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LICENSE AND CO-DEVELOPMENT AGREEMENT

Development Agreement

LICENSE AND CO-DEVELOPMENT AGREEMENT | Document Parties: PROGENICS PHARMACEUTICALS INC | WYETH-WHITEHALL PHARMACEUTICALS, INC.,  | WYETH-AYERST LEDERLE, INC., | PROGENICS PHARMACEUTICALS, INC.  | PROGENICS PHARMACEUTICALS NEVADA, INC. You are currently viewing:
This Development Agreement involves

PROGENICS PHARMACEUTICALS INC | WYETH-WHITEHALL PHARMACEUTICALS, INC., | WYETH-AYERST LEDERLE, INC., | PROGENICS PHARMACEUTICALS, INC. | PROGENICS PHARMACEUTICALS NEVADA, INC.

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Title: LICENSE AND CO-DEVELOPMENT AGREEMENT
Governing Law: Delaware     Date: 3/15/2006
Industry: Biotechnology and Drugs     Sector: Healthcare

LICENSE AND CO-DEVELOPMENT AGREEMENT, Parties: progenics pharmaceuticals inc , wyeth-whitehall pharmaceuticals  inc.   , wyeth-ayerst lederle  inc.  , progenics pharmaceuticals  inc.  , progenics pharmaceuticals nevada  inc.
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Exhibit 10.26

 

 

 

LICENSE AND CO-DEVELOPMENT AGREEMENT

 

 

 

by and among

 

 

 

WYETH,

 

acting through its

 

WYETH PHARMACEUTICALS DIVISION,

 

 

 

WYETH-WHITEHALL PHARMACEUTICALS, INC.,

 

 

 

WYETH-AYERST LEDERLE, INC.,

 

 

 

and

 

 

 

PROGENICS PHARMACEUTICALS, INC.

 

and

 

PROGENICS PHARMACEUTICALS NEVADA, INC.

 

 

 

Dated as of December 23, 2005

 

 

 

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TABLE OF CONTENTS

                                                                                                     

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SCHEDULES

 

Schedule 1.10   Chemical Drawing of Compound

Schedule 8.4.2   Press Release

Schedule 9.2   Progenics Disclosure Schedule

 

 

EXHIBITS

 

EXHIBIT A Co-Promotion Agreement

 

 

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LICENSE AND CO-DEVELOPMENT AGREEMENT

 

This License and Co-Development Agreement (the “ Agreement ”) is entered into this 23 rd day of December, 2005 (the “ Effective Date ”), by and among Wyeth, acting through its Wyeth Pharmaceuticals Division, a corporation organized and existing under the laws of the State of Delaware and having a principal place of business at 500 Arcola Road, Collegeville, Pennsylvania 19426, Wyeth-Whitehall Pharmaceuticals, Inc., a corporation having a principal place of business at Road No. 3, Kilometer 142.1, Guayama, Puerto Rico 00784, and Wyeth-Ayerst Lederle, Inc. a corporation having a principal place of business at 65th Infantry Road, Kilometer 9.7, Carolina, Puerto Rico 00987-4904 (collectively “ Wyeth ”) and Progenics Pharmaceuticals, Inc., a corporation organized and existing under the laws of the State of Delaware and having a principal place of business at 777 Old Saw Mill River Road, Tarrytown, NY 10591 (“ Progenics ”) and Progenics Pharmaceuticals Nevada, Inc., a corporation organized and existing under the laws of the State of Nevada and having a principal place of business at 777 Old Saw Mill River Road, Tarrytown, NY 10591 (“ ProNev ”). Wyeth and Progenics may each be referred to herein individually as a “ Party ” and collectively as the “ Parties .”

 

BACKGROUND

 

A.   Wyeth Pharmaceuticals is the pharmaceutical division of Wyeth, a global company devoted, among other businesses, to discovering, developing, manufacturing and marketing human pharmaceutical products.

 

B.   Wyeth-Whitehall Pharmaceuticals, Inc. and Wyeth-Ayerst Lederle, Inc. are indirect subsidiaries of Wyeth.

 

C.   Progenics is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products. Progenics is developing [*] (“[*]”), for the treatment of post-operative bowel dysfunction and opioid-induced constipation associated with chronic pain and advanced medical illness.

 

D.   ProNev is a direct, wholly-owned subsidiary of Progenics.

 

E.   Progenics owns or has rights under certain patents, patent applications, other valuable technology and know-how relating to [*] and has conducted and is conducting certain clinical trials for [*].

 

F.   Wyeth and Progenics wish to collaborate regarding the development of [*] and Progenics wishes to grant to Wyeth, and Wyeth wishes to receive from Progenics, an exclusive worldwide license to develop and commercialize [*].

 

AGREEMENT

 

NOW THEREFORE, in consideration of the mutual promises and covenants set forth below and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:

 

 

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1.  

 

Capitalized terms not otherwise defined herein shall have the following meanings:

 

1.1.    Affiliate(s). “Affiliate(s)”means, as of any point in time and for so long as such relationship continues to exist with respect to any Person, any other Person which controls, is controlled by or is under common control with such Person. A Person shall be regarded as in control of another Person if it owns or controls more than 50% of the equity securities of the subject Person entitled to vote in the election of directors (or, in the case of a Person that is not a corporation, for the election of the corresponding managing authority); provided , however , that the term “Affiliate” shall not include a Person in which any other Person owns a majority of the ordinary voting power necessary to elect a majority of the board of directors or other governing board, but is restricted from electing such majority by contract or otherwise, until such time as such restrictions are no longer in effect.

 

1.2.    Calendar Quarter. “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31, for so long as this Agreement is in effect. 

 

1.3.    Calendar Year. “Calendar Year” means any calendar year.

 

1.4.    Claim. “Claim” means any claim, action, cause of action, chose in action, or suit (in contract or tort or otherwise), litigation, arbitration, investigation, opposition, hearing, complaint, demand, notice or proceeding to, from, by or before any arbitrator, court, administrative organization, or other governmental authority or other Person.

 

1.5.    Collaboration. “Collaboration” means the Development and Commercialization activities of the Parties under this Agreement.

 

1.6.    Combination Product. “Combination Product” means any Product that contains the Compound as an active ingredient together with one or more other active ingredients and is sold for a single invoiced price, e.g., where the Compound is packaged for sale together with a second compound or biologic as an active ingredient (either as a single fixed dose or as separate doses).

 

1.7.    Commercialization. “Commercialization” means all activities related to the commercial exploitation of the Compound and the Products, including without limitation the manufacture, supply, use, importation, exportation, marketing, promotion, distribution, pre-launch, launch, sale, offering for sale and conducting Phase 4 Clinical Trials of the Products. When used as a verb, “Commercialize” or “Commercializing” means to engage in Commercialization. 

 

1.8.    Commercially Reasonable Efforts. “Commercially Reasonable Efforts” means efforts and resources normally used by the Party required to use such efforts and resources for a product, proposed product or technology owned by it or to which it has rights, which is of similar commercial potential at a similar stage in its development or product life, taking into account issues of [*].

 

 

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1.9.    Committee. “Committee” means the JSC, JDC, and/or JCC as the context requires.

 

1.10.    Compound. “Compound” means [*] ([*]) which is chemically defined as [*] and its pharmacologically acceptable salts, together with their solvates, hydrates, hemihydrates, metabolites, pro-drugs, esters, and if applicable, any isomers or racemates thereof, [*]. The “Compound” does not include the Excluded Molecules. A chemical drawing of [*] is attached as Schedule 1.10 .

 

1.11.    Confidential Information. “Confidential Information” means, with respect to each Party, any non-public proprietary data, information or materials that belongs in whole or in part to such Party, its Affiliates or Sublicensees and information otherwise designated by such Party as Confidential Information of such Party hereunder.

 

1.12.    Control or Controlled. “Control” or “Controlled” means with respect to any material, item of information, or intellectual property right, the possession, whether by ownership or license, of the right to grant a license with respect thereto. 

 

1.13.    Co-Promotion Territory. “Co-Promotion Territory”   means the United States of America, including its territories and possessions.

 

1.14.    Development. “Development” means all activities related to the development of Products and obtaining Regulatory Approval for Products, including, without limitation, all activities related to research, development, preclinical testing, stability testing, toxicology, formulation, clinical trials, regulatory affairs, statistical analysis, report writing, manufacturing process and scale up, qualification and validation activities, quality assurance/quality control development and regulatory filing creation and submission related to obtaining Regulatory Approval for Products. When used as a verb “Develop” means to engage in Development.

 

1.15.    Excluded Molecules. “Excluded Molecules” means [*] ([*]), chemically defined as [*] and its pharmacologically acceptable salts, together with their solvates, hydrates, hemihydrates, metabolites, pro-drugs, esters, and if applicable, any isomers or racemates thereof, [*].

 

1.16.    FDA. “FDA” means the United States Food and Drug Administration or any successor agency thereto.

 

1.17.    FD&C Act. “FD&C Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended, and the rules and regulations promulgated thereunder.

 

1.18.    Field. “Field” means all prophylactic or therapeutic pharmaceutical uses of Compound for the diagnosis, treatment or prevention of disease in humans.

 

1.19.    First Commercial Sale. “First Commercial Sale” means, with respect to any Product and with respect to any country of the Territory, the first sale of such Product to a Third Party in such country after such Product has been granted Regulatory Marketing Approval by a Regulatory Authority having jurisdiction for such country.

 

 

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1.20.    FTE. “FTE” means the full time equivalent effort of one Progenics employee who participates directly in the activities under an approved Development Plan. For purposes of this definition, “full time equivalent effort” shall mean [*] of work per year with reimbursement based on actual hours worked.

 

1.21.    FTE Rate. “FTE Rate” means the hourly rate of $[*] per hour for Development work to be performed by Progenics during Calendar Year 2006, increasing at the beginning of each subsequent Calendar Year over the prior year amount by the increase of the Consumer Price Index- All Urban Consumers during the prior year.

 

1.22.    GAAP. “GAAP” means U.S. generally accepted accounting principles consistently applied.

 

1.23.    GMP. “GMP” means good manufacturing practices, as such term is defined in the FD&C Act, applicable to the manufacture of the Products and the Compound.

 

1.24.    IND. “IND” means an Investigational New Drug Application, as defined in the FD&C Act, that is required to be submitted with the FDA before beginning clinical testing in human subjects, or an equivalent foreign filing.

 

1.25.    IV Product. “IV Product” means any Product that is formulated to be administered intravenously.

 

1.26.    JCC. “JCC” means the Joint Commercialization Committee established in accordance with Section 3.4 (Joint Commercialization Committee (JCC)).

 

1.27.    JDC. “JDC” means the Joint Development Committee established in accordance with Section 3.3 (Joint Development Committee (JDC)).

 

1.28.    Joint Know-How. “Joint Know-How” means any Know-How made or created in the course of Collaboration jointly by (i) employees or agents of Progenics or any of its Affiliates, and (ii) employees or agents of Wyeth or any of its Affiliates.

 

1.29.    Joint Patent Rights. “Joint Patent Rights” means any Patent Rights related to any invention, development or discovery made or created in the course of the Collaboration jointly by (i) employees or agents of Progenics or any of its Affiliates, and (ii) employees or agents of Wyeth or any of its Affiliates, as determined in accordance with Section 7.1.1 (Inventorship).

 

1.30.    Joint Technology. “Joint Technology” means the Joint Know-How and the Joint Patent Rights.

 

1.31.    JSC. “JSC” means the Joint Steering Committee established in accordance with Section 3.2 (Joint Steering Committee (JSC)).

 

1.32.    Know-How. “Know-How” means any confidential unpatented or unpatentable invention, development, discovery, technology, cell line, biological material, compound, probe,

 

 

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sequence, technical information, method, biological material, or other confidential information or material.

 

1.33.    Licensed Activit(y/ies). “Licensed Activit(y/ies)” means, collectively, the Development and Commercialization of any Product, the practice of any Progenics Technology or Joint Technology or the exercise of any other right granted by Progenics to Wyeth under this Agreement, in each case as permitted under this Agreement.

 

1.34.    Major Market Country. A “Major Market Country” means any of [*].

 

1.35.    [*] .

 

1.36.    Net Sales. “Net Sales” means the gross amounts invoiced for sales of all Products by Wyeth, its Affiliates and Sublicensees (each a “ Selling Person ”) to Third Parties which are not Sublicensees, less the following deductions, in each case to the extent specifically related to the Product and taken by the Selling Person or otherwise paid for or accrued by the Selling Person (“ Permitted Deductions ”):

 

(i)   trade, cash, promotional and quantity discounts, and wholesaler fees.

 

(ii)   taxes on sales (such as excise, sales or use taxes or value added taxes) to the extent imposed upon and paid directly with respect to the sales price (and excluding national, sales or local taxes based on income);

 

(iii)   freight, insurance, packing costs and other transportation charges to the extent included in the invoice price to the buyer;

 

(iv)   amounts repaid or credits taken by reason of damaged goods, rejections, defects, expired dating, recalls, returns or because of retroactive price changes;

 

(v)   charge back payments and rebates granted to (a) managed healthcare organizations, (b) federal, state and/or provincial and/or local governments or other agencies, (c) purchasers and reimbursers, or (d) trade customers, including without limitation, wholesalers   and chain and pharmacy buying groups, all only to the extent permitted by applicable law and regulations; and

 

(vi)   documented customs duties actually paid by the Selling Person.

 

Products provided by Wyeth, its Affiliates or Sublicensees, free of charge, for administration to patients enrolled in clinical trials or distributed at no charge to eligible patients shall not be included in Net Sales, provided that Wyeth, its Affiliates and Sublicensees receive no cash consideration from such clinical trials or such use of Product.

 

It is understood that accruals taken as a deduction against Net Sales will be periodically reviewed by Wyeth in accordance with GAAP and if any accrual is reversed by Wyeth a corresponding credit will be made to Net Sales in the period in which the reversal is made.

 

 

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Bundling . Where a Product is “bundled” for sale together with one or more other products in a country or is offered as a “loss leader” to encourage the sale of one or more other product(s), Net Sales of such Product shall be [*] by Wyeth, its Affiliate or Sublicensee (less the Permitted Deductions) [*], which [*].

 

Combination Sales . If a Product is sold as a Combination Product (a “ Combination Sale ”), the Net Sales for such Combination Product shall be the portion of such Combination Sale allocable to the Compound determined as follows:

 

Except as provided below, the Net Sales amount for a Combination Sale shall equal the [*], where:

 

[*].

 

Where the calculation of Net Sales resulting from a Combination Sale in a country cannot be determined by the foregoing method, the calculation of Net Sales for such Combination Sale shall be [*].

 

EXCEPT THAT the Net Sales of a Combination Product shall not be reduced by any fraction if:

 

(i)    [*];

 

(ii)    [*]; and

 

(iii)    [*].

 

1.37.    NDA. “NDA” means a New Drug Application, as defined in the FD&C Act, that is filed with the FDA to formally propose that the FDA approve a new drug for sale and marketing in the U.S., or an equivalent application or submission.

 

1.38.    Non-Royalty Sublicense Income. “Non-Royalty Sublicense Income” means [*]consideration received by Wyeth or a Wyeth Affiliate in consideration for the grant of any Sublicense, [*]. Non-Royalty Sublicense Income includes, without limitation, [*] paid to Wyeth or a Wyeth Affiliate by or on behalf of the Sublicensee in consideration for the Sublicense (other than [*] for Development of the Products in [*]). In addition to excluding [*] Non-Royalty Sublicense Income will exclude payments received in consideration for [*], including without limitation payments made to Wyeth or its Affiliates (i) in consideration of [*].

 

1.39.    Oral Product. “Oral Product” means any Product that is formulated to be taken orally.

 

1.40.    Outside Contractor. “Outside Contractor” means any person other than a Sublicensee contracted by Progenics or Wyeth to provide products or services relating to the Collaboration, including, without limitation, contract manufacturing services, clinical services or regulatory services that contribute to the performance of its responsibilities under the Development Plan or that result in any work product or other information that Progenics or

 

 

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Wyeth could include or might reasonably be expected to include in any document or report, including, without limitation, a Registrational Filing, submitted to a Government Authority or be subject to review by a Government Authority, including, without limitation the FDA.

 

1.41.    Patent Rights. “Patent Rights” means any and all (a) U.S. or foreign patents, (b) U.S. or foreign patent applications, including, without limitation, all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon, (c) U.S. or foreign patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including, without limitation, supplementary protection certificates or the equivalent thereof, and (d) other forms of government-issued right substantially similar to any of the foregoing.

 

1.42.    Person. “Person” means any individual or legal entity. 

 

1.43.    Phase 3 Clinical Trial. “Phase 3 Clinical Trial” means a human clinical study on sufficient numbers of patients that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the pharmaceutical product in the dosage range to be prescribed, and to support Regulatory Approval of such pharmaceutical product or label expansion of such pharmaceutical product. 

 

1.44.    Phase 4 Clinical Trial. “Phase 4 Clinical Trial” means product support clinical trials of a Product not for the purpose of obtaining Regulatory Marketing Approval, which are commenced before or after receipt of Regulatory Marketing Approval of such Product.

 

1.45.    Product. “Product” means a product containing the Compound as an active ingredient, including without limitation a Combination Product.

 

1.46.    Progenics Change of Control. “Progenics Change of Control” means the occurrence of any of the following events: (i) Progenics directly or indirectly sells, conveys or otherwise disposes of all or substantially all of Progenics’ assets or business to a Top 15 Pharmaceutical Company or any Affiliate of a Top 15 Pharmaceutical Company; (ii) Progenics or any of its controlling Affiliates merges with or into or consolidates with any Top 15 Pharmaceutical Company or any Affiliate of a Top 15 Pharmaceutical Company; (iii) any other transaction or series of related transactions as a result of which a Top 15 Pharmaceutical Company or an Affiliate of a Top 15 Pharmaceutical Company is able to elect a majority of the members of the board of directors of Progenics or any of its controlling Affiliates. For the purpose of this definition, a “controlling Affiliate” is an Affiliate that “controls” Progenics, as such term is used in the definition of Affiliates in Section 1.1 (Affiliates).

 

1.47.    Progenics Development Costs. “Progenics Development Costs” means expenses of Progenics incurred in accordance with an approved Development Plan and Progenics Development Cost Budget approved by the JSC or agreed by the Parties, consisting of (i) the cost of actual direct FTEs, as recorded in the Progenics [*] time reporting system or any other mutually agreed and auditable time tracking system, costed at the FTE Rate, and (ii) direct out-of-pocket expenses incurred in the performance of activities assigned to Progenics under such Development Plan.

 

 

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1.48.    Progenics Development Cost Budget. “Progenics Development Cost Budget” means the three-year, quarter-by-quarter rolling budget for Progenics Development Costs approved annually by the JSC. The initial Progenics Development Cost Budget has been agreed by the Parties simultaneously with the execution of this Agreement.

 

1.49.    Progenics Know-How. “Progenics Know-How” means Know-How Controlled by Progenics or its Affiliates as of the Effective Date or at any time during the Term which relates to the Compound or a Product or to the use of the Compound or a Product; provided , however , that if a Third Party becomes an Affiliate of Progenics pursuant to a transaction or series of related transactions as a result of which such Third Party is able to elect a majority of the members of the board of directors of Progenics (or its successor company) or any of its “controlling Affiliates” (as defined in Section 1.46 (Progenics Change of Control), “Progenics Know-How” will not include any Know-How that was Controlled by such Third Party (and not by Progenics) prior to the completion of such transaction or series of related transactions.

 

1.50.    Progenics Patent Rights. “Progenics Patent Rights” means any Patent Right Controlled by Progenics or its Affiliates as of the Effective Date or at any time during the Term that relates to, claims, or if issued, would be infringed by an unlicensed Third Party’s manufacture, use, sale, importation, Development or Commercialization of the Compound, or any Product; provided , however , that if a Third Party becomes an Affiliate of Progenics pursuant to a transaction or series of related transactions as a result of which such Third Party is able to elect a majority of the members of the board of directors of Progenics (or its successor company) or any of its “controlling Affiliates” (as defined in Section 1.46 (Progenics Change of Control), “Progenics Patent Rights” will not include any Patent Rights that were Controlled by such Third Party prior to the completion of such transaction or series of related transactions. Progenics Patent Rights as of the Effective Date are identified on Schedule 9.2.

 

1.51.    Progenics Technology. “Progenics Technology” means the Progenics Know-How and the Progenics Patent Rights. 

 

1.52.    Progenics Third Party Agreement. “Progenics Third Party Agreement” means any agreement in effect as of the Effective Date under which Progenics or any of its Affiliates is granted any license or otherwise has any rights or interests under any Progenics Technology or which relates to the supply or clinical study of the Compound or any Product, including without limitation the agreements listed in Schedule 9.2(C) under the heading “Progenics Third Party Agreements.”

 

1.53.    Recall. “Recall” means, with respect to any pharmaceutical product, a “recall” or a “product withdrawal” or a “stock recovery” or any similar term as utilized by any Regulatory Authority under such Regulatory Authority’s procedures regarding the recall of pharmaceutical products, as the same may be amended from time to time, and shall include any post-sale warning or mailing of information regarding such product, including any warnings or mailings described in the Regulatory Authority’s product recall procedures.

 

1.54.    Registrational Filing. “Registrational Filing” means an application submitted to the appropriate Regulatory Authority seeking a Regulatory Marketing Approval.

 

 

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1.55.    Regulatory Approval. “Regulatory Approval” means the technical, medical and scientific licenses, registrations, authorizations and approvals of any Regulatory Authority necessary for the development, clinical testing, commercial manufacture, distribution, marketing, promotion, offer for sale, use, import, export or sale of a Product in a regulatory jurisdiction, including, without limitation, INDs, NDAs, or Biologic License Applications (“ BLAs ”), supplements and amendments, pre- and post- approvals, pricing and third party reimbursement approvals, labeling approvals, and drug master files (“ DMFs ”).

 

1.56.    Regulatory Authority. “Regulatory Authority” means, with respect to a country in the Territory, any national (e.g., the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the European Agency for the Evaluation of Medicinal Products), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity involved in the granting of a Regulatory Approval for such country or countries.

 

1.57.    Regulatory Marketing Approval. “Regulatory Marketing Approval” means, with respect to any Product in any country or region and in any indication, Regulatory Approval authorizing the marketing of such Product in such country or region for such indication. For the sake of clarity, Regulatory Marketing Approval shall be deemed to have occurred when the FDA or its foreign equivalent sends a Letter of Approval or its foreign equivalent.

 

1.58.    Regulatory Pricing Approval. “Regulatory Pricing Approval” means, with respect to any Product in any country or region, the achievement of all applicable pricing and reimbursement approvals with respect to such Product in such country or region.

 

1.59.    Royalty Period. “Royalty Period” means with respect to any particular Product in any particular country, the period of time beginning on [*] and extending until the later of (a)   [*], (b) [*], and (c) [*].

 

1.60.    SC Product. “SC Product” means any Product that is formulated to be administered by a subcutaneous injection.

 

1.61.    Sublicense. “Sublicense” means, directly or indirectly, to sublicense, grant any other right with respect to, or agree not to assert, any right licensed to Wyeth under this Agreement. When used as a noun, “Sublicense” means any agreement to Sublicense. 

 

1.62.    Sublicensee. “Sublicensee” means any Third Party who is granted a Sublicense.

 

1.63.    Territory. “Territory” means the entire world.

 

1.64.    Third Party. “Third Party” means any Person other than Wyeth, Progenics or their respective Affiliates.

 

1.65.    Title 11. “Title 11” shall have the meaning set forth in Section 10.5.3 (Rights to Intellectual Property).

 

1.66.    Top 5 EU Market Country. A “Top 5 EU Market Country” means any of [*].

 

 

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1.67.    Top 15 Pharmaceutical Company. Top 15 Pharmaceutical Company means, at any given time, any of the fifteen (15) largest pharmaceutical or biopharmaceutical companies in world (other than Wyeth), measured by the stock market value of the equity capitalization of the companies at that time.

 

1.68.    Unauthorized Generic Product. “Unauthorized Generic Product” means, with respect to any Product, a pharmaceutical product (other than the Product itself) sold by an unlicensed Third Party that contains the Compound and gains Regulatory Marketing Approval for one of the same indications as such Product without de novo evidence of safety and efficacy, such as through an abbreviated new drug application as defined in 21 U.S.C. 355(j) or an application submitted pursuant to 21 U.S.C. 355(b)(2) (or their equivalents outside the United States).

 

1.69.    Unauthorized Generic Product Market. “Unauthorized Generic Product Market” means, with respect to any Product in any country in the Territory, the sum of [*]. Unauthorized Generic Product sales shall be determined using independent market data (where available), such as that published by IMS.

 

1.70.    Valid Claim. “Valid Claim” means a claim of a patent application or an issued and unexpired patent that has not been held unpatentable, revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and that has not been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise. If a claim of a pending patent application has not issued as a claim of an issued patent within [*] years after the earliest priority date for such claim, such claim shall cease to be a Valid Claim unless and until such claim becomes an issued claim of an issued patent.

 

1.71.    Wyeth Collaboration Know-How. “Wyeth Collaboration Know-How” means Know-How relating to the Collaboration or the Compound or the Products, Controlled as of the Effective Date or at any time during the Term by Wyeth or its Affiliates, that is made or created in the course of the Collaboration solely by employees or agents of Wyeth or any of its Affiliates or Sublicensees, other than Progenics Know-How and Joint Know-How.

 

1.72.    Wyeth Collaboration Patent Rights. “Wyeth Collaboration Patent Rights” means any Patent Right Controlled by Wyeth or its Affiliates that claim inventions invented solely by employees or agents of Wyeth or any of its Affiliates or Sublicensees (as determined in accordance with Section 7.1.1 (Inventorship)) arising out of the Collaboration that, if issued, would be infringed by an unlicensed Third Party’s manufacture, use, sale, importation, Development or Commercialization of the Compound or any Product, other than Progenics Patent Rights and Joint Patent Rights.

 

1.73.    Wyeth Independent Patent Rights. “Wyeth Independent Patent Rights” means any Patent Right Controlled by Wyeth or its Affiliates that, if issued, would be infringed by an unlicensed Third Party’s manufacture, use, sale, importation, Development or Commercialization of the Compound or any Product, other than Wyeth Collaboration Patent Rights, the Progenics Patent Rights and the Joint Patent Rights.

 

 

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1.74.    Additional Definitions. Definitions for each of the following defined terms are set forth in the section of this Agreement indicated below:

 

Definition

Section

 

 

Agreement

Introduction

Commercialization Payments

6.4

Co-Promotion Agreement

5.1

Co-Promotion Option

5.1

Debtor Party

10.5.1

Designated Countries

7.2.1

Development Account

6.2.2

Development Cost Summary

6.2.2

Development Payments

6.3

Development Plan

4.1

Disclosing Party

8.1

Effective Date

Introduction

Estimated Quarterly Development Costs

6.2.2

Executive Officers

3.1.3

Indemnified Party

11.3

Indemnifying Party

11.3

Liability

11.1

Licensed Progenics Patent Rights

9.2(a)

Negotiation Period

2.3.2(d)

Non-Debtor Party

10.5.1

Owned Progenics Patent Rights

9.2(a)

Partial Termination

10.2.1

Party Vote

3.1.3

Permitted Deductions

1.36

Progenics

Introduction

Progenics Indemnified Party

11.1

Progenics Regulatory Filings/Approvals

12.1.4(a)

ProNev

Introduction

Receiving Party

8.1

Responsible Executive

13.19

[*]

Background

Selling Person

1.36

[*]

1.36

Sued Party

7.2.7(c)

Term

10.1

Terminated Products

10.4.3

Terminated Territory

10.4.1(f)

Third Party IP Rights

7.2.7(b)

Transferred Regulatory Filings/Approvals

12.1.4(b)

UR Labs Acquisition Agreements

9.2(e)

UR Labs-Progenics Agreement

10.6.1

 

 

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Working Group

3.3.4

Wyeth

Introduction

Wyeth Non-Defaulting Termination

10.6.2

Wyeth Indemnified Party

11.2

 

2.  

LICENSE GRANTS AND RELATED MATTERS.

 

2.1.    Exclusive License from Progenics to Wyeth. Subject to the terms and conditions of this Agreement, Progenics hereby grants to Wyeth in the Field an exclusive (even as to Progenics, other than as set forth in Section 2.2 (Retained Rights)) license under the Progenics Technology and Joint Technology, with the right to sublicense as set forth in Section 2.3.1 (Sublicenses), to make, have made, use, Develop, sell, offer to sell, have sold, import, export, and otherwise exploit and Commercialize the Compound and Products in the Territory. Wyeth acknowledges that with respect to those Progenics Patent Rights that are Controlled by Progenics pursuant to the Third Party Agreements, the foregoing license is subject to the rights of the Third Party licensors under such Third Party Agreements.

 

2.2.    Retained Rights.  Subject to the terms and conditions of this Agreement, Progenics retains the non-exclusive, non-transferable, non-licensable right under the Progenics Technology and Joint Technology only (i) to make, have made, import, export and use the Compound and Develop the Compound and the Products for the purpose of performing its obligations under this Agreement, and (ii) to make and use the Compound and use the Products for research and development purposes and quality control and quality assurance related to the development and commercialization of the Excluded Molecules. Other than as set forth in this Section 2.2, no right is retained by Progenics to offer for sale or sell the Compound to any Third Party in the Territory or to make, have made, use, sell, offer for sale, import, export or otherwise exploit or Commercialize Products in the Territory.

 

2.3.    Sublicenses

 

2.3.1.    General. Wyeth shall have the right to grant Sublicenses of any and all rights granted to Wyeth under this Agreement to its Affiliates in the Territory, without the requirement of any prior approval by Progenics. Except as provided in Section 2.8 ([*]), Wyeth may not Sublicense its obligation to Develop the Products in any Major Market Country to a Third Party. In addition, Wyeth shall have the right to grant Sublicenses of any and all rights granted to Wyeth under this Agreement to Commercialize the Products after Regulatory Marketing Approval to any Third Party for countries outside the Major Market Countries, without the requirement of prior written approval of Progenics. Wyeth shall also have the right on a Product-by-Product basis to grant Sublicenses of any and all rights granted to Wyeth under this Agreement to Commercialize Products, after Regulatory Marketing Approval, in the Major Market Countries, with the prior written consent of Progenics, not to be unreasonably withheld or delayed. It is understood and agreed that Progenics’ consent may be reasonably withheld in the event that Wyeth seeks to Sublicense its rights to a Third Party that Commercializes a prescription pharmaceutical product in a Major Market Country that

 

 

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competes with or addresses similar indications to any Product. Any Sublicense by Wyeth in the United States shall only be for the purpose of augmenting the Commercialization activities in the United States and shall not be for the purpose of replacing Wyeth’s Commercialization activities in the United States. Wyeth will provide to Progenics a complete and final English language draft of any Sublicense for comments by Progenics at least ten (10) business days prior to entering into such Sublicense and will provide to Progenics a complete and final English language copy of each Sublicense within ten (10) business days after entering into the Sublicense. Wyeth shall remain responsible for the payment to Progenics of all royalties payable under this Agreement with respect to Net Sales made by all Wyeth Affiliates or Sublicensees. In connection with the granting of any Sublicense, Progenics shall provide Wyeth and the Sublicensee (or prospective Sublicensee), at the request of Wyeth, Progenics’ written confirmation of Wyeth’s ongoing rights under this Agreement, including the right to grant Sublicenses. Wyeth shall be responsible for the making of all payments due, and the making of all reports under this Agreement by reason of the sales of any Products by its Sublicensees. Each Sublicensee shall agree in writing to keep books and records in accordance with the relevant provisions of this Agreement. Wyeth shall ensure that each of its Affiliates and permitted Sublicensees accepts and complies with all of the terms and conditions of this Agreement as if they were a party to this Agreement. 

 

2.3.2.    Progenics Right of First Negotiation. Wyeth hereby grants to Progenics a right of first negotiation to be the Sublicensee under any Sublicense that Wyeth may elect to grant to any Third Party in any Major Market Country (other than [*]), but only if Wyeth determines, in its sole discretion, that Progenics is capable of performing the activities covered by the Sublicense in the relevant country or countries, which right of first negotiation is granted on the following terms and conditions:

 

(a)  

General. Wyeth shall not grant a Sublicense to any Third Party in any Major Market Country (other than [*]), unless and until Wyeth provides a written notice to Progenics (a “ Sublicense Notice ”), which notice will identify the general scope and purpose of the Sublicense that Wyeth proposes to grant and the Major Market Country or Countries to which it will apply and will either (A) invite Progenics to negotiate regarding such a Sublicense; or (B) inform Progenics that Wyeth has determined that Progenics is not capable of performing the activities covered by the proposed Sublicense in the relevant country or countries. If the Sublicense Notice invites Progenics to negotiate regarding a Sublicense, Wyeth shall not grant Sublicense to any Third Party in the relevant country or countries until:

 

(i)  

Progenics notifies Wyeth that it declines the opportunity to negotiate with Wyeth regarding such a Sublicense;

 

(ii)  

Progenics does not respond to Wyeth within thirty (30) days after receipt of the Sublicense Notice; or

 

(iii)  

the Negotiation Period (as defined below) expires before Wyeth and Progenics have entered into a Sublicense.

 

 

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(b)  

Capability / Refusal / Failure to Respond. If (A) Wyeth determines that Progenics is not capable of performing the activities covered by the proposed Sublicense in the relevant country or countries, or (B) Progenics responds to the Sublicense Notice by declining to negotiate with Wyeth regarding the proposed Sublicense, or (C) Progenics does not respond to a Sublicense Notice within the thirty (30) day period provided for in clause (ii) of Section 2.3.2(a) (General), then Wyeth will have no obligation to negotiate with Progenics with respect to any Sublicense in the relevant country or countries, and Wyeth will be free to grant one or more Sublicense to one or more Third Parties in such country or countries at Wyeth’s sole discretion.

 

(c)  

Consultation Regarding Capabilities. Wyeth shall not determine that Progenics is not capable of performing the activities covered by the proposed Sublicense in the relevant country or countries unless and until Wyeth has given Progenics a reasonable opportunity to make a presentation to Wyeth demonstrating its capabilities. Once Wyeth has provided such opportunity to Progenics, however, Wyeth may determine whether Progenics is capable of performing the activities covered by the Sublicense in the relevant country or countries in its sole discretion.

 

(d)  

Negotiation Period. If the Sublicense Notice invites Progenics to negotiate regarding such a Sublicense and Progenics notifies Wyeth, within thirty (30) days after receipt of the Sublicense Notice that it desires to negotiate with Wyeth regarding the proposed a Sublicense, the Parties shall negotiate in good faith with each other for sixty (60) days (or such longer period as mutually agreed by the parties) (the “ Negotiation Period ”) regarding a mutually satisfactory Sublicense. Neither party shall be obligated to enter into a Sublicense. In the event that the Negotiation Period expires before Wyeth and Progenics have entered into a Sublicense, Wyeth will have no further obligation to negotiate with Progenics with respect to any Sublicense in the relevant country or countries, and Wyeth will be free to grant one or more Sublicenses to one or more Third Parties in such country or countries at Wyeth’s sole discretion, subject to the terms and conditions of Section 2.3.1 (Sublicenses; General). However, if negotiations between the Parties end without the Parties executing a Sublicense agreement for such country or countries, then Wyeth shall not enter into any Sublicense of comparable scope in such country or countries containing financial terms that are more favorable to the third party than the financial terms that Progenics last offered to Wyeth during the Negotiation Period without first offering Progenics such Sublicense containing such financial terms; provided , however , that Wyeth shall not be obligated to first offer such more favorable financial terms to Progenics if Wyeth determines, in its sole discretion, that Progenics is no longer capable of performing the activities covered by the Sublicense in the relevant country or countries after once again giving Progenics an opportunity to make a presentation to Wyeth in accordance with Section 2.3.2(c) (Consultation Regarding Capabilities). 

 

 

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(e)  

Termination of Right. The right of first negotiation granted to Progenics in this Section 2.3.2 (Progenics Right of First Negotiation) shall be extinguished upon the occurrence of a Progenics Change of Control.

 

2.3.3.    Non-Royalty Sublicense Income. Wyeth shall pay Progenics [*]   percent ([15]%) of all Non-Royalty Sublicense Income that Wyeth and its Affiliates receive from Sublicensees. Wyeth shall pay Progenics the required percentage of Non-Royalty Sublicense Income within [*] ([*]) days of receiving such Non-Royalty Sublicense Income.

 

2.4.    Direct Licenses to Affiliates. Wyeth may at any time request and authorize Progenics to grant licenses as to countries outside the United States directly to Affiliates of Wyeth outside the United States by giving written notice designating to whom a direct license is to be granted. Upon receipt of any such notice, Progenics shall enter into and sign a separate direct license agreement with such designated Affiliate of Wyeth. All such direct license agreements shall be consistent with the terms and conditions of this Agreement, except for such modifications as may be required by the laws and regulations in the country in which the direct license will be exercised; provided, however, that Progenics shall have no obligation to enter into any such direct license agreement if the effect of entering into such agreement (and continuing as a Party to this Agreement) would be to increase the level of obligations owed by or risks assumed by Progenics, or decrease the consideration owed to Progenics, relative to the obligations owed by, risks assumed by, or consideration owed to Progenics under this Agreement or otherwise adversely affect Progenics. In countries where validity of the direct license agreement requires prior government approval or registration, such direct license agreement shall not become binding between the parties thereto until such approval or registration is granted, which approval or registration shall be obtained by Wyeth. All costs of making a direct license, including Progenics' reasonable attorneys fees, under this Section 2.4 shall be borne by Wyeth. Wyeth shall be responsible to Progenics for the performance of its Affiliates under these direct licenses.

 

2.5.    Fully Paid-Up, Royalty Free License. After expiration of the Royalty Period for any Product in a country, including any extended period under Section 6.5.2 (Extended Exclusivity Based on Wyeth Independent Patent Rights), the license granted to Wyeth under Section 2.1 (Exclusive License from Progenics to Wyeth) with respect to such Product in such country shall be a fully paid-up, perpetual, non-exclusive, irrevocable, royalty-free license, provided , however , in the event that the Royalty Period is resumed under the provisions of Section 1.59 (Royalty Period) the license granted to Wyeth shall revert to its original form until the Royalty Period resumption ends.

 

2.6.    Progenics Third Party Agreements. Progenics shall exercise its rights under the Progenics Third Party Agreements in a manner that is as consistent as possible with the terms of this Agreement in consultation with and as reasonably requested by Wyeth. Without the prior written consent of Wyeth, Progenics shall not voluntarily (i) amend or modify, or consent to any action that may be taken under, any Progenics Third Party Agreement, the effect of which would adversely affect Wyeth’s rights under this Agreement, or (ii) terminate or engage in any act or omission that constitutes or would constitute, with or without the giving of notice or the passage of time, an event that would permit the licensor under the Progenics Third Party Agreements to

 

 

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terminate the Progenics Third Party Agreements. Progenics shall immediately notify Wyeth of any such event or of the receipt by Progenics of any notice of breach or termination of any Progenics Third Party Agreement. Progenics shall take all reasonable actions necessary, or permit such actions to be taken in its name by Wyeth, to maintain and enforce Progenics' rights under the Progenics Third Party Agreements in a manner consistent with the terms of this Agreement. Wyeth will reimburse Progenics for any non- de minimis out-of-pocket expenses incurred by Progenics to comply with the previous sentence.

 

2.7.    Know-How Transfer.

 

2.7.1.    Disclosure of Know-How.  Commencing promptly after the Effective Date, Progenics shall disclose the then existing Progenics Know-How to Wyeth. During the Term of the Agreement, Progenics shall disclose to Wyeth all Progenics Know-How and Joint Know-How that is developed by Progenics or otherwise comes into Progenics’ Control other than Know-How related exclusively to the Excluded Molecules. Furthermore, during the Term of the Agreement, Wyeth shall disclose to Progenics any Joint Know-How and Wyeth Collaboration Know-How that is related to Progenics Development and Commercialization activities under the Agreement or that the JDC or JSC determines should be disclosed to Progenics. Any such Know-How disclosure shall be accomplished through periodic delivery of documentation and meetings/telephone calls on a reasonable schedule agreed by the Parties in accordance with Section 2.7.2 (Transfer of Know-How).

 

2.7.2.    Transfer of Know-How. Without limiting the generality of Section 2.7.1 (Disclosure of Know-How), on a mutually agreed periodic basis or at a Party’s request within a reasonable time not to exceed thirty (30) days from the date of the request, each Party shall deliver to the requesting Party copies (for documentation and information) or samples (for tangible materials) of any documents, files, diagrams, plans, specifications, designs, recipes, schematics, reports, notes, data, models, prototypes, chemical or biological materials, or other documentation or tangible materials recording or embodying the Know-How in its possession required to be disclosed to the requesting Party pursuant to Section 2.7.1 (Disclosure of Know-How) or otherwise under this Agreement. In addition, on a mutually agreed periodic basis or at a Party’s request, technically qualified scientists and engineers from each Party will meet and/or participate in telephone conference calls on a reasonable mutually agreed schedule as reasonably necessary to fully disclose all such Know-How. An officer of Progenics and a representative of Wyeth shall mutually agree from time to time on the most appropriate method for the disclosure of Know-How between the Parties.

 

2.8.    [*]. 

 

2.9.    No Implied Rights. Except as expressly provided in this Agreement, neither Party shall be deemed to have granted the other Party any license or other right with respect to any intellectual property of such Party.

 

 

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3.  

GOVERNANCE OF COL LABORATION

 

3.1.    Management of the Collaboration and General Committee Procedures.

 

3.1.1.    Overview. A Joint Steering Committee as defined in Section 3.2 (Joint Steering Committee), a Joint Development Committee as defined in Section 3.3 (Joint Development Committee) and a Joint Commercialization Committee as defined in Section 3.4 (Joint Commercialization Committee) shall be established. Each Committee shall have the responsibilities and authority allocated to it in this Section 3 (Governance of Collaboration) and elsewhere in this Agreement. The following procedures shall apply to the Committees under this Agreement.

 

3.1.2.    Meetings. Each Committee shall hold meetings at such times as it elects to do so, but in any event the JSC shall meet face-to-face no less than three times per year in the first two years following the Effective Date, and twice per year thereafter, with additional meetings to be called by either co-chairperson of the JSC on an ad-hoc basis. The JDC shall meet face-to-face no less than three times annually, with additional meetings to be called by either co-chairperson of the JDC on an ad-hoc basis. The JCC shall meet face-to-face no less than three times annually through the first two years after the First Commercial Sale of a Product in the U.S., and thereafter no less than twice annually, with additional meetings to be called by the chairperson of the JCC or, as necessary, Progenics on an ad hoc basis. Ad-hoc meetings may be held face-to-face, by teleconference, video or Webex, as determined by the Committee chairpersons. Each face-to-face meeting of the JSC and JDC shall be held alternatively at Wyeth’s facilities in Collegeville, Pennsylvania and Progenics’ facilities in Tarrytown, New York or at such locations as the Committee may otherwise agree. Each face-to-face meeting of the JCC shall be held at Wyeth’s facilities in Collegeville, Pennsylvania or at such locations as the JCC may otherwise agree. Other employees of each Party involved in the Development, Commercialization or intellectual property protection of Products may attend meetings of such Committee as non-voting participants with the permission of the co-chairpersons, and, with the consent of each Party, consultants, representatives, or advisors involved in the same activities may attend meetings of such Committee as non-voting observers; provided , however , that such Third Party representatives are under obligations of confidentiality and non-use applicable to the Confidential Information of each Party that are at least as stringent as those set forth in Section   8   (Confidentiality). Each Party shall be responsible for all its own expenses of participating in any Committee.

 

3.1.3.    Decision Making.  Each Party’s designees on the JSC and JDC shall, collectively, have one (1) vote (the “ Party Vote ”) on all matters brought before the respective Committee. Except as expressly provided in this Section 3.1.3, each of the JSC and JDC shall decide as to all matters within its jurisdiction by unanimous Party Vote; provided, however, that neither the JSC nor the JDC shall have the authority to amend or modify, or waive compliance with, this Agreement. In the event of a tie Party Vote of the designees of Wyeth and Progenics on the JDC as to matters within such the jurisdiction of such Committee, the co-chairpersons of the JDC shall refer the matter to

 

 

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the JSC for resolution. In the event that such a matter cannot be resolved by the JSC within ten (10) business days of it being referred to the JSC, or in the event of a tie Party Vote of the designees of Wyeth and Progenics on the JSC with respect to any other matter within the JSC’s jurisdiction, the co-chairpersons of the JSC shall refer the matter to [*]. In the event that such matters cannot be resolved by these executives within [*] ([*]) business days, then the matter shall be referred to the [*]. If after good faith discussions by the [*], agreement cannot be reached within [*] ([*]) business days, then the [*] shall decide upon a mechanism to resolve the matter. 

 

3.1.4.    Meeting Agendas. Each Party will have an equal right to place items on the JSC and JDC agendas through the co-chairperson of the JSC or JDC designated by such Party. Wyeth shall generally set the agenda for the JCC, but Progenics may place particular topics on the agenda for discussion at any JCC meeting by giving the JCC chairperson written notice of Progenics’ desire to discuss such topic. Each Party will disclose to the other Party its proposed agenda items along with appropriate information at least five (5) business days in advance of each Committee meeting; provided, however, that under exigent circumstances requiring JSC or JDC input, a Party may provide its agenda items for a JSC or JDC meeting to the other Party within a lesser period of time in advance of the meeting, or may propose that there not be a specific agenda for a particular JSC or JDC meeting, so long as the other Party consents to such later addition of such agenda items or the absence of a specific agenda for such JSC or JDC meeting.

 

3.2.    Joint Steering Committee (JSC).

 

3.2.1.    Formation and Purpose. Within fifteen (15) days after the Effective Date, Wyeth and Progenics shall establish the JSC, which shall coordinate the Parties’ key activities under this Agreement and have the additional responsibilities provided for in this Agreement. The JSC will dissolve upon the expiration of the Term of this Agreement.

 

3.2.2.    Membership and Chairpersons. Each party shall designate two (2) senior executives with appropriate expertise to serve as members of the JSC. Each Party may replace any of its JSC representatives at any time upon written notice to the other Party. The JSC shall have two co-chairpersons, one designated by each of Wyeth and Progenics. The co-chairpersons shall be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting of the JSC, and preparing and issuing minutes of each meeting within thirty (30) days thereafter. Such minutes will not be finalized until each Party reviews and confirms the accuracy of such minutes in writing or by unanimous Party Vote at a subsequent Committee meeting.

 

3.2.3.    Specific Responsibilities of the JSC. The JSC shall have responsibility for the overall strategic and operational direction of the Parties’ collaboration under this Agreement, including without limitation:

 

(a)    [*];

 

 

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(b)    [*];

 

(c)    [*];

 

(d)    [*];

 

(e)    [*];

 

(f)    [*];

 

(g)    [*];

 

(h)    [*]; and

 

(i)    [*].

 

3.3.    Joint Development Committee (JDC).

 

3.3.1.    Formation and Purpose. Within fifteen (15) days after the Effective Date, the Parties shall establish the JDC, which shall oversee, coordinate and expedite the Development of, and the making of regulatory submissions for, the Products in order to obtain Regulatory Approvals. At any time that any Products are being Developed under this Agreement, the JDC shall exist and receive and comment upon periodic reports concerning the status of Product Development and the Development Plan. The JDC shall also facilitate the flow of information with respect to Development activities being conducted and will oversee all clinical trials for any Product, excluding Phase 4 Clinical Trials which shall be the sole responsibility of Wyeth.

 

3.3.2.    Membership and Chairpersons. Each Party shall designate three (3) representatives with appropriate expertise to serve as members of the JDC. Each Party may replace its JDC representative at any time upon written notice to the other Party. The JDC shall have two co-chairpersons, one designated by each of Progenics and Wyeth. The chairpersons shall be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting of the JDC, and preparing and issuing minutes of each meeting within thirty (30) days thereafter. Such minutes will not be finalized until each Party reviews and confirms the accuracy of such minutes in writing or by unanimous Party Vote at a subsequent meeting of the Committee.

 

3.3.3.    Specific Responsibilities of the JDC. The JDC shall have responsibility for overseeing, coordinating and expediting the Development of the Compound and the Products, including without limitation:

 

(a)    [*];

 

(b)    [*];

 

(c)    [*];

 

 

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(d)    [*];

 

(e)    [*];

 

(f)    [*];

 

(g)    [*];

 

(h)    [*];

 

(i)    [*];

 

(j)    [*]; and

 

(k)    [*].

 

3.3.4.    Working Groups. From time to time the JDC may establish and delegate duties to other committees, sub-committees, or directed teams (each a “ Working Group ”) on an “as needed” basis to oversee particular projects or activities. Each such Working Group shall be constituted and shall operate as the JDC determines. Working Groups may be established on an ad hoc basis for purposes of a specific project for the life of a Product, or on such other basis as the applicable Committee may determine. Each Working Group and its activities shall be subject to the oversight, review and approval of, and shall report to the JDC. In no event shall the authority of any Working Group exceed that specified for the JDC in this Section 3   (Governance of the Collaboration).

 

3.4.    Joint Commercialization Committee (JCC).

 

3.4.1.    Formation of JCC. Within sixty (60) days of the Effective Date, the Parties shall establish the JCC, which shall facilitate the exchange of information between the Parties regarding the Commercialization of the Products.

 

3.4.2.    Membership. The JCC shall be composed of representatives selected by both Parties in number and function according to the responsibilities of each Party. The chairperson of the JCC shall be designated by Wyeth.

 

3.4.3.    Responsibilities of the JCC. The JCC shall have responsibility for facilitating open communication between the Parties on matters relating to the Commercialization of Products. The JCC shall not be a voting body. Decisions with respect to Commercialization of the Product will be made solely by Wyeth consistent with this Agreement and the Co-Promotion Agreement.

 

4.  

DEVE LOPMENT

 

4.1.    Development Plan. The Development of the Products will be conducted by or on behalf of the Parties pursuant to a mutually agreed development plan that will govern all aspects of Development of the Products worldwide (as such plan is in effect from time to time, the

 

 

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Development Plan ”). An outline of the initial Development Plan for a SC Product, IV Product and Oral Product has been agreed by the Parties. This outline shall not include a development plan for [*]. The JDC shall be responsible for reviewing and endorsing the Development Plan. The Development Plan for the Products shall be updated on an as-needed basis, but in no event less than once annually. The Parties shall cause the JDC to complete the initial Development Plan for the SC Product, IV Product and Oral Product within ninety (90) days of the Effective Date. [*]. In addition, unless such information is included in the Development Plan itself, with each update of the Development Plan Wyeth shall provide the JDC with a written summary of the human resources that Wyeth expects to deploy to accomplish its responsibilities under the Development Plan.

 

4.2.    Development Responsibilities of the Parties.

 

4.2.1.    Progenics Development Responsibilities. Progenics shall be responsible for and shall use Commercially Reasonable Efforts to:

 

(a)    Develop the SC Product and the IV Product in the United States in accordance with the Development Plan and the Progenics Development Cost Budget until these Products receive Regulatory Marketing Approval in the U.S., including without limitation (i) preparing and submitting and/or revising and amending Registrational Filings, (ii) conducting and managing all clinical trials included in the Development Plan, and (iii) obtaining and maintaining Regulatory Approvals for the SC Product and IV Product;

 

(b)    perform the work to be performed by Progenics under the Development Plan in accordance with their estimated timelines;

 

(c)    perform any other work necessary and appropriate as determined by the JDC and otherwise cooperate with Wyeth in support of Wyeth’s efforts under the Development Plan;

 

(d)    disclose to Wyeth all data, information and other Progenics Know-How and Joint Know-How reasonably necessary in support of Development of the Products; and

 

(e)    manufacture through contract manufacturers (approved in the Development Plan or by agreement of the Parties) 100% of the Parties’ requirements of the Compound and/or Products for Development; it being understood and agreed that any Compound and/or Product supplied by Progenics for clinical use shall be manufactured under GMP conditions. The Parties will transfer responsibility for the supply of the Compound and or Products for Development to Wyeth at a mutually agreed time as soon as reasonably and commercially practicable consistent with Progenics’ current contractual obligations. The Parties will enter into a Quality Agreement for clinical trial supplies of Compound and/or Product within sixty (60) days of the Effective Date.

 

 

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4.2.2.    Wyeth Development Responsibilities. Wyeth shall be responsible for and shall use Commercially Reasonable Efforts to:

 

(a)    Develop the Oral Product in the Territory in accordance with the Development Plan, including without limitation (i) preparing and submitting and/or revising and amending Registrational Filings, (ii) conducting and managing all clinical trials included in the Development Plan, and (iii) obtaining and maintaining Regulatory Approvals for the Oral Product;

 

(b)    Develop the SC Product and IV Product outside the United States in accordance with the Development Plan, including without limitation (i) preparing and submitting and/or revising and amending Registrational Filings, (ii) conducting and managing all clinical trials included in the Development Plan, and (ii) obtaining and maintaining Regulatory Approvals for the SC Product and IV Product;

 

(c)    perform the work to be performed by Wyeth under the Development Plan in accordance with their estimated timelines;

 

(d)    perform any other work necessary and appropriate as determined by the JDC and otherwise cooperate with Progenics in support of Progenics' efforts under the Development Plan;

 

(e)    disclose to Progenics all data, information and other Wyeth Collaboration Know-How and Joint Know-How reasonably necessary in support of Development of the Products;

 

(f)    determine, in Wyeth’s sole discretion, whether to perform any Phase 4 Clinical Trials for any Product, and conduct and manage any such Phase 4 Clinical Trial and any Phase 4 Clinical Trial required by any Regulatory Authority;

 

(g)    if the JSC determines to Develop any Combination Product or Product formulation other than the Oral Product, SC Product or IV Product, or any other indication for a Product, Develop such Product or indication in accordance with the Development Plan, including without limitation (i) preparing and submitting and/or revising and amending Registrational Filings for such Product, (ii) conducting and managing all clinical trials included in the Development Plan for such Products, and (iii) obtaining and maintaining Regulatory Approvals for such Products; and

 

(h)    upon the transfer of responsibility for the supply of the Compound and/or Products for Development from Progenics to Wyeth as required by 4.2.1(e) (Progenics Development Responsibilities) and the transfer of Know-How and the assignment of agreements as required by Section 5.3.2 (Transfer of Manufacturing Know-How) and 5.3.3 (Assignment of Supply and License Agreements), manufacture either directly through a contract manufacturer

 

 

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100% of the Parties’ requirements of Compound and/or Products for Development, it being understood that all Compound and/or Product supplied by Wyeth for clinical use shall be manufactured under GMP conditions.

 

4.2.3.    Efforts. Wyeth’s obligations under Section 4.2.2 (Wyeth Development Responsibilities) to use Commercially Reasonable Efforts will be satisfied if Wyeth uses Commercially Reasonable Efforts in the Major Market Countries. Wyeth shall not be in breach of its obligation under this Section 4.2 (Development Responsibilities of the Parties) for failing to use Commercially Reasonable Efforts in countries other than the Major Market Countries. Furthermore, Wyeth shall be relieved of its obligation to use Commercially Reasonable Efforts in any particular country if a Third Party Controls Patent Rights that would be infringed by the making, using, or selling of a Product in such country and Wyeth or its Affiliates or Sublicensee(s) are unable to obtain a license under such Patent Rights on commercially reasonable terms or configure the Product so as to avoid infringement through the use of Commercially Reasonable Efforts.

 

4.3.    Unforeseen Events. The Parties recognize that the Development Plan and the objectives set forth therein are based upon numerous assumptions which are not in the control of the Parties. In view of the numerous assumptions underlying the Development Plan, the proposed timeframe for achieving the objectives and events described in the Development Plan will be regularly reviewed by the JDC to reflect unforeseen matters. In the event that despite the use of Commercially Reasonable Efforts by the Parties, safety, toxicology, formulation, manufacturing, regulatory, or other issues beyond the control of the Parties arise that prevent either Party from fulfilling the objectives of the Development Plan within the timeframe set forth in the Development Plan, the JDC will discuss any appropriate revisions to the Development Plan, which revisions the other Party shall not unreasonably oppose, provided that the Party can demonstrate its use of Commercially Reasonable Efforts to Develop the Product.

 

4.4.    Subcontracting. Each Party may contract with one or more Outside Contractors to perform any or all of its obligations under the Development Plan; provided, however, that (i) except as otherwise agreed to by the JDC each Outside Contractor shall be approved by the JDC for the proposed work, such approval not to be unreasonably withheld; and (ii) the contracting Party provides the other Party with a true and accurate copy of each agreement pursuant to which such Outside Contractor is engaged promptly after execution thereof.

 

4.5.    Records. Each Party shall maintain, and shall use Commercially Reasonable Efforts to cause its Outside Contractors to maintain, accurate and complete records of all activities related to the Development of the Products, as consistent with the responsibilities of such Party under this Agreement, and all results of any trials, studies and other investigations conducted under this Agreement by or on behalf of such Party, and its Affiliates and Outside Contractors, as applicable.

 

4.6.    Reports on Development. For so long as either Party continues to Develop a Product under this Agreement, it shall provide the other Party and the JDC with periodic reports containing relevant information regarding data and results, activities, and timelines, related to regulatory filings and clinical trials of such Product conducted or overseen by such Party. In addition, through its representatives on the JDC, each Party shall make periodic oral reports to

 

 

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the JDC, updating the JDC as to the status and results of such Party’s Development efforts with respect to any Product, for so long as the JDC continues in existence.

 

 

5.1.    Co-Promotion Option.  Subject to the terms and conditions of this Section 5.1 and the other provisions of this Agreement, Wyeth hereby grants to Progenics an option (the " Co-Promotion Option ") to enter into a Co-Promotion Agreement with Wyeth substantially in the form attached to this Agreement as Exhibit B (the “ Co-Promotion Agreement ”), under which Progenics would detail one or more Products to the defined audiences in the Co-Promotion Territory. Progenics may exercise the Co-Promotion Option by providing Wyeth with written notice of exercise of the Co-Promotion Option (which notice shall indicate the initial number of sales representatives that Progenics desires to field), at least [*] ([*]) months prior to the beginning of the Calendar Year during which Progenics wishes to co-promote the Products, except in the case where Progenics wishes to commence co-promotion with the launch of a Product, in which case Progenics shall provide Wyeth with written notice no later than [*] ([*]) days after the filing of the NDA related to the Product. Upon the exercise of the Co-Promotion Option, the Parties shall promptly enter into the Co-Promotion Agreement. 

 

5.2.    Wyeth’s Commercialization Responsibilities and Efforts. 

 

5.2.1.    Responsibilities. Wyeth shall be responsible for the Commercialization of the SC, IV and Oral Products and such other Products as the JSC shall determine it is advisable to Develop throughout the Territory and, subject to Section 6.2 (Post-Effective Date Development Expenses), shall pay 100% of the costs of Commercialization of the Products. Except as provided in the Co-Promotion Agreement, Wyeth shall be solely responsible for the Commercialization of Products throughout the Territory. Without limiting the foregoing, Wyeth shall be solely responsible for distribution and pricing of Products and shall book all sales of Products in the Territory. 

 

§    Efforts. Wyeth shall use Commercially Reasonable Efforts to pre-launch, launch, promote, market, distribute, sell in finished pharmaceutical form, and otherwise Commercialize Products in the Territory. Commercially Reasonable Efforts expended by a Sublicensee in a given country which is not a Major Market Country shall satisfy Wyeth’s efforts obligations in that country. Wyeth’s Commercialization efforts shall include, without limitation, using Commercially Reasonable Efforts to commit sales, marketing and detail resources and provide marketing and promotional materials and efforts for the Products. Wyeth’s obligations under this Section 5.2 (Wyeth’s Commercialization Responsibilities and Efforts) to use Commercially Reasonable Efforts will be satisfied if Wyeth uses Commercially Reasonable Efforts in the Major Market Countries. Wyeth shall not be in breach of its obligation under this Section 5.2 (Wyeth’s Commercialization Responsibilities and Efforts) for failing to use Commercially Reasonable Efforts outside the Major Market Countries. Furthermore, Wyeth shall be relieved of its obligation to use Commercially Reasonable Efforts with respect to a Product in any particular country if a Third Party Controls Patent Rights that would be infringed by the making, using, or selling of such Product in such country and

 

 

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Wyeth or its Affiliates or Sublicensee(s) are unable to obtain a license under such Patent Rights on commercially reasonable terms or configure the Product so as to avoid infringement through the use of Commercially Reasonable Efforts.

 

5.3.    Supply.

 

5.3.1.    Supply. Wyeth shall be solely responsible at its expense for the manufacture and supply of 100% of the Compound and finished Products for Commercialization both as bulk active pharmaceutical ingredient (API) and as finished and packaged products.

 

5.3.2.    Transfer of Manufacturing Know-How. Progenics will disclose to Wyeth, a Wyeth Affiliate, and/or Wyeth’s Third Party contract manufacturer all relevant Progenics Know-How relating to the manufacture of the Compound and/or Products. Without limiting the generality of the foregoing, at Wyeth’s request, Progenics will deliver to Wyeth, a Wyeth Affiliate, and/or Wyeth’s Third Party contract manufacturer copies (for documents and information) and samples (for materials) of any documents, files, diagrams, plans, specifications, designs, recipes, schematics, reports, models, prototypes, chemical or biologic materials, or other tangible documentation or material in Progenics’ possession relating to the manufacture of the Compound and Products. In addition, at Wyeth’s request, and on a commercially reasonable schedule and at a commercially reasonable venue to be agreed on by the Parties, technically qualified personnel from each Party will meet and/or participate in telephone conference calls as reasonably necessary to exchange knowledge necessary to fully disclose all such Progenics Know-How.

 

5.3.3.    Assignment of Supply and License Agreements. At Wyeth’s written request in connection with the transfer of responsibility for manufacture under Section 4.2.1(e) (Progenics Development Responsibilities), Progenics shall use Commercially Reasonable Efforts to promptly assign and transfer to Wyeth any existing supply agreements related to the supply of the Compound or the Products, including its supply agreements with Mallinckrodt Inc. and DSM Pharmaceuticals, Inc. Furthermore, to the extent necessary to permit Wyeth to manufacture the Compound and Products as contemplated by this Agreement, Progenics shall use Commercially Reasonable Efforts to Sublicense to Wyeth any license agreement under which Progenics licenses any intellectual property rights from any Third Party related to the manufacture of the Compound or the Products. If the terms of any of the agreements referred to in the previous two sentences require the consent of the other party thereto to affect its assignment, then upon Wyeth’s request for an assignment, until Progenics is able to obtain such consent and affect such assignment Progenics will exercise its rights under such agreements for the benefit of Wyeth and as reasonably requested by Wyeth. In the event of any assignment to Wyeth under this Section 5.3.3, Wyeth shall assume full responsibility for satisfying all obligations of Progenics under any assigned agreement to the extent arising after such assignment and assumption.

 

5.4.    Marketing Materials and Corporate Branding. Wyeth shall be solely responsible at its expense for all pre-marketing and marketing efforts and for creating all

 

 

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packaging and promotional materials for the Products. Subject to Progenics’ reasonable approval, the corporate name of Progenics shall appear on all Product packaging in the Territory and the Progenics corporate name and logo shall appear on the package insert for all Products in the Co-Promotion Territory, subject, in each case, to compliance with applicable law and regulatory requirements. In addition, if the Parties enter into the Co-Promotion Agreement, the Progenics corporate name and logo shall appear on all promotional materials for the Products in the Co-Promotion Territory, subject to compliance with applicable law and regulatory requirements.

 

5.5.    Sharing of Information; Progenics Commercial Organization. 

 

5.5.1.    Sharing of Information. Wyeth shall provide Progenics with a copy of Wyeth’s commercialization plan for the Products and any updates thereof, including without limitation information regarding strategies for Commercialization and detailing of Products, market research and strategy, promotional activities, and sales plans and forecasts, and shall report to Progenics on the progress in its implementation of the commercialization plan through the JCC. Commencing on the Effective Date, Progenics shall have the right to have a representative of Progenics attend meetings of Wyeth’s sales and marketing team for the Product at Progenics’ expense. All such commercial information shall be Wyeth’s Confidential Information for the purposes of Section 8.1 (Confidentiality).

 

5.5.2.    Progenics Commercial Goals. Wyeth recognizes Progenics’ long term desire to build a commercial organization and shall assist Progenics in Progenics’ planning to establish its commercial organization. Commencing on the Effective Date, Progenics shall have the right to have a representative of Progenics participate as a regular, full-time member of the Wyeth brand team for the Products at Progenics’ expense. Wyeth shall provide such Progenics representative with a regular office at its Collegeville, PA facility to facilitate his or her participation on the brand team, but such representative shall at all times remain a Progenics employee.

 

6.  

PAYMENTS BY WYETH TO PROGENICS.

 

6.1.    Reimbursement of Pre-Effective Date Development Costs. Wyeth shall pay Progenics sixty million dollars ($60,000,000) within five (5) business days of the Effective Date as partial reimbursement of research and development costs incurred by Progenics to Develop the Compound prior to the Effective Date. This payment is nonrefundable and noncreditable.

 

6.2.    Post-Effective Date Development Costs.   

 

6.2.1.    Assumption of Progenics Development Costs. Beginning on January 1, 2006, Wyeth shall reimburse to Progenics 100% of the Progenics Development Costs in addition to paying 100% of Wyeth’s own Development costs and expenses, subject to the terms and conditions of this Section 6.2.

 

6.2.2.    Payment of Expenses; Development Accounts; Reimbursement. Progenics shall be responsible and pay for all Progenics Development Costs, subject to

 

 

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reimbursement by Wyeth as provided in this Section 6.2 (Post-Effective Date Development Expenses). Subject to the limitations set forth in Section 6.2.3 (Expense Limitations), Progenics shall charge all Progenics Development Costs incurred by it or its Affiliates to a separate account created by Progenics on its books and records solely for the purpose of tracking Progenics Development Costs (the “ Development Account ”). Before the start of each Calendar Quarter, Progenics shall submit to Wyeth, based on the most recent Progenics Development Cost Budget approved by the JSC or agreed by the Parties, a written good faith estimate of expenses that will be charged to its Development Account during such Calendar Quarter. Wyeth shall pay to Progenics the amount of that estimate (the “ Estimated Quarterly Development Costs ”) within thirty (30) days of start of the Calendar Quarter. Within fifteen (15) days after the end of each Calendar Quarter, Progenics shall submit to the Wyeth a written summary of all expenses actually charged to its Development Account during such Calendar Quarter together with reasonable supporting documentation for such expenses (the summary and documentation, collectively, the “ Development Cost Summary ”). If the estimated payment for that Calendar Quarter was less than the amount of Progenics Development Costs actually incurred by Progenics in that Calendar Quarter, Wyeth shall make a reconciling payment to Progenics at the same time as Wyeth pays Progenics Estimated Quarterly Development Costs for the following Calendar Quarter. If the estimated payment for that Calendar Quarter was more than the amount of Progenics Development Costs actually incurred by Progenics in that Calendar Quarter, Wyeth shall offset the amount of such excess against the payment of the Estimated Quarterly Development Costs for the following Calendar Quarter. If Progenics fails to submit the Development Cost Summary for a Calendar Quarter within fifteen (15) days of the end of such Calendar Quarter as required by this Section 6.2.2, then Wyeth may delay payment of the Estimated Progenics Development Costs for the following Calendar Quarter by the number of days that such Development Cost Summary is late.

 

6.2.3.    Expense Limitations and Progenics Development Cost Budget. Wyeth shall not be required to reimburse Progenics for any Progenics Development Costs to the extent that they exceed the amount budgeted for that Calendar Year in the most recent Progenics Development Cost Budget approved by the JSC or agreed by the Parties, unless the JDC approves such excess Progenics Development Costs. The efforts of the employees of Progenics or its Affiliates in performing activities under this Agreement shall be charged to Progenics’ Development Account at the FTE Rate. Only those efforts that are contemplated by the applicable Development Plan shall be chargeable by Progenics to its Development Account. All payments made by Progenics to a Third Party in connection with the performance of its activities under a Development Plan shall be charged to Progenics’ Development Account at Progenics’ actual out-of-pocket cost. At the time of the annual update of the Development Plan for the Products, the Progenics Development Cost Budget shall also be approved, as determined by the JSC. If the JSC is unable to agree on any changes to the Progenics Development Cost Budget, then Progenics shall be entitled to continue its spending for activities budgeted in the most recent Progenics Development Cost Budget approved by the JSC or agreed by the Parties for which Wyeth shall reimburse Progenics in

 

 

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accordance with Section 6.2.2 (Payment of Expenses; Development Accounts; Reimbursement).

 

6.2.4.    Payments Under Third Party Agreements. Progenics shall be solely responsible for all obligations under the Progenics Third Party Agreements (including, without limitation, any such obligations that relate to the Progenics Technology). Wyeth shall be solely responsible for any obligations under agreements with Third Parties entered into by Wyeth or its Affiliates or its Sublicensees after the Effective Date related to the Development or Commercialization of the Products. As to the [*], Progenics shall be responsible for [*] under the [*] if no Product is developed that would require the payment of a royalty under the [*]. In the event that the JSC determines to Develop a Product that [*], Wyeth shall [*].

 

6.2.5.    Records and Audits. Progenics shall keep and maintain accurate and complete records showing the expenses incurred by it in performing its activities under the Development Plan during the three (3) preceding Calendar Years, which books and records shall be in sufficient detail such that Development Expenses can accurately be determined. Upon fifteen (15) days prior written notice from Wyeth, Progenics shall permit an independent certified public accounting firm of nationally recognized standing, selected by Wyeth and reasonably acceptable to Progenics, to examine, at Wyeth’s sole expense,


 
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