Common use of Manufacture and Supply Clause in Contracts

Manufacture and Supply. Agenus shall have responsibility for selecting and monitoring the Manufacturing vendors, and for otherwise being responsible for Manufacturing activities, with respect to each Product in the Field and in the Territory in accordance with the applicable Development Plan. At any time that the JSC determines, acting in good faith, that some or all Manufacturing responsibilities for a particular Project should be transferred from Agenus to Incyte because the failure to transfer such responsibilities would be reasonably likely to have a material adverse effect on such Project, the Project Management Team for the applicable Project shall agree upon an appropriate plan for transferring the applicable Manufacturing activities, and all related Know-How, to Incyte with Agenus having the right to approve any plan involving its activities, such approval not to be unreasonably withheld, conditioned or delayed. Agenus shall use Commercially Reasonable Efforts to transfer any such Manufacturing activities and related Know-How in accordance with such plan. Any such transfer shall be considered a Development Cost or Allowable Expense. The Party responsible for Manufacturing shall keep the other Party reasonably informed, through the JSC, in connection with the performance of all Manufacturing activities for Products in the Field. The responsible Party shall respond within a reasonable time frame to all reasonable inquiries by the other Party with respect to any information provided pursuant to this Section 4.8. Any information disclosed pursuant to this Section 4.8 shall be the Confidential Information of the responsible Party, unless such information is already the Confidential Information of the other [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. EXHIBIT 10.22

Appears in 1 contract

Samples: Development and Commercialization Agreement (Agenus Inc)

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Manufacture and Supply. Agenus shall have responsibility Exelixis, through one or more Third Party contract manufacturers, will provide all Supplied Product for selecting and monitoring the Manufacturing vendors, and for otherwise being responsible for Manufacturing activities, with respect to each Product use in the Field Development and in Commercialization of the Territory in accordance with Products under this Agreement. All Supplied Product supplied by Exelixis to Collaborator shall be at a price equal to [ * ]. During the applicable Development Plan. At any time that the JSC determinesTerm, acting in good faith, that some or all Manufacturing responsibilities for a particular Project should be transferred from Agenus to Incyte because the failure to transfer such responsibilities would be reasonably likely to have a material adverse effect on such Project, the Project Management Team for the applicable Project shall agree upon an appropriate plan for transferring the applicable Manufacturing activities, and all related Know-How, to Incyte with Agenus having the right to approve any plan involving its activities, such approval not to be unreasonably withheld, conditioned or delayed. Agenus Exelixis shall use Commercially Reasonable Efforts to transfer [ * ]. If [ * ] for particular Supplied Product is reasonably expected to exceed [ * ] per tablet of any such Manufacturing activities dose strength, Exelixis shall inform Collaborator promptly, and related Know-How discuss with Collaborator in accordance with such plangood faith a reasonable mitigation plan to reduce [ * ]. Any such transfer Exelixis (through one or more Third Party contract manufacturers) shall be considered a Development Cost or Allowable Expense. The Party exclusively responsible for Manufacturing shall keep the other Party reasonably informed, through the JSC, in connection with the performance supply of all Manufacturing activities for Products in the Field. The responsible Party shall respond within a reasonable time frame Supplied Product to all reasonable inquiries by the other Party with respect to any information provided pursuant to this Section 4.8. Any information disclosed pursuant to this Section 4.8 Collaborator and Collaborator shall be exclusively responsible, at its expense, for the Confidential Information Finished Manufacture of the responsible Party, unless such information is already the Confidential Information of the other [**Finished Product. 40 [ * ] = Portions of Certain confidential information contained in this exhibit have document, marked by brackets, has been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been and filed separately with the CommissionSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. EXHIBIT 10.22[ * ] of the Supplied Product used in the Development work under the GDP shall be included in the Development Cost and shared by the Parties in accordance with Section 4.5. Exelixis shall source such Supplied Product supply for both Parties either from a facility owned by Exelixis or from a reputable, qualified, and certified Third Party and, in the event that Collaborator is responsible for conducting any Clinical Studies pursuant to Section 4.2 or 4.3, Exelixis shall provide such supply to Collaborator for such Clinical Studies in accordance with the GDP. As soon as reasonably practicable after the Effective Date, but in any event prior to the initial supply of the Supplied Product to Collaborator for use in Development work, the Parties shall enter into supply agreements for the manufacture and supply of the Supplied Product to Collaborator for use in Development or Commercialization activities (each, a “Supply Agreement”), and a Quality Agreement setting forth in detail the quality assurance arrangements and procedures for Exelixis’ manufacture of Supplied Product (the “Quality Agreement”). Exelixis shall, upon Collaborator’s reasonable request, allow Collaborator to access Exelixis and/or its manufacturing facility of the Supplied Product, as applicable, for the purpose of regulatory and Collaborator’s reasonable in-house auditing.

Appears in 1 contract

Samples: Collaboration and License Agreement (Exelixis, Inc.)

Manufacture and Supply. Agenus shall have responsibility Exelixis, through one or more Third Party contract manufacturers, will provide all Supplied Product for selecting and monitoring the Manufacturing vendors, and for otherwise being responsible for Manufacturing activities, with respect to each Product use in the Field Development and in Commercialization of the Territory in accordance with Products under this Agreement. All Supplied Product supplied by Exelixis to Collaborator shall be at a price equal to [ * ]. During the applicable Development Plan. At any time that the JSC determinesTerm, acting in good faith, that some or all Manufacturing responsibilities for a particular Project should be transferred from Agenus to Incyte because the failure to transfer such responsibilities would be reasonably likely to have a material adverse effect on such Project, the Project Management Team for the applicable Project shall agree upon an appropriate plan for transferring the applicable Manufacturing activities, and all related Know-How, to Incyte with Agenus having the right to approve any plan involving its activities, such approval not to be unreasonably withheld, conditioned or delayed. Agenus Exelixis shall use Commercially Reasonable Efforts to transfer [ * ]. If [ * ] for particular Supplied Product is reasonably expected to exceed [ * ] per tablet of any such Manufacturing activities dose strength, Exelixis shall inform Collaborator promptly, and related Know-How discuss with Collaborator in good faith a reasonable mitigation plan to reduce [ * ]. Exelixis (through one or more Third Party contract manufacturers) shall be exclusively responsible for the supply of Supplied Product to Collaborator and Collaborator shall be exclusively responsible, at its expense, for the Finished Manufacture of the Finished Product. [ * ] of the Supplied Product used in the Development work under the GDP shall be included in the Development Cost and shared by the Parties in accordance with Section 4.5. Exelixis shall source such plan. Any such transfer shall be considered Supplied Product supply for both Parties either from a Development Cost facility owned by Exelixis or Allowable Expense. The from a reputable, qualified, and certified Third Party and, in the event that Collaborator is responsible for Manufacturing conducting any Clinical Studies pursuant to Section 4.2 or 4.3, Exelixis shall keep the other Party reasonably informed, through the JSC, provide such supply to Collaborator for such Clinical Studies in connection accordance with the performance of all Manufacturing activities for Products GDP. As soon as reasonably practicable after the Effective Date, but in any event prior to the Field. The responsible Party shall respond within a reasonable time frame to all reasonable inquiries by the other Party with respect to any information provided pursuant to this Section 4.8. Any information disclosed pursuant to this Section 4.8 shall be the Confidential Information initial supply of the responsible PartySupplied Product to Collaborator for use in Development work, unless such information is already the Confidential Information Parties shall enter into supply agreements for the manufacture and supply of the other [**] = Portions Supplied Product to Collaborator for use in Development or Commercialization activities (each, a “Supply Agreement”), and a Quality Agreement setting forth in detail the quality assurance arrangements and procedures for Exelixis’ manufacture of this exhibit have been omitted pursuant Supplied Product (the “Quality Agreement”). Exelixis shall, upon Collaborator’s reasonable request, allow Collaborator to a confidential treatment request. An unredacted version access Exelixis and/or its manufacturing facility of this exhibit has been filed separately with the Commission. EXHIBIT 10.22Supplied Product, as applicable, for the purpose of regulatory and Collaborator’s reasonable in-house auditing.

Appears in 1 contract

Samples: Collaboration and License Agreement (Exelixis, Inc.)

Manufacture and Supply. Agenus shall have responsibility Exelixis, through one or more Third Party contract manufacturers, will provide all Supplied Product for selecting and monitoring the Manufacturing vendors, and for otherwise being responsible for Manufacturing activities, with respect to each Product use in the Field Development and in Commercialization of the Territory in accordance with Products under this Agreement. All Supplied Product supplied by Exelixis to Collaborator shall be at a price equal to [ * ]. During the applicable Development Plan. At any time that the JSC determinesTerm, acting in good faith, that some or all Manufacturing responsibilities for a particular Project should be transferred from Agenus to Incyte because the failure to transfer such responsibilities would be reasonably likely to have a material adverse effect on such Project, the Project Management Team for the applicable Project shall agree upon an appropriate plan for transferring the applicable Manufacturing activities, and all related Know-How, to Incyte with Agenus having the right to approve any plan involving its activities, such approval not to be unreasonably withheld, conditioned or delayed. Agenus Exelixis shall use Commercially Reasonable Efforts to transfer [ * ]. If [ * ] for particular Supplied Product is reasonably expected to exceed [ * ] per tablet of any such Manufacturing activities dose strength, Exelixis shall inform Collaborator promptly, and related Know-How discuss with Collaborator in good faith a reasonable mitigation plan to reduce [ * ]. Exelixis (through one or more Third Party contract manufacturers) shall be exclusively responsible for the supply of Supplied Product to Collaborator and Collaborator shall be exclusively responsible, at its expense, for the Finished Manufacture of the Finished Product. [ * ] of the Supplied Product used in the Development work under the GDP shall be included in the Development Cost and shared by the Parties in accordance with Section 4.5. Exelixis shall source such plan. Any such transfer shall be considered Supplied Product supply for both Parties either from a Development Cost facility owned by Exelixis or Allowable Expense. The from a reputable, qualified, and certified Third Party and, in the event that Collaborator is responsible for Manufacturing conducting any Clinical Studies pursuant to Section 4.2 or 4.3, Exelixis shall keep the other Party reasonably informed, through the JSC, provide such supply to Collaborator for such Clinical Studies in connection accordance with the performance of all Manufacturing activities for Products GDP. As soon as reasonably practicable after the Effective Date, but in any event prior to the Field. The responsible Party shall respond within a reasonable time frame to all reasonable inquiries by the other Party with respect to any information provided pursuant to this Section 4.8. Any information disclosed pursuant to this Section 4.8 shall be the Confidential Information initial supply of the responsible PartySupplied Product to Collaborator for use in Development work, unless such information is already the Confidential Information Parties shall enter into supply agreements for the manufacture and supply of the other [**Supplied Product to Collaborator for use in Development or Commercialization activities (each, a “Supply Agreement”), and a Quality Agreement setting forth in detail the quality assurance arrangements and procedures for Exelixis’ manufacture of Supplied Product (the “Quality Agreement”). Exelixis shall, upon Collaborator’s reasonable request, allow Collaborator to access Exelixis and/or its manufacturing facility of the Supplied Product, as applicable, for the purpose of regulatory and Collaborator’s reasonable in-house auditing. [ * ] = Portions of Certain confidential information contained in this exhibit have document, marked by brackets, has been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been and filed separately with the Commission. EXHIBIT 10.22Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Appears in 1 contract

Samples: Collaboration and License Agreement (Exelixis, Inc.)

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Manufacture and Supply. Agenus shall have responsibility for selecting and monitoring the Manufacturing vendors, and for otherwise being responsible for Manufacturing activities, with respect to each Product in the Field and in the Territory in accordance with the applicable Development Plan. At any time that the JSC determines, acting in good faith, that some or all Manufacturing responsibilities for a particular Project should be transferred from Agenus to Incyte because the failure to transfer such responsibilities would be reasonably likely to have a material adverse effect on such Project, the Project Management Team for the applicable Project shall agree upon an appropriate plan for transferring the applicable Manufacturing activities, and all related Know-How, to Incyte with Agenus having the right to approve any plan involving its activities, such approval not to be unreasonably withheld, conditioned or delayed. Agenus shall use Commercially Reasonable Efforts to transfer any such Manufacturing activities and related Know-How in accordance with such plan. Any such transfer shall be considered a Development Cost or Allowable Expense. The Party responsible for Manufacturing shall keep the other Party reasonably informed, through the JSC, in connection with the performance of all Manufacturing activities for Products in the Field. The responsible Party shall respond within a reasonable time frame to all reasonable inquiries by the other Party with respect to any information provided pursuant to this Section 4.8. Any information disclosed pursuant to this Section 4.8 shall be the Confidential Information of the responsible Party, unless such information is already the Confidential Information of the other [**] = Portions of Party. Each Party shall use Commercially Reasonable Efforts to conduct the activities described in this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. EXHIBIT 10.22Section 4.8 for which such Party is responsible.

Appears in 1 contract

Samples: License, Development and Commercialization Agreement (Incyte Corp)

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