Common use of DEVELOPMENT AND REGISTRATION Clause in Contracts

DEVELOPMENT AND REGISTRATION. 3.1 As of the Effective Date and subject always to MSD's retained rights to the Patents, the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture, and commercialisation of the Products to be sold or supplied by the Licensee in the Territory under this Agreement. 3.2 Licensee agrees that it will manufacture the Substance and the Product in a manner consistent with (i) WHO Pre-qualification standards; or (ii) the standards of any SRA. Licensee will not sell any Product without WHO Prequalification or SRA approval, or through any provisional or emergency use authorizations available through WHO or an SRA, and will comply with applicable regulatory requirements in the country of manufacturing and the country of sale. 3.3 Licensee shall submit a complete file for WHO Pre-qualification or any SRA approval within 36 months from the Effective Date for any existing formulation of the Products, or within a period to be agreed among MSD, MPP and Licensee for any new formulation of the Product. Licensee will diligently pursue such applications following submission. The Licensee agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity in the Territory in relation to any data relating to the Products. 3.4 For the period beginning from the Effective Date, within 10 Business Days following the end of each Agreement Quarter, Licensee shall provide MPP with a quarterly written report covering all its activities related to the development and testing of all Products and/or Substance (as permitted and to the extent applicable) and the obtaining of necessary governmental approvals; these shall include (but is not limited and to the extent applicable and permitted) to its (a) Products and/or Substance in its development pipeline, (b) status of development of each Product and/or Substance in development,

DEVELOPMENT AND REGISTRATION. 3.1 4.1 As of the Sublicence Effective Date and subject always to MSD's Novartis’s retained rights to the PatentsManufacturing Patent and the Patents (and those of its licensees), the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture, manufacture and commercialisation of the Products to be sold or supplied orsupplied by the Licensee in the Field in the Territory under this Agreement. 3.2 4.2 The Licensee agrees that it will manufacture the Substance and the distribute Raw Materials and Product pursuant to this Agreement in a manner consistent full compliance with (i) WHO Pre-pre- qualification standards; or (ii) GMP and GDP and (ii) the standards of any SRAStringent Regulatory Authority. Where such standards are not yet available, the Licensee will not sell any Product without obtain temporary approval through a WHO Prequalification or SRA approvalExpert Review Panel, or through any provisional or emergency use authorizations available through WHO or an SRA, as appropriate and will comply with applicable regulatory requirements if applicable. 4.3 The Licensee shall obtain from the relevant authorities in the each country of manufacturing the Territory and maintain in force, as appropriate, all health registrations, permissions, consents and regulatory authorisations relating to the importation, manufacture and sale of the Products (including but not limited to Import Waivers where applicable) which are necessary to enable the Products to be sold or supplied in each country of salethe Territory in accordance with this Agreement. 3.3 4.4 Licensee shall submit a complete file for WHO Pre-qualification or any SRA Stringent Regulatory Authority approval as soon as possible and in any event not later than within 36 months from the Sublicence Effective Date for any existing formulation of in each case using the Products, or within a period to be agreed among MSD, MPP fastest approval route possible and Licensee for any new formulation of the Product. Licensee will diligently pursue such applications following submission. . 4.5 The Licensee agreesshall file for Regulatory Approval for the Product before the Relevant Regulatory Authority in each country of the Territory as soon as possible and in any event not later than 36 months from the Sublicense Effective Date and will diligently pursue such applications following submission. 4.6 If the Licensee sells, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity supplies or otherwise disposes of any Product in the Territory in relation but has not obtained the necessary approvals as per this Agreement, the Licensor shall be entitled to any data relating immediately terminate this Agreement by providing written notice to the ProductsLicensee. 3.4 For the period beginning from the Effective Date, within 10 Business Days following the end of each Agreement Quarter, Licensee shall provide MPP with a quarterly written report covering all its activities related to the development and testing of all Products and/or Substance (as permitted and to the extent applicable) and the obtaining of necessary governmental approvals; these shall include (but is not limited and to the extent applicable and permitted) to its (a) Products and/or Substance in its development pipeline, (b) status of development of each Product and/or Substance in development,

DEVELOPMENT AND REGISTRATION. 3.1 As of the Effective Date and subject always to MSD's AbbVie’s retained rights to the AbbVie Patents, the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture, manufacture and commercialisation of the Licensed Products to be sold or supplied by the Licensee in the Territory under this Agreement. 3.2 Licensee will be solely responsible at its expense for making or having made all of its respective requirements for the Licensed Products in conformity with all applicable specifications in the Territory and will hold all relevant authorizations and permits required in this respect. 3.3 Licensee agrees that it will manufacture the Substance Licensed Compounds and the Licensed Product in a manner consistent with (i) WHO PreWorld Health Organization (“WHO”) pre-qualification standards; or (ii) the standards of any SRAStringent Regulatory Authority, as defined by the WHO. Where such approvals are not yet available, the Licensee will not sell any Product without obtain temporary approval through a WHO Prequalification or SRA approval, or through any provisional or emergency use authorizations available through WHO or an SRA, and Expert Review Panel. 3.4 The Licensee will comply with applicable regulatory requirements obtain from the relevant authorities in the country Territory and maintain in force all health registrations, permissions, consents and regulatory authorisations relating to the importation, manufacture and sale of manufacturing the Licensed Products which are necessary to enable the Licensed Products to be sold or supplied in the Territory in accordance with this Agreement. Licensor and the country of sale. 3.3 Licensee shall submit a complete file for WHO Pre-qualification or any SRA approval within 36 months from shall, as soon as practicable after the Effective Date for any existing formulation Date, confer to agree upon reasonable milestones towards the registration of the Licensed Products, or within a period to be agreed among MSD, MPP and Licensee for any new formulation of the Product. Licensee will diligently pursue such applications following submission. The Licensee agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity in the Territory in relation to any data relating to the Licensed Products. 3.4 For the period beginning from the Effective Date, within 3.5 Within 10 Business Days following the end of each Agreement Quarter, Licensee shall provide MPP Licensor with a quarterly written report covering all its activities related to setting forth the development and testing of all Products and/or Substance (as permitted and to the extent applicable) and the obtaining of necessary governmental approvals; these shall include (but is not limited and to the extent applicable and permitted) to its (a) Products and/or Substance in its development pipeline, (b) status of development and regulatory filing, in any country, of each Product and/or Substance the Licensed Compound and Licensed Product, in development,accordance with the reporting template as set forth in Exhibit F. The Parties agree to meet on a quarterly basis regarding such reports and also review development and filing status of Licensed Products. Licensor agrees that information contained in quarterly and other such reports shall be treated as Confidential Information; provided, however, that such information may be shared with AbbVie (with AbbVie treating such reports as Confidential Information); and that aggregated data may be publicly disclosed by Licensor. 3.6 The Licensee will manufacture and sell the Licensed Products and Licensed Compounds in accordance with all laws and regulations relevant to the manufacture and sale of the Licensed Products and Licensed Compounds and in accordance with good industry practice.

DEVELOPMENT AND REGISTRATION. 3.1 As of the Effective Date and subject always to MSD's retained rights to the Patents, the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture, and DocuSign Envelope ID: 4CE20236-04CA-4B30-8D1A-9D3D06558FC4 commercialisation of the Products to be sold or supplied by the Licensee in the Territory under this Agreement. 3.2 Licensee agrees that it will manufacture the Substance and the Product in a manner consistent with (i) WHO Pre-qualification standards; or (ii) the standards of any SRA. Licensee will not sell any Product without WHO Prequalification or SRA approval, or through any provisional or emergency use authorizations available through WHO or an SRA, and will comply with applicable regulatory requirements in the country of manufacturing and the country of sale. 3.3 Licensee shall submit a complete file for WHO Pre-qualification or any SRA approval within 36 months from the Effective Date for any existing formulation of the Products, or within a period to be agreed among MSD, MPP and Licensee for any new formulation of the Product. Licensee will diligently pursue such applications following submission. The Licensee agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity in the Territory in relation to any data relating to the Products. 3.4 For the period beginning from the Effective Date, within 10 Business Days following the end of each Agreement Quarter, Licensee shall provide MPP with a quarterly written report covering all its activities related to the development and testing of all Products and/or Substance (as permitted and to the extent applicable) and the obtaining of necessary governmental approvals; these shall include (but is not limited and to the extent applicable and permitted) to its (a) Products and/or Substance in its development pipeline, (b) status of development of each Product and/or Substance in development,

DEVELOPMENT AND REGISTRATION. 3.1 As of the Effective Date and subject always to MSD's retained rights to the Patents, the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture, and DocuSign Envelope ID: AA5A3FE2-ED27-4E48-BA92-55B70228604C commercialisation of the Products to be sold or supplied by the Licensee in the Territory under this Agreement. 3.2 Licensee agrees that it will manufacture the Substance and the Product in a manner consistent with (i) WHO Pre-qualification standards; or (ii) the standards of any SRA. Licensee will not sell any Product without WHO Prequalification or SRA approval, or through any provisional or emergency use authorizations available through WHO or an SRA, and will comply with applicable regulatory requirements in the country of manufacturing and the country of sale. 3.3 Licensee shall submit a complete file for WHO Pre-qualification or any SRA approval within 36 months from the Effective Date for any existing formulation of the Products, or within a period to be agreed among MSD, MPP and Licensee for any new formulation of the Product. Licensee will diligently pursue such applications following submission. The Licensee agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity in the Territory in relation to any data relating to the Products. 3.4 For the period beginning from the Effective Date, within 10 Business Days following the end of each Agreement Quarter, Licensee shall provide MPP with a quarterly written report covering all its activities related to the development and testing of all Products and/or Substance (as permitted and to the extent applicable) and the obtaining of necessary governmental approvals; these shall include (but is not limited and to the extent applicable and permitted) to its (a) Products and/or Substance in its development pipeline, (b) status of development of each Product and/or Substance in development,

DEVELOPMENT AND REGISTRATION. 3.1 As of the Effective Date and subject always to MSD's retained rights to the Patents, the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture, and DocuSign Envelope ID: 2EDB93D3-290C-4578-91F8-9E7C2C9AB42E commercialisation of the Products to be sold or supplied by the Licensee in the Territory under this Agreement. 3.2 Licensee agrees that it will manufacture the Substance and the Product in a manner consistent with (i) WHO Pre-qualification standards; or (ii) the standards of any SRA. Licensee will not sell any Product without WHO Prequalification or SRA approval, or through any provisional or emergency use authorizations available through WHO or an SRA, and will comply with applicable regulatory requirements in the country of manufacturing and the country of sale. 3.3 Licensee shall submit a complete file for WHO Pre-qualification or any SRA approval within 36 months from the Effective Date for any existing formulation of the Products, or within a period to be agreed among MSD, MPP and Licensee for any new formulation of the Product. Licensee will diligently pursue such applications following submission. The Licensee agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity in the Territory in relation to any data relating to the Products. 3.4 For the period beginning from the Effective Date, within 10 Business Days following the end of each Agreement Quarter, Licensee shall provide MPP with a quarterly written report covering all its activities related to the development and testing of all Products and/or Substance (as permitted and to the extent applicable) and the obtaining of necessary governmental approvals; these shall include (but is not limited and to the extent applicable and permitted) to its (a) Products and/or Substance in its development pipeline, (b) status of development of each Product and/or Substance in development,

DEVELOPMENT AND REGISTRATION. 3.1 As of the Effective Date and subject always to MSD's retained rights to the Patents, the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture, and DocuSign Envelope ID: B7A8C789-433F-4E3D-B51B-6D189345BC26 commercialisation of the Products to be sold or supplied by the Licensee in the Territory under this Agreement. 3.2 Licensee agrees that it will manufacture the Substance and the Product in a manner consistent with (i) WHO Pre-qualification standards; or (ii) the standards of any SRA. Licensee will not sell any Product without WHO Prequalification or SRA approval, or through any provisional or emergency use authorizations available through WHO or an SRA, and will comply with applicable regulatory requirements in the country of manufacturing and the country of sale. 3.3 Licensee shall submit a complete file for WHO Pre-qualification or any SRA approval within 36 months from the Effective Date for any existing formulation of the Products, or within a period to be agreed among MSD, MPP and Licensee for any new formulation of the Product. Licensee will diligently pursue such applications following submission. The Licensee agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity in the Territory in relation to any data relating to the Products. 3.4 For the period beginning from the Effective Date, within 10 Business Days following the end of each Agreement Quarter, Licensee shall provide MPP with a quarterly written report covering all its activities related to the development and testing of all Products and/or Substance (as permitted and to the extent applicable) and the obtaining of necessary governmental approvals; these shall include (but is not limited and to the extent applicable and permitted) to its (a) Products and/or Substance in its development pipeline, (b) status of development of each Product and/or Substance in development,

DEVELOPMENT AND REGISTRATION. 3.1 As of the Effective Date and subject always to MSD's retained rights to the Patents, the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture, and DocuSign Envelope ID: C36B61B8-31EC-4A9C-AE01-0FC0E44D78D5 commercialisation of the Products to be sold or supplied by the Licensee in the Territory under this Agreement. 3.2 Licensee agrees that it will manufacture the Substance and the Product in a manner consistent with (i) WHO Pre-qualification standards; or (ii) the standards of any SRA. Licensee will not sell any Product without WHO Prequalification or SRA approval, or through any provisional or emergency use authorizations available through WHO or an SRA, and will comply with applicable regulatory requirements in the country of manufacturing and the country of sale. 3.3 Licensee shall submit a complete file for WHO Pre-qualification or any SRA approval within 36 months from the Effective Date for any existing formulation of the Products, or within a period to be agreed among MSD, MPP and Licensee for any new formulation of the Product. Licensee will diligently pursue such applications following submission. The Licensee agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity in the Territory in relation to any data relating to the Products. 3.4 For the period beginning from the Effective Date, within 10 Business Days following the end of each Agreement Quarter, Licensee shall provide MPP with a quarterly written report covering all its activities related to the development and testing of all Products and/or Substance (as permitted and to the extent applicable) and the obtaining of necessary governmental approvals; these shall include (but is not limited and to the extent applicable and permitted) to its (a) Products and/or Substance in its development pipeline, (b) status of development of each Product and/or Substance in development,

DEVELOPMENT AND REGISTRATION. 3.1 As of the Effective Date and subject always to MSDMerck's retained rights to the PatentsLicensed Patent Rights, the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture, manufacture and commercialisation of the Products to be sold or supplied by the Licensee in the Territory under this Agreement. 3.2 Licensee agrees that it will manufacture the Substance Licensed Compound and the Licensed Product in a manner consistent with (i) WHO Pre-qualification standards; or (ii) the standards of any SRA. Licensee will not sell any Licensed Product without WHO Prequalification or SRA approval, or through any provisional or emergency use authorizations available through WHO or an SRA, and will comply with applicable regulatory requirements in the country of manufacturing and the country of sale. 3.3 Licensee shall submit a complete file for FDA tentative approval or WHO Pre-qualification or any SRA approval within 36 months from the Effective Date for any existing formulation of the Licensed Products, or within a period to be agreed among MSDMerck, MPP Licensor and Licensee for any new formulation of the Licensed Product. Licensee will diligently pursue such applications following submission. The Licensee agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity in the Territory in relation to any data relating to the Licensed Products. 3.4 For the period beginning from the Effective Date, within Within 10 Business Days following the end of each Agreement Quarter, Licensee shall provide MPP Licensor with a quarterly written report covering all its activities related setting forth in relation to the development and testing of all Products and/or Substance (as permitted and to the extent applicable) and the obtaining of necessary governmental approvals; these shall include (but is not limited and to the extent applicable and permitted) to its that Agreement Quarter (a) Licensed Products and/or Substance Licensed Compound in its development pipeline, (b) status of development of each Licensed Product and/or Substance Licensed Compound in development,, (c) regulatory filing plan for the Licensed Compound and/or each Licensed Product, and (d) a list of regulatory authorities, including as applicable the FDA, WHO and authorities in the countries within the Territory with which such regulatory approvals or authorizations have been filed and/or obtained for the Licensed Compound and/or any Licensed Product. The Parties agree to meet on a quarterly basis or as reasonably requested by the Licensor, to review development and filing status and also regarding such reports concerning Licensed Products and/or Licensed Compound. Licensor agrees that information contained in quarterly and other such reports shall be treated as Confidential Information; provided, however, that such information may be shared with Merck (with Merck treating such reports as Confidential Information); and that aggregated data may be publicly disclosed by Licensor. 3.5 The Licensee will manufacture and sell the Licensed Compounds and Licensed Products in accordance with all laws and regulations relevant to the manufacture and sale of the Licensed Compounds and Licensed Products and in accordance with good industry practice in addition to provisions contained in 3.2.