Common use of Active Materials and Qualification of Additional Sources of Supply Clause in Contracts

Active Materials and Qualification of Additional Sources of Supply. (a) Client will at its sole cost and expense deliver the Active Materials to Patheon in accordance with Section 2.1(f). If applicable, Patheon and the Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. The Active Materials will be held by Patheon on behalf of Client as set forth in this Agreement. Title to the Active Materials will at all times remain the property of Client. Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services. Client will be responsible for paying for all rejected Product that arises from defects in the Active Materials which could not be reasonably discoverable by Patheon using the test methods set forth in the Specifications. Client’s failure to supply Patheon with Active Materials in accordance with the timeframes set forth in Section 2.1(f) will not be deemed a breach of this Agreement. (b) If Client asks Patheon to qualify an additional source for the Active Material or any Component, Patheon may agree to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The parties will agree on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, this work at a minimum will include: (i) laboratory testing to confirm the Active Material meets existing specifications; (ii) manufacture of an experimental batch of Product that will be placed on [***] accelerated stability; and (iii) manufacture of [***] validation batches that will be placed on concurrent stability (one batch may be the registration batch if manufactured at full scale).

Active Materials and Qualification of Additional Sources of Supply. (a) Client will at its sole cost and expense deliver the Active Materials to Patheon in accordance with Section 2.1(f). If applicable, Patheon and the Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. The Active Materials will be held by Patheon on behalf of Client as set forth in this Agreement. Title to the Active Materials will at all times remain the property of Client. Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services. Client will be responsible for paying for all rejected Product that arises from defects in the Active Materials which could not be reasonably discoverable by Patheon using the test methods set forth in the Specifications. Client’s failure to supply Patheon with Active Materials in accordance with the timeframes set forth in Section 2.1(f) will not be deemed a breach of this Agreement. (b) If Client asks Patheon to qualify an additional source for the Active Material or any Component, Patheon may agree to will evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The parties will agree on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, this work at will be defined and mutually agreed upon based on applicable Comparability Protocols, FDA Guidance Documents, and commitments made to a minimum Regulatory Agency. Section 6.1(d) will include: (i) laboratory testing apply to confirm all Product manufactured using the newly approved Active Material meets existing specificationsor Component because of the limited material characterization that is performed on additional sources of supply. (c) Patheon will advise Client within three days of becoming aware of potential supply problems, including delays and/or delivery of non-conforming Active Material or Components from a Client designated additional source; and (ii) manufacture Patheon and Client will cooperate to reduce or eliminate any supply problems from these additional sources of an experimental batch of Product that supply. Client will be placed obligated to certify a Client designated source of supply on [***] accelerated stability; an annual basis at its expense and (iii) manufacture will provide Patheon with copies of [***] validation batches that these annual certifications. If Patheon is required to certify a Client designated additional sources of supply, it will be placed on concurrent stability (one batch may be the registration batch if manufactured do so at full scale)Client’s expense.

Active Materials and Qualification of Additional Sources of Supply. (a) Client will at its sole cost and expense deliver the Active Materials to Patheon in accordance with Section 2.1(f)0. If applicable, Patheon and the Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. The Active Materials and Client-Supplied Components will be held by Patheon on behalf of Client as set forth in this Agreement and (subject to Section 2.2) the risk of loss for the Active Materials and the Client-Supplied Components shall transfer to Patheon during any time when the Active Materials and the Client-Supplied Components are held by Patheon under this Agreement. Title to the Active Materials and Client-Supplied Components will at all times remain the property of Client. Any Active Materials and Client-Supplied Components received by Patheon will only be used by Patheon to perform the Manufacturing Services. Client will be responsible for paying for all rejected Product that arises from defects in the Active Materials which could not be reasonably discoverable by Patheon using the test methods set forth in the Specifications. Client’s failure to supply Patheon with Active Materials in accordance with the timeframes set forth in Section 2.1(f) will not be deemed a breach of this Agreement. (b) If Client asks Patheon to qualify an additional source for the Active Material or any Component, Patheon may agree to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The parties will negotiate in good faith to agree in writing on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, unless otherwise agreed by the parties, this work at a minimum will include: (i) laboratory testing to confirm the Active Material meets existing specifications; (ii) manufacture of an experimental batch of Product that will be placed on [***] three months accelerated stability; and (iii) manufacture of [***] three full-scale validation batches that will be placed on concurrent stability (one batch may be the registration batch if manufactured at full scale). Section 6.1(d) will apply to all Products manufactured using the newly approved Active Material or Component because of the limited material characterization that is performed on additional sources of supply. (c) Patheon will promptly advise Client if it encounters supply problems, including delays and/or delivery of non-conforming Active Material or Components from a Client designated additional source. Patheon and Client will cooperate to reduce or eliminate any supply problems from these additional sources of supply. Client will be obligated to certify all Client designated sources of supply on an annual basis at its expense and will provide Patheon with copies of these annual certifications. If Patheon agrees to certify a Client designated additional source of supply on behalf of Client, it will do so at Client’s expense, subject to prior written agreement of the parties.

Active Materials and Qualification of Additional Sources of Supply. (a) Client will at its sole cost and expense deliver the Active Materials to Patheon in accordance with Section 2.1(f). If applicable, Patheon and the Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. The Active Materials will be held by Patheon on behalf of Client as set forth in this Agreement. Title to the Active Materials will at all times remain the property of Client. Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing ServicesServices for Client. Client will be responsible for paying for all rejected Product that arises from defects in the Active Materials which could not be reasonably discoverable by Patheon using the test methods set forth in the Specifications. Client’s failure to supply Patheon with Active Materials in accordance with the timeframes set forth in Section 2.1(f) will not be deemed a breach of this Agreement.[* * *] (b) If Client asks Patheon to qualify an additional source for the Active Material or any Component, Patheon may agree shall agree, pending an agreed-upon scope of work as discussed below, to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The parties Parties will agree on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, this work at a minimum will include: (i) laboratory testing to confirm the Active Material meets existing specificationsSpecifications; (ii) manufacture of an experimental batch of Product that will be placed on [***] three months accelerated stability; and (iii) manufacture of [***] three full-scale validation batches that will be placed on concurrent stability (one batch may be the registration batch if manufactured at full scale). (c) Patheon will promptly advise Client if it encounters supply problems, including delays and/or delivery of non-conforming Active Material or Components from a Client designated additional source. Patheon and Client will cooperate to reduce or eliminate any supply problems from these additional sources of supply. [* * *]

Active Materials and Qualification of Additional Sources of Supply. (a) Client will at its sole cost and expense deliver the Active Materials to Patheon in accordance with Section 2.1(f). If applicable, Patheon and the Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. The Active Materials will be held by Patheon on behalf of Client as set forth in this Agreement. Title to the Active Materials will at all times remain the property of Client. Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services. Client will be responsible for paying for all rejected Product that arises from defects in the Active Materials which could not be reasonably discoverable by Patheon using the test methods set forth in the Specifications. Client’s failure to supply Patheon with Active Materials in accordance with the timeframes set forth in Section 2.1(f) will not be deemed a breach of this Agreement. (b) If Client asks Patheon to qualify an additional source for the Active Material or any Component, Patheon may agree to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The parties will agree on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, this work at a minimum will may include: (i) laboratory testing to confirm the Active Material meets existing specifications; (ii) manufacture of an experimental batch of Product that will be placed on [***] three months accelerated stability; and (iii) manufacture of [***] three full-scale validation batches that will be placed on concurrent stability (one batch may be the registration batch if manufactured at full scale). Section 6.1(d) will apply to all Product manufactured using the newly approved Active Material or Component because of the limited material characterization that is performed on additional sources of supply.

Active Materials and Qualification of Additional Sources of Supply. (a) Client will at its sole cost and expense deliver the Active Materials to Patheon in accordance with Section 2.1(f2.1(g). If applicable, Patheon and the Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. The Active Materials will be held by Patheon on behalf of Client as set forth in this Agreement. Title to the Active Materials will at all times remain the property of Client. Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing ServicesServices for Client hereunder. Client will be responsible for paying for all rejected Product that arises from defects in the Active Materials which (i) could not be reasonably discoverable by Patheon using the test methods set forth in the Specifications. Client’s ; and (ii) are not due to the failure by Patheon to supply Patheon with Active Materials perform the Manufacturing Services in accordance with the timeframes set forth in Section 2.1(f) will not be deemed a breach Specifications, cGMPs, or Applicable Laws or the wilful misconduct of this AgreementPatheon. (b) If Client asks Patheon to qualify an additional source for the Active Material or any Component, Patheon may agree to shall evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The parties will agree on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, this work at a minimum will include: (i) laboratory testing to confirm the Active Material meets existing specifications; (ii) manufacture of an experimental batch of Product that will be placed on [***] 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). (c) Patheon will promptly advise Client if it encounters supply problems, including delays and/or delivery of non-conforming Active Material or Components from a Client designated additional source; and Patheon and Client will cooperate to reduce or eliminate any supply problems from these additional sources of supply. Client will be obligated to certify all Client designated sources of supply on an annual basis at its expense and will provide Patheon with copies of these annual certifications. If Patheon agrees to certify a Client designated additional sources of supply on behalf of Client, it will do so at Client’s expense.

Active Materials and Qualification of Additional Sources of Supply. (a) Client Indivior will at its sole cost and expense deliver the Active Materials to Patheon in accordance with Section 2.1(f). If applicable, Patheon and the Client Indivior will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. ClientIndivior’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Client Indivior or ClientIndivior’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. The Active Materials will be held by Patheon on behalf of Client Indivior as set forth in this Agreement. Title to the Active Materials will at all times remain the property of ClientIndivior. Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services. Client Indivior will be responsible for paying for all rejected Product that arises from defects in the Active Materials which could not be reasonably discoverable by Patheon using the test methods set forth in the Specifications. Client’s failure to supply Patheon with Active Materials in accordance with the timeframes set forth in Section 2.1(f) will not be deemed a breach of this Agreement. (b) If Client Indivior asks Patheon to qualify an additional source for the Active Material or any Component, Patheon may agree to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The parties will agree on the scope of work to be performed by Patheon at ClientIndivior’s cost. For an Active Material, this work at a minimum will include: (i) laboratory testing to confirm the Active Material meets existing specificationsSpecifications; (ii) manufacture of an experimental batch of Product that will be placed on [***] three months accelerated stability; and (iii) manufacture of [***] three full-scale validation batches that will be placed on concurrent stability (one batch may be the registration batch if manufactured at full scale). Section 6.1(d) will apply to all Products manufactured using the newly approved Active Material or Component because of the limited material characterization that is performed on additional sources of supply. (c) Patheon will promptly advise Indivior if it encounters supply problems, including delays and/or delivery of non-conforming Active Material or Components from an Indivior designated additional source. Patheon and Indivior will cooperate to reduce or eliminate any supply problems from these additional sources of supply. Indivior will be obligated to certify all Indivior designated sources of supply on an annual basis at its expense and will provide Patheon with copies of these annual certifications. If Patheon agrees to certify a Indivior designated additional sources of supply on behalf of Indivior, it will do so at Indivior’s expense.

Active Materials and Qualification of Additional Sources of Supply. (a) Client will at its sole cost and expense deliver the Active Materials to Patheon in accordance with Section 2.1(f2.1(g). If applicable, Patheon and the Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. [*] The Active Materials will be held by Patheon on behalf of Client as set forth in this Agreement. Title to the Active Materials will at all times remain the property of Client. Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services. Client will be responsible for paying for all rejected Product that arises from defects in the Active Materials which could not be reasonably discoverable by Patheon using the test methods set forth in the Specifications. Client’s failure to supply Patheon with Active Materials in accordance with the timeframes set forth in Section 2.1(f) will not be deemed a breach of this Agreement. (b) If Client asks Patheon to qualify an additional source for the an Active Material or any Component, Patheon may agree to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The parties will agree on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, this work at a minimum will include: (i) laboratory testing to confirm the Active Material meets existing specifications; (ii) manufacture of an experimental batch Batch of Product that will be placed on [***] three months accelerated stability; and (iii) manufacture of [***] a mutually agreed upon number of full-scale validation batches Batches that will be placed on concurrent stability (one batch Batch may be the registration batch Batch if manufactured at full scale). Section 6.1(d) will apply to all Product manufactured using the newly approved Active Material or Component because of the limited material characterization that is performed on additional sources of supply. (c) If will promptly advise Client if it encounters supply problems, including delays and/or delivery of non-conforming Active Material or Components from a Client designated additional source. Patheon and Client will cooperate to reduce or eliminate any supply problems from these additional sources of supply. Client will be obligated to re-qualify all Client designated sources of supply on an annual basis at its expense and will provide Patheon with copies of these annual re-qualifications. If Patheon agrees to qualify or re-qualify Client designated additional sources of supply on behalf of Client, it will do so at Client’s expense. [*] = 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.

Active Materials and Qualification of Additional Sources of Supply. (a) Client will at its sole cost and expense deliver Deliver the Active Materials to Patheon in accordance with Section 2.1(f). If applicable, Patheon and the Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. The Active Materials will be held by Patheon on behalf of Client as set forth in this Agreement. Title to the Active Materials will at all times remain the property of Client, provided that, subject to 2.2, Patheon will be responsible for (including liable for any loss of) Active Materials once received by Patheon in accordance with this Agreement. Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services. Client will be responsible for paying for all rejected Product to the extent that the rejection arises from defects in the Active Materials which could not be reasonably discoverable by Patheon using the test methods set forth in the Specifications. Client’s failure to supply Patheon with Active Materials in accordance with the timeframes set forth in Section 2.1(f) will not be deemed a breach of this Agreement. (b) If Client asks Patheon to qualify an additional source for the Active Material or any Component, Patheon may agree to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The parties will agree in advance on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, this work at a minimum will include: (i) laboratory testing to confirm the Active Material meets existing specifications; (ii) manufacture Manufacture of an experimental batch of Product that will be placed on [***] three months accelerated stability; and (iii) manufacture Manufacture of [***] three full-scale validation batches that will be placed on concurrent stability (one batch may be the registration batch if manufactured Manufactured at full scale). Section 6.1(d) will apply to all Products Manufactured using the newly approved Active Material or Component because of the limited material characterization that is performed on additional sources of supply. (c) Patheon will promptly advise Client if it encounters supply problems, including delays and/or delivery of non-conforming Active Material or Components from a Client designated additional source. Patheon and Client will use Commercially Reasonable Endeavours to reduce or eliminate any supply problems from these additional sources of supply. Client will be obligated to certify all Client designated sources of supply on an annual basis at its expense and will provide Patheon with copies of these annual certifications. If Patheon agrees to certify Client designated additional sources of supply on behalf of Client, it will do so at Client’s expense.

Active Materials and Qualification of Additional Sources of Supply. (a) Client will at its sole cost and expense deliver the Active Materials to Patheon in accordance with Section 2.1(f2.1(g). If applicable, Patheon and the Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. The Active Materials and Client-Supplied Components will be held by Patheon on behalf of Client as set forth in this Agreement and the risk of loss for the Active Materials and Client-Supplied Components shall transfer to Patheon during any time while the Active Materials are held by Patheon under this Agreement. Title to the Active Materials and Client-Supplied Components will at all times remain the property of Client. Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services. Client will be responsible for paying for all rejected Product that arises from defects in the Active Materials which could not be reasonably discoverable by Patheon using the test methods set forth in the Specifications. Client’s failure to supply Patheon with Active Materials in accordance with the timeframes set forth in Section 2.1(f) will not be deemed a breach of this Agreement. (b) If Client asks Patheon to qualify an additional source for the Active Material or any Component, Patheon may agree to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The parties will agree in writing on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, unless otherwise agreed by the parties, this work at a minimum will include: (i) laboratory testing to confirm the Active Material meets existing specifications; (ii) manufacture of an experimental batch of Product that will be placed on [***] three months accelerated stability; and (iii) manufacture of [***] three full-scale validation batches that will be placed on concurrent stability (one batch may be the registration batch if manufactured at full scale). Section 6.1(d) will apply to all Product manufactured using the newly approved Active Material or Component because of the limited material characterization that is performed on additional sources of supply. (c) Patheon will promptly advise Client if it encounters supply problems, including delays and/or delivery of non-conforming Active Material or Components from a Client designated additional source; and Patheon and Client will cooperate to reduce or eliminate any supply problems from these additional sources of supply. Client will be obligated to certify all Client designated sources of supply on an annual basis at its expense and will provide Patheon with copies of these annual certifications. If Patheon agrees to certify a Client designated additional sources of supply on behalf of Client, it will do so at Client’s expense subject to written agreement of the parties.

Active Materials and Qualification of Additional Sources of Supply. (a) Client will at its sole cost and expense deliver the Active Materials to Patheon in accordance with Section 2.1(f2.1(g). If applicable, Patheon and the Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. [*] The Active Materials will be held by Patheon on behalf of Client as set forth in this Agreement. Title to the Active Materials will at all times remain the property of Client. Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services. Client will be responsible for paying for all rejected Product that arises from defects in the Active Materials which could not be reasonably discoverable by Patheon using the test methods set forth in the Specifications. Client’s failure to supply Patheon with Active Materials in accordance with the timeframes set forth in Section 2.1(f) will not be deemed a breach of this Agreement. (b) If Client asks Patheon to qualify an additional source for the an Active Material or any Component, Patheon may agree to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The parties will agree on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, this work at a minimum will include: (i) laboratory testing to confirm the Active Material meets existing specifications; (ii) manufacture of an experimental batch Batch of Product that will be placed on [***] three months accelerated stability; and (iii) manufacture of [***] a mutually agreed upon number of full-scale validation batches Batches that will be placed on concurrent stability (one batch Batch may be the registration batch Batch if manufactured at full scale). Section 6.1 (d) will apply to all Product manufactured using the newly approved Active Material or Component because of the limited material characterization that is performed on additional sources of supply. (c) If will promptly advise Client if it encounters supply problems, including delays and/or delivery of non-conforming Active Material or Components from a Client designated additional source. Patheon and Client will cooperate to reduce or eliminate any supply problems from these additional sources of supply. Client will be obligated to re-qualify all Client designated sources of supply on an annual basis at its expense and will provide Patheon with copies of these annual re-qualifications. If Patheon agrees to qualify or re-qualify Client designated additional sources of supply on behalf of Client, it will do so at Client’s expense.

Active Materials and Qualification of Additional Sources of Supply. (a) Client will at its sole cost and expense deliver the Active Materials to Patheon in accordance with Section 2.1(f2.1(g). If applicable, Patheon and the Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. [*] The Active Materials will be held by Patheon on behalf of Client as set forth in this Agreement. Title to the Active Materials will at all times remain the property of Client. Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services. Client will be responsible for paying for all rejected Product that arises from defects in the Active Materials which could not be reasonably discoverable by Patheon using the test methods set forth in the Specifications. Client’s failure to supply Patheon with Active Materials in accordance with the timeframes set forth in Section 2.1(f) will not be deemed a breach of this Agreement. (b) If Client asks Patheon to qualify an additional source for the an Active Material or any Component, Patheon may agree to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The parties will agree on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, this work at a minimum will include: (i) laboratory testing to confirm the Active Material meets existing specifications; (ii) manufacture of an experimental batch Batch of Product that will be placed on [***] three months accelerated stability; and (iii) manufacture of [***] a mutually agreed upon number of full-scale validation batches Batches that will be placed on concurrent stability (one batch Batch may be the registration batch Batch if manufactured at full scale). Section 6.1(d) will apply to all Product manufactured using the newly approved Active Material or Component because of the limited material characterization that is performed on additional sources of supply. (c) If will promptly advise Client if it encounters supply problems, including delays and/or delivery of non-conforming Active Material or Components from a Client designated additional source. Patheon and Client will cooperate to reduce or eliminate any supply problems from these additional sources of supply. Client will be obligated to re-qualify all Client designated sources of supply on an annual basis at its expense and will provide Patheon with copies of these annual re-qualifications. If Patheon agrees to qualify or re-qualify Client designated additional sources of supply on behalf of Client, it will do so at Client’s expense.

Active Materials and Qualification of Additional Sources of Supply. (a) Client will at its sole cost and expense deliver the Active Materials to Patheon in accordance with Section 2.1(f). If applicable, Patheon and the Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. The Active Materials will be held by Patheon on behalf of Client as set forth in this Agreement. Title to the Active Materials will at all times remain the property of Client. Unless so authorized by (a) Client; (b) a court appointed administrator, receiver or other insolvency specialist; or (c) otherwise under a judicial proceeding or a court decision, Patheon shall not at any time sell or offer for sale, assign, mortgage, lease or allow any lien or other security interest to be created upon, or permit any seizure or confiscation of, the Active Materials while in Patheon’s possession. Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services. Client will be responsible for paying for all rejected Product that arises from defects Within 10 Business Days of Patheon’s receipt of any Active Materials, Patheon shall review the accompanying cGMP documentation and incoming identification testing and perform any tests required in the Quality Agreement and the Specifications to confirm the Active Materials which could not be reasonably discoverable by Patheon using conform with the test methods set forth Specifications, the Quality Agreement, Applicable Law (including cGMP) and this Agreement and were received in the Specificationsquantity indicated in the shipment-related documentation. Client’s failure In the event Patheon notifies Client of non-conformity of any Active Material received by Patheon, Client shall have the right to supply confirm such findings of non-conformity. Client shall promptly investigate such deficiency and provide Patheon with instructions on how to handle the deficient Active Materials in accordance with the timeframes set forth in Section 2.1(f) will not be deemed a breach of this AgreementMaterial. (b) If Client asks Patheon to qualify an additional source for the Active Material or any Component, Patheon may agree to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The parties will agree on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, this work at a minimum will include: (i) laboratory testing to confirm the Active Material meets existing specifications; [**] and (ii) manufacture of an experimental batch of Product that will be placed on [***] accelerated stability]. (c) Patheon will promptly advise Client if it encounters supply problems, including delays and/or delivery of non-conforming Active Material or Components from a Client designated additional source; and (iii) manufacture Patheon and Client will cooperate to reduce or eliminate any supply problems from these additional sources of supply. Client will be obligated to certify all Client designated sources of supply on an annual basis at its expense and will provide Patheon with copies of these annual certifications. If Patheon agrees to certify a Client designated additional sources of supply on behalf of Client, it will do so at Client’s expense. [***] validation batches that will be placed on concurrent stability (one batch may be = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the registration batch if manufactured at full scale)Commission.