Provision Language
Definitions
“Field” means the pre-exposure prophylaxis of at-risk persons weighing at least 35 kg to reduce the risk of sexually acquired HIV-1 infection.
“Patent Rights” means rights under any unexpired letters patent or any pending patent applications as set forth (each patent or patent application identified by its PCT application number and/or WIPO publication number where applicable) in Appendix C attached hereto, that are granted or pending, relating to the Compound and/or Licensed Product, including divisionals, continuations, continuations-in-part, reissues, renewals, substitutions, registrations, re-examinations, revalidations, extensions, supplementary protection certificates, paediatric exclusivity, and the like of any such patents and patent applications, and international (e.g., WIPO), regional (e.g., EP or EA), and foreign national equivalents of the foregoing, in each case to the extent controlled by ViiV or any of its Affiliates.
“Permitted Market” means the Private Markets and Public Markets in the Territory set out in Appendix B.
“Private Market” means any entity in any country in the Territory that is not in the Public Market.
“Public Market” means: (A) the following organisations to the extent that they are not for profit organisations: (i) the government of any country in the Territory, including the ministries and agencies of such government, appointed procurement agencies acting on behalf of such government, and institutions and programs funded by such government such as state-run hospitals and prison services (referred to together as “Government”); (ii) non-government organisations (“NGOs”) recognized by the applicable Government; (iii) organisations of the United Nation working for or in a country of the Territory, including but not limited to UNDP and UNICEF; (iv) Médecins Sans Frontieres, Save the Children, OXFAM and the International Committee of the Red Cross (ICRC); and (v) the funding mechanisms (and programs funded by such mechanisms) Unitaid, PEPFAR, U.S. Agency for International Development, Children’s Investment Fund Foundation or Global Fund, or procurement agencies acting on their behalf, to the extent that they support local implementation of public HIV prevention program(s) for people >35 kg at risk of HIV infection in a country of the Territory; and (B) Third Party distributors, solely to the extent that such Third Party distributors distribute the Licensed Product to or for one or more entities identified in (A) of this Clause 1.48.
3. Grant of Licence
3.1 Subject to the terms and conditions of this Agreement ViiV hereby grants to the MPPF a non-exclusive, non-transferable licence under the Patent Rights to enter into Sublicences with Successful Applicants.
3.2 No rights are hereby granted for any other purpose and the MPPF agrees that it will not use or exploit the Patent Rights itself or grant sublicences: (i) to entities other than Successful Applicants; and/or (ii) other than in the form of the Sublicence.
3.3 The number of Sublicences granted pursuant to Clause 3.1 shall be limited to three (3), subject to the following:
(A) if at any time during the Term, the MPPF considers that public health demand for Licensed Product is not met by the volume of Licensed Product sold or otherwise supplied pursuant to the then existing Sublicences (other than due to temporary interruptions to existing supply), the MPPF shall notify ViiV of the same, sharing appropriate supporting evidence. If ViiV determines, acting reasonably, that the evidence demonstrates a public health need for additional Licensed Product in the Territory, it shall grant the MPPF the right to enter into additional Sublicence(s) under Clause 3.1, the number of which shall be determined by ViiV based on the evidence shared by the MPPF; and
(B) if at any time during the Term, any Sublicence is terminated pursuant to Clause 21 of such Sublicence, MPPF shall have the right to grant additional Sublicence(s) under Clause 3.1 to bring the number of Sublicenses back up to 3 (or such other number of Sublicenses as agreed by ViiV pursuant to Clause 3.3(A)).
4. Licensee Selection Process
4.1 The MPPF will coordinate the Licensee Selection Process and the subsequent execution of a Sublicence between the MPPF and each Successful Applicant.
4.2 Promptly after the Effective Date (and in any event within ninety (90) days of the Effective Date), or pursuant to Clause 4.5 below, the MPPF will identify and notify ViiV of up to a maximum of three (3) Third Parties, each of which has:
(A) demonstrated possession of, or demonstrated readiness to acquire, adequate infrastructure (operating under current Good Manufacturing Practice), technical capability, capacity, and willingness to (i) develop Licensed Compound and Licensed Product, and (ii) manufacture Licensed Product in a manner consistent with WHO pre-qualification standards or the standards of any 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;
(B) demonstrated possession of adequate infrastructure to enable it to distribute and supply Licensed Product to the majority of the Territory;
(C) provided a current EcoVadis report, or if the Third Party has no current report, has committed to obtaining such EcoVadis report as quickly as possible; and
(D) in place a quick and efficient batch trace procedure following the GS1 Global Traceability or comparable standard, so as to enable the identification and location of Licensed Compound and Licensed Products from individual batches with minimal delay and the ability to implement upon request,
collectively the “Selection Criteria”. At the same time, the MPPF shall provide documentary evidence, to ViiV’s satisfaction, that each proposed Third Party meets such Selection Criteria.
4.3 Within fifteen (15) Business Days of receipt by ViiV of satisfactory documentary evidence that such proposed Third Party meet the Selection Criteria, ViiV shall inform the MPPF in writing whether it agrees or disagrees that the Third Party proposed by the MPPF meet the Selection Criteria. In the event ViiV considers that the proposed Third Party has not satisfied the Selection Criteria, ViiV shall provide its reasons. In the event ViiV considers that the Third Party has satisfied the Selection Criteria, ViiV shall as soon as reasonably practicable undertake and complete any additional due diligence on such Third Party as it, in its sole discretion, considers necessary, and inform the MPPF of the outcome of such due diligence. MPPF shall facilitate compliance by the Third Party with the due diligence process. A Third Party who has satisfied the Selection Criteria and who has successfully passed ViiV’s due diligence process shall be referred to in this Agreement as a “Successful Applicant”.
4.4 Following ViiV’s written confirmation that a Third Party proposed by the MPPF is a Successful Applicant pursuant to Clause 4.3, the MPPF shall promptly (and in any event within one (1) Calendar Month of the Effective Date) execute a Sublicence with such Successful Applicant.
4.5 If at any time during the Term, the MPPF has the right to grant additional Sublicences pursuant to Clauses 3.3A and/or 3.3B, MPPF shall re-initiate the Licensee Selection Process in order to identify qualified sublicensee(s) up to the maximum number of permitted Sublicensees.
8. Sublicence Compliance
8.1 Monitoring – The MPPF shall, using all reasonable care, diligence and skill, actively monitor each Sublicensee’s compliance with the terms of its Sublicence, including:
(A) Reporting – procuring that all Sublicensees provide the reports referred to in Clauses 8 and 13 of the Sublicence in a timely manner and in accordance with the terms of those Clauses and any Reporting Guidance (where applicable). If, notwithstanding the MPPF’s efforts, a Sublicensee does not provide such reports:
(i) in the case of reports under Clause 8 of the Sublicence, within five (5) Business Days after the ten (10) Business Day period provided under the terms of the Sublicence; or
(ii) in the case of the report under Clause 13 of the Sublicence, (a) within five (5) Business Days after the required ten (10) Business Day period provided under Clause 13.2.4 of the Sublicence and (b) promptly in the case of clinical trial reports (provided under Clause 13.2.5 of the Sublicence) at the conclusion of the relevant clinical research),
the MPPF shall inform ViiV of the same and provide details of its efforts to date to procure such reports;
(B) Approved Royalty Country Public Procurement – verifying that every sale or supply of Licensed Product for use in the Public Market of a Royalty Country was made in accordance with an Approved Royalty Country Public Procurement and report the outcome of such verification to ViiV (summarising the steps taken by the MPPF in reaching such outcome) in the relevant quarterly report under Clause 6.3;
(C) Non-diversion – verifying that:
(i) all sales and/or supplies of Licensed Product by each Sublicensee were made in compliance with Clause 10 of the Sublicence; and
(ii) the volume of Licensed Product sold and/or supplied by Sublicensee(s) for use in any Permitted Market for any period of time is commensurate with the demand for Licenced Product(s) in such Permitted Market for such period of time, as reasonably estimated by the MPPF. If the volume of Licenced Product sold and/or supplied by Sublicensee(s) for use in a Permitted Market exceeds such demand, the MPPF shall take reasonable steps to determine whether any Sublicensee has breached the terms of its Sublicence;
(D) Royalty calculations – verifying the accuracy of any royalty calculation included in or accompanying each sales report provided by the Sublicensee pursuant to Clause 9 of the Sublicence. If an error is identified by the MPPF in respect of such a royalty calculation, the MPPF shall promptly take all steps necessary to ensure that such error is rectified and that the correct amount of royalties payable under the Sublicence is remitted to ViiV;
(E) Royalty payment – where applicable, ensuring the timely quarterly (i) delivery of invoices issued by ViiV in respect of royalties owed to ViiV pursuant to (and in accordance with) Clause 9 of the Sublicence to each Sublicensee and (ii) payment of such royalties (together with any interest due) to ViiV (or to such other person as ViiV has nominated). ViiV shall use reasonable endeavours to issue all invoices in a timely manner to ensure compliance by the MPPF with the timelines under Clause 9 of the Sublicence;
(F) Pharmacovigilance – monitor the activities and duties of each Sublicensee as regards pharmacovigilance obligations under Clause 13 of the Sublicence, and (b) otherwise procuring to MPP any significant safety issue that may (i) impact the benefit/risk ratio of the Product, (ii) require urgent communication by Licensees to health care professionals regarding Licensed Product or (iii) require the restriction of the use of the Product in a certain population. The MPPF shall promptly forward any such communications to each Licensee; and
(G) Audit rights – fully exercising the audit right set out in Clause 19 of the Sublicence at the MPPF’s own cost as soon as the MPPF has reasonable cause to believe an audit is necessary (including grounds for suspecting non-compliance with the Sublicence).
Schedule 2: Form of Sublicense
3. GRANT OF LICENCE
3.1 Scope of licence. Subject to the terms and conditions of this Agreement and to the extent to which the Licensor has the right to grant a licence in respect of the Patent Rights, the Licensor hereby grants to the Licensee a non-exclusive, royalty-bearing (in relation to Royalty Countries), non-sublicensable (other than to Approved Affiliates and Approved Local Distributors in accordance with Clauses 3.2 or 3.3 below), non-transferable licence of the Patent Rights, to the extent necessary, to:
3.1.1 obtain Regulatory Approval for Licensed Product;
3.1.2 manufacture, sell, or otherwise supply Licensed Product solely for use in the Field in the Permitted Market; and
3.1.3 sell or otherwise supply Licensed Compound to a Cabotegravir Licensee for use under a Cabotegravir Licence.
3.2 Affiliates. Upon Licensor’s prior written approval, such approval not to be unreasonably withheld, Licensee shall have the right, pursuant to the licence granted to it under Clause 3.1, to grant sublicences to any of its Affiliates, which the Licensee has demonstrated by means of appropriate supporting documents is an Affiliate of the Licensee. The Licensor shall respond to any requests for approval within thirty (30) days of receipt of appropriate supporting documents from the Licensee, with an approval or a written statement of why the request is not been approved. Any Affiliate of the Licensee approved by the Licensor pursuant to this Clause 3.2 shall be referred to in this Agreement as an “Approved Affiliate”.
3.3 Local Distributors. The Licensor acknowledges that in some countries of the Territory, for Licensed Product to be lawfully sold or otherwise supplied, Regulatory Approval must to be held in the name of a local entity registered in such country (“Local Distributor”). Where Licenced Product can only be lawfully sold or otherwise supplied in a country of the Territory by a Local Distributor, and an Approved Affiliate of the Licensee cannot act as such Local Distributor pursuant to Clause 3.2, the Licensee may submit a written request to the Licensor to use a Third Party that is not an Affiliate as a Local Distributor in such country. Such request shall be supported by appropriate documentation on (a) the need to use a Local Distributor and (b) due diligence on the Third Party. The Licensor, acting reasonably, shall consider the request and respond within thirty (30) days of receipt of all appropriate supporting documents from the Licensee, with an approval or a written statement of why the request is not been approved. Any Third Party approved in writing by the Licensor pursuant to this Clause 3.3 shall be referred to in this Agreement as an “Approved Local Distributor”. The Licensee shall have the right, pursuant to the licence granted to it under Clause 3.1, to grant a sublicence to such Approved Local Distributor, solely to the extent necessary for such Approved Local Distributor to obtain Regulatory Approval and/or sell or otherwise supply the Licensed Product in the relevant country of the Territory.
3.4 Approved Sublicensees – Licensee shall ensure that any Approved Affiliate and/or Approved Local Distributor (each an “Approved Sublicensee” and together “Approved Sublicensees”) complies with all the terms of this Agreement as if it was the Licensee under this Agreement, and Licensee shall be liable for the acts and omissions of such Approved Sublicensee as if such acts and/or omissions were the act and/or omissions of the Licensee. In the event an Approved Sublicensee fails to comply with any terms of this Agreement, the Licensor shall have the right to withdraw its approval of such Approved Sublicensee with immediate effect by providing written notice to the Licensee.
4. DEVELOPMENT, REGISTRATION AND COMMERCIALISATION
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4.3 Timelines for Regulatory Approval. The Licensee shall file, for Regulatory Approval (for both an oral Licensed Product and an extended-release Licensed Product) before at least one Relevant Regulatory Authority as soon as possible and in any event not later than 60 months from the Effective Date, in each case using the fastest approval route possible. Licensee shall also, upon Licensor’s reasonable request, file for regulatory approval before the Relevant Regulatory Authority for any subsequent Licensed Product within a reasonable time.
7. TRADE DRESS AND TRADE MARKS
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7.3 Trade Dress. The Licensee shall ensure that the Trade Dress of each Licensed Product is visually differentiated from that of products sold or supplied by ViiV and/or its Affiliates in a manner further elaborated under the Trade Dress Guidance.
7.4 Approval.
7.4.1 The Licensee shall seek the Licensor’s written approval (such approval not to be unreasonably withheld or conditioned):
(a) to register (if applicable) and use a Trade Mark in relation to a Licenced Product, prior to such registration or such use, whichever is the earliest; and
(b) to use a Trade Dress in relation to a Licensed Product (including any Trade Dress in any promotional materials for the Licensed Product), prior to such use.
7.4.2 Licensee shall submit the request for approval via the Licensor’s online trade dress portal or in any other manner specified by Licensor, providing all documentation necessary to consider the request (as further elaborated in the Trade Dress Guidance). Licensor shall use reasonable endeavours to ensure a response to any request for approval is provided within forty-five (45) days of receipt of all necessary documentation, with an approval or a written statement of why the request is not being approved. For the avoidance of doubt, the Trade Dress Guidance does not limit in any way the Licensor’s right to refuse to provide approval under this Clause 7.4, and the basis of Licensor’s refusal to provide approval under this Clause 7.4 shall not be limited to breaches of Clauses 7.2.
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7.7 Acknowledgment. The Licensee shall ensure that all elements of the Trade Dress (including external, intermediate and internal elements) relating to a Licensed Product, carry a clear statement in bold type that the Licensed Product has been produced under a licence from the Medicines Patent Pool and ViiV Healthcare, unless inclusion of such statement is prohibited by Applicable Law, national procurement policy or the relevant Regulatory Authority. Where inclusion of the statement is prohibited, the Licensee shall inform the Licensor of the prohibition and provide appropriate supporting evidence.
14. IMPROVEMENTS AND PATENT PROSECUTION, ENFORCEMENT AND DEFENCE
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14.2 Improvements Licence. The Licensee hereby grants to the Licensor and ViiV a perpetual, irrevocable, worldwide, royalty free, non-exclusive licence to use any Improvement, Improvement Patent Rights and related know-how (and shall promptly execute such document as ViiV may reasonably request accordingly). The Licensor shall not sublicense such rights to any Third Party, provided, however, that should the Licensor desire to sublicense any such rights, the Licensee and the Licensor agree to enter into good-faith negotiations regarding such sublicence. ViiV shall be entitled to grant sublicences (without further right to sublicense) under such licence only to its:
14.2.1 Affiliates; and/or
14.2.2 contract manufacturers, distributors and service providers solely for use in connection with their engagement of commercialising ViiV products.