Master Alliance Provisions Guide (MAPGuide)

MSD – MPP, Molnupiravir License Agreement

  • Consortium structure & management | Reporting Requirements

MSD-MPP Agreement

4. MPP Obligations

4.1 Monitoring of Compliance. MPP agrees to monitor compliance with each Sublicense by each Sublicensee, as follows:

(a) reviewing with all reasonable skill and care any reports provided to MPP by the Sublicensee under Sections 3.4 and 9.2 of the Sublicense;
(b) within 30 days of the expiry of the ten Business Day period referred to in Section 9.2 of the Sublicense, assessing in relation to each Sublicensee whether the supplies of Products made in the relevant Agreement Quarter were made in accordance with the terms of the Sublicense, and if they were not, reporting the outcome of such assessment to MSD.

Reports. For the period beginning from the Effective Date, within 30 Business Days following the end of each quarter, MPP will submit to MSD a quarterly progress report covering Sublicensees’ 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 to and to the extent applicable and permitted) each Sublicensee’s (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) sublicensees’ activities, if applicable. MSD agrees that information contained in quarterly and other such reports shall be treated as Confidential Information. MPP will also report to MSD the date of first commercial sale of each Product within five (5) business days thereafter. After the first sale anywhere in the Territory, MPP will make quarterly royalty reports to MSD within 30 days after the quarters ending March 31, June 30, September 30, and December 31, of each year. Each such royalty report will include at least the requirements as further stated in Appendix 3 of the Sublicense and in line with applicable competition laws. If no sales had occurred during the reporting period, a statement to this effect is required in the royalty report for that period. MPP shall also provide the names and addresses of any new Sublicensees along with a summary of the material terms of each new Sublicense entered into during the reporting quarter. MPP shall prohibit Sublicensees from transferring, assigning, or otherwise conveying any of the authorizations, registrations, or permits related to the Product, as set forth in the Sublicense to any third party (“Proposed Assignment”). Where there is a Proposed Assignment, MSD shall be immediately notified and at its sole discretion, decide whether to approve such Proposed Assignment.

Form of Sublicense Agreement

3. Development and Registration

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.

9. Statements, Reporting And Right To Audit

9.2 After the first sale anywhere in the Territory, within 20 Business Days following the end of each Agreement Quarter, the Licensee shall deliver to MPP a statement accounting for, inter alia, all royalties calculations, Products and/or Substance (in terms of smallest units and patient packs for each formulation) sold or supplied by the Licensee under this Agreement during such Agreement Quarter in the Reporting Template as set forth in Appendix 3. 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.