Common use of Changes or Modifications in Manufacturing Activities Clause in Contracts

Changes or Modifications in Manufacturing Activities. Sutro shall not make any changes to the Specifications, processes, Facilities, raw materials, raw material suppliers or any other item that would affect the Manufacturing activities related to the Product (a “Manufacturing Change”) that (a) would require a change to the applicable Drug Master File, (b) would be reasonably expected to cause SutroVax to be materially delayed obtaining any Regulatory Approval with respect to Vaccine Compositions or (c) causes the Product to not meet the Specification therefor (including the Activity Test with respect to Extract); without SutroVax’s prior written consent (not to be unreasonably withheld, conditioned or delated). Notwithstanding the foregoing, Sutro shall promptly make and implement such changes as are required by Applicable Law provided that, prior to implementation, Sutro shall provide notice thereof to SutroVax and confer with SutroVax with respect to its timelines, estimated effect on Price and other issues regarding such implementation. Sutro shall provide SutroVax at least [***] days’ written notice prior to implementing any Manufacturing Change. Sutro shall not make any change to the Specification for a Product without SutroVax’s prior written consent. In addition, SutroVax shall have the right to request changes in or modifications to the Specifications and Sutro will consider in good faith any such requested changes or modifications. All such changes or modifications shall be documented in writing and shall be signed by an authorized representative of SutroVax and Sutro. If such changes or modifications result in a material change in Sutro’s Manufacturing costs or lead times, the Parties shall agree upon an appropriate adjustment to the Price or in the delivery schedules, as the case may be, for Product(s) to be provided by Sutro hereunder. Sutro shall promptly implement any agreed upon changes to the Specifications.

Changes or Modifications in Manufacturing Activities. Sutro Supplier shall not make any changes to the Specifications, processes, FacilitiesFacility, raw materials, raw material suppliers or any other item in any manner that would affect the Manufacturing activities related to the Product (a “Manufacturing Change”) that (a) would require a change to the applicable Drug Master FileProduct, (b) would be reasonably expected to cause SutroVax to be materially delayed obtaining any Regulatory Approval with respect to Vaccine Compositions or (c) causes the Product to not meet the Specification therefor (including the Activity Test with respect to Extract); without SutroVaxBuyer’s prior written consent (approval, which shall not to be unreasonably delayed or withheld, conditioned or delated). Notwithstanding the foregoing, Sutro Supplier shall promptly make and implement such changes as are required by Applicable applicable Law (“Required Changes”), provided that, prior to implementation, Sutro all such Required Changes shall provide notice thereof be subject to SutroVax and confer with SutroVax Buyer’s written approval, including with respect to its the timelines, estimated effect on Price and other issues regarding such implementation. Sutro shall provide SutroVax at least [***] days’ written notice prior to implementing any Manufacturing Change. Sutro shall not make any change to the Specification for a Product without SutroVax’s prior written consent. In addition, SutroVax Buyer shall have the right to request changes in or modifications to the Specifications and Sutro will consider in good faith any such requested changes or modificationsSpecifications. All such changes or modifications shall be documented in writing and shall be signed by an authorized representative of SutroVax Buyer and SutroSupplier. If such changes or modifications result in a material change in SutroSupplier’s Manufacturing costs or lead times, the Parties shall agree upon an appropriate adjustment to the Price or in the delivery schedules, as the case may be, for Product(s) to be provided by Sutro Supplier hereunder. Sutro Supplier shall promptly implement any all such agreed upon changes to the Specifications. CONFIDENTIAL TREATMENT GRANTED UNDER C.F.R. SECTION 240.24b-2. [****] INDICATES OMITTED MATERIAL THAT HAS BEEN GRANTED CONFIDENTIAL TREATMENT BY THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION.