Common use of Local Distributors Clause in Contracts

Local Distributors. Where Product can only be lawfully sold or otherwise supplied in a country of the Territory by a Local Distributor, and the Sublicensee or its approved Affiliate cannot act as such Local Distributor pursuant to Clause 2.6 of the Sublicence Agreement, MPP may submit a written request to Novartis for Novartis’s approval for its Sublicensee to use a Third Party that is not an Affiliate as a Local Distributor in such country of the Territory. MPP’s request shall be supported by appropriate documentation on (a) the Sublicensee’s need to use a Local Distributor and (b) due diligence on the Third Party. Novartis, acting reasonably, shall consider the request and respond within thirty (30) days of receipt of all appropriate supporting documents from the MPP, with an approval or a written statement of why the request is not approved. Any Third Party approved in writing by Novartis pursuant to this Clause 18.6 shall be referred to in this Agreement as an “Approved Local Distributor”. The Sublicensee shall have the right, pursuant to the licence granted to it under Clause 2.1(b) of the Sublicence Agreement, to grant a sublicence (without the right to further sublicence) to such Approved Local Distributor, solely to the extent necessary for such Approved Local Distributor to obtain Regulatory Approval and/or sell or otherwise supply the Product in the relevant country of the Territory on behalf of the Sublicensee and subject to the Approved Local Distributor’s written agreement to be bound by the terms of the Sublicence Agreement. MPP shall be responsible for obtaining the Approved Local Distributor’s written agreement to be bound by the terms of the Sublicense Agreement. Clause 18.6 of this Agreement and Clause 2.6 of the Sublicence Agreement shall not be construed as conferring any right for the Approved Local Distributor or any Third Party to manufacture, distribute or supply Products for its own development, use, or sale of the Products inside or outside the relevant country of the Territory, to manufacture, distribute or supply of the Products to the Sublicensee and/or an Affiliate for any use or sale outside of the Field or outside of the relevant country of the Territory, or to manufacture, distribute or supply of the Products on behalf of any entity other than the Sublicensee. In the event an Approved Local Distributor fails to comply with any terms of this Agreement, Novartis shall have the right to withdraw its approval of such Approved Local Distributor with immediate effect by providing written notice to MPP. 6. This definition of “Third Party(ies)” is amended in its entirety in Schedule 1: Form of Sublicense to the Agreement is replaced in its entirety as follows:

Local Distributors. The Licensor acknowledges that in some countries of the Territory, for the Product to be lawfully sold or otherwise supplied, Regulatory Approval must be held in the name of a local entity registered in such country (“Local Distributor”). Where Product can only be lawfully sold or otherwise supplied in a country of the Territory by a Local Distributor, and the Sublicensee or its an approved Affiliate of the Licensee cannot act as such Local Distributor pursuant to Clause 2.6 of 2.6, the Sublicence Agreement, MPP Licensee may submit a written request to Novartis for Novartis’s approval for its Sublicensee the Licensor to use a Third Party that is not an Affiliate as a Local Distributor in such country of the Territorycountry. MPP’s Such request shall be supported by appropriate documentation on (a) the Sublicensee’s need to use a Local Distributor and (b) due diligence on the Third Party. NovartisThe Licensor, acting reasonably, shall consider the request and respond within thirty forty- five (3045) days of receipt of all appropriate supporting documents from the MPPLicensee, with an approval or a written statement of why the request is not approved. Any Third Party approved in writing by Novartis the Licensor pursuant to this Clause 18.6 2.6 shall be referred to in this Agreement as an “Approved Local Distributor”. The Sublicensee Licensee shall have the right, pursuant to the licence granted to it under Clause 2.1(b) of the Sublicence Agreement), to grant a sublicence (without the right to further sublicence) to such Approved Local Distributor, solely to the extent necessary for such Approved Local Distributor to obtain Regulatory Approval and/or sell or otherwise supply the Product in the relevant country of the Territory on behalf of the Sublicensee Licensee and subject to the Approved Local Distributor’s written agreement to be bound by the terms of the Sublicence Agreement. MPP shall be responsible for obtaining the Approved Local Distributor’s written agreement to be bound by the terms of the Sublicense this Agreement. Clause 18.6 of this Agreement and Clause 2.6 of the Sublicence Agreement shall not be construed as conferring any right for the Approved Local Distributor or any Third Party to manufacture, distribute or supply Products for its own development, use, or sale of the Products inside or outside the relevant country of the Territory, to for manufacture, distribute or supply of the Products to the Sublicensee Licensee and/or an Affiliate for any use or sale outside of the Field or outside of the relevant country of the Territory, or to for manufacture, distribute or supply of the Products on behalf of any entity other than the SublicenseeLicensee. Licensee shall ensure that Approved Local Distributor complies with all the terms of this Agreement as if it was the Licensee under this Agreement, and Licensee shall be liable for the acts and omissions of such Approved Local Distributor as if such acts and/or omissions were the act and/or omissions of the Licensee. In the event an Approved Local Distributor fails to comply with any terms of this Agreement, Novartis the Licensor shall have the right to withdraw its approval of such Approved Local Distributor with immediate effect by providing written notice to MPPthe Licensee, who will ensure that the Approved Local Distributor withdraws or otherwise doesn’t make use of the Market Authorization obtained in the name of the Approved Local Distributor. 611. This definition The original paragraph of “Third Party(ies)” is amended in its entirety in Clause 2.6 of the Schedule 1: Form of Sublicense to the Agreement is renumbered as Clause 2.7 and is replaced in its entirety as follows: