Manufacturing Facility. In manufacturing any Products, Supplier shall maintain an organization and facilities, including, without limitation, suitable equipment and tools, in accordance with standards generally accepted in the industry, and employ adequately trained and competent personnel in all functions. Supplier will keep complete and accurate records in all material respects with respect to Products it manufactures pursuant to this Agreement. Supplier shall, upon S&W’s request from time to time by providing at least 7 days prior notice, allow S&W or its representatives access to Supplier’s facilities to inspect the manufacture and assembly of the Products during reasonable hours, and provide S&W with such records in the possession of Supplier, as S&W may reasonably request, relating to the manufacture of Products and the source of any raw materials and components used in the Products; provided, however, in no event shall such inspection interfere with the business of Supplier.

Manufacturing Facility. All Product made under this Agreement shall be manufactured, packaged and stored only at Alba’s Facility. Alba’s Facility shall meet or exceed all applicable requirements for development, manufacture, sale and distribution to intended markets, including but not limited to cGMPs as they relate to Product. Alba also agrees to make any changes to its Facility and/or manufacturing processes necessary to comply with its obligations under this Agreement. Any changes made by Alba to its Facilities, processes and equipment shall be made only in accordance Article 6 (Improvements and Change to Process).

Manufacturing at Facility. [[Bachem CH:Organization]] shall Manufacture all Drug Substance supplied hereunder at the Facility. Manufacturing of Drug Substance may not be relocated from the Facility without Apellis’ prior written consent (in its sole discretion). Any such relocation of the Manufacturing of Drug Substance shall comply with the Applicable Laws (including cGMPs) and shall be made in accordance with Sections 4.2(b) and 4.2(c))], and the Quality Agreement, to the extent applicable. Without limiting the foregoing, in the event that [[Bachem CH:Organization]] desires to relocate the Manufacturing of Drug Substance, in connection with such relocation, the Parties shall discuss any amendments to this Agreement as reasonably requested by Apellis or the [[Bachem CH:Organization]] (as the case may be), including with respect to # the Delivery Terms, # provisions related to transfer of title, in each case, to take into account the relocation of such activities, and # the procedures to be followed to secure any Regulatory Approvals required by in connection with such relocation. [[Bachem CH:Organization]] shall be responsible for the costs of any relocation and any Drug Substance cost increase in connection with such relocation.

Manufacturing. Subject to the terms and conditions of this Agreement (including Section 5.3 and Annex 2) and the Manufacturing and Supply Agreement, Bioeq shall have the sole responsibility for the Manufacturing and supply of the Licensed Products to Licensee for Commercialization in the Field in the Territory.

Manufacturing. Allogene will have the exclusive right (subject to [Sections 2.2.4 and 4.5]) to Manufacture Allogene Licensed Products Targeting such Allogene Target itself or through one or more Affiliates or Third Parties selected by Allogene. Allogene will have no diligence obligations with respect to the Manufacture of Allogene Licensed Products except to the extent necessary to fulfill the Allogene Diligence Obligations. Allogene will be responsible for 100% of the associated costs for the manufacturing of Allogene Licensed Products.

Manufacturing. During the Term, [[FibroGen:Organization]] will have the exclusive right to Manufacture and supply the Licensed Compounds and Licensed Products itself or through one or more Affiliates or [[FibroGen:Organization]] CMOs for Exploitation in the Field in the Territory.

Manufacturing. Upon [[EPIZYME:Organization]]’s request, EISAI shall, as part of the transition plan to be mutually agreed by the Parties under [clause (c) above], at [[EPIZYME:Organization]]’s expense, transfer to [[EPIZYME:Organization]] (or its designee) any processes, documents, materials and other Know-How, to the extent the foregoing is Controlled by EISAI as of the effective date of termination and used in the Manufacture of Licensed Products in the Field as they exist as of the date of termination.

Manufacturing. Upon EISAI’s request, [[EPIZYME:Organization]] shall, as part of the transition plan to be mutually agreed by the Parties under clause (e) below, at EISAI’s expense, transfer to EISAI (or its designee) any processes, documents, materials and other Know-How, to the extent the foregoing is Controlled by [[EPIZYME:Organization]] as of the effective date of termination and used in the Manufacture of Licensed Products in the Field as they exist as of the date of termination; provided that, upon EISAI’s request and pursuant to a supply agreement to be negotiated in good faith by the Parties, at a purchase price equal to [[EPIZYME:Organization]]’s Cost of Goods for clinical supplies and ​ of [[EPIZYME:Organization]]’s Cost of Goods for commercial supplies, supply EISAI with clinical and commercial quantities of the Licensed Products for the [[EPIZYME:Organization]] Territory in the dosage strengths, formulations and presentations under Development or being Commercialized by [[EPIZYME:Organization]], in either case, as of the effective date of termination, until the earlier of: # ​ months after the effective date of termination; or # establishment by EISAI of an alternative supply for such Licensed Products on commercially reasonable terms.

Manufacturing. Evoke will Manufacture or have Manufactured Product by suppliers of its choice.

Manufacturing. Subject to the terms of this Agreement, Acceleron will have sole and exclusive control over all matters relating to manufacture and supply of Collaboration Molecules and Products, itself or through one or more Affiliates or Third Parties selected by Acceleron in its sole discretion.