Provision Language
AbbVie – MPP Agreement
2. License Grants
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2.4 AbbVie shall provide, upon MPP’s request, a Sublicensee with NCE Exclusivity or other regulatory exclusivity waivers to the extent required by the applicable regulatory authorities in order to manufacture or sell Licensed Product(s) in the Territory in accordance with the terms of the Sublicense.
4. MPP Obligations
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4.2 Reports. MPP will send to AbbVie within 30 days following the end of each calendar quarter (i) the number of units of Licensed Products sold by strength / formulation by country, and (ii) the amount of Licensed Compound manufactured under this Agreement for the purpose of making Licensed Products. MPP shall also provide AbbVie with a quarterly written report setting forth each Sublicensee’s (a) Licensed Products development pipeline, (b) status of development of each Licensed Product in development, (c) regulatory filing plan with the WHO Pre-qualification Programme or a Stringent Regulatory Authority (“Stringent Regulatory Authority”), defined as regulatory authorities which are members, observers or associates of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, as may be updated from time to time 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. AbbVie agrees that information contained in quarterly and other such reports shall be treated as Confidential Information.
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4.6 Pharmacovigilance. If MPP or any Sublicensee becomes aware of any adverse reaction relating to the Licensed Products in connection with this Agreement or a Sublicense Agreement, MPP or the relevant Sublicensee shall inform AbbVie within 24 hours of its becoming aware and cooperate with AbbVie in fulfilling AbbVie’s reporting responsibilities under applicable laws and regulations.
Form of Sublicense
3. Development and Registration
3.1 As of the Effective Date and subject always to AbbVie’s retained rights to AbbVie Patents, the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture and commercialisation of the Licensed Products to be sold or supplied by the Licensee in the Territory under this Agreement.
3.2 Licensee will be solely responsible at its expense for making or having made all of its respective requirements for the Licensed Products in conformity with all applicable specifications in the Territory and will hold all relevant authorizations and permits required in this respect.
3.3 Licensee agrees that it will manufacture Licensed Compounds and Licensed Product in a manner consistent with (i) World Health Organization (“WHO”) pre-qualification standards; or (ii) the standards of any Stringent Regulatory Authority (“Stringent Regulatory Authority”), defined as regulatory authorities which are members, observers or associates of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, as may be updated from time to time. Where such approvals are not yet available, the Licensee will obtain temporary approval through a WHO Expert Review Panel.
3.4 The Licensee will obtain from the relevant authorities in the Territory and maintain in force all health registrations, permissions, consents and regulatory authorisations relating to the importation, manufacture and sale of the Licensed Products which are necessary to enable the Licensed Products to be sold or supplied in the Territory in accordance with this Agreement. Licensee shall file for approval of a New Formulation before either the WHO pre qualification programme or a Stringent Regulatory Authority not later than 20 months from the Effective Date in respect of the Licensed Compound and not later than 24 months from the Effective Date in respect to at least one New Formulation, and 42 months if human trials other than bioequivalence studies are required. Licensor and Licensee shall, as soon as practicable after the Effective Date, confer to agree upon reasonable milestones towards the development of a New Formulation in line with these registration timeframes. Licensee shall also, upon Licensor’s reasonable request, file for regulatory approval before the Relevant Regulatory Authority for any subsequent New Formulations within a reasonable time. 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 Licensed Products.
3.5 Within 10 Business Days following the end of each Agreement Quarter, Licensee shall provide Licensor with a quarterly written report setting forth in relation to that Agreement 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, and (d) a list of countries within the Territory for which such regulatory approvals or authorizations have been filed or obtained for any Licensed Product. The Parties agree to meet on a quarterly basis regarding such reports and also review development and filing status of Licensed Products. Licensor 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 AbbVie (with AbbVie treating such reports as Confidential Information); and that aggregated data may be publicly disclosed by Licensor.
3.6 The Licensee will manufacture and sell the Licensed Products and Licensed Compounds in accordance with all laws and regulations relevant to the manufacture and sale of the Licensed Products and Licensed Compounds and in accordance with good industry practice.
4. Pharmacovigilance
4.1 Licensee undertakes that it will maintain until the termination of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled) pharmacovigilance and risk management systems, procedures and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement.
4.2 If Licensee becomes aware of any adverse reaction relating to the Licensed Products in connection with this Agreement, Licensee shall inform Licensor and AbbVie within 1 day of its becoming aware and cooperate with AbbVie in fulfilling AbbVie’s reporting responsibilities under applicable laws and regulations.
4.3 Licensee undertakes that it will ensure that it will comply with all applicable laws and regulations regarding the Licensed Products in the Territory including without limitation those laws and regulations relating to risk management, drug safety and pharmacovigilance.
4.4 Licensee will be responsible for fulfilling all pharmacovigilance activities as per the local regulations and requirements for the Licensed Products in the Territory and provide Licensor with a report containing information regarding all such activities. Such report shall be provided annually and otherwise on reasonable request by the Licensor.