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).
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
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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.
5. SUPPLY AND DISTRIBUTION
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5.2 In each country of the Territory the Licensee shall, acting in compliance with all applicable laws and regulations, use its best endeavours to commercialise and maximise access to the Product(s) as soon as it has obtained Regulatory Approval for such Product(s) in the relevant country.
8. NON-DIVERSION
8.1 Except as provided under this Agreement and to the extent that such restrictions comply with applicable law, the Licensee shall not, directly or indirectly, donate, distribute, sell or supply: Products or Raw Materials outside the Territory where there is a
(a) Manufacturing Patent or Non-Territory Patent, for the duration of the relevant Manufacturing Patent or Non-Territory Patent; or
(b) Products or Raw Material to any Third Party in the Territory that the Licensee knows, believes or ought reasonably to suspect will sell or supply Products or Raw Material outside the Territory where there is a Manufacturing Patent or Non-Territory Patent, for the duration of the relevant Manufacturing Patent or Non- Territory Patent.
8.2 The Licensee shall maintain a quick and efficient batch trace procedure following the GS1 Global Traceability or comparable standards so as to enable the identification and location of Product from individual batches with minimal delay.
8.3 If at any time the Licensee becomes aware that it, or a Third Party to which it has sold or supplied Product(s), has sold or supplied Product(s) for use in breach of the terms of this Agreement, the Licensee shall:
i. immediately notify the Licensor and Novartis in writing, providing details of such breach; and
ii. provide to the Licensor and Novartis, within thirty (30) days of such notification, details of a mitigation plan to ensure that such sale or supply in breach of this Agreement is not repeated.
APPENDIX C: LIST OF COUNTRIES FORMING THE TERRITORY FOR MANUFACTURING PATENT
The Territory shall include the foregoing list of low- and middle-income countries (LMICs) as at the Effective Date. In the event that the World Bank changes its own classification of LMICs following the Effective Date, the Parties may, by agreement in writing, amend the Territory accordingly.
India is defined in Appendix A1 as Manufacturing Territory only.
