Provision Language
Definitions
“Import Waiver” shall mean, in respect of a country of the Territory in which, at the time of the intended sale or supply, the Product(s) do(es) not have Regulatory Approval, all export and import licences, authorisations, permits, consents or approvals necessary to supply, sell and/or offer for sale that Product (or those Products) in that country.
“Relevant Regulatory Authority” shall mean (i) in relation to a particular country in the Territory, any applicable federal, national, regional, state, provincial, or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Products in that country, or (ii) WHO pre-qualification programme where such approval has been deemed adequate by the authority referred to in (i).
Novartis – MPP Agreement
3. Licensee Selection Process
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3.1 Promptly after the Effective Date (and in any event within sixty (60) days of the Effective Date), MPP will identify proposed sublicensees who have:
(A) demonstrated possession of adequate infrastructure and capabilities to enable the Sublicensee to distribute and supply Product to every country in the Territory under GDP;
(B) production facilities operating under current Good Manufacturing Practice;
5. Regulatory Waiver
Novartis will as reasonably requested provide the Sublicensee with applicable regulatory exclusivity waivers, to the extent required by the Relevant Regulatory Authorities for national registration in the Territory of the Products.
Form of Sublicense
2. GRANT OF SUBLICENCE
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2.6 No supplies prior to regulatory approvals. Notwithstanding the Effective Date of this Agreement, the Licensee undertakes not to sell or otherwise supply a Product in a country of the Territory prior to:
A. Regulatory Approval in that country, unless the sale or supply is made pursuant to an Import Waiver; and
B. WHO prequalification or Stringent Regulatory Authority approval, or through any provisional authorizations available through WHO or a Stringent Regulatory Authority.
4. DEVELOPMENT AND REGISTRATION
4.1 As of the Sublicence Effective Date and subject always to Novartis’s retained rights to the Manufacturing Patent and the Patents (and those of its licensees), the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture and commercialisation of the Products to be sold or supplied by the Licensee in the Field in the Territory under this Agreement.
4.2 The Licensee agrees that it will manufacture and distribute Raw Materials and Product pursuant to this Agreement in full compliance with (i) WHO pre qualification standards; (ii) GMP and GDP and (ii) the standards of any Stringent Regulatory Authority. Where such standards are not yet available, the Licensee will obtain temporary approval through a WHO Expert Review Panel, as appropriate and if applicable.
4.3 The Licensee shall obtain from the relevant authorities in each country of the Territory and maintain in force, as appropriate, all health registrations, permissions, consents and regulatory authorisations relating to the importation, manufacture and sale of the Products (including but not limited to Import Waivers where applicable) which are necessary to enable the Products to be sold or supplied in each country of the Territory in accordance with this Agreement.
4.4 Licensee shall file for WHO Pre-qualification or any Stringent Regulatory Authority approval as soon as possible and in any event not later than within 36 months from the Sublicence Effective Date in each case using the fastest approval route possible and will diligently pursue such applications following submission.
4.5 The Licensee shall file for Regulatory Approval for the Product before the Relevant Regulatory Authority in each country of the Territory as soon as possible and in any event not later than 36 months from the Sublicense Effective Date and will diligently pursue such applications following submission.
4.6 If the Licensee sells, supplies or otherwise disposes of any Product in the Territory but has not obtained the necessary approvals as per this Agreement, the Licensor shall be entitled to immediately terminate this Agreement by providing written notice to the Licensee.
5 SUPPLY AND DISTRIBUTION
5.1 The Licensee shall be solely responsible for providing its own clinical, promotional and commercial infrastructure to support the manufacture and sale of the Products in the Territory. 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 Products.
7. PHARMACOVIGILANCE
7.1 Licensee undertakes that it will comply with all applicable laws and regulations regarding the Products in the Territory including without limitation those laws and regulations relating to risk management, drug safety and pharmacovigilance. 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.
7.2 Licensee will be responsible for fulfilling all pharmacovigilance activities as per the local regulations and requirements for the Products in the Territory and provide Licensor, at Licensor’s request, with a report containing information regarding all such activities upon reasonable request by the Licensor.
7.3 If Licensee becomes aware of any adverse reaction relating to the Products in connection with this Agreement, Licensee shall inform MPP and Novartis within 5 Business Day of it becoming aware and cooperate with Novartis in fulfilling Novartis’s reporting responsibilities under applicable laws and regulations.
15. WARRANTIES, INDEMNITIES, COMPLIANCE WITH LAW
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15.8 The Licensee shall manufacture and sell the Products in accordance with all laws and regulations relevant to the manufacture and sale of the Products and in accordance with good industry practice, including without limitation GMP and GDP.