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. (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.
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 2004-01. 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 [*] = 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. 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. Athenex will be the exclusive supplier to Almirall, its Affiliates, and its and their Sublicensees of Clinical Supply and Commercial Supply or, in the event Almirall decides at it sole criteria to manufacture Commercial Supply (Drug Product), of Compound (Drug Substance) for purposes of Almirall’s, its Affiliates or subcontractors’ manufacture of Commercial Supply. Athenex shall supply such Clinical Supply, Commercial Supply or Compound to Almirall, as the case may be, as described in, and during the term of, the supply agreement that will be attached hereto as Schedule 3A (the “Supply Agreement”), which shall be agreed and finalized between the Parties within ninety (90) days of the Execution Date of this Agreement. The Supply Agreement shall be prepared in accordance with the Head of Terms attached hereto as Schedule 3A. Almirall reserves the right to manufacture, have manufactured, or obtain Commercial Supply (Drug Product) from any source other than Athenex, including, as applicable, pursuant to the exercise of certain related back-up supply rights that may be set forth in the Supply Agreement, and including following the termination or expiration of the Supply Agreement with respect thereto. Athenex shall conduct all necessary activities, at its own cost, to assure that a proper manufacturing site (including but not limited to TergusPharma—Durham manufacturing facility—or Athenex Pharma Solutions – Xxxxxxxx manufacturing site-) is ready for the purposes of obtaining Regulatory Approvals in the expected timelines and to start (and continue) supplies of Commercial Supply to Almirall in accordance with the Head of Terms and the Supply Agreement. The Parties agree to adjust the financials of this Agreement in the event a delay in the Parties entering into the Supply Agreement or a delay in Athenex’s manufacturing and supply activities, including but not limited to related Development and regulatory activities necessary for obtaining Regulatory Approvals in the expected date, materially and adversely impacts the commercial value of the Licensed Product as of the Execution Date.
Clinical and Commercial Supply. AstraZeneca shall be responsible for, or shall procure, the manufacture of toxicology, clinical and commercial materials, including without limitation any Candidate Drug, Product or Combination Product in the Territory and for all costs associated therewith. AstraZeneca shall use Commercially Reasonable Efforts to make necessary filings to obtain, or cause a Third Party manufacturer to obtain, Health Registration Approval for the manufacture of Candidate Drugs or Product or any Combination Product(s) in the Territory.
Clinical and Commercial Supply. 5.1.1 Phase 3 Clinical Supply. KKC shall be the initial manufacturing lead for the Product (the “Manufacturing Lead”). As Manufacturing Lead, KKC shall use its Commercially Reasonable Efforts to supply mutually agreed clinical quantities (for the Global Phase 3 Registrational Studies and any additional phase 1 Clinical Studies initiated prior to the Manufacturing Transfer and included in the Global Development Plan) of the Product for the Development of the Product in accordance with the Global Development Plan and the Clinical Supply Agreement, including out of any inventory of the Product existing as of the Effective Date. Subject to Section 5.2 (Transfer of Manufacturing Technology), the parties will discuss the ability of Amgen to supply the Global Phase 3 Registrational Studies from and after the Manufacturing Transfer.
