Common use of Local Distributors Clause in Contracts

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 an approved Affiliate of the Licensee cannot act as such Local Distributor pursuant to Clause 2.6, the Licensee may submit a written request to the Licensor to use a Third Party that is not an Affiliate as a Local Distributor in such country. Such request shall be supported by appropriate documentation on (a) the need to use a Local Distributor and (b) due diligence on the Third Party. The Licensor, acting reasonably, shall consider the request and respond within forty- five (45) days of receipt of all appropriate supporting documents from the Licensee, with an approval or a written statement of why the request is not approved. Any Third Party approved in writing by the Licensor pursuant to this Clause 2.6 shall be referred to in this Agreement as an “Approved Local Distributor”. The Licensee shall have the right, pursuant to the licence granted to it under Clause 2.1(b), 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 Licensee and subject to the Approved Local Distributor’s written agreement to be bound by the terms of this Agreement. Clause 2.6 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, for manufacture, distribute or supply of the Products to the Licensee and/or an Affiliate for any use or sale outside of the Field or outside of the relevant country of the Territory, or for manufacture, distribute or supply of the Products on behalf of any entity other than the Licensee. 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, the Licensor shall have the right to withdraw its approval of such Approved Local Distributor with immediate effect by providing written notice to the 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. 11. The original paragraph of 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:

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 an the Sublicensee or its approved Affiliate of the Licensee cannot act as such Local Distributor pursuant to Clause 2.62.6 of the Sublicence Agreement, the Licensee MPP may submit a written request to the Licensor Novartis for Novartis’s approval for its Sublicensee to use a Third Party that is not an Affiliate as a Local Distributor in such countrycountry of the Territory. Such 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. The LicensorNovartis, acting reasonably, shall consider the request and respond within forty- five thirty (4530) days of receipt of all appropriate supporting documents from the LicenseeMPP, with an approval or a written statement of why the request is not approved. Any Third Party approved in writing by the Licensor Novartis pursuant to this Clause 2.6 18.6 shall be referred to in this Agreement as an “Approved Local Distributor”. The Licensee 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 Licensee Sublicensee and subject to the Approved Local Distributor’s written agreement to be bound by the terms of this 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, for to manufacture, distribute or supply of the Products to the Licensee Sublicensee and/or an Affiliate for any use or sale outside of the Field or outside of the relevant country of the Territory, or for to manufacture, distribute or supply of the Products on behalf of any entity other than the Licensee. 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 LicenseeSublicensee. In the event an Approved Local Distributor fails to comply with any terms of this Agreement, the Licensor Novartis shall have the right to withdraw its approval of such Approved Local Distributor with immediate effect by providing written notice to the 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 DistributorMPP. 116. The original paragraph This definition of Clause 2.6 of the “Third Party(ies)” is amended in its entirety in Schedule 1: Form of Sublicense to the Agreement is renumbered as Clause 2.7 and is replaced in its entirety as follows: