Attached files
| file | filename |
|---|---|
| 10-Q - NAVIDEA BIOPHARMACEUTICALS, INC. | v193075_10q.htm |
| EX-32.2 - NAVIDEA BIOPHARMACEUTICALS, INC. | v193075_ex32-2.htm |
| EX-32.1 - NAVIDEA BIOPHARMACEUTICALS, INC. | v193075_ex32-1.htm |
| EX-31.1 - NAVIDEA BIOPHARMACEUTICALS, INC. | v193075_ex31-1.htm |
| EX-31.2 - NAVIDEA BIOPHARMACEUTICALS, INC. | v193075_ex31-2.htm |
Confidential
Treatment – Asterisked material
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
Exhibit
10.1
MANUFACTURE AND SUPPLY
AGREEMENT
THIS MANUFACTURE AND SUPPLY
AGREEMENT is entered into this 30th day of November 2009, by and between
Reliable Biopharmaceutical Corporation, a corporation organized under the laws
of the State of Missouri, with its principal offices located at 1945 Walton
Road, St. Louis, Missouri 63114 ("RELIABLE") and Neoprobe Corporation, a
corporation organized under the laws of the State of Delaware, with offices
located at 425 Metro Place North, Suite 300, Dublin, Ohio 43017-1367
("NEOPROBE").
WITNESSETH
WHEREAS,
NEOPROBE desires to engage RELIABLE to manufacture and supply NEOPROBE with such
requirements of the Active Pharmaceutical Ingredient (as defined below) as
needed and ordered by NEOPROBE in accordance with the terms and conditions set
forth in this Agreement; and
WHEREAS,
RELIABLE is willing to manufacture and supply to NEOPROBE such requirements of
Active Pharmaceutical Ingredient as needed and ordered by NEOPROBE in accordance
with the terms and conditions set forth in this Agreement.
NOW,
THEREFORE, in consideration of the premises and of the mutual covenants and
agreements set forth in this Agreement, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parties (as defined below) agree as follows:
1. DEFINITIONS
In
addition to the terms defined elsewhere herein, the following words and phrases
shall, for purposes of this Agreement, have the following meanings (with any
term or phrase referred to below, or defined elsewhere in this Agreement, in the
singular to include the plural and vice versa as the context
requires):
1.1 "Active Pharmaceutical
Ingredient" or "API" shall mean bulk,
unformulated Lymphoseek Ligand.
1.2 "Affiliate" shall
mean, with respect to a Party, any Person that is controlled by, controls, or is
under common control with such Party. For this purpose, "control" of
a corporation or other business entity shall mean: (i) the direct or indirect
beneficial ownership of more than fifty percent (50%) in the equity of, or the
right to appoint more than fifty percent (50%) of the directors or management of
such corporation or other business entity; or (ii) the possession, directly or
indirectly, of the power to direct the management or policies of an entity,
whether through the ownership of voting securities, by contract or
otherwise.
*Asterisked
material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
1.3 "Agreement" shall mean
this manufacture and supply agreement together with the recitals and all
exhibits annexed hereto.
1.4 "Approval" shall mean
any and all approvals, licenses, registrations or authorizations of the
applicable Regulatory Authority necessary for the marketing of Finished Products
in the relevant country in the Territory.
1.5 "Calendar Quarter"
shall mean a period of three (3) consecutive months ending at midnight, Eastern
Time on the last day of March, June, September, or December,
respectively.
1.6 "cGMP" shall mean
current Good Manufacturing Practice as established by the FDA and all other
applicable laws and regulations, including all applicable U.S., federal, state,
foreign, and local environmental, health and safety law and regulations in
effect at the time and place of Manufacture of the API.
1.7 "Commercial Contract
Year" shall mean a year of 365 days (or 366 days in a leap year)
beginning on the date the first Approval is received and ending one (1)
year thereafter and so on year-by-year. "Commercial Contract Year One"
shall mean the first such year; " Commercial Contract Year Two"
shall mean the second such year, and so on, year-by-year.
1.8 "DMF(s)" shall mean
the drug master file(s) covering the analysis and manufacture of the API,
comprising any and all technical information in the possession of RELIABLE (or
an Affiliate thereof), including, without limitation, analytical methods,
stability and pharmaceutical data, impurities, and manufacturing processes with
respect to the API.
1.9 "Effective Date" shall
mean the date first set forth above.
1.10 “Emergency Supply
Conditions” or “ESC” shall mean
conditions under which (a) RELIABLE is unable to fill any Purchase Order placed
by NEOPROBE in accordance with Article 3, or (b) inventory of the API held
by RELIABLE falls below the required quantity of safety stock then in effect, in
either case as a result of either (i) Force Majeure, or (ii) any reason
related to RELIABLE’s inability to supply the Product.
1.11 Finished Products" or
"Finished
Product" shall mean such human pharmaceutical products containing API for
which NEOPROBE may receive Approval from a Regulatory Authority.
1.12 "FDA" shall mean the
United States Food and Drug Administration and all agencies under its direct
control or any successor governmental entity.
1.13 "FFDCA" shall mean the
Federal Food, Drug and Cosmetic Act of 1934, as amended from time to time, and
the regulations promulgated pursuant thereto, or any successor statute adopted
to replace such act.
*Asterisked
material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
1.14 "Indemnitee " shall
have the meaning assigned to such term in Section 11.3.
1.15 "Manufacture" and
"Manufacturing"
and other forms of such word or phrase shall refer to the manufacturing,
handling, packaging, storage and/or disposal of the API and the raw materials
and components used in connection therewith.
1.16 "NDA" means a New Drug
Application filed in the U.S. with the FDA pursuant to its rules and regulations
as more fully defined in Title 21 of the U.S. Code of Federal Regulations,
Section 314.50, et.
seq, and any equivalent application filed with any Regulatory Authority
with respect to any other country in the Territory.
1.17 "Party" or "Parties" shall mean
RELIABLE or NEOPROBE, and, when used in the plural, shall mean RELIABLE and
NEOPROBE
1.18 "Person" shall mean
any individual, partnership, association, corporation, or other business
entity.
1.19 "Regulatory Authority"
shall mean the FDA in the U.S., and any health regulatory authority(ies) in any
country in the Territory that is a counterpart to the FDA and holds
responsibility for granting Approval in the relevant country of the Territory,
and any successor(s) thereto.
1.20 "Specifications" shall
mean the specifications set forth in Exhibit A annexed hereto and made a
part hereof, as same may be modified, in writing,
from time to time, by the Parties.
1.21 "Territory" shall mean
worldwide.
2. TERM
This
Agreement shall become effective as of the Effective Date and shall remain in
full force and effect, unless earlier terminated pursuant to one of the
provisions of Section 12 hereof, for a period ending upon the expiration of ten
(10) Commercial Contract Years (the "Initial Term"). NEOPROBE shall
notify RELIABLE in writing promptly upon receipt of Approval from the
FDA. Following expiration of the Initial Term, this Agreement shall
be renewable by NEOPROBE, upon the same terms and conditions, for successive
three (3) year periods (a "Renewal Term") upon written notice to RELIABLE
delivered at any time prior to the expiration of the Initial Term or any Renewal
Term then in effect, and RELIABLE’S written acceptance of the notice. For purposes of this
Agreement "Term" shall refer collectively to the Initial Term and any Renewal
Terms, unless the context otherwise requires.
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*Asterisked
material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
3. SUPPLY.
3.1 Supply of
API. Subject to the terms and conditions of this Agreement,
and provided that NEOPROBE is not in material breach of its obligations
hereunder, RELIABLE shall supply on an exclusive basis quantities of API ordered
by NEOPROBE from time to time during the Term for use in the Finished Product
for the Territory. During the Term of this Agreement and subject to
the terms contained herein, NEOPROBE shall purchase the API exclusively from
RELIABLE, except as otherwise set forth herein, The Parties recognize
and acknowledge that NEOPROBE's business may be dependent on the supply of API
to NEOPROBE by RELIABLE as specified hereunder.
3.2 Forecasts and
Orders.
3.2.1 Commercial
Supply.
(a) NEOPROBE
agrees to either: (i) pay RELIABLE a capacity reservation fee of $[*] per year
if no purchases of API are planned during a Commercial Contract Year covered by
the Term of this Agreement, beginning in calendar year 2011; or (ii) continue to
purchase [*]% of its commercial requirements of API for use in the Finished
Product in the Territory from RELIABLE (provided that RELIABLE is not in
material breach of its obligations hereunder) during a Commercial Contract
Year. In the event that NEOPROBE submits Commercial Orders (as
defined in paragraph (c) below) for API with respect to any Commercial Contract
Year for less than $[*], as set forth above, (and RELIABLE is not in material
breach of its obligations hereunder), NEOPROBE will pay to RELIABLE the
difference between: (a) the aggregate amounts actually paid by NEOPROBE to
RELIABLE during such Commercial Contract Year; and
(b) $[*]. Such payment will be made by NEOPROBE to
RELIABLE within thirty (30) days after the end of such Commercial Contract
Year.
(b) After
product launch, NEOPROBE shall submit, in writing, to RELIABLE a good faith,
initial forecast of the quantities of API estimated to be required on a Calendar
Quarter basis during the following twelve (12) month period, which forecast
shall be for be for planning purposes only; and
(c) thereafter,
no later than fifteen (15) days prior to the first day of each Calendar Quarter
("Q1"), NEOPROBE will provide RELIABLE with a good faith, rolling twelve (12)
month forecast of its requirements for API in the Territory. The
forecast for Q1 shall be binding on RELIABLE and NEOPROBE and shall constitute a
firm purchase order ("Commercial Order") for such quantities of API which
NEOPROBE shall be committed to purchase during such Q1 period. The
information for the remaining Calendar Quarters shall be for planning purposes
only. Each Commercial Order shall be made pursuant to purchase orders
which are in a form mutually acceptable to the Parties in accordance with
Section 3.2.4 and shall specify the quantity of API ordered, the destination to
which the API is to be delivered and the time and manner of delivery (including
the carrier to be used) in accordance with Section 4.3 and elsewhere in this
Agreement. Subject to Section 5.2, NEOPROBE shall purchase [*]% of
its commercial requirements of API for use in the Finished Product in the
Territory from RELIABLE provided that RELIABLE is not in material breach of its
obligations hereunder.
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*Asterisked
material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
3.2.2 Additional
Orders. RELIABLE shall supply NEOPROBE with: (a) the
quantities set forth on each such Commercial Order; and (b) such additional
amounts that NEOPROBE may order in excess of its forecasted amounts constituting
Commercial Orders hereunder, provided, that RELIABLE shall
have confirmed and accepted such additional orders within thirty (30) days of
RELIABLE's receipt of any such additional purchase order. RELIABLE
agrees to use commercially reasonable best efforts to supply the quantities of
API set forth in any such additional orders, but in no event will RELIABLE be
required to accept any changed order in excess of [*]% of the amount of the
original Purchase Order.
3.2.3 Reserved Capacity;
Inventory. RELIABLE covenants to maintain: (a) capacity to
manufacture on an annualized basis [*]% of the forecasted
requirements of API set forth in any twelve month forecast submitted by NEOPROBE
in accordance with this Agreement; and (b) as a safeguard against any potential
short-term interruption in its manufacturing operations, reasonable safety stock
of API in an amount of not less than three (3) months' average of NEOPROBE's
forecasted requirements of API. RELIABLE will have the right to reduce the
safety stock, to adequate levels based on the percentage difference between the
forecasted quantity and actual orders.
3.2.4 Emergency Supply
Conditions. Upon the occurrence of Emergency Supply
Conditions, RELIABLE shall give prompt written notice to NEOPROBE (the “ESC Notice”) and such
notice shall set forth the date on which the Emergency Supply Conditions began
(the “ESC
Date”). Promptly after the issuance of such ESC Notice,
RELIABLE agrees to meet with NEOPROBE as reasonably requested by NEOPROBE to
discuss options to resolve the Emergency Supply Conditions and to minimize the
impact of such Emergency Supply Condition to NEOPROBE. In any case,
RELIABLE shall cooperate with NEOPROBE in taking all actions that the NEOPROBE
deems reasonably necessary in order to remedy such Emergency Supply Condition,
which may include any or all of the following in the order of sequence
below:
(a) RELIABLE
shall provide assurances acceptable to NEOPROBE, such acceptance not to be
unreasonably withheld or delayed, that, within a period of ninety (90) days from
the ESC Date, RELIABLE will be able to rectify the supply condition and return
safety stock to the level required under this Agreement;
(b) The
cancellation by NEOPROBE, without penalty, of all or any of the current Purchase
Orders affected by such Emergency Supply Condition and obtain its requirements
of Product or replacement product elsewhere during the expected period of the
Emergency Supply Conditions;
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*Asterisked
material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
(c) If
the supply condition rectification proposed above is not acceptable or does not
work, RELIABLE shall provide a Technical Transfer (as defined in Section 3.2.5
below) to a third-party manufacturer identified by NEOPROBE in order to supply
such quantity of Product to NEOPROBE as RELIABLE is unable to
supply. RELIABLE’s provision of an ESC Notice shall not be
interpreted in any manner to relieve RELIABLE of its obligations under this
Agreement, nor shall it prevent NEOPROBE from pursuing any and all rights and
remedies NEOPROBE may have based on RELIABLE’s failure to deliver the Products
in accordance with the terms of this Agreement.
3.2.5
Third-Party Manufacturer (TPM)
and Technical Transfer
(a) If
NEOPROBE elects to appoint a TPM to supply the Product after receipt of an ESC
notice, NEOPROBE shall so notify RELIABLE within ninety (90) days of its receipt
of the ESC Notice from RELIABLE. Within thirty (30) days after
NEOPROBE identifies the TPM to RELIABLE, RELIABLE shall initiate a RELIABLE
Technical Transfer to the TPM. [*]. In addition, RELIABLE
shall reasonably assist the TPM in the transfer and the start-up of
manufacturing operations for the Product and shall make the necessary plans,
formulations and manufacturing processes and procedures available to the
TPM. Further, RELIABLE shall grant the TPM access to its regulatory
files and shall supply such other technical or regulatory assistance as is
reasonably requested by the TPM with respect to the RELIABLE Intellectual
Property. RELIABLE shall have the right to require that the TPM agree
to confidentiality obligations with respect to the Technical Transfer that are
no less restrictive than those contained herein.
(b) RELIABLE
acknowledges and agrees that NEOPROBE shall be entitled to all of the rights and
protections set forth in Section 365(n) of Title 11 of the United States Code
with respect to the RELIABLE Transfer License, any sublicense in the Third Party
Rights and all other related rights as provided herein.
3.2.6 Form of Purchase
Order. NEOPROBE's Commercial Orders shall be made pursuant to
a written purchase order which shall provide for shipment in accordance with
reasonable delivery schedules and lead times as may be agreed upon from time to
time by RELIABLE and NEOPROBE. The terms and conditions of this
Agreement shall apply to all purchase orders issued hereunder, and, if any terms
or conditions contained in such purchase orders shall conflict with any terms
and conditions contained herein, the terms of this Agreement shall
control. No additional terms or conditions set forth in any such
purchase order (other than the quantities and delivery dates set forth therein
and conforming to the provisions of this Agreement) shall be binding upon
RELIABLE, unless agreed to in writing by RELIABLE. Any additional or
inconsistent terms or conditions of any purchase order, acknowledgment or
similar standardized form given or received pursuant to this Agreement shall
have no force and effect and such terms and conditions are hereby expressly
excluded.
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*Asterisked
material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
3.3 Payment for
Registration/Filing Outside the United States. NEOPROBE shall
have the option to expand sales of the Finished Product outside the United
States to include such country, or countries, as it may, in its sole discretion,
determine. Such option may be exercised by NEOPROBE at any time upon
written notice to RELIABLE; provided, however that
NEOPROBE and RELIABLE negotiate in good faith to reach agreement on the terms
and conditions under which RELIABLE shall provide services in support of NEOPROBE's
regulatory obligations in such country, or countries), including, without
limitation, all filings with Regulatory Authorities in such country, or
countries. However, for the purposes of this section, RELIABLE
agrees that any regulatory/registration support associated with a filing in the
European Union (EU) will be provided by RELIABLE at no cost to
NEOPROBE.
4. PRICE; PAYMENTS;
DELIVERY
4.1 Price. The price
payable to RELIABLE hereunder for Commercial Orders of API shall be calculated
as set forth on Exhibit B, "Price Structure for Commercial Orders".
4.2 Payments. NEOPROBE
shall pay all undisputed invoices net within thirty (30) days of the receipt of
the invoice by: (i) bank wire transfer; (ii) automated clearinghouse (electronic
funds transfer); or (iii) such other means as the Parties may otherwise agree;
in United States Dollars to such bank account as RELIABLE may from time to time
designate. In the event that NEOPROBE is delinquent in payment of any undisputed
invoices hereunder beyond the terms set forth in this Section 4.2, RELIABLE, in
its discretion, may suspend further shipments of API. Undisputed
amounts not paid when due shall accrue interest payable at the rate of one
percent (1.0%) per month, not to exceed the maximum rate of interest permitted
by law. Any such interest charges shall be due and payable on
demand.
4.3 Delivery; Risk of
Loss. All API shall be packaged and labeled as instructed by NEOPROBE,
and shall be accompanied by appropriate certificates of analysis. All
API shall be appropriately labeled with a traceable batch number and date of
manufacture. RELIABLE shall ship each shipment, FCA RELIABLE's
facilities in St. Louis, Missouri, to NEOPROBE’s designee’s facility ( Incoterms
2000), or such other designees’ location specified in the purchase order for the
applicable Commercial Order, as instructed by NEOPROBE. Any special
packing expenses shall be borne by RELIABLE. Delivery of all API sold
by RELIABLE to NEOPROBE hereunder shall be made, and title thereto and risk of
loss thereof shall pass, to NEOPROBE upon transfer of the API into the
possession of NEOPROBE's freight carrier.
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*Asterisked
material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
5. ACCEPTANCE AND
REJECTION
5.1 Notification of
Defects. All API shall be received subject to NEOPROBE's, or
its designee's, inspection and may be rejected by NEOPROBE, or such designee, if
any such API does not conform to the Specifications or otherwise fails to be
delivered in the condition warranted as set forth in Section
10.1. NEOPROBE, or its designee: (i) shall notify RELIABLE in
writing within thirty (30) days after delivery to NEOPROBE, or its designee, of
any shipment of API containing obvious physical damage, obvious packaging
defects or quantity discrepancies that are evident upon visual inspection of the
packaged API without affecting the integrity of the API's packaging; and (ii)
will notify RELIABLE of nonconformity within thirty (30) days from its discovery
within sixty (60) days after delivery to NEOPROBE or its designees of any latent
defects, or NEOPROBE's rights as to such obvious or latent nonconformance shall
be waived. At RELIABLE's request, NEOPROBE, or its designee,
shall promptly supply either samples of the API that are allegedly defective or
a reasonably detailed statement of its reasons for rejection and a report of any
pertinent analysis performed by NEOPROBE, or its designee, on the allegedly
nonconforming API, together with the methods and procedures
used. RELIABLE shall notify NEOPROBE as promptly and as reasonably
possible, but in any event within thirty (30) business days after receipt of
such notice of rejection, whether it accepts NEOPROBE's assertions of
nonconformity.
5.1.1 Dispute
Resolution. If there is a disagreement between the Parties as
to whether any API conforms to the Specifications, then samples and/or batch
records, as appropriate, from the batch that is in dispute promptly will be
submitted for testing and evaluation to an independent testing laboratory as
shall be agreed to in writing by both Parties. The determination of
such independent testing laboratory shall be binding upon the
Parties. If it is determined that the nonconformity is due to
damage to API: (a) caused by NEOPROBE or its agents; or (b) which occurs
subsequent to delivery of such API to NEOPROBE or its designee, RELIABLE shall
have no liability to NEOPROBE with respect to such nonconformity and the cost of
any testing and evaluation by such testing laboratory shall be borne by
NEOPROBE. If the nonconformity is caused by RELIABLE, then RELIABLE
shall terminate the invoice issued for such shipment of nonconforming API,
or if payment therefore has previously been made by NEOPROBE, at NEOPROBE's
sole option, either refund to NEOPROBE the amount of such invoice, or credit the
amount of such payment against any other amounts then due to
RELIABLE.
5.1.2 Replacement. Notwithstanding
the preceding, if any API is determined to be damaged or defective, upon
NEOPROBE's request, RELIABLE shall promptly deliver, or cause to be delivered,
to NEOPROBE, or its designee, conforming API in the same quantity as the
rejected API, on a date to be reasonably agreed upon by both parties after the
date of such request.
5.2 Notification. RELIABLE
shall notify NEOPROBE immediately in the event it discovers facts or
circumstances, which could: (i) adversely affect the API's conformance to the
Specifications; or (ii) RELIABLE’s ability to meet shipping dates or quantity
requirements.
5.3 Returns. RELIABLE
shall, at its sole cost and expense, accept for return and replacement any
non-conforming API manufactured and supplied to NEOPROBE under this Agreement
for which notice has been given pursuant to Section 5.1; provided, that, NEOPROBE
obtains prior shipping authorization from RELIABLE, which shall be issued
promptly, and in no case more than thirty (30) days.
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*Asterisked
material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
6. MANUFACTURE OF
API
6.1 cGMP
Manufacture. The API shall be manufactured in accordance with
cGMP promulgated by the FDA, the Specifications and pursuant to the DMF and/or
the procedures filed with the FDA via an NDA. RELIABLE shall promptly
advise NEOPROBE of any process changes proposed by RELIABLE for the manufacture
of the API. RELIABLE shall pay all regulatory costs involved in the
implementation of such process change; provided, however that no
changes shall be made to any manufacturing process which would cause the API to
fail to comply with NEOPROBE’s Approval (including, without limitation, any
requirements of the NDA). Concerning pre-approval changes required
for regulatory approval, RELIABLE shall provide regulatory support to NEOPROBE
in connection with all submissions, reports and filings required by any
Regulatory Authority in the Territory; except with respect to any
country or countries outside the United States to which NEOPROBE has elected to
expand sales of the Finished Product as provided in Section 3.3. The cost of
support that RELIABLE provides for any pre-approval changes shall be borne by
NEOPROBE.
6.2 Testing. For
quality control, RELIABLE shall conduct in-process and final controls in
accordance with test procedures agreed to by the Parties (the "Testing
Methods"). RELIABLE shall be responsible for the validation of all
Manufacturing processes and processing systems and shall establish programs for
change control for the validated Manufacturing process(es), systems, and
computer systems.
6.3 Records Retention;
Samples. RELIABLE shall store for each shipment of API
Manufactured by RELIABLE hereunder complete and accurate records pertaining to
the Manufacture and testing of the API, validation /stability/ developmental
data and all other Manufacturing documentation required by applicable law,
regulatory requirements and cGMP, as well as retain samples of such API for two
(2) years beyond expiration of the API or such longer period as the Parties may
agree. RELIABLE shall provide quality control examination of the
retained sample representing the beginning, middle and end of the packaging
operation prior to release to assure the API’s packaging is in accordance with
the Specifications. RELIABLE shall also be responsible for storing
and maintaining retention samples of each batch of raw material utilized in the
manufacture of API in accordance with all regulatory requirements and
cGMP.
6.4 Complaints. RELIABLE
shall be responsible for the investigation of any complaints regarding the API
arising from the Manufacturing process following notification from
NEOPROBE.
6.5 Annual
Reviews. RELIABLE will provide NEOPROBE with annual product
reviews which will include complaint and stability analysis. Such
reviews shall be available at time of audits or upon request.
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*Asterisked
material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
7. FDA INSPECTIONS AND
COMMUNICATIONS
RELIABLE
shall promptly notify NEOPROBE of any FDA notices of violation or deficiency
letters relating to the API or any facility in which the API is produced, to the
extent that a deficiency letter relating to such facility relates to the
Manufacture of the API. Each Party shall promptly deliver to the
other Party all reports, data information and correspondence received by it from
the FDA or any state or local authority with respect to the API (or Finished
Product if the report, data and/or correspondence relate to the API) and any
cGMP issues relating thereto and any written response information, data or
correspondence delivered by such Party to the FDA at any state or local
authority with respect to the API and shall cooperate to the extent reasonably
requested by such other Party in its response to the FDA or such other state or
local authority.
8. COMPLAINT HANDLING; ADVERSE DRUG
REACTION REPORTS; RECALLS
8.1 Complaint
Handling. Except as otherwise provided below in
Section 8.2, in the event that RELIABLE or NEOPROBE receives any complaint,
claims or adverse reaction reports regarding API, including notices from the FDA
regarding any alleged regulatory non-compliance of the Finished Product, each
Party shall, within five (5) business days, provide the other with all
information contained in the complaint, report, or notice and such additional
information regarding the API as may be reasonably requested, NEOPROBE and
RELIABLE shall each comply, at a minimum, with FDA and cGMP requirements for
complaint handling.
8.2 Adverse Drug Reaction Reports.
If either Party becomes aware that the API contains a defect which could or did
cause death or injury, such Party shall immediately by FAX and telephone provide
the other with a complete (where required by law) description of all relevant
details known to such Party concerning any such incident, including but not
limited to, a description of any defect and such other information which may be
necessary to report the incident to the FDA. NEOPROBE will be
responsible for preparing adverse drug reaction reports, administering adverse
drug reaction files relating to the API purchased hereunder and filing all such
reports with FDA, at its sole expense.
8.3 Recall. If
NEOPROBE recalls, detains or retains any Finished Product (voluntarily or by
order of a Regulatory Authority), RELIABLE agrees to reasonably cooperate in
such actions, at NEOPROBE's sole expense; except if the recall,
detention or retention action for the Finished Product is due to any negligence,
recklessness or willful intentional acts or omissions or a breach of any
representation or covenant or breach of warranty by RELIABLE or its Affiliates,
then and in such event, RELIABLE shall bear all reasonable direct, documented
costs associated with said action and shall bear the actual cost of conducting
such action or withdrawal, including costs imposed by the applicable Regulatory
Authority(ies) such as costs for detention and inspection, in accordance with
the recall guidelines of the applicable Regulatory Authority(ies) or standard
U.S. pharmaceutical industry practices. However, the aggregate
liability of RELIABLE under the preceding sentence will not exceed the amount
paid by NEOPROBE to RELIABLE for the purchase order under which the API in
question was bought by NEOPROBE.
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material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
9. ACCESS TO FACILITIES
9.1 Site
Inspection. Upon reasonable notice and subject to the
confidentiality provisions of Article 14 below, NEOPROBE shall have the right,
exercisable upon prior written notice on an annual basis, or more frequently as
may reasonably be requested, during normal business hours, with a maximum of two
(2) persons, to inspect those areas of the facilities where API is manufactured
for NEOPROBE (or its Affiliates) and to review RELIABLE's compliance with the
Specifications, applicable environmental, health and safety regulations, cGMP
and good laboratory practices, and to evaluate RELIABLE's capability for
responding effectively to any spills or releases of hazardous materials utilized
or produced by RELIABLE in the Manufacture of the API.
9.2 Licenses and
Permits. At any time during the Term, RELIABLE shall permit
NEOPROBE's representatives to review RELIABLE's licenses and permits relating to
the Manufacture of API.
10. REPRESENTATIONS AND
WARRANTIES
10.1 Warranties by
RELIABLE. RELIABLE warrants to NEOPROBE that the API
manufactured by or for RELIABLE and sold to NEOPROBE under this Agreement
shall:
10.1.1 Conform
to the Specifications and shall be manufactured in a FDA approved facility in
accordance with the DMF on file for the API and in accordance with
cGMP;
10.1.2 Not
be adulterated or misbranded within the meaning of the FFDCA, or within the
meaning of any applicable state or municipal law in which the definitions of
adulteration and misbranding are substantially the same as those contained in
the FFDCA, as such are constituted and effective at the time of delivery and
will not be an article which may not, under the provisions of Section 505 of the
FFDCA, be introduced into interstate commerce;
10.1.3 Be
fit for its particular purpose in the manufacture of the Finished Product; and
RELIABLE further warrants that RELIABLE is not knowingly infringing on any
patent held by third parties, nor knowingly using any trade secrets in an
unauthorized manner, relating to the manufacture of the API;
10.1.4 Be
materially in compliance with all applicable U.S., state, and local laws and
regulations governing RELIABLE’s manufacture of the API, including cGMP, as
applied to bulk pharmaceutical chemicals regulated by the FDA, as well as all
applicable RELIABLE standard operating procedures during the Term of this
Agreement.
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material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
10.2 Warranty by
NEOPROBE. NEOPROBE represents and warrants to RELIABLE
that NEOPROBE has the legal right and authority to have the API made for it by
RELIABLE as provided herein , except that this warranty does not extend to
materials, methods or processes selected by RELIABLE (and not specified by
NEOPROBE) for Manufacturing of the API.
11. INDEMNIFICATION
11.1 Indemnification by
NEOPROBE. NEOPROBE agrees to indemnify, defend and hold
RELIABLE, its Affiliates, and their respective agents, directors, officers, and
employees harmless against any and all liability, loss, damage, cost, or expense
resulting from any third party claim or suit brought against RELIABLE to the
extent such: (i) is caused by gross negligence, recklessness or willful
misconduct in the Manufacturing, marketing, distribution, sale or use of the
Finished Product by, or on behalf of NEOPROBE, except to the extent such is
caused by gross negligence, recklessness or willful misconduct in the
Manufacture of the API by, or on behalf of, RELIABLE; (ii) is caused by
NEOPROBE's breach of the warranty set forth in Section 10.2 hereof or
breach of any material obligation of NEOPROBE or its relevant Affiliates
contained in this Agreement; (iii) arises out of a claim of infringement of any
patent or the unauthorized use of a trade secret resulting from the Manufacture,
marketing, distribution, sale or use of the Finished Product by, or on behalf
of, NEOPROBE, except to the extent such infringement action is based on the
materials, methods or processes selected by RELIABLE (and not specified by
NEOPROBE) for Manufacturing the API; or (iv) arises out of or results from any:
(a) warranty claims, (b) product recalls, or (c) tort claims of personal injury
(including death) or property damage relating to or arising out of the
Manufacturing, marketing, distribution, sale or use of the Finished Product,
except to the extent such is caused by gross negligence, recklessness or willful
misconduct in the Manufacture of the API by, or on behalf of,
RELIABLE. Nothing in the foregoing sentence however limits the
liability of RELIABLE under Section 8.3 with respect to recalls, detentions or
retentions.
11.2 Indemnification by
RELIABLE. RELIABLE agrees to indemnify, defend and hold
NEOPROBE, its Affiliates, and their respective agents, directors, officers, and
employees harmless against any and all liability, loss, damage, cost, or expense
resulting from any third party claim or suit brought against NEOPROBE to the
extent such: (i) is caused by gross negligence, recklessness or willful
misconduct in the Manufacture of the API by, or on behalf of, RELIABLE; (ii) is
caused by RELIABLE's breach of any of the warranties set forth in Section 10.1
hereof or breach of any material obligation of RELIABLE or its relevant
Affiliates contained in this Agreement; (iii) arises out of a claim of
infringement of any patent or the unauthorized use of a trade secret resulting
from the materials, methods or processes selected by RELIABLE (and not specified
by NEOPROBE) for Manufacturing the API; or (iv) arises out of or results from
any: (a) warranty claims, (b) product recalls, or (c) tort claims of personal
injury (including death) or property damage relating to or arising out of gross
negligence, recklessness or willful misconduct in the Manufacture of the API by,
or on behalf of, RELIABLE.
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material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
11.3 Procedure. In the event that any
person entitled to indemnification under Section 11.1 or Section 11.2 (an
"Indemnitee") is seeking such indemnification, such Indemnitee shall: (i)
inform, in writing, the indemnifying Party of the claim as soon as reasonably
practicable after such Indemnitee receives notice of such claim; (ii) permit the
indemnifying Party to assume direction and control of the defense of the claim
(including the sole right to settle it at the sole discretion of the
indemnifying Party; provided
that such settlement does not impose any obligation on, or otherwise
adversely affect, the Indemnitee or another Party); (iii) cooperate as requested
(at the expense of the indemnifying Party) in the defense of the claim; and (iv)
undertake all reasonable steps to mitigate any loss, damage or expense with
respect to the claim(s). Notwithstanding the preceding, nothing herein shall be
construed as prohibiting an Indemnitee from participating in the defense of such
claim or suit at its own expense.
11.4 RELIABLE Limitation of
Liability. THE REPRESENTATIONS AND WARRANTIES OF RELIABLE SET
FORTH IN SECTION 10.1 ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,
INCLUDING WARRANTIES OF MERCHANTABILITY AND/OR FITNESS FOR ANY
PURPOSE. FURTHERMORE, EXCEPT WITH RESPECT TO RELIABLE’S
INDEMNIFICATION OBLIGATIONS SET FORTH IN SECTION 11.2, AND THE OBLIGATIONS OF
CONFIDENTIALITY SET FORTH IN SECTION 14, RELIABLE SHALL NOT BE LIABLE, AND
RELIABLE HEREBY EXPRESSLY DISCLAIMS, ANY LIABILITY FOR SPECIAL, INCIDENTAL,
INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM A BREACH OF THIS AGREEMENT, THE
BREACH OF ANY REPRESENTATION OR WARRANTY, OR ANY OTHER THEORY, WHETHER SOUNDING
IN TORT OR IN CONTRACT.
11.5 NEOPROBE Limitation of
Liability. THE REPRESENTATION AND WARRANTY OF NEOPROBE SET FORTH IN
SECTION 10.2 IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING
WARRANTIES OF MERCHANTABILITY AND/OR FITNESS FOR ANY
PURPOSE. FURTHERMORE, EXCEPT WITH RESPECT TO NEOPROBE’S
INDEMNIFICATION OBLIGATIONS SET FORTH IN SECTION 11.1, AND THE OBLIGATIONS OF
CONFIDENTIALITY SET FORTH IN SECTION 14, NEOPROBE SHALL NOT BE LIABLE, AND
NEOPROBE HEREBY EXPRESSLY DISCLAIMS, ANY LIABILITY FOR SPECIAL, INCIDENTAL,
INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM A BREACH OF THIS AGREEMENT, THE
BREACH OF ANY REPRESENTATION OR WARRANTY, OR ANY OTHER THEORY, WHETHER SOUNDING
IN TORT OR IN CONTRACT.
12. TERMINATION
12.1 Termination. This
Agreement shall terminate upon the occurrence of any of the following events or
conditions which termination shall automatically occur where termination by a
specified Party is not indicated and shall occur by action of the specified
Party where so indicated:
12.1.1 The
expiration of the Initial Term or any Renewal Term as set forth in Section
2;
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material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
12.1.2 The
material breach by either Party of any provision of this Agreement which is not
cured within thirty (30) days from the date of written notice delivered to the
defaulting Party in the case of a payment default, and within sixty (60) days
from the date of such notice in all other cases; provided, however, that only
the non-breaching Party can terminate this Agreement pursuant to this Section
12.1.2;
12.1.3 The
mutual written agreement of the Parties to this Agreement;
12.1.4 By
the non-affected Party upon the continuation of any Force Majeure Event under
Section 13 for a continuous period of six (6) months or longer; or
12.2 Effect of
Termination.
12.2.1 Termination,
relinquishment or expiration of this Agreement for any reason shall be without
prejudice to any rights that shall have accrued to the benefit of any Party
prior to such termination, relinquishment or expiration. Such
termination, relinquishment or expiration shall not relieve any Party from
obligations that are expressly indicated to survive termination of this
Agreement.
12.2.2 All
of the Parties' rights and obligations under, and/or the provisions contained
in, Sections 3.1, 5, 6, 8, 10, 11, 12.2, 14, 15.2, 15.5, 15.11, 15.12 and 15.14
shall survive expiration, termination or relinquishment of this
Agreement.
13. FORCE MAJEURE
Except
for the obligation of any Party to make payments to the other Party pursuant to
this Agreement (which shall not be deferred or extended for any reason), neither
Party to this Agreement shall be responsible to the other Party for any failure
to perform or delay in performing if such failure or delay is due to any strike,
riot, civil commotion, sabotage, embargo, war or act of God or other cause
beyond its reasonable control (a "Force Majeure Event"); provided, that in any case of a
failure of a supplier to RELIABLE, such event shall not be deemed a Force
Majeure Event hereunder if RELIABLE’s maintenance of a reasonable safety stock
of raw materials would have prevented the occurrence of such
event. The Party suffering the occurrence of the Force Majeure Event
shall immediately notify the other Party as soon as practicable of such
inability and of the period for which such inability is expected to continue,
and any time for performance hereunder shall be extended by the actual time of
delay caused by the Force Majeure Event; provided, that the Party
suffering such Force Majeure Event uses commercially reasonable efforts to
mitigate; and further
provided, that, in the event of any Force Majeure Event affecting
RELIABLE, the purchase requirements set forth in Section 3.2.1 shall be waived
for the Commercial Contract Year in which such Force Majeure Event occurs and
continues to occur.
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material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
14. CONFIDENTIALITY.
14.1 Confidential
Information. In carrying out the terms of this Agreement it
may be necessary that one Party disclose to the other certain information, which
is considered by the disclosing Party to be proprietary and of a confidential
nature. As used herein "Confidential Information" shall mean any and
all information, know-how and data, technical or non-technical concerning any
Finished Product or Active Pharmaceutical Ingredient, the manufacture, marketing
and sale of which is disclosed under this Agreement as set forth below and which
NEOPROBE or RELIABLE, as the case may be, considers to be and treats as
proprietary and/or confidential. Confidential Information shall
include, but shall not be limited to plans, processes, compositions,
formulations, specifications, samples, systems, techniques, analyses, production
and quality control data, testing data, marketing and financial data, and such
other information or data relating to any Finished Product or Active
Pharmaceutical Ingredient or its Manufacture, marketing or sale.
14.2 Non-Use;
Non-Disclosure. The receiving Party shall not use the
disclosing Party's Confidential Information for any purpose other than for
purposes of performing its obligations under this Agreement and shall divulge
the information only to those of its employees and consultants who have a need
to know it as a part of the receiving Party's obligations hereunder; provided that, said employees
and consultants shall be subject to confidentiality agreements containing
provisions of the same character and scope as this Section 14. The
receiving Party shall not disclose the disclosing Party's Confidential
Information to any third party without the express prior written consent of the
disclosing Party.
14.3 Termination;
Exceptions. The obligations of confidentiality as provided
herein shall terminate five (5) years from the expiration or termination of this
Agreement and shall impose no obligation upon the receiving Party with respect
to any portion of the received information which: (i) was known to or in the
possession of the receiving Party prior to the disclosure hereunder, and
not through a prior disclosure subject to confidential treatment by the
disclosing Party, as documented by business records; or (ii) is or becomes
publicly known through no fault attributable to the receiving Party; or (iii) is
provided to the receiving Party from a source independent of the disclosing
Party without breach of a confidential or fiduciary relationship with the
disclosing Party concerning the information; or (iv) is developed by the
receiving Party independently of any disclosure from the disclosing Party and
such independent development can be demonstrated by competent written proof of
the receiving Party; or (v) is required to be disclosed by law or court order,
provided that notice is promptly delivered to the other Party in order to
provide an opportunity to seek a protective order or other similar order with
respect to the disclosure of such information and thereafter discloses only the
minimum information required to be disclosed in order to comply with the
request, whether or not a protective order or other similar order is obtained by
the other Party.
14.4 Duties Upon Expiration or
Termination. Upon expiration or earlier termination of this
Agreement, the receiving Party shall, as the disclosing Party may direct in
writing, either destroy or return to the disclosing Party all its Confidential
Information disclosed to the receiving Part hereunder, together with all copies
thereof, provided, however, the receiving Party may retain one archival copy
thereof for the purpose of determining any continuing obligations of
confidentiality.
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material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
15. GENERAL
PROVISIONS
15.1 Successors and
Assigns. The terms and provisions hereof shall inure to the
benefit of, and be binding upon RELIABLE, NEOPROBE and their respective
successors and permitted assigns. Neither Party may assign this
Agreement or any of its rights or obligations under this Agreement without the
prior written consent of the other Party, except that: (i) assignments
to an Affiliate of a Party may be made upon written notice thereof to the other
Party, accompanied by an undertaking, in form satisfactory to the other Party,
that such assigning Party shall not be released of any obligations and remain
primarily liable; and (ii) either Party may assign this Agreement without the
prior written consent of the other Party, to a third party that acquires all or
substantially all of the business or assets of the assigning Party to which this
Agreement pertains (whether by merger, reorganization, acquisition, sale or
otherwise). Any attempt to assign this Agreement in violation of the
provisions set forth herein shall be deemed a default by the assigning Party
under this Agreement and null and void. This Agreement shall be
binding upon and inure to the benefit of any permitted assign.
15.2 Notices. Any
notice, request, instruction or other communication required or permitted to be
given under this Agreement shall be in writing and shall be given by sending
such notice properly addressed to the other Party's address shown below (or any
other address as either Party may indicate by notice in writing to the other
pursuant to this Section 15.2, from time to time) by: (i) hand delivery, or (ii)
prepaid registered or certified mail, return receipt requested, or (iii)
facsimile transmission (receipt verified), or (iv) via nationally recognized
overnight courier, as follows:
|
If
to RELIABLE:
|
Reliable
Biopharmaceutical Corporation
|
|
1945
Walton Road
|
|
|
St.
Louis, MO 63114
|
|
|
Attention:
President
|
|
|
Fax
Number: (314) 429-0937
|
|
|
Phone
Number: (314) 429-7700
|
|
|
If
to NEOPROBE:
|
Neoprobe
Corporation
|
|
425
Metro Place North, Suite 300
|
|
|
Dublin,
Ohio 43017
|
|
|
Attention:
President
|
|
|
Fax
Number: (614) 793-7520
|
|
|
Phone
Number: (614) 793-7500
|
If hand
delivered or by facsimile transmission, the date of delivery shall be deemed to
be the date on which such notice or request was given. If sent by
overnight express courier service, the date of delivery shall be deemed to be
the next business day after such notice or request was deposited with such
service. If sent by registered or certified mail, the date of
delivery shall be deemed to be the third business day after such notice or
request was deposited with the U.S. postal service.
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material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
15.3 Publicity. Except
to the extent required by law or deemed appropriate by legal counsel to comply
with securities laws, including the furnishing of a press release and the filing
of such documents and information with the Securities and Exchange Commission as
may be required by federal securities laws and the filing of any report,
statement or document required by any other federal or state regulatory body,
neither Party to this Agreement shall publish, disclose or otherwise announce
the existence of this Agreement or the terms hereof with out the consent of the
other Party, which consent shall not be unreasonably withheld.
15.4 Waiver. Neither
Party may waive or release any of its rights or interests in this Agreement
except in writing. The failure of either Party to terminate or seek redress for
a breach of, or to insist upon strict performance of any term, covenant,
condition or provision contained in, this Agreement shall not prevent a similar
subsequent act from constituting a breach of this Agreement. No waiver by either
Party of any condition or term in any one or more instances shall be construed
as a continuing waiver of such condition or term or of another condition or
term.
15.5 Export
Clause. Each Party acknowledges that the laws and regulations
of the United States restrict the export and re-export of commodities and
technical data of United States origin. Each Party agrees that it
will not export or re-export restricted commodities or the technical data of the
other Party in any form without the appropriate United States and foreign
government licenses.
15.6 Independence of
Parties. Nothing herein shall be construed to create any relationship of
employer and employee, agent and principal, partnership or joint venture between
the Parties. Each Party is an independent
contractor. Neither Party shall assume, either directly or
indirectly, any liability of or for the other Party. Neither Party
shall have the authority to bind or obligate the other Party and neither Party
shall represent that it has such authority.
15.7 Entire Agreement.
This Agreement, along with the Exhibits hereto, contains all the covenants,
promises, agreements, warranties, representations, conditions and understandings
between the Parties with respect to the Manufacture and sale of the API and
supersedes and terminates all prior agreements and understanding between the
Parties. There are no covenants, promises, agreements, warranties,
representations, conditions or understandings, either oral or written, between
the Parties other than as set forth herein and therein. No subsequent
alteration, amendment, change or addition to this Agreement shall be binding
upon the Parties hereto unless reduced to writing and signed by the respective
authorized officers of the Parties.
15.8 Partial
Invalidity. If any portion of this Agreement is determined to
be illegal or otherwise unenforceable by a court of competent jurisdiction or by
an administrative agency of competent jurisdiction, the Parties shall negotiate
in good faith a valid, legal and enforceable substitute provision that most
nearly reflects the original intent of the Parties and all other provisions
hereof shall continue to be in full force and effect according to the terms
hereof. Such invalidity, illegality or unenforceability shall not
affect the validity, legality or enforceability of such provision in any other
jurisdiction.
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material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
15.9 Performance
Warranty. Each Party hereby acknowledges and agrees that it
shall be responsible for, and irrevocably, absolutely and unconditionally
guarantees, the full and timely performance as and when due under, and
observance of all the covenants, terms, conditions and agreements set forth in
this, Agreement by its Affiliate(s).
15.10 Headings. The
headings and captions used in this Agreement are for the convenience of
reference only and shall not be construed as part of this Agreement or as a
limitation on the scope of any provisions of this Agreement.
15.11 Dispute Resolution.
The Parties recognize that disputes as to certain matters may from time to time
arise during the term of this Agreement which relate to any Party's rights
and/or obligations hereunder. If the Parties cannot resolve any such
dispute within thirty (30) calendar days after notice of a dispute from one
Party, either Party may, by notice to the other in accordance with Section 15.2,
have such dispute referred to the President of NEOPROBE, or such other person
holding a similar position as designated by NEOPROBE from time to time, and the
President of RELIABLE, or such other person holding a similar position as
designated by RELIABLE from time to time (such officers collectively, the
"Executive Officers"). The Executive Officers shall meet promptly to
negotiate in good faith the matter referred and to determine a
resolution. During such period of negotiations, any applicable time
periods under this Agreement shall be tolled. If the Executive
Officers are unable to determine a resolution in a timely manner, which
shall in no case be more than thirty (30) days after the matter was referred to
them, the Party that originally providing notice hereunder may commence
litigation with respect to the subject matter of the dispute and with respect to
any other claims it may have and thereafter neither Party hereto shall have any
further obligation under this Section 15.11.
15.12 Governing
Law. This Agreement shall be governed and construed in
accordance with the laws of the State of Missouri, without regard to principles
of conflicts of law.
15.13 No Implied
Rights. No right or license is granted under this Agreement by
either Party to the other, either expressly or by implication, except as those
set forth explicitly herein. Nothing contained in this Agreement
shall impose an obligation of exclusivity on one by the other.
15.14 Waiver of Jury
Trial. EACH PARTY HERETO HEREBY WAIVES, TO THE FULLEST EXTENT
PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT
TO ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF, UNDER OR IN CONNECTION
WITH THIS AGREEMENT. EACH PARTY HERETO (i) CERTIFIES THAT NO
REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY
OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION,
SEEK TO ENFORCE THAT FOREGOING WAIVER, AND (ii) ACKNOWLEDGES THAT IT AND THE
OTHER PARTIES HERETO HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT AND ANY
RELATED INSTRUMENTS, AS APPLICABLE, BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS
AND CERTIFICATIONS IN THIS SECTION 15.14.
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material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
15.15 Counterparts. This
Agreement may be executed in any number of counterparts, each of which shall be
an original as against either Party whose signature appears thereon, but all of
which taken together shall constitute but one and the same
instrument.
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material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
IN
WITNESS WHEREOF, the Parties hereto have set their hands and seals on the date
written at the beginning hereof.
|
Reliable
Biopharmaceutical Corp.
|
Neoprobe
Corporation
|
|||
|
By:
|
/s/ Michael E. Zeleski
|
By:
|
/s/ David C. Bupp
|
|
|
Name: Michael
E. Zeleski
|
Name: David
C. Bupp
|
|||
|
Title: President
|
Title: President
|
|||
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material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
EXHIBIT
A
PRODUCT
SPECIFICATIONS
Product:
Formula:
|
Specification
|
Limits
|
|
|
[*]
|
[*]
|
|
[*]
Storage
Condition: [*]
*Asterisked
material has been omitted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment.
EXHIBIT
B
PRICE STRUCTURE FOR
COMMERCIAL ORDERS
NEOPROBE
shall pay RELIABLE for all API ordered hereunder on a unit price per gram basis,
based on the total number of grams ordered in each Commercial Contract Year,
which shall be calculated as follows:
1) An
estimated unit price per gram of API for the Commercial Contract Year shall be
established prior to the commencement of such year utilizing the firm order of
grams of API for Q1 (as such term is defined in the Agreement) set forth in
NEOPROBE's good faith forecast submitted to RELIABLE not less than 15 days prior
to the commencement of such Commercial Contract Year, on an aggregate,
annualized basis and in reference to the table set forth below:
|
Annual Forecast Volume
|
Unit Price per Gram (USD)
|
|
|
[*]
|
[*]
|
|
|
[*]
|
[*]
|
|
|
[*]
|
[*]
|
|
|
[*]
|
[*]
|
2) All
Commercial Orders of API during each Commercial Contract Year shall be priced at
the estimated unit price per gram established in the above table in accordance
with Paragraph 1 of this Exhibit B.