Exhibit 10.20
SUPPLY AGREEMENT
This supply agreement is entered into as of July 1, 1996 (the "Effective
Date") between PerImmune, Inc. ("PerImmune") and Progenics Pharmaceuticals,
Inc. (each singularly a "Party" and collectively the "Parties") with
reference to the following:
RECITALS
WHEREAS, PerImmune, Inc. manufactures purified keyhole limpet hemocyanin
("KLH"); and
WHEREAS, Progenics Pharmaceuticals, Inc. is performing research and
development in the field of vaccines for human cancers and is interested in
purchasing KLH from PerImmune, Inc. for use as a carrier protein for such
vaccines;
THEREFORE, the parties agree as follows:
1. DEFINITIONS. The following terms shall have the following meanings for
purposes of this Agreement:
1.1 "AFFILIATE" means any corporation, firm, partnership or other
entity, whether de jure or de facto, which directly or indirectly owns, is
owned by, or is under common ownership with a party to this Agreement to the
extent of at least fifty percent (50%) of the equity (or such lesser
percentage which is the maximum allowed to be owned by a foreign corporation
in a particular jurisdiction) having the power to vote on or direct the
affairs of the entity and any person, firm, partnership, corporation or other
entity actually controlled by, controlling, or under common control with a
party to this Agreement. For example, Akzo, N.Y. is an Affiliate of PerImmune
pursuant to this definition.
1.2 "AGREEMENT" means this Supply Agreement, including any exhibits,
schedules or other attachments thereto, as any of the foregoing may be
validly amended and agreed to in writing by the Parties from time to time.
1.3 "COMMERCIAL INTRODUCTION" means the date of first commercial sale
(other than for purposes of obtaining regulatory approval) of a Ganglioside
Vaccine by Progenies Pharmaceuticals, Inc.
1.4 "EFFECTIVE DATE" is defined in the introductory paragraph.
1.5 "FULLY BURDENED MANUFACTURING COST" means the actual cost of
Manufacture by PerImmune of KLH under a Manufacturing Process in compliance
with
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cGMPs, which actual cost shall be comprised of the cost of goods produced as
determined in accordance with United States generally accepted accounting
principles, [***]
1.6 "cGLPs" means the current Good Laboratory Practices for Finished
Pharmaceuticals pursuant to 21 C.F.R. 58 et sea., as amended from time to
time.
1.7 "cGMPs" means the current Good Manufacturing Practices for Finished
Pharmaceuticals pursuant to 21 C.F.R. 210 et seci., as amended from time to
time.
1.8 "KLH" means keyhole limpet hemocyanin.
1.9 "KLH REQUIREMENTS" means the amount of KLH in bulk which Progenics
Pharmaceuticals, Inc. may require for all research and development,
pre-clinical and human clinical testing of Ganglioside Vaccines and, after
Commercial Introduction, production of Ganglioside Vaccines for commercial
sales.
1.10 "KNOW-HOW" means materials, data, results, formulae, designs,
specifications, methods, processes, improvements, techniques, ideas,
discoveries, technical information, process information, clinical information
and any other information, whether or not any of the foregoing is patentable,
which is confidential (in accordance with Section 5 hereof and proprietary to
PerImmune now or hereafter during the Term of this Agreement, to the extent
that any of the foregoing relates to the development, manufacture, use or
sale of KLH in connection with the development, manufacture, use or sale of
any Gangiloside Vaccine, provided however, that the term "Know-how" shall not
include any of the foregoing that is subject to proprietary rights of third
parties.
1.11 "GANGLIOSIDE VACCINE" means any vaccine or vaccines comprising
purified gangliosides (whether alone or in combination) conjugated to KLH for
the prevention or treatment of human cancers. A ganglioside is a neuraminic
acid containing glycolipids.
1.12 "MANUFACTURE" OR "MANUFACTURING PROCESS" means the aseptic-storage,
handling, production, processing and packaging of KLH in accordance with this
Agreement.
1.13 ."MANUFACTURING YEAR" means each calendar year commencing on or after
January 1, 1995.
1.14 "PARTY" and "PARTIES" are defined in the introductory paragraph.
1.15 "PERIMMUNE" means PERIMMUNE, INC., (formerly Organon Teknika
Corporation Biotechnology Research Institute) , a Delaware corporation, its
Affiliates and its successors and permitted assigns.
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1.16 "SPECIFICATIONS" is defined in Exhibit A
1.17 "TERM" is defined in Section 4.1.
1.18 "PROGENICS" means Progenics Pharmaceuticals, Inc., a Delaware
corporation, its Affiliates and its permitted successors and assigns.
2. MANUFACTURE AND SUPPLY.
2.1 GENERAL. [***] PerImmune hereby agrees, at its sole expense, to
commit all reasonably necessary facilities, appropriately trained personnel,
machinery, equipment, utilities and other PerImmune resources required to
satisfy its obligations under this Agreement.
PerImmune hereby agrees, at its sole expense, to commit
all reasonably necessary facilities, appropriately trained personnel,
machinery, equipment, utilities and other PerImmune resources required to
satisfy its obligations under this Agreement.
2.2 PERIMMUNE TRANSFER PRICE OF KLH.
[***]
In addition, in order to verify the production cost of KLH, Progenics will
have the right to pay for an independent certified public accountant, ("CPA")
to inspect the records of PerImmune once per year during regular business
hours, provided that such accountant has entered into a confidentiality
agreement with PerImmune which is satisfactory to PerImmune. The CPA shall
then compile a report which states only PerImmune's Fully Burdened
manufacturing Cost for KLH which may be used by the Parties for negotiating
the transfer price.
In addition, in order to verify the production
cost of KLH, Progenics will have the right to pay for an independent
certified public accountant, ("CPA") to inspect the records of PerImmune once
per year during regular business hours, provided that such accountant has
entered into a confidentiality agreement with PerImmune which is satisfactory
to PerImmune. The CPA shall then compile a report which states only
PerImmune's Fully Burdened Manufacturing Cost for KLH which may be used by
the Parties for negotiating the transfer price.
2.3 PERlMMUNE'S REPRESENTATIONS, WARRANTIES AND COVENANTS. PerImmune
hereby represents and warrants to Progenics as follows:
(a) PRE-CLINICAL STUDY AND HUMAN CLINICAL TRIAL USE, PerImmune shall
Manufacture all KLH Requirements for use in any vaccine used in connection
with any pre-clinical study or human clinical trial of any Ganglioside
Vaccine (i) strictly in compliance with (A) this Agreement, (B) all
Specifications, and (C) all applicable laws
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and regulations, including but not limited to cGMPs to the extent applicable,
and (ii) in a PerImmune facility holding all applicable licenses in the
jurisdiction of Manufacture.
(b) COMMERCIAL USE. PerImmune shall Manufacture all KLH Requirements for
use in the commercialization of any Ganglioside Vaccine (i) strictly in
compliance with (A) this Agreement, (B) all Specifications, and (C) all
applicable laws and regulations, including but not limited to cGMPs to the
extent applicable, and (ii) in a PerImmune facility holding all applicable
licenses in the jurisdiction of Manufacture.
(c) CERTIFICATE OF ANALYSIS: NON-COMPLYING KLH. Before, during and after
Manufacture of KLH Requirements, PerImmune shall obtain samples, monitor the
Manufacturing Process and the environment of such Manufacture, and keep such
technical books and records of all of the foregoing as are required under the
Specifications and Procedures and all applicable laws and regulations,
including but not limited to cGLPs or cGMPs (as appropriate and applicable).
PerImmune shall test each lot of KLH requirements Manufactured for Progenics
or as required under the Specifications. Together with each such lot of KLH
Requirements, PerImmune shall provide a written certificate of analysis which
shall set forth the results of such testing by PerImmune and PerImmune's
quality control approval of such lot of KLH Requirements. PerImmune's
obligations under this section 2.3(c) shall be performed at PerImmune's sole
expense. Progenics shall be entitled to test any such KLH Requirements in
accordance with the Specifications, at Progenics' sole expense. Without
limiting any of Progenics' other rights or remedies under this Agreement with
respect to any KLH Requirements supplied hereunder that do not comply with
applicable representations and warranties under this Section 2.3, and
provided PerImmune reasonably confirms Progenics' test results, the Parties
agree that; (i) Progenics shall not be obligated to pay PerImmune the
transfer price applicable to such non-complying KLH Requirements; (ii) if
Progenics has already paid for such non-complying KLH Requirements, Progenics
shall be entitled to a credit against future purchases for the amount paid to
PerImmune therefor; (iii) PerImmune shall, on a priority basis, Manufacture
and supply to Progenics, as applicable, replacement KLH Requirements in full
compliance with this Section 2.3; and (iv) PerImmune shall bear the full cost
of returning or destroying the non-complying KLH Requirements.
2.4 Procedures for Estimating, Ordering and Supplying - KLH REQUIREMENTS.
Subject to the other terms of this Agreement:
(a) ANNUAL DEMAND FORECAST FOR EACH MANUFACTURING YEAR. During the Term,
commencing on July 1 , 1996 and on an on-going quarterly basis as described
below, Progenics will provide PerImmune with a written rolling annual demand
forecast of KLH Requirements for each manufacturing Year which shall be
binding as to the first quarter and non-binding as to the remaining three (3)
quarters. Thereafter, Progenics shall provide an updated annual demand
forecast on a quarterly
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basis no later than ninety (90) days in advance of the commencement of the
first (and binding) quarter covered by such annual demand forecast. The
Parties also agree that the variance, if any, between the binding forecast of
a given quarter and the last nonbinding forecast for such quarter shall be
between [***] and [***]
meaning that Progenics' binding forecast for such quarter must be at least
[***] but not more than [***]
of such last non-binding forecasted amount for such quarter.
(b) PURCHASE ORDERS. Progenics shall place a firm purchase order or
purchase orders with PerImmune setting forth (i) the quantities of KLH
Requirements to be Manufactured and supplied hereunder, (ii) the schedule for
receipt from PerImmune of such batch(es) of KLH Requirements, and (iii)
instructions for shipping and packaging. Each such firm purchase order shall
be submitted no later than thirty (30) days in advance of the first scheduled
date of receipt thereof. Subject to the other terms of this Agreement,
Progenics shall be obligated to place firm purchase orders with PerImmune
for, and PerImmune hereby commits to Manufacture and supply hereunder
pursuant to such firm purchase orders, [***] of the
amount of KLH Requirements in the then-binding quarter of each annual demand
forecast under Section 2.4(b); provided, however, that: (A) the Parties may
mutually agree in writing to amend any such firm purchase order; (B)
PerImmune in its discretion may agree to Manufacture and supply hereunder
additional amounts of KLH Requirements in excess of the then-binding amount,
provided that Progenics places firm purchase order(s) for such excess KLH
Requirements on a timely basis; and (C) PerImmune agrees to provide Progenics
with as much advance written notice as possible (and in any case at least
thirty (30) days' written advance notice) if PerImmune determines that any
scheduled delivery of KLH Requirements pursuant to any purchase order will be
delayed by more than fifteen (15) days for any reason of which PerImmune
becomes aware.
2.5 PRIORITY.
a) PRIORITY AMONG CUSTOMERS. PerImmune hereby agrees and acknowledges
that, in the event that PerImmune is unable to satisfy in full its
obligations under this Agreement to Manufacture and supply
[***] of KLH Requirements as well as PerImmune's obligations to
third parties with respect to Manufacture and supply of KLH, PerImmune shall
use reasonable efforts to satisfy its obligations under this Agreement and,
in the event of any shortage of KLH available to meet all such obligations,
PerImmune shall allocate proportionately all available KLH among Progenics
and such third parties with highest priority for the Manufacture and supply
of KLH for purposes of outstanding firm purchase orders for comparable
delivery time frames. In such event PerImmune, shall be permitted to invoice,
and Progenics agrees to pay, the additional expenses of PerImmune for such
efforts.
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(b) INABILITY TO SUPPLY. In the event that PerImmune is unable to supply
[***] of Progenics' purchase orders for two consecutive quarters, then
PerImmune agrees to provide Progenics the right and license to use the
relevant Know-how to manufacture or have manufactured KLH for use in
producing Ganglioside Vaccine, and to fully cooperate with regulatory
authorities to qualify Progenics and/or its designee as a manufacturer of
KLH. In such event, at Progenics' request, PerImmune shall promptly disclose
to Progenics all Know-how and information reasonably necessary to manufacture
KLH and the parties shall mutually agree upon a reasonable schedule for
gradually reducing the amount of KLH purchased by Progenics from PerImmune,
until such time PerImmune is able to reasonably demonstrate the ability to
supply Progenics with its requirements.
(c) ASSURANCE OF SUPPLY. Progenics and PerImmune will cooperate to
anticipate Progenics' long-term requirements for KLH Requirements supply, and
PerImmune will take reasonable measures to assure that Progenics' and its
Partners' KLH Requirements can be met, which measures may include the
maintenance of adequate safety stocks of KLH.
2.6. REGULATORY APPROVAL OF MANUFACTURING. PerImmune shall be solely
responsible, at its sole cost and expense, for obtaining all necessary
regulatory approvals particular to KLH for Manufacture and supply of KLH
Requirements. Progenics shall advise PerImmune of any new Specifications
required by the United States Food and Drug Administration or the Federal
Food, Drug and Cosmetic Act (or the equivalent regulatory authority or law In
other countries) with respect to any Ganglioside Vaccine. PerImmune shall not
modify in any manner any Specifications without Progenics prior written
consent (which consent shall not be unreasonably withheld).
2.7 REGULATORY FILINGS. Without limiting the generality of the
foregoing, for purposes of supporting all preclinical studies and human
clinical trials and all regulatory filings, applications and approvals on the
part of Progenics with respect to any Ganglioside Vaccine, PerImmune hereby
agrees that on an on-going basis during the Term: (1) PerImmune shall permit
Progenics to reference PerImmune's drug master file and/or Investigational
New Drug Applications (IND's) for KLH with the United States Food and Drug
Administration; (ii) to the extent not subject to the proprietary rights of
third parties, PerImmune shall provide Progenics with all pre-clinical and
clinical data, results and other relevant information with respect to KLH
(including but not limited to information regarding the toxicity, safety and
stability of KLH) that is (A) submitted by PerImmune in connection with any
Investigational New Drug application or other regulatory filing with respect
to KLH from time to time during the Term or (B) otherwise in PerImmune's
possession from time to time during the Term; and (iii) a PerImmune
representative, at Progenics' request, shall attend periodic meetings to
discuss the progress of clinical trials of any Ganglioside Vaccines.
Progenics will reimburse
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PerImmune for the foregoing assistance only (i) for its reasonable out-of
pocket expenses, including but not limited to travel, and (ii) PerImmune's
fully burdened costs of performing technical studies or engaging outside
services subject to the prior approval of Progenics.
a) ADVERSE EVENTS REPORTING. On an on-going basis during the Term and
for at least ten (10) years after the expiration or termination of this
Agreement, each Party agrees to provide the other Party with any written
information in its possession which indicates adverse effects in humans
associated with KLH or any products using KLH.
2.8 PERIMMUNE RECORDKEEPING AND INSPECTION.
(a) TECHNICAL RECORDS. With respect to any Manufacture and supply of KLH
Requirements, PerImmune shall, at its expense, keep properly completed
technical books and records, test data and reports as required under the
Specifications and all applicable laws and regulations, including but not
limited to cGLPs or cGMPs (as appropriate), and in any case shall maintain
such technical Information for at least two (2) years from the expiration
date of the relevant Ganglioside Vaccine or longer if required under
applicable laws and regulations (including but not limited to cGLPs and
cGMPs, as applicable). During regular business hours and upon reasonable
advance written request, PerImmune shall make any such technical information
available to Progenics for inspection.
(b) FINANCIAL RECORDS. During the Term, PerImmune shall keep for at
least three (3) years records of its Fully Burdened Manufacturing Costs, and
the calculations thereof in sufficient detail to permit Progenics designee,
reasonably acceptable to PerImmune, to confirm the accuracy thereof. At the
request of Progenics, and not more frequently than once per year, upon at
least five (5) business days' prior written notice, and at the expense of
Progenics (except as otherwise provided below), PerImmune shall permit a
nationally recognized, independent, certified public accountant selected by
Progenics and acceptable to PerImmune to inspect (during regular business
hours) any such PerImmune records for the then-preceding three (3) years
solely to the extent necessary to verify such costs, margins and
calculations, provided that such accountant in advance has entered into a
confidentiality agreement with PerImmune and Progenics substantially similar
to the confidentiality provisions of this Agreement, limiting the use and
disclosure of such information to authorized representatives of the Parties.
Results of any such inspection shall be made available to both Parties. If
such inspection reveals a deficiency in the calculation of PerImmune's Fully
Burdened Manufacturing Cost to PerImmune resulting in an overpayment to
PerImmune of the transfer price by [***] , PerImmune shall
pay all costs and expenses of such inspection.
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(c) QUALITY AUDIT. Upon submission of a proposal by Progenics which is
approved by PerImmune, PerImmune shall permit Progenics to audit, in
cooperation with PerImmune's personnel, production, packaging, and quality
control facilities of PerImmune and any of its significant suppliers as they
relate to production of KLH to allow Progenics to verify PerImmune's
compliance with its responsibilities under this Agreement.
2.9 LIABILITY.
(a) INDEMNIFICATION BY PROGENICS. Except as otherwise provided in
Sections 2.9(b) or (c), Progenics will defend, indemnify and hold harmless
PerImmune against any and all claims, actions, liabilities, damages, losses,
costs or expenses, including reasonable attorney's fees, based upon or
arising out of the sales or use of any Ganglioside Vaccine by Progenics,
provided that PerImmune gives Progenics prompt notice thereof in writing,
permits Progenics to control the investigation, preparation and defense
thereof (including any compromise or settlement thereof and any appeal) and
provides reasonable assistance to Progenics, at Progenics expense, in that
regard.
(b) LIABILITY. Each Party assumes full responsibility and liability for
any injury, damage or expense which it or its employees, agents and invitees
incur and which arise from its manufacture, handling and use of KLH or
Ganglioside Vaccines, except to the extent such injury, damage or expense
arises from the negligence or willful misconduct of the other Party.
(c) INDEMNIFICATION BY PERIMMUNE. PerImmune will defend, indemnify and
hold harmless Progenics against any and all claims, actions, liabilities,
damages, losses, costs or expense (including reasonable attorneys' fees)
including without limitation expenses of total or partial product recalls in
connection with the manufacture, use or sale of Ganglioside Vaccines (i)
based upon the gross negligence or willful misconduct of PerImmune or its
employees arising out of the Manufacture or shipment of KLH Requirements by
PerImmune or based upon a manufacturing defect in KLH Requirements
manufactured by PerImmune; or (ii) the failure of PerImmune to comply with
governmental regulations with respect to KLH, provided that Progenics or its
Partners give PerImmune prompt notice thereof in writing, permits PerImmune
to control the investigation, preparation and defense thereof (including any
compromise or settlement thereof and any appeal) and provides reasonable
assistance to PerImmune, at PerImmune's expense, in that regard.
3. CONFIDENTIALITY.
3.1. Each party agrees to take such steps and, when necessary to protect
the rights of the other, shall cause its employees and agents and its
Affiliates employees and agents, to take such steps as are reasonably
required to protect and keep
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confidential, and shall not use, publicize or otherwise disclose to third
parties other than Affiliates, Confidential Information (as defined below) of
the other party, which was acquired from the other party pursuant to this
Agreement, including, without limitation, following procedures designed to
limit access of such information to those persons having a need to know it.
The parties agree not to disclose or use such Confidential Information except
as they may be entitled to do so or if necessary pursuant to or in the
performance of this Agreement.
3.2 The obligation of confidentiality and restriction on use imposed by
the foregoing Subsection 3.1 shall not apply to any particular item of
Confidential Information that:
3. 2.1 is known or generally available, or subsequently becomes known or
generally available, to the public, or is otherwise at the time of disclosure
or subsequently becomes part of the public domain, whether by printed
publication or otherwise through no fault of the receiving parties;
3.2.2 the receiving party can demonstrate by competent evidence, based
in substance upon writings and/or physical evidence, (i) was known to the
receiving party at the time of receipt or (ii) is furnished to the receiving
party without obligation of confidentiality or non-use by a third party,
either before or after the time of its disclosure by the disclosing party,
which third party is not restricted by a confidential undertaking to the
disclosing party at the time of the disclosure;
3.2.3 the receiving party can demonstrate by competent evidence, based
in substance upon writings and/or physical evidence, has been developed
independently for the receiving party by persons not having access to the
Confidential information; or
3.2.4 is the Confidential Information of the disclosing party and that
the disclosing party discloses to a non-Affiliate party without restriction.
3.3 The obligations of confidentiality and restriction on use under this
Section 3 shall continue to be binding upon the parties for a period of five
years following termination of this Agreement.
3.4 Either party may also disclose Confidential Information disclosed to
it by the other party to the extent, and only to the extent, such disclosure
is necessary for such party to comply with applicable governmental laws or
regulations. The party that desires to so disclose Information shall give the
other party reasonable advance notice of any such proposed disclosure
pursuant to such compliance with law or regulation, shall use its best
efforts to secure confidential treatment of the Information thus disclosed,
and shall advise the other party in writing of the manner in which that was
done.
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3.5 For purposes of this Agreement, Confidential Information shall
mean: (a) data, inventions, Information, processes, know-how, patent
applications, trade secrets and similar intellectual property rights of a
party, including, without limitation, the original and copies of all
documents, inventions, laboratory notebooks, drawings, specifications,
devices, equipment, prototype models and tangible manifestations embodying
any technology disclosed hereunder, (b) a party's customer lists and
marketing, sales, costs, royalty and similar information related to the
manufacture or sale of KLH or other part of the Parties' business, and (c)
any other information disclosed in writing and marked as "Confidential
Information" or, if disclosed orally, reduced to writing and marked as
"Confidential Information" and submitted within thirty (30) days of the
original oral disclosure.
3.6 PERMITTED DISCLOSURES. Each Party may disclose the other Party's
information to the extent such disclosure is reasonably necessary in
prosecuting or defending litigation, filing, prosecuting or maintaining
patent applications or patents, complying with applicable laws or
regulations, or, in the case of Progenics, conducting preclinical or clinical
trials or preparing or filing regulatory filings with respect to Ganglioside
Vaccines; provided, however, that if a Party is required to make any
disclosure of the other Party's information furnished pursuant to this
Agreement, it will give reasonable advance notice of such disclosure
requirements to the other Party and, except to the extent inappropriate in
the case of patent applications, will use its best efforts to secure
confidential treatment of such information required to be disclosed.
4. TERM: TERMINATION.
4.1 TERM. The term of this Agreement shall be for three years from the
Effective Date and will renew automatically for successive 12 month periods
unless sooner terminated as provided in this Section 4.
4.2 MATERIAL BREACH. Subject to Section 8.6, failure by either Party to
comply with any of the material obligations contained in this Agreement shall
entitle the other Party to give to the Party in default notice specifying the
nature of the default and requiring it to make good such default. If such
default is not cured within sixty (60) days after the receipt of such notice,
the notifying Party shall be entitled, without prejudice to any of its other
rights conferred on it by this Agreement and in addition to any other
remedies available to it by law or in equity, to terminate this Agreement
effective upon written notice to the other Party. The right of a Party to
terminate this Agreement, as herein above provided, shall not be affected in
any way by its waiver or failure to take action with respect to any previous
default.
4.3 INSOLVENCY OR BANKRuPTCY. Either Party may, in addition to any other
remedies available to it by law or in equity, terminate this Agreement, in
whole or in part as the terminating Party may determine, effective upon
written notice to the other Party, in the event the other party shall have
become insolvent or bankrupt, or shall have
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made an assignment for the benefit of its creditors, or there shall have been
appointed a trustee or receiver of the other Party for all or a substantial
part of its property, or any case or proceeding shall have been commenced
seeking reorganization, liquidation, dissolution, winding-up, arrangement,
composition or readjustment of its debts or any other relief under any
bankruptcy, insolvency, reorganization or other similar act or law of any
jurisdiction now or hereafter in effect, or there shall have been issued a
warrant of attachment, execution, disdain or similar process against, any
substantial part of the property of the other Party, and any such event shall
have continued for sixty (60) days undismissed, unbounded and undischarged.
4.4 ACCRUED RIGHTS, SURVIVING OBLIGATIONS: PARTNERS. Expiration or any
termination of this Agreement for any reason shall be without prejudice to
any rights which shall have accrued to the benefit of either Party prior to
such expiration or termination. Such expiration or termination shall not
relieve either Party from obligations which are expressly indicated to
survive expiration or termination of this Agreement, which obligations
include, without limitation, those under Sections 2.8, 2.9, 3, 5, 6 and 7.
5. PERIMMUNE PATENT RIGHTS.
PerImmune shall not assert against Progenics or its customers any
patents now or hereinafter owned or controlled by PerImmune which concern KLH
or any Ganglioside Vaccine of Progenics which incorporates KLH. This Section
shall continue to apply to any Affiliate of PerImmune which ceases to be an
Affiliate of PerImmune as defined by this Agreement.
6. PERiMMUNE REPRESENTATIONS AND WARRANTIES.
PerImmune represents and warrants that:
(a) the execution and delivery of this Agreement and the performance of
the transactions contemplated hereby have been duly authorized by PerImmune;
(b) the performance by PerImmune of any of the terms and conditions of
this Agreement on its part to be performed does not and will not constitute a
breach or violation of any other agreement or understanding, written or oral,
to which it is a party;
(c) To the best of PerImmune's knowledge, there are no adverse
proceedings, claims or actions pending, or threatened, relating to KLH and at
the time of disclosure and delivery thereof to Progenics and PerImmune shall
have the full right
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and legal capacity to disclose and deliver KLH without violating the rights
of third parties.
7. ARBITRATION.
Any dispute, controversy or claim between the Parties, arising out of or
relating to this Agreement or the Parties' respective rights and obligations
hereunder either during or after the Term (including the question as to
whether any such matter is arbitrable) shall be subject to binding
arbitration in accordance with then-existing commercial arbitration rules of
the American Arbitration Association. The Parties agree that, in the course
of any such arbitration, service of any notice at their respective addresses
in accordance with Section 8.11 of this Agreement shall be valid and
sufficient, and any arbitration hereunder shall be in the jurisdiction of the
defendant Party, which in the case of Progenics shall be New York and in the
case of PerImmune shall be Maryland. In any such arbitration, an award shall
be rendered by a majority of the members of a board of arbitration consisting
of three (3) members, one (1) of whom shall be chosen by each of Progenics
and PerImmune and the third of whom shall be appointed by mutual agreement of
such two (2) arbitrators. In the event of failure of such two (2) arbitrators
to agree within sixty (60) days after the commencement of arbitration (as
defined below) upon appointment of the third arbitrator, or, in the event
that either Party shall fail to appoint an arbitrator within thirty (30) days
after the commencement of the arbitration proceedings, the third arbitrator
or (upon request of the other Party) the second arbitrator and the third
arbitrator, as the case may be, shall be appointed by the American
Arbitration Association in accordance with its then existing commercial
arbitration rules. For purposes of this Section, the "commencement of the
arbitration proceeding" shall mean the date upon which the defendant Party
receives from the American Arbitration Association a copy of the request for
arbitration filed by the party desiring to have recourse to arbitration. The
decision of the arbitrators shall be in writing and shall set forth the basis
therefor. The Parties shall abide by all awards rendered in arbitration
proceedings, and such awards may be enforced and executed upon in any court
having jurisdiction over the Party against whom enforcement of such award is
to be sought. The Parties shall divide equally the administrative charges,
arbitrators' fees, and related expenses of arbitration, but each Party shall
pay its own legal fees incurred in connection with any such arbitration;
provided, however, if the arbitrators determine that one Party prevailed
clearly and substantially over the other Party, then the non-prevailing Party
shall also pay the reasonable attorneys' fees and expert witness costs and
other arbitration costs of the prevailing Party.
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8. MISCELLANEOUS PROVISIONS.
8.1 NO PARTNERSHIP. Nothing in this Agreement is intended or shall be
deemed to constitute a partnership, distributorship, agency employer-employee
or joint venture relationship between the Parties. No Party shall incur any
debts or make any commitments for the other, except to the extent, if at all,
specifically provided herein.
8.2 ASSIGNMENTS. Neither Party shall assign any of its rights or
obligations hereunder or this Agreement, except that either Party may do so:
(a) as incident to the merger, consolidation, reorganization or acquisition
of stock or assets affecting substantially all of the assets or voting
control of such Party; (b) to any wholly owned subsidiary if such Party
remains liable and responsible for the performance and observance of all of
the subsidiary's duties and obligations hereunder; (c) with the prior written
consent of the other Party; or (d) as incident to an agreement between
Progenics and a major corporate partner. This Agreement shall be binding upon
the successors and permitted assigns of the Parties and the name of a Party
appearing herein shall be deemed to include the names of such Party's
successors and permitted assigns to the extent necessary to carry out the
intent of this Agreement. Any assignment not in accordance with this Section
8.2 shall be void.
8.3 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of
this Agreement.
8.4 NO NAME OR TRADEMARK RIGHTS. Except as otherwise provided herein,
no right, express or implied, is granted by this Agreement to use in any
manner the names "PerImmune, Inc." or "Progenics Pharmaceuticals, Inc." or
any contraction thereof or any other trade name or trademark of PerImmune or
Progenics in connection with the performance of this Agreement.
8.5 PUBLIC ANNOUNCEMENT. Except as may otherwise be required by
applicable law or regulation, neither Party shall make any public
announcement concerning this Agreement or the subject matter hereof without
the prior written consent of the other Party (not to be unreasonably
withheld).
8.6 FORCE MAJEURE. If any default or delay occurs which prevents or
materially impairs a Party's performance and is due to a cause beyond the
Party's reasonable control, including but not limited to any act of any god
or demon, flood, fire, explosion, earthquake, casualty, accident, war,
revolution, civil commotion, blockade or embargo, injunction, law,
proclamation, order, regulation or governmental demand, the affected Party
promptly shall notify the other Party in writing of such cause and shall
exercise diligent efforts to resume performance under this Agreement as soon
as possible. Neither Party shall be liable to the other Party for any loss or
damage due to such cause. Neither Party may terminate this Agreement because
of such default or delay.
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8.7 ENTIRE AGREEMENT OF THE PARTIES: AMENDMENTS. This Agreement,
including the exhibits attached hereto which are incorporated herein,
constitutes and contains the entire understanding and agreement of the
Parties and cancels and supersedes any and all prior negotiations,
correspondence, understandings and agreements, whether verbal or written,
between the Parties respecting the subject matter hereof. No waiver,
modification or amendment of any provision of this Agreement shall be valid
or effective unless made in writing and signed by a duly authorized officer
of each of the Parties.
8.8 SEVERABILITY. In the event that any of the provisions of this
Agreement shall for any reason be held by any court or authority of competent
jurisdiction to be invalid, illegal or unenforceable, such provision or
provisions shall be validly reformed to as nearly as possible approximate the
intent of the Parties and, if unreformable, shall be divisible and deleted in
such jurisdiction; elsewhere, this Agreement shall not be affected so long as
the Parties are still able to realize the principal benefits bargained for in
this Agreement.
8.9 CAPTIONS. The captions to this Agreement are for convenience only,
and are to be of no force or effect in construing or interpreting any of the
provisions of this Agreement.
8.10 APPLICABLE LAW. This Agreement shall be governed by and
interpreted in accordance with the laws of Maryland.
8.11 NOTICE. All notices and other communications shall be deemed to
have been duly given when delivered in person or by registered or certified
mail (postage prepaid, returned receipt requested) to the respective parties
as follows:
If To Progenics:
Xxxx X. Xxxxxx, M.D., Ph.D.
Chairman and CEO
---------------------------
000 Xxx Xxx Xxxx Xxxxx Xxxx
---------------------------
Xxxxxxxxx, XX 00000
----------------------------
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If To PerImmune:
Xxxxxxx X. Xxxxx, Xx.
------------------------
President & CEO
0000 Xxxxxxx Xxxxx
------------------------
Xxxxxxxxx, XX 00000
------------------------
8.12 SURVIVAL. The representations, warranties, covenants and
agreements made herein shall survive any investigation made by a Party and
shall be able to be relied fully on by the Parties.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
signed by their respective corporate officers, duly authorized as of the day
and year first above written. PerImmune, Inc., represents and warrants that
it has the right and authority to provide to Progenics the material and
rights set forth in this agreement pursuant to the transfer of relevant right
and authority from Akzo Nobel to PerImmune.
PERIMMUNE, INC. PROGENICS PHARMACEUTICALS, INC.
By: /s/ Xxxxxxx X. Xxxxx, Xx. By: Xxxx X. Xxxxxx
---------------------------- ----------------------
Name: Xxxxxxx X. Xxxxx, Xx. Name: Xxxx X. Xxxxxx
--------------------------- -----------------------
Title: President & CEO Title: Chairman and CEO
--------------------------- -----------------------
As set forth in this Exhibit A, the following are the specifications for the
Manufacture of KLH, as may from time to time be required by the Food and Drug
Administration (the "Specifications").
EXHIBIT A
ORGANON TEKNIKA
[GRAPHIC] AKZO
CERTIFICATE OF ANALYSIS
KEYHOLE LIMPET HEMOCYANIN
[***]
[***] Confidential Treatment Requested
