Attached files
file | filename |
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10-Q - FORM 10-Q - GEN PROBE INC | a59286e10vq.htm |
EX-10.2 - EX-10.2 - GEN PROBE INC | a59286exv10w2.htm |
EX-31.1 - EX-31.1 - GEN PROBE INC | a59286exv31w1.htm |
EX-32.1 - EX-32.1 - GEN PROBE INC | a59286exv32w1.htm |
EX-31.2 - EX-31.2 - GEN PROBE INC | a59286exv31w2.htm |
EX-32.2 - EX-32.2 - GEN PROBE INC | a59286exv32w2.htm |
EXCEL - IDEA: XBRL DOCUMENT - GEN PROBE INC | Financial_Report.xls |
Exhibit 10.3
***Text Omitted and Filed Separately
with the Securities and Exchange Commission.
Confidential Treatment Requested
Under 17 C.F.R. Sections 200.80(b)(4)
and 240.24b-2
with the Securities and Exchange Commission.
Confidential Treatment Requested
Under 17 C.F.R. Sections 200.80(b)(4)
and 240.24b-2
PRODUCT DEVELOPMENT ADDENDUM
FOR THE PANTHER INSTRUMENT
AND ULTRIO ELITE ASSAY
FOR THE PANTHER INSTRUMENT
AND ULTRIO ELITE ASSAY
This Addendum for the Development of the Panther Instrument and the Ultrio Elite Assay (Panther
Addendum) is entered into, effective as of July 24, 2009 (Addendum Effective Date) and signed
March 11, 2011 (Addendum Signature Date), pursuant to and amending that certain Restated
Agreement entered into as of July 24, 2009 (Agreement) by and between Gen-Probe Incorporated, a
Delaware corporation (Gen-Probe) with a principal place of business at 10210 Genetic Center
Drive, San Diego, CA 92121, and Novartis Vaccines and Diagnostics, Inc., a Delaware corporation
(Novartis) with a place of business at 4560 Horton Street, Emeryville, CA 94608 (Novartis and
Gen-Probe each is individually referred to as a Party and together are referred to as the
Parties).
RECITALS
A. Prior to the date of this Panther Addendum, Gen-Probe has expended significant effort and
resources in the development of a molecular diagnostic analyzer known as the Panther Instrument for
use in the Clinical Diagnostic Field.
B. By this Panther Addendum, the Parties desire to set forth terms and conditions for the
adaptation and development of the Panther Instrument, related software and the Ultrio Elite Assay
(as hereinafter defined) for use in the Blood Screening Field pursuant to the Agreement, as
clarified and amended by the terms and conditions more particularly described herein.
AGREEMENT
NOW, THEREFORE, for and in consideration of the mutual covenants and agreements set forth in
this Panther Addendum, the Parties agree as follows:
1. Definitions. All capitalized terms used but not defined in this Panther
Addendum shall have the meanings set forth in the Agreement.
1.1 Addendum Effective Date shall mean July 24, 2009.
1.2 Addendum Signature Date shall mean March 11, 2011.
1.3 Addendum Term is defined in Section 7.1.
1.4 Agreement shall mean the July 24, 2009 Restated Agreement between the
Parties, as amended or supplemented in writing by the Parties before or after the Addendum
Effective Date.
1.5 Budget means the budgeted Panther Development Costs as of the Addendum
Effective Date. The Budget shall include the estimated cost of the Panther Development Program on
a monthly basis through the end of the Panther Development Program. The approved Budget as of the
Addendum Effective Date is as established within the Panther
Program Documents. The Budget may be amended from time to time in accordance with the provisions
of Section 3 below.
1.6 Development Completion Date means the first date on which all of the
following events have occurred: (i) validation and verification of the Panther Instrument against
the then current PRD has been completed by Gen-Probe and Novartis following assay integration
activities for the Ultrio Elite Assay to be offered for use with the instrument, with Novartis
Final Acceptance; (ii) the manufacturer has released the instrument design for manufacturing; (iii)
all activities to obtain the CE mark, which will permit sale of the Panther Instrument within the
European Union, have been completed, and (iv) all activities to obtain the CE mark, which will
permit sale of the Ultrio Elite Assay within the European Union, have been completed.
1.7 Final Acceptance. After completion of verification and validation
testing and documentation thereof for the Panther Instrument and the Ultrio Elite Assay (the
Primary Verification Documentation and Validation Reports), Gen-Probes Vice President,
Instrument Systems shall provide Novartis with written certification (the Initial Certification)
that Gen-Probe has satisfactorily completed such verification and validation and that the Primary
Verification Documentation and Validation Reports, including testing trace matrix between the
instrument PRD, SRS and other relevant testing activities, are available for inspection by Novartis
at Gen-Probe. The certification by Gen-Probe shall be delivered to Novartis by separate delivery
to (a) the Head, Development and (b) the Alliance Manager.
1.7.1 Novartis shall promptly review the Primary Verification Documentation and
Validation Report at Gen-Probe. Gen-Probe will make the necessary facilities and staff available
without delay to accommodate Novartis timely review of the Primary Verification Documentation and
Validation Report. The Primary Verification Documentation and Validation Report shall be
Confidential pursuant to the terms of the Agreement. Following Novartis review, Novartis shall be
entitled to copy upon request the Validation Report and shall be entitled to copy upon request and
with reasonable justification designated portions of the Verification Documentation. Novartis shall
notify Gen-Probe in writing within seventy-five (75) days of its receipt of the Initial
Certification (the Initial Review Period) of any material non-conformance between the Panther
Instrument as submitted to validation by Gen-Probe and the specifications of the Product
Requirements Documents for the Panther Instrument.
1.7.2 Any disagreement by Gen-Probe with Novartis identification of an alleged
material nonconformance shall be resolved in accordance with Article 11 of the Agreement.
1.7.3 Upon Gen-Probes receipt and acceptance without dispute of Novartis written
notice of non-acceptance, Gen-Probe shall promptly work to rectify any material non-conformities
and shall thereafter provide Novartis such further verification and validation certification with
respect to correction of the material non-conformities. Gen-Probe shall also make available to
Novartis the Verification Documentation and Validation Report with respect to correction of each
material non-conformity (the Secondary Verification Documentation and Validation Report) for
further review in accordance with the provisions of this section.
2
1.7.4 Novartis shall promptly review the Secondary Verification Documentation and
Validation Report with respect to correction of each non-conformity and shall notify Gen-Probe in
writing within twenty (20) days of its receipt of the verification and validation certification
(the Secondary Review Period) of any failure to correct the material non-conformance(s)
previously identified by Novartis. Novartis shall not assert non-conformities in the course of the
Secondary Review Period which could have been identified in the Initial Review Period.
1.7.5 Novartis shall be deemed to have finally accepted the Panther Instrument
and/or assay upon the earlier of: 1) Novartis receipt and written acceptance of all initial
Panther Instrument deliverables pursuant to this Panther Addendum; or (ii) the expiration of the
Initial Review Period and any Secondary Review Periods, absent notification by Novartis to
Gen-Probe within the applicable period of any material non-conformance between the Panther
Instrument as submitted to validation by Gen-Probe and the specifications of the Product
Requirements Documents for the Panther Instrument. Notwithstanding the foregoing, Novartis shall
also be conclusively deemed to have finally accepted the Panther Instrument design upon Novartis
sale or placement of either (i) any one Panther instrument to a Third Party for use as a full
production instrument to process blood screening assays that become the test of record on which
blood is released to the general public or (ii) more than ten (10) Panther instruments to Third
Parties for any use whatsoever.
1.8 FTE Labor Rate is defined in Section 4.5 below.
1.9 Material Modification means a change or amendment to the then current
PRD that materially affects the requirements set forth in any of the then-current Panther Program
Documents, including, without limitation, any modification to the PRD that materially affects assay
sensitivity or specificity or materially affects the Timeline or the costs set forth in the Budget,
as further defined in Section 3.3 below.
1.10 Non-material Modification means a change or amendment to the then
current PRD other than a Material Modification. Written agreement between the Parties that a
modification is a Non-material Modification hereunder as described in Section 3.2 below shall be
conclusive.
1.11 Panther Development Costs means the fully-burdened cost of conducting
the Panther Development Program, subject to Section 4.1.3 of this Panther Addendum. Costs will be
calculated in accordance with United States generally accepted accounting principles, consistently
applied (U.S. GAAP), or as otherwise mutually agreed in writing between the Parties.
1.12 Panther Development Program means the general ongoing systematic
process of modifying and validating the Panther Instrument, developing the related software,
developing the Ultrio Elite Assay, and integration of the Ultrio Elite assay for use on the Panther
Instrument for the Blood Screening Field under the terms of this Panther Addendum, as such
development program is detailed in the Panther Program Documents, through the Development
Completion Dates. [ *** ]
***Confidential Treatment Requested.
3
[ *** ]
1.13 Panther Program Document(s) means the written project detail(s) for the
development of the Panther Instrument, related software, and Ultrio Elite Assay for the Blood
Screening Field pursuant to this Panther Addendum, consisting of (i) the Product Requirements
Documents (PRDs), including the Software Requirements Specifications (SRS), (ii) the Project
Plans, (iii) the Resource Plans, (iv) the Budgets and (v) the Timelines, each of which is contained
in a secure file accessible by the Parties. The Panther Program Documents may be modified from
time to time as agreed by the Parties. The Panther Program Documents shall be kept in a secure
electronic file at the offices of Gen-Probe, copies of which shall be accessible by the Novartis
upon request.
1.14 Panther Instrument means the integrated, fully automated laboratory
instrument for use in the Blood Screening Field and related software for DNA/RNA amplified assay
processing incorporating all systems required to support TMA assay processes and associated reagent
product lines for NAT testing in the Blood Screening Field for low to mid-volume laboratories, as
further defined by the Panther Program Documents.
1.15 Post Development Enhancements means all additional enhancements agreed
to by the Parties in accordance with this Agreement to be implemented after the Development
Completion Date to improve functionality, reliability, and/or performance of the Panther Instrument
and/or related software. The agreed Post Development Enhancements as of the Addendum Signature
Date are set forth in Section 2.5.5, below. Depending on timeline and resource considerations,
certain of such agreed Post Development Enhancements may be accomplished prior to the Development
Completion Date.
1.16 Product Requirements Documents (or PRDs) means (a) the requirement
specifications for the Panther Instrument for use in the Blood Screening Field and, as used in this
Panther Addendum (including the Software Requirements Specifications (or SRS) document and
specifications related to the integration of WNV assay in accordance with the pre-existing WNV
assay PRD), and (b) the requirement specifications for the Ultrio Elite Assay. The operative
Product Requirements Document for the Panther Instrument and the operative Product Requirements
Document for the Ultrio Elite Assay in each case as of the Addendum Signature Date, are attached
hereto as Exhibit A and Exhibit B, respectively. The PRDs may be amended from time to time in
accordance with the provisions of Section 3 below.
1.17 Program Completion Date means six (6) months after the later to occur
of (i) the date the CE mark has been obtained for the Panther Instrument for use with the Ultrio
Elite Assay, and (ii) completion of the agreed Post Development Enhancements identified in Section
2.5.5, but in no event later than the expiration of the Blood Screening Term.
1.18 Project Plans means the plans for technical aspects and equipment
requirements pursuant to and as further described within the Panther Program Documents, and quality
assurance regarding the Panther Development Program. The Project Plans identify the business
organization and a generalized scheme for development and validation of the Panther Instrument
(including software), the Ultrio Elite Assay and validation of the WNV assay on the Panther
***Confidential Treatment Requested.
4
Instrument (as an agreed Post Development Enhancement). The Project Plans may be amended from time
to time in accordance with the provisions of Section 3 below.
1.19 Resource Plans means the description of (i) a Partys personnel to be
allocated to the Panther Development Program, including the name of the specific personnel or the
qualification or grade of unidentified personnel, and dedicated amount of time and periods for the
commitment of such personnel required for the Panther Development Program, and (ii) equipment,
tools, software, or other special items, the purchase, license or leasing of which is specifically
required for use by such personnel to support the Panther Development Program. The Resource Plans
may be amended from time to time in accordance with the provisions of Section 3 below. The
Resource Plans, as they may be amended from time to time, shall be retained in a secure electronic
folder accessible by both Parties.
1.20 Software Requirements Specifications (or SRS) means the
specifications for the software for the Panther Instrument for use in the Blood Screening Field.
The SRS may be amended from time to time in accordance with the provisions of Section 3 below. For
purposes of this Panther Addendum, the operative Software Requirements Specifications at any time
shall be the version of the Software Requirements Specifications which at that time has been most
recently generated by Gen-Probe.
1.21 Timelines means the overall timelines for the Panther Development
Program. The operative Timeline for Panther Instrument, Ultrio Elite Assay development, and WNV
product testing and certification update as of the Addendum Signature Date is attached hereto as
Exhibit D.
1.22 Ultrio Elite Assay means the in vitro nucleic acid test for the
qualitative detection of human immunodeficiency virus Type 1 (HIV-1) RNA, human immunodeficiency
virus Type 2 (HIV-2) RNA, hepatitis B virus (HBV) DNA, and hepatitis C virus (HCV) RNA in human
plasma for use in the Blood Screening Field, as well as the companion HIV, HBV and HCV
discriminatory probe reagents for the qualitative detection of the specified virus following a
positive, undifferentiated result from the Ultrio Elite assay. The Ultrio Elite HIV discriminatory
probe reagents will not discriminate between HIV-1 and HIV-2.
1.23 Validation Report means, as the context requires, any and all of the
written reports to be prepared by Gen-Probe detailing the validation for the Ultrio Elite Assay and
the validation of the Panther Instrument (including the validation of integration of the WNV assay
on the Panther Instrument, as a Post Development Enhancement), including a testing trace matrix
between the then current PRD and other relevant testing activities of the Panther Instrument as
further defined in Section 2.5.3 below.
1.24 Verification Documentation means any and all documentation created and
maintained by Gen-Probe in connection with Gen-Probes verification of the Panther Instrument,
verification of the Ultrio Elite Assay, and verification of the integration of the WNV assay on the
Panther Instrument, as a Post Development Enhancement.
5
2. Panther Development Program.
2.1 Objective. Subject to the terms of the Agreement, as amended by this
Panther Addendum, the Parties shall use Commercially Reasonable Efforts to conduct their respective
obligations under the Panther Development Program as established in accordance with the terms
hereof, and, subject to Section 2.5.7 hereof, shall apply for and endeavor to obtain such
regulatory approvals as necessary or appropriate to provide for the use and sale in the Blood
Screening Field of the Panther Instrument and Ultrio Elite Assay in the European Economic
Community, in accordance with Section 2.5.7, below. Novartis acknowledges and agrees that
Gen-Probe will continue its pre-existing development program for the Panther Instrument in the
Clinical Diagnostic Field.
2.1.1 Interpretation of Agreement. Recognizing the time interval between
the Addendum Effective Date and the Addendum Signature Date, the parties agree that this Panther
Addendum should be interpreted reasonably and practically to give effect to its provisions in
consideration of such time interval and the provisions hereof should therefore generally be given
limited effect prior to the Addendum Signature Date, such that they should apply only where
reasonably necessary to achieve their fundamental purpose.
2.2 General Conduct of Development. The Parties, using Commercially
Reasonable Efforts, shall conduct their respective obligations under the Panther Development
Program in compliance in all material respects with all applicable laws and regulations and all
applicable good laboratory, clinical and manufacturing practices. In addition, each Party shall
proceed diligently with its respective obligations under the Panther Development Program and shall
use its respective Commercially Reasonable Efforts to achieve the objectives of the Panther
Development Program efficiently and expeditiously. The Parties shall allocate such personnel,
equipment, facilities and other resources to the Panther Development Program to carry out its
respective obligations and to accomplish the objectives thereof, all as is more particularly
described in the Panther Program Documents, as amended from time to time during the term of this
Panther Addendum, in accordance with the provisions of Section 3. Novartis shall retain the right
to consult with Gen-Probe regarding the Panther Program Documents and Gen-Probe shall reasonably
consider Novartis advice.
2.3 No Liability if Commercially Reasonable Efforts Are Expended. The
Parties acknowledge that the Panther Development Program is subject to the risks inherent in all
new product development programs. Subject to all terms and conditions of this Addendum, neither
Party will be in breach of its obligations to the other hereunder and such Party shall be deemed to
have exercised Commercially Reasonable Efforts, so long as such Party shall have committed the
resources described in the Project Plan and the Resource Plan. By way of example and not
limitation, failure to achieve the Timeline shall not be considered a breach of this Addendum if
the responsible party has exercised Commercially Reasonable Efforts by committing the agreed
resources as defined in the Panther Program Documents. The payment of Panther Development Costs
between the Parties shall be due and payable without regard to any specified deliverable set forth
in the Project Plan.
6
2.4 Project Management.
2.4.1 Project Manager. The Panther Development Program and Ultrio Elite
Assay Development Program will be managed by a Project Manager appointed by Gen-Probe, whose
responsibilities are described in Section 2.4.2. Any change by Gen-Probe of the Project Manager
must be approved by the Supervisory Board, which approval shall not be unreasonably withheld.
2.4.2 Gen-Probe Project Managers Responsibilities. The Gen-Probe Project
Manager shall be responsible for the following activities, together with such other activities as
the parties may agree:
(a) Fostering and assuring regular and complete communication between Gen-Probe and
Novartis concerning the status of the development programs.
(b) The Gen-Probe Project Manager shall notify Novartis Alliance Manager promptly
of any actual or expected problems, delays, or budget overruns that may be material to the Panther
Development Program. Without limiting the foregoing, the Gen-Probe Project Manager shall notify
Novartis Alliance Manager of any expected variances from the then-current budget of greater than
(i) fifteen percent (15%) or $250,000 for any calendar month, whichever is the lesser, and/or (ii)
ten percent (10%) or $250,000 for any calendar quarter, whichever is the lesser.
(c) Managing all matters relating to the Panther Development Program and Ultrio
Elite Assay Development Program under this Addendum, including each partys respective
responsibilities and contributions and receiving reports from each party;
(d) Providing written monthly progress reports to the parties and presenting status
reports to the Supervisory Board;
(e) Submitting and receiving the reports, materials and documents required to be
delivered under this Addendum;
(f) Overseeing the process of proposing, and submitting to the parties, any proposed
modifications to Panther Program Documents, and in the event the parties cannot agree, presenting
the same to the Supervisory Board in an objective and neutral manner. The Gen-Probe Project Manager
will have responsibility for documenting changes to scope all requests to Supervisory Board must
include impact to latest business case, as well as impact to current timeline and budget.
(g) Arranging any meetings to be held between the parties (other than Operating
Committee and Supervisory Board meetings) and participating, to the extent appropriate, in such
meetings; and
(h) Maintaining a record of all material communications and deliveries between the
parties of which the Gen-Probe Project Manager is aware, consistent with the parties protocol for
such sharing of confidential information.
7
2.4.3 Meetings of the Operating Committee. In addition to their
responsibilities set forth under Section 4.2 of the Agreement, the Novartis/Gen-Probe Operating
Committee shall implement monthly Panther Development Program budget sessions to discuss the
forecasts of the financial aspects of the Panther Development Program for the following month. The
Gen-Probe Project Manager shall notify the Operating Committee of any expected variances from the
then-current budget of greater than (i) fifteen percent (15%) or $250,000 for any calendar month,
whichever is the lesser and/or (ii) ten percent (10%) or $250,000 for any calendar quarter,
whichever is the lesser, and the Operating Committee shall notify the Supervisory Board of any such
expected variances.
2.4.4 Meetings of the Supervisory Board. The Supervisory Board shall meet from time to
time during the term of this Panther Addendum, but not less frequently than once each calendar
quarter during the term hereof. Not less frequently than quarterly, a regular agenda item at the
regularly scheduled Supervisory Board meeting shall be to receive a report from the Project Manager
and conduct a review of the Panther Development Program to assess progress of the programs and
provide guidance as appropriate.
2.4.5 Disagreements. Disagreements that cannot be resolved by mutual agreement of the
Parties (including by resolution reached at the Operating Committee) may be brought to the
Supervisory Board for review and resolution. However, work will proceed in accordance with the
principally responsible Partys method of choice, while the issue in contention is reviewed by the
Supervisory Board. If a disagreement arises in a functional area for which responsibility is
shared and resolution cannot be achieved at the Supervisory Board level, except as to
Regulatory/Licensure Strategy that shall be governed by Section 2.5.7, work shall be suspended in
such functional area until a resolution is reached pursuant to Article 11 of the Agreement,
including arbitration if the disagreement is subject to arbitration.
2.5 Development Responsibilities
2.5.1 Principal Responsibility; General Statement. The Parties intend that
the Panther Development Program (including the development of the related software) will be
coordinated by Gen-Probe. Gen-Probe will continue to allow Novartis delegates to review and
comment on the current PRD and risk assessment related design control documentation and will allow
Novartis delegates to review and comment on proposed revisions to such documentation. Subject to
the terms of this Addendum, the Parties shall continue to cooperate with respect to possible
changes to the Panther Program Documents. Gen-Probe shall have the power to make day-to-day
decisions regarding instrument development, consistent with the overall Panther Development Program
and the terms of this Addendum.
(a) Notwithstanding the above, the Operating Committee shall be notified pursuant
to Section 2.4.3, above, of any planned variances to the then-current mutually approved budget that
is greater than (i) fifteen percent (15%) or $250,000 for any calendar month, whichever is the
lesser, or (ii) ten percent (10%) or $250,000 for any calendar quarter, whichever is the lesser or
(iii) a variance of greater than or equal to sixty (60) calendar days from the then-current
mutually approved launch date as identified in Exhibit D (Timeline). Additionally, in the case of
(ii) and (iii) above, the Supervisory Board shall be notified pursuant to Section 2.4.3., above, of
any such variances and such variances shall be considered by the Supervisory Board at
8
the earliest convenient opportunity. All development work will proceed until any such variance can
be considered by the Supervisory Board. Unless such variance is approved by the Supervisory Board
after consideration, development work giving rise to the variance shall be suspended and the
parties shall proceed pursuant to and in accordance with section 2.4.5 or as otherwise directed by
the Supervisory Board.
2.5.2 Deliverables. Gen-Probe shall use its Commercially Reasonable Efforts
to develop and deliver or otherwise make available to Novartis, in accordance with the Panther
Program Documents: (i) the validation and verification plans for the Panther Instrument and the
Ultrio Elite Assay, (ii) completed Validation Reports for the Panther Instrument and the Ultrio
Elite Assay; (iii) the Verification Documentation; (iv) the testing trace matrix between the PRD,
SRS and testing documentation; (v) risk assessment related to design control documentation; (vi)
the manufacturers release of the instrument design for manufacturing; (vii) documentation allowing
the Panther Instrument and Ultrio Elite Assay to bear the CE mark; and (viii) the manufacturers
declarations according to 2004/108/EC for the Panther Instrument and Ultrio Elite Assay, each
signed by an authorized representative(s) of such manufacturer (collectively, the Deliverables).
2.5.3 Testing, Verification, Validation. Upon its completion of development
of the Panther Instrument, Gen-Probe will perform verification, validation, and assay integration
testing for the Ultrio Elite Assay and the Panther Instrument according to current Good
Manufacturing Practices (cGMP) pursuant to the Parties Quality Agreement for Alliance
Partnership, dated May 28, 2009 (Quality Agreement), and in accordance with In Vitro Diagnostic
Directive 98-79-EC governing In Vitro Diagnostic Devices of the European Union and the current
United States Food and Drug Administration Quality System Regulations (QSR) under Part 820 of
Title 21 of the Code of Federal Regulations, and will promptly thereafter provide Novartis
reasonable access to the details and results of such testing as set forth in written Validation
Reports and in the Verification Documentation. The Validation Report for the Panther Instrument
will include a testing trace matrix between the then current PRD and SRS and other relevant testing
activities. Gen-Probe shall also be responsible, on the terms of this Addendum, to perform
validation and verification activities for pooling hardware and software for the Panther Instrument
and for integration of the WNV assay on the Panther Instrument. Novartis shall be responsible to
perform validation and verification activities for NAT Manager software for use in conjunction with
the Panther Instrument. Any disagreement about whether the final design of the Panther Instrument
conforms to the PRD and SRS shall be resolved in accordance with Article 11 of the Agreement,
including arbitration.
2.5.4 Shared Responsibilities; General Statement. The parties have agreed
to share responsibility for certain functions pursuant to the terms of the Agreement (including but
not limited to Section 3.1.6 of the Agreement and pursuant to their May 28, 2009 Quality Agreement
for Alliance Management. The Parties hereby expressly incorporate the provisions of the Agreement
and the Quality Agreement concerning the shared functions into this Panther Addendum and agree to
conduct the Panther Development Program in accordance with the prior agreements, except to the
extent specifically otherwise stated herein.
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2.5.5 Principal and Shared Responsibilities. Without limiting the general
statements set forth above, the Parties agree to allocate specific responsibility as follows:
Principal | Shared | |||
Function | Responsibility | Responsibility | ||
DEVELOPMENT ACTIVITIES |
||||
Coordination of Panther Development Program
|
Gen-Probe | |||
Supervise and coordinate instrument
development in accordance with PRD,
including SRS
|
Gen-Probe | |||
Develop assay software product labeling
|
Gen-Probe/Novartis | |||
Prepare Labeling translations
|
Gen-Probe/Novartis | |||
Develop validation strategy for, and
validate instrument and software
|
Gen-Probe | |||
Develop verification strategy for, and
verify instrument and software
|
Gen-Probe | |||
Develop, Validate, and Verify Panther
instrument interface for NAT Manager
1/
|
Gen-Probe | |||
Develop training materials, operator
manuals, and Instructions for Use (IFU)
for Panther Instrument and Ultrio Elite
Assay [ *** ]
|
Gen-Probe/Novartis | |||
Develop regulatory licensure/strategy for
Panther Instrument and related software
|
Gen-Probe/Novartis | |||
Obtain CE Mark for Panther Instrument and
Ultrio Elite Assay
|
Gen-Probe | |||
Develop Ultrio Elite Assay and 250 test
kit configuration; integrate Ultrio Elite
Assay on Panther Instrument; obtain CE
mark for Ultrio Elite Assay
|
Gen-Probe | |||
AGREED POST DEVELOPMENT ENHANCEMENTS2 |
||||
[ *** ]
|
[ *** ] | |||
[ *** ]
|
[ *** ] | |||
[ *** ]
|
[ *** ] | |||
[ *** ]
|
[ *** ] | |||
ADDITIONAL POST DEVELOPMENT ENHANCEMENTS |
||||
Identify additional potential instrument
enhancements
|
Gen-Probe/Novartis |
1/ | [ *** ] | |
2/ | The parties shall use Commercially Reasonable Efforts to accomplish the Agreed Post-Development Enhancements as agreed upon in the Timeline attached herein as Exhibit D. |
***Confidential Treatment Requested.
10
2.5.6 Out-Sourced Development. Gen-Probe has previously retained STRATEC
Biomedical Systems AG (Stratec) to design, develop and manufacture the Panther Instrument and has
entered into binding agreements with Stratec in connection with such activities. Novartis has been
provided with the Development Agreement for Panther Instrument System and the Supply Agreement
for Panther Instrument System entered into between Gen-Probe and Stratec in November 2006.
Gen-Probe has previously retained other contractors, including the RND Group, to contribute to
various aspects of Panther design and development. Novartis acknowledges and agrees to Gen-Probes
continued use of such contractors in connection with the Panther Development Program. Stratecs
facilities are currently located at Birkenfeld, Germany, or Beringen, Switzerland, and in
recognition of Stratecs role as contract manufacturer of the Instruments and the location of its
facilities, Gen-Probe will use its best commercial efforts to assure that the country of origin
for Panther Instruments is a country within the European Economic Community or that, when
CE-marked, the Instruments otherwise satisfy country of origin requirements for regulatory
purposes, if and where applicable, based upon the location of Stratecs manufacturing facilities.
2.5.7 Regulatory/Licensure. [ *** ] pursuant to the Agreement
(including but not limited to Section 3.1.6 of the Agreement) and pursuant to the May 28, 2009
Quality Agreement for Alliance Management, with respect to the Panther Development Program,
Gen-Probe agrees to use its best efforts to: (i) regularly review blood screening
regulatory/licensure strategy and management of regulatory submissions with Novartis, (ii) provide
draft copies of all written regulatory submissions to Novartis at least five working days prior to
the proposed date of their submission, (iii) make available the appropriate personnel for a
discussion of any advice or recommendations of Novartis on any regulatory submissions, and (iv)
reasonably consider such advice or recommendations, but Gen-Probe is not required to accept such
advice and/or recommendations. All disagreements on regulatory/licensure issues shall be addressed
by the Supervisory Board and, if necessary, by implementation of the escalation procedure described
in Article 11 of the Agreement, excluding arbitration. For issues that cannot be resolved through
such procedures, Gen-Probes Chief Executive Officer shall have the right to make the final
decision. Gen-Probe shall have no obligation under this Panther Addendum to apply for or endeavor
to obtain regulatory approval for any Panther Instrument that fails to meet the criteria set forth
in the applicable Panther Program Documents. Gen-Probe shall be considered the legal manufacturer
of any finished medical devices developed under this Panther Development Addendum. Following the
Development Completion Date, the parties will share the cost of clinical trials and regulatory and
licensing activities that are approved by the Supervisory Board for the Panther Instrument and for
Blood Screening Assays (including the Ultrio Elite Assay).
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3. Panther Enhancement Program.
3.1 Request for Modifications. Either Party may propose Material or
Non-material Modifications to the then current PRD. The process for approval and implementation of
any such proposed modifications shall be governed by this Section 3. The Gen-Probe Project Manager
will review any proposed modification to the then current PRD. The Gen-Probe Project Manager shall
review requested changes and make a determination whether such requested modifications are Material
or Non-material Modifications prior to submission to the Supervisory Board.
3.2 Non-Material Modifications. Unless the changes to the Panther
Development Program described in Section 3.1 constitute a Material Modification, any Non-Material
Modification shall be reported in the applicable monthly summary progress report to the Supervisory
Board and shall not be subject to the approval process described in Section 3.3 below.
3.3 Material Modifications.
3.3.1 Request for Material Modifications. In the event that one Party
desires to request a Material Modification to the then current PRD during the term hereof, such
Party (the requesting Party) shall submit to the other Party such request in writing and in
sufficient detail to enable the other Party (the receiving Party) to evaluate the request.
Without limiting the foregoing, the requesting Party shall prepare a revised draft version of the
applicable Panther Program Documents, reflecting any changes necessary to fully implement the
requested Material Modification. Promptly upon receipt of a request for Material Modification, but
no more than thirty (30) days thereafter, the Parties shall conduct a preliminary analysis of the
impact that the proposed Material Modification would have, including, without limitation, the
impact on the potential profitability of the Panther Instrument. Should either Party conclude, in
its reasonable discretion, that the potential for later profits is materially and adversely
affected by failure to implement any proposed change to the then current PRD as requested in
accordance with this Section 3, such Requesting Party may elect not to fund the development work
required for the Material Modification, subject to the rights granted to the Parties under Section
3.3.2(c), below [ *** ]. If a proposed Material Modification is not
reasonably expected to have a material adverse impact on the Budget, neither party shall
unreasonably withhold consent thereto.
3.3.2 Acceptance of Modified Instrument Requirements.
(a) The Supervisory Board shall promptly, but no later than thirty (30) days after
the preparation of the modified PRD, meet and confer about the proposed modifications. No modified
PRD shall be effective unless approved by the Supervisory Board.
(b) At such time as the Supervisory Board shall have accepted the modified PRD
incorporating a Material Modification, or any portion thereof, the Parties shall evidence such
agreement by initialing and dating a summary of the revised PRD. The PRD as so modified and
approved shall automatically be incorporated by reference into this Panther
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Addendum. In order to evidence their agreement to the revised PRD, the Parties shall include
it in a separately stored file in which all amendments and modifications to Panther Program
Documents will be kept. Such file shall be accessible by the Novartis Alliance Manager at any time
upon reasonable notice to Gen-Probe.
(c) If a Party elects, in its reasonable discretion, not to fund the development
work required for any proposed Material Modification, then if the other Party elects to solely fund
such development work, the additional development work shall be deemed to be conducted pursuant to
Section 3.1.2(c) of the Agreement and the funding party shall be entitled to recover the cost of
such additional development work in accordance with Section 3.1.4(b) of the Agreement; [ *** ].
3.4 Notice of Significant Changes. Each Party will provide three (3)
calendar months notice, unless otherwise agreed by the Parties, to the other Party prior to any
proposal of a significant reduction or increase in resources from the then-current Resource Plan in
order to allow the affected Party time to divert resources either to or from the Panther
Development Program. Subject to Sections 3.2 and 3.3 above, any significant changes to the Budget
or the Resource Plan shall be effective only upon the expiration of three (3) months from the
delivery of such notice, unless the Parties both agree to a shorter period of time in writing.
3.5 Changes to Panther Instrument or Related Software After Development
Completion Date. The Parties recognize that after the Development Completion Date the market
may demand or regulatory changes may require that special enhancements or modifications be made to
the then current PRD, and that either Party may desire to adopt such changes. From and after the
Development Completion Date but no later than the Program Completion Date, each Party will notify
the Supervisory Board promptly upon receipt of a request from a customer, or upon identification of
regulatory changes that may require the Parties to implement any enhancement, modification or other
change to the Panther Instrument or related software. The Supervisory Board shall promptly, but
not later than the earlier of (i) thirty (30) days after receipt from a Party of such request for
changes, or (ii) the next regularly scheduled Supervisory Board meeting, meet and confer regarding
such requested change. The Supervisory Board shall decide (i) whether the requested changes should
be implemented and (ii) whether the requested changes can be implemented under the terms of this
Panther Addendum or are significant enough to warrant a new development program under the terms of
Article 3 of the Agreement, in which case the Parties shall use the process more particularly
described in Section 3.2 of the Agreement. Notwithstanding the foregoing, nothing herein shall
obligate either Party to conduct development work after the Development Completion Date with
respect to the Panther Instrument or related software, without regard to whether the other Party
indicates a willingness to pay some portion or the entire costs of such development.
3.6 Performance Upgrades After Program Completion Date. The Supervisory Board
shall seek to agree upon a budget for a continuing reliability improvement program for the Panther
Instrument following the Development Completion Date. Outside of such an approved program, the
Supervisory Board shall decide whether upgrades (including improvements to
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instrument reliability) to the Panther Instrument should be implemented; provided,
however, that Gen-Probe may reasonably and in good faith undertake the development of reliability
improvements at its sole discretion so long as Gen-Probe alone bears the cost of development of
such improvements. If the Supervisory Board decides to implement such upgrades to the Panther
Instrument, a new development program may be implemented under the terms of Article 3 of the
Agreement, in which case the Parties shall use the process more particularly described in Section
3.2 of the Agreement.
4. Panther Development Costs.
4.1 Novartis Initial Funding Obligations. [ *** ]
4.1.1 [ *** ]
4.1.2 [ *** ]
4.1.3 Purchase of Panther Instruments. [ *** ]
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[ *** ]
4.2 Cost Sharing Details re Certain Activities. [ *** ]
4.3 Additional Post Development Activities and Costs. [ *** ]
4.4 Milestone Payment. [ *** ]
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[ *** ]
4.5 Calculation of Panther Development Costs; FTE Labor Rate.
4.5.1 The Parties have agreed to include certain categories of the Panther Development
Costs within an agreed-upon labor rate for full time equivalent personnel (the FTE Labor Rate).
Those categories of Panther Development Costs included within the FTE Labor Rate are those costs
more particularly described in Schedule 4.5.
4.5.2 The FTE Labor Rate in effect as of the Addendum Effective Date is set forth in
paragraph 1 on the attached Schedule 4.5. Each year the Parties will evaluate
and re-set a FTE Labor Rate for the budget for the new calendar year based on the Parties budgets
for the then-current calendar year and consistent with the requirements below. In the event the
Parties shall not have agreed upon a new FTE Labor Rate before commencement of a calendar year, the
Parties shall use the rate in effect during the immediately preceding calendar year for billing
purposes, subject to true-up calculations at such time as the FTE Labor Rate for the then-current
calendar year has been agreed.
4.5.3 In addition to the annual reset described above, either Party shall have the
right to request a change in the FTE Labor Rate reflected on the attached Schedule 4.5 to
be applied on a prospective basis under the approval process set forth in Section 3. Acceptance of
such request for modification shall be governed by Section 3.3 of this Panther Addendum.
4.5.4 In addition to the foregoing, throughout the term of this Panther Addendum:
(a) each Party shall have the same FTE Labor Rate applicable to it as is applied to
the other Party, subject to any agreed modifications; and
(b) in the event either Party requests a modification to the FTE Labor Rate
hereunder, the modified FTE Labor Rate shall be calculated using the same methodology as that used
to calculate the FTE Labor Rate in effect as of the Addendum Effective Date.
4.5.5 Monthly Notices; Payments. At the end of each month, Gen-Probe shall
calculate its actual expenditures and FTE Labor amounts for Panther Development Costs it incurred
during such month and shall promptly provide to Novartis a reasonably detailed written breakdown of
such costs and all invoices will be due and payable thirty (30) days from the date of receipt of
the invoice.
4.5.6 Right to Audit and Verify. Each Party is entitled to review,
evaluate, and in its discretion independently verify the basis of and actual expenditures incurred
by the other Party for which such Party requests reimbursement as Panther Development Costs
hereunder, in accordance with the provisions of Section 7.3 of the Agreement, including, without
limitation, actual expenditures after the Addendum Effective Date but prior to the execution of
this Panther Addendum.
***Confidential Treatment Requested.
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4.6 Payment of Panther Development Costs.
4.6.1 Panther Development Costs. [ *** ]
4.6.2 Monthly Invoices; Payments for Panther Development Costs. At the end
of each month or as agreed to by the Parties, Gen-Probe shall calculate its actual expenditures for
Panther Development Costs it incurred during such month and shall promptly provide to Novartis a
reasonably detailed written breakdown of such costs. All approved invoices will be due and payable
thirty (30) days from the date of receipt of the invoice.
4.6.3 Comparison with Resource Plan and Original Budget. Thirty days prior
to the beginning of each year of the Panther Development Program, Gen-Probe shall present to
Novartis for Novartis approval a quarterly aggregated Budget forecast. The planned resources, and
the associated costs, will be broken out on a monthly basis and analyzed against the Resource Plan,
the Project Plan, and reflected in the Budget.
4.7 Payments Regarding Shared Responsibilities. [ *** ]
5. Rights to Manufacture and Sell. The Parties respective rights to
manufacture, have manufactured, distribute and sell the Panther Instrument shall be governed by
Section 3.1.8 of the Agreement.
6. Ownership; License Grant.
6.1 Ownership. Ownership of any Inventions made in the course of the
Panther Development Program shall be determined in accordance with Article 8 of the Agreement.
6.2 License Grant. During the Blood Screening Term, Gen-Probe hereby grants
to Novartis a license under all intellectual property rights of Gen-Probe now-owned or hereafter
acquired to the extent reasonably necessary for Novartis to perform its obligations under the
Panther Development Program and for the use and sale of the Panther Instruments and related
software in the Blood Screening Field in accordance with the terms of the Agreement, but only to
the extent that Gen-Probe has or hereafter acquires an ownership or other licensable interest in
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such intellectual property rights and has the right to grant licenses, immunities or other
rights thereunder. During the Blood Screening Term, Novartis hereby grants to Gen-Probe a license
under all intellectual property rights of Novartis now-owned or hereafter acquired to the extent
reasonably necessary for Gen-Probe to perform its obligations under the Panther Development
Program and for the manufacture, use or sale of the Panther Instruments and related software in the
Clinical Diagnostic Field, but only to the extent that Novartis has or hereafter acquires an
ownership or other licensable interest in such intellectual property rights and has the right to
grant licenses, immunities or other rights thereunder. The licenses hereby granted shall extend
only to the extent of the design and development of the Panther Instruments as of the date of this
Panther Addendum and to any future modifications approved and adopted in accordance with the terms
hereof. The licenses hereby granted shall be royalty-free except to the extent the licensing Party
has an obligation to pay royalties to a Third Party pursuant to the Agreement. The license granted
by Gen-Probe in Section 3.1.10(c) of the Agreement shall apply to the manufacture of Panther
Instruments by or for Novartis for use in the Blood Screening Field. Except as expressly provided
herein, neither Party grants to the other Party any license or other interest in and to such
Partys intellectual property rights or other rights.
6.3 Commercialization. Section 5.4 of the Agreement established the terms
for forecasting, ordering, supplying and shipping Blood Screening Instruments. Except as otherwise
expressly provided herein, the provisions of Section 5.4 of the Agreement pertaining to Tigris
Instruments shall apply, mutatis mutandis, to Panther Instruments.
6.4 Panther Instruments will be manufactured and supplied by Stratec Biomedical
Systems AG pursuant to the November 2006 Supply Agreement for Panther Instrument between Gen-Probe
and Stratec (the Supply Agreement). On the terms of the Agreement and this Panther Addendum,
Gen-Probe will combine its own forecasts and orders for Panther Instruments for use in the Clinical
Diagnostics Field with Novartis orders for Panther Instruments in the Blood Screening Field.
Novartis or its Affiliates shall order Spare Parts for Panther Instruments directly from Stratec.
6.4.1 Novartis Forecasts. The Parties recognize that forecasting the first
year for Panther Instruments will be difficult. The Parties agree to work together to address the
first year supply of Panther Instruments and to use Commercially Reasonable Efforts to satisfy the
market need.
(a) Initial Forecast. Not less than six months prior to the date of the
first anticipated delivery of Panther Instruments for use in the Blood Screening Field by Gen-Probe
to Novartis, Novartis shall prepare and provide Gen-Probe with a written forecast of the estimated
requirements of Novartis and its Affiliates for Panther Instruments for each of the twelve (12)
calendar months beginning with the month of the first anticipated delivery of any Panther
Instrument (the Initial Forecast). Gen-Probe shall respond to Novartis forecast in writing
within thirty (30) days and shall have no obligation with respect to such forecast unless it has
approved such forecast in writing. The number of Panther Instruments included in the first quarter
of the Initial Forecast shall be deemed to have been ordered by Novartis on a binding basis (firm
purchase order).
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(b) Supplemental Initial Forecast. Not less than three months prior to the
date of the first anticipated delivery of any Panther Instrument, Novartis shall prepare and
provide Gen-Probe with a more current written forecast for Panther Instruments covering the same
period. Gen-Probe shall respond to Novartis updated forecast in writing within ten (10) days.
Gen-Probe shall have no obligation with respect to such updated forecast unless it has approved
such forecast in writing.
(c) Regular Rolling Forecasts. Not later than the first day of the last
month of each calendar quarter following the submission of the initial forecast, Novartis shall
deliver to Gen-Probe with a regular rolling forecast for the twelve (12) month period commencing
with the quarter that will begin approximately 120 days after such regular rolling forecast is due.
Each forecast shall include the anticipated number of Panther Instruments and the desired delivery
dates. Novartis agrees that such forecasts shall be prepared in good faith in order to facilitate
STRATECs timely supply according to the terms of this Addendum and the Supply Agreement.
(d) Binding Effect. Notwithstanding any other provision of the Agreement or
this Addendum, Novartis regular rolling forecasts shall be binding upon Novartis only as set forth
in this section. The number of Panther Instruments included in the first quarter of each regular
rolling forecast shall be deemed to have been ordered by Novartis on a binding basis (firm purchase
order). The number of Products included in the second quarter of each regular rolling forecast
shall be deemed to be a binding commitment to order at -50%/+50% of those Products (by including
them in the first quarter of the next rolling forecast). The number of Products included in the
third and fourth quarter of each regular rolling forecast shall be non-binding on either party and
will be provided for planning purposes only.
(e) Purchase Orders. Contemporaneous with the delivery of each forecast,
Novartis shall provide Gen-Probe with a purchase order reflecting its binding commitment,
consistent with its forecasts under Section 6.3.1(c) above, for delivery of Panther Instruments in
the first quarter of such forecast. Such orders shall indicate the quantity of Panther Instruments
to be delivered and the requested delivery. Gen-Probe shall confirm, in a writing delivered by
facsimile transmission or electronic mail to Novartis, receipt of each purchase order within five
(5) business days of receipt. [ *** ]
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(f) Additional Purchase Orders. If Novartis desires to enter a bid to a
potential customer that Novartis cannot fill with Panther Instruments that it has already ordered
hereunder, Novartis shall consult with Gen-Probe regarding such bid, and Gen-Probe shall notify
Novartis as to whether Stratec will be able to deliver such Panther Instruments within the
prescribed time.
(g) Forecasts In Excess of Supply.
[ *** ]
6.4.2 Transfer Price. [ *** ]
6.4.3 Compensation to Gen-Probe for Panther Instruments. [ *** ]
***Confidential Treatment Requested.
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6.4.4 Novartis Remedy for Reliability Deficiencies. Gen-Probe and Stratec
have entered into a Reliability Agreement with respect to the Panther Instrument. Prior to be
Addendum Effective Date, Gen-Probe has provided a copy of the Reliability Agreement to Novartis.
Following the Addendum Effective Date, Gen-Probe and Novartis shall use their best efforts to
modify the Reliability Agreement so as to adopt a three-way Reliability Agreement between Stratec,
Gen-Probe, and Novartis with respect to Panther Instruments for use in the Blood Screening Field,
maintaining the warranty terms and conditions previously negotiated between Gen-Probe and Stratec.
Following the Development Completion Date and the effective date of the three-way Agreement,
Novartis sole remedy for instruments that fail to meet the requirements of the Reliability
Agreement criteria will be through a claim against Stratec pursuant to the Reliability Agreement,
and Gen-Probe shall not have any liability to Novartis in connection with the failure of any
Panther Instrument to meet the requirements of the Reliability Agreement. If for any reason the
three-way Reliability Agreement is not adopted prior to the Development Completion Date, Gen-Probe
shall indemnify Novartis against the cost of repair or replacement, as necessary and in accordance
with the Reliability Agreement, of any Panther Instrument due to the failure of such Panther
Instrument to meet the requirements of the Reliability Agreement, and Gen-Probe shall have no other
liability to Novartis regarding the failure of Panther Instruments to meet such requirements.
7. Addendum Effective Date; Term; Termination.
7.1 Term of Panther Addendum. This Panther Addendum shall become effective
on the Addendum Effective Date and shall continue in effect through the Blood Screening Term, as it
may be amended or extended from time to time, unless sooner terminated in accordance with the
provisions of the Agreement.
7.2 Termination for Breach. Termination for breach shall be in accordance
with Article 10 of the Agreement.
8. Dispute Resolution/Escalation.
8.1 Escalation Process. Prior to implementing the arbitration process more
particularly described in Article 11 of the Agreement, the Parties agree to escalate any dispute
first to a discussion between the Novartis Alliance Manager and the Gen-Probe Project Manager, and
if they cannot agree, then to the Supervisory Board. However the Parties explicitly acknowledge
that in the event of the need for an urgent decision the Party with primary responsibility will
proceed to make the decision, and implement accordingly, but will follow the procedures set forth
under Section 2.4.5 above should there be a disagreement between the Parties regarding the decision
made. It is agreed that the Party with primary responsibility will make all reasonable and timely
efforts to inform the other Party of the issue requiring such urgent decision, particularly where
the issue is one of some consequence.
8.2 Remedies in Event of Default. Neither Party shall be entitled to
exercise any remedy otherwise available to it at law or in equity unless and until such Party shall
have provided the other Party with notice of such event of default, reasonably specifying the
nature of the default, and any applicable period of time for cure thereof shall have expired
without cure, and the procedures defined in Article 11 of the Agreement shall have been first
exhausted.
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8.3 Survival. Any provision of this Panther Addendum that imposes or
contemplates continuing obligations by virtue of the nature of the provision will survive the
expiration or termination of the Panther Addendum, but under no circumstances shall either Party
call for arbitration of any claim or dispute arising out of this Panther Addendum after such period
of time as would normally bar the initiation of legal proceedings to litigate such claim or dispute
under the laws of the State of California.
9. No Other Amendment. Except as expressly set forth in this Panther Addendum,
all other terms and conditions of the Agreement, are hereby ratified and shall continue in full
force and effect. In the event of a conflict between the terms of this Panther Addendum and the
Agreement, or any attachments herein, the terms of this Panther Addendum shall control.
10. Counterparts. This Panther Addendum may be executed in counterparts, each of
which shall be deemed an original, and all of which together shall constitute one and the same
instrument.
[SIGNATURE PAGE IMMEDIATELY FOLLOWS]
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IN WITNESS WHEREOF, the Parties have caused this Panther Addendum to be executed and the persons
signing below warrant that they are duly authorized to sign for and on behalf of the respective
Parties.
GEN-PROBE INCORPORATED, a Delaware corporation |
NOVARTIS VACCINES AND DIAGNOSTICS, INC., a Delaware corporation |
|||||||||
By:
|
/s/ Carl W. Hull
|
By: | /s/ Peter Maag
|
|||||||
President and Chief Executive Officer | President, Diagnostics | |||||||||
Date:
|
March 11, 2011 | Date: | March 21, 2011 |
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Schedule 4.5
FTE Labor Rate
1. FTE Labor Rate. $[ *** ] per FTE per calendar year
2. Panther Development Costs included within FTE Labor Rate. Panther Development
Costs included within FTE Labor Rate consist of all attributable costs associated with the
development of the Panther Instrument and related software incurred prior to the Development
Completion Date and includes pilot development; validation studies necessary for product and
process licensure; and the manufacture and ultimate disposition of conformance lots of material,
calculated as follows:
(a) Development costs include: research and development associated with the Panther
Development Program; validation exclusively associated with the Panther Instrument and related
software; development lots; document preparation specific to the development;
(b) The planned resources, and the associated costs, will be broken out on a monthly basis and
analyzed against the Resource Plan included within the Project Plan, and reflected in the Budget;
(c) Salaried staff costs included within the Budget will be adjusted to reflect actual staff
costs. Salary information may be aggregated to protect the identity of individuals. This salary
information will be verifiable on a need to know basis to a select number of personnel from each
company;
(d) Cost for wage laborers plus the applicable overhead charge for such labor paid to
personnel described in the Resource Plan, including the Panther Development Program project manager
and/or development director and personnel engaged to perform QA testing for the Panther Development
Program;
(e) Costs for engineering prototypes and developing pilot modules required for the Panther
Development Program;
(f) Costs of inventory consumed in the Panther Development Program, including raw material,
intermediates and finished goods, Prototypes and conformance lots, whether reject or not, that
arise from the Panther Development Program or are necessary to support the Panther Development
Program, and waste material, including raw materials and development materials that arise from the
Panther Development Program but excluding scrap materials used strictly for internal research
purposes or consumed in development programs other than the Panther Development Program;
(g) Costs for conformance product documentation;
(h) Costs for courier and mail service fees for delivery of items between Gen-Probe and
Novartis;
(i) Costs of travel, lodging and reasonable per diem expenses for employee and consultants of
Gen-Probe or Novartis incurred in furtherance of their activities hereunder, providing training or
participating on the Supervisory Board or designee to the extent such costs are not included within
the overhead charge applicable to labor costs;
(j) Costs of foreign regulatory submissions or registrations for the Panther Instrument and
related software for use in the Blood Screening Field.
(k) Such other categories as the Parties may agree in writing from time to time;
(l) All budgeted expenses of departments directly involved with the Panther
Development Program; and
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(m) Appropriate portions of budgeted costs of departments indirectly involved in the Panther
Development Program.
3. Panther Development Costs not included within FTE Labor Rate.
(a) Significant Third Party consultant charges (i.e. CRO, regulatory expertise, etc.) to the
extent not captured within the FTE rates in Item 2 above;
(b) Third Party development and hardware acquisition costs (other than the reasonable
amortized cost of all instruments utilized that are necessary for the research and development of
such quantities of the Panther Instrument during the Panther Development Program which shall be
included in the FTE Rate.
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EXHIBIT A
Panther Instrument Product Requirements Document
[ *** ]
***Confidential Treatment Requested.
EXHIBIT B
Ultrio Elite Assay Product Requirements Document
[ *** ]
***Confidential Treatment Requested.
EXHIBIT C
Panther Instrument and Ultrio Elite Assay Development Timeline
[ *** ]
***Confidential Treatment Requested.