Commercial Supply. Each Party shall be responsible for, and have the right to manufacture and supply (itself or through a Third Party contract manufacturer) at its cost, all Program 1 Antibody and Program 1 Product for commercialization purposes in such Party’s territory. If the Parties agreed on a Program 1 Joint Manufacturing Process, Incyte shall lead process development for commercial supply in accordance with Section 6.3(a) and the Parties shall coordinate through the JMC to determine second source and supply continuity matters applicable to each Party’s territory with each Party having the right to determine the supply chain for its respective territory. All costs of either Party for such process development will be treated as Development Costs. The Parties may also mutually agree that one Party shall be responsible for commercial supply of Program 1 Product and Program 1 Antibody worldwide, and in such case the Parties shall cooperate in good faith to agree upon the terms of such supply, which may include either Party or both Parties entering into a commercial supply agreement with a Third Party contract manufacturer for such supply. Whichever Party the Parties determine that will manufacture Program 1 Antibody and Program 1 Product for commercialization, the other Party may request that the manufacturing Party supply such Program 1 Antibody and Program 1 Product to such other Party. Upon such Party’s request for supply of Program 1 Antibody and Program 1 Product, the Parties shall negotiate in good faith a commercial supply agreement that provides for the manufacturing Party to supply such other Party with Program 1 Antibody and Program 1 Product for Commercialization purposes at the [*], as well as other customary terms and provisions. If the Parties agree to contract with a Third Party contract manufacturer for commercial supply of Program 1 Antibody and Program 1 Product, [*] shall lead such negotiations, shall permit [*] to review and comment on any draft supply agreements, and shall consider [*] comments in good faith. [*] may request, and [*] shall consider, at its discretion, that [*] becomes a party to such Third Party supply agreement for the purposes of obtaining its commercial supply of Program 1 Antibody and Program 1 Product.
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Commercial Supply. Each Party shall be responsible for, and have the right to manufacture and supply (itself or through a Third Party contract manufacturer) at its cost, all Program 1 Antibody and Program 1 Product for commercialization purposes in such Party’s territory. If the Parties agreed on a Program 1 Joint Manufacturing Process, Incyte shall lead process development for commercial supply in accordance with Section 6.3(a) and the Parties shall coordinate through the JMC to determine second source and supply continuity matters applicable to each Party’s territory with each Party having the right to determine the supply chain for its respective territory. All costs of either Party for such process development will be treated as Development Costs. The Parties may also mutually agree that one Party shall be responsible for commercial supply of Program 1 Product and Program 1 Antibody worldwide, and in such case the Parties shall cooperate in good faith to agree upon the terms of such supply, which may include either Party or both Parties entering into a commercial supply agreement with a Third Party contract manufacturer for such supply. Whichever Party the Parties determine that will manufacture Program 1 Antibody and Program 1 Product for commercialization, the other Party may request that the manufacturing Party supply such Program 1 Antibody and Program 1 Product to such other Party. Upon such Party’s request for supply of Program 1 Antibody and Program 1 ProductFurthermore, the Parties shall will negotiate in good faith a and mutually agree on one or more commercial supply agreement that provides agreement(s) and quality agreement(s) simultaneously with the negotiation of the Commercialization Terms. The commercial supply agreement(s) shall be in accordance with the following commercial terms:
7.4.2.1 The Manufacturing Party shall be entitled to charge (i) the Transfer Price for each batch of Product delivered in accordance with the relevant commercial supply agreement, or (ii) where intermediates, drug substance or bulk drug product is supplied for Manufacturing the Product, the Manufacturing Costs (as further defined in Section 1.93) for any such intermediates, drug substance or bulk drug product, but in each case of (i) and (ii), all supplies shall be made by the Manufacturing Party on a buy/sell model. Such Transfer Price (or Manufacturing Cost) shall be invoiced by the Manufacturing Party upon delivery of the Products and shall be payable by the other Party within [***] from receipt of such invoice.
7.4.2.2 The Transfer Price (or Manufacturing Cost) shall be adjusted on a yearly basis for all commercial supply agreements in accordance with relevant cost developments.
7.4.2.3 The Parties will work together, subject to and observing applicable Laws, and agree the volumes of Product Materials to be purchased from Third Party suppliers for the manufacturing purposes of this Agreement and to [***] of either Party to supply source the other Party's requirements for such Product Materials for its Manufacturing activities pursuant to this Agreement, which sourced Product Materials shall then be sold, at cost, to that other Party with Program 1 Antibody [***].
7.4.2.4 [***].
7.4.2.5 The Parties will cooperate and Program 1 use Commercially Reasonable Efforts to manufacture or cause to be manufactured and continuously supply the Product for Commercialization purposes at distribution and use in the [*]Field by customers and patients in the Territory. The JCC shall determine, by mutual consent, the allocation of supplies of Product in the Territory on a fair and equitable basis, subject also to any applicable Law, export controls, any government supply obligations, supply obligations included in any Third Party Funder agreements, supply obligations pursuant to advance purchase agreements, including agreements with any Governmental Authority, as well as other customary terms and provisions. If supplies reasonably required by BioNTech for product identical to the Parties agree to contract with a Third Party contract manufacturer for commercial supply of Program 1 Antibody and Program 1 ProductProduct in the Fosun Territory; provided, [*] shall lead such negotiations, shall permit [*] to review and comment on any draft supply agreements, and shall consider [*] comments in good faith. [*] may request, and [*] shall consider, at its discretionhowever, that [*] becomes a party to such Third Party supply agreement the allocation of supplies required for the purposes of obtaining its commercial supply this Agreement shall take precedence over supplies for other uses, which priority shall be the primary consideration for such determination. Notwithstanding the foregoing, neither Party will have liability to the other Party by virtue of Program 1 Antibody and Program 1 Productany shortage or allocation.
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Commercial Supply. Each (a) The Lead Marketing Party shall be responsible for, and have the right is entitled to either engage a Third Party to manufacture and supply Collaboration Product as may be required for Commercialization, or to manufacture and supply itself all or a portion of the Collaboration Product required for Commercialization (itself or through but in any event shall do one of the foregoing so that the Collaboration Product is supplied). If Nuvelo manufactures, the Collaboration Product shall be supplied at [*] of Manufacturing Costs. If a Third Party contract manufacturermanufactures, then the Collaboration Product shall be supplied at [*] of the price charged by the Third Party, and the time spent by Nuvelo FTEs to manage the Third Party supplier shall be excluded from the calculation of Manufacturing Costs, Development Costs and Allowable Commercialization Expenses. Manufacturing Costs for Commercialization (with the [*]) at its costare part of Cost of Goods and thus are an Allowable Commercialization Expense, all Program 1 Antibody and Program 1 in each case to the full extent provided in the Financial Appendix.
(b) At any time after the Effective Date but before the Commencement of the first Phase 3 Trial of a Collaboration Product (or, if earlier, the first pivotal trial of the Collaboration Product), the JSC shall discuss without any decision-making authority or ability to refer to any dispute resolution for commercialization purposes in such Party’s territory. If the Parties agreed on a Program 1 Joint Manufacturing Process, Incyte shall lead process development for commercial supply decision-making in accordance with Section 6.3(a) 2.4 and the Parties Lead [*] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended. Marketing Party shall coordinate through the JMC determine, if, whether and from whom to determine second source and solicit competitive bids for Commercial supply continuity matters applicable to each Party’s territory with each Party having the right to determine the supply chain for its respective territory. All costs of either Party for such process development will be treated as Development CostsCollaboration Product. The Parties may also mutually agree that one Lead Marketing Party shall subsequently determine, which Third Party entity, if any, shall be selected as the commercial manufacturer of the Collaboration Product. The Lead Marketing Party shall be responsible for commercial negotiating a separate supply agreement for Commercial supply with the Third Party manufacturer, if any. Such supply agreement shall in any event: (i) provide for the Non-Lead to receive supply of Program 1 Collaboration Product on the same terms and Program 1 Antibody worldwideconditions as the Lead if and only if the Non-Lead becomes the Lead Marketing Party in a territory or territories in accordance with this Agreement, (ii) provide for the agreement to be assignable to the Non-Lead if there is an opt-out or termination of this Agreement resulting in the Non-Lead becoming the Lead Marketing Party or Non-Removed Party in accordance with this Agreement, and in such case the Parties (iii) be otherwise consistent with this Agreement. The Non-Lead shall cooperate in good faith to agree upon the terms of such supply, which may include either Party or both Parties entering into a commercial supply agreement with a Third Party contract manufacturer for such supply. Whichever Party the Parties determine that will manufacture Program 1 Antibody and Program 1 Product for commercialization, the other Party may request that the manufacturing Party supply such Program 1 Antibody and Program 1 Product to such other Party. Upon such Party’s request for supply of Program 1 Antibody and Program 1 Product, the Parties shall negotiate in good faith a commercial supply agreement that provides for the manufacturing Party to supply such other Party with Program 1 Antibody and Program 1 Product for Commercialization purposes at the [*], as well as other customary terms and provisions. If the Parties agree to contract with a Third Party contract manufacturer for commercial supply of Program 1 Antibody and Program 1 Product, [*] shall lead such negotiations, shall permit [*] be entitled to review and comment on any each draft supply agreementsthat is to be sent to the Third Party in advance, and shall the Lead will reasonably consider [*] comments in good faithprovided by the Non-Lead. [*] The Parties recognize that it may requestbe advantageous to have more than one source for Collaboration Product, and [*] shall consider, at its discretion, that [*] becomes a party to such Third Party the Lead may enter into multiple supply agreement agreements for the purposes of obtaining its commercial supply of Program 1 Antibody and Program 1 ProductCollaboration Products in accordance with this Section 5.2(b).
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Samples: Collaboration Agreement (Nuvelo Inc)
Commercial Supply. Each Party shall be responsible for, and have the right to manufacture and supply (itself or through a Third Party contract manufacturer) at its cost, all Program 1 Antibody and Program 1 Product for commercialization purposes in such Party’s territory. If the Parties agreed on a Program 1 Joint Manufacturing Process, Incyte shall lead process development for commercial supply in accordance with Section 6.3(a) and the Parties shall coordinate through the JMC to determine second source and supply continuity matters applicable to each Party’s territory with each Party having the right to determine the supply chain for its respective territory. All costs of either Party for such process development will be treated as Development Costs. The Parties may also mutually agree that one Party shall be responsible for commercial supply of Program 1 Product and Program 1 Antibody worldwide, and in such case the Parties shall cooperate in good faith to agree upon the terms of such supply, which may include either Party or both Parties entering into a commercial supply agreement with a Third Party contract manufacturer for such supply. Whichever Party the Parties determine that will manufacture Program 1 Antibody and Program 1 Product for commercialization, the other Party may request that the manufacturing Party supply such Program 1 Antibody and Program 1 Product to such other Party. Upon such Party’s request for supply of Program 1 Antibody and Program 1 Product, the Parties shall negotiate in good faith a commercial supply agreement that provides for the manufacturing Party to supply such other Party with Program 1 Antibody and Program 1 Product for Commercialization purposes at the [**], as well as other customary terms and provisions. If the Parties agree to contract with a Third Party contract manufacturer for commercial supply of Program 1 Antibody and Program 1 Product, [**] shall lead such negotiations, shall permit [**] to review and comment on any draft supply agreements, and shall consider [**] comments in good faith. [**] may request, and [**] shall consider, at its discretion, that [**] becomes a party to such Third Party supply agreement for the purposes of obtaining its commercial supply of Program 1 Antibody and Program 1 Product.
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Commercial Supply. Each Party (a) The initial Development Plan designates the initial commercial Supplier of the Combination Product, which Supplier shall be responsible forthe source of Combination Product supply for purposes of the NDA filing and Launch in the United States. Within [ * ] after the Effective Date, the JCC shall determine the most cost-efficient manner in which to source the commercial supply of the Combination Product, including, without limitation, one or more alternate suppliers. Thereafter, during the term of this Agreement, the JCC shall review annually the appropriate source(s) of commercial supply of the Combination Product after Launch in the United States and agree upon appropriate changes. Each Member Party may propose interim changes with respect thereto from time to time between such reviews, which changes the JCC shall adopt if failure to do so would be likely to have a material adverse effect on the right Combination Product business. If Gilead or BMS desires to manufacture be considered as a possible Supplier of the Combination Product, it shall submit a confidential written proposal to the JV for consideration by the JCC alongside written proposals submitted by recognized, reliable and sufficiently capitalized Third Parties and/or the supply terms pertaining to the initial Supplier. Any proposal submitted by a possible Supplier shall include an offer to perform any required tableting, blistering, packaging, labeling, analytical testing and storage activities with respect to commercial supplies of the Combination Product. The JCC shall select a Person to supply the [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. JV with commercial supplies of the Combination Product on the basis of price, quality, reliability, GMP compliance, security of supply and other relevant commercial considerations. If a Third Party is selected as a Supplier, the JCC shall designate a Member Party to manage the relationship with that Supplier. Any supply contract between the JV and Gilead or BMS as Supplier shall be negotiated on an arm’s-length basis and shall contain such terms and conditions as are customary in the pharmaceutical industry, modified as appropriate for the Combination Product. The Parties anticipate that, following the Amended Effective Date, the JV and Gilead will negotiate an amendment to that certain Product Supply Services Agreement entered into by the JV and Gilead as of May 24, 2006, as well as the related Quality Agreement, for the purpose of establishing commercial supply arrangements with respect to the Combination Product for Canada.
(itself b) The JCC, directly or through a Third Party contract manufacturerdesignated Member Party, and in coordination with the JDC, shall monitor Manufacturing capacity of, and forecasts and orders for, the Combination Product submitted to the relevant Supplier(s) to ensure that adequate commercial supplies of the Combination Product will be available to meet the demand therefor as projected by the JCC in commercial unit volume forecasts. The JCC shall prepare [ * ] rolling unit volume forecasts at its costleast [ * ] before the commencement of each forecast period, all Program 1 Antibody and Program 1 shall update such unit volume forecasts on a [ * ] basis, or as the JCC deems necessary and appropriate.
(c) In connection with the Manufacture by the Supplier of the commercial supply of the Combination Product for commercialization purposes the JV, Gilead and BMS each shall supply to the JV quantities of FTC and TDF, in such Party’s territory. If the Parties agreed on a Program 1 Joint Manufacturing Processcase of Gilead, Incyte shall lead process development for commercial supply and EFV, in the case of BMS, and in each case in the form of bulk active pharmaceutical ingredient, pursuant to and in accordance with Section 6.3(a) and the Parties shall coordinate through the JMC to determine second source and supply continuity matters applicable to each Party’s territory with each Party having the right to determine the supply chain for its their respective territorySupply Agreements. All costs of either Party for such process development will be treated as Development Costs. The Parties may also mutually agree that one Party shall be responsible for commercial supply of Program 1 Product and Program 1 Antibody worldwide, and in such case the Parties shall cooperate in good faith to agree upon the terms In consideration of such supply, which may include either Party or both Parties entering into a commercial supply agreement with a Third Party contract manufacturer for such supply. Whichever Party the Parties determine that will manufacture Program 1 Antibody JV shall pay to Gilead and Program 1 Product for commercializationBMS, respectively, the other Party may request that Gilead Transfer Price and the manufacturing Party supply such Program 1 Antibody BMS Transfer Price. The JDC shall monitor orders under the respective Supply Agreements to assure consistency in the quantities of FTC, TDF and Program 1 Product to such other Party. Upon such Party’s request for supply of Program 1 Antibody and Program 1 Product, EFV ordered by the Parties shall negotiate in good faith a commercial supply agreement that provides for the manufacturing Party to supply such other Party with Program 1 Antibody and Program 1 Product for Commercialization purposes at the [*], as well as other customary terms and provisions. If the Parties agree to contract with a Third Party contract manufacturer for commercial supply of Program 1 Antibody and Program 1 Product, [*] shall lead such negotiations, shall permit [*] to review and comment on any draft supply agreements, and shall consider [*] comments in good faith. [*] may request, and [*] shall consider, at its discretion, that [*] becomes a party to such Third Party supply agreement for the purposes of obtaining its commercial supply of Program 1 Antibody and Program 1 ProductJV thereunder.
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