Manufacturing and Stability Testing Costs. For Products manufactured in the United States or Puerto Rico, [[Organization A:Organization]] may adjust the Price for inflation, based upon the preliminary number for any increase in the Producer Price Index pcu325412325412 for Pharmaceutical Preparation Manufacturing ("PPI") published by the United States Department of Labor, Bureau of Labor Statistics in August of the preceding Year compared to the final number for the same month of the Year prior to that, unless the parties otherwise agree in writing. On or about November 1st of each Year, [[Organization A:Organization]] will give Client a statement setting forth the calculation for the inflation adjustment to be applied in calculating the Price for the next Year. For Products manufactured outside the United States or Puerto Rico, [[Organization A:Organization]] may similarly adjust the Price for inflation using an inflation index to be agreed by the parties in a Product Agreement.

Stability Testing. GEMA shall be responsible for conducting stability studies in accordance with cGMP and ICH standards. Without limiting the foregoing, SAVARA shall have the right to review and approve(a) the protocols used for such stability studies and # a written report provided by GEMA to SAVARA upon completion of the stability studies. SAVARA shall have access to and the right to use all reference standards generated in the supply of API hereunder.

Stability Testing and Quality Reports. Upon execution of the Agreement, Aguettant shall conduct ​ stability testing ​ and provide to AcelRx ​ quality review reports of the Products and the stability data thereof as required for Regulatory Approval in the Territory. In case AcelRx or a Regulatory Authority requires any additional stability testing for the Products, all costs related to such additional stability testing shall be borne by AcelRx.

Stability Testing. [[Organization A:Organization]] will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in [Schedule C] to a Product Agreement. [[Organization A:Organization]] will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, [[Organization A:Organization]] will notify Client within ​, after which [[Organization A:Organization]] and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. [[Organization A:Organization]] will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws. [[Organization A:Organization]] will give Client all stability test data and results at Client's request.

Manufacturing and Stability Testing Costs. For Products manufactured in the United States or Puerto Rico, [[Organization A:Organization]] may adjust the conversion component of the Price and the annual stability testing costs for inflation, based upon the preliminary number for any increase in the Producer Price Index pcu325412325412 for Pharmaceutical Preparation Manufacturing (“PPI”) published by the United States Department of Labor, Bureau of Labor Statistics in June of the preceding Year compared to the final number for the same month of the Year prior to that (based on the average of the monthly changes over the 12-month period), unless the parties otherwise agree in writing. [[Organization A:Organization]] will give Client a statement setting forth the calculation for the inflation adjustment to be applied in calculating the Price for the next Year. For Products manufactured outside the United States or Puerto Rico, [[Organization A:Organization]] may similarly adjust the Price for inflation using an inflation index to be agreed by the parties in a Product Agreement.

Manufacturing and Stability Testing Costs. Patheon may adjust the conversion component of the Price and the annual stability testing costs for inflation, based upon the preliminary number for any increase in the “Indices de salaires mensuels de base des salaries de l'industrie pharmaceutique”, published by Les Entreprises du médicament (LEEM) during the prior Contractual Year (For illustration: http://www.leem.org/article/les-indices-des-salaires-de-lindustrie-pharmaceutique) in August of the preceding Year compared to the final number for the same month of the Year prior to that, unless the parties otherwise agree in writing. On or about ​ of each Year, Patheon will give Client a statement setting forth the calculation for the inflation adjustment to be applied in calculating the Price for the next Year.

Stability Testing. CCX will conduct stability testing on the API and Bulk Drug Products in accordance with the protocols set out in the Specifications. CCX will not make any changes to these testing protocols without prior written approval from VF. If a confirmed stability test failure occurs, CCX will notify VF within ​ Business Days, after which CCX and VF will have ​ Business Days to review the documents. CCX will provide VF with an opportunity to review and comment on CCX’s proposed response to its CMOs with respect to a confirmed stability test failure, which CCX shall reasonably consider. CCX and VF will jointly agree on the measures to be undertaken to investigate the cause of the failure, including which Party will bear the cost of the investigation. CCX will not be liable for these costs unless it has failed to perform the Manufacturing and/or the stability testing in accordance with the Specifications and cGMPs. CCX will give VF all stability test data and results promptly upon VF’s request. Notwithstanding anything to the contrary, taking any regulatory actions into account, CCX shall ​ with respect to the proceedings and methods to be to be undertaken in such investigations, and shall communicate with its CMOs regarding such matters. CCX shall provide to VF a copy of any related correspondence from its CMOs within ​ Business Days after CCX’s receipt thereof.

Stability Testing. [[Organization A:Organization]] will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in [Schedule C] to a Product Agreement. [[Organization A:Organization]] will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, [[Organization A:Organization]] will notify Client within ​ Business Day, after which ​. [[Organization A:Organization]] will not be liable for these costs unless it has failed to perform the Manufacturing Services and/or the stability testing in accordance with the Specifications and cGMPs. [[Organization A:Organization]] will give Client all stability test data and results promptly upon Client’s request.

Stability Testing. Patheon will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in [Schedule C]. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within ​, after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications and cGMPs. Patheon will give Client all stability test data and results at Client’s request.

Manufacturing and Stability Testing Costs. Patheon may adjust the conversion component of the Price and the annual stability testing costs for inflation, based upon the preliminary number for any increase in the inflation index stated in the Product Agreement in August of the preceding Year compared to the final number for the same month of the Year prior to that, unless the parties otherwise agree in writing. On or before ​ of each Year, Patheon will give Client a statement setting forth the calculation for the inflation adjustment to be applied in calculating the Price for the next Year. In no event shall any increase over the preceding Year pursuant to this Section 4.2(a) exceed ​ percent (​) during the first ​ Years of a Product Agreement. Thereafter, this restriction shall not apply.