Common use of DEVELOPMENT AND REGISTRATION Clause in Contracts

DEVELOPMENT AND REGISTRATION. 4.1. The Sublicensee agrees that it will manufacture Materials and Product in a manner consistent with (i) WHO pre-qualification standards; or (ii) the standards of any Stringent Regulatory Authority, defined as a regulatory authority which was a member or observer of the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”), or associated with an ICH member through a legally-binding, mutual recognition agreement, in each case as before 23 October 2015. Where such standards are not yet available, the Sublicensee will obtain temporary approval through a WHO Expert Review Panel, as appropriate and if applicable. 4.2. The Sublicensee shall: A. obtain from the relevant authorities in each country and maintain in force, as appropriate, all health registrations, permissions, consents and regulatory authorisations relating to the importation, manufacture and sale of the Products which are necessary to enable the Products to be sold or supplied in each country in accordance with this Agreement. B. file for WHO Pre-qualification or any Stringent Regulatory Authority approval as soon as possible and in any event not later than within 24 months from the Effective Date in each case using the fastest approval route possible and will diligently pursue such applications following submission. C. 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. 4.3. If the Sublicensee manufactures, sells, supplies or otherwise disposes of any Product but has not obtained the necessary compliance with laws or approvals as per this Agreement, MPP shall be entitled to immediately terminate this Agreement by providing written notice to the Sublicensee.

DEVELOPMENT AND REGISTRATION. 4.1. The Sublicensee agrees that it will manufacture Materials and the Product in a manner consistent with (i) WHO pre-qualification standards; or (ii) the standards of any Stringent Regulatory Authority, defined as a regulatory authority which was a member or observer of the International Council on Harmonization Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”), or associated with an ICH member through a legally-binding, mutual recognition agreement, in each case as before 23 October 2015. Where such standards are not yet available, the Sublicensee will obtain temporary approval through a WHO Expert Review Panel, as appropriate and if applicable. 4.2. The Sublicensee shall: A. i. obtain from the relevant authorities in each country and maintain in force, as appropriate, all health registrations, permissions, consents and regulatory authorisations relating to the importation, manufacture and sale of the Products which are necessary to enable the Products to be sold or supplied in each country in accordance with this Agreement. B. ii. file for WHO Pre-qualification or any Stringent Regulatory Authority approval as soon as possible and in any event not later than within 24 months from the Effective Date in each case using the fastest approval route possible and will diligently pursue such applications following submission. C. iii. 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. 4.3. If the Sublicensee manufactures, sells, supplies or otherwise disposes of any Product but has not obtained the necessary compliance with laws or approvals as per this Agreement, MPP shall be entitled to immediately terminate this Agreement by providing written notice to the Sublicensee.