Master Alliance Provisions Guide (MAPGuide)

ViiV – MPP, HIV Prevention Medicine (Cabotegravir LA for PrEP), License Agreement

  • Business model | Governance

2. Governance

2.1 As soon as reasonably practicable and in any event within thirty (30) days after the Effective Date, the Parties will establish a steering committee (the “Steering Committee”). The Steering Committee shall be responsible for: (i) reviewing the performance of the Parties’ respective obligations under this Agreement; (ii) reviewing the performance of the Sublicensee and the MPPF’s respective obligations under each Sublicence; (iii) facilitating communication between the Parties; (iv) considering whether any amendments or extensions are required to this Agreement or any Sublicence (subject always to Clause 18 and 26).

2.2 The Steering Committee shall be composed of four (4) persons (“Members”), two (2) Members from each Party, each with appropriate seniority and operational expertise. Each Party may replace any of its Members, either on an ad hoc or permanent basis. A Party that replaces a Member shall notify the other Party prior to the next scheduled meeting of the Steering Committee. The quorum for a meeting of the Steering Committee shall be one (1) Member of each Party, or the relevant Member’s replacement. Both Parties may invite a reasonable number of additional experts and/or advisors and/or observers to attend a part or the whole of each Steering Committee meeting, if and as the need arises, with prior notification to the Steering Committee and subject to obligations of confidentiality no less onerous than those in Clause 13.

2.3 The venue for the Steering Committee meetings shall be agreed by the Steering Committee and such meetings shall be held on a quarterly basis, either in person or by tele-/video-conference, or as frequently as the Members may agree shall be reasonably necessary. Each Party shall bear responsibility for all travel and other related costs for its Members and representatives to attend and/or participate in Steering Committee meetings.

2.4 A Member from the MPPF shall: chair each Steering Committee meeting; prepare and distribute in advance of each meeting a draft agenda; and record and circulate draft minutes of each meeting within five (5) Business Days of the meeting. Any comments on the draft minutes must be provided to the relevant drafting MPPF Member in writing within fourteen (14) days after receipt. The Members shall act in good faith to attempt to resolve any disputes over the content of the Steering Committee minutes as quickly as possible. If, however the Parties cannot agree on the content of the Steering Committee minutes it shall be noted in the minutes that the Parties did not agree on the content of the minutes and each Party’s view shall be recorded.

2.5 The Members of the Steering Committee shall act in good faith and cooperate with one another and seek agreement with respect to issues to be decided by the Steering Committee. All decisions are to be made by unanimous consensus of Members in attendance and voting, with the MPPF Members collectively having one vote and the ViiV Members collectively having one vote. If the Steering Committee is unable to decide a matter by consensus within ten (10) Business Days of the matter first being discussed at a Steering Committee meeting following inclusion on a draft agenda distributed to the Steering Committee Members, the issue shall be resolved pursuant to Clause 29.

29. Governing Law and Dispute Resolution

29.1 This Agreement and any dispute or claim arising under or relating to this Agreement or its subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the laws of England and Wales.

29.2 The Parties wish to facilitate the resolution of any dispute arising out of or relating to this Agreement including but not limited to the breach, termination, interpretation or validity thereof (a “Dispute”) in an expedient manner by mutual cooperation and agree to follow the procedures set forth in this Clause 29 to resolve any such Dispute.

29.3 ESCALATION – If a Dispute cannot be resolved between the Parties within thirty (30) days of written notice by one Party to another, such Dispute shall be referred in writing to the Parties’ respective executive officers or their designees for attempted resolution by good faith negotiations which shall take place within thirty (30) days after such referral (or within such other time period as may be agreed by the Parties in writing).

29.4 MEDIATION – Any Dispute remaining unresolved thirty (30) days (or such other time period as may be agreed by the Parties in writing) after referral to the Parties’ executive officers pursuant to Clause 29.3 shall first be submitted to mediation in accordance with the Rules of Mediation of the International Chamber of Commerce.

29.5 ARBITRATION – Any Party may refer any Dispute not resolved by mediation within forty-five (45) days (or within such other time period as may be agreed by the Parties in writing) after the appointment of the mediator, for resolution by final and binding arbitration conducted in accordance with the Rules of Arbitration of the International Chamber of Commerce (the “ICC Rules”) provided that to the extent that the following provisions of this Clause conflict with the said ICC Rules the following provisions shall prevail:

(A) the arbitration shall be conducted by a sole arbitrator;

(B) the seat of the arbitration shall be London;

(C) the language of the arbitration shall be English;

(D) the decision of the arbitrator shall be final and binding on the Parties;

(E) judgment upon the arbitration award may be entered by any court having jurisdiction thereof or having jurisdiction over the relevant Party and its assets; and

(F) all documents and proceedings in any arbitration pursuant to this Clause 29.5 shall be confidential and all hearings shall be held in private, save to the extent necessary to enforce any award or to comply with any requirement of any lawful authorities. No public statement shall be made with regard to any arbitral proceedings save to the extent agreed between the Parties in writing.

29.6 INJUNCTIVE RELIEF – Notwithstanding the foregoing, nothing in this Clause 29 shall be construed as precluding a Party from bringing an action in court for interim injunctive relief or other interim equitable relief.

Schedule 2 – Form of Sublicense

2. CONTRACT MANAGEMENT

2.1 Within thirty (30) days following the expiration of every ten (10) Business Day period referred to in Clause 8 of this Agreement, Licensee agrees to meet and confer with Licensor to review the operational elements of, and compliance with, this Agreement including but not limited to performance of the Licensee’s obligations under this Agreement (“Quarterly Meeting”).

2.2 At each Quarterly Meeting, the Parties will review Licensee’s Development Activities and regulatory activities and plans and sales of the Licensed Products.

2.3 Licensee shall promptly take corrective actions in relation to any identified non compliance of its obligations under this Agreement, as agreed during each Quarterly Meeting.

34. GOVERNING LAW AND DISPUTE RESOLUTION

34.1 This Agreement and any non-contractual obligations arising out of or in connection with it shall be governed by the laws of England and Wales.

34.2 The Parties wish to facilitate the resolution of any dispute arising out of or relating to this Agreement including but not limited to the breach, termination, interpretation or validity thereof (a “Dispute”) in an expedient manner by mutual cooperation and agree to follow the procedures set forth in this Clause 34 to resolve any such Dispute.

34.3 ESCALATION – If a Dispute cannot be resolved between the Parties within thirty (30) days of written notice by one Party to another, such Dispute shall be referred in writing to the Parties’ respective executive officers or their designees for attempted resolution by good faith negotiations which shall take place within thirty (30) days after such referral (or within such other time period as may be agreed by the Parties in writing).

34.4 MEDIATION – Any Dispute remaining unresolved thirty (30) days (or such other time period as may be agreed by the Parties in writing) after referral to the Parties’ executive officers pursuant to Clause 34.3 shall first be submitted to mediation in accordance with WIPO mediation Rules. Such mediation shall be attended on behalf of each Party for at least one session by a senior executive with authority to resolve the dispute and shall be held in Geneva, Switzerland, except where the claim is brought by ViiV, its Affiliates and/or any Indemnified Person (pursuant to the rights granted under Clause 24), in which such mediation shall be held in London, UK.

34.5 ARBITRATION – Any Party may refer any Dispute not resolved by mediation within forty-five (45) days (or such other time period as may be agreed by the Parties in writing) after the appointment of a mediator pursuant to Clause 34.4, for resolution by final and binding arbitration conducted in accordance with the WIPO Arbitration Rules. The arbitration shall be conducted in English and the arbitral tribunal shall consist of three arbitrators. The place of arbitration shall be Geneva, Switzerland, except where the claim is brought by ViiV, its Affiliates and/or any Indemnified Person (pursuant to the rights granted under Clause 24), in which case the place of arbitration shall be London, United Kingdom. Parties do not object to arbitration proceedings being held online.

34.6 INJUNCTIVE RELIEF – Notwithstanding the foregoing, nothing in this Clause 34 shall be construed as precluding a Party (or any Third Party beneficiary under this Agreement) from bringing an action in court for interim injunctive relief or other interim equitable relief.