Common use of Development and Manufacture of Product Clause in Contracts

Development and Manufacture of Product. 5.1 Piramal will perform all Services at the Facility, and will hold at the Facility all Equipment, Bolt Materials and other items used in the Services. Piramal may change the location of the Facility or use any additional facility for the performance of Services by providing Bolt at least [***] prior written notice, and receiving Bolt’s prior written consent, [***]. The Parties agree that [***]. Piramal will maintain the Facility and all Equipment required for the Manufacture of Product in a state of repair and operating ·efficiency consistent with the requirements of cGMP, the applicable Statement of Work and Applicable Law. 5.2 The scope of Services under a Statement of Work may be changed only through a written change order signed by both Parties (“Change Order”) in substantially the form attached hereto as Exhibit 2. If a change to a Statement of Work is identified by a Party, that Party will notify the other Party as soon as is reasonably possible. Piramal will provide Bolt with a Change Order containing a description of the required modifications and their effect on the scope, fees and timelines specified in the Statement of Work within approximately [***] of receiving or providing such notice. If the Change Order is not acceptable to Bolt, the Parties will use reasonable efforts to agree on a Change Order that is mutually acceptable. If practicable, Piramal will continue to work under the existing Statement(s) of Work during any such negotiations but will not commence work in accordance with the Change Order until it is authorized in writing by Bolt. Should Bolt request (in writing by Bolt’s primary Technical Contact or its Chief Business Officer) Piramal to perform additional services without there being a valid Change Order in place, Bolt shall be liable for the costs of such additional services at commercial rates consistent with the original Statement of Work. 5.3 Any change or modification to the Manufacturing Process or Specifications for any Product must be approved in writing in advance by Bolt and will be made in accordance with the provisions of the Quality Agreement. 5.4 Piramal will take and retain, for such period and in such quantities as may be required by cGMP and the Quality Agreement, samples of Product produced using the Manufacturing Process developed under this Agreement. 5.5 Piramal will keep complete and accurate original records (or certified copies thereof), including, without limitation, reports, accounts, notes, data, and records of all information and results obtained from performance of Services (collectively, the “Records”). All Records will be the sole property of Bolt. Upon Bolt’s written request, Piramal will promptly provide Bolt with copies of such Records. Piramal will not transfer, deliver or otherwise provide any such Records to any third party, without the prior written approval of Bolt. While in the possession or control of Piramal, Records will be made available for inspection, examination and copying by or on behalf of Bolt. All original Records of the Development and Manufacture of Product hereunder will be retained and archived by Piramal in accordance with the Quality Agreement for the period of time set forth therein (the “Retention Period”). Following the Retention Period, Piramal will not destroy the Records without first giving Bolt written notice and the opportunity to further store the Records or have the records transferred to Bolt or its designee, in each case at Bolt’s expense. 5.6 Should Bolt wish to cancel any Services, Bolt and Piramal shall meet to discuss the financial impact of the canceled Services and any associated credits or costs that Piramal may need to refund or charge Bolt. If the canceled Services involve one or more cGMP manufacturing slots, then Bolt will reimburse Piramal [***] as set forth in the applicable Statement of Work (but excluding the cost of any materials not yet purchased for such cGMP manufacturing and the costs included for related analytical testing) as follows: [***] [*** ] If Piramal is able to schedule another client to utilize the cancelled cGMP slot, then Piramal will reduce the above cancellation fee payable by Bolt by [***].

Development and Manufacture of Product. 5.1 Piramal will perform all Services at the Facility, and will hold at the Facility all Equipment, Bolt PLUS THERAPEUTICS Materials and other items used in the Services. Piramal may change the location of the Facility or use any additional facility for the performance of Services by providing Bolt PLUS THERAPEUTICS is given at least [***] prior written notice, and receiving BoltPLUS THERAPEUTICS’s prior written consent, [***]which consent will not be unreasonably withheld or delayed. The Parties agree that [***]it will be reasonable for PLUS THERAPEUTICS to withhold such consent pending satisfactory completion of a quality assurance audit and/or regulatory impact assessment of the new location or additional facility, as the case may be. Piramal will maintain the Facility and all Equipment required for the Manufacture of Product in a state of repair and operating ·efficiency consistent with the requirements of cGMP, the applicable Statement of Work cGMP and Applicable Law. 5.2 The scope of Services under a Statement of Work Project Proposal may be changed only through a written change order signed by both Parties (“Change Order”) in substantially the form attached hereto as Exhibit 2. If a change to a Statement of Work Project Proposal is identified by a Party, that Party will notify the other Party as soon as is reasonably possible. Piramal will provide Bolt PLUS THERAPEUTICS with a Change Order containing a description of the required modifications and their effect on the scope, fees and timelines specified in the Statement of Work Project Proposal within approximately [***] ten (10) business days of receiving or providing such notice. If the Change Order is not acceptable to BoltPLUS THERAPEUTICS, the Parties will use reasonable efforts to agree on a Change Order that is mutually acceptable. If practicable, Piramal will continue to work under the existing Statement(s) of Work during any such negotiations but will not commence work in accordance with the Change Order until it is authorized in writing by Bolt. Should Bolt request (in writing by Bolt’s primary Technical Contact or its Chief Business Officer) Piramal to perform additional services without there being a valid Change Order in place, Bolt shall be liable for the costs of such additional services at commercial rates consistent with the original Statement of Work.[***] 5.3 Any change or modification to the Manufacturing Process or Specifications for any Product must be approved in writing in advance by Bolt PLUS THERAPEUTICS and will be made in accordance with the provisions of the Quality Agreementrelevant QTA (if applicable). 5.4 If provided for in the Project Proposal, Piramal will may take and retain, for such period and in such quantities as may be required by cGMP and the Quality Agreementrelevant QTA, samples of Product produced using from the Manufacturing Process developed produced under this Agreement. Further, Piramal will submit such samples to PLUS THERAPEUTICS, upon PLUS THERAPEUTICS’s written request and at PLUS THERAPEUTICS’s sole cost and expense. 5.5 Piramal will keep complete and accurate original records (or certified copies thereof)records, including, without limitation, reports, accounts, notes, data, and records of all information and results obtained from performance of Services (collectively, the “Records”). All Records will be the sole property of BoltPLUS THERAPEUTICS. Upon BoltPLUS THERAPEUTICS’s written request, Piramal will promptly provide Bolt PLUS THERAPEUTICS with copies of such Records. Piramal will not transfer, deliver or otherwise provide any such Records to any third party, without the prior written approval of BoltPLUS THERAPEUTICS. While in the possession or control of Piramal, Records will be made available for inspection, examination and copying by or on behalf of BoltPLUS THERAPEUTICS. All original Records of the Development and Manufacture of Product hereunder will be retained and archived by Piramal in accordance with the Quality Agreement for the QTA between PLUS THERAPEUTICS and Piramal or in accordance with Applicable Laws, whichever period of time set forth therein is greater (the “Retention Period”). Following the Retention Period, Piramal will not destroy the Records without first giving Bolt PLUS THERAPEUTICS written notice and the opportunity to further store the Records or have the records transferred to Bolt or its designee, in each case at BoltPLUS THERAPEUTICS’s expense. 5.6 Should Bolt the PLUS THERAPEUTICS wish to cancel or reschedule any Services, Bolt then PLUS THERAPEUTICS and Piramal shall meet to discuss the financial impact of the canceled Services cancelled or rescheduled services and any associated credits or costs non-cancellable expenses that Piramal may need to refund or charge BoltPLUS THERAPEUTICS. If the canceled Services involve one cancelled or more rescheduled services include cancellation of cGMP manufacturing slots, slots then Bolt PLUS THERAPEUTICS will reimburse Piramal [***] as set forth in for the applicable Statement of Work (but excluding the cost of any materials not yet purchased for such cGMP manufacturing and the per batch costs included for related analytical testing) as follows: [***] [*** *] If Piramal is able to schedule another client to utilize the cancelled cGMP slot, then Piramal will reduce the above cancellation fee payable by Bolt by [***] [***] [***] [***] [***] [***] [***] [***] [***] [***].