Manufacturing Responsibility. Licensee will be responsible for the manufacturing of the Licensed Compound and Licensed Product for use by Licensee, its Affiliates, and its sublicensees in the Field in the Territory.
Manufacturing Responsibility. (a) Prior to the Launch Date of the Product, Corium shall use commercially reasonable efforts to manufacture the Product for the pivotal BE Studies and the product process validation batches.
Manufacturing Responsibility. Subject to the terms and conditions of this Agreement, Corium will use commercially reasonable efforts: (i) to supply quantities of the Product to Agile, in accordance with the Development Program, for pre-Launch-Date testing and clinical studies as Agile shall from time to time request; and (ii) after the Launch Date of the Product and throughout the remainder of the Term, to maintain Corium’s manufacturing capability for the Product and to sell Products to Agile as necessary to satisfy Agile’s quantity requirements of such Products, as such requirements are reflected in forecasts submitted by Agile to Corium as provided in Section 3.3(b).
Manufacturing Responsibility. Except as provided in Section 4.1, Provention shall have sole responsibility for, at its sole cost and expense, all Manufacturing-related activities, including Manufacturing, or having Manufactured, clinical and commercial supplies of the Compound and the Products for Development and Commercialization in the Field in the Territory.
Manufacturing Responsibility. After the Effective Date, Licensee will be responsible for the manufacturing and any ongoing or future stability studies related to the Licensed Compound and Licensed Product for use by Licensee, its Affiliates and its sublicensees in the Field in the Territory.
Manufacturing Responsibility. Product manufacturing shall be the responsibility of Abbott and Abbott, at its sole discretion, may (1) modify or terminate Assigned Third Party Manufacturing Agreements, subject to the terms of such agreements; (2) negotiate with Neurocrine or its designee an agreement for the manufacture and supply Compound or Product to Abbott, its Affiliates or Sublicensees which agreement will contain standard manufacturing commercial terms, conditions and payments mutually acceptable to Neurocrine and Abbott (for avoidance of doubt Neurocrine will not be obligated to enter into such a manufacturing agreement if it mutually acceptable terms cannot be negotiated); (3) transfer some or all of the manufacture of the Product to locations selected by Abbott, (4) modify the manufacturing process for Products, (5) modify the quality assurance process for the manufacture or release of Product, and (5) take such other actions related to the manufacture of Products that Abbott deems appropriate.
Manufacturing Responsibility a. Prior to the Launch Date, Perrigo shall use Diligent Efforts to manufacture the Product for the pivotal in vitro and in vivo bioequivalence studies and the Product process validation batches. Manufacturing shall be designed to enable Perrigo to lawfully market the Product in the Territory in accordance with the approved ANDA.
Manufacturing Responsibility. As between the Parties, Tigercat will be responsible for the Manufacturing of any Licensed Compound and Licensed Product for use by Tigercat, its Affiliates, and its sublicensees and any Third Parties in the Field in the Territory.
Manufacturing Responsibility. Until the completion of technology transfer [*] as set forth in Section 8.1, or the execution of a manufacturing and supply agreement [*], but in no event longer than [*], Prothena shall be responsible for providing manufacturing-related services to Roche, including but not limited to the supply of quantities of Lead Compound and Lead Product manufactured under the BI Supply Agreement as requested by Roche for technical, non-clinical and clinical Development in the Territory. The costs related to such activities at BI as requested by Roche shall be shared as a Development Cost for the Shared Territory or borne for the Royalty Territory by Roche [*], as applicable. For purposes of clarity, all costs for clinical supply of Lead Compound and/or Lead Product already manufactured as of the Effective Date shall be borne by Prothena, as well as costs of stability testing incurred prior to the Effective Date, but costs incurred after the Effective Date for ongoing stability testing for such material will be shared as a Development Cost. After such date, Roche shall have sole responsibility for all manufacturing-related activities, including without limitation obtaining and making available adequate supplies of Licensed Compounds and Licensed Products for Development and Commercialization in the Territory.
Manufacturing Responsibility. (a) Until the completion of any transfer of responsibility to CURAGEN as provided in (b) below, TOPOTARGET shall use reasonable commercial efforts, to the extent it is reasonably capable of doing so, to supply CURAGEN, itself or through TOPOTARGET’s use of Third Party manufacturers, with CURAGEN’s requirements for Collaboration Products for use under this Agreement. The cost to CURAGEN of Collaboration Products supplied for use in the Development Program for studies conducted at CURAGEN’s expense, including without limitation studies conducted under the CRADA so long as CURAGEN has rights to use all resulting data in the Territory, shall be [********] of the invoiced price TOPOTARGET pays therefor or [********] of TOPOTARGET’s fully burdened cost of goods sold (which cost shall not include process development costs). Any supply for commercial purposes shall be at a price to be agreed for each Collaboration Product, assuring a reasonable profit to TOPOTARGET. TOPOTARGET shall manufacture Collaboration Products, or shall cause TOPOTARGET’s Third Party manufacturers to manufacture same, in accordance with current Good Manufacturing Practices under 21 C.F.R. 210 and 211 and all applicable laws, rules and regulations. TOPOTARGET shall provide CURAGEN with copies of, or permission to reference, as appropriate, any Drug Master File or similar filing (“DMF”) made by TOPOTARGET with respect to any Collaboration Product, and shall not withdraw or modify any such DMF without prior written notice to CURAGEN. TOPOTARGET shall promptly notify CURAGEN of any event which could materially affect TOPOTARGET’s ability to supply Collaboration Product to CURAGEN hereunder, and shall provide to CURAGEN copies of any correspondence with any regulatory authority that relates to its manufacturing activities with respect to Collaboration Products.
