Provision Language
8. REPORTING
8.1. MPP will send to University within 30 business days following the end of each calendar year, a written report setting forth each Licensee’s (a) Licensed Products development pipeline, (b) status of development of each Licensed Product in development, (c) regulatory filing plan for each Licensed Product, and (d) a list of countries within the Territory for which such regulatory approvals or authorizations have been obtained for any Licensed Product.
9. UNIVERSITY HIV TREATMENT ADVANCES
9.1 The University will communicate in writing to MPP within a reasonable time, but in any case not to exceed 120 days, any technical development that may improve the treatment of HIV, including but not limited to ARV-SDNs, which the University is developing or has developed, is disclosed to the IP Manager of the University after the Effective Date, and is free from any Encumbrances that would prevent such a disclosure. In the event of an Encumbrance, the University will commit its reasonable endeavours to remove any such Encumbrance(s). The University’s obligation to communicate technical developments according to Clause 9.1 shall expire on the fifth anniversary of the Effective Date unless renewed or extended in writing.
9.2 Upon receiving from the University a disclosure of a technical development that may improve the treatment of HIV, in accordance with Clause 9.1, MPP shall inform the University within 120 days whether the said technical development is of interest.
9.3 In the event MPP wishes the technical development to be licensed to MPP and the technical development is free from any Encumbrance and is an advancement of an ARV-SDN, then the University and MPP shall amend Schedule 1 to incorporate any relevant patents and patent applications and/or effective a suitable transfer of know-how in accordance with Clause 5.1.
9.4 In the event a technical development in accordance with clause 9.1 has been disclosed to Liverpool IP after the Effective Date, is free from any Encumbrance, is not an advancement of an ARV-SDN and is of interest to MPP in accordance with Clause 9.2, then the University and MPP shall discuss in good faith a new license agreement for said technical development.
Schedule 4 – Development Agreement Term Sheet
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4. Improvements: If at any time during the term of the Sub-licence Agreement the Development Partner (or any of its employees, agents, or other persons acting under its authority) makes, develops, conceives, acquires, reduces to practice, becomes entitled to or secures control over any Improvement it will communicate such Improvement to MPP and University in full together with all available information concerning the mode of working and using the same. MPP and University will treat this information as confidential.
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9. Reporting: Within ten (10) business days following the end of each calendar quarter, Development Partner will be required to provide MPP and the University with a quarterly written report setting forth in relation to that quarter the following and those specified under Schedule 2 specific activity 12: (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 (dollar value) spent in the reporting period if any, (c) scale up of ARV-SDN, (d) Licensed Products in its development pipeline, (e) status of development of each Licensed Product in development, (f) regulatory filing plan for each Licensed Product, and (g) a list of countries within the Territory for which such regulatory approvals or authorizations have been filed or obtained for any Licensed Product, (h) any scientific discoveries or Know-how developed; i) any other information that MPP and University may require to monitor progress and implementation of the projects. MPP and Licensee will agree to meet on a quarterly basis regarding such reports and also review development and filing status of Licensed Products. 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 the University, MPP’s funders, University’s funder, and funders, if any, of the project under consideration; and that status update may be publicly disclosed by the MPP or University. Within thirty (30) days of the end of the Development Partner’s programme they will deliver to MPP and the University a complete dossier of information allow MPP to effect an efficient technology transfer to the Commercialisation Partner and the University to effect an efficient technology transfer to its licensees outside the Territory.
10. Audit: The Development Partner will permit MPP and University, individually or together, and when required, through a certified public accountant 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 University. MPP or University will provide Development Partner with a commercially reasonable period of notice of the proposed audit. MPP and University, 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. If any audit reveals a discrepancy of more than 5% to the detriment of the University and/or MPP, Development Partner will reimburse MPP or the University for the cost of that audit.
Schedule 5 – Commercialization Agreement Term Sheet
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5. Improvements: If at any time during the term of the Commercialisation Agreement the Commercialisation Partner (or any of its employees, agents, or other persons acting under its authority) makes, develops, conceives, acquires, reduces to practice, becomes entitled to or secures control over any Improvement it shall communicate such Improvement to MPP and University in full together with all available information concerning the mode of working and using the same. MPP and University shall treat this information as confidential.
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10. Reporting: Within 10 business days following the end of each calendar quarter, Commercialisation Partner will be required to provide MPP and the University with a quarterly written report setting forth in relation to that quarter (a) Licensed Products in its development pipeline, (b) status of development of each licensed Product in development, (c) regulatory filing plan for each licensed Product, (d) a list of countries within the Territory for which such regulatory approvals or authorizations have been filed or obtained for any Licensed Product and (e) the Licensed Products (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; f) any scientific discoveries or Know how developed related to the Licensed Technology. MPP and Licensee will agree to meet on a quarterly basis regarding such reports and also review development and filing status of Licensed Products. 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 the University; and that aggregated data may be publicly disclosed by MPP.
11. Audit: Commercialisation Partner will permit MPP and University, individually or together, through a certified public accountant 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 University. MPP or University will provide Commercialisation Partner with a commercially reasonable period of notice of the proposed audit. MPP and University, 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 the University and/or MPP, Commercialisation Partner will reimburse MPP or the University for the cost of that audit.