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Execution Version Exhibit 10.29
LICENSE AGREEMENT
by and among
ONO PHARMACEUTICAL CO., LTD.
and
PROGENICS PHARMACEUTICALS, INC.
Dated as of October 16, 2008
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TABLE OF CONTENTS Page
1. DEFINITIONS. 1
2. LICENSE GRANTS AND RELATED MATTERS. 13
3. GOVERNANCE OF COLLABORATION 17
4. DEVELOPMENT 21
5. COMMERCIALIZATION 22
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6. PAYMENTS BY ONO TO PROGENICS. 25
7. INTELLECTUAL PROPERTY. 29
8. CONFIDENTIALITY. 38
9. REPRESENTATIONS AND WARRANTIES. 40
10. TERM AND TERMINATION. 43
11. INDEMNIFICATION AND INSURANCE. 50
12. REGULATORY MATTERS, PRODUCT SAFETY ISSUES, PRODUCT RECALLS. 51
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13. MISCELLANEOUS. 53
SCHEDULES
Schedule I Chemical Drawing of Compound Schedule 9.2 Progenics Disclosure Schedule Schedule 9.2(A) Owned Progenics Patent Rights Schedule 9.2(B) Licensed Progenics Patent Rights Schedule 9.2(C) Progenics Third Party Agreements Schedule 9.2(D) Exceptions
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This LICENSE AGREEMENT (the “Agreement”) is made and entered into as of October 16, 2008 (the “ Effective Date ”), by and between Ono Pharmaceutical Co., Ltd., a corporation existing under the laws of Japan and having a place of business at 8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka 541-8564, Japan (“ Ono ”) 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 ”). Ono and Progenics may each be referred to herein individually as a “ Party ” and, collectively, as the “ Parties .”
BACKGROUND
A. Ono is in the business of discovering, developing, manufacturing and marketing human pharmaceutical products for the Japanese market.
B. Progenics is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products. Progenics has developed [*] (“[*]”) for the treatment of opioid-induced constipation associated with advanced illness.
C. Progenics owns or has rights under certain patents, patent applications, other valuable technology and know-how relating to [*].
D. Ono and Progenics wish to collaborate regarding the development of the subcutaneous formulation of [*] for the Japanese market, and Progenics wishes to grant to Ono, and Ono wishes to receive from Progenics a license to Develop and Commercialize the subcutaneous formulation of [*] in Japan.
E. Progenics wishes to grant to Ono an option to Develop and Commercialize Additional Formulations in Japan.
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:
Capitalized terms not otherwise defined herein shall have the following meanings:
Additional Formulations. “Additional Formulations” means the oral formulation of the Compound, the intravenous formulation of the Compound and each other formulation of the Compound which may be developed by Progenics or Wyeth, as to which Progenics Controls the Development and Commercialization rights for the Territory, but excludes the Initial Formulation.
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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 fifty percent (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.
API. “API” means active pharmaceutical ingredient.
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.
Calendar Year. “Calendar Year” means any calendar year.
Claim. “Claim”, when used other than in connection with the contents of a patent, 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.
Collaboration. “Collaboration” means the Development and Commercialization activities of Ono in the Territory, and the supporting activities of Progenics to be agreed upon by the Parties, or as expressly set forth herein, for such Development and Commercialization under this Agreement.
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 one or more other compounds or biologic products as an active ingredient (either as a single fixed dose or as separate doses).
Commercialization. “Commercialization” means all activities related to the commercial exploitation of any Product, including the manufacture, supply, use, importation, exportation, marketing, promotion, distribution, pre-launch, launch, sale and offering for sale of the Product. When used as a verb, “Commercialize” or “Commercializing” means to engage in Commercialization.
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, (i) taking into account issues of: [*].
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Committee. “Committee” means the JSC, JDC, and/or JCC as the context requires.
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 I .
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, or is controlled by, such Party or its Affiliates and information otherwise designated by such Party as Confidential Information of such Party hereunder.
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.
Controlling Affiliate. “Controlling Affiliate” means an Affiliate that controls (as such term is used in the definition of Affiliate) Progenics.
Development. “Development” means all activities related to the development of any Product and obtaining Regulatory Approval for a Product, including all activities related to research, development, preclinical testing, stability testing, toxicology, formulation, product line-extensions, clinical trials, regulatory affairs, statistical analysis, report writing, manufacturing process and scale up, qualification and validation activities, product life-cycle management, quality assurance/quality control development and regulatory filing creation and submission related to obtaining Regulatory Approval for the Product. When used as a verb, “Develop” or “Developing” means to engage in Development.
Drug Price Approval. “Drug Price Approval” means National Health Institute (NHI) price approval, or any comparable price approval by the Japanese national government or the government of any prefecture in the Territory.
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[*].
FDA. “FDA” means the United States Food and Drug Administration or any successor agency thereto.
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Field. With respect to any Product, “Field” means all prophylactic or therapeutic pharmaceutical uses of such Product for the diagnosis, treatment or prevention of disease in humans.
First Commercial Sale. “First Commercial Sale” means, with respect to any Product and with respect to the Territory, the first sale of such Product to a Third Party in the Territory after such Product has been granted Regulatory Marketing Approval by a Regulatory Authority in the Territory.
[*]
FTE Rate. “FTE Rate” means the hourly rate of [*] per hour for certain activities that Ono requests Progenics to perform under the Collaboration. This hourly rate shall apply to Progenics activities during Calendar Year 2008, and will be adjusted at the beginning of each subsequent Calendar Year from the prior year amount by the change in the United States Department of Labor Bureau of Labor Statistics Consumer Price Index- All Urban Consumers during the prior year.
GAAP. “GAAP” means Japanese Accounting Standards as defined from time-to-time by the Accounting Standards Board of Japan, Financial Accounting Standards Foundation and generally accepted accounting principles consistently applied in Japan.
Generic Product. “Generic Product” means any Product sold by a Third Party in the Territory:
(i) for which Regulatory Marketing Approval and Drug Price Approval have been obtained in the Territory by a Third Party;
(ii) which is authorized to be sold for an indication for which Ono or its Affiliates (or a permitted sublicensee hereunder) has obtained Regulatory Marketing Approval and Drug Price Approval in the Territory; and
(iii) which is sold after the end of the [*] Royalty Period.
Generic Product Market Share. “Generic Product Market Share” means, for any Calendar Quarter, with respect to any Product, [*], where:
[*]. Generic Product sales shall be determined using independent market data published by IMS or its successor (provided such data is generally comparable to that provided by IMS with respect to the Territory as of the Effective Date) or another mutually agreed provider of independent market data.
GMP. “GMP” means the laws and regulations of the Territory where the Compound and/or any Product is manufactured and which relate to the manufacture of the Compound and/or any Product, including but not limited to the current Good Manufacturing Practices as specified in any applicable laws, rules, regulations and guidelines in the Territory and/or any other relevant jurisdiction.
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Initial Formulation. “Initial Formulation” means the subcutaneous formulation of the Compound.
[*] Royalty Period. “[*] Royalty Period” means with respect to a Product, the period of time beginning [*] and extending until the later of (i) [*], or (ii) [*].
IND. “IND” means an investigational new drug application, clinical study application, clinical trial exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformity with the requirements of such Regulatory Authority.
Japanese Regulatory Authority. “Japanese Regulatory Authority” means the Regulatory Authority authorized to grant Regulatory Marketing Approval in the Territory.
JCC. “JCC” means the Joint Commercialization Committee established in accordance with Section 3.4 (Joint Commercialization Committee (JCC)).
JDC. “JDC” means the Joint Development Committee established in accordance with Section 3.3 (Joint Development Committee (JDC)).
Joint Know-How. “Joint Know-How” means any Know-How 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 Ono or any of its Affiliates.
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 Ono or any of its Affiliates, as determined in accordance with Section 7.1.1 (Inventorship).
Joint Technology. “Joint Technology” means the Joint Know-How and the Joint Patent Rights.
JSC. “JSC” means the Joint Steering Committee established in accordance with Section 3.2 (Joint Steering Committee (JSC)).
Know-How. “Know-How” means any confidential unpatented or unpatentable invention, development, discovery, technology, cell line, biological material, compound, probe, sequence, technical information, method, biological material, or other confidential information or material.
Licensed Activit(y/ies). “Licensed Activit(y/ies)” means, collectively, the Development and Commercialization of any Product in the Territory, the practice of any Progenics Technology or Joint Technology or the exercise of any other right granted by Progenics to Ono under this Agreement, in each case to the extent permitted under this Agreement.
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NDA. “NDA” means a New Drug Application that is filed with the FDA to formally propose that the FDA approve a new drug for sale and marketing in the United States, or an equivalent application or submission.
Net Sales. “Net Sales” means the gross amounts invoiced (“ Gross Sales ”) for sales of all Products by Ono and its Affiliates and its permitted sublicensees (each, a “ Selling Person ”) to Third Parties, less the following deductions, in each case to the extent specifically related to a 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 for the Product [*];
(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, rebates and returns 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;
(vi) [*]; and
(vii) documented customs duties actually paid by the Selling Person.
A quantity of Product not in excess of the industry standard provided by Ono or its Affiliates, 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 Ono and its Affiliates 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 Ono in accordance with GAAP and if any accrual is reversed by Ono a corresponding credit will be made to Net Sales in the period in which the reversal is made.
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Bundling
Any bundling of the Product is subject to prior JSC review and written approval. Where a Product is “bundled” for sale together with one or more other products 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 Ono or its Affiliates (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 the Territory 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) [*].
The foregoing adjustments shall, in the event there is more than one active ingredient in addition to the Compound, in addition to a Product, included in a Combination Product, apply mutatis mutandis .
Ono Collaboration Know-How. “Ono Collaboration Know-How” means any Know-How relating to the Collaboration or the Compound or any Product, Controlled as of the Effective Date or at any time during the Term by Ono or its Affiliates, that is made or created in the course of the Collaboration solely by employees or agents of Ono or any of its Affiliates.
Ono Collaboration Patent Rights. “Ono Collaboration Patent Rights” means any Patent Right Controlled by Ono or its Affiliates that claims inventions invented solely by employees or agents of Ono or any of its Affiliates (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.
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Ono Collaboration Technology. “Ono Collaboration Technology” means Ono Collaboration Know-How and Ono Collaboration Patent Rights.
Ono Fiscal Year. “Ono Fiscal Year” shall mean each successive period of twelve (12) months commencing on April 1 of a Calendar Year and ending on March 31 of a Calendar Year.
Ono Independent Patent Rights. “Ono Independent Patent Rights” means any Patent Right Controlled by Ono 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 the Progenics Patent Rights, the Joint Patent Rights, the Wyeth Collaboration Patent Rights, the Wyeth Collaboration Joint Patent Rights and the Ono Collaboration Patent Rights.
Outside Contractor. “Outside Contractor” means any Person contracted by Ono to provide products or services relating to the Collaboration, including 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 Ono could include or might reasonably be expected to include in any document or report, including, a Registrational Filing, submitted to a Regulatory Authority or subject to review by a Regulatory Authority.
Partial Termination Agreement. “Partial Termination Agreement” means that certain Partial Termination Agreement of even date herewith by and among the parties to the Wyeth Agreement providing for the partial termination of the Wyeth Agreement with respect to the Territory.
Patent Rights. “Patent Rights” means any and all (i) United States or non-United States patents, (ii) United States or non-United States patent applications, including, without limitation, all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon, (iii) United States or non-United States patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates or the equivalent thereof, and (iv) other forms of government-issued rights substantially similar to any of the foregoing.
Patent Term Extension. “Patent Term Extension” shall mean any extension of Patent Rights that may be granted by any patent office or regulatory office, including supplemental protection certificates (“ SPCs ”).
Person. “Person” means any individual or legal entity.
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Phase 3 Clinical Trial. “Phase 3 Clinical Trial” means a human clinical study in Phase III as specified in the ICH E8 Guidelines.
[*] Royalty Period. “[*] Royalty Period” means the period of time following the expiration of the [*] Royalty Period and extending until [*].
Product. “Product” means a pharmaceutical product containing the Initial Formulation, including a Combination Product.
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 Initial Formulation or a Product or to the use of the Initial Formulation or a Product. For the purposes hereof, “Progenics Know-How” does not include Wyeth Collaboration Know-How, Wyeth Collaboration Joint Know-How, or Know-How Controlled by a Third Party which 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 (a " Controlling Third Party ") to the extent such Controlling Third Party's Know-How was Controlled by such Controlling Third Party (and not by Progenics) prior to the completion of such transaction or series of related transactions.
Progenics Patent Rights. “Progenics Patent Rights” means any Patent Right in the Territory 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 Initial Formulation or any Product. For the purposes hereof, “Progenics Patent Rights” does not include Wyeth Collaboration Patent Rights, Wyeth Collaboration Joint Patent Rights or Patent Rights Controlled by a Controlling Third Party to the extent such Controlling Third Party's Patent Rights were Controlled by such Controlling Third Party (and not by Progenics) prior to the completion of such transaction or series of related transactions. Progenics Patent Rights in the Territory as of the Effective Date are identified on Schedule 9.2(A) and (B) .
Progenics Technology. “Progenics Technology” means the Progenics Know-How and the Progenics Patent Rights.
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 Initial Formulation or any Product in the Territory, including the agreements listed in Schedule 9.2(C) under the heading “Progenics Third Party Agreements.”
ProNev . “ProNev” means 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, USA and a direct, wholly-owned subsidiary of Progenics.
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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.
Registrational Filing. “Registrational Filing” means an application submitted to the Regulatory Authority in the Territory seeking a Regulatory Marketing Approval.
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 drug product in a regulatory jurisdiction, including INDs, Registrational Filings, supplements and amendments, pre- and post- approvals, Drug Price Approval, labeling approvals, and drug master files.
Regulatory Authority. “Regulatory Authority” means any national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity involved in the granting of a Regulatory Approval, including the Japanese Regulatory Authority.
Regulatory Marketing Approval. “Regulatory Marketing Approval” means a Regulatory Approval authorizing the marketing of a Product in the Territory for any indication. For the sake of clarity, Regulatory Marketing Approval shall be deemed to have occurred when the Regulatory Authority sends a notification of such Regulatory Marketing Approval to the applicant seeking Regulatory Marketing Approval.
Sublicense. “Sublicense” means, directly or indirectly, to sublicense, grant any other right with respect to, or agree not to assert, any right licensed to Ono under this Agreement. When used as a noun, “Sublicense” means any agreement to Sublicense.
Territory. “Territory” means the country of Japan (Nihon/Nippon Koku).
Third Party. “Third Party” means any Person other than Ono, Progenics or their respective Affiliates or permitted sublicensees.
Title 11. “Title 11” shall have the meaning set forth in Section 10.5.2 (Effect on Licenses).
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.
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Wyeth. “Wyeth” means Wyeth, a Delaware corporation.
Wyeth Agreement. “Wyeth Agreement” means the License and Co-Development Agreement by and among Wyeth, Wyeth Whitehall Pharmaceuticals, Inc., Wyeth Ayerst Lederle, Inc., Progenics and ProNev, dated as of December 23, 2005, providing for a collaboration of the parties thereto (the “ Wyeth Collaboration ”).
Wyeth Collaboration Know-How. “Wyeth Collaboration Know-How” means the “Wyeth Collaboration Know-How” as such term is defined in the Wyeth Agreement, as and to the extent such rights subsist in the Territory and as and to the extent Controlled by Progenics or its Affiliates as of the Effective Date or at any time during the Term, which relates to the Initial Formulation or a Product or to the use of the Initial Formulation or a Product.
Wyeth Collaboration Patent Rights. “Wyeth Collaboration Patent Rights” means the “Wyeth Collaboration Patent Rights” as such term is defined in the Wyeth Agreement, as and to the extent such rights subsist in the Territory and as and to the extent Controlled by Progenics or its Affiliates as of the Effective Date or at any time during the Term, which relates to the Initial Formulation or a Product or to the use of the Initial Formulation or a Product.
Wyeth Collaboration Joint Know-How. “Wyeth Collaboration Joint Know-How” means the “Joint Know-How” as such term is defined in the Wyeth Agreement, as and to the extent such rights subsist in the Territory and as and to the extent Controlled by Progenics or its Affiliates as of the Effective Date or at any time during the Term, which relates to the Initial Formulation or a Product or to the use of the Initial Formulation or a Product.
Wyeth Collaboration Joint Patent Rights. “Wyeth Collaboration Joint Patent Rights” means the “Joint Patent Rights” as such term is defined in the Wyeth Agreement, as and to the extent such rights subsist in the Territory and as and to the extent Controlled by Progenics or its Affiliates as of the Effective Date or at any time during the Term, which relates to the Initial Formulation or a Product or to the use of the Initial Formulation or a Product.
Additional Definitions. Definitions for each of the following defined terms are set forth in the section of this Agreement indicated below:
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2.1. License from Progenics to Ono. Subject to the terms and conditions of this Agreement, Progenics hereby grants to Ono in the Field (i) an exclusive license, even as to Progenics, under the Progenics Technology and Progenics’ interest in the Joint Technology and the Wyeth Collaboration Joint Patent Rights and Wyeth Collaboration Joint Know-How, and (ii) a nonexclusive license under the Wyeth Collaboration Patent Rights, Wyeth Collaboration Know-How and Wyeth’s interest in the Wyeth Collaboration Joint Patent Rights and Wyeth Collaboration Joint Know-How, in each case with the right to Sublicense the foregoing rights solely as set forth in Section 2.2 (Sublicenses), to make, have made, use, Develop, sell, offer to sell, have sold, import, and otherwise exploit and Commercialize Products in the Territory, provided that the foregoing grant shall consist solely of Know-How and Patent Rights subsisting in the Territory. Ono shall also have the right, subject to the written approval of Progenics on a country-by-country, manufacturer-by-manufacturer basis, which approval shall not be unreasonably withheld, to have the API or finished goods for any Product made for Ono by one or more Third Party manufacturers outside the Territory, solely for the purpose of selling Products in the Territory. Ono acknowledges that with respect to those Progenics Patent Rights that are Controlled by Progenics pursuant to Progenics Third Party Agreements, the license granted in this Section is subject to the rights of the Progenics Third Party licensors under such Progenics Third Party Agreements. Ono will not sell the Compound or any Product (a) outside of the Territory; or (b) to any Third Party that Ono knows or should know, with the exercise of reasonable diligence and prudence, intends to sell the Compound or any Product outside of the Territory.
2.2. Sublicenses. Ono shall have the right to grant Sublicenses of any and all rights granted to Ono under this Agreement to its Affiliates in the Territory, with the prior approval by Progenics, which shall not be unreasonably withheld or delayed, subject to the execution and delivery of any such Affiliate of a Sublicense agreement consistent with the terms and conditions of this Agreement and reasonably satisfactory to Progenics. Except as otherwise set forth in this Section 2.2 (Sublicenses), Ono shall not have the right to grant Sublicenses of any rights granted to Ono to any Third Parties without the prior written approval of Progenics, which approval may be withheld for any reason or no reason.
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2.3. Sen-yo Jisshiken Tohroku/Tsujyo Jisshiken Tohroku. Upon Ono’s request, Progenics shall make Commercially Reasonable Efforts to cause Wyeth and/or Progenics Third Party licensors of Progenics Third Party Agreements including the University of Chicago and/or Wyeth to register “Sen-yo Jisshiken Tohroku” for Progenics to the extent Progenics is granting exclusive rights to Ono hereunder and/or “Tsujyo Jisshiken Tohroku” for Progenics to the extent Progenics is granting a non-exclusive rights to Ono hereunder. In the event such Sen-yo Jisshiken Tohroku and/or Tsujyo Jisshiken Tohroku for Progenics is registered by Wyeth and/or Progenics Third Party licensors, then Progenics shall transfer or assign such registration to Ono, in order to make Ono enjoy a position of an exclusive licensee, to the extent Progenics is granting exclusive rights to Ono hereunder, and/or a non-exclusive licensee, to the extent Progenics is granting non-exclusive rights to Ono hereunder, subject to this Agreement, with respect to Wyeth Collaboration Patent Rights and Wyeth Collaboration Joint Patent Rights and/or such Progenics Third Party licensor’s patents and patent applications which are represented as Progenics Patent Rights in accordance with the patent law of Japan; provided, however , that Ono shall promptly ask Wyeth and/or Progenics Third Party licensors, through Progenics, to cancel such registration of Sen-yo Jisshiken Tohroku and/or Tsujyo Jisshiken Tohroku in cooperation with Ono in the event of early termination for any reason pursuant to Section 10 of this Agreement (except to the extent that Ono continues to have the license granted by Progenics in spite of the early termination or in accordance with the provision of Section 2.7 (Fully Paid-Up, Royalty Free License)) or in the event that Ono ceases to sell Product during the Term for any reason. In the event that Wyeth and/or a Progenics Third Party licensor decides to register Sen-yo Jisshiken Tohroku and/or Tsujyo Jisshiken for Progenics, Ono shall, subject to this Agreement, carry out, at Ono’s sole expense and in cooperation with Progenics and Wyeth and/or Progenics Third Party licensor, actual proceedings with regard to such registration and transfer of Sen-yo Jisshiken Tohroku and/or Tsujyo Jisshiken for Progenics. Any representative, confirmatory or redacted agreement, executed for the administrative purpose of registering Ono's license rights hereunder, shall not be construed to have been executed for any purpose other than to effect registration, and shall not in any way affect the Parties’ respective rights and obligations under this Agreement.
2.4. Participation in Progenics’ Right of First Refusal. The Parties hereby acknowledge that Progenics has been granted, pursuant to that certain letter agreement (the “ 2001 Agreement ”) dated as of September 20, 2001 by and among the University of Chicago, on behalf of itself and its affiliate ARCH Development Corporation (the “ University ”), and Progenics, a right of first refusal to negotiate a license with respect to certain inventions Controlled by the University (collectively, “ Inventions ”). Progenics shall (i) promptly give Ono written notice of any Inventions that are subject to Progenics’ right of first refusal under the 2001 Agreement of which Progenics becomes aware and (ii) if Progenics determines to enter into a license with the University to license any such Inventions, offer Ono an opportunity to participate, on terms reasonably satisfactory to Progenics and Ono, in such license.
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2.5. License from Ono to Progenics. Ono hereby grants to Progenics a non-exclusive license under the Ono Collaboration Patent Rights and the Ono Collaboration Know-How, and a non-exclusive license under Ono’s interest in the Joint Patent Rights and Ono’s interest in the Joint Know-How, in each case with a right to sublicense, to research, make, have made, manufacture, have manufactured, use, develop, sell, offer to sell or use, have sold, market, promote, import, export, and otherwise exploit and commercialize the Compound and/or any products containing the Compound outside the Territory, without any compensation or royalty relating thereto during the Term. Progenics shall timely notify Ono of any sublicenses. An agreement with any sublicensee shall provide that such sublicense is consistent with and subject to the material terms and conditions of this Agreement, including without limitation the material obligations of Progenics hereunder.
2.6. Non-Exclusive License Grant.
2.6.1. Non-Exclusive License from Progenics to Ono. In the event that the exercise by Ono or its Affiliates of the rights granted by Progenics in Section 2.1 (License from Progenics to Ono) above would infringe any Patent Rights Controlled by Progenics or its Affiliates, and which Patent Rights are not covered by the grants in Section 2.1 (License from Progenics to Ono), Progenics hereby grants to Ono and its Affiliates during the Term, to the extent Progenics is legally able to do so, a non-exclusive, royalty-free license in the Territory under such Patent Rights solely to the extent necessary for Ono and its Affiliates to exploit the rights granted to Ono and its Affiliates under Section 2.1 (License from Progenics to Ono) of this Agreement, and subject to the same reservations of rights of Progenics.
2.6.2. Non-Exclusive License from Ono to Progenics. In the event that the exercise by Progenics, its Affiliates, licensees, including Wyeth, or sublicensees of the rights granted by Ono in Section 2.5 (License from Ono to Progenics) would infringe any Patent Rights Controlled by Ono or its Affiliates, and which Patent Rights are not covered by the grant in Section 2.5 (License from Ono to Progenics), Ono hereby grants to Progenics, its Affiliates, licensees and sublicensees to the extent Ono is legally able to do so, a non-exclusive, sublicensable, royalty-free license outside the Territory under such Patent Rights solely to the extent necessary for Progenics, its Affiliates, licensee and sublicensees to exploit the rights granted to Progenics and its Affiliates under Section 2.5 (License from Ono to Progenics) of this Agreement and subject to the same reservations of rights of Ono.
2.6.3. Non-Assertion by Ono . Ono shall not assert any Ono Independent Patent Rights against Progenics, its Affiliates or its licensees or sublicensees relating to the Development, Commercialization or other exploitation of the Compound or any product containing the Compound outside the Territory.
2.7. Fully Paid-Up, Royalty Free License. After expiration of the Term for any Product the license granted to Ono under Section 2.1 (License from Progenics to Ono) and Section 2.6.1 (Non-Exclusive License from Progenics to Ono) with respect to such Product shall be a fully paid-up, perpetual, non-exclusive, irrevocable, royalty-free license. After expiration of the Term for any Product the license granted to Progenics under Section 2.5 (License from Ono to Progenics) shall become a fully paid-up, perpetual, non-exclusive, irrevocable, sublicenseable, royalty-free license; provided, however , in the event Progenics desires to obtain an exclusive license under Ono Collaboration Patent Rights and/or Joint Patent Rights, the Parties shall negotiate in good faith the terms and conditions of such licenses.
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2.8. 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 Ono.
2.9. Know-How Disclosure and Transfer. Commencing promptly after the Effective Date, Progenics shall disclose the then existing Progenics Know-How and then existing Know-How included in the Wyeth Collaboration Know-How and the Wyeth Collaboration Joint Know-How to Ono necessary for the Collaboration. During the Term, Progenics shall promptly disclose to Ono all Progenics Know-How, Know-How included in the Wyeth Collaboration Know-How and Wyeth Collaboration Joint Know-How and Joint Know-How that is developed by Progenics or otherwise comes into Progenics’ Control necessary for the Collaboration, except for Know-How related exclusively to the Excluded Molecules. Furthermore, during the Term, Ono shall promptly disclose to Progenics any Joint Know-How and Ono Collaboration Know-How. Disclosure of Know-How by Progenics as provided in this Section 2.9 (Know-How Disclosure and Transfer) shall be accomplished through: (i) [*]; and (ii) [*]. [*].
2.10. Costs of Assistance. Progenics shall perform the activities it is required to perform under Section 2.9 (Know-How Disclosure and Transfer), Article 3 (Governance of Collaboration), Section 5.2.2 (Transfer of Manufacturing Know-How) and Article 7 (Intellectual Property), except as otherwise specifically provided therein, at no charge to Ono. If Ono shall request that Progenics perform any other activities in connection with the Collaboration or the Commercialization and Development of the Initial Formulation or any Product, then Ono shall reimburse Progenics for any and all costs Progenics incurs, including out-of-pocket costs (including travel) and personnel costs at the FTE Rate. Ono shall reimburse Progenics for such costs within thirty (30) days of Ono’s receipt of an invoice therefor accompanied by reasonable documentation. Without limiting the generality of the foregoing, Progenics, upon Ono's request, shall use Commercially Reasonable Efforts to prepare reports, analyze data, produce materials not covered by Section 2.9 (Know-How Disclosure and Transfer) and review Ono documents only in case such review is specifically requested by Ono, subject to payment of costs as provided in this Section 2.10 (Cost of Assistance).
2.11. 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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3.1. 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 no less than twice per year until Japanese Regulatory Marketing Approval, and once per year thereafter, with additional meetings to be called by either co-chairperson of the JSC on an ad-hoc basis and held face-to-face, by telephone, by video or Webex, as they reasonably agree. At least one meeting of the JSC each year shall be held face-to-face. The JDC shall meet no less than twice annually, face-to-face, by telephone, by video or Webex, with additional meetings to be called by either co-chairperson of the JDC on an ad-hoc basis. The JCC shall meet, commencing upon formation under Section 3.4.1 (Formation of JCC), no less than twice annually, with additional meetings to be called by either co-chairperson of the JCC or, as necessary, Progenics on an ad hoc basis. JCC meetings may be held face-to-face, by teleconference, video or Webex, as determined by the Committee chairpersons. Venue of the meetings of each Committee shall alternate between the premises of the Parties, if not held by telephone, video or Webex, unless the Parties agree otherwise. Other employees of each Party involved in the Development, Commercialization or intellectual property protection of the Product may attend meetings of such Committee as non-voting participants with the permission of the co-chairpersons. [*]
3.1.3. Decision Making. Each Party’s designees on the JSC, JDC and JCC 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 (Decision Making), each of the JSC, JDC and JCC shall decide as to all matters within its jurisdiction by unanimous Party Vote; provided, however, that no such Committees shall have the authority to amend or modify, or waive compliance with, this Agreement, and, provided further , that the Party Vote of each Party shall be subject to the approval of such Party’s management. In the event that a Party’s management does not concur with the Party Vote of such Party, such Party shall notify the other Party in writing (which may be by email) of such disapproval within [*] days after the Party Vote, but as promptly as possible. In the event that a Party does not give notice of its disapproval of any Committee decision as provided for herein, such Party shall be deemed to have ratified any such Committee decision. In the event of a tie Party Vote of the designees of Ono and Progenics on the JDC or JCC as to matters within the jurisdiction of such Committees, or in the event a Party’s management does not approve of the vote cast, the co-chairpersons of the JDC or JCC shall refer the matter to the JSC for resolution. In the event that such a matter cannot be resolved by the JSC within [*] days of it being referred to the JSC, or in the event of a tie Party Vote of the designees of Ono 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 after good faith negotiations within [*] days, then the matter shall be referred to the [*]. If after good faith discussions by [*], agreement cannot be reached within [*] days, then [*] shall decide upon a mechanism to resolve the matter.
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3.1.4. Meeting Agendas. Each Party will have an equal right to place items on the JSC, JDC and JCC agendas through the co-chairperson of the JSC, JDC or JCC designated by such Party. Each Party will disclose to the other Party its proposed agenda items along with appropriate information at least [*] days in advance of each Committee meeting; provided, however, that under exigent circumstances requiring JSC, JDC or JCC input, a Party may provide its agenda items for a JSC, JDC or JCC 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, JDC or JCC 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, JDC or JCC meeting.
3.2. Joint Steering Committee (JSC).
3.2.1. Formation and Purpose. Within fifteen (15) days after the Effective Date, Ono and Progenics shall nominate the members of the JSC, which shall coordinate the Parties’ key activities under this Agreement and have the additional responsibilities provided for in this Agreement. The first JSC meeting will be held at Ono’s facilities on a mutually agreeable date within [*] days after the Effective Date. The JSC will dissolve upon the expiration of the Term.
3.2.2. Membership and Chairpersons. Each Party shall designate [*] 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 Ono 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 [*] 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:
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(a) [*];
(b) [*];
(c) [*];
(d) [*];
(e) [*];
(f) [*];
(g) [*];
(h) [*];
(i) [*]; and
(j) [*].
3.3. Joint Development Committee (JDC).
3.3.1. Formation and Purpose. Within fifteen (15) days after the Effective Date, the Parties shall nominate the members of the JDC, which shall oversee, coordinate and expedite the Development of, and the making of regulatory submissions for, the Product in order to obtain Regulatory Approvals. The first JDC meeting will be held at Ono’s facilities on a mutually agreeable date within [*] days after the Effective Date following preparation by Ono of the Development Plan for the purpose of review and approval of the Development Plan. At any time that any Product is 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.
3.3.2. Membership and Chairpersons. Each Party shall designate [*] 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 Ono. 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 [*] 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 JDC.
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3.3.3. Specific Responsibilities of the JDC. The JDC shall have responsibility for overseeing, coordinating and expediting the Development of the Initial Formulation and the Product for Commercialization in the Territory, including, without limitation:
(a) [*];
(b) [*];
(c) [*];
(d) [*];
(e) [*];
(f) [*];
(g) [*];
(h) [*];
(i) [*]; and
(j) [*].
3.4. Joint Commercialization Committee (JCC).
3.4.1. Formation of JCC. The Parties shall nominate the members of, and establish, the JCC, which shall facilitate the exchange of information between the Parties regarding the Commercialization of the Product in the Territory, [*].
3.4.2. Membership. The JCC shall be composed of at least [*] representatives designated by each Party in number and function according to the responsibilities of each Party. The JCC shall have two co-chairpersons, one designated by each of Progenics and Ono. The chairpersons shall be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting of the JCC, and preparing and issuing minutes of each meeting within [*] 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.
3.4.3. Responsibilities of the JCC. The JCC shall have responsibility for overseeing, coordinating and expediting the Commercialization of the Product in the Territory, including:
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(a) [*];
(b) [*];
(c) [*];
(d) [*];
(e) [*];
(f) [*]; and
(g) [*].
3.5. Working Groups. From time to time Progenics and Ono may establish and delegate duties to other committees, subcommittees, or directed teams (each, a “ Working Group ”) on an “as needed” basis to oversee particular projects or activities, including intellectual property, manufacturing, CMC, Development and Commercialization, and similar matters. Each such Working Group shall be constituted and shall operate as the applicable Committee delegates its responsibilities. Each Working Group and its activities shall be subject to the oversight, review and approval of, and shall report to, the applicable Committee. In no event shall the authority of any Working Group exceed that specified for the applicable Committee.
4.1. Development Plan. The Development of the Product will be conducted by or on behalf of Ono pursuant to a mutually agreed development plan that will govern all aspects of Development of the Product in the Territory (as such plan is in effect from time to time, the “ Development Plan ”). The initial Development Plan will be prepared by Ono within [*] days of the Effective Date and shall become a part of this Agreement as Appendix I. The JDC shall be responsible for reviewing and endorsing the Development Plan. The Development Plan shall be updated subject to approval by both Parties, on an as-needed basis, but in no event less than once annually.
4.2. Development Responsibilities of Ono. Ono shall pay one hundred percent (100%) of the Development costs to Develop the Products in the Territory; and Ono shall be solely responsible for, and shall use Commercially Reasonable Efforts to:
4.2.1. Develop the Product(s) in the Territory in accordance with the Development Plan, including (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 Product;
4.2.2. perform the work under the Development Plan in accordance with the estimated timelines set forth therein;
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4.2.3. obtain Regulatory Approval from Regulatory Authorities for the Product(s) in the Territory;
4.2.4. make all required correspondence and any official communications (except where Progenics may be required by applicable law or Regulatory Authority to communicate) regarding the Product(s) with Regulatory Authority in the Territory;
4.2.5. perform any other work necessary and appropriate as determined by the JDC;
4.2.6. disclose to Progenics all data, information and other Ono Collaboration Know-How and Joint Know-How; and
4.2.7. if the JSC decides to Develop any Combination Product, Develop such Combination Product in the Territory in accordance with the Development Plan, including, without limitation, (i) preparing and submitting and/or revising and amending Registrational Filings for such Combination Product, (ii) conducting and managing all clinical trials included in the Development Plan for such Combination Product, and (iii) obtaining and maintaining Regulatory Approvals for such Combination Product.
4.3. [*] Development Activities. Ono shall Develop the Product in accordance with the Development Plan, as the Development Plan may be revised with the review and approval of the JDC from time to time. [*].
4.4. Records. Ono 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 Product, as consistent with the responsibilities of Ono under this Agreement, and all results of any trials, studies and other investigations conducted under this Agreement by or on behalf of Ono, and its Affiliates and Outside Contractors, as applicable.
4.5. Reports on Development. For so long as Ono continues to Develop a Product under this Agreement, it shall provide 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 Ono. In addition, through its representatives on the JDC, each Party shall make periodic oral reports to 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. Ono’s Commercialization Responsibilities and Efforts.
5.1.1. Responsibilities. Subject to the supervision of the JSC and the JCC, Ono shall be responsible for the Commercialization of the Product in the Territory and shall pay one hundred percent (100%) of the costs of Commercialization of the Product; and Ono shall be solely responsible for distribution and pricing of the Product and shall book all sales of the Product in the Territory.
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5.1.2. Efforts. Ono shall use Commercially Reasonable Efforts to pre-launch, launch, promote, market, distribute, sell in finished pharmaceutical form, and otherwise Commercialize Products in the Territory. Ono’s Commercially Reasonable Efforts in Commercialization of the Product shall include the following:
(a) [*];
(b) [*]; and
(c) [*].
5.2. Supply.
5.2.1. Supply. Ono shall be solely responsible at its expense for the manufacture, and/or acquisition, and supply of one hundred percent (100%) of the Initial Formulation and finished Product, including packaging and labeling, for Commercialization both as bulk API and as finished and packaged Products, it being understood that all Compound and/or Product supplied by Ono for clinical use shall be manufactured under GMP conditions.
5.2.2. Transfer of Manufacturing Know-How. Progenics will disclose to Ono, Ono’s Affiliates, and/or Ono’s Third Party contract manufacturer all relevant Progenics Know-How and Know-How included in the Wyeth Collaboration Know-How and Wyeth Collaboration Joint Know-How relating to the manufacture of the Initial Formulation and/or Products. Progenics shall use its Commercially Reasonable Efforts to cause Wyeth to provide Ono with that cooperation, inventory, technology, know-how and documentation set forth in Section 10.4.1(d) of the Wyeth Agreement. Such Know-How disclosure shall include the transfer of data and information stored on the computer systems of Progenics for the NDA.
5.3. Marketing Materials and Corporate Branding. Subject to Section 7.3 (Trademarks), Ono shall be solely responsible at its expense for all pre-marketing and marketing efforts and for creating all packaging and promotional materials for the Product. Subject to Progenics’ reasonable approval of the form and presentation thereof, the corporate name and logo of Progenics shall appear on all Product packaging, package inserts and promotional materials in the Territory, subject, in each case, to compliance with applicable law and regulatory requirements.
5.4. Sharing of Information. Without limiting the provisions regarding the JCC under Section 3.4.3 (Responsibilities of the JCC), Ono shall provide the JCC with a copy of Ono’s Commercialization Plan for any Product and any updates thereof, including, without limitation, information regarding strategies for Commercialization and detailing of the Product, market research and strategy, promotional activities, and sales plans and forecasts, and Ono shall report to the JCC on the progress of its implementation of the Commercialization Plan. All such commercial information shall be Ono’s Confidential Information for the purposes of Section 8.1 (Confidentiality).
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5.5. Option to Develop and Commercialize Additional Formulations
5.5.1. Provided Ono is in compliance with all material terms of this Agreement, including performing its obligations under the Development Plan, during the [*] commencing on [*] of a product using an Additional Formulation (the “ Option Period ”), Ono shall, provided that the Additional Formulation does not infringe the Patent Rights of any Third Party in the Territory, have the option to obtain the right to Develop and Commercialize in the Territory the Additional Formulation (the “ Additional Formulation Option ”). Ono shall be entitled to an Additional Formulation Option for each different Additional Formulation, but the Option shall arise only upon [*] for the first product using that Additional Formulation, and no further option shall arise if other products using that Additional Formulation subsequently receive [*].
5.5.2. If Ono exercises the Additional Formulation Option in a timely manner, then Ono and Progenics will promptly enter into good faith negotiations for a period of [*] (the “ Negotiation Period ”) [*], the Parties will enter into an agreement pursuant to which Ono will develop and commercialize the Additional Formulation on terms substantially similar to those contained herein. Notwithstanding the foregoing, and in consideration for [*], Ono shall not be required to pay [*] to Progenics for any Additional Formulation that Ono elects to develop and commercialize in the Territory, but shall pay [*] as shall be commercially reasonable.
5.5.3. If Ono does not timely elect to exercise its Additional Formulation Option hereunder, or if is not entitled to exercise the Additional Formulation Option because it is not in compliance with all material terms of this Agreement as provided in Section 5.5.1, or if Ono and Progenics are unable to reach agreement on [*] during the Negotiation Period, Progenics may, at its discretion, provided it has bargained in good faith, license the development and commercialization of the Additional Formulation to a Third Party, or develop and commercialize the Additional Formulation on its own, in the Territory at any time thereafter, so long as [*] entered into with, if applicable, any Third Party are, on the whole, at least as favorable to Progenics as [*] in the negotiations following the exercise of the Additional Formulations Option (ignoring for the purposes of this comparison the amount [*] fee payable by the Third Party).
5.6. Developmental Research License. At any time during the Term Ono may submit a written request to Progenics requesting the right to engage in research activities in the Territory with respect to any Additional Formulation. Progenics may grant or decline to grant any such request in its sole discretion. Any eventual license pertaining to any such research request shall be on terms mutually agreeable to Progenics and Ono.
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5.7. Non-Competition. Subject to [*], except for the Development and Commercialization of any Product in the Territory, or for other purposes related to this Agreement, Ono shall not, and shall ensure that its Affiliates do not, either alone or in conjunction with a Third Party, directly or indirectly (i) [*], or (ii) [*]. In the event that Ono intends to [*], either alone or with any Third Parties, with respect to [*], Ono shall, prior to [*].
6.1. Upfront License Fee Payment. Ono shall pay to Progenics upon the execution of this Agreement fifteen million United States dollars ($15,000,000) as a one-time nonrefundable and noncreditable license fee in partial consideration for the licenses granted under Section 2 (License Grants and Related Matters) hereof. Such amount shall be paid within twenty (20) business days after receipt by Ono of an invoice from Progenics. If Progenics does not provide to Ono prior to the time that payment is required all necessary Japanese taxation documents, Ono shall nevertheless make the payment required hereunder subject to Section 6.5.3 (Taxes and Withholding).
6.2. Development Milestone Payments. In partial consideration for the licenses granted to Ono under Section 2 (License Grants and Related Matters) hereof, Ono shall pay to Progenics the following one-time, nonrefundable, noncreditable research and development payments (“ Development Milestone Payments ”) in United States dollars within twenty (20) business days of receipt by Ono of an invoice and all taxation documents necessary for the payment of each Development Milestone Payment (each a “ Development Milestone ”), provided that if Progenics does not provide all such taxation documents, Ono shall nevertheless make the payment required hereunder subject to Section 6.5.3 (Taxes and Withholding). [*]
6.3. Commercialization Milestone Payments. In partial consideration for the licenses granted to Ono under Section 2 (License Grants and Related Matters) hereof, Ono shall pay to Progenics the following one-time, nonrefundable, noncreditable Commercialization milestone payments (“ Commercialization Payments ”) in United States dollars within twenty (20) business days of receipt by Ono of an invoice. If Progenics does not provide to Ono prior to the time that payment is required all necessary Japanese taxation documents, Ono shall nevertheless make the payment required hereunder subject to Section 6.5.3 (Taxes and Withholding). [*]
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