Common use of API Clause in Contracts

API. A. Client shall supply to Catalent for Processing, at Client’s sole cost, the API and applicable reference standards in quantities sufficient to meet Client’s requirements for each Product as further set forth in Article 4. Catalent shall serve as the importer of record and import the API on Client’s behalf and at Client’s expense. Prior to importation of any of the API by Catalent for Processing and delivery to Catalent by Client of any of the reference standard, Client shall provide to Catalent a copy of the API Certificate of Analysis and the API Material Safety Data Sheet, as amended, and any subsequent revisions thereto. Client shall be responsible for qualification of the API supplier and associated API testing. Client shall supply the reference standards, and Certificate of Analysis FOB the Facility no later than sixty (60) days before the scheduled Processing Date upon which such API will be used by Catalent. Upon receipt of the API, Catalent shall conduct identification testing of the API. Unless otherwise expressly required by the Specifications, Catalent shall have no obligation to test the API to confirm that it meets the associated specifications or Certificate of Analysis, or otherwise test the API. Catalent shall use the API solely and exclusively for Processing under this Agreement. B. All API provided by Client shall meet applicable Specifications that apply thereto, and shall be produced in accordance with all Applicable Laws. C. Catalent shall inspect API as received to verify its identity and, if expressly required to do so by the Specifications, shall give Client oral and written notice of any nonconformity with Specifications within thirty (30) calendar days of receipt of API by Catalent. Client shall provide a PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [***] DENOTES OMISSIONS. Certificate of Analysis with each delivery of API and such certificate shall be the basis for drug potency. D. Client shall retain title to API and all Client-Supplied Materials at all times, and Client shall bear the risk of loss thereof until the time API and/or Client-Supplied Materials are delivered to Catalent’s loading dock at its Facility, provided that Catalent’s risk of loss of API and other Client-supplied Materials shall be subject to Section 3.1(E), Section 5.3 and Article 14. E. If Catalent becomes liable to Client for loss of API or Client-Supplied Materials under the preceding paragraph, the measure of damages shall be limited to (1) the internal, actual total cost of all of Client’s materials, direct labor and services required to produce and inspect the replacement of such Drug; and (2) the internal, actual total cost to package and deliver replacement API to Catalent’s Facility.

API. A. Client shall supply to Catalent for Processing, at Client’s sole costcost and risk, the API and API, applicable reference standards and any other Client-supplied Materials, DDP (Incoterms 2010) the Facility in quantities sufficient to meet Client’s requirements for each Product Product, as further set forth in Article 47. Client shall deliver such items, together with associated certificates of analysis, to the Facility no later than [**] days before the Processing Date upon which such items will be used by Catalent. Client shall be responsible at its expense for securing any necessary export or import clearances or permits required in respect of supply to Catalent of such items. Catalent shall serve as the importer of record use such items solely and import the API on Client’s behalf and at Client’s expenseexclusively for Processing. Prior to importation delivery of any of the API by Catalent for Processing and delivery to Catalent by Client of any of the reference standardsuch items, Client shall provide to Catalent a copy of the API Certificate of Analysis all associated material safety data sheets, safe handling instructions and the API Material Safety Data Sheet, as amendedhealth and environmental information, and shall promptly provide any subsequent updates or revisions thereto. In addition, beginning no earlier than [**] months prior to the Commencement Date, Client shall deliver to Catalent a monthly report, together with the Rolling Forecast submitted pursuant to Section 7.1, which tracks the following supply chain information with respect to raw materials for each API batch ordered by Client for use in Product: order date, manufacture lot number, quantity, ship date, customs clearance date and arrival date at Catalent (the “API Procurement Tracking Report”). The API Procurement Tracking Report shall be responsible for qualification provided in substantially the form set forth in Attachment F. B. Within [**] days of the receipt of API supplier and associated API testing. Client shall supply the reference standards, and Certificate of Analysis FOB the Facility no later than sixty (60) days before the scheduled Processing Date upon which such API will be used or any other Client-supplied Materials by Catalent. Upon receipt of the API, Catalent shall conduct identification testing of the APIinspect and test such items to verify their identity. Unless otherwise expressly required by the Specifications, Catalent shall have no obligation to test the API such items to confirm that it meets they meet the associated specifications or Certificate certificate of Analysis, analysis or otherwise test otherwise; but in the API. event that Catalent shall use the API solely and exclusively for Processing under this Agreement. B. All API provided by Client shall meet applicable Specifications that apply thereto, and shall be produced in accordance detects a nonconformity with all Applicable Laws. C. Catalent shall inspect API as received to verify its identity and, if expressly required to do so by the Specifications, Catalent shall give Client prompt oral and written notice of such nonconformity. Catalent shall not be liable for any nonconformity with Specifications within thirty (30) calendar days defects in API or any other Client-supplied Materials, or in Product as a result of receipt defective API or any other Client-supplied Materials, unless Catalent failed to properly perform the foregoing obligations. Catalent shall follow Client’s reasonable written instructions in respect of return or disposal of defective API by Catalent. Client shall provide a PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [***] DENOTES OMISSIONS. Certificate of Analysis with each delivery of API or any other Client-supplied Materials, at Client’s sole cost and such certificate shall be the basis for drug potencyrisk. D. C. Client shall retain title to API and all any other Client-Supplied supplied Materials at all times, times and Client shall bear the risk of loss thereof until thereof, except and to the time extent any such loss arises from the gross negligence or willful misconduct of Catalent. Notwithstanding the foregoing, Catalent retains liability of up to [**] dollars ($[**]) for any loss or damage to API and/or Client-Supplied Materials are delivered per Batch in Process per event to the extent such loss or damage arises from the negligence of Catalent’s loading dock at its Facility, provided that Catalent’s risk of loss of API [**] Certain information in this document has been omitted and other Client-supplied Materials shall be subject filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to Section 3.1(E), Section 5.3 and Article 14the omitted portions. E. If Catalent becomes liable to Client for loss of API or Client-Supplied Materials under the preceding paragraph, the measure of damages shall be limited to (1) the internal, actual total cost of all of Client’s materials, direct labor and services required to produce and inspect the replacement of such Drug; and (2) the internal, actual total cost to package and deliver replacement API to Catalent’s Facility.

API. A. Client shall supply to Catalent for Processing, at Client’s 's sole cost, the API and applicable reference standards in quantities sufficient to meet Client’s 's requirements for each Product as further set forth in Article 4. Catalent shall serve as the importer of record and import the API on Client’s 's behalf and at Client’s 's expense. Prior to importation of any of the API by Catalent for Processing and delivery to Catalent by Client of any of the reference standard, Client shall provide to Catalent a copy of the API Certificate of Analysis and the API Material Safety Data Sheet, as amended, and any subsequent revisions thereto. Client shall be responsible for qualification of the API supplier and associated API testing. Client shall supply the reference standards, and Certificate of Analysis FOB the Facility no later than sixty (60) days before the scheduled Processing Date upon which such API will be used by Catalent. Upon receipt of the API, Catalent shall conduct identification testing of the API. Unless otherwise expressly required by the Specifications, Catalent shall have no obligation to test the API to confirm that it meets the associated specifications or Certificate of Analysis, or otherwise test the API. Catalent shall use the API solely and exclusively for Processing under this Agreement. B. All API provided by Client shall meet applicable Specifications that apply thereto, and shall be produced in accordance with all Applicable Laws. C. Catalent shall inspect API as received to verify its identity and, if expressly required to do so by the Specifications, shall give Client oral and written notice of any nonconformity with Specifications within thirty (30) calendar days of receipt of API by Catalent. Client shall provide a PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [***] DENOTES OMISSIONS. Certificate of Analysis with each delivery of API and such certificate shall be the basis for drug potency. D. Client shall retain title to API and all Client-Supplied Materials at all times, and Client shall bear the risk of loss thereof until the time API and/or Client-Supplied Materials are delivered to Catalent’s 's loading dock at its Facility, provided that Catalent’s 's risk of loss of API and other Client-supplied Materials shall be subject to Section 3.1(E), Section 5.3 and Article 14. E. If Catalent becomes liable to Client for loss of API or Client-Supplied Materials under the preceding paragraph, the measure of damages shall be limited to (1) the internal, actual total cost of all of Client’s 's materials, direct labor and services required to produce and inspect the replacement of such Drug; and (2) the internal, actual total cost to package and deliver replacement API to Catalent’s 's Facility.

API. A. Client shall supply to Catalent for Processing, at Client’s sole cost, the API and applicable reference standards in quantities sufficient to meet Client’s requirements for each Product as further set forth in Article 4. Catalent shall serve as the importer of record and import the API on Client’s behalf and at Client’s expense. Prior to importation of any of the API by Catalent for Processing and delivery to Catalent by Client of any of the reference standard, Client shall provide to Catalent a copy of the API Certificate of Analysis and the API Material Safety Data SheetSheet (“MSDS”), as amended, and any subsequent revisions thereto. Client shall be responsible for qualification of the API supplier and associated API testing. Client shall supply the reference standards, and Certificate of Analysis FOB the Facility no later than sixty (60) days before the scheduled Processing Date upon which such API will be used by Catalent. Upon receipt of the API, Catalent shall conduct identification testing of the API. Unless otherwise expressly required by the Specifications, Catalent shall have no obligation to test the API to confirm that it meets the associated specifications or Certificate of Analysis, or otherwise test the API. Catalent shall use the API solely and exclusively for Processing under this Agreement. B. All API provided by Client shall meet applicable Specifications that apply thereto, and shall be produced in accordance with all Applicable Laws. C. Catalent shall inspect API as received to verify its identity and, if expressly required to do so by the Specifications, shall give Client oral and written notice of any nonconformity with Specifications within thirty (30) calendar days of receipt of API by Catalent. Client shall provide a PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [***] DENOTES OMISSIONS. Certificate of Analysis with each delivery of API and such certificate shall be the basis for drug potency. D. Client shall retain title to API and all Client-Supplied Materials at all times, and Client shall bear the risk of loss thereof until the time API and/or Client-Supplied Materials are delivered to Catalent’s loading dock at its Facility, provided that Catalent’s risk of loss of API and other Client-supplied Materials shall be subject to Section 3.1(E), Section 5.3 and Article 14. E. If Catalent becomes liable to Client for loss of API or Client-Supplied Materials under the preceding paragraph, the measure of damages shall be limited to (1) the internal, actual total cost of all of Client’s materials, direct labor and services required to produce and inspect the replacement of such Drug; and (2) the internal, actual total cost to package and deliver replacement API to Catalent’s Facility.