult with Micromet regarding
the prosecution of such [***] , and (iii) undertake the prosecution
and defense of [***] in a way that will not be detrimental
to the prosecution, issuance and validity of any Patents that are part
of [***] Technology, [***] Technology, [***] Technology, [***] Technology, [***] Technology.
6.3.5 Cooperation. Each
Party will provide the other Party with summaries (or copies as reasonably
requested) of patent applications, office actions (including restriction
requirements) and substantive correspondence with the applicable patent office
for such Patents and made during the preceding Calendar Quarter. Each
Party will cooperate with the other Party, execute all lawful papers and
instruments and make all rightful oaths and declarations as may be necessary in
the preparation, prosecution and maintenance of all patents and other filings
referred to in this Section 6.3.
6.4 Enforcement of
Patents.
6.4.1 Notice. If either
Party learns that a Third Party is infringing or allegedly infringing any Patent
licensed by either Party under this Agreement and such infringement relates to
the development, manufacture, use or sale of a Product it will promptly notify
the other Party thereof including available evidence of
infringement. The Parties will cooperate and use reasonable efforts
to stop such alleged infringement without litigation.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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6.4.2 Enforcement
Actions.
(a) The
Party owning the infringed or allegedly infringed Patent will have the first
right (but not the obligation) to take the appropriate steps to remove the
infringement or alleged infringement thereof by a Third Party, including, by
initiation, prosecution and control at its own expense of any suit, proceeding
or other legal action by counsel of its own choice. BI will
reasonably inform Micromet and consult with Micromet regarding the enforcement
of [***] Technology and will give reasonable consideration
to any suggestions or recommendations of Micromet concerning the enforcement of
such Patents to the extent [***] to [***] ;
provided, that BI will
be obligated to implement any such suggestions or recommendations from Micromet
that, in Micromet’s reasonable determination, are necessary to avoid a
detrimental effect on the prosecution, scope, enforceability or validity of
Patents that are part
of [***] Technology, [***] Technology, [***] Technology, [***] Technology,
or [***] Technology.
(b) If
an action brought by a Party pursuant to this Section 6.4.2 relates to the
manufacture, use or sale of a Product, then the Party that is not the plaintiff
in such action will have the right, at its own expense, to be represented in any
such action by counsel of its own choice. In addition, such Party
agrees to be joined as party plaintiff if necessary to prosecute the action or
proceeding and to give the other Party reasonable assistance and authority to
file and prosecute the suit; provided, however, that neither Party
will be required to transfer any right, title or interest in or to any property
to the other Party or any other party to confer standing on a Party hereunder,
other than expressly provided in this Agreement.
(c) If
the alleged infringement of a Patent is based on the fact that a Third Party is
selling a product that is [***] to the [***] ,
and if a Party fails to bring an action or proceeding to remove the infringement
pursuant to subsections (a) and (b) above within [***] (
[***] ) [***] (or such longer period as reasonably
required by a Party if no material harm is reasonably expected to result from
such additional time period) of a written request for such action by
the other Party, then such other Party will have the right (but not the
obligation) to bring any such action or proceeding by counsel of its own choice;
provided, however, that
the Party owning such Patent will have the right to approve in writing any
settlement of any claim, suit or action involving its Patents
(d) If
the alleged infringement of a Patent is based on the fact that a Third Party is
selling a product that is [***] to the [***] ,
any settlements, damages or other monetary awards (the “Recovery”) recovered by a
Party in an action pursuant to this Section 6.4.2 will be allocated first to the
direct external costs and expenses of the Party bringing suit, and second to the
direct external costs and expenses (if any) of the other Party, with any
remaining amounts (if any) to be allocated as follows:
(i) If
BI pursued such action, the Recovery will be deemed to be Net Sales and BI will
pay Micromet as provided in Section 8.4 (without taking into account any
reduction under Section 8.4.2 or 8.4.5).
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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(ii) If
Micromet pursued such action, the Recovery will be retained by Micromet to the
extent that the Recovery is based on the damages incurred by Micromet, and
deemed Net Sales to the extent based on the damages incurred by BI (without
taking into account any reduction under Section 8.4.2 or 8.4.5), and Micromet
will pay the portion of such Recovery based on the damages incurred by BI to BI
after deducting amounts due to Micromet thereon pursuant to Section 8.4 (without
taking into account any reduction under Section 8.4.2 or 8.4.5).
In all
other cases regarding the enforcement of any Patent under this Section 6.4, any
Recovery will be retained by the Party maintaining the action and if maintained
jointly, in proportion to the costs and expenses incurred by the Parties in
maintaining such action, in each case after deducting each Party’s legal
expenses and costs incurred in such action.
6.5 Consequences
of Patent Challenge.
6.5.1 Each
Party will have the right to terminate this Agreement by written notice
effective upon receipt if the other Party or any of its Affiliates directly, or
indirectly through assistance granted to a Third Party, commence any
interference or opposition proceeding, challenge the validity or enforceability
of, or oppose any extension of or the grant of a supplementary protection
certificate with respect to, in case of Micromet any Patent within
the [***] Technology or in case of BI any Patent within
the [***] Technology, [***] Technology, [***] Technology, [***] Technology
or [***] Technology (each such action a “Patent
Challenge”).
6.5.2 BI
will include provisions in all agreements granting sublicenses of BI’s rights
hereunder providing that if the sublicensee or any of its affiliates undertake a
Patent Challenge with respect to any Patent within the Licensed Technology under
which the sublicensee is sublicensed, BI will be permitted to terminate such
sublicense agreement. If a sublicensee of BI (or an affiliate of such
sublicensee) undertakes a Patent Challenge of any such Patent under which such
sublicensee is sublicensed, then BI upon receipt of notice from Micromet of such
Patent Challenge, will terminate the applicable sublicense
agreement.
7.
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License
Grants
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7.1 License Grants by
Micromet. Subject to the terms and conditions set forth in
this Agreement, Micromet grants to BI an exclusive, royalty-bearing license or
sublicense, under the Licensed Technology, to research, develop, make, have
made, use, offer for sale, sell, import, export and otherwise Commercialize
Products in the Field in the Territory.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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7.2 [***] . BI
acknowledges and agrees that it has received a copy of each [***] ,
and that the sublicense granted in Section 7.1 under
any [***] Technology is subject to the terms and
conditions of the applicable [***] (including, by way of
example, the [***] of
the [***] to [***] thereunder). BI
covenants not to take or fail to take any action that violates the terms of
such [***] applicable to [***] , or that would
cause Micromet to be in breach of any of the terms of the [***] ;
provided, that the
Parties acknowledge that Micromet is obligated
to [***] due pursuant to
such [***] in accordance with Section 8.5.1 or 8.5.2, as
applicable.
7.3 Access
to [***] Technology.
7.3.1 Promptly
after Micromet’s generation, but at
least [***] per [***] , Micromet will provide
BI with a summary, in reasonable detail, of
new [***] Technology that has been generated by Micromet’s
own employees, agents or Service Providers since the last such
report.
7.3.2 Promptly
after Micromet’s acquisition or license, but at
least [***] per [***] , Micromet will provide
BI with a summary of new [***] t Technology that has been acquired or
in-licensed by Micromet (other than [***] Technology that
is [***] included in the definition of Licensed Technology
as a result of
its [***] by [***] own [***] or [***]
) since the last such report. Such report will describe the
new [***] Technology that has been acquired or in-licensed
by Micromet in such detail as reasonably required for BI to determine its
interest in seeking a license thereunder pursuant to this Section 7.3.2 and will
describe any payments that would become due by Micromet on account of the grant
of a license or sublicense to BI under the terms of this Agreement and to the
extent arising from the development, manufacture, or Commercialization of
Products. In addition, Micromet will provide BI with notice of any
such [***] Technology that Micromet intends to use or
incorporate in its research and development activities hereunder and
will [***] such use or
incorporation [***] BI’s [***] .
7.3.3 If
BI desires to obtain a license under the Patents or Know-How described in
Section 7.3.2 in connection with its development, manufacture or
Commercialization of Products hereunder, then BI will provide Micromet with
prompt written notice. Following Micromet’s receipt of such notice,
this Agreement will be amended without the need for further action by the
Parties as follows: (a) the selected [***] Technology will
be included in the Licensed Technology, (b) BI will
be [***] for all [***] to a Third
Party to the extent arising [***] from the grant of a
license or sublicense as to BI under this Agreement and the development,
manufacture, or Commercialization of Products hereunder, however excluding
any [***] or [***] to
such [***] (unless
such [***] are [***] to
the [***] for the specific Product), and (c) any license
granted to BI will be subject to the terms and conditions of any Third Party
license agreement under which such [***] Technology
is [***] to or [***] by [***] .
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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7.4 Access
to [***] Technology.
7.4.1 Promptly
after Micromet becomes aware of any [***] Technology, but
at least [***] per [***] , Micromet will
provide BI with a reasonably detailed summary of
new [***] Technology, that
is [***] a [***] by BI in connection
with its development, manufacture or Commercialization of Products
hereunder. Micromet will provide BI with notice of
any [***] Technology that
Micromet [***] to [***] or [***] in
its research and development activities hereunder and
will [***] such [***] or [***] without
BI’s express written consent. BI acknowledges that it only may
receive a right to license Patents and Know-How of
a [***] that, if evaluated under this Agreement (treating
such Patent or Know-How as [***] Technology) would be
eligible for license by the particular [***] under
substantially similar terms and conditions (including financial terms) in all
material respects. Micromet’s summary of
such [***] Technology will contain such detail as
reasonably required for BI to determine its interest in seeking a license
thereunder pursuant to this Section 7.4.1. If BI desires to obtain a
license under such Patents or Know-How, then BI will provide Micromet with
written notice of such determination, and the Parties (and the
applicable [***] to the extent required) will negotiate in
good faith an amendment to this Agreement pursuant to which
such [***] Technology will be included in
the [***] Technology and licensed to BI under the terms of
this Agreement and the terms of Micromet’s agreement with the
applicable [***] .
7.4.2 Subject
to Section 7.4.1, (a) BI will be responsible for all payments, if any, due to a
Third Party on account of any sublicense to
any [***] Technology to the extent arising from BI’s
practice of the license granted to BI, and (b) such license only will be granted
to the extent that BI permits the license of
corresponding [***] Technology, if it existed, to
such [***] .
7.5 Sublicensing by
BI. Subject to the terms and conditions of this Agreement, BI
will have the right to sublicense all or part of the rights granted under
Section 7.1: (a) at any time, to an Affiliate but only for such
period of time as such entity remains an Affiliate of BI, or to a Service
Provider solely to the extent necessary for the performance of any contract
research, contract manufacturing or other similar service, (b)
to [***] with an [***] for the
development or Commercialization of
Products [***] the [***] and [***] qualified
and experienced to perform the sublicensed activities, without the prior consent
of Micromet, and (c) to any entity not covered by the foregoing clauses (a) and
(b), with the prior consent of Micromet. In each case and as a
condition of such sublicense, BI will remain responsible to Micromet for the
performance of BI’s obligations under this Agreement (either directly by BI or
by BI’s sublicensee), will ensure that each sublicense agreement requires such
sublicensee to comply with the terms of this Agreement set forth in Sections 3,
4, 5.6, 6.5, 7, 9.5, 10, as applicable to such sublicensee and such
terms to ensure that BI will provide Micromet with the rights and licenses under
this Agreement, and will provide Micromet with the identity of such
sublicensee. Further, BI will ensure that the actions of such
sublicensee do not negatively impact the development or Commercialization of
Products in the [***] and [***] .
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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7.6 License
Grants by BI.
7.6.1
[***] Technology. Subject to the terms and
conditions set forth in this Agreement, BI grants to Micromet a non-exclusive,
worldwide, fully-paid, royalty-free license, under
the [***] Technology, to research, develop, and only in
the U.S. to co-promote Products pursuant to this Agreement, all only to the
extent necessary for Micromet to perform its obligations under this Agreement
and the Co-Promotion Agreement, as applicable. Such license will be
sublicensable solely to Affiliates of Micromet and Service Providers for the
provision of services to Micromet. Micromet shall ensure and
incorporate effective measures that the [***] Technology,
especially the related Know-How, shall solely be used for the purpose of the
collaboration with BI under this Agreement in accordance with the respective
Research Plan and Development Plan, without any information exchange
to [***] .
7.6.2 [***] Technology; [***] Technology. Subject
to the terms and conditions set forth in this Agreement, BI grants to Micromet a
non-exclusive, worldwide, fully-paid, royalty-free license under
the [***] Technology, [***] Technology
and [***] Technology, if any, to research, develop, make
and only in the U.S. to co-promote Product(s), all only to the extent necessary
for Micromet to perform its obligations under this Agreement and the
Co-Promotion Agreement, as applicable. Such license will be
sublicensable solely to Affiliates of Micromet and Service Providers for the
provision of services to Micromet. Micromet shall ensure and
incorporate effective measures that the [***] Technology
and [***] Technology, especially the related Know-How,
shall solely be used for the purpose of the collaboration of BI and Micromet in
accordance with the respective Research Plan and Development Plan, without any
information exchange to [***] except as expressly
permitted under this Agreement.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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7.6.3 Sublicensing
by Micromet to Micromet Collaborators.
(a) Sublicensing
of [***] Technology. Except as provided in Section
13.1 or this Section 7.6.3, Micromet will have the right to grant sublicenses in
any particular [***] Technology, with the right to grant
further sublicenses, to [***] as of
the [***] and solely with respect to
their [***] Products generated under an
agreement [***] as
of [***] of [***] ; provided, however, in each case and as
a condition of such sublicense that: (a) Micromet’s agreement with the
particular [***] would permit Micromet to grant to BI a
license, under substantially similar terms and conditions (including financial
terms and any restrictions on licensing) in all material respects (to be
evidenced to BI, e.g.,
by providing an excerpt of the agreement with the [***] ), to an
invention identical to such [***] Technology that,
hypothetically, had been conceived or reduced to practice solely by
such [***] in the performance of its activities under the
applicable agreement, and (b) Micromet remains responsible to BI for the
performance of Micromet’s obligations under this Agreement (either directly by
Micromet or by Micromet’s sublicensee). For clarity, in case of any
dispute whether the condition of such sublicense are substantially similar in
all material respects, the dispute resolution procedure according to 17.4.2
shall apply. In the event that Micromet desires to use
the [***] Technology in connection with
a [***] agreement that does
not [***] as of [***] , then Micromet may
request from BI to enter good faith negotiations regarding the terms of a
sublicense agreement (including financial terms consisting of
a [***] not to exceed [***] , or such other
financial terms as the Parties may mutually agree) under which Micromet would
sublicense the [***] Technology to
a [***] solely in connection with
the [***] Products that are the subject of
the [***] between Micromet and such [***] ,
with the procedures described in Exhibit K applying to
any failure by the Parties to agree on the terms of such separate agreement
within [***] ( [***]
) [***] following the start of negotiations.
(b) Sublicensing
of [***] Technology. Micromet will have
the right to grant sublicenses in any
particular [***] Technology, with the right to grant
further sublicenses, to [***] ; provided, however, in each case and as
a condition of such sublicense that: (a) Micromet’s agreement with the
particular [***] would permit Micromet to grant to BI a
license, under substantially similar terms and conditions (including financial
terms and any restrictions on licensing) in all material respects, to an
invention identical to such [***] Technology that,
hypothetically, had been conceived or reduced to practice solely by
such [***] in the performance of its activities under the
applicable agreement, and (b) Micromet remains responsible to BI for the
performance of Micromet’s obligations under this Agreement (either directly by
Micromet or by Micromet’s sublicensee).
(c) Third Party
Obligations. For the avoidance of doubt, the rights to
sublicense granted in Sections 7.6.3 (a) and (b) shall be subject to the
conditions and financial terms imposed on BI by its Third Party licensor, if
any, for any [***] Technology
or [***] Technology. BI will notify Micromet in
advance of the application of such terms and conditions to
Micromet.
7.6.4 Grant Back of Licensed
Technology. BI hereby grants to Micromet a non-exclusive
license of all rights in the Licensed Technology granted to BI pursuant to
Section 7.1, solely to the extent necessary for Micromet to perform its
obligations under this Agreement and the Co-Promotion Agreement, as
applicable. Such license will be sublicensable solely to Affiliates
of Micromet and Service Providers for the provision of services to
Micromet.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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7.6.5 License for [***]
. Subject to the terms and conditions set forth in this
Agreement, BI grants to Micromet a non-exclusive, worldwide, license under
the [***] Technology
and [***] Technology, if any, to research, develop, make,
use, offer for sale, sell, import, export and commercialize [***]
. Such license shall be fully-paid up except to the extent of any
conditions and financial terms imposed on BI by its Third Party licensor, if
any, for any [***] Technology
or [***] Technology. If Micromet desires to
receive an exclusive version of the foregoing license with respect
to [***] (which would be [***] and
not [***] ), the Parties will negotiate in good faith the terms for
such exclusive license grant. Micromet will have the right under the
foregoing non-exclusive license to grant sublicenses in any
particular [***] Technology
or [***] Technology to its Affiliates and Service
Providers who are not also [***] (including, by way of
example, contract manufacturers, distributors or recognized sales
agents).
7.7 [***] Technology; [***] Technology.
7.7.1 Each
Party covenants that it will not subject
any [***] Technology to any lien, encumbrance, security
interest and/or other imposition that would effect the other Party’s title or
right to use the [***] Technology under this Agreement or
to sell or otherwise assign its rights thereunder without consent of the other
Party, except as otherwise provided in this Agreement or in connection with any
permitted transfer or assignment of this Agreement.
7.7.2 BI
covenants that it will not subject any [***] Technology to
any lien, encumbrance, security interest and/or other imposition that would
effect Micromet’s title or right to use
the [***] Technology under this Agreement (including
the [***] of such [***] Technology
under Section 13.1(h)) or to sell or otherwise assign its rights thereunder
without consent of the other Party, except as otherwise provided in this
Agreement or in connection with any permitted transfer or assignment of this
Agreement.
7.7.3 BI
will not and will cause its Affiliates not to, grant any right, license or
interest or otherwise transfer its interest in any
(i) [***] Technology (except in connection with any
permitted transfer or assignment of this Agreement) to any Third Party to
develop (including pre-clinical or clinical testing), manufacture, market, sell,
promote or otherwise commercialize any [***] that contains
or comprises any [***] binding to the [***] ;
and (ii) [***] Technology (except in connection with any
permitted transfer or assignment of this Agreement) to any Third Party to
develop (including pre-clinical or clinical testing), manufacture, market, sell,
promote or otherwise commercialize any [***] that contains
or comprises any [***] , in each case excluding any Product and
except for any rights granted for the limited purposes described in Section
3.6. Notwithstanding, subsection (i) above shall not restrict BI from
performing [***] Activities using
the [***] Technology, including manufacturing, if such
activities are performed by BI solely as a contract manufacturer on behalf of
one or more Third Parties for a product owned or controlled by a Third
Party.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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7.7.4 Micromet
will not and will cause its Affiliates not to, grant any right, license or
interest or otherwise transfer its interest in
any [***] Technology (except in connection with any
permitted transfer or assignment of this Agreement) to (i) any Third Party to
develop (including pre-clinical or clinical testing), manufacture, market, sell,
promote or otherwise commercialize any [***] that contains
or comprises a [***] against
the [***] except for any rights granted for the limited
purposes described in Section 3.6, or (ii) any Third Party that is not
a [***] , except in each case in connection with any permitted
transfer or assignment of this Agreement.
7.8 Retained Rights; Covenant Not to
Practice.
7.8.1 BI Covenants. BI
hereby covenants and agrees not to use or practice
any [***] Technology, nor cause or authorize any Affiliate
or Third Party to use or practice any [***] Technology,
other than as expressly permitted by this Agreement. In addition, BI
hereby covenants and agrees not to use or practice or license
any [***] Technology
or [***] Technology nor cause or authorize any Affiliate
or Third Party to use or practice any of the foregoing, for the development,
manufacture, or commercialization of
a [***] the [***] , except as required for BI
to perform its obligations under this Agreement, provided, that it will not be
a breach of this Section 7.8.1 for BI to
perform [***] Activities, including manufacturing, if such
activities are performed by BI solely as a contract manufacturer on behalf of
one or more Third Parties for a product owned or controlled by a Third
Party. BI covenants that it will not subject
any [***] Technology
or [***] Technology to any lien, encumbrance, security
interest and/or other imposition that would limit or restrict Micromet’s
licenses under Sections 7.6 or 13.1.
7.8.2 Micromet
Covenants. Micromet hereby covenants and agrees not to use or
practice
any [***] Technology, [***] Technology or [***] Technology,
nor to cause or authorize any Affiliate or Third Party to use or practice
any [***] Technology, [***] Technology
or [***] Technology, other than as expressly permitted by
this Agreement. In addition, Micromet hereby covenants and agrees not
to use, practice or license (other than to BI)
the [***] Technology, nor cause or authorize any Affiliate
or Third Party to use, practice or license
the [***] Technology for the development, manufacture or
commercialization of a Product, except as required for Micromet to perform its
obligations under this Agreement. Micromet covenants that it will not
subject any [***] Technology to any lien, encumbrance,
security interest and/or other imposition that would limit or restrict BI’s
licenses under Sections 7.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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7.8.3 Retained
Rights. Except for the rights specifically granted in this
Agreement, Micromet reserves all rights to intellectual property Controlled by
Micromet and its Affiliates (including
the [***] Technology
and [***] Technology) and reserves the right to utilize or
allow Third Parties to practice such rights consistent with the terms of this
Agreement. In addition, Micromet reserves all rights in
the [***] Technology to the extent necessary for it to
conduct the activities assigned to it under the Research Plan and Development
Plan. Except for the rights specifically granted in this Agreement,
BI reserves all rights to the [***] Technology and
reserves the right to utilize or allow Third Parties to utilize
the [***] Technology consistent with the terms of this
Agreement. No implied licenses are granted by either Party under this
Agreement.
7.9 Exclusivity.
7.9.1 Until
the [***] of [***] in accordance
with [***] , each Party will not, and
will cause its Affiliates not to, either directly or through any Third Party,
develop (through pre-clinical or clinical testing), manufacture, market, sell,
promote or otherwise commercialize a pharmaceutical product (other than a
Product developed or Commercialized under this Agreement) containing or
comprising (a) an [***] to
the [***] and (b)
any [***] to [***] (a “ [***] Product”),
nor grant any license or other rights to a Third Party to conduct any of the
foregoing; provided,
that it will not be a breach of this Section 7.9.1 for BI to
perform [***] Activities, including manufacturing, with
respect to a [***] Product if such activities are
performed by BI solely as a contract manufacturer on behalf of one or more Third
Parties who own or control
such [***] Product.
7.9.2 In
the event that any Party undergoes a Change of Control (other than a transaction
described in Section 7.9.3) resulting in such Party Controlling
a [***] Product, then the terms of Section 7.9.1
will [***] to [***] or [***] , by or on behalf
of a Party or its Affiliates, the development, use, manufacture, marketing,
sale, promotion or commercialization of any [***] Product
that, as of [***] [***] of such Change of
Control: (i) was Controlled by such Third Party acquiror and was the subject of
an ongoing research or development program, or was being Commercialized by such
Third Party acquiror, or (ii) was Controlled by such Third Party acquiror and
was not claimed or covered by any intellectual property rights Controlled by the
Party that underwent the Change of Control.
7.9.3 Subject
to Section 7.9.2, in the event that a Party or any of its Affiliates acquires
all or substantially all of the assets of a Third Party (whether in a Change of
Control of such Third Party or otherwise, but excluding in a Change of Control
of a Party covered by Section 7.9.2) and in such transaction obtains Control of
a [***] Product that would result in a violation of the
terms of Section 7.9.1 with respect to [***] , however only if
such [***] Product [***] in
the [***] of [***] in [***] by [***] compared
to the Product estimated in line with general industry standards, then, the
Party or its Affiliate will (a) notify the other Party in writing no later
than [***] ( [***] ) [***] after
consummation of such transaction, (b) unless otherwise agreed by the
Parties, [***] of [***] Product [***] by
an [***] (without [***] ) to
a [***] of all of such Party’s and its
Affiliate’s [***] to
such [***] Product not later
than [***] ( [***]
) [***] from [***] of
such [***] Product (or in the case of BI obtaining Control
of a [***] Product, BI may terminate this
Agreement [***] in its entirety
with [***] ( [***] ) [***] prior
written notice within [***] ( [***]
) [***] following such transaction covered by this Section
7.9.3 (in which case the consequences under Section 13.1 shall apply to such
terminated [***] ), and (c) notify the other Party in writing of
such [***] .
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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8.
|
Fees
and Payments
|
8.1 Initial Fees. After
the Effective Date and BI’s receipt of a duly executed original of this
Agreement and an original invoice by Micromet, BI will pay to Micromet within
thirty (30) days an upfront payment, in an amount equal to Five Million Euros
(€5,000,000).
8.2 Contribution of Parties
to [***] Collaboration Expenses. As set
forth in Section 3
above, the Research Plan and Development Plan will each include a budget
of [***] Collaboration Expenses to be
incurred. After the
first [***] of [***] for
a [***] or [***] of
the [***] , whichever comes first, [***] will be responsible for
all costs incurred by [***] in the research and
development of the Products and will therefore
pay [***] for [***] Collaboration
Expenses in the manner set forth in this Section 8.2.
8.2.1 After
the [***] , [***] will report
to [***] and the Co-Chairs of the JSC
within [***] ( [***] ) [***] after
the end of each Calendar Quarter the [***] Collaboration
Expenses actually incurred during such Calendar Quarter. Such report
will specify in reasonable detail (including at least the hours spent per work
package as well as copies of invoices of external costs and further details as
agreed in advance by the Parties) all [***] Collaboration
Expenses actually incurred during such Calendar
Quarter. If [***] disagrees with the contents
of such report, then [***] will
notify [***] in writing and the Parties will seek to
resolve any questions related to such accounting statements
within [***] ( [***]
) [***] following [***] receipt of
such notice. This reporting procedure will be in place until the
earlier of (i) [***] of [***] for
a [***] or (ii) [***] of
the [***] is [***] .
8.2.2 After
the earlier of
(i) [***] of [***] for
a [***] or (ii) [***] of
the [***] , [***] will within the
first [***] ( [***] ) [***] of the
start of each Calendar Quarter for which reimbursement is
due [***] to [***] the amount of
any [***] Collaboration Expenses budgeted for such
Calendar Quarter. [***] will report
to [***] and the Co-Chairs of the JSC
within [***] ( [***] ) [***] after
the end of each Calendar Quarter the [***] Collaboration
Expenses actually incurred by it during such Calendar Quarter. Such
report will specify in reasonable detail (as agreed in advance by the Parties)
all [***] Collaboration Expenses incurred during such
Calendar Quarter and will be accompanied by an invoice, and such other
appropriate supporting documentation as may be required by [***]
. If [***] disagrees with the contents of
such report, then [***] will
notify [***] in writing and the Parties will seek to
resolve any questions related to the invoice and accounting statements
within [***] ( [***]
) [***] following receipt
by [***] of [***] invoice and
report. If the amount of
actual [***] Collaboration Expenses incurred during such
Calendar Quarter exceeds the amount of [***] pre-payment,
then [***] will pay the exceeding amount
to [***] within [***] ( [***]
) [***] . If the amount of
actual [***] Collaboration Expenses incurred during such
Calendar Quarter is less than the amount
of [***] pre-payment, then [***] may
credit the amount of such overpayment against future pre-payments
of [***] Collaboration Expenses hereunder.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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8.2.3 [***] will
have the right at reasonable times and upon reasonable prior notice to retain an
independent accounting firm to audit [***] records as
provided in Section 9.5.2 to confirm the accuracy
of [***] costs and reports with respect
to [***] Collaboration Expenses under this
Agreement.
8.2.4 If [***] anticipates
that any [***] Collaboration Expenses that are subject to
reimbursement under this Section 8.2 may exceed an amount equal
to [***] % of the budget (i.e., [***] % over
the estimated budget) for the associated tasks as set forth in the Research Plan
or Development Plan, as applicable (such excess, a “Cost Overrun”),
then [***] will give notice to the Co-Chairs of the JSC of
such anticipated Cost Overrun, and the JSC will decide in good faith whether to
modify the applicable plan to reduce the costs appropriately or to increase the
budget for such tasks so that there is no longer a Cost Overrun. In
any event, the Parties acknowledge that, except as expressly set forth in the
definition of “ [***] Collaboration Expenses” with respect to the
re-performance of certain activities, [***] shall not be
obligated to perform any activities for which [***] will
not reimburse [***] .
8.3 Development
Milestones. BI will inform Micromet in writing upon the
occurrence of a milestone event set forth below. BI will pay Micromet
the non-refundable, non-creditable payment in the corresponding amount as set
forth below within [***] ( [***]
) [***] after receipt of an original invoice from
Micromet:
Milestone
|
|||||
Milestone Event
|
Payments
|
||||
1.
|
[***] of
a [***] by the [***]
|
€ | [*** | ] | |
2.
|
[***] of
a [***]
|
€ | [*** | ] | |
3.
|
[***] to
an [***] in the [***] for
a [***]
|
€ | [*** | ] | |
4.
|
[***] of
the [***] for a [***]
|
€ | [*** | ] | |
5.
|
[***] of [***] in
the [***] other
than [***] for [***]
|
€ | [*** | ] | |
6.
|
[***] in
the [***] other
than [***] for [***]
|
€ | [*** | ] |
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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If a
milestone event described above is achieved that is subsequent to a preceding
milestone event with respect to which BI has not yet made the corresponding
milestone payment, the preceding milestone event is deemed achieved, and the
corresponding milestone payment is due and payable together with the payment of
the milestone payment for the subsequent milestone event. Milestone
payments [***] will each be due only once upon the first
achievement of the milestone, irrespective of whether they are achieved by the
first Product or a subsequent Product developed under this Agreement; milestone
payments [***] will be due for each Product.
8.4 Royalties.
8.4.1 Royalty Rates in the ROW
Territory. Within [***] ( [***]
) [***] of the end of each Calendar Quarter during the
Term during which there were Net Sales of a Product in the ROW Territory, BI
will pay to Micromet, as a consideration of the licenses granted by Micromet to
BI under Section 7, a royalty equal to:
(a)
[***] percent ( [***] %) of the annual, aggregate Net Sales of such
Product in the ROW Territory that are less than € [***] ;
(b)
[***] percent ( [***] %) of the annual, aggregate Net Sales of such
Product in the ROW Territory that are equal to or greater than €
[***] and less than € [***] ; and
(c)
[***] percent ( [***] %) of the annual, aggregate Net Sales of such
Product in the ROW Territory that are greater than € [***]
.
By way of
example, if, during any calendar year during the Royalty Term, the amount of Net
Sales of a Product in the ROW Territory is € [***] , then Micromet will
receive [***] % of € [***] + [***] % of €
[***] + [***] % of € [***] .
Royalties
due under this Section 8.4.1 will be paid on a country-by-country basis and will
commence upon First Commercial Sale of a Product in a particular country in the
ROW Territory and will expire in such country upon the later of: (i)
the [***] of
the [***] [***] of
any [***] within
the [***] (including
any [***] [***] BI and
any [***] within
the [***] Technology) that [***]
, [***] , by the sale or import of the Product in such country, (ii)
the [***] of [***] for such Product
in such country, or (iii) [***] ( [***] ) [***] from
the First Commercial Sale of such Product in such country; provided, that if a
particular Product has been launched in [***] , then BI’s obligation
to make royalty payments pursuant to this clause (iii) with respect to such
Product shall [***] for [***] (
[***] ) [***] after the First Commercial Sale of such
Product in the [***] (such period the “Royalty Term”).
8.4.2 Royalty Reduction
upon [***] Competition. Starting with
the [***] during which a Product
faces [***] Competition in one or more countries of
the [***] , the royalty payment due to Micromet for sales of such
particular Product in the [***] shall be calculated as
follows:
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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(a) The
Net Sales of such particular Product in those countries
with [***] Competition will
be [***] as follows:
(i) [***] percent ( [***] %) if the Net Sales of such
Product during the most recent Calendar Quarter
are [***] percent ( [***] %),
but [***] percent ( [***]
%), [***] than the [***] of such
Product in such country (as defined in Section 1.36), and
(ii) [***] percent ( [***] %) if the Net Sales of such
Product during the most recent Calendar Quarter
are [***] percent ( [***]
%) [***] the [***] of such Product
in such country (such reduced Net Sales amount, the “Adjusted Net Sales”). These
sales will be then added to the Net Sales determined in countries
without [***] Competition (“Base Net
Sales”). The sum of Base Net Sales and Adjusted Net Sales
constituting the total Net Sales (the “Total Net
Sales”).
(b) The
royalty payment due to Micromet for total sales of such particular Product shall
be calculated based upon these [***] Total Net Sales in
the ROW Territory.
(c) In
case of any reconciliation required due to fluctuations in the amount
of [***] Competition (either within a country or in
additional countries) during a calendar year, the reconciliation will be done
within the first quarter of the following calendar year. BI shall pay
any amounts due resulting from the reconciliation together with the royalty
payment for the first Calendar Quarter of the following year. Amounts due from
Micromet shall be deducted from the royalty payment for the first Calendar
Quarter of the following year.
8.4.3 Sales Participation Payments in the
U.S. Within [***] ( [***]
) [***] of the end of each Calendar Quarter during the
Sales Participation Term (as defined below) during which there were Net Sales of
a Product in the U.S., BI will pay to Micromet on a Product-by-Product basis, as
a consideration of the licenses granted by Micromet to BI under Section 7 and
Micromet’s co-promotion of such Product in the U.S., an amount (a “Sales Participation Payment”)
equal to:
(a)
[***] percent ( [***] %) of the aggregate Net Sales of such Product
in the U.S., during the period commencing
upon [***] of [***] in the U.S. and
ending at the [***] following such [***]
;
(b)
[***] percent ( [***] %) of the aggregate Net Sales of such Product
in the U.S., for the [***] following the expiration of the
period described in Section 8.4.3(a) above;
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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(c)
[***] percent ( [***] %) of the aggregate Net Sales of such Product
in the U.S., for the [***] following the expiration of the
period described in Section 8.4.3(b) above; and
(d)
[***] percent ( [***] %) of the aggregate Net Sales of such Product
in the U.S.,
for [***] the [***] following the
expiration of the period described in Section 8.4.3(c) above.
By way of
example, if the [***] of a [***] in the U.S. occurs
on [***] , then the [***] % sales participation rate for such
Product will apply from [***] through [***] ; thereafter,
the [***] rates will apply from [***] of
[***] through [***] of the [***] .
Payments
due under this Section 8.4.3 will commence upon First Commercial Sale of a
Product in the U.S. and continue until the later of: (i)
the [***] of the [***] of
any [***] within
the [***] Technology (including
any [***] with BI and
any [***] within
the [***] Technology) that would be infringed, absent a
license, by the sale or import of the Product in the U.S., (ii)
the [***] of [***] for such Product
in the U.S., or (iii) [***] ( [***] ) [***] from
the First Commercial Sale of such Product in the U.S. (such period, the “Sales Participation
Term”).
8.4.4 Reduction for U.S.
Payments. If [***] is
not [***] a particular Product in the U.S. during a
particular Calendar Quarter due to the various circumstances described in this
Agreement and Exhibit
G (to be set forth in the Co-Promotion Agreement), then
the [***] of the [***] payable by BI
to Micromet under [***] for such Product for such Calendar
Quarter will be [***] as follows:
(a) [***] percent ( [***] %) of Net Sales
if [***] of [***] in accordance
with [***] or [***] the Co-Promotion
Agreement [***] , (b) [***] percent ( [***] %)
of Net Sales if [***] after
a [***] of [***] in accordance
with [***] , or (c) [***] percent ( [***] %) of
Net Sales if [***] the Co-Promotion Agreement or
the [***] pursuant to [***] of this
Agreement or the Co-Promotion Agreement, except as provided
in [***] of Exhibit
G.
8.4.5 Reduction
for [***] Competition. For any Calendar
Quarter during which [***] Competition in the U.S., the
Sales Participation Payment due to Micromet for sales of such Product in the
U.S. during such Calendar Quarter shall [***] percent (
[***] %) of Net Sales, without [***] pursuant
to [***] above or [***] . In
case of any reconciliation required due to fluctuations in the amount
of [***] Competition in the U.S. during a calendar year,
the reconciliation will be done within the first quarter of the following
calendar year. BI shall pay any amounts due resulting from the
reconciliation together with the Sales Participation Payment for the first
Calendar Quarter of the following year. Amounts due from Micromet shall be
deducted from the Sales Participation Payment for the first Calendar Quarter of
the following year.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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8.4.6 Acknowledgement. BI
acknowledges that Micromet will be co-promoting the Product in the U.S. and BI
will continue to enjoy substantial benefit from such activities and its license
under, and the transfer to BI of certain elements of, the Licensed Technology
pursuant to this Agreement (including without limitation Micromet’s Know-How
licensed to BI) as well as from BI’s own development of BI Technology derived
from the practice of such license and BI’s use of such Licensed Technology, even
after [***] of all [***] owned or
Controlled by [***] the [***] in
a [***] in the Territory. In addition, BI
acknowledges the application of a [***] in
the [***] is more convenient to the Parties, facilitates
the payment of royalties, and reduces accounting burdens on the Parties.
Accordingly, the Parties have agreed
to [***] the [***] throughout
the [***] .
8.5 Payments under [***] ;
Third Party Licenses.
8.5.1 [***] will
be solely responsible for making any payments that become due after the
Effective Date to the licensors or assignors under the agreements listed in
Exhibit H-1.
8.5.2 [***] will
be solely responsible for [***] a development and
commercial license, pursuant to the [***] described on
Exhibit H-1, for the use of
the [***] with the Collaboration Target (such development
and commercial license agreement, the “
[***] License”). The [***] License
shall be [***] by [***] , at
the [***] . Effective upon execution of
the [***] License, (i) any licenses granted
to [***] under the [***] License
will be deemed to be within the [***] Technology, and (ii)
the [***] License will be deemed to be
an [***] solely for purposes of the acknowledgements and
covenants set forth in Section 7.2 and the [***] set forth
in Section 13.5. Payments due under the [***] License will
be [***] as follows: [***] will bear
any [***] , and [***] will bear
any [***] ; provided, that if Micromet’s
Sales Participation Payments in the U.S. have
been [***] pursuant to Sections 8.4.4 or 8.4.5 above, for
any reason, then [***] will bear
the [***] due under
the [***] License for [***] of any
Product that [***] before [***] of
the [***] under the [***] License in
the [***] [***] will
invoice [***] for any amounts that become due under
the [***] License and are reimbursable
by [***] under this Section 8.5.2
and [***] will pay all such invoices
within [***] ( [***] ) [***] of
receipt thereof.
8.5.3 In
the event that a Party desires to pursue a license to certain Third Party
intellectual property rights in connection with
the [***] or [***] of [***]
, such Party will use Commercially Reasonable Efforts to obtain such license on
reasonable terms as applicable to the [***] .
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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(a)
[***] will be solely responsible for negotiating and obtaining such a
license under commercially reasonable terms for any Third Party Patent that (i)
covers the [***] and
further [***] or [***] , (ii) claims
the [***] of a [***] , the [***] ,
any [***] used in a [***] , or
the [***] of [***] , and (iii) would
be [***] by
the [***] or [***] of
the [***] , in
the [***] a [***] from [***]
, due to
the [***] of [***] contained in
any [***] within
the [***] Technology [***] or [***] of
the [***] . During the negotiations, and
before [***] will enter into such
license, [***] will inform [***] on
the negotiated terms. [***] may provide comments to any
proposed terms; [***] will be responsible for establishing
the final terms of such
agreement. If [***] does not agree to such
terms (such agreement not to be unreasonably withheld, conditioned or delayed),
then the applicable Patent will be excluded from the definition
of [***] Technology, notwithstanding anything to the
contrary in this Agreement. In the
event [***] obtains a license pursuant to this Section
8.5.3(a) and [***] has agreed to the terms of such
license, then such agreement will be included on Exhibit
H-2, [***] rights in and to any Patent or Know-How
licensed under such agreement will be subject to the terms and limitations, if
any, of such agreement, and the payments made to such Third Party will
be [***] as follows: [***] will bear
any upfront and milestone payments
that [***] to [***] (subject to
the [***] described below),
and [***] will bear
any [***] or [***]
. [***] will [***] for any
amounts that become due under the agreements on Exhibit H-2 and
are [***] under this Section 8.5.3(a)
and [***] will [***] all
such [***] within [***] ( [***]
) [***] of receipt
thereof. [***] may [***] the
amount of any [***] the [***] due
from [***] to [***] under Sections
8.3 or 8.4 of this Agreement. Upon termination of this Agreement, if
(i) [***] has
paid [***] for [***] and [***] under
the agreements on Exhibit H-2 and
(ii) [***] has not had
the [***] to [***] the [***] of
such [***] using the [***] described
in the preceding sentence, then within [***] ( [***]
) [***] following such
termination, [***] will pay
to [***] an amount equal to [***] of
any such [***] .
(b)
[***] will be solely responsible for negotiating and obtaining such
a license under commercially reasonable terms for any Third Party Patent that
(i) covers the [***] and further [***] or [***] ,
(ii) claims the [***] of a [***] , the [***] , any
[***] used in a [***] , or the [***] of [***] ,
and (iii) would be [***] by the [***] or
[***] of the [***] , in the [***] a [***]
from [***] , due to the [***] of [***] Technology
to which [***] has already taken a license under Section [***]
. Prior to the initiation of any negotiations, the JSC must reasonably and
in good faith approve the acquisition of such Third Party Patent license and
update the Research Plan or Development Plan, as applicable, to reflect the
incorporation of the licensed technology into the then-current research and
development program. During the negotiations, and before [***]
will enter into such license, [***] will inform [***] on
the negotiated terms. [***] may provide comments, and will be
entitled to accept or reject such license under the negotiated terms.
If [***] does not agree to such terms, then the applicable Patent
will be excluded from the definition of [***] Technology,
notwithstanding anything to the contrary in this Agreement. In the
event [***] obtains a license pursuant to this Section 8.5.3(b)
and [***] has agreed to the terms of such license, then such
agreement will be included on Exhibit H-3,
[***] rights in and to any Patent or Know-How licensed under such
agreement will be subject to the terms and limitations, if any, of such
agreement, and the payments made to such Third Party will be [***]
as follows: [***] will bear any [***] and
[***] [***] that [***] to a [***] ,
and [***] will [***] any [***] payments;
provided, that
[***] share of [***] payable under all agreements on Exhibit H-3 in
[***] on a [***] , will [***] of [***]
(which [***] will [***] , as [***] on a
[***] basis, by the [***] the [***] between
[***] and the sum of the [***] under the agreements set forth
on Exhibit H-1 according
to [***] and Exhibit
H-2 according to [***] . For clarity, the [***]
of any such [***] will not [***] and total
[***] payable under Exhibit H-3 by
[***] will not [***] in the aggregate, calculated on a
worldwide basis. Example: The [***] due by [***]
under Exhibit H-1 according to
Section 8.5.2 and Exhibit H-2
according to Section 8.5.3(a) are in total [***] calculated on a
worldwide basis, then the [***] for any [***] by
[***] under Exhibit H-3 by
[***] to a [***] of [***] calculated on a
worldwide basis. [***] will [***] for any amounts
that become due under the agreements on Exhibit H-3 and
are [***] [***] under this Section 8.5.3(b) and
[***] will [***] all such [***] within [***]
( [***] ) [***] of receipt thereof.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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(c)
[***] will be solely responsible for negotiating and obtaining any
license other than those described in Sections 8.5.3(a) and (b) above for any
Third Party rights relating to the [***] , any [***] thereto,
or any [***] (including, without limitation, [***]
of [***] or [***] , [***] or [***]
of [***] , and [***] ); [***] will reasonably
inform [***] regarding the status of such license. In the
event [***] obtains such a license, [***] will be
[***] responsible for any [***] associated therewith.
Any Patents or Know-How included in such license will be [***]
Technology for purposes of this Agreement.
8.5.4
Micromet will duly execute and deliver, or cause to be duly
executed and delivered, such further instruments and does and cause to be done
such further acts and things, including the filing of such assignments,
agreements, documents and instruments, as may be necessary or as BI may
reasonably request for BI to operate under the agreements listed in Exhibits H-1, H-2 and H-3.
9.
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Payment
Terms
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9.1 Payment Method;
Interest. All amounts due hereunder to Micromet will be paid in
Euros, except the Sales Participation Payments in the U.S. which will be paid in
U.S. Dollars. Payments will be made as stated in the applicable sections upon
BI’s receipt of corresponding original invoices from Micromet, by wire transfer
in immediately available funds to accounts designated by
Micromet. Any payments or portions thereof due hereunder which are
not paid on the date such payments are due under this Agreement will bear
interest at the lower of (i) [***] ( [***] ) percentage
points over the three month LIBOR rate of the respective currency which applied
on the due date, or (ii) the maximum rate permitted by law, calculated on the
number of days such payment is delinquent. All payments set forth in this
Agreement are expressed to be exclusive of value added tax (VAT); if VAT is due
on any such payments, then it will be set forth as a separate line item on the
applicable invoice.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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9.2 Withholding
Tax.
9.2.1 Generally. If laws or
regulations require withholding of any taxes imposed upon a Party on account of
any royalties and advance payments, paid under this Agreement, such taxes shall
be deducted by the other Party as required by law from such remittable royalty
and advance payment and shall be paid by the other Party to the proper tax
authorities. Official receipts of payment of any withholding tax shall be
secured and sent to the Party as evidence of such payment. The Parties shall
exercise their best efforts to ensure that any withholding taxes imposed are
reduced as far as possible under the provisions of any relevant tax
treaty.
9.2.2 Imposition of Withholding due to BI’s
Action. If BI (or BI’s Affiliates or successors) is required
to make a payment to Micromet that is subject to a deduction or withholding of
tax, then (a) if such deduction or withholding of tax obligation arises as a
result of any action taken by BI or BI’s Affiliates or successors, including a
change of domicile, any assignment or transfer of all or a portion of this
Agreement as permitted under this Agreement or any sublicense of rights or
obligations hereunder to an Affiliate or Third Party and such action has the
effect of increasing the amount of tax deducted or withheld (a “BI Withholding Tax Action”),
then notwithstanding Section 9.2.1, the payment by BI (in respect of which such
deduction or withholding of tax is required to be made) will be increased by the
amount necessary (the “Additional Amounts”) to ensure
that Micromet receives an amount equal to the same amount that it would have
received had no BI Withholding Tax Action occurred, and (b) the Additional
Amounts will be deducted and withheld by BI from the increased payment made by
BI to Micromet. The Additional Amounts, along with any other tax
deducted and withheld from the payment made by BI, will be timely remitted to
the proper tax authority for the account of Micromet in accordance with
Applicable Law and BI will provide Micromet with evidence of such remittance in
accordance with Section 9.2.1.
9.3 Reports. BI will
accompany each payment of royalties or Sales Participation Payments under this
Agreement with a report containing on a country-for-country basis a detailed and
itemized calculation of Net Sales of a Product in the Territory during the
preceding Calendar Quarter. BI will make all such payments and submit
such reports within [***] ( [***]
) [***] following the end of the applicable Calendar
Quarter.
9.4 Currency
Conversion. When Products are sold for monies other than Euro,
the earned royalties in the ROW Territory will be determined by (i) converting
the Net Sales in each country in the Territory into Euro, using the monthly
exchange rates as customarily used by BI in its regular accounting system
(momentarily the monthly exchange rates published by the European Central Bank
(ECB) in Frankfurt/Main, Germany) and (ii) calculating the respective royalty
payments per country based on the respective Euro values.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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9.5 Records Retention;
Audit.
9.5.1 Record
Retention. Each Party will maintain complete and accurate
books, records and accounts used for the determination of (a) any Micromet
Collaboration Expenses that the other Party is required to reimburse under this
Agreement and (b) Net Sales, in sufficient detail to confirm the accuracy of any
payments required under this Agreement, which books, records and accounts will
be retained by such Party until [***] ( [***]
) [***] after the end of the period to which such books,
records and accounts pertain.
9.5.2 Audit. Each Party
will have the right to have an independent certified public accounting firm of
internationally recognized standing, reasonably acceptable to the other Party,
have access during normal business hours, and upon reasonable prior written
notice, to such of the records of the other Party and its Affiliates as may be
reasonably necessary to verify the accuracy of Micromet Collaboration Expenses
or Net Sales for any calendar quarter ending not more
than [***] ( [***] ) [***] prior to
the date of such request; provided, however, that no Party will
have the right to conduct more than one such audit in
any [***] period. The accounting firm will
disclose to the Parties only whether the Micromet Collaboration Expenses or Net
Sales reported by the audited Party are correct or incorrect and the specific
details concerning any discrepancies. The Parties
have [***] ( [***] ) [***] to review
and verify the disclosed report. The auditing Party will bear all
costs of such audit, unless the audit reveals a discrepancy in the auditing
Party’s favor of more than [***] percent ( [***] %), in
which case the audited Party will bear the cost of the audit. The
results of such accounting firm will be final, absent manifest
error.
9.5.3 Payment of Additional
Amounts. If, based on the results of any audit, additional
payments are owed Micromet under this Agreement, then BI will make such
additional payments after the accounting firm’s written report is delivered to
both Parties within [***] ( [***]
) [***] after the review period. If, based on
the results of any audit, any payments made by BI to Micromet exceeded the
amounts due and payable under this Agreement, such excess will be paid to BI
within [***] ( [***] ) [***] after
Micromet’s receipt of the audit results.
9.5.4 Confidentiality. Each
Party will treat all information subject to review under this Section 9.5 in
accordance with the provisions of Section 10 and will cause its accounting firm
to enter into a reasonably acceptable confidentiality agreement with the audited
Party obligating such firm to maintain all such financial information in
confidence pursuant to such confidentiality agreement.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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10.
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Confidentiality
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10.1 Definition. During
the Term and subject to the terms and conditions of this Agreement, a Party (the
“Disclosing Party”) may
communicate to the other Party (the “Receiving Party”) information
in connection with this Agreement or the performance of its obligations under
this Agreement, including, any information in reports provided pursuant to this
Agreement, scientific and manufacturing information and plans, marketing and
business plans, and financial and personnel matters relating to a Party or its
present or future products, sales, suppliers, customers, employees, investors or
business (collectively, “Confidential
Information”). The Parties agree that the terms of this
Agreement are deemed Confidential Information of both Parties and will be
subject to the restrictions on use and disclosure set forth
herein. Confidential Information also includes any information
disclosed prior to the Effective Date pursuant to that certain Confidentiality
Agreement between the Parties dated [***] .
10.2 Exclusions. Notwithstanding
the foregoing, any information of a Party will not be deemed Confidential
Information with respect to the Receiving Party for purposes of this Agreement
if such information:
10.2.1 was
already known or available to the Receiving Party or its Affiliates at the time
of disclosure to the Receiving Party, other than under an obligation of
confidentiality or non-use to the Disclosing Party;
10.2.2 was
generally available or known to parties reasonably skilled in the field to which
such information pertains or was otherwise part of the public domain at the time
of its disclosure to the Receiving Party;
10.2.3 became
generally available or known to parties reasonably skilled in the field to which
such information pertains or otherwise became part of the public domain after
its disclosure to the Receiving Party, other than through the Receiving Party’s
breach of its obligations under this Section 10;
10.2.4 was
disclosed to the Receiving Party, other than under an obligation of
confidentiality or non-use, by a Third Party who had no obligation to the
Disclosing Party not to disclose such information to others; or
10.2.5 was
independently discovered or developed by the Receiving Party or its Affiliates,
as evidenced by their written records, without the use of, and by personnel who
had no access to, Confidential Information of the Disclosing Party.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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10.3 Disclosure and Use
Restriction. Except as expressly provided herein, the Parties agree
that, during the Term and for [***] ( [***]
) [***] thereafter, each Party and its Affiliates will
keep completely confidential and will not publish or otherwise disclose any
Confidential Information of the other Party or its
Affiliates. Neither Party will use any Confidential Information of
the other Party without such other Party’s consent, except as expressly
permitted by this Agreement.
10.4 Authorized
Disclosure. Each Party may use and disclose Confidential
Information of the other Party to the extent that such use and disclosure
is:
10.4.1 made
in response to a valid order of a court of competent jurisdiction or other
governmental or regulatory body of competent jurisdiction; provided, however, that such Party will
first have given notice to such other Party and given such other Party a
reasonable opportunity to quash such order and to obtain a protective order
requiring that the Confidential Information and documents that are the subject
of such order be held in confidence by such court or governmental or regulatory
body or, if disclosed, be used only for the purposes for which the order was
issued; and provided,
further, that if a disclosure order is not quashed or a protective order is not
obtained, the Confidential Information disclosed in response to such court or
governmental order will be limited to that information which is legally required
to be disclosed in response to such court or governmental order;
10.4.2 otherwise
required by Applicable Laws, regulations or the rules of any nationally
recognized security exchange; provided, however, that the Disclosing
Party will provide such other Party with notice of such disclosure in advance
thereof to the extent practicable;
10.4.3 made
by such Party to the Regulatory Authorities as required in connection with any
Regulatory Filing of INDs, BLAs, Marketing Approval applications, or similar
applications or requests for Marketing Approvals; provided, however, that reasonable
measures will be taken to assure confidential treatment of such
information;
10.4.4 made
by such Party, in connection with the performance of this Agreement, on a
need-to-know basis to Affiliates, research parties, employees, consultants,
representatives or agents, each of whom prior to disclosure must be bound by
obligations of confidentiality and non-use at least equivalent in scope to those
set forth in this Section 10;
10.4.5 made
by such Party to existing or potential acquirers or merger candidates,
investment bankers or existing or potential investors, including venture capital
firms or other financial institutions, each of whom prior to disclosure must be
bound by obligations of confidentiality and non-use at least equivalent in scope
to those set forth in this Section 10; or
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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10.4.6 made
in a patent application expressly permitted to be filed under Section
6.
11.
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Public
Communications
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11.1 General
Provisions. The Parties will cooperate with respect to the
timing and content of communications with the public regarding the development
and marketing of a Product, subject to the provisions of this Section
11.
11.2 Press Releases. The
Parties agree that the public announcement of the execution of this Agreement
will be made by a press release in substantially the form attached as Exhibit
I. The text of any subsequent press releases by a Party
relating to this Agreement or to the performance hereunder, will first be
reviewed and approved by the other Party (such approval not to be unreasonably
withheld, delayed or conditioned). The Parties agree that Micromet may make the
following disclosures: (i) without BI’s approval any disclosure which is
required by law, including disclosures required by the U.S. Securities and
Exchange Commission or made pursuant to the requirements of the national
securities exchange or other stock market on which Micromet’s securities are
traded, as advised by Micromet’s counsel, and (ii) press releases confirming the
receipt by Micromet of any milestone payments (without disclosure of the
respective amount unless required by Applicable Law) and, with respect to a
Product, the [***] [***] of the
first [***] and the first [***] in
any [***] , as well as
the [***] of [***] in
any [***] , or upon such other events as the Parties mutually
agree. In each such case, Micromet will give BI prior notice of any
such intended disclosure, especially in regard of any financial disclosure or
project progress statements relating to this Agreement, with appropriate lead
time, and will incorporate any comments by BI on the proposed
disclosure.
11.3
Publications and
Presentations. Up to [***] of the [***] of
the [***] and at least [***] ( [***] ) [***]
prior to submission of any material related to the research or development
activities hereunder for publication in print or electronic media or
presentation at conferences, the submitting Party will provide to the other
Party a draft of such material for its review and comment. The receiving
Party will provide any comments to the submitting Party within [***]
( [***] ) [***] of receipt of such materials, and (a) if BI is the
submitting Party, then BI will review and consider in good faith any comments
provided by Micromet, or (b) if Micromet is the submitting Party, then Micromet
will implement any comments reasonably provided by BI. In addition, any
information determined by the other Party to be its Confidential Information
must be removed upon request of the other Party. If requested in writing
by the other Party, the submitting Party will withhold material from submission
for publication or presentation for an additional [***] ( [***]
) [***] to allow for the filing of a patent application or the
taking of such measures to establish and preserve proprietary rights in the
information in the material being submitted for publication or
presentation. After [***] for the [***] shall not
publish any publication or presentation, in print or electronic media, relating
to [***] to the [***] without [***] prior
written consent.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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11.4 Previous
Disclosures. A Party may publicly disclose without regard to
the requirements of this Section 11 any information that was previously
disclosed in compliance with such requirements or any information that is
available in the public domain, other than through a Party’s breach of its
obligations under this Agreement.
12.
|
Term
and Termination
|
12.1 Term. The term of
this Agreement (the “Term”) will commence on the
Effective Date and will expire upon the expiration and satisfaction of all
payment obligations hereunder for Products, unless earlier terminated as
provided in this Agreement.
12.2 Termination
for Material Breach.
12.2.1 If
a Party (the “Breaching
Party”) commits a material breach of this Agreement, the other Party (the
“Non-Breaching Party”)
may give to the Breaching Party written notice specifying the nature of the
material breach and requiring the Breaching Party to make good or otherwise cure
such material breach.
12.2.2 If
such material breach is not cured within [***] ( [***]
) [***] after the receipt of notice pursuant to Section
12.2.1 above, the Non-Breaching Party will have the right, on written notice to
the Breaching Party, to terminate this Agreement without prejudice to any of its
other rights and remedies conferred on it by this Agreement or by law. Any such
termination shall become effective at the end of
such [***] ( [***] ) [***] period
unless the breaching Party has cured any such breach prior to the expiration of
the [***] ( [***] ) [***] period;
provided, however, that in the event of
a good faith dispute with respect to the existence of a material breach
(including as to whether BI has used Commercially Reasonable Efforts as required
in this Agreement) arising following the [***] of
the [***] of a [***] ,
the [***] ( [***] ) [***] cure
period shall be [***] until [***] as
the [***] is [***] pursuant to
Section [***] hereof. If the material breach is confirmed
by the judgment of the court and not cured within the applicable cure periods
described in this Section 12.2 below after the receipt of such decision by the
court, the non-breaching Party shall have the right on written notice to the
breaching Party, to immediately terminate this Agreement. In the
event that the court has confirmed (i) a breach of a Party’s obligation to use
Commercially Reasonable Efforts as required under this Agreement, the breaching
Party shall cure such breach within a reasonable time frame, however no later
than [***] ( [***] ) [***] after the
receipt of the decision of the court; (ii) a breach of a Party’s payment
obligation under this Agreement, the breaching Party shall cure such breach no
later than [***] ( [***]
) [***] after the receipt of the decision of the court;
and (iii) a breach of a Party’s obligation under this Agreement other than as
covered by the immediately preceding clauses (i) or (ii), the breaching Party
shall cure such breach within [***] , however no later
than [***] ( [***] ) [***] after the
receipt of the decision of the court. For clarity, this Agreement
will remain in effect during the pendency of any dispute and each Party will
continue to perform its obligations hereunder.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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12.2.3 In
the event of any Dispute under this Agreement regarding a Party’s payment
obligations under this Agreement submitted to a court under Section 17.4.3, the
paying Party shall be required to deposit all disputed payment amounts into an
interest-bearing escrow account established by the Parties. Upon the
resolution of such Dispute, the court shall direct the disposition of the
escrowed funds (including interest accrued) to the prevailing party in
accordance with the court’s ruling on such Dispute together with any damages as
awarded by the court.
12.3 Termination at
Will. BI may terminate this Agreement in its entirety with
ninety (90) days prior written notice to Micromet at any time prior to the First
Commercial Sale of a Product anywhere in the Territory. Thereafter,
BI may terminate this Agreement in its entirety with at least one hundred eighty
(180) days’ prior written notice to Micromet.
12.4 Termination at Certain Decision
Points. If [***] does not take certain
actions as specifically described in
Sections [***] and [***] then [***] may [***] this
Agreement in its entirety with [***] ( [***]
) [***] prior written notice to [***] ; provided,
that [***] shall submit any dispute regarding such
termination right to the dispute resolution procedure described in Section
17.4.2.
13.
|
Effects
of Termination
|
13.1 Program Transfer upon Termination.
Upon any termination of this Agreement, BI will transfer or assign to
Micromet or its designee the materials, documentation, processes, Regulatory
Filings, licenses, and other items as are reasonably necessary for Micromet to
continue the development and commercialization of Products (such transfer,
including the actions listed below hereafter referred to as the “Program Transfer”). Without
limiting the generality of the foregoing, BI hereby agrees to (effective only
upon such termination) the following:
(a) Know-How and
Data. BI will provide Micromet with copies of any Know-How,
data, materials, reports and information in BI’s possession or control that were
developed under this Agreement or in winding down the clinical trials and other
development activities to the extent relating to Products and as far as
reasonably necessary to continue development or Commercialization of the
Products (it being understood that BI will be allowed to retain copies of any
such materials); provided, however, that the manufacture
for commercial sale will be subject to Section 13.1(e) below.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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(b) Regulatory
Filings. BI will transfer to Micromet any Regulatory Filings
and Marketing Approvals for Products.
(c) Clinical Trials. At
BI’s discretion, BI will either (i) transfer to Micromet the management and
continued performance of or (ii) complete at [***]
and [***] any clinical trials for such Product in which at
least one (1) volunteer or patient has been dosed with a Product, provided that
there are no safety issues, at the effective date of termination and keep
Micromet informed of progress in completing such studies.
(d) Existing Product
Supply. BI will transfer to Micromet or destroy, at Micromet’s
decision, on commercially reasonable terms, all clinical and commercial supplies
of such Product in BI’s possession or control.
(e) Future Product
Supply. At BI’s discretion, BI will either: (i) transfer the
manufacturing process as then Controlled by BI and any Third Party manufacturer
of the Product to Micromet or its designee (which will be designated by Micromet
as soon as reasonably practical but in no event later
than [***] ( [***] ) [***] following
the effective date of the termination of this Agreement) including the following
assistance: consulting service, up to two (2) project transfer meetings, access
to BI’s technical experts as necessary to establish and validate such process at
the facility of Micromet or its designee, provided that such assistance is
limited to [***] ( [***]
) [***] [***] within [***] (
[***] ) [***] , with additional support available by mutual agreement
between the Parties and [***] at BI’s [***] ,
or (ii) supply Micromet with such Product for clinical development or commercial
sale on commercially reasonable terms to be agreed upon by the Parties and set
forth in a separate supply agreement (such terms to be substantially similar to
the terms of other arm’s length manufacturing arrangements entered into by BI at
such time, including an audit and inspection right for Micromet to assure
compliance with GxP), with the procedures described in Exhibit K applying to
any failure by the Parties to agree on the terms of such separate agreement
within [***] ( [***]
) [***] following the effective date of the
termination.
(f) Third Party Contracts. BI will
assign to Micromet as far as legally possible any or all agreements between BI
and Third Parties, relating solely to the development or manufacture of such
Product.
(g) Product Marks and Other
Rights. BI will [***] an exclusive,
worldwide, transferrable, irrevocable license (with the right to grant and
authorize the further grant of sublicenses) to Micromet of BI’s entire right,
title and interest in and to any trademarks, trade dress, logos, slogans,
designs and copyrights, in each case relating solely to such Product, including
any registrations for the foregoing.
(h) Reversion of [***]
. BI will [***] to Micromet its interest
in any [***] Technology
or [***] Technology to the extent such interest
was [***] by Micromet to BI pursuant to
Section [***] or by the operation of
Section [***] , respectively.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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(i) Product License. BI
will grant to Micromet a worldwide, royalty-bearing (solely as provided under
the terms of Section 13.2(a) or (b)), transferrable, irrevocable license (with
the right to grant and authorize the further grant of sublicenses) to research,
develop, make, use, offer for sale, sell, import, export and otherwise
commercialize the Product with such license granted on (i) an exclusive basis
(i.e., exclusive as to
the Product) under
any [***] Technology, [***] Technology
and [***] in any [***] Technology
(after having given effect to the [***] in Section 13.1(h)
above); and (ii) a non-exclusive basis under
the [***] Technology and
any [***] Technology. In the event that any
such [***] Technology, [***] Technology, [***] Technology
and any [***] Technology is subject to any Third Party
licenses of BI, any such sublicense to Micromet shall be granted to Micromet
under the same conditions BI has licensed such technology from the respective
Third Party. BI will notify Micromet in advance of the
application of such terms and conditions to Micromet.
(j) [***] Product
License. BI will grant to Micromet a worldwide,
royalty-bearing (solely as provided under the terms of Section 13.2(c)),
transferrable, irrevocable, license (with the right to grant and authorize the
further grant of sublicenses) to research, develop, make, use, offer for sale,
sell, import, export and otherwise commercialize products containing or
comprising [***] to the [***] (other
than [***] ) with such license granted on (i) a non-exclusive basis
under
any [***] Technology, [***] Technology
and [***] Technology and (ii) an exclusive basis
under [***] in any [***] Technology
(after having given effect to the [***] in Section 13.1(h)
above). In the event that any
such [***] Technology, [***] Technology
and any [***] Technology is subject to any Third Party
licenses of BI, any such sublicense to Micromet shall be granted to Micromet
under the same conditions BI has licensed such technology from the respective
Third Party. BI will notify Micromet in advance of the application of
such terms and conditions to Micromet.
(k) [***] Product
License. BI will grant to Micromet a worldwide, non-exclusive,
royalty-free, transferrable, irrevocable license (with the right to grant and
authorize the further grant of sublicenses) to research, develop, make, use,
offer for sale, sell, import, export and otherwise
commercialize [***] Products under
the [***] Technology, [***] Technology
and [***] in any [***] Technology
(after having given effect to the [***] in Section 13.1(h)
above). In the event that any such [***] Technology and
any such [***] Technology is subject to any Third Party
licenses of BI, any such sublicense to Micromet shall be granted to Micromet
under the same conditions BI has licensed such technology from the respective
Third Party. BI will notify Micromet in advance of the application of
such terms and conditions to Micromet.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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(l) [***] Product
License. BI will grant to Micromet a worldwide, non-exclusive,
royalty-bearing (solely as provided under the terms of Section 13.2(d)),
transferrable, irrevocable, license (with the right to grant and authorize the
further grant of sublicenses) to research, develop, make, use, offer for sale,
sell, import and export [***] under
the [***] Technology, [***] Technology,
and [***] in any [***] Technology
(after having given effect to the [***] in Section 13.1(h)
above). In the event that any such [***] Technology and
any such [***] Technology is subject to any Third Party
licenses of BI, any such sublicense to Micromet shall be granted to Micromet
under the same conditions BI has licensed such technology from the respective
Third Party. BI will notify Micromet in advance of the application of
such terms and conditions to Micromet.
(m) BI
Limitations. From and after the effective date of termination,
BI will refrain, and cause its Affiliates to refrain, from granting any right,
license or interest or otherwise transferring its interest in any
(i) [***] Technology
or [***] Technology, to develop (including pre-clinical or
clinical testing), manufacture, market, sell, promote or otherwise commercialize
any [***] [***] the [***] or
(ii) [***] Technology (after having given effect to
the [***] in Section 13.1(h) above) to develop (including
pre-clinical or clinical testing), manufacture, market, sell, promote or
otherwise commercialize any [***] ; provided, that it will not be
a breach of this Section 13.1(m) for BI to
perform [***] Activities, including manufacturing, with
respect to a [***] if such activities are performed by BI
solely as a contract manufacturer on behalf of one or more Third Parties who own
or control such [***] .
13.2 Royalty Payments Following Program
Transfer. Following any Program Transfer, Micromet will pay BI
a royalty in connection with the licenses granted by BI in Sections 13.1(g),
(i), (j), and (l) in accordance with the following:
(a) Product Royalties Applicable in the
Event of Termination [***] to [***] of a [***]
. In the event of any termination of this Agreement
[***] to the [***] of a [***] , Micromet will pay BI a
royalty of [***] % of Net Sales of Products that (i) are [***]
using a [***] that was (a) [***] by BI in connection
with its [***] under this Agreement, (b) [***] for
[***] by BI to Micromet according to Section 13.1(e); and (c)
[***] by BI to Micromet upon Micromet’s confirmation, or (ii) are
[***] or [***] in any [***] within the
[***] Technology, [***] Technology, [***]
Technology, [***] Technology or [***] Technology (after
having given effect to the [***] in Section 13.1(h) above), which
such [***] , in each case, [***] as of the [***]
of [***] . The term of such royalty will commence in any applicable
country upon the First Commercial Sale of such Product in such country and will
expire on a country-by-country basis upon the [***] of the
[***] of any [***] within the [***] [***]
, [***] Technology, [***] Technology, [***]
Technology or [***] Technology that [***] a [***]
, by [***] or [***] of such Product in such
country. If there is no such [***] and the royalty due
under this Section 13.2(a) is due on account of the [***] of
the [***] as described in clause (i) above, then the term of such
royalty will expire on a country-by-country basis [***] the First
Commercial Sale of such Product in such country.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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(b)
Product Royalties
Applicable in the Event of Termination [***] of a [***]
. In the event of any termination [***]
the [***] of a [***] , Micromet will pay BI the
royalties set forth on Exhibit J for Net
Sales of Products in consideration of the licenses granted under Sections
13.1(g) and (i) above. The term of such royalty will commence in any
applicable country upon the First Commercial Sale of a Product in such country
and will expire on a country-by-country basis upon the later of: (i) the
[***] of the [***] of any [***] within the
[***] Technology, [***] Technology, [***]
Technology, [***] Technology or [***] [***]
in any [***] Technology (after having given effect to the
[***] in Section 13.1(h) above) as of the date of such termination
that [***] by the [***] or [***] of the
Product in such country, (ii) the [***] of [***] for
such Product in such country, or (iii) [***] [***] the First
Commercial Sale of such Product in such country.
(c)
Royalties
For [***] Products. In consideration of the
licenses granted by BI under Section 13.1(j) above, Micromet will pay BI a
royalty of [***] % on Net Sales of products licensed under Section
13.1(j), the [***] or [***] of [***]
is [***] or [***] by any [***] of any
[***] within the [***] Technology, [***]
Technology, [***] Technology or [***] Technology (after
having given effect to the [***] in Section 13.1(h) above).
The term of such royalty will commence in any applicable country upon the First
Commercial Sale of a Product in such country and will expire on a
country-by-country basis upon the [***] of the l [***] of
any [***] within the [***] Technology, [***]
Technology, [***] Technology or [***] in any
[***] Technology (after having given effect to the [***] in
Section 13.1(h) above) as of the [***] of such [***]
that [***] by the [***] or [***] of such
product in such country.
(d)
[***]
Royalties. In consideration of the licenses granted to
Micromet under Section 13.1(l), Micromet will pay BI a royalty (to be negotiated
by the Parties in good faith prior to the termination of this Agreement and
subject to the [***] below) on Net Sales of [***] , the
[***] or [***] is [***] or [***] by
any [***] of any [***] within
the [***] Technology
or [***] Technology. The term of such royalty
will commence in any applicable country upon the First Commercial Sale of
a [***] in such country and will expire on a
country-by-country basis upon the [***] of
the [***] of any [***] within
the [***] Technology
or [***] Technology [***] of
the [***] of
such [***] that [***] , by
the [***] or [***] of
the [***] in such country. Any royalty payable
under this Section 13.2(d) shall not exceed [***] % in
the [***] per [***] where
such [***] is [***] by [***] within [***] of
[***]
the [***] Technology
or [***] Technology, respectively, and shall
not [***] % in
the [***] per [***] if
the [***] is [***] by [***] the [***] Technology
and [***] Technology. The procedures described
in Exhibit K
will apply to any failure by the Parties to agree on the amount of such royalty
within [***] ( [***]
) [***] following the effective date of the
termination.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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(e) Royalty Payment
Terms. All royalties payable under this Section 13.2 will be
due within [***] ( [***] ) [***] of
the end of each Calendar Quarter during which there were Net Sales of such
Products in the Territory and will be reported and paid in accordance with the
terms of Section 9 of this Agreement. Following the expiration of the
royalty term in a country for an applicable license described in this Section
13.2 above, such license shall be fully-paid.
13.3 Funding during Notice Period and
Payment of Committed Expenses. During the period from
providing a notice of termination pursuant to Section 12.3 through the
termination of this Agreement, BI will continue to perform the Development Plan
and [***] [***] for
its [***] in accordance with the terms of this Agreement;
provided, that Micromet
will use reasonable efforts to wind down its ongoing activities. In
addition, upon termination of this Agreement pursuant to Section 12.3, BI will
pay to Micromet any non-cancellable amounts that Micromet is obligated to pay to
Third Parties based on legally binding commitments made in accordance with the
Research Plan or Development Plan prior to the date of such notice of
termination.
13.4 Termination of
Licenses. Upon any termination of this Agreement, all rights
and licenses granted by Micromet to BI hereunder will terminate.
13.5 Rights upon
Expiration. Upon expiration of the Royalty Term in all
countries of the ROW Territory for a particular Product and the last Sales
Participation Payment according to Section 8.4.3 in the U.S. for such Product,
BI will have a non-exclusive, fully paid, royalty-free right and license under
all Know-How in the Licensed Technology to make, have made, use, sell, offer for
sale, and import such Product in the Territory in the
Field. Notwithstanding the foregoing, BI will make any payments under
any [***] , the agreements listed in [***] and [***] and any other
payments due to Third Parties for any intellectual property rights licensed to
BI pursuant to this
Agreement, for as long as such payments are due under such agreements, and BI’s
rights as a licensee or sublicensee under such intellectual property rights will
remain subject to BI’s compliance the payment and other terms
thereof.
13.6 Material Breach by
Micromet. In case the court has confirmed a material breach by
Micromet, BI may, within [***] ( [***]
) [***] following such confirmation, upon written notice
to Micromet either terminate this Agreement (with the consequences as outlined
above) or exercise its right under this Section 13.6 to modify the Parties
obligations under this Agreement as follows:
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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(a) All
committees, including the JSC, formed under Section 2 will be disbanded and the
Parties’ obligations under Section 2 (other than Section 2.3) will terminate and
be of no further effect.
(b) Micromet
will terminate and wind down its activities under Section 3
and [***] will have no further obligation whatsoever
to [***] for any [***] that
are [***] after
the [***] of [***] written notice
(other than
any [***] or [***] associated with
such [***] ). Micromet’s obligations under Section 3 shall
terminate and BI shall thereafter be responsible for all development of all
Products.
(c) BI’s
obligations under this Agreement will remain in effect; provided, that BI will not be
obligated to share information with Micromet as described in the terms of
Sections 3, 4 and 5 except for the terms of Section 4.2.2, and Sections 5.3, 5.4
and 5.5. In addition, following the exercise of its rights
under this Section 13.6, BI will deliver to Micromet (i) an overview of BI’s
then-current Development Plan in similar detail as the Initial R&D Plan on
an annual basis not later than [***] of each calendar year
and a summary report of the development and manufacturing activities related to
the Product performed by BI reasonably describing BI’s activity during such
period, key milestones and objectives for such activities and a current timeline
for future activities on a semi-annual basis (not later
than [***] and [***] of each
calendar year), and (ii) a copy of a summary commercial plan that describes the
launch and subsequent Commercialization activities for the Product in the
U.S.
(d) In
the notice delivered under this Section 13.6, BI may elect to terminate
Micromet’s Co-Promotion right under Section 4.5, including the termination of
any Co-Promotion Agreement entered into the Parties under such
Section. In connection with any such termination, (i) the Parties
will have no further obligations under Section 4.5, including the obligation to
enter into a Co-Promotion Agreement and any Co-Promotion Agreement will be
terminated in accordance with the terms of Exhibit G, (ii) the
Sales Participation Payment [***] as provided in
Section [***] , and (iii) BI will be solely responsible for
and [***] and [***] associated with the
Commercialization of Products throughout the Territory during the
Term.
(e) All
licenses granted by a Party to the other Party under this Agreement will
continue in accordance with the terms of this Agreement.
(f) BI
will have the right to set-off, against any payments or other amounts due to
Micromet by BI but not yet paid by BI, all direct damages established in the
litigation under Section 17.4 (or as agreed in writing by Micromet) suffered by
BI, based on the material breach that gave rise to BI’s termination
right. If BI elects this set-off remedy, then such remedy will be
exclusive and in lieu of all other remedies that may be available to BI for such
material breach.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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13.7 Serious Material Breach by a
Party. The Parties acknowledge that certain serious material
breaches may result in substantial harm and damage to the non-breaching Party
and that a court should consider in such case the appropriate economic
remedy—which remedy may include the termination of royalty or other payment
obligations—taking into consideration the harm to the economic value of the
Product, a Party’s investment in such Product and the future economic viability
of the Product to be developed or commercialized in under this Agreement in one
or more specific territories. The Parties agree that a serious
material breach would be an extraordinary circumstance involving a Party’s
intentional or grossly negligent failure to maintain the license rights granted
under this Agreement, to preserve material Confidential Information relating to
the Product, or to maintain any Patent covering the sale of the Product, in each
case that would result in (or would be reasonably expected to result in) the
loss of all intellectual property or regulatory exclusivity for the Product in
all of the Major Markets or would otherwise fundamentally deny a Party the
economic or other benefits conferred under this Agreement.
13.8 Material Breach by
BI. In the case of a material breach by BI which is
disputed by BI and is subsequently confirmed by the court pursuant to Section
17.4, then, notwithstanding any provision in this Agreement to the contrary,
Micromet will be entitled
to [***] or [***] (including [***]
) resulting from
the [***] in [***] and [***] of
the [***] that was caused by such material breach and the
resolution of such dispute in the courts.
13.9 Accrued
Rights. Termination of this Agreement for any reason will be
without prejudice to any rights that will have accrued to the benefit of a Party
prior to the effective date of such termination. Such termination
will not relieve a Party from obligations that are expressly indicated to
survive the termination of this Agreement.
13.10 Survival. Sections
5.4, 5.6, 6.1, 6.2.1, 8 (with respect to any unpaid amounts due), 9, 10, 13, 14,
15, 16 and 17, together with any definitions used or exhibits referenced
therein, will survive any termination or expiration of this
Agreement.
14.
|
Indemnification
and Insurance
|
14.1 Indemnification of
Micromet. BI will indemnify Micromet and its Affiliates, and
their respective directors, officers, and employees (each, a “Micromet Indemnitee”), and
defend and hold each of them harmless from and against any and all losses,
damages, liabilities, costs and expenses (including reasonable attorneys’ fees
and expenses) (collectively, “Losses”) arising in connection
with any and all claims, demands, lawsuits, or investigations by a Third Party
(each a “Third Party
Claim”) against a Micromet Indemnitee, to the extent caused by or arising
out of: (a) any breach by BI of this Agreement, (b) the gross negligence or
willful misconduct on the part of BI, its Affiliates, or contractors in
performing any activity contemplated by this Agreement, (c) the development,
manufacture, use, handling, storage, supply, Commercialization or other
disposition of Product by BI, its Affiliates or its/their sublicensees; or (d)
any [***] by BI or its Affiliates; in each case, excluding
any Losses to the extent Micromet has an obligation to indemnify BI pursuant to
Section 14.2.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
63
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Omitted and Filed Separately
Confidential
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Under
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Execution
Copy
14.2 Indemnification of
BI. Micromet will indemnify BI, its Affiliates, and their
respective directors, officers, and employees (each, a “BI Indemnitee”), and defend
and hold each of them harmless from and against any and all Losses arising in
connection with any Third Party Claim against a BI Indemnitee, to the extent
caused by or arising out of: (a) any breach by Micromet of this Agreement; (b)
the gross negligence or willful misconduct on the part of Micromet, its
Affiliates, or contractors in performing any activity contemplated by
this Agreement; (c) the performance of Micromet’s development activities under
the [***] , or (d) from the manufacture, use, handling, storage,
supply, sale or other disposition of Product by Micromet or its Affiliates, or
contractors; in each case, excluding any Losses to the extent BI has an
obligation to indemnify Micromet and its Affiliates pursuant to Section
14.1.
14.3 Notice of
Claim. All indemnification claims in respect of any BI
Indemnitee or Micromet Indemnitee seeking indemnity under Sections 14.1 or 14.2
(collectively, the “Indemnitees” and each an
“Indemnitee”) will be
made solely by the corresponding Party (the “Indemnified Party”). The
Indemnified Party will give the indemnifying Party (the “Indemnifying Party”) prompt
written notice (an “Indemnification Claim Notice”)
of any Losses or discovery of fact upon which such Indemnified Party intends to
base a request for indemnification under Section 14.1 or Section 14.2, but in no
event will the Indemnifying Party be liable for any Losses that result from any
delay in providing such notice. Each Indemnification Claim Notice
must contain a description of the claim and the nature and amount of such Loss
(to the extent that the nature and amount of such Loss are known at such
time). Together with the Indemnification Claim Notice, the
Indemnified Party will furnish promptly to the Indemnifying Party copies of all
notices and documents (including court papers) received by any Indemnitee in
connection with the Third Party Claim.
14.4 Control of
Defense. At its option, the Indemnifying Party may assume the
defense of any Third Party Claim subject to indemnification as provided for in
Sections 14.1 and 14.2 by giving written notice to the Indemnified Party within
thirty (30) days after the Indemnifying Party’s receipt of an Indemnification
Claim Notice. Upon assuming the defense of a Third Party Claim, the
Indemnifying Party may select and appoint the lead legal counsel for the defense
of the Third Party Claim. Should the Indemnifying Party assume the
defense of a Third Party Claim, the Indemnifying Party will not be liable to the
Indemnified Party or any other Indemnitee for any legal expenses subsequently
incurred by such Indemnified Party or other Indemnitee in connection with the
analysis, defense or settlement of the Third Party Claim, except as provided in
Section 14.5.
*** Certain confidential information contained in this document,
marked by brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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Copy
14.5 Right to Participate in
Defense. Without limiting Section 14.4, any Indemnitee will be
entitled to participate in, but not control, the defense of such Third Party
Claim and to employ counsel of its choice for such purpose; provided, however, that such employment
will be at the Indemnitee’s own expense unless (a) the employment thereof has
been specifically authorized by the Indemnifying Party in writing, or (b) the
Indemnifying Party has failed to assume the defense and employ counsel in
accordance with Section 14.4 (in which case the Indemnified Party will control
the defense).
14.6 Settlement. With
respect to any Losses relating solely to the payment of money damages in
connection with a Third Party Claim and that will not result in the Indemnitee’s
becoming subject to injunctive or other relief or otherwise adversely affect the
business of the Indemnitee in any manner, and as to which the Indemnifying Party
has acknowledged in writing the obligation to indemnify the Indemnitee
hereunder, the Indemnifying Party will have the sole right to consent to the
entry of any judgment, enter into any settlement or otherwise dispose of such
Loss, on such terms as the Indemnifying Party, in its sole discretion, will deem
appropriate. The Indemnifying Party will pay all amounts on behalf of the
Indemnified Party at or prior to the time of the entry of
judgment. With respect to all other Losses in connection with Third
Party Claims, where the Indemnifying Party has assumed the defense of the Third
Party Claim in accordance with Section 14.4, the Indemnifying Party will have
authority to consent to the entry of any judgment, enter into any settlement or
otherwise dispose of such Loss provided it obtains the prior written consent of
the Indemnified Party (which consent will be at the Indemnified Party’s sole and
absolute discretion). The Indemnifying Party that has assumed the
defense of the Third Party Claim in accordance with Section 14.4 will not be
liable for any settlement or other disposition of a Loss by an Indemnitee that
is reached without the written consent of such Indemnifying
Party. Regardless of whether the Indemnifying Party chooses to
defend any Third Party Claim, no Indemnitee will admit any liability
with respect to, or settle, compromise or discharge, any Third Party Claim
without first offering to the Indemnifying Party the opportunity to assume the
defense of the Third Party Claim in accordance with Section 14.5.
14.7 Cooperation. If the
Indemnifying Party chooses to defend any Third Party Claim, the Indemnified
Party will, and will cause each other Indemnitee to, cooperate in the defense
thereof and will furnish such records, information and testimony, provide such
witnesses and attend such conferences, discovery proceedings, hearings, trials
and appeals as may be reasonably requested in connection with the defense of
such Third Party Claim. Such cooperation will include access during
normal business hours afforded to the Indemnifying Party to, and reasonable
retention by the Indemnified Party of, records and information that are
reasonably relevant to such Third Party Claim, and making Indemnitees and other
employees and agents available on a mutually convenient basis to provide
additional information and explanation of any material provided hereunder. The
Indemnifying Party will reimburse the Indemnified Party for all its reasonable
out-of-pocket expenses in connection with such cooperation.
14.8 Expenses. Except as
provided above, the reasonable and verifiable costs and expenses, including fees
and disbursements of counsel, incurred by the Indemnified Party in connection
with any claim will be reimbursed on a calendar quarter basis by the
Indemnifying Party, without prejudice to the Indemnifying Party’s right to
contest the Indemnified Party’s right to indemnification and subject to refund
in the event the Indemnifying Party is ultimately held not to be obligated to
indemnify the Indemnified Party.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
65
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Under
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Copy
14.9 Insurance. During
the Term, each Party will have and maintain such types and amounts of liability
insurance including self-insurance as is normal and customary in the industry
generally for similarly situated parties, and will upon request provide the
other Party with a certificate of insurance in that regard, along with any
amendments and revisions thereto.
15.
|
Representations
and Warranties
|
15.1 Mutual Representations and
Warranties. Each Party hereby represents and warrants to the
other Party that, as of the Effective Date:
15.1.1 Such
Party (a) has the corporate power and authority to enter into this Agreement and
perform its obligations hereunder, and (b) has taken all necessary corporate
action on its part required to authorize the execution and delivery of this
Agreement and the performance of its obligations hereunder.
15.1.2 This
Agreement has been duly executed and delivered on behalf of such Party and
constitutes a legal, valid and binding obligation of such Party and is
enforceable against it in accordance with its terms subject to the effects of
bankruptcy, insolvency or other laws of general application affecting the
enforcement of creditor rights and judicial principles affecting the
availability of specific performance.
15.1.3 The
execution and delivery of this Agreement and the performance of such Party’s
obligations hereunder (a) do not conflict with or violate any requirement of any
provision of the articles of incorporation, bylaws or any similar instrument of
such Party in any material way, and (b) do not conflict with, violate, or breach
or constitute a default or require any consent under, any contractual obligation
or court or administrative order by which such Party is bound.
15.2 Additional Representations and
Warranties of Micromet. Micromet hereby represents and
warrants to BI that, as of the Effective Date:
15.2.1 Micromet
is a corporation duly organized, validly existing and in good standing under the
laws of Germany, and has full corporate power and authority and the legal right
to own and operate its property and assets and to carry on its business as it is
now being conducted and as it is contemplated to be conducted by this
Agreement.
15.2.2 Micromet
has the right and authority to grant the rights and licenses granted to BI
pursuant to the terms and conditions of this Agreement, and Micromet has not
granted any right, license, or interest in, to, or under
the [***] Technology that is inconsistent with the rights,
licenses, and interests granted to BI under the terms and conditions of this
Agreement.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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Execution
Copy
15.2.3 To
the knowledge of Micromet’s officers and Micromet’s Intellectual Property
department (after due inquiry): (i) Micromet has not received any written
allegation from a Third Party that any Patent within
the [***] Technology is invalid or unenforceable and (ii)
no Patent within the [***] Technology is subject to
interference, reexamination, reissue, revocation, opposition, appeal or other
administrative proceedings.
15.2.4 Micromet
has not received, with respect to the [***] Technology,
any notice of infringement or any written communication relating in any way to a
possible infringement of any Third Party patent rights by its activities prior
to the Effective Date or the activities of either Party contemplated by this
Agreement.
15.3 Additional Representations and
Warranties of BI. BI hereby represents and warrants to
Micromet that, as of the Effective Date:
15.3.1 BI
is a corporation duly organized, validly existing and in good standing under the
laws of Germany, and has full corporate power and authority and the legal right
to own and operate its property and assets and to carry on its business as it is
now being conducted and as it is contemplated to be conducted by this
Agreement.
15.3.2 BI
has the right and authority to grant the rights and licenses granted to Micromet
pursuant to the terms and conditions of this Agreement, and BI has not granted
any right, license, or interest in, to, or under
the [***] Technology that is inconsistent with the rights,
licenses, and interests granted to Micromet under the terms and conditions of
this Agreement.
15.3.3 To
the knowledge of BI’s officers and the head of BI’s Intellectual Property
department (i) BI has not received any written allegation from a Third Party
that any Patent within the [***] Technology that relates
to the [***] or a Product is invalid or unenforceable and
(ii) no Patent within the [***] Technology that relates to
the [***] or a Product is subject to interference,
reexamination, reissue, revocation, opposition, appeal or other administrative
proceedings.
15.3.4 BI
has not received, with respect to the [***] Technology,
any notice of infringement or any written communication relating in any way to a
possible infringement of any Third Party patent rights by its activities prior
to the Effective Date relating to the [***] or the
activities of either Party contemplated by this Agreement.
15.3.5 Exhibit L sets forth
all Patents within the [***] Technology that claim or
cover the [***] , [***] ,
or [***] that target the [***] .
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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Copy
15.4 Compliance. Each
Party will conduct its respective activities under this Agreement with respect
to a Product in good scientific manner, and in compliance in all material
respects with all requirements of Applicable Laws and solely in accordance with
the then-current Research Plan or Development Plan, as applicable.
16.
|
Disclaimer;
Limitation of Liability
|
16.1 Disclaimer of
Warranty. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN
SECTION 15, BI AND MICROMET MAKE NO REPRESENTATIONS AND GRANT NO WARRANTIES,
EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR
OTHERWISE, AND BI AND MICROMET EACH SPECIFICALLY DISCLAIM ANY OTHER
REPRESENTATIONS AND WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS, STATUTORY OR
IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A
PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR
THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES.
16.2 Limitation of
Liability. EXCEPT AS SPECIFICALLY SET FORTH IN SECTION 13.8 IN
NO EVENT WILL EITHER PARTY BE LIABLE FOR LOST PROFITS, OR FOR ANY SPECIAL,
INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES HOWEVER CAUSED, ON ANY
THEORY OF LIABILITY AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES, ARISING UNDER ANY CAUSE OF ACTION AND ARISING IN
ANY WAY OUT OF THIS AGREEMENT. THE FOREGOING LIMITATIONS WILL NOT
APPLY TO AN AWARD OF ENHANCED DAMAGES AVAILABLE UNDER THE PATENT LAWS FOR
WILLFUL PATENT INFRINGEMENT AND WILL NOT LIMIT EITHER PARTY'S OBLIGATIONS TO THE
OTHER PARTY UNDER SECTIONS 10 AND 14.
17.
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Miscellaneous
|
17.1 Force
Majeure. Neither Party will be held liable or responsible to
the other Party or be deemed to have defaulted under or breached this Agreement
for failure or delay in fulfilling or performing any term of this Agreement when
such failure or delay is caused by or results from events beyond the reasonable
control of the non-performing Party, including fires, floods, embargoes,
shortages, epidemics, pandemics, quarantines, war, acts of terrorism, acts of
war (whether war be declared or not), insurrections, riots, civil commotion,
strikes, lockouts or other labor disturbances, acts of God or acts, omissions or
delays in acting by any Governmental Authority. The non-performing
Party will notify the other Party of such force majeure within ten (10) Business
Days after such occurrence by giving written notice to the other Party stating
the nature of the event, its anticipated duration, and any action being taken to
avoid or minimize its effect. The suspension of performance will be
of no greater scope and no longer duration than is necessary and the
non-performing Party will use commercially reasonable efforts to remedy its
inability to perform.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
68
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Under
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17.2 Assignment. Neither
Party will sell, transfer, assign, delegate, pledge or otherwise dispose of,
whether voluntarily, involuntarily, by operation of law or otherwise, this
Agreement or any of its rights or obligations under this Agreement without the
prior written consent of the other Party (which consent may be granted, withheld
or conditioned at such other Party’s sole and absolute discretion); provided, however, that either Party
may assign or transfer this Agreement or any of its rights or obligations under
this Agreement without the consent of the other Party (a) to any Affiliate of
such Party, provided that such transfer and assignment will be effective for
only so long as such Affiliate remains an Affiliate, or (b) to any Third Party
with which it merges or consolidates, or to which it transfers all or
substantially all of its assets. In addition, in the event that in
connection with any Change of Control of, or the acquisition of a Third Party by
BI, a Governmental Authority requires the sale, transfer or divestiture of BI’s
rights in and to a Product, then BI may assign this Agreement in whole or in
part to a Third Party, within the [***] ( [***]
) [***] period following the closing of such Change of
Control or acquisition, subject to Micromet’s consent not to be unreasonably
withheld (it being understood that such consent may be withheld, among other
reasons, in the event such Third Party is developing or commercializing a
product that may be competitive with a Product). Any such assignment
will not be effective unless and until the relevant Affiliate assignee, Third
Party assignee or surviving entity assumes in writing all of the assigning
Party’s obligations under this Agreement. A copy of such written
assumption of obligations will be provided to the other Party upon
request. Any purported assignment or transfer in violation of this
section will be void ab initio
and of no force or effect.
17.3 Severability. If
any provision of this Agreement is held to be illegal, invalid or unenforceable
under any present or future law, and if the rights or obligations of either
Party under this Agreement will not be materially and adversely affected
thereby, (a) such provision will be fully severable, (b) this Agreement will be
construed and enforced as if such illegal, invalid or unenforceable provision
had never comprised a part of this Agreement, (c) the remaining provisions of
this Agreement will remain in full force and effect and will not be affected by
the illegal, invalid or unenforceable provision or by its severance from this
Agreement, and (d) in lieu of such illegal, invalid or unenforceable provision,
there will be added automatically as a part of this Agreement a legal, valid and
enforceable provision as similar in terms to such illegal, invalid or
unenforceable provision as may be possible and reasonably acceptable to the
Parties.
17.4 Governing Law; Dispute
Resolution.
17.4.1 This
Agreement, and any claim, dispute, or controversy of whatever nature arising out
of or relating to this Agreement will be governed by and construed in accordance
with the laws of Germany, without giving effect to any principles, statutory
provisions or other rules of choice of law that would require the application of
the laws of a different country.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
69
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Under
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Execution
Copy
17.4.2 The
Parties will try to settle their differences amicably between themselves and
according to the escalation and communication procedures stipulated in this
Agreement. If any claim, dispute, or controversy of whatever nature
arising out of or relating to this Agreement, including the performance or
alleged non-performance of a Party of its obligations under this Agreement
arises between the Parties (each a “Dispute”), a Party will,
before initiating any proceedings pursuant to Section 17.4.3, notify the other
Party in writing of such Dispute. If the Parties are unable to
resolve the Dispute within [***] ( [***]
) [***] of receipt of the written notice by the other
Party, such dispute will be referred to the Executive Officers of each of the
Parties who will meet in person at least once and use their good faith efforts
to resolve the Dispute within [***] ( [***]
) [***] after such referral.
17.4.3 If
a Dispute is not resolved as provided in the preceding Section 17.4.2, whether
before or after termination of this Agreement, the Parties hereby agree that all
Disputes will be submitted exclusively to the courts of competent jurisdiction
located in Dusseldorf, Germany. Each Party hereby consents to
personal jurisdiction and venue in, and agrees to service of process issued or
authorized by, such court. Notwithstanding the foregoing, either Party may seek
injunctive relief in any court in any jurisdiction where
appropriate. Each Party will pay its legal fees and costs related to
the litigation (including witness and expert fees).
17.5 Notices. All
notices or other communications that are required or permitted hereunder will be
in writing and delivered personally, sent by facsimile (and promptly confirmed
by personal delivery or overnight courier as provided in this Agreement), or
sent by internationally-recognized overnight courier addressed as
follows:
If to BI,
to:
Boehringer
Ingelheim International GmbH
Binger
Str. 173
55216
Ingelheim
Germany
Attention:
Head of PM Business Development & Licensing/Strategy
Facsimile:
[***]
with a
copy to:
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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Treatment Requested
Under
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Execution
Copy
Boehringer
Ingelheim International GmbH
Binger
Str. 173
55216
Ingelheim
Germany
Attention:
Head of Business Law
Facsimile:
[***]
If to
Micromet, to:
Micromet
AG
Staffelseestr.
2
81477
Munich
Germany
Attention:
Head of Business Development
Facsimile:
[***]
with a
copy to:
Micromet,
Inc.
6707
Democracy Boulevard
Suite
505
Bethesda,
MD 20817
Attention:
General Counsel
Facsimile:
[***]
or to
such other address as the Party to whom notice is to be given may have furnished
to the other Party in writing. Any such communication will be deemed
to have been given (i) when delivered, if personally delivered or sent by
facsimile on the same day if a Business Day and if not on the next business day
following delivery, and (ii) on the second business day after dispatch, if sent
by internationally-recognized overnight courier. It is understood and
agreed that this Section 17.5 is not intended to govern the day-to-day business
communications necessary between the Parties in performing their obligations, in
due course, under the terms of this Agreement.
17.6 Entire Agreement;
Modifications. This Agreement sets forth and constitutes the
entire agreement and understanding between the Parties with respect to the
subject matter of this Agreement and all prior agreements, understanding,
promises and representations, whether written or oral, with respect thereto are
superseded by this Agreement, including the Confidentiality Agreement between
the Parties dated June 25, 2008. Each Party confirms that it is not
relying on any representations or warranties of the other Party except those
that are expressly made in this Agreement. No amendment or
modification of this Agreement will be binding upon the Parties unless made in
writing and duly executed by authorized representatives of both
Parties.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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Under
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Execution
Copy
17.7 Relationship of the
Parties. The relationship between the Parties is and will be
that of independent contractors, and does and will not constitute a partnership,
joint venture or agency. Neither Party will have
the authority to make any statements, representations or commitments of any
kind, or to take any actions, which are binding on the other Party, except with
the prior written consent of the other Party to do so. All persons
employed by a Party will be employees of such Party and not of the other Party
and all costs and obligations incurred by reason of any such employment will be
for the account and expense of such Party.
17.8 Waiver. Any term or
condition of this Agreement may be waived at any time by the Party that is
entitled to the benefit of such term or condition, but no such waiver will be
effective unless set forth in a written instrument duly executed by or on behalf
of the Party waiving such term or condition. The waiver by either
Party of any right under this Agreement or of claims based on the failure to
perform or a breach by the other Party will not be deemed a waiver of any other
right under this Agreement or of any other breach or failure by said other Party
whether of a similar nature or otherwise.
17.9 Counterparts. This
Agreement may be executed in two (2) or more counterparts, each of which will be
deemed an original, but all of which together will constitute one and the same
instrument.
17.10 No Benefit to Third
Parties. The representations, warranties, covenants and
agreements set forth in this Agreement are for the sole benefit of the Parties
hereto and their successors and permitted assigns, and they will not be
construed as conferring any rights on any other parties.
17.11 Further
Assurance. Each Party will duly execute and deliver, or cause
to be duly executed and delivered, such further instruments and do and cause to
be done such further acts and things, including the filing of such assignments,
agreements, documents and instruments, as may be necessary or as the other Party
may reasonably request in connection with this Agreement or to carry out more
effectively the provisions and purposes, or to better assure and confirm unto
such other Party its rights and remedies under this Agreement.
17.12 English
Language. This Agreement has been written and executed in the
English language. Any translation into any other language will not be
an official version hereof, and in the event of any conflict in interpretation
between the English version and such translation, the English version will
control.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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Under
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Execution
Copy
17.13 Construction. Except
where the context otherwise requires, wherever used, the singular will include
the plural, the plural the singular, the use of any gender will be applicable to
all genders, the word “or” is used in the inclusive sense (and/or) and the terms
“will” and “shall” shall be construed to have the same meaning. The
captions of this Agreement are for convenience of reference only and in no way
define, describe, extend or limit the scope or intent of this Agreement or the
intent of any provision contained in this Agreement. The term
“including” as used herein means including, without limiting the generality of
any description preceding such term. References to “Section” or
“Exhibit” are references to the numbered sections of this Agreement and the
exhibits attached to this Agreement, unless expressly stated
otherwise.
[Remainder
of this page is left blank intentionally]
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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IN WITNESS WHEREOF, the
Parties hereto have caused this Agreement to be executed by their duly
authorized representatives as of the date first above written.
Micromet
AG
|
Boehringer
Ingelheim
|
|||
International
GmbH
|
||||
By:
|
/s/ Jens Hennecke
|
By:
|
/s/ Stephan Lensky
|
|
Name:
|
Jens
Hennecke
|
Name:
|
Dr.
Stephan Lensky
|
|
Title:
|
SVP
Business Development,
|
Title:
|
Head
of Strategic Transactions &
|
|
Vorstand
|
Alliance
Management
|
|||
By:
|
/s/ Patrick Baeuerle
|
By:
|
/s/ Dorothee
Schwall-Rudolph
|
|
Name:
|
Patrick
Baeuerle
|
Name:
|
Dorothee
Schwall-Rudolph
|
|
Title:
|
SVP
& CSO, Vorstand
|
Title:
|
Corporate
Counsel
|
|
Legal
Department Review:____
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
74
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Exhibit
A
Collaboration
Target
Amino
acid sequence ( [***] of [***] ):
[***]
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Exhibit
B
Joint
Project Teams
Creation Time
|
Responsibilities
|
Frequency of Meeting/
|
|||||
Joint
Research Project Team (“JRPT”)
|
Promptly
following the Effective Date
|
·
|
Oversee
the day-to-day activities of the Parties in the performance of the
Research Plan
|
At
least once per calendar quarter, until selection of a [***] ;
thereafter, as needed for any [***]
|
|||
·
|
Develop
and propose updates to the Research Plan for review and approval by the
JSC
|
||||||
·
|
Provide
a quarterly written report to the JSC summarizing the Parties’ progress
with respect to the research of Products under this
Agreement
|
||||||
·
|
Take
such other actions as are expressly delegated to the JRPT by the JSC or by
the terms of this Agreement
|
||||||
Joint
Development Project Team (“JDPT”)
|
After
selection of the first [***]
|
·
|
Oversee
the day-to-day activities of the Parties in the performance of the
Development Plan
|
Once
per calendar quarter until [***] l in
the [***]
|
|||
·
|
Develop
and propose updates to the Development Plan for review and approval by the
JSC
|
||||||
·
|
Provide
a quarterly written report to the JSC summarizing the Parties’ progress
with respect to the development of Products under this
Agreement
|
||||||
·
|
Take
such other actions as are expressly delegated to the JDPT by the JSC or by
the terms of this
Agreement
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Joint
Commercialization Project Team (“JCPT”)
|
Upon
execution of the Co-Promotion Agreement
|
·
|
Oversee
the activities of the Parties according to the U.S. Commercialization Plan
and review the ROW Commercialization Plan
|
At
least once per quarter during such time as Products are co-promoted in the
U.S. under this Agreement and the Co-Promotion Agreement
|
|||
·
|
Coordinate
the activities of the Parties pursuant to the Co-Promotion
Agreement
|
||||||
·
|
If
required by the JSC, provide a quarterly written report to the JSC
summarizing the Parties’ progress with respect to the co-promotion of
Products under this Agreement in the U.S.
|
||||||
·
|
Take
such other actions as are expressly delegated to the JCPT by the JSC or by
the terms of this
Agreement
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Exhibit
C
Initial
R&D Plan
(i) Activity
list
[***]
Activity
list: overview of [***] per quarter
[***]
Activity
list: overview of [***] at [***] per
quarter
[***]
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
(ii)
Summary of work packages
[***]
(iii)
Project overview
[***]
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Exhibit
D
Patents
within [***] Technology
[***]
Application
Number
|
Application
Filing Date
|
Country
|
Title of Application
|
Status
|
Patent Number
|
|||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
||||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
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[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
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[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
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[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
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[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
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[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
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[***]
|
[***]
|
[***]
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[***]
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[***]
|
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[***]
|
[***]
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[***]
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[***]
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[***]
|
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[***]
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[***]
|
[***]
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[***]
|
[***]
|
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[***]
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[***]
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[***]
|
[***]
|
[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Application
Number
|
Application
Filing Date
|
Country
|
Title of Application
|
Status
|
Patent Number
|
|||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
||||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
[***] [***]
Application
Number
|
Application
Filing Date
|
Country
|
Title of Application
|
Status
|
Patent Number
|
|||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
||||||
[***]
|
[***]
|
[***]
|
[***]
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[***]
|
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[***]
|
[***]
|
[***]
|
[***]
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[***]
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[***]
|
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[***]
|
[***]
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[***]
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[***]
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[***]
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[***]
|
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
|
[***]
|
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[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
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[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Exhibit
E
[***]
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Exhibit
F
[***]
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
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[***]
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[***]
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[***]
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[***]
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[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Exhibit
G
Material
Terms of Co-Promotion Agreement
INTRODUCTION
Subject
to the terms and conditions of the Agreement, Micromet has the right to
co-promote the Product in the United States by
providing [***] in the level of sales Details in
accordance with the U.S. Commercialization Plan. This schedule
outlines the framework for this part of the collaboration to be negotiated in
good faith by the Parties pursuant to Section 4.5.1 of the Agreement which the
Parties agree to adhere to for the Co-Promotion Agreement as
follows:
As used
in this Exhibit G,
“Co-promote”
shall mean to promote jointly a Product through BI (or any Affiliate
Sublicensees) and Micromet's (or its Affiliates’) own respective sales forces
under a single trademark.
“Details”
shall mean face to-face sales presentations with the primary purpose to discuss
the benefits and features of the Product made to target physicians, nurses,
pharmacists and other individuals who provide health care services to patients,
however shall exclude any presentations provided by other means, e.g. via e-mail
or internet and/or a participation in a speaker program.
“Co-Promotion
Term” shall mean, on a Product-by-Product basis, the time period beginning with
the execution of the Co-Promotion Agreement and ending at the expiry of the
Sales Participation Term for such Product, unless the Co-Promotion Agreement is
terminated earlier as provided in Section 11 of this Exhibit G.
“ [***]
Threshold” shall mean that a Product, at any time following First Commercial
Sale in the U.S., [***] to [***] worldwide [***] of [***] in [***] consecutive
[***] ; provided, that
if a Party exercises its [***] rights under this Exhibit G for [***] to meet the
foregoing [***] during the [***] following First Commercial Sale in the U.S.
then the following conditions also shall be satisfied (i) the [***] for the
Product in the U.S. between the [***] and [***] is [***] and (ii) the
then-current Development Plan (applying Commercially Reasonable Efforts) does
not provide for the launch of a new indication or other Regulatory Approval in
the U.S. that [***] to result in the [***] in excess of [***] . The Parties will
refer any dispute regarding the application of the [***] Threshold to the
dispute resolution procedure set forth in Section 17.4.2 of the
Agreement.
All
Section references included in this Exhibit G refer to the Agreement, unless
otherwise provided. Any capitalized terms not defined in this Exhibit G shall
have the meaning set forth in the Agreement.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
1.
|
GENERAL
OBJECTIVE
|
Promoting
and Detailing the Product(s) in the United States to optimize the
commercialization of such Product(s) in the U.S. The Parties agree that that
promotional activities in combination with Detailing and alternative
measurements of sales activity, such as number of field sales representatives
[***] the [***] of
their [***] on a Product, shall be reasonably considered
when negotiating the Co-Promotion Agreement given current market conditions for
the Product.
2.
|
GRANT OF CO-PROMOTION
RIGHTS TO MICROMET
|
Subject
to the terms of the Co-Promotion Agreement:
|
2.1.
|
Micromet
will have a co-exclusive right and obligation, together with BI or its
Affiliates in the U.S., to co-promote the Product during the Co-Promotion
Term with its or its Affiliates’ own established sales
force.
|
|
2.2.
|
Micromet
will not directly or indirectly sell, promote or Detail the Product for
any indication in the U.S., other than pursuant to the Co-Promotion
Agreement. In addition, each Party will not grant any rights to
or permit or authorize any Third Party to co-promote and/or Detail the
Product for any indication in the U.S., except in connection with a
permitted transfer of the Co-Promotion Agreement described in Section 11
of this Exhibit G.
|
3.
|
COMMITTEE AND
RESPONSIBILITY
|
|
3.1.
|
According
to Section 2.2.1 and this Exhibit G, Micromet and BI shall establish a
Joint Commercialization Project Team (JCPT) with [***]
. The JCPT shall be responsible for managing the deployment of
the Micromet and BI field sales forces to ensure that the most recent U.S.
Commercialization Plan is successfully implemented and that the required
numbers of Details are being made to the appropriate
targets. The JCPT will review and implement, after JSC
approval, the U.S. Commercialization Plan [***]
. [***]
|
|
3.2.
|
The
JCPT shall meet [***] unless otherwise mutually
agreed by the Parties. Either Party may replace its respective JCPT
representative(s) at any time with prior written notice to the other
Party. The JCPT Leader of each Party shall ensure that the
necessary information is distributed to the respective JCPT members as
well as other personnel of such Party, on a need to know
basis. The terms of Section 2.2 will apply to the activities of
the JCPT.
|
|
3.3.
|
Each
Party will bear its own costs, including travel and lodging costs, and any
other expenses, for personnel serving on the
JCPT.
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
4.
|
U.S. COMMERCIALIZATION
PLAN
|
The
Parties will co-promote the Product according to the most recent U.S.
Commercialization Plan then in effect for such Product in the United
States. BI will be responsible for preparing and updating the U.S.
Commercialization Plan for further discussion at the JCPT [***]
. [***] The U.S. Commercialization Plan will
be consistent with the terms of the Agreement (including this Exhibit G) and
include a detailed plan of marketing and promotional tactics and implementation,
target list, Detailing requirements, a reasonable allocation of responsibilities
between the Parties with respect to Key Opinion Leaders (KOLs), and a strategic
marketing and promotional plan for the U.S. [***]
5.
|
TRAINING AND
COMMENCEMENT OF CO-PROMOTION
|
|
5.1.
|
BI
shall provide, [***] to Micromet (i) reasonable
quantities of training materials appropriate to train sales
representatives for the co-promotion of the Product, and (ii) the same
sales training on each Product for Micromet Sales representatives who will
be promoting such Product as the training on the Product BI provides to
its own sales representatives who promote such Product in the United
States. Micromet shall be responsible for the travel and
housing costs of its Sales representatives for such training with no
reimbursement of such costs by BI.
|
|
5.2.
|
During
the Co-Promotion Term, subject to coordination and agreement between the
Parties, each Party will have the right to attend and participate in any
Product-related meetings for the United States of the other Party’s sales
representatives for the purposes of co-promotion of the Product, including
any regional, district or launch meetings during which such Party’s sales
representatives will receive either formal or informal training about the
Product, market conditions or competitive products. Each Party
will provide the other Party with reasonable advance notice of any such
meeting for this purpose. Each Party will make reasonable
efforts to keep the Product-related portions of such meetings independent
from other matters.
|
6.
|
CUSTOMER AND TRADE
CONTACTS
|
BI will
be solely responsible for all contracts and contacts with wholesalers, retailers
and all other Third Party purchasers, including managed care organisations
(public and commercial), hospitals and clinical centers, governmental entities,
etc., consistent with the strategies set forth in the most recently updated U.S.
Commercialization Plan; provided, that the foregoing
will not limit Micromet’s ability to conduct Detailing to applicable target
physicians and other applicable persons.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
7.
|
DETAILING
|
7.1.
|
Co-Promotion
Efforts
|
Both BI
and Micromet will deploy their respective sales representatives effectively to
co-promote the Product in the United States in accordance with the terms of the
Agreement, the Co-Promotion Agreement and the most recently updated U.S.
Commercialization Plan. In conducting such co-promotion, Micromet and
BI will use Commercially Reasonable Efforts consistent with generally accepted
pharmaceutical industry business practices and in compliance with all Applicable
Laws. Each Party shall only use appropriately qualified and trained sales
representatives with good knowledge in the oncological area. Each Party will
maintain those records required by Applicable Law in connection with such
co-promotion activities and Micromet will allow BI to inspect such records on
reasonable request. Each Party will have and maintain a formalized
comprehensive compliance plan and program in place during the Co-Promotion
Term. BI will have the right to review Micromet’s policies and may
provide comments to facilitate compliance with Applicable Laws and industry
practices. Representatives of each Party, or their designees, will
meet periodically to evaluate Micromet’s marketing and promotional practices in
order to ensure that they remain compliant with Applicable Laws and industry
practices. The Co-Promotion Agreement will contain an appropriate
mechanism to address and correct any actual or potential non-compliance of
Micromet’s marketing and/or promotional practices with Applicable Law or
industry practices.
7.2.
|
Detailing
Requirements
|
Each
Party will receive and be responsible for
performing [***] in the level of sales Details target set
forth in the then-current U.S. Commercialization Plan. The U.S.
Commercialization Plan will allocate Detailing priority (e.g. primary or
secondary Details) and Detailing targets (including applicable target physician
groups, centers of excellence, high prescribing physicians and geographic
territories) in a reasonable and equitable manner as between the
Parties.
|
7.3.
|
Increases
in Detailing
|
Each
Party, in its sole discretion, may increase its Detailing activities above its
Detailing requirements at any time and at [***] . Any such
increase will not obligate the other Party to increase its Detailing activities
or [***] , including [***] , except that BI will provide
Micromet with reasonable additional quantities of promotional materials or
sample packs as Micromet may request to the extent reasonably
available. In addition, any increase in Detailing will be coordinated
with the other Party so that the strategies set forth in the most recently
updated U.S. Commercialization Plan are followed.
|
7.4.
|
Distribution
of Targeted Doctors
|
BI will
be responsible for annually preparing and updating a target call list of health
care professionals (including KOLs) to whom each of BI and Micromet will provide
Details together with an allocation of promotional activities directed at KOLs,
which shall be discussed in the JCPT and reasonably incorporating Micromet’s
comments and suggestions with respect to any additions/deletions to the target
call list(s) and shall be finally approved by the JSC. The targets
will be [***] assigned to each Party in the target call
list, reflecting an equal allocation of Detailing efforts, targets represented
over the United States, and health care professional
specialists. Consistent with the foregoing, the Parties will discuss
and reasonably consider in good faith an allocation of Details by target
prescribing physician groups based upon then-current market conditions and the
capabilities and other promotional activities of a Party [***]
.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
|
7.5.
|
Field Sales
Force Expenses
|
Each
Party will be responsible for its own respective sales representatives and
internal marketing organizations and the expenses of its sales representatives,
except as specified otherwise in this Exhibit G with respect to training and
promotional support to be provided by BI.
|
7.6.
|
Incentives
|
Each
Party will reward its personnel for promoting the Product
through [***] .
|
7.7.
|
Detailing
Reports
|
On a
periodic basis (to be agreed upon) each Party will provide to the JCPT a
comprehensive Detailing report, including, for example: number of Details, the
use of sample packs (if any), and such other details concerning frequency and
other similar Detailing data, including coverage by specialty, number of group
Details, as may be mutually agreed upon. Both Parties will keep accurate and
complete electronic records in a reasonably acceptable format of each Detail
carried out by its sales representatives.
|
7.8.
|
Detailing
Shortfalls
|
The
Parties will agree to a minimum Detail performance level for the Parties
(e.g., [***] % of the Party’s U.S. Commercialization Plan
requirements), and a [***] mechanism
(and/or [***] right) in the event that the
performance [***] .
|
7.9.
|
Contract
Sales Forces
|
Each
Party shall use its own professional sales representatives and may not
subcontract its field sales force (i.e. contract sales force) to fulfil its
co-promotion obligations, unless otherwise expressly agreed by the other
Party.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
8.
|
PROMOTIONAL AND
SAMPLING ACTIVITIES
|
|
8.1.
|
Promotional
Activities
|
With
respect to the co-promotion of each Product, BI will be solely responsible for
creating, approving, and producing all promotional materials and will keep
Micromet via the JCPT reasonably informed, subject to the terms of the
Agreement. BI will provide Micromet with a level of sales and
promotional support comparable to the support BI provides to its sales
force. BI will own all rights to all promotional materials, including
all copyrights. No Product label, labelling or promotional materials
will be used or distributed by the Parties, unless approved by
BI. Micromet’s sales representatives will conduct only those
promotional and other sales activities relating to the Product that have been
approved in advance in accordance with the most recently updated U.S.
Commercialization Plan. Micromet’s sales representatives shall not
modify, change or alter the promotional, advertising, educational and
communication materials provided by BI in any way whatsoever, without the
express prior written consent of BI. Each Party’s sales
representatives shall use such materials solely for the purpose of performing
their obligations under this Agreement. Micromet shall ensure that
its sales representatives perform in compliance with all Applicable Laws, rules
and regulations.
|
8.2.
|
Sample
Packs and Promotional
Materials
|
BI will
provide Micromet [***] , with promotional, advertising, educational
and communication materials, consistent with the most recently updated U.S.
Commercialization Plan and at least as comparable as BI provides to its sales
representatives. Sample packs, in case BI decides to use sample packs
of the Product, and promotional materials will be allocated to each Party on an
equitable basis, based on the Parties’ Detailing requirements under the U.S.
Commercialization Plan. Micromet will use sample packs strictly in
accordance with the U.S. Commercialization Plan and will distribute sample packs
in full compliance with all Applicable Laws. BI will be responsible
for the filing of any necessary sample pack reports with the
FDA. Micromet’s sales representatives will utilize only the
promotional, advertising, educational and communication materials so approved
and provided to them by BI, and will not utilize any other promotional,
advertising, educational or communication materials or other materials relating
to or referring to the Product. All promotional material will be
owned by BI, and Micromet will have no rights with respect to such promotional
materials other than the right to use the promotional materials for the
performance of the co-promotion. Micromet will not reproduce any
promotional materials without the prior written consent of BI. If
promotional materials are removed from circulation, Micromet will immediately
advise its sales representatives to discontinue use of the previously approved
promotional materials and destroy or return them to BI as the Parties
agree.
|
8.3.
|
Packaging,
No Alteration or Repackaging
|
To the
extent allowable by Applicable Law, Product packaging, promotional materials and
Product labeling for use in the U.S. will carry, in an appropriate location, the
Micromet Marks, subject to BI’s reasonable approval of the size, position and
location thereof. Micromet will not alter any promotional materials,
labels or sample packs provided by BI, repackage any product or sample packs, or
use any promotional materials, labels or sample packs not provided or approved
by BI in connection with the Product.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
9.
|
SALES PROCESSING AND
PRODUCT DISTRIBUTION.
|
|
9.1.
|
Sales
Processing
|
If for
any reason Micromet receives orders for the Product, Micromet will promptly
forward such orders to BI or its designee.
|
9.2.
|
Pharmacovigilance
|
The
Co-promotion Agreement shall contain such terms as are necessary to enable the
Parties to fulfil their pharmacovigilance obligations under Applicable Laws and
to exchange Medical and Drug Information as permitted under Applicable
Laws.
|
9.3.
|
Communication
with Regulatory Authorities
|
Subject
to Section 5.2, BI shall remain solely responsible for all communications with
Regulatory Authorities in the United States.
|
9.4.
|
Product
liability (including product
recalls)
|
BI shall
be solely responsible for the safety, quality and efficacy of all Products
marketed in the United States and any claims arising from use made of any
Product. In the event of a Product recall, the Parties shall
cooperate with each other as reasonably requested in conducting such recall in
accordance with the terms of the Agreement.
10.
|
TRANSFERABILITY
|
The
co-promotion right under Section 4.5.1 or any resulting Co-Promotion Agreement
between the Parties shall not be assignable, sublicenseable or transferable by
either Party, except to an Affiliate or to any Third Party in connection with an
assignment or transfer of the Agreement permitted under Section 17.2; provided, that the foregoing
shall not limit BI’s rights under Section 4.5.3.
11.
|
TERMINATION
|
11.1.
|
Micromet
Termination Rights. Micromet shall have the right to
terminate the Co-Promotion Agreement with respect to a Product upon any of
the following: (a) [***] ( [***] ) [***]
prior written notice to BI (or upon [***] ( [***] )
[***] prior written notice if such termination will be effective
upon the expiration of the Sales Participation Term) for any reason other
than those specified in the following subsections; (b) upon
[***] ( [***] ) [***] written notice if a Product
[***] the [***] which may be exercised in the
[***] ; (c) upon [***] ( [***] ) [***] notice if
the reduction for [***] Competition under Section 8.4.5
applies to the Product for the U.S.; and (d) upon [***] (
[***] ) [***] written notice following an uncured material
breach (to be defined in the Co-Promotion Agreement) by BI of the
Co-Promotion Agreement that is confirmed pursuant to the dispute
resolution process set forth in Section
17.4.
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
11.2.
|
Financial
Consequences of Termination by Micromet. In addition to the
consequences described in Section 11.6 of this Exhibit G, upon any
termination by Micromet the Sales Participation Payments payable to
Micromet under Section 8.4.3 shall be [***] as
follows:
|
|
·
|
[***]
% as provided in [***] for any [***] in accordance
with [***] of this Exhibit
G;
|
|
·
|
[***]
% as provided in [***] ) for any [***] in accordance
with [***] (b) of this Exhibit
G;
|
|
·
|
[***]
(other than the [***] specified in [***] 5) for any
termination in accordance with [***] of this Exhibit G;
and
|
|
·
|
[***]
for any termination in accordance with [***] of this Exhibit
G.
|
11.3.
|
BI
Termination Rights. After consultation with the JCPT and JSC,
BI shall have the right to terminate the Co-Promotion Agreement with
respect to a Product upon any of the following: (a) upon
[***] ( [***] ) [***] written notice if a Product
[***] the [***] (which may be exercised in the
[***] ) and BI [***] its [***] of the
Product [***] (applying Commercially Reasonable Efforts) or if
Micromet mutually agrees to the termination; (b) upon [***] (
[***] ) [***] written notice following any uncured material
breach (to be defined in the Co-Promotion Agreement) of Micromet’s
obligations under the Co-Promotion Agreement that is confirmed pursuant to
the dispute resolution process set forth in Section 17.4; (c) upon
[***] ( [***] ) [***] prior written notice to Micromet
to be effective on or following the date that is [***] to
the [***] of the [***] in the U.S. as reasonably
established in good faith by BI; or (d) in accordance with Section 4.5.3
of the Agreement.
|
11.4.
|
Financial
Consequences of a Termination by BI. In addition to the
consequences described in Section 11.6 of this Exhibit G, upon any
termination by BI the Sales Participation Payments payable to Micromet
under Section 8.4.3 shall be [***] as
follows:
|
|
·
|
By [***]
% as provided in [***] for any termination in
accordance with [***] of this Exhibit G (or for any
other reason not covered by Section 11.3(d) of this Exhibit G);
and
|
|
·
|
By [***]
% as provided in [***] for any termination in
accordance with [***] ) of this Exhibit
G.
|
11.5.
|
Expiration. In
addition, the Co-Promotion Agreement will terminate upon any termination
of the Agreement.
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
11.6.
|
General
Consequences. In connection with any termination of the
Co-Promotion Agreement, (i) each Party’s obligations under such agreement
will cease; (ii) BI will assume full responsibility for the continued
promotion of the Product in accordance with the terms of the Agreement,
(ii) the JCPT and JSC will cease; and (iii) the Co-Promotion Term will end
at the effective date of termination. For clarity, termination
of the Co-Promotion Agreement shall not limit Micromet’s or BI’s
obligations under the Agreement.
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Exhibit
H-1
[***] (
[***] as of [***] )
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Exhibit
H-2
[***] (relating
to [***] of [***] Technology)
[***]
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Exhibit
H-3
[***] (relating
to [***] Technology [***] as
of [***] [***] )
[***]
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Exhibit
I
Press
Release
[***]
Boehringer
Ingelheim and Micromet Announce Global Collaboration for Multiple Myeloma BiTE
Antibody
Ingelheim, Germany, and Bethesda, MD,
USA, May 5, 2010 — Boehringer Ingelheim and
Micromet, Inc. (Nasdaq: MITI) announced today that they have entered into a
collaboration agreement for the research, development and commercialization of a
new BiTE antibody for the treatment of multiple myeloma.
Despite
recent advances in the treatment of multiple myeloma, the disease remains
largely incurable. While the majority of patients initially respond
to treatment, almost all of these patients will eventually relapse.
“Multiple
myeloma will be an indication of focus for Micromet and we are very pleased to
collaborate with Boehringer Ingelheim, an industry leader with a proven track
record of successful partnerships,” said Christian Itin, Ph.D., Micromet’s
President and Chief Executive Officer. “In line with the strategic importance of
hemato-oncology for Micromet we have retained U.S. co-promotion rights for this
product candidate consistent with our goal of building a commercial hematology
franchise in the United States.”
"We
recognize the advantage of combining Micromet’s BiTE antibody platform with our
target identification and development expertise and we believe that a BiTE
antibody has the potential to address the significant unmet medical need of
patients with multiple myeloma,” said Wolfgang Rettig, M.D., Ph.D., Head of Corporate
Research, Boehringer Ingelheim. “This collaboration builds on the unique
strengths of Micromet and Boehringer Ingelheim."
Micromet
and Boehringer Ingelheim will collaborate on the development of the BiTE
antibody. Micromet is responsible for discovery of the BiTE antibody and will
jointly conduct with Boehringer Ingelheim further pre-clinical
studies. Boehringer Ingelheim is responsible for all manufacturing
activities, clinical development and worldwide commercialization subject to
Micromet’s co-promotion right in the U.S. Micromet will bear the costs up to a
pre-defined amount for its preclinical activities. During commercialization
Micromet will solely bear the costs for its sales force in the
U.S. All other costs for research, development, manufacturing and
commercialization of the BiTE antibody will be borne by Boehringer
Ingelheim.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Under the
terms of the agreement Boehringer Ingelheim will pay Micromet an upfront cash
payment of €5 million (approximately $6.6 million). Micromet is eligible to
receive development and regulatory milestone payments of up to €50 million
(approximately $66 million) and tiered low double-digit royalties on product
sales outside the U.S. In the U.S. Micromet and Boehringer Ingelheim will
jointly co-promote the BiTE antibody with commercial terms commensurate with a
profit split.
About
BiTE Antibodies
BiTE®
antibodies are designed to direct the body's cytotoxic, or cell-destroying, T
cells against tumor cells, and represent a new therapeutic approach to cancer
therapy. Typically, antibodies cannot engage T cells because T cells lack the
appropriate receptors for binding antibodies. BiTE antibodies have been shown to
bind T cells to tumor cells, ultimately inducing a self-destruction process in
the tumor cells referred to as apoptosis or programmed cell death. In the
presence of BiTE antibodies, T cells have been demonstrated to serially
eliminate tumor cells, which explains the activity of BiTE antibodies at very
low concentrations. Through the killing process, T cells start to proliferate,
which leads to an increased number of T cells at the site of
attack.
About
Boehringer Ingelheim
The
Boehringer Ingelheim group is one of the world’s 15 leading pharmaceutical
companies. Headquartered in Ingelheim, Germany, it operates globally with 142
affiliates in 50 countries and more than 41,500 employees. Since it was founded
in 1885, the family-owned company has been committed to researching, developing,
manufacturing and marketing novel products of high therapeutic value for human
and veterinary medicine.
In 2009,
Boehringer Ingelheim posted net sales of 12.7 billion euro while spending 21% of
net sales in its largest business segment Prescription Medicines on research and
development.
For more
information please visit www.boehringer-ingelheim.com
About
Micromet, Inc.
Micromet,
Inc. is a biopharmaceutical company focused on the discovery, development and
commercialization of antibody-based therapies for the treatment of cancer. Its
product development pipeline includes novel antibodies generated with its
proprietary BiTE® technology, as well as conventional monoclonal antibodies. Two
of Micromet's BiTE antibodies and three of its conventional antibodies are
currently in clinical trials. Micromet has collaborations with a
number of leading pharmaceutical and biotechnology companies, including
sanofi-aventis, Bayer Schering Pharma, Merck Serono, Boehringer Ingelheim, MedImmune and Nycomed.
Additional information can be found at www.micromet-inc.com
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Safe
Harbor Statement
This
release contains certain forward-looking statements that involve risks and
uncertainties that could cause actual results to be materially different from
historical results or from any future results expressed or implied by such
forward-looking statements. These forward-looking statements include statements
regarding the operation of the global collaboration with Boehringer Ingelheim,
the efficacy, safety and intended utilization of our product candidates,
including the BiTE antibody that is the subject of the agreement with Boehringer
Ingelheim, the mode of action of BiTE antibodies, the conduct, timing and
results of future clinical trials, expectations of the future expansion of our
product pipeline and collaborations, and the future payment of milestone and
royalty payments by Boehringer Ingelheim. You are urged to consider statements
that include the words "ongoing," "may," "will," "believes," "potential,"
"expects," "plans," "anticipates," "intends," or the negative of those words or
other similar words to be uncertain and forward-looking. Factors that may cause
actual results to differ materially from any future results expressed or implied
by any forward-looking statements include the risk that product candidates that
appeared promising in early research, preclinical studies or clinical trials do
not demonstrate safety and/or efficacy in subsequent clinical trials, the risk
that encouraging results from early research, preclinical studies or clinical
trials may not be confirmed upon further analysis of the detailed results of
such research, preclinical study or clinical trial, the risk that additional
information relating to the safety, efficacy or tolerability of our product
candidates may be discovered upon further analysis of preclinical or clinical
trial data, the risk that we or our collaborators will not obtain approval to
market our product candidates, the risks associated with reliance on outside
financing to meet capital requirements, and the risks associated with reliance
on collaborators, including sanofi-aventis, Merck Serono, Boehringer Ingelheim,
and Nycomed, for the funding or conduct of further development and
commercialization activities relating to our product candidates. These factors
and others are more fully discussed in Micromet's Annual Report on Form 10-K for
the fiscal year ended December 31, 2009, filed with the SEC on March 5, 2010, as
well as other filings by the company with the SEC.
Contacts:
Micromet,
Inc.
Jennifer
Neiman
Director,
Corporate Communications
240-235-0246
jennifer.neiman@micromet-inc.com
Boehringer
Ingelheim GmbH
Julia
Meyer-Kleinmann
Director
Corporate Communications
Phone
+49/6132/77 82 71
Fax
+49/6132/77 70 77
press@boehringer-ingelheim.com
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Exhibit
J
Post-Termination
Royalties
[***] of [***] at Termination
|
Royalty Rate
|
||
After [***] of [***]
, and before [***] to an [***] in
the [***] dy
|
[***
|
]% | |
After [***] to
an [***] in the [***] , and
before [***] of the [***]
|
[***
|
]% | |
After [***] of
the [***] , and before the [***] of
the [***]
|
[***
|
]% | |
After [***] of
the [***] , and before the [***] in
a [***]
|
[***
|
]% | |
After
the [***] in a [***] , and before
the [***] in a [***]
|
[***
|
]% | |
After
the [***] in a [***]
|
|
[***
|
]% |
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Exhibit
K
Dispute
Resolution Procedures
1.
|
The
Parties will resolve certain disputes stipulated in this Agreement by
final and binding expertise proceedings in accordance with this Exhibit
K. The Parties will select a mutually agreeable expert
who has significant relevant experience in the subject matter of the
disputed issue and no affiliation or pre-existing relationship with either
Party. If the Parties cannot agree on an expert
within [***] ( [***]
) [***] after the senior executive officers have
failed to resolve the disagreement, either Party may request the
appointment of the expert in accordance with the provisions for the
appointment of experts under the Rules for Expertise of the International
Chamber of Commerce. The date on which such expert is selected
will be the “Proceeding
Commencement Date.”
|
2.
|
Each
Party will prepare and, within [***] ( [***]
) [***] after the Expertise Proceedings Commencement
Date, deliver to both the expert and the other Party its proposed
agreement and a memorandum in support thereof (the “Support
Memorandum”). The expert will also be provided with a
copy of this Agreement.
|
3.
|
Within [***] (
[***] ) [***] after the receipt of all proposed
agreements and Support Memoranda, the expert shall select from the two
proposals provided by the Parties the proposal that the expert believes
more accurately reflects the intention of the Parties to this Agreement
and the industry customs regarding the manufacture, development and
commercialization (including, as applicable, co-promotion) of comparable
pharmaceutical products. The expert’s decision will be provided
in writing.
|
4.
|
The
expert will have reasonable discretion to request additional information,
hold a hearing, and extend the time frame for reaching their decision
regarding the dispute at issue.
|
5.
|
The
expert’s fees and expenses will be shared equally by the
Parties. Each Party will bear and pay its own expenses incurred
in connection with any dispute resolution under this Exhibit
K.
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Exhibit
L
[***] Patents,
or Patents claiming [***] to [***] ,
Within [***] Technology as of the Effective
Date
1.)
|
[***] Technology:
Patent
|
[***]
2.)
|
[***] Technology:
Know-How
|
a)
|
[***] know-how
relating to [***] as well
as [***] the [***] (including
the [***] ), as disclosed
by [***] to [***] in
a [***] on the Effective
Date.
|
b)
|
Certain
proprietary Know-How existing at [***] as of the
Effective Date with regard to [***] Technology,
which has been [***] at an [***]
.
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Exhibit
M
Micromet
Marks
“BITE”
“MICROMET”
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
Exhibit
N
[***]
[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text
Omitted and Filed Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Execution
Copy
[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
|
[***]
|
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.