Costs Not Included in Price. 3.4.1. API, reference standards, and Client-supplied materials to be supplied by AcelRx at no cost to Patheon.
3.4.2. API complete QC testing or special API testing requests. NOTE: This testing will be mandatory if AcelRx has not performed the verification testing specified in 3.3.5.
3.4.3. Stability testing program − Patheon can store and test in accordance with an agreed protocol and ICH guidelines. See proposal C-CRC-101285-R0.
3.4.4. Regulatory support and CTD files updating
3.4.5. Routine periodic auditing of component suppliers not currently on Patheon’s approved list
3.4.6. Annual Review (“AR”). Any additional data or report requested by AcelRx beyond the scope of cGMPs and customary FDA or other regulatory agencies requirements will be subject to an additional fee to be agreed upon between Patheon and AcelRx.
3.4.7. Technology transfer fees including packaging serialization readiness. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
3.4.8. Artworks origination and update costs including one off costs at suppliers.
3.4.9. Label copy change and batch record changes initiated by AcelRx.
3.4.10. Any specific visual inspection of the bulk or of the finished products outside of standard release testing.
3.4.11. Testing required to support OOS results or stability failures, testing required in support of complaint investigations and testing of products which exceeds routine testing that are not related to Patheon’s performance.
3.4.12. Copy of the Annual Product Review Report. Pricing of this service will depend on the level of complexity required by AcelRx.
3.4.13. The impact of new continued process verification (CPV) requirements.
Costs Not Included in Price. 3.7.2.1. Product manufactured and packaged according to the approved and registered specifications.
3.7.2.2. Raw material costs and packaging components. Procurement, storage, inventory control and Quality Control (“QC”) testing of all raw materials & packaging materials.
3.7.2.3. API, reference standards, and Client-supplied materials to be supplied by AcelRx at no cost to Patheon.
3.7.2.4. API complete QC testing or special API testing requests. NOTE: This testing will be mandatory if AcelRx has not performed the verification testing specified.
3.7.2.5. Annual Review (“AR”). Any additional data or report requested by AcelRx beyond the scope of cGMPs and customary FDA or other regulatory agencies requirements will be subject to an additional fee to be agreed upon between Patheon and AcelRx.
3.7.2.6. Testing required to support OOS results or stability failures, testing required in support of complaint investigations and testing of products which exceeds routine testing that are not related to Patheon’s performance.
Costs Not Included in Price. 1.2.1. Product manufactured and packaged according to the approved and registered specifications.
1.2.2. Raw material costs and packaging components. Procurement, storage, inventory control and Quality Control (“QC”) testing of all raw materials & packaging materials.
1.2.3. API, reference standards, and Client-supplied materials to be supplied by AcelRx at no cost to Patheon.
1.2.4. API complete QC testing or special API testing requests. NOTE: This testing will be mandatory if AcelRx has not performed the verification testing specified.
1.2.5. Any additional data or report requested by AcelRx beyond the scope of cGMPs and customary FDA or other regulatory agencies requirements will be subject to an additional fee to be agreed upon between Patheon and AcelRx.
1.2.6. Regulatory support (such as preparation of Annual Report and Chemistry, Manufacturing, and Controls (“CMC”) files). Regulatory support work is subject to an additional fee and will be charged at a rate of [*].
1.2.7. Testing required to support OOS results or stability failures, testing required in support of complaint investigations and testing of products which exceeds routine testing that are not related to Patheon’s performance.
Costs Not Included in Price. 4.1 API, reference standards, and client-supplied materials to be supplied by Cara Therapeutics at no cost to Patheon.
4.2 API complete QC testing or special API testing requests. NOTE this testing will be mandatory if Cara Therapeutics has not performed the verification testing specified in 3.6.
4.3 Stability testing program − Patheon can store and test in accordance with an agreed protocol and ICH guidelines.
4.4 Any additional data or report requested by Cara Therapeutics beyond the scope of cGMPs and customary FDA or other regulatory agencies requirements will be subject to an additional fee to be agreed upon between Patheon and Cara Therapeutics.
4.5 Regulatory support (such as preparation of Annual Report and Chemistry, Manufacturing, and Controls (“CMC”) files). Regulatory support work is subject to an additional fee and will be charged at a rate of [***].
4.6 Label copy change and batch record changes initiated by Cara Therapeutics.
4.7 Any specific visual inspection of the bulk or of the finished products outside of standard release testing.
4.8 Testing required to support OOS results or stability failures, testing required in support of complaint investigations and testing of products which exceeds routine testing that are not related to Patheon’s performance.
4.9 Copy of the Product Quality Review Report. Pricing of this service will depend on the level of complexity required by Cara Therapeutics.
Costs Not Included in Price. The parties may desire to include any of the following costs at a later time by agreement in writing or by amendment to this PA. [***]SCHEDULE C
