Provision Language
2. GRANT OF LICENCE AND RESERVATION OF RIGHTS
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2.6 Medincell shall inform MPP about the status of the Development, including without limitation the Stage Gates, of the Final Product on a regular basis and at least biannually or upon MPP’s request. Medincell shall further provide, upon MPP request, the MPP Licensee with pre-clinical data and related documentation generated by Medincell in relation to the Licensed Product to the extent that such documents are reasonably necessary for the Development or registration or commercialisation of the Final Product.
3. RIGHT TO SUB-LICENSE TO MPP LICENSEES
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3.5. MPP agrees to monitor compliance of each MPP Licensee. Such monitoring shall include:
3.5.1 reviewing with all reasonable skill and care any reports provided to MPP by the MPP Licensee under the relevant sections of the Sub-Licence Agreement;
3.5.2 fully exercising the audit right set out in the Sub-Licence Agreement(s) as soon as MPP has reasonable cause to believe (or as soon as MedinCell and MPP have agreed that they have reasonable cause to believe) an audit is necessary.
3.6. If MPP becomes aware of any act or omission of an MPP Licensee which constitutes a breach of the relevant Sub-Licence Agreement, then MPP shall notify MedinCell immediately and (i) if the breach is capable of correction and does not give rise to an immediate right of termination under the Sub-Licence Agreement, direct the relevant MPP Licensee in writing to cure the breach, with a simultaneous copy of that writing to MedinCell; and (ii) if the breach remains uncured at the end of the specified period, or if there are otherwise grounds for termination under the Sub-Licence Agreement, and in each case if so requested by MedinCell, procure the termination of the relevant Sub-Licence Agreement in accordance with its terms.
7. REPORTING
7.1. During the period that MPP Sublicensees are Developing the Final Product, MPP will send to MedinCell within 30 days following the end of each quarter, a written report setting forth each MPP Licensee’s (a) Final Product development pipeline, (b) status of Development of each Final Product in Development, (c) regulatory filing plan for each Final Product, and (d) a list of countries within the Territory for which such regulatory approvals or authorizations have been obtained during the reporting period for any Final Product.
7.2. During the period that MPP Sublicensees are Commercializing the Final Product in the Territory, MPP will send MedinCell within 30 days following the end of each quarter the number of Final Products sold in the Territory.
Schedule 3. Development Agreement Term Sheet
3. Improvements:
3.1 Severable Improvements: The Development Partner shall promptly disclose to MedinCell and MPP in such detail as MedinCell and/or MPP may reasonably require a written description of all Severable Improvements that it may develop, conceive or reduce to practice during the Term. The Parties shall discuss in good faith an arrangement suitable to both MedinCell and the Development Partner which should take into account a fair and reasonable compensation for the Development Partner as well as commercial strategy of MedinCell.
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9. Reporting: Within 30 days following the end of each calendar quarter, Development Partner will be required to provide MPP with a quarterly written report setting forth in relation to that quarter the following: (a) summary of project implementation and current schedule of anticipated events or milestones including status of readiness of labs, plants, machinery as required, (b) details of project related specific recruitments and a summary of resources (Euros value) spent in the reporting period if any, (c) the Final Product in its development pipeline, (e) status of development of each Final Product in development, (f) any Improvements; (g) any other information that MPP and MedinCell may require to monitor progress and implementation of the projects. MPP and the Development Partner will agree to meet on a quarterly basis regarding such reports. MPP agrees that information contained in quarterly and other such reports shall be treated as confidential; provided, however, that such information may be shared with MedinCell, MPP’s funders, MedinCell’s funder, and funders, if any, of the project under consideration; and that status update may be publicly disclosed by the MPP or MedinCell. Within thirty (30) days of the end of the Development Partner’s programme they will deliver to MPP and MedinCell a complete dossier of information allow MPP to effect an efficient technology transfer to the Commercialisation Partner and MedinCell to effect an efficient technology transfer to its licensees including its licensees outside the Territory.
10. Audit: The Development Partner will permit MPP and MedinCell, individually or together, and when required, through an independent third party auditor or consultant nominated by MPP or MedinCell respectively to: (i) inspect and audit the performance of, and compliance with, the Development Agreement and the applicable laws; and (ii) inspect and audit all documents and other records relating to the performance of the Development Agreement. Development Partner will cooperate with and provide all reasonable assistance to MPP or MedinCell, their respective officers, employees, agents, advisors, representatives or consultants exercising their rights under this provision. MPP or MedinCell will provide Development Partner with a commercially reasonable period of notice of the proposed audit. MPP and MedinCell, each individually, agree that such audits will not be conducted more than once in any 12-month period, unless the prior audit has shown evidence of the failure of Development Partner to perform in compliance with the Development Agreement or applicable laws.
Schedule 4. Commercialisation Agreement Term Sheet
5. Improvements:
5.1 Severable Improvements: The Commercialisation Partner shall promptly disclose to MedinCell and MPP in such detail as MedinCell and/or MPP may reasonably require a written description of all Severable Improvements that it may develop, conceive or reduce to practice during the Term. The Parties shall discuss in good faith an arrangement suitable to both MedinCell and the Commercialisation Partner which should take into account a fair and reasonable compensation for the Commercialisation Partner as well as commercial strategy of MedinCell.
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9. Reporting: Within 30 days following the end of each calendar quarter, Commercialisation Partner will be required to provide MPP with a quarterly written report setting forth in relation to that quarter (a) the Final Product in its development pipeline, (b) status of development of each Final Product in development, (c) regulatory filing plan for each Final Product, (d) a list of countries within the Territory for which such regulatory approvals or authorizations have been filed or obtained for any Final Product and (e) the Final Product (in terms of smallest units and patient packs for each formulation) sold or supplied by the Licensee under the Commercialisation Agreement during such agreement quarter, on a country-by-country basis and the related royalties for the Private Sector; (f) any Improvements. MPP and Licensee will agree to meet on a quarterly basis regarding such reports and also review development and filing status of the Final Product. MPP will agree that information contained in quarterly and other such reports shall be treated as confidential; provided, however, that such information may be shared with MedinCell and Unitaid; and that aggregated data may be publicly disclosed by MPP.
10. Audit: Commercialisation Partner will permit MPP and MedinCell, individually or together, through an independent third party auditor or consultant nominated by MPP or MedinCell to: (i) inspect and audit the performance of, and compliance with, the Commercialisation Agreement and the applicable laws; and (ii) inspect and audit all documents and other records relating to the performance of the Commercialisation Agreement. Commercialisation Partner will cooperate with and provide all reasonable assistance to MPP or MedinCell. MPP or MedinCell will provide Commercialisation Partner with a commercially reasonable period of notice of the proposed audit. MPP and MedinCell, each individually, agree that such audits will not be conducted more than once in any 12-month period, unless the prior audit has shown evidence of the failure of Licensee to perform in compliance with the Commercialisation Agreement or applicable laws. If any audit reveals a discrepancy of more than 5% to the detriment of MedinCell and/or MPP, Commercialisation Partner will reimburse MPP or MedinCell for the cost of that audit. The result of the audit will be binding, and in the event that the audit reveals a failure to comply with the Price Commitment, the Commercialisation Partner will implement any adjustment to the Affordable Price deemed required by MPP or MedinCell as a result of the audit.