Form of Sublicense Agreement
3. 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, (c) regulatory filing plan for WHO Pre-qualification Programme and/or a Stringent Regulatory Authority for each Product, (d) a list of regulatory authorities, including as applicable the FDA, WHO and authorities in the countries within the Territory for which such regulatory approvals or authorizations have been filed and/or obtained for any Product, (e) summary of work completed and in progress, (f) current schedule of anticipated events and milestones, (g) anticipated market introduction dates and (h) its activities, if applicable. Licensee will also report to MPP the date of first commercial sale of each Product within five (5) business days thereafter.
3.5 The Parties agree to meet on a quarterly basis or as reasonably requested by the MPP, to review development and filing status and also regarding such reports concerning Products and/or Substance. MPP 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 MSD (with MSD treating such reports as Confidential Information); and that aggregated data may be publicly disclosed by MPP. Licensee shall, at its own expense and using its own resources, and using all due care in accordance with the prevailing standard of professional competence in a regulatory function in the pharmaceutical industry, obtain, maintain and operate in compliance with (a) the Key Approvals and (b) all other authorizations, licenses, permits, registrations, and regulations which may from time to time be required by any Agency for Licensee to import, manufacture, promote, and sell the Product in the Territory. Licensee will not sell Product in any country in the Territory prior to obtaining both local health Agency approval or authorization in the country where the Product is manufactured and/or local health Agency approval or authorization in the country in the Territory where the Product is sold and Commercialized. Licensee shall provide quarterly written reports to MPP notifying MPP about the registration process and providing MPP with any other information in this regard that MPP may reasonably require. Licensee shall not transfer, assign, or otherwise convey any of the authorizations, registrations, or permits related to the Product, as set forth above in this Section, to any Affiliate without the prior written notice to MPP and MSD.
3.6 Licensee will manufacture and sell the Substance and Products in accordance with all laws and regulations relevant to the manufacture and sale of the Substance and Products and in accordance with good industry practice in addition to provisions contained in 3.2.
3.7 Licensee shall not transfer, assign, or otherwise convey any of the authorizations, registrations, or permits related to the Product, as set forth above in this Section, to any Third Party without the prior permission of MPP, and which may be withheld at MPP’s sole discretion in the case of a proposed transfer to a Third Party.
3.8 Licensee shall promote, Commercialize and sell the Product in strict adherence to regulatory, professional, and legal requirements in the Territory and shall do nothing which would jeopardize the good will or reputation of MPP or MSD or the reputation of the Product.
3.9 This Section 3 shall always be subject to the provisions of Section 3B. Where there is any inconsistency between the two Sections, Section 3B shall prevail.