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 a Product, Corium shall use commercially reasonable efforts to manufacture the Products for the pivotal bioequivalence studies and the product process validation batches.
(b) After the Launch Date of a Product and during the Term, Corium shall manufacture, test, release and supply Products to Xxxx in accordance with this Agreement.
(c) Corium shall supply exclusively to Xxxx, and Xxxx shall purchase exclusively from Corium for use and distribution in the Territory, all of Xxxx’x requirements for the Products. Corium shall not supply the Products to any Person, other than to Xxxx and its Affiliates, unless such Persons have agreed not to promote, market, sell or distribute the Products or any AB rated generic equivalent of such Products in the Territory. In the event that any such Person fails to comply with such restrictions, Corium shall immediately notify Xxxx and shall cause such Person to cease such activities.
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. (a) BioNumerik will be responsible for all manufacturing activities of the Product, including the use of existing or mutually agreed upon contractor-manufacturers for the manufacture and supply of the Product to Takeda, and Takeda agrees to purchase from BioNumerik, Takeda's entire requirement of the Product in the Territory under the conditions set forth herein. BioNumerik agrees to hire only contract-manufacturers that Takeda approves in writing before manufacturing by the contract-manufacturer begins, provided that Takeda will not unreasonably withhold approval of a prospective qualified contract-manufacturer. A list of potential contract-manufacturers that have already been approved by Takeda is set forth on Exhibit G hereto.
(b) BioNumerik hereby grants Takeda the right to audit manufacturing related operations for the Product, including but not limited to audits of the following: sources, procurement and utilization of raw materials, API production, Final Drug Product production, FDA inspections and reporting, operations involving importation or exportation of raw materials, API or Final Drug Product; label production, carton production, final packaged form of Product production, transportation, quality assurance, and shipping, and inspect the facilities of BioNumerik and its contract-manufacturers that manufacture the Product for the Territory for the foregoing purposes, all subject to Takeda reasonably cooperating with BioNumerik and its contract-manufacturers regarding the timing and scope of any such audits. BioNumerik agrees to substantially comply and to use Commercially Diligent Efforts to cause its contract-manufacturers to substantially comply with (i) Takeda's reasonable advice on quality assurance and (ii) all applicable laws, regulations, guidelines and standards governing manufacture of the Product. Both Parties agree to cooperate with each other in reducing the costs for the manufacture of the Product and in keeping a high standard of quality and regulatory compliance regarding the manufacturing process.
(c) BioNumerik will, at its cost, assure that appropriate back-up suppliers are available in the event that BioNumerik or its contract-manufacturers are unable to supply or are materially delayed in supplying the Product to Takeda.
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. 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 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.
b. After the Launch Date and during the Term, Perrigo shall manufacture, test, release, sell, market and distribute the Product in the Territory in accordance with this Agreement.
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. 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. 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.