Common use of API and Components Clause in Contracts

API and Components. (a) Client will [**] deliver the API and any Client-Supplied Components to the Manufacturing Site [**]. Client’s obligation will include [**]. Unless otherwise agreed in writing, Client or Client’s designated broker will be the “Importer” or “Importer of Record” (or equivalent, as understood under Applicable Laws) for API, Client-Supplied Components, drug products and intermediates imported to the Manufacturing Site, and Client is responsible for compliance with Applicable Laws relating to that role. For API or Client-Supplied Components which may be subject to import or export to or from [**], Client agrees that its vendors and carriers will comply with applicable requirements of Applicable Law. (b) Unless otherwise agreed in writing between the parties, the API and any Client-Supplied Components must be delivered by Client to the Manufacturing Site at least [**] before the scheduled manufacture date for Product covered by a Firm Order in sufficient quantity to enable Patheon to manufacture the agreed quantities of Product. Unless otherwise agreed, Patheon reserves the right to [**]. If (i) Client fails to deliver the API or Client-Supplied Components within the agreed time period, or (ii) such API fails to meet its Specifications, and, [**], Patheon is unable to manufacture Product on the scheduled date because of either scenario described in Section 3.3(b)(i) or 3.3(b)(ii), then [**], unless otherwise agreed. (c) Patheon will control the unloading of API and Client-Supplied Components arriving at the Manufacturing Site and Client will comply and ensure that its carrier complies with all reasonable directions of Patheon related to such unloading. The API and Client-Supplied Components will be held by Patheon on behalf of Client as set out in this Agreement and the Quality Agreement. The API and Client-Supplied Components will at all times remain the property of Client. Any API and Client-Supplied Components received by Patheon will only be used by Patheon to perform the Manufacturing Services. (d) Client will [**] that all shipments of API are accompanied by the required documentation as specified in the applicable Quality Agreement. (e) If Client asks Patheon to qualify an additional supplier for the API or any Component, the parties must agree on the scope of work to be performed by Patheon and the additional fees to be paid by Client. For any API or any Component, this work may include: (i) laboratory testing to confirm the API or Component meets existing Specifications; (ii) manufacture of an experimental batch of Product that will be placed on [**] stability; and (iii) manufacture of [**] validation batches that will be placed on concurrent stability [**] (f) Patheon will promptly advise Client in accordance with the Quality Agreement if it encounters API or Client-supplied Component problems, including delays or delivery of non-conforming API or Client-supplied Components from a Client designated additional supplier. The parties will cooperate to reduce or eliminate any such supply problems from these additional suppliers. If supply problems persist, [**]. Client will qualify or certify (as appropriate) all Client designated additional suppliers on an annual basis at its expense and will provide Patheon with copies of the relevant annual reports. If Patheon agrees to certify or qualify a Client designated additional supplier on behalf of Client, it will do so for an additional fee payable by Client.

API and Components. (a) Client will [**] at its sole cost and expense deliver the API and any Client-Supplied Components to the Manufacturing Site [***]. Client’s obligation will include [**]obtaining the release of the API and any Client-Supplied Components from the applicable customs agency and Regulatory Authority. Unless otherwise agreed in writing, Client or Client’s designated broker will be the “Importer” or “Importer of Record” (or equivalent, as understood under Applicable LawsLaws to Client) for API, Client-Supplied Components, drug products and intermediates imported to the Manufacturing Site, and Client is responsible for compliance with Applicable Laws to Client (and the cost of compliance) relating to that role. For API or Client-Supplied Components which may be subject to import or export to or from [**]the United States, Client agrees that its vendors and carriers will comply with applicable requirements of Applicable Lawthe U.S. Customs and Border Protection Service and the Customs Trade Partnership Against Terrorism. (b) Unless otherwise agreed in writing between the parties, the API and any Client-Supplied Components Components, together with any associated certificates of analysis, must be delivered by the Client to the Manufacturing Site at least [***] days before the scheduled manufacture date for Product covered by a Firm Order in sufficient quantity to enable Patheon to manufacture the agreed quantities of ProductProduct for that Firm Order. Unless otherwise agreedPatheon will store the quantity of API reasonably necessary for all Firm Orders free of charge. For purposes of this Agreement, the quantity of API delivered to Patheon reserves will be considered reasonable if it can be used for the right manufacture of any outstanding Firm Orders. Additional amounts of API whose storage is requested by Client may be subject to a fee of $[**]*] per month per pallet. If (i) Client fails to deliver the API or Client-Supplied Components within the agreed time period, or (ii) such API fails to meet its Specifications, period and, [**]making commercially reasonable efforts, Patheon is unable to manufacture all or part of the Product on the scheduled date because of either scenario described in and is unable to replace the lost manufacturing capacity with another Patheon client, the Firm Order will be considered cancelled by Client and Section 3.3(b)(i5.1(e) or 3.3(b)(ii), then [**], unless otherwise agreedwill apply. (c) Patheon will control the unloading of API and Client-Supplied Components arriving at the Manufacturing Site and Client will comply and ensure that its carrier complies with all reasonable related directions of Patheon related to such unloadingPatheon. The API and Client-Supplied Components will be held by Patheon on behalf of Client as set out in this Agreement Agreement, any safety data sheets, safe handling instructions and the Quality Agreementhealth and environmental information associated therewith. The API and Client-Supplied Components will at all times remain the property of Client. Any API and Client-Supplied Components received by Patheon will only be used by Patheon to perform the Manufacturing Services. (d) Client will [**] ensure that: (i) all delivered API meets the Specifications for that API; and (ii) all shipments of API are accompanied by the required documentation as specified in the applicable Quality Agreement. Patheon will collect samples of API and deliver them to a third party designated by Client for testing in accordance with the Processing Instructions. (e) If Client asks Patheon to qualify an additional supplier for the API or any Component, the parties must agree on the scope of work to be performed by Patheon and the additional fees to be paid by Client. For any API or any Component, this work may at a minimum will include: (i) laboratory ​ ​ ​ ​ ​ ​ testing to confirm the API or Component meets existing Specifications; (ii) manufacture of an experimental batch of Product that will be placed on [**] three months accelerated stability; and (iii) manufacture of [**] full-scale validation batches that will be placed on concurrent stability [**] (one batch may be the registration batch if manufactured at full scale). (f) Unless otherwise mutually agreed, Patheon will provide Client with monthly written inventory reports of API, Components (including Client-Supplied Components), Products and intermediates, in each case in the form generated by Patheon’s electronic inventory management platform, as well as monthly written cycle count reports. Patheon will promptly advise Client in accordance with the Quality Agreement if it encounters API or Client-supplied Component supply problems, including delays or delivery of non-conforming API or Client-supplied Components from a Client designated additional supplier. The parties will cooperate to reduce or eliminate any such supply problems from these additional suppliers. If supply problems persist, [**]. Client will qualify or certify (as appropriate) any and all new Client designated additional suppliers on an annual basis at its expense and will provide Patheon with copies of the relevant annual reports. If Patheon agrees to certify or qualify a Client designated additional supplier on behalf of Client, it will do so for an additional fee payable by Client.

API and Components. (a) With respect to Patheon’s manufacture of a particular Product, Client will [**] will, at its sole cost and expense, use reasonable efforts to deliver the API and any Client-Supplied Components for such Product to the applicable Manufacturing Site [**]Site, such delivery to be effected DDP (Incoterms 2010). Client’s obligation will include [**]obtaining the release of the API and any Client-Supplied Components from the applicable customs agency and Regulatory Authority. Unless otherwise agreed in writing, Client or Client’s designated broker will be the “Importer” or “Importer of Record” (or equivalent, as understood under Applicable Laws) for API, such API Confidential Page 12 of 47 and Client-Supplied Components, drug products and intermediates Components to the extent imported to the Manufacturing Site, and Client is responsible for compliance with Applicable Laws (and the cost of compliance) relating to that rolerole as the importer. For API or Client-Supplied Components which may be subject to import or export to or from [**]the United States, Client agrees that its vendors and carriers will comply with applicable requirements of Applicable Lawthe U.S. Customs and Border Protection Service and the Customs Trade Partnership Against Terrorism. (b) Unless otherwise agreed in writing between the partiesParties, the API and any Client-Supplied Components must shall be delivered by the Client to the Manufacturing Site at least [***] before the scheduled manufacture start date for Product covered by a Firm Order in sufficient quantity to enable Patheon to manufacture the agreed quantities of Product, and if such delivery is not timely made, then Patheon is not obligated to initiate such manufacture campaign (but will use reasonable efforts to do so, if the applicable API and any Client-Supplied Components are delivered by Client at time that allows Patheon to commence such manufacturing at the scheduled date) until a revised date, such date to be agreed by the parties, both acting reasonably and in good faith, such date to be as soon as practicable after such delivery by Client, taking into account Patheon’s other business commitments. Unless otherwise agreed, Patheon reserves the right to [**]refuse to store any quantity of API materially in excess of the amount necessary for the particular Manufacturing Services covered by a Firm Order, at its sole discretion at any time. If (i) Client fails to does not deliver the API or Client-Supplied Components within the agreed time period, or (ii) such API fails to meet its Specifications, period and, [**]making commercially reasonable efforts, Patheon is unable to manufacture Product on the scheduled date because of either scenario described the delay in such delivery, the delivery date for the Products under such Firm Order will be considered a postponement of the Release Date by Client to a new Release Date based on the revised manufacturing initiation date agreed to by the Parties as referred to above, and Section 3.3(b)(i5.1(e) or 3.3(b)(ii), then [**], unless otherwise agreedwill apply. Patheon will reschedule manufacture under a replacement purchase order at Client’s request subject to Patheon’s manufacturing slot availability at the time of the request. (c) Patheon will control the unloading of API and Client-Supplied Components arriving at the Manufacturing Site Site, and Client will comply and ensure that its carrier complies with all related reasonable unloading directions of Patheon related to such unloadingPatheon. The API and Client-Supplied Components will be held by Patheon on behalf of Client as set out in this Agreement and the Quality Agreement. The API and Client-Supplied Components will at all times remain the property of Client. Any API and Client-Supplied Components received by Patheon will only be used by Patheon to perform the applicable Manufacturing Services. (d) Client will [**] ensure that: (i) all delivered API meets the specifications for that API as set forth in the applicable Processing Instructions; and (ii) all shipments of API to Patheon are accompanied by the required documentation as specified in the applicable Quality Agreement. (e) If Client asks Patheon to qualify an additional supplier for the API or any Component, the parties Parties must agree on the scope of work to be performed by Patheon and the additional fees to be paid by ClientClient for such work performed. For any such API or any Component, this work may at a minimum will include: (i) laboratory testing to confirm the API or Component meets existing SpecificationsConfidential Page 13 of 47 specifications therefor as set forth in the applicable Processing Instructions; (ii) manufacture of an experimental batch of Product using such API or Component that will be placed on [**] three months accelerated stability; and (iii) manufacture of [**] full-scale validation batches that will be placed on concurrent stability [**] (one batch may be the registration batch if manufactured at full scale). (f) Patheon will promptly advise Client in accordance with the Quality Agreement if it encounters API or Client-supplied Component supply problems, including delays or and/or delivery of non-conforming API or Client-supplied Components from a Client designated additional supplier. The parties In such event, the Parties will cooperate to reduce or eliminate any such supply problems from these additional suppliers. If supply problems persist, [**]Patheon may suspend the Manufacturing Services affected by the problems until it is satisfied that the Client has resolved the problems with its supplier or appointed an alternative supplier. Client will qualify or certify (as appropriateaccording to typical industry standards) all Client designated additional suppliers on an annual basis at its expense and will provide Patheon with copies of the relevant these annual reportscertifications. If Patheon agrees to certify or qualify a Client designated additional supplier on behalf of Client, it will do so for an additional fee agreed to and payable by Client.

API and Components. (a) Client will [**] will, at its sole cost and expense, deliver the API and any Client-Supplied Components to the Manufacturing Site [**]DDP (Incoterms 2010). Client’s obligation with respect to such delivery will include [**]consist of obtaining the release of the API and any Client-Supplied Components from the applicable customs agency and Regulatory Authority. Unless otherwise agreed in writing, Client or Client’s designated broker will be the “Importer” or “Importer of Record” (or equivalent, as understood under Applicable Laws) for API, Client-Supplied Components, drug products and intermediates imported to the Manufacturing Site, and Client is responsible for compliance with Applicable Laws (and the cost of compliance) relating to that role. For API or Client-Supplied Components which may be subject to import or export to or from [**]the United States, Client agrees that its vendors and carriers will comply with applicable requirements of Applicable Lawthe U.S. Customs and Border Protection Service and the Customs Trade Partnership Against Terrorism. (b) Unless otherwise agreed in writing between the parties, the API and any Client-Supplied Components must be delivered by the Client to the Manufacturing Site at least [***] before the scheduled manufacture date for Product covered by a Firm Order in sufficient quantity to enable Patheon to manufacture the agreed quantities of Product. Unless otherwise agreed, Patheon reserves the right to [**]refuse to store any quantity of API in excess of the amount necessary for the Firm Order, at its sole discretion at any time but will use its commercially reasonable efforts to store such excess quantities. If (i) Client fails to deliver the API or Client-Supplied Components within the agreed time period, or (ii) such API fails to meet its Specifications, period and, [**]after making commercially reasonable efforts, Patheon is unable to manufacture Product on the scheduled date because of either scenario described in the delay, the Firm Order will be considered cancelled by Client and Section 3.3(b)(i5.1(e) or 3.3(b)(ii), then [**], unless otherwise agreedwill apply. (c) Patheon will control the unloading of API and Client-Supplied Components arriving at the Manufacturing Site and Client will comply and ensure that its carrier complies with all reasonable related directions of Patheon related to such unloadingPatheon. The API and Client-Supplied Components will be held by Patheon on behalf of Client as set out in this Agreement and the Quality Agreement. The API and Client-Supplied Components will at all times remain the property of Client. Any API and Client-Supplied Components received by Patheon will only be used by Patheon to perform the Manufacturing Services. (d) Client will [**] ensure that: (i) all delivered API meets the specifications for that API and (ii) all shipments of API are accompanied by the required documentation as specified in the applicable Quality Agreement. (e) If Client asks Patheon to qualify an additional supplier for the API or any Component, the parties must agree on the scope of work to be performed by Patheon and the additional fees to be paid by Client. For any API or any Component, this work may at a minimum will include: (i) laboratory testing to confirm the API or Component meets existing Specificationsspecifications; (ii) manufacture of an experimental batch of Product that will be placed on [***] accelerated stability; and (iii) manufacture of [**] full-scale validation batches that will be placed on concurrent stability [**] (f) one batch may be the registration batch if manufactured at full scale). Patheon will promptly advise Client in accordance with the Quality Agreement if it encounters API or Client-supplied Supplied Component or Component supply problems, including delays or delivery of non-conforming API or Client-supplied Components from a Client designated additional supplier. The parties will cooperate to reduce or eliminate any such supply problems from these additional suppliers. If supply problems persist, [**]Patheon may suspend the Manufacturing Services affected by the problems until it is satisfied that the Client has resolved the problems with its supplier or appointed an alternative supplier. Client will qualify or certify (as appropriate) all Client designated additional suppliers on an annual basis at its expense and will provide Patheon with copies of the relevant annual reports. If Patheon agrees to certify or qualify a Client designated additional supplier on behalf of Client, it will do so for an additional agreed-upon fee payable by Client.

API and Components. (a) Client will [**] at its sole cost and expense deliver the API and any Client-Supplied Components to the Manufacturing Site [**]DDP (Incoterms 2010). Client’s obligation will include [**]obtaining the release of the API and any Client-Supplied Components from the applicable customs agency and Regulatory Authority. Unless otherwise agreed in writing, Client or Client’s designated broker will be the “Importer” or “Importer of Record” (or equivalent, as understood under Applicable Laws) for API, Client-Supplied Components, drug products and intermediates imported to the Manufacturing Site, and Client is responsible for compliance with Applicable Laws (and the cost of compliance) relating to that role. For API or Client-Supplied Components which may be subject to import or export to or from [**]the United States, Client agrees that its vendors and carriers will comply with applicable requirements of Applicable Lawthe U.S. Customs and Border Protection Service and the Customs Trade Partnership Against Terrorism. (b) Unless otherwise agreed in writing between the parties, the API and any Client-Supplied Components must be delivered by the Client to the Manufacturing Site at least [**] 45 days before the scheduled manufacture date for Product covered by a Firm Order in sufficient quantity to enable Patheon to manufacture the agreed quantities of Product. Unless otherwise agreed, Patheon reserves the right to [**]refuse to store any quantity of API in excess of the amount necessary for the Firm Order, at its sole discretion at any time. If (i) Client fails to deliver the API or Client-Supplied Components within the agreed time period, or (ii) such API fails to meet its Specifications, period and, [**]making commercially reasonable efforts, Patheon is unable to manufacture Product on the scheduled date because of either scenario described in the delay, the Firm Order will be considered cancelled by Client and Section 3.3(b)(i5.1(e) or 3.3(b)(ii), then [**], unless otherwise agreedwill apply. (c) Patheon will control the unloading of API and Client-Supplied Components arriving at the Manufacturing Site and Client will comply and ensure that its carrier complies with all reasonable related directions of Patheon related to such unloadingPatheon. The API and Client-Supplied Components will be held by Patheon on behalf of Client as set out in this Agreement and the Quality Agreement. The API and Client-Supplied Components will at all times remain the property of Client. Any API and Client-Supplied Components received by Patheon will only be used by Patheon to perform the Manufacturing Services. (d) Client will [**] ensure that: (i) all delivered API meets the specifications for that API; and (ii) all shipments of API are accompanied by the required documentation as specified in the applicable Quality Agreement. (e) If Client asks Patheon to qualify an additional supplier for the API or any Component, the parties must agree on the scope of work to be performed by Patheon and the additional fees to be paid by Client. For any API or any Component, this work may at a minimum will include: (i) laboratory testing to confirm the API or Component meets existing Specificationsspecifications; (ii) manufacture of an experimental batch of Product that will be placed on [**] three months accelerated stability; and (iii) manufacture of [**] full-scale validation batches that will be placed on concurrent stability [**] (one batch may be the registration batch if manufactured at full scale). (f) Patheon will promptly advise Client in accordance with the Quality Agreement if it encounters API or Client-supplied Component supply problems, including delays or delivery of non-conforming API or Client-supplied Components from a Client designated additional supplier. The parties will cooperate to reduce or eliminate any such supply problems from these additional suppliers. If supply problems persist, [**]Patheon may suspend the Manufacturing Services affected by the problems until it is satisfied that the Client has resolved the problems with its supplier or appointed an alternative supplier. Client will qualify or certify (as appropriate) all Client designated additional suppliers on an annual basis at its expense and will provide Patheon with copies of the relevant annual reports. If Patheon agrees to certify or qualify a Client designated additional supplier on behalf of Client, it will do so for an additional fee payable by Client.