Common use of Licensee Selection Process Clause in Contracts

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.‌

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 3.1 Promptly after the Effective Date (and in any event within ninety sixty (9060) days of the Effective Date), or pursuant to Clause 4.5 3.7 below, the MPPF will identify and notify ViiV of up to a maximum of three (3) Third Parties, each of which hasproposed sublicensees who have: (A) demonstrated possession of, an Existing Adult Licence from the MPPF 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 2015ViiV; (B) obtained at least tentative FDA approval or World Health Organization (WHO) pre- qualification for a Licensed Mono Product; (C) demonstrated possession of adequate infrastructure to enable it the Sublicensee to distribute and supply Licensed Product to the majority of every country in the Territory; (CD) provided a production facilities operating under current EcoVadis reportGood Manufacturing Practice; (E) adequate environment, or if the Third Party has no current report, has committed health and safety measures in place; (F) undergone and passed an anti-bribery and corruption assessment to obtaining such EcoVadis report as quickly as possibleensure compliance with applicable anti-corruption laws; and (DG) in place a quick and efficient batch trace procedure following the GS1 Global Traceability or comparable standard, Standards in place 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 requestthe same at the MPPF’s or ViiV’s request if at any time the MPPF or ViiV is of the opinion that any batch or batches of the Product have been, or may have been, diverted (i) outside the Public Market in the Territory and/or (ii) outside the Territory, collectively the “Selection Criteria”. At the same time, the MPPF shall provide documentary evidence, to ViiV’s satisfaction, that each proposed Third Party sublicensee meets such Selection Criteria. 4.3 3.2 Within fifteen ten (1510) Business Days of receipt by ViiV of satisfactory documentary evidence that such proposed Third Party sublicensees meet the Selection Criteria, ViiV shall inform the MPPF in writing whether it agrees or disagrees that the Third Party entities proposed by the MPPF meet the Selection CriteriaCriteria and may be Sublicensees. In the event ViiV considers that the proposed Third Party has not satisfied the Selection Criteriacase of disagreement, ViiV shall provide its reasonsreasons for considering that the Selection Criteria have not been sufficiently satisfied for the entity to be considered a suitable sublicensee. In the event ViiV considers that of a disagreement, the Third Party has satisfied Parties shall resolve the Selection Criteria, ViiV shall as soon as reasonably practicable undertake and complete any additional due diligence on such Third‌ Party as it, disagreement in its sole discretion, considers necessary, and inform the MPPF accordance with Clause 30 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”Agreement. 4.4 3.3 Following ViiV’s written confirmation that a Third Party sublicensee proposed by the MPPF is a Successful Applicant acceptable to ViiV pursuant to Clause 4.33.2, the MPPF shall promptly (and in any event within one (1) Calendar Month of the Effective Date) execute a Sublicence in the form included at Schedule 1 with such Successful Applicantsublicensee. 4.5 If 3.4 The MPPF shall procure that at the same time as any time during Sublicence is entered into, the Termrelevant Sublicensee also enters into a Letter of Indemnity. Within thirty (30) days of the execution of such Sublicence and Letter of Indemnity, the MPPF shall provide to ViiV (i) a fully executed copy of the relevant Sublicence and (ii) two originals of the relevant Letter of Indemnity. 3.5 The MPPF 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 ViiV’s express prior consent in writing, signed by or on behalf of ViiV. 3.6 ViiV shall provide to any Sublicensee such consents which it has the right legal capacity to grant additional Sublicences give as are necessary to enable such Sublicensee to perform its obligations under Clauses 4.2 and 4.3 of the Sublicence. 3.7 In the event that any Sublicence is terminated pursuant to Clauses 3.3A and/or 3.3BClause 13.12 of the Sublicence, MPPF shall be entitled to re-initiate the Licensee Selection Process in order to identify qualified sublicensee(s) up to the maximum number of permitted Sublicensees.‌three (3) Sublicensees.