Provision Language
Definitions
“Manufacturing Patent” shall mean shall mean the patents as set out in Appendix A1.
“Manufacturing Territory” shall mean the country of India and the Patent Territory.
“Non-Territory Patents” shall mean, in relation to those countries falling outside of the Manufacturing Territory and Territory, any patents and patent applications in such countries equivalent to the Patents.
“Novartis Trademarks” shall mean trademarks, service marks, design marks, trade dress, trade names, corporate names, logos, domain names, now existing or hereafter adopted or acquired, whether registered or unregistered, including without limitation any applications or registrations therefor, and all goodwill connected with the use thereof and symbolized thereby, that are owned, controlled or used by Novartis or its Affiliates.
“Novartis Trade Dress” shall mean any aspect of the Product labelling, artwork or packaging, and associated marketing and advertising, including, but not limited to fonts, colours, and such other distinguishing features and elements comprising the look and feel or overall appearance of the Novartis Products;
“Patents” shall mean the patents and patent applications as set out in Appendix A2.
“Patent Territory” shall mean all those countries as are set out in Appendix A2 hereto.
“Raw Materials” shall mean, as the context admits and requires, the active ingredients which are protected by the Patents and which are required to prepare the Products in final consumer package form as envisaged under the licences granted under Clause 2.1.
Novartis – MPP License
2. GRANT OF LICENCE
2.1 Subject to the terms and conditions of this Agreement, Novartis hereby grants to MPP (a) a non-exclusive, royalty-free, non-transferable, non-sublicensable (except to Sublicensees) licence under the Manufacturing Patent and Patents to enter into Sublicences with Sublicensees to make, have made, export or import the Raw Materials and the Products in the Manufacturing Territory exclusively for Sublicensee’s use, offer for sale, sale, or import of the Product in the Field in the Territory, and (b) a non-exclusive, royalty-bearing, nonsublicensable (except to Sublicensees), non-transferable licence under the Patents to enter into Sublicences with Sublicensees exclusively for Sublicensee’s use, offer for sale, sale, export, or import of the Product in the Field in the Patent Territory, as set out in the Sublicence as attached as Schedule 1 of this Agreement. MPP shall request from each Sublicensee the royalties (as defined in the Sublicence Agreement) to be paid in accordance with the requirements of applicable Sublicence Agreement. Royalties shall be paid for the Patent Territory only, and such royalties shall be re-invested into the ATOM coalition, as described in further details in the ATOM coalition frame agreement.
2.2 No rights are hereby granted for any other purpose and MPP agrees that it will not use or exploit the Manufacturing Patent or the Patents itself or grant sublicences or other rights thereto: (i) to entities other than Sublicensees; and/or (ii) other than in the form of the Sublicence.
2.3 MPP will coordinate the Licensee Selection Process as described below and the subsequent execution of Sublicences between MPP and Sublicensees.
2.4 No rights in any Novartis Trademarks or Novartis Trade Dress are granted to MPP or Sublicensees under this Agreement.
(A) MPP shall require that Sublicensees do not, appropriate or otherwise use, apply to register or register any Novartis Trademarks or Novartis Trade Dress on or in connection with the Products anywhere in the world, including without limitation in connection with any sale, distribution, promotion, or marketing of the Product.
(B) MPP will require that a complete description of any trademark to be used by Sublicensees in connection with the sale of the Products in the Territory shall be submitted to MPP to be transmitted to Novartis for Novartis’s written approval prior to use or filing an application to register such trademark or trade dress. Such written approval shall be given within thirty (30) days following receipt by Novartis from MPP of all relevant documentation necessary to consider the Sublicensee’s request. Such approval may be withheld if the subject trademark is determined by Novartis, in its sole discretion, to be identical or confusingly similar to any Novartis Trademark or Novartis Trade Dress; provided, however, that any such approval shall not waive any rights of Novartis or its Affiliates with respect to the Novartis Trademarks.
(C) In addition to the foregoing, for the avoidance of doubt, MPP shall require that Sublicensees do not: (a) register or, in connection with the sale of any Products, use any trademark, trade name or trade dress which is identical to or confusingly similar (as Novartis shall determine in its sole discretion) to any Novartis Trademark or Novartis Trade Dress; (b) use trade dress, packaging (both internal and external) or labelling which is the same as or similar (as Novartis shall determine in its sole discretion) to that of Novartis or any Affiliate of Novartis in connection with the sale of any Products; or (c) give the impression to the public, to physicians or to the trade that the Products are manufactured by, or in any way connected with, Novartis or any of its Affiliates.
(D) Notwithstanding the foregoing, in reviewing and/or granting approval to any Sublicensee for use of any trademark and trade dress in connection with the sale of any Products, MPP agrees that Novartis shall have no obligation to (i) assess the availability or validity of, any proposed trademark or trade dress; (ii) determine the ability of the Sublicensee to use or register any proposed trademark or trade dress; or (iii) determine whether the proposed trademark or trade dress is the same or similar to any other trademark or trade dress of any party, including but not limited to the Sublicensee or any other MPP Licensee in connection with any products, including the licensed Products. Novartis shall have no liability to MPP, Sublicensee or any other party, for the use or registration of any trademark or trade dress that is the same or similar to that used by Sublicensee or another MPP Licensee.
3. Licensee Selection Process
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;
(C) adequate, ESG, health and safety measures in place;
(D) undergone and passed an anti-bribery and corruption assessment in accordance with agreed criteria for assessing anti-bribery and corruption to ensure compliance with applicable anti-corruption laws; and
(E) undergone and passed export controls and trade compliance assessment in accordance with agreed criteria for assessing export controls and trade compliance.
3.2 During the Licensee Selection Process, MPP shall keep Novartis informed of the proposed Sublicensees and shall upon completion of the Licensee Selection Process promptly notify Novartis in writing of the entities MPP proposes to become the Sublicensees.Novartis shall within thirty (30) Calendar Days of such notification (acting reasonably) either approve or reject one or more of the proposed Sublicensees. For the avoidance of doubt if the proposed Sublicensee intends to use subcontractors including for supply of active ingredients, such subcontractor shall be approved by both MPP and Novartis as part of the Licensee Selection Process.
3.3 MPP shall not authorise or agree to any amendments to the terms of the Sublicence as set out in Schedule 1, whether before or after the execution of such Sublicence, without Novartis’s express prior consent in writing, signed by or on behalf of Novartis.
3.4 Novartis shall provide to any Sublicensee such consents which it has the legal capacity to give as are reasonably necessary to enable such Sublicensee to perform its obligations under the Sublicence.
Form of Sublicense
2. GRANT OF SUBLICENCE
2.1 Subject to the terms and conditions of this Agreement (including without limitation Clauses 2.3, 2.4, and 2.5) and to the extent to which the Licensor has the right to grant a licence in respect of the Manufacturing Patent and the Patents, the Licensor hereby grants to the Licensee (a) a non-exclusive, royalty-free, non-sublicensable, non transferable licence under the Manufacturing Patent and Patents to make, have made, export or import the Raw Materials and the Products in the Manufacturing Territory exclusively for Licensee’s use, offer for sale, sale, or import of the Product in the Field in the Territory, and (b) a non-exclusive, royalty-bearing, non sublicensable, non-transferable licence under the Patents exclusively for Licensee’s use, offer for sale, sale, export, or import of the Product in the Field in the Patent Territory.
2.2 Notwithstanding anything contained in this Agreement, nothing in this Agreement shall be construed to prevent the Licensee from engaging in any activities inside or outside of the Manufacturing Territory and Territory that would not infringe a Manufacturing Patent, Patent or Non-Territory Patent granted and in force in such country.
2.3 [NAME OF LICENSEE] undertakes to pay the royalties for the Patent Territory to Licensor as further set out in Appendix D.
2.4 If [NAME OF LICENSEE] wishes to involve any of its Affiliates in the performance of the Agreement, prior to doing so, [NAME OF LICENSEE] shall notify in writing the Licensor of the entity’s name and provide appropriate supporting documents evidencing that the entity is an Affiliate of [NAME OF LICENSEE] . [NAME OF LICENSEE] shall ensure that such Affiliate agrees in writing to be bound by the terms of this Agreement prior to its performance. The Licensor shall notify in writing Novartis of [NAME OF LICENSEE]’s Affiliates, if any, as soon as possible but no later than ten (10) Business Days for every Affiliate.
2.5 The Licensee’s licence to have manufactured by Third-Parties, listed in Appendix B, Raw Materials and Products in accordance with Clause 2.1 shall be limited solely to manufacture on behalf of the Licensee of (i) Raw Materials for supply solely to the Licensee for Licensee’s use and sale of the Product in the Field in the Territory and (ii) Products for supply solely to the Licensee for its use and sale in the Field in the Territory. Clause 2.1 shall not be construed as conferring any right for a Third Party to manufacture Raw Materials and/or Products for its own development, use, or sale of the Raw Materials and/or Products inside or outside of the Territory, for supply of the Raw Materials and/or Products to the Licensee and/or an Affiliate for any use or sale outside of the Field or outside of the Territory, or for supply of the Raw Materials and/or Products to any entity other than the Licensee.
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.
10. INTELLECTUAL PROPERTY
10.1 If at any time during the term of this Agreement the Licensee (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 the Licensor and Novartis in full together with all available information concerning the mode of working and using the same. The Licensor and Novartis shall treat this information as Confidential Information.
10.2 The Licensee hereby grants to the Licensor and Novartis a perpetual, irrevocable, worldwide, royalty-free, fully paid-up, non-exclusive licence to use any Improvement, Improvement Patent and related Know-How (and shall promptly execute such document as Novartis may reasonably request accordingly). Novartis shall be entitled to grant sublicences (without further right to sublicense) under such licence only to its: – Affiliates; and/or – contract manufacturers, distributors, research collaborators, and service providers solely for development, manufacture, sale, import, export and/or commercialising Novartis products and/or – purchasers of Novartis’ rights in the Product and/or Raw Materials.
10.3 The Licensee shall have no rights in relation to the conduct of any matter relating to the Manufacturing Patent, the Patents or any other patents or patent applications owned or controlled by Novartis, including the filing, prosecution and maintenance thereof.
11. TRADEMARKS
11.1 No rights in any Novartis Trademarks or Novartis Trade Dress are granted to Licensee under this Agreement.
(A) Licensee shall not appropriate or otherwise use, register to use or register any Novartis Trademarks or Novartis Trade Dress in connection with the Products anywhere in the world, including without limitation in connection with the sale, distribution, promotion, or marketing of the Products.
(B) A complete description of any trademark or trade dress proposed to be used or registered by Licensee in connection with the sale of the Product in the Territory shall be submitted to MPP for Novartis’s written approval prior to use or filing an application to register such trademark. MPP shall promptly review such request and refer it to Novartis.
(C) Licensee shall provide any additional information required by MPP in relation to such request. The response to Licensee for any request for approval shall be given within thirty (30) days of receipt by Novartis from MPP of all relevant documentation necessary to consider Licensee’s request. Such approval may be withheld if the subject trademark is determined by Novartis, in its sole discretion, to be identical to or confusingly similar to any Novartis Trademarks or Novartis Trade Dress; provided, however, that any such approval shall not waive any rights of Novartis or its Affiliates with respect to the Novartis Trademarks or Novartis Trade Dress.
(D) Notwithstanding the foregoing, in reviewing and/or granting approval to Licensee for use of any trademark or trade dress in connection with the sale of any Product, Licensee acknowledges and agrees that Novartis shall have no obligation to assess the availability or validity of, or the ability of the Licensee to use, the proposed trademark or trade dress or determine whether the proposed trademark or trade dress is the same or is similar to any trademark proposed to be used by and/or approved by Novartis for use by Licensee or any other MPP Licensee in connection with the Products. Novartis shall have no liability to any party, including the Licensee or any other MPP Licensee, for the use or registration of any trademark, or trade dress that is the same or similar to that of Licensee or any other party.
(E) In addition to the foregoing, for the avoidance of doubt, Licensee agrees that it shall not or cause any other party to: (i) register apply to register or, in connection with the sale of any Product, use any trademark, logo or trade name which is identical to or confusingly similar (as Novartis shall determine in its sole discretion) to any Novartis Trademark; (ii) use trade dress, packaging (both internal and external) or labelling, advertising or marketing material which is the same as or similar (as Novartis shall determine in its sole discretion) to that of Novartis or any Affiliate in connection with the sale of any Product; or (iii) give the impression to the public, to physicians or to the trade that the Product is manufactured by, or in any way connected with, Novartis or its Affiliates.
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11.4 The Licensee shall ensure that packaging (whether external, intermediate or internal), data sheets and promotional materials for the Products to be sold or otherwise supplied by the Licensee under this Agreement shall carry, to the extent permitted by the applicable law, clear statements in bold type that: (a) the Products have been produced under a licence from the Medicines Patent Pool; (b) any other use is not authorised.
APPENDIX A1 – MANUFACTURING PATENT
India Patent No. 237430
APPENDIX A2 – THE PATENTS AND PATENT TERRITORY
APPENDIX C: LIST OF COUNTRIES FORMING THE TERRITORY FOR MANUFACTURING PATENT
