Manufacturing Subcontracting Clause Samples

Manufacturing Subcontracting. Each Party (or its Affiliate) may subcontract the performance of any of its CMC Development or Manufacturing activities with respect to the Licensed Compounds or Licensed Products in accordance with Section 4.2.4, provided that the applicable Subcontractor(s) satisfy any subcontractor criteria established by the JMC.

Manufacturing Subcontracting. Subject to Section 2.3, Livzon may perform any activities in support of its Manufacturing of Collaboration Product through subcontracting to a Third Party contractor or contract manufacturing organization; provided that: (a) none of Epirus’s rights hereunder are materially adversely affected as a result of such subcontracting; (b) any such Third Party subcontractor to whom Livzon discloses Confidential Information has entered into an appropriate written agreement obligating such Third Party to be bound by obligations of confidentiality and restrictions on use of such Confidential Information that are no less restrictive than the obligations in Article 10; (c) Livzon will retain or obtain ownership of any and all intellectual property (and patent rights covering such intellectual property) made by such Third Party in performing such services for Livzon that are necessary for the Development, Manufacturing, and/or Commercialization; and (d) Livzon shall at all times be responsible for the performance of such subcontractor. Any dispute regarding the subcontracting of Manufacturing activities shall be referred to the JSC for resolution pursuant to Section 3.2.4.

Manufacturing Subcontracting. REGENX shall have the right to engage one (1) or more Third Party subcontractors to perform any or all of REGENX’s Manufacturing obligations hereunder; provided that, (a) no such permitted subcontracting shall relieve REGENX of any obligation (except to the extent satisfactorily performed by such subcontractor) of any liability hereunder and REGENX shall be and remain fully responsible and liable therefor, and (b) the agreement pursuant to which REGENX engages any Third Party subcontractor shall (i) be consistent in all material respects with this Agreement, (ii) contain terms obligating such subcontractor to comply with the confidentiality, intellectual property and all other relevant provisions of this Agreement, (iii) contain terms obligating such subcontractor to permit Nippon Shinyaku rights of inspection, access and audit substantially similar to those provided to Nippon Shinyaku in this Agreement and (iv) [****], REGENX shall provide a complete, unredacted copy of the sublicense or amendment, as applicable, written in the English language for Nippon Shinyaku’s records; provided that REGENX may provide a copy of the sublicense to Nippon Shinyaku with commercially sensitive or confidential information redacted that is neither reasonably necessary to confirm REGENX’s compliance with this Agreement nor specific to the Licensed Products or REGENX Technology. REGENX shall ensure that each subcontractor accepts and complies with all of the applicable terms and conditions of this Agreement as if such permitted subcontractor were a party to this Agreement. REGENX hereby waives any requirement that Nippon Shinyaku exhaust any right, power or remedy, or proceed against any subcontractor for any obligation or performance under this Agreement prior to proceeding directly against REGENX. For clarity, Third Party Suppliers, as subcontractors, shall also be required to comply with the provisions of Section 5.2.3.