Manufacturing Matters. At AVEO’s option, to be exercised no later than the later of [**] days after the effective date of termination or [**] days after AVEO’s receipt of the applicable manufacturing agreements referenced below (subject to any applicable confidentiality restrictions), Schering-Plough shall be responsible for:
(i) assignment to AVEO of each manufacturing agreement specific to Licensed Products, if such agreement is then in effect and such assignment is permitted under such agreement or by the applicable Third Party; provided that Schering-Plough shall have no obligation to pay any compensation to the Third Party to effectuate such agreement; AVEO shall assume all of Schering-Plough’s rights and obligations under such agreement, including paying any and all royalties, fees and other consideration due such Third Party under such agreement; Schering-Plough shall be released, to the extent the applicable Third Party will permit such release, from any obligation arising out of such manufacturing agreement following such assignment; and AVEO shall execute such documentation reasonably satisfactory to Schering-Plough to effectuate such agreement;
(ii) reasonable cooperation with AVEO to transfer copies of those manufacturing documents and materials, at AVEO’s cost and expense, that are used (at the time of the termination) by Schering-Plough in the Manufacture of Licensed Products to the extent such manufacturing documents and materials are not obtained by AVEO pursuant to Section 12.6(c)(i);
(iii) for a period of up to [**] months following the effective date of termination, reasonably cooperate with AVEO to transfer Manufacturing technologies which are used (at the time of the termination) and Controlled by Schering-Plough in the Manufacture of Licensed Products, provided that AVEO shall reimburse Schering-Plough for Schering-Plough’s reasonable FTE costs and out-of-pocket expenses necessary to provide such requested assistance, to the extent such Manufacturing technologies are not obtained by AVEO pursuant to the assignment of agreements pursuant to Section 12.6(c)(i);
(iv) sale of Schering-Plough’s then existing inventory of Licensed Products to AVEO, at Schering-Plough’s standard costs of goods sold for such Licensed Product, plus a markup of [**] percent ([**]%); and
(v) if, as of the effective date of termination, Schering-Plough or an Affiliate is engaged in the Manufacture of Licensed Product that is in clinical Development or is being Commercialized, then Sche...
Manufacturing Matters. (i) To the extent vTv so requests within [***] days after the effective date of termination, Reneo shall use commercially reasonable efforts to, and to cause any Affiliate it controls (within the meaning of Section 1.1) to, [***]; provided that [***]; provided, further, that, [***].
(ii) To the extent vTv so requests, for a period of up to [***] months following the effective date of termination, Reneo and any Affiliate it controls (within the meaning of Section 1.1) shall [***].
Manufacturing Matters. At Quark’s option, to be exercised no later than [ * ] after the effective date of termination,
(i) use reasonable efforts to [ * ],
(ii) not object if Quark desires to contract directly with any Third Party supplier of Biomolecules or Licensed Products whose agreements are not assigned pursuant to paragraph (i) above for the supply of such Biomolecules and Licensed Products,
(iii) cooperate with Quark in reasonable respects to transfer manufacturing documents and materials which are used by Pfizer in the manufacture of Applicable Biomolecules or Applicable Licensed Products to the extent such manufacturing documents and materials are not obtained by Quark pursuant to the assignment of agreements pursuant to paragraph (i) above,
(iv) for a period of up to [ * ] following the effective date of termination, cooperate with Quark, at Quark’s request, in reasonable respects to transfer manufacturing know how which are used by Pfizer in the manufacture of Applicable Biomolecules or Applicable Licensed Products, provided Quark shall reimburse Pfizer for Pfizer’s reasonable internal and out-of-pocket expenses incurred to provide such requested assistance, to the extent such manufacturing know how is not obtained by Quark pursuant to the assignment of agreements pursuant to paragraph (i) above, and
(v) sell Pfizer’s then existing inventory of Biomolecules and Licensed Products to Quark, at [ * ], but only if the following conditions have been met: (A) such Biomolecules and Licensed Products meets the applicable release specifications; and (B) Pfizer does not believe the continued use of such Biomolecules and Licensed Products reasonably causes safety concerns;
Manufacturing Matters. At SYNTA’s option, ROCHE shall:
(a) To the extent assignable and related to Licensed Compounds or Licensed Products, assign to SYNTA each manufacturing agreement then in effect with respect to the Manufacture of such Licensed Compounds and Licensed Products;
(b) transfer Manufacturing documents and materials which are used (at the time of the termination) by or on behalf of ROCHE, its Affiliates or Sublicensees in the Manufacture of such Licensed Compounds and Licensed Products; and
(c) upon SYNTA’s request, sell to SYNTA (or its designee) ROCHE’s then-existing inventory of such Licensed Compounds and Licensed Products, at ROCHE’s FBMC;
Manufacturing Matters. Where Pfizer is the Lead Development Party and responsible for preparing the filings for Regulatory Approval, BioNTech shall provide all reasonable assistance to Pfizer in such filings, including preparation of the CMC portions of the Common Technical Document in English and supporting ancillary cGMP documents and analytical data as required to meet specific regulatory filing and approval requirements. Each Party shall promptly provide the other with copies of material written correspondence as reasonably necessary to permit each Party to comply with its relevant regulatory obligations described in the Agreement or as otherwise reasonably requested.
Manufacturing Matters. Prior to completion of the Technology and Process Transfer, Translate Bio will prepare CMC Module 3 of the Common Technical Document in English for Products, at Sanofi’s expense, and Sanofi will modify as appropriate such module for use in its Regulatory Filings. “Common Technical Document” means the set of specifications for the application of a dossier for the registration of medicines formatted according to the International Conference on Harmonization (ICH) of technical requirements for registration of pharmaceuticals for human use
Manufacturing Matters. Each party shall promptly inform each other party in the event that it becomes aware of any matters which might reasonably be expected to have an adverse impact on the ability to supply trade Product to wholesalers or other customers within [***] ([***]) days of any specified delivery date. Notwithstanding the generality of the foregoing, Santarus agrees to notify S2 and VeroScience within [***] ([***]) hours after Santarus has become aware of any event or circumstance related to the manufacture of the Product that would reasonably be expected to impact the safety or efficacy of Product that has been released for commercial distribution or that would reasonably be expected to cause such released Product to be adulterated or misbranded within the meaning of the Act.
Manufacturing Matters. Any one or more of the following:
(A) assignment of each manufacturing agreement specific to any Selected Compounds or Licensed Products to MethylGene, if such agreement is then in effect and such assignment is permitted under such agreement or by the applicable Third Party;
(B) cooperation with MethylGene in reasonable respects to transfer manufacturing documents and materials which are used and Controlled (at the time of the termination) by Otsuka in the Manufacture of Selected Compounds and Licensed Products to the extent such manufacturing documents and materials are not obtained by MethylGene pursuant to the assignment of agreements pursuant to paragraph (A) above;
(C) for a period of up to six (6) months following the effective date of termination, cooperation with MethylGene in reasonable respects to transfer Manufacturing technologies which are used and Controlled (at the time of the termination) by Otsuka in the Manufacture of Selected Compounds and Licensed Products, provided that MethylGene shall reimburse Otsuka for Otsuka’s reasonable out-of-pocket expenses to provide such requested assistance, to the extent such Manufacturing technologies are not obtained by MethylGene pursuant to the assignment of agreements pursuant to paragraph (A) above;
(D) sale of Otsuka’s then existing inventory of Selected Compounds and Licensed Products to MethylGene, at Otsuka’s fully-loaded cost of Manufacture;
Manufacturing Matters. Notwithstanding the provisions of Section 6.1 (Amgen Responsibility), with respect to Amgen Products manufactured by Kite, Kite shall assist with the […***…] for any such Amgen Product, with sufficient information to satisfy […***…]. Additionally, Kite shall provide Amgen with copies of all supporting documentation in its possession reasonably necessary to generate the […***…]. Working with Amgen, Kite shall prepare the […***…] for the first Amgen Product directed against the first Amgen Target. If requirements are identified for additional countries by Amgen, then, upon notification, Amgen may request additional regulatory information from Kite be provided. Kite will meet this request if the data is […***…]. In addition, in order to address questions Amgen may receive from health authorities (globally) in response to submissions of Regulatory Filings, Kite will assist in the preparation of responses based on information that would be found in: various technical reports, notebooks, executed batch records, master batch records, SOPs, validation protocols and reports, vendor certificates, and third party study reports and other CMC related documents not otherwise included in the […***…]. Amgen shall reimburse all of Kite’s costs and expenses (including internal FTE costs at the FTE Rate) incurred in connection therewith.
Manufacturing Matters. In order to assist the Designated Regulatory Party, the Manufacturing Lead will prepare [*] in English for the relevant Product, and the Designated Regulatory Party will modify as appropriate such module for use in Regulatory Filings in the Collaboration Territory. The Manufacturing Lead will have the option, in order to protect proprietary manufacturing information, to take over operational responsibility from the Designated Regulatory Party for some or all correspondence and for specified official communications, including the preparation and submission of all Regulatory Filings required to be filed with any Governmental Authority in the Collaboration Territory with respect to the manufacture of a Product (except to the extent such transfer of operational responsibility is prohibited by Applicable Law or a Governmental Authority). With respect to any such correspondence and communication, each Party will promptly provide the other with copies of material written correspondence as reasonably necessary to permit each Party to comply with its relevant regulatory obligations or as otherwise reasonably requested; provided, that the Manufacturing Lead will not be required to disclose proprietary or competitively sensitive information unless such disclosure is required by Applicable Law.
