Clinical and Commercial Supply. On a transitional basis, Company shall supply mutually agreed quantities of IMMU-132 for use by Licensee for the activities contemplated under the Development Plan and as otherwise for commercial launch and inventory build, at a transfer price equal to Company’s Fully Burdened Cost plus *** percent (***%). Such transfer price shall be paid by Licensee no later than *** (***) days after Licensee’s receipt of a shipment of IMMU-132. Company shall (or cause its Affiliates to) (a) manufacture (or have manufactured on its behalf) IMMU-132 in accordance with GMP and (b) provide, and shall use Commercially Reasonable Efforts to cause Company’s Third Party manufacturer(s) to provide, all reasonable access, as requested by Licensee, to audit the manufacturing process. For clarity, this provision does not apply to Existing Inventory.
Clinical and Commercial Supply. (a) HuLuc63 Product. Prior to the completion of PDL’s transfer under Section 6.2 of the Manufacturing technology for HuLuc63, PDL shall Manufacture, or arrange with Third Parties for the Manufacture of (or shall maintain existing agreements with Third Parties for the Manufacture of), HuLuc63 Product for the purpose of transitional supply of HuLuc63 Product for any ongoing Phase I Clinical Trials or Phase II Clinical Trials with respect to HuLuc63 Product and any pre-clinical Development activities set forth in the initial Global Development Plan. As part of such Phase I Clinical Trial and Phase II Clinical Trial supply, and prior to the technology transfer to BMS described in Section 6.2, PDL shall be responsible for testing the supplies of HuLuc63 Product. Prior to transfer of the IND to BMS, PDL shall be responsible for release and stability testing. Once the IND is transferred to BMS, then PDL will enable BMS’ manufacturing and quality units to review manufacturing records and test results performed and to release supplies of HuLuc63 Product. Upon such technology transfer (which shall include the transfer of all test methods), BMS shall be responsible for all testing and releasing of supplies of HuLuc63 Product. PDL shall continue and complete stability studies with respect to the materials manufactured prior to technology transfer to BMS. From and after the Effective Date, PDL shall not enter into any agreements with Third Parties for the manufacture of HuLuc63 Product without the prior written consent of BMS. The costs and expenses incurred by PDL in carrying out such Manufacturing (or the costs associated with any such agreements with Third Parties) shall be treated as Development Costs. After the completion of PDL’s transfer of the applicable Manufacturing technology under Section 6.2(a), BMS shall be responsible for Manufacturing, or arranging with Third Parties for the Manufacture of, HuLuc63 Product, in bulk and finished form, for use in Development and for commercial sale.
Clinical and Commercial Supply. The provisions set forth in this Section 6.2, including its subsections, relate exclusively to the manufacture and supply of GMP-quality Amanitin Toxin Constructs and Amanitin.
Clinical and Commercial Supply. Any costs and expenses incurred by either BMS or EXEL in carrying out Manufacturing shall be: (a) in the event that such expenses relate to Manufacture for use of a Co-Developed Product for Development use in the Co-Development Territory, treated as Development Costs; (b) in the event that such expenses relate to Manufacture for use of a Co-Developed Product for Commercial sale in the U.S., treated as Allowable Expenses; and (c) in all other cases, reimbursed one hundred percent (100%) by BMS. Prior to the transfer under Section 6.2 of the Manufacturing technology for the XL281, EXEL shall Manufacture, or arrange with a Third Party for the Manufacture of, such XL281 Product for the clinical supply of the Exelixis Clinical Trials relating to such XL281 Product. After the completion of EXEL’s transfer under Section 6.2 of the Manufacturing technology for a given Product, BMS shall Manufacture, or arrange with Third Parties for the Manufacture of, such Products (in bulk and finished form) for use in Development and Commercialization. BMS shall at all times be the Lead Party with respect to manufacturing process development as such activities relate to Manufacturing.
Clinical and Commercial Supply. The Parties acknowledge that Adolor is working with Corium to develop and supply for Adolor a sterile lidocaine patch for clinical and commercial supply. As provided in Section 3.10(d), Adolor consents to EpiCept negotiating and entering into a contract with Corium pursuant to which Corium manufactures for and supplies to EpiCept clinical and commercial supplies of sterile lidocaine patches for use by EpiCept, its Affiliates or licensees outside the Territory. Adolor shall advise Corium that Corium may disclose confidential information regarding the lidocaine patch manufactured by Corium to EpiCept which information is required by EpiCept to use the lidocaine patch manufactured by Corium in EpiCept's European clinical trial EPC 2004-0l. With respect to clinical supplies for EpiCept's European clinical trial EPC 2004-01, such patches shall have the same specifications as the sterile lidocaine patches which Corium is manufacturing' for Adolor. Within five (5) business days after written request of EpiCept, Adolor shall give written notice of such consent to Corium. The terms of such purchase and supply shall be the subject of a separate agreement between EpiCept and Corium. Neither party makes any representation and warranty with respect to (i) supplies of sterile lidocaine patches purchased by either party from Corium, (ii) analytical methods, release specifications, or any data or information related to supplies of sterile lidocaine patches purchased by either party from Corium. EpiCept and Adolor expressly acknowledge and agree that neither party shall have any liability whatsoever to the other party for any such sterile lidocaine patches purchased by a party from Corium, analytical methods, release specifications, any data or information or otherwise. As additional examples and in no way limiting the foregoing, neither party makes any representation and warranty (i) that any such sterile lidocaine patch made, used, sold or otherwise purchased by either party from Corium is or will be free from infringement of patents, copyrights, trademarks, industrial design or other intellectual property rights of any Third Party; (ii) regarding the effectiveness, value, safety, non toxicity, patentability, or design of any such sterile lidocaine patch; and/or (iii) the accuracy or completeness of any data or information provided by Corium to either party. ADOLOR AND EPICEPT EXPRESSLY DISCLAIM AND RENOUNCE ANY AND ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT ...
Clinical and Commercial Supply. After BMS’ selection of a Collaboration Program and prior to the completion of EXEL’s transfer under Section 7.3 of the Manufacturing technology for the Collaboration Compounds in such Collaboration Program, EXEL shall Manufacture, or arrange with Third Parties for the Manufacture of, the Lead Compound in such Collaboration Program for the purpose of transitional supply of Lead Compound for the first Phase I Clinical Trial of such Lead Compound. As part of such Phase I Clinical Trial supply, EXEL will enable BMS’ regulatory function to test and release all supplies of such Lead Compound for such Phase I Clinical Trial (if applicable). The costs and expenses incurred by EXEL in carrying out such Manufacturing shall be either: (a) treated as Development Expenses in the event that such expenses relate to a Co-Developed Product; or (b) reimbursed one hundred percent (100%) by BMS in the in the event that such expenses relate to a Royalty-Bearing Product. After the completion of EXEL’s transfer under Section 7.3 of the Manufacturing technology for the Collaboration Compounds in such Collaboration Program, BMS shall Manufacture, or arrange with Third Parties for the Manufacture of, Collaboration Compounds and Products (in bulk and finished form) for use in Development and for commercial sale.
Clinical and Commercial Supply. On a Licensed Product-by-Licensed Product basis, no later than (a) for clinical supply, [***] months after the Effective Date and (b) for commercial supply, [***] months prior to the anticipated First Commercial Sale of such Licensed Product (each date, a “Supply Election Date”), Licensee will elect to obtain supply of Licensed Product via the Importation Model or the Localization Model, as set forth in this Section 6.1 (Clinical and Commercial Supply). Licensee will be allowed to elect either the Importation Model, subject to Licensor’s agreement pursuant to 6.1.1 (Importation Model), or Localization Model for both clinical and commercial supply, provided that if Licensee elects the Localization Model for clinical supply, it will be deemed to have also elected the Localization Model for commercial supply.
Clinical and Commercial Supply. In the event that [**] with respect to a Royalty-Bearing Product [**] Manufacture and supply such Royalty-Bearing Product [**] after the applicable Opt-Out Point or such earlier time as may be agreed[**]. In the event that [**] with respect to a Royalty-Bearing Product [**] Manufacture and supply such Royalty-Bearing Product to [**] for [**] after such Opt-Out Point or such earlier time as may be agreed[**]; provided that [**] such Royalty-Bearing Product [**]The Continuing Party shall pay[**]the Opt-Out Party for any such Royalty-Bearing Product supplied pursuant to this Section 6.4 at the Cost of Goods Sold of such Royalty-Bearing Product.
Clinical and Commercial Supply. (i) Subject to Sections 6.7(b) and 6.7(e), for each Cold Component provided to GSK Canada pursuant to Section 4.5(a), GSK Canada shall pay Corixa a transfer price equal to [*] of the Standard Cost of Goods for such Cold Component.
(ii) Subject to Sections 6.7(b) and 6.7(e), for each Hot Component provided to GSK Canada pursuant to Section 4.5(b), GSK Canada shall pay Corixa a ---------------------------------- * Confidential Treatment requested. 43. <PAGE> transfer price equal to X minus Y, where X is [*] of the Standard Cost of Goods for the Therapy containing such Hot Component and Y is the total amount received by Corixa or invoiced by Corixa within the past thirty (30) days and not yet received, pursuant to Section 6.7(a)(i), for the two Cold Components in such Therapy.
Clinical and Commercial Supply. Company shall have the sole responsibility for and sole authority with respect to Manufacturing all Fixed Dose Combination Products (i) for use in Clinical Trials and other Development activities to be conducted by Company in the Company Field in the Company Territory and (ii) for use and sale by Company in the Company Field in the Company Territory. Company shall bear all costs of such Manufacturing, subject to the terms of ARTICLE 8. TESARO shall have the right to request and conduct an audit of all manufacturing sites where all Fixed Dose Combination Products are manufactured by or for Company only if, and to the extent that, TESARO has the right under this Agreement to use such Fixed Dose Combination Products in a Clinical Trial sponsored by TESARO or to sell such Fixed Dose Combination Products under its trade name. Company shall facilitate the accommodation of such request; provided, that Company personnel shall accompany any TESARO personnel conducting such audit. Following the completion of such audit, TESARO may request the remediation of deficiencies that are not in compliance with GMP and identified by TESARO during such audit. In the case of any Critical Observation that Company or its contract manufacturer cannot or will not remediate, TESARO will have the right to request the use of different manufacturers for the supply of Fixed Dose Combination Products.
