Provision Language
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.
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.
9. Statements, Reporting And Right To Audit
9.1 Licensee will keep full, true, and accurate books and records containing all particulars that may be necessary for the purpose of showing the amount of royalties payable to MSD and Licensee’s compliance with other obligations under this Agreement and applicable laws. Said books and records will be kept at Licensee’s principal place of business or the principal place of business of the appropriate division of Licensee to which this Agreement relates. Said books and records and the supporting data will be open at all reasonable times during normal business hours upon at least fifteen (15) days’ advance written notice, for three (3) years following the end of the calendar year to which they pertain, to the inspection and audit (on site if Licensee so requests) by independent certified public accountants hired by MSD and MPP, individually or together and reasonably acceptable to Licensee for the purpose of verifying Licensee’s royalty reports or compliance in other respects with this Agreement and applicable laws. Such certified public accountants will be bound to hold all information in confidence except as necessary to communicate Licensee’s non–compliance with this Agreement to MSD and/or MPP. The fees and expenses of the certified public accountants performing such an examination will be borne by MSD and/or MPP. However, if an error in underpaid royalties to MSD of more than five percent (5%) of the total royalties due for any year is discovered, then the fees and expenses of these representatives will be borne by Licensee.
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.
11. Exchange Of Information, Confidentiality And Publications
11.1 Licensee may conduct studies or basic research or pre–clinical, clinical, or other trials with the Substance and/or the Product, provided that Licensee has obtained MSD’s prior written consent through MPP, which may be withheld at MSD’s sole discretion. A response by MSD should be provided within 90 business days after receiving the suggested study protocol from the Licensee. In the event MSD approves any such studies or trials in accordance with this Section 11, then, at the option of MSD, MSD may have its representative monitor any approved studies or trials.
11.2 In the event that any such studies or trials have been approved by MSD, Licensee will pay for any necessary supplies and, upon completion of such studies or trials, Licensee shall furnish free of charge to MSD and its Affiliates in the English language all data and information, especially any adverse drug experiences, derived from any such studies, pre–clinical or clinical trials carried out by Licensee relating to the Product, in such detail and at such times as MSD may reasonably request for non–commercial and internal use and disclosure to any Third Party in compliance with the contractual obligations of MSD and its Affiliates. Any such Affiliates which are recipients of such information pursuant to the foregoing shall be under the same obligation of confidentiality as set forth in this Section. If MSD and its Affiliates want to use the data and information for any other purpose, the Licensee and MSD shall negotiate in good faith.