Certain Development by Sutro Sample Clauses

Certain Development by Sutro. Notwithstanding anything to the contrary in this Agreement: (a) Sutro (or its designee) shall be responsible for conducting, at its own cost and expense, corrective, preventive, remediation and implementation activities in connection with a Linker-Payload manufacturing issue related to failure of purity specification and to provide, at its own cost and expense, a revised master batch record for GMP Manufacture of Linker-Payload (“Remediation Activities”). The Remediation Activities shall include incorporation of the following into the master batch record for GMP Manufacture of Linker-Payload: (i) [*] (ii) [*] (iii) [*] and (iv) all the preceding steps (i) to (iii) shall be introduced into the master batch record through a change control. Sutro shall also be responsible, at ▇▇▇▇▇’▇ expense, for the GMP Manufacture of a new GMP batch of Linker-Payload. Such expense shall be borne by Ipsen as part of the Cost of Goods for the Licensed Product, which Sutro will supply to Ipsen under Section 5.1. Under the oversight of the JMC, Sutro shall provide Ipsen with a report detailing the implementation and performance of each step plan described above, provide reports as reasonably necessary on the status of the Remediation Activities, and issue a quality certification evidencing completion of the Remediation Activities. [*] Without limiting Sutro’s obligations in this Section 4.3, Ipsen will have the right at its own discretion, at any time (but will not have the obligation), to take over the responsibility of the conduct of the Remediation Activities at ▇▇▇▇▇’▇ cost (including Sutro’s Internal Costs and External Expenses, if applicable) (“▇▇▇▇▇’▇ Cost”). (b) Sutro (or its designee) shall be responsible for preparing and providing Ipsen, at Sutro’s own cost and expense (except for item (iii) below): (i) [*] (ii) [*] (iii) [*]; and (iv) [*]. ((i), (iii) and (iv) together the “Module 3 Package,” for clarity, excluding (ii)). Each document of the Module 3 Package referred to in (i), (ii) and (iv) shall be made available to Ipsen on an on-going basis for ▇▇▇▇▇’▇ review and comments until the first IND Clearance for Licensed Product. As of the Effective Date, the Parties have agreed upon a proposed timeline of submission of the Module 3 Package set forth in Schedule 4.3(b). Once Sutro has delivered to Ipsen the last document of the Module 3 Package (the date of such delivery, the “Module 3 Delivery Date”), Sutro shall notify Ipsen in writing that the Module 3 Package was ...