Manufacture by CMO Clause Samples
The 'Manufacture by CMO' clause defines the terms under which a Contract Manufacturing Organization (CMO) is responsible for producing goods or products on behalf of another party. This clause typically outlines the standards, specifications, and quality requirements the CMO must meet, as well as procedures for ordering, delivery timelines, and compliance with regulatory obligations. Its core function is to ensure that manufacturing responsibilities are clearly allocated and that the products are produced consistently and in accordance with agreed-upon standards, thereby reducing the risk of disputes and ensuring supply chain reliability.
Manufacture by CMO. For each Licensed Product, until the first Marketing Approval is obtained for such Licensed Product in the US or EU (via the EMA centralized procedure), all manufacturing of the Licensed Products for use in IND Enabling Studies or Clinical Trials (including for all purposes of this Section 4.8, any components, intermediates, or active pharmaceutical ingredients thereof, collectively “Product Materials”) by or on behalf of Arcus or an Arcus Partner shall be performed by one or more established, generally reliable Third Party contract manufacturers of pharmaceutical products (each, a “CMO”). *** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Manufacture by CMO. Subject to Section 2.1(b), all Manufacturing of the Products (excluding Line Extensions and NUCYNTA® oral solution, which is not currently Commercialized in the Territory) (the “Supplied Products”) (including the components, intermediates and active pharmaceutical ingredients of such Supplied Products, collectively, the “Product Materials”) for Commercialization in the Territory will be performed by one or more established, generally reliable Third Party contract manufacturers of pharmaceutical products engaged by Depomed (each, a “CMO”).
Manufacture by CMO. Subject to Section 2.1(b), all Manufacturing of the Products (excluding Line Extensions and NUCYNTA® oral solution, which is not currently Commercialized in the Territory) (the “Supplied Products”) (including the components, intermediates and active pharmaceutical ingredients of such Supplied Products, collectively, the “Product Materials”) for Commercialization in the Territory will be performed by one or more established, generally reliable Third Party contract manufacturers of pharmaceutical products engaged by Depomed (each, a “CMO”). Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions marked [***].
Manufacture by CMO. Unless otherwise agreed by the Parties, if Sangamo is performing the Sangamo Manufacturing Activities through one or more CMOs, then, in connection with the transition of any Manufacturing responsibilities to Biogen for a given Product, the Parties will discuss in good faith the assignment or transfer to Biogen of the agreements between Sangamo and one or more of such CMOs. Sangamo will use reasonable efforts to ensure that any such agreement between Sangamo and such a CMO that is specific to a Product under this Agreement permits Sangamo to assign such agreement to Biogen. 53 [*] = 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.
Manufacture by CMO. If Denali utilizes one or more CMOs to supply Option Product to Biogen, then as long as Denali uses [***] to perform its obligations and to exercise its rights under its applicable agreement(s) with such CMO, including seeking or exercising all remedies provided by such CMO under such agreement(s), then [***]. Unless otherwise agreed by the Parties, if Denali is performing the Denali Manufacturing Activities through one or more CMOs, then, in connection with the transition of any Manufacturing responsibilities to Biogen for a given Option Product, the Parties will discuss in good faith [***].
Manufacture by CMO. Unless otherwise agreed by the Parties, if Arrowhead is performing the Arrowhead Manufacturing Activities through one or more CMOs, then, in connection with the transition of Manufacturing responsibility to Takeda, the Parties will discuss in good faith the assignment or transfer to Takeda of the agreements between Arrowhead and one or more of such CMOs. Arrowhead will use reasonable efforts to ensure that any such agreement between Arrowhead and such a CMO that is specific to a Product under this Agreement permits Arrowhead to assign such agreement to Takeda.