Costs Included in Price. 3.3.1. Product manufactured according to the approved and registered specifications.
3.3.2. Estimated material costs. Material costs included in the pricing are best estimates based on Patheon’s current standards and specifications and do not include any extraordinary or custom raw materials. Final material costs will be provided after confirmation of specifications and formal quotations have been received from the suppliers. The cost of materials to AcelRx will be [*].
3.3.3. Procurement, storage, inventory control and Quality Control (“QC”) testing of all required raw materials to supply the Product, including storage of Client-supplied components to meet firm order requirements or such time as agreed between the parties to accommodate long lead time items.
3.3.4. Qualification and auditing of all raw material (with the exception of Client-supplied raw material). [*] = 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.
3.3.5. Active Pharmaceutical Ingredients (“API”) identity test. AcelRx will audit and approve the Vendor and ensure cGMP compliance. If Patheon is to release an API or other Client stipulated material based on “ID only”, AcelRx will ensure the required verification testing by an independent laboratory has been completed.
3.3.6. Standard certificate of analysis (“COA”) and Standard certificate of compliance (“COC”)
3.3.7. GMP batch release
3.3.8. GMP required retention samples and executed batch records retention API, bulk product and finished packaged product retention samples, and completed batch production records, as required by the cGMP Regulations or other governing regulations, for one year past the expiration date of the product.
3.3.9. Deviation investigations and copies of deviation reports
3.3.10. Batch Record copies for validation batches, first ten commercial batches, and one commercial batch per Year thereafter.
3.3.11. Common HPLC/GC columns, reagents, and lab supplies
3.3.12. Copy of the Annual Product Review Report. Patheon will supply on an annual basis all Product data in its control, including release test results, complaint test results, and all investigations (in manufacturing, testing, and storage), that Client reasonably requires in order to complete any filing under any applicable regulatory regime, including any Annual Report that ...
Costs Included in Price. 3.7.1.1. Product tested according to the approved and registered specifications. [*] = 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.
Costs Included in Price. 1.1.1. Stability testing program
