Licensee Selection Process Sample Clauses
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.
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 Par...