Master Alliance Provisions Guide (MAPGuide)

Population Council – TherapeuticsMD, Nestorone Contraceptive Ring, License Agreement

  • Business model | Governance


4.1 Joint Product Committee

4.1.1 Formation. Within 30 days of the Effective Date of the Agreement, the Parties will establish a joint product committee (the “JPC”). The JPC will be composed of six (6) members, three (3) members appointed by each Party, including at least one research and development executive or his or her designee from each Party, and will have the right to create subcommittees as needed. Promptly following the Effective Date, each Party will appoint its initial representatives to the JPC. Each Party may replace its JPC representatives at any time upon written notice to the other Party. LICENSEE will designate one of its representatives as the Chairperson of the JPC. The Chairperson will be responsible for scheduling meetings, preparing and circulating an agenda in advance of each meeting, preparing and issuing minutes of each meeting within thirty (30) days thereafter, revising such minutes to reflect timely comments thereon, and overseeing the ratification of such revised minutes.

4.1.2 Meetings. The JPC will meet at such times and such places as will be determined from time to time by LICENSEE and the Council, but in any event, not less than twice in each calendar year. Members of the JPC may participate in meetings of the JPC in person or by conference telephone call. A quorum for the conduct of business by the Joint Product Committee will consist of a majority of the members designated by LICENSEE and a majority of the members designated by the Council.

4.1.3 Duties of the Joint Product Committee. The JPC will:

(a) Oversee the planning and implementation of development activities, including post-Regulatory Approval activities;

(b) Review results of the development activities and discuss modifications to any planned development activities;

(c) Facilitate the exchange of regulatory documents and other regulatory information between the Parties;

(d) Review the Marketing Plan developed by LICENSEE and its implementation;

(e) Discuss the state of the markets for Licensed Product in the Territory and opportunities and issues concerning the Commercialization of Licensed Product, including consideration of marketing and promotional strategy, marketing research plans, labeling, Licensed Product positioning and Licensed Product profile issues;

(f) Monitor the sales efforts of Licensee in the Territory;

(g) Oversee and update the Outreach Plan; provided that any changes during the Exclusivity Term to Paragraph 4 of the Outreach Plan will not be subject to decision by the JPC and must be made, if at all, by amendment or modification of this Agreement.

(h) Have authority to establish one or more other committees that report to the JPC and assist the JPC in carrying out its responsibilities, which other committees will be subordinate to the JPC, will have such membership and responsibilities as the JPC will determine, and may be disbanded by the JPC at any time;

(i) Resolve, or attempt to resolve any disputes not resolved by any subordinate committee created by the JPC; and

(j) Perform such other functions as appropriate to further the purposes of this Agreement and as allocated to it jointly in writing by the Parties.

4.1.4 Decision Making; Authority. The JPC will make its decisions by consensus, with each Party’s representatives collectively having one vote. If the JPC is unable to reach consensus regarding a matter before it, the issue will be presented by the JPC to the Parties’ Applicable Senior Officers for resolution. Once an issue has been presented to the Applicable Senior Officers, they will have fifteen (15) days to make a final determination regarding the issue in dispute. In the event that the Applicable Senior Officers are unable to reach a final determination within such fifteen (15) day period, then:

(a) Council will have authority to make the final decision with respect to all issues relating to all clinical, regulatory, and development matters prior to the NDA Response Date and any matters thereafter for which the Council has sole financial responsibility under this Agreement; and

(b) LICENSEE will have authority to make the final decision with respect to all issues not set forth in the foregoing (a) or Section 4.2.2(c), subject to LICENSEE fulfilling its obligations under this Agreement, including with respect to using Commercially Reasonable Efforts as required hereunder. For the avoidance of any doubt, LICENSEE will have exclusive right to establish pricing of the Licensed Product in the Territory.

4.1.5 General Principles.

(a) The JPC and any subordinate committees have no authority beyond the specific responsibilities set forth in this Agreement with respect to such committee. Any subordinate committee created by the JPC will have such duties and responsibilities delegated to such committee by the JPC, so long as such duties and responsibilities do not exceed the power and authority assigned to the JPC hereunder. In particular, and without limiting the generality of the foregoing, no committee may amend or modify the terms or provisions of this Agreement.

(b) Each Party will ensure that its representatives to a committee have appropriate expertise and authority to serve as members of such committee. With the consent of the representatives of each Party serving on a particular committee, other representatives of each Party may attend meetings of that committee as observers. Each Party will be responsible for all of its own expenses of participating in committee meetings. Each Party will use good faith and cooperative efforts to facilitate and assist the efforts of the committees.

(c) Each committee will continue to exist until the first to occur of (i) the Parties mutually agreeing to dissolve it, or (ii) the expiration of all payment obligations described in Article III.

(d) The Parties may form any other committees as they will mutually agree.



14.2 Governing Law. For all matters other than the scope and validity of patents, this Agreement will be deemed to have been made in the State of New York and its form, execution, validity, construction and effect will be determined in accordance with the laws of the State of New York, without giving effect to the principles of conflicts of law thereof and the Parties agree to the personal jurisdiction of and venue in any federal court located in the Southern District of New York or state court located in New York County, New York. The application of the United Nations Convention for Contracts for the International Sales of Goods is hereby expressly excluded.

14.3 Dispute Resolution. If a dispute arises between the Parties under or with respect to this Agreement (a “Dispute”), it will first be submitted to the respective chief executive officers of the Parties for resolution by good-faith negotiation. Any Dispute not resolved by such good-faith negotiation after thirty (30) days from the first notification by one Party to the other Party of the existence of such Dispute may be submitted thereafter by one or both Parties to Arbitration in accordance with this Section 14.3. Any Dispute not settled by negotiation between the Parties will be finally resolved by, arbitration in accordance with the Commercial Arbitration Rules of the American Arbitration Association (“AAA”) then in effect (the “Rules”), except as modified herein. The place of arbitration will be New York, New York. If the amount in controversy is $4 million or less (including all claims and counterclaims) there will be one (1) neutral and impartial arbitrator who will be agreed upon by the Parties within twenty (20) days of receipt by respondent of a copy of the demand for arbitration. If the amount in controversy is more than $4 million (including all claims and counterclaims) there will be three (3) neutral and impartial arbitrators, of whom each Party will appoint one (1) within thirty (30) days of the receipt by the respondent of the demand for arbitration. The two (2) arbitrators so appointed will select the chair of the arbitral tribunal within thirty (30) days of the appointment of the second arbitrator. If any arbitrator is not appointed within the time limit provided herein, such arbitrator will be appointed by the AAA in accordance with the listing, striking, and ranking procedures in the Rules. Any arbitrator appointed by the AAA will be a retired judge or a practicing attorney with no less than fifteen (15) years of experience with commercial cases and an experienced arbitrator, who will if practicable, have substantial experience with transactions or disputes related to the field of pharmaceuticals and/or, if applicable, intellectual property. In rendering an award, the arbitral tribunal will be required to follow the laws of the state of New York. The arbitral tribunal is not empowered to award damages in excess of compensatory damages, and each party hereby irrevocably waives any right to recover punitive, exemplary, multiple or similar damages with respect to any Dispute. Any arbitration proceedings, decision, or award rendered hereunder and the validity, effect, and interpretation of this arbitration provision will be governed by the Federal Arbitration Act, 9 U.S.C. §1 et seq. The award will be in writing and will state the findings of fact and conclusions of law on which it is based. The award will be final and binding upon the Parties and will be the sole and exclusive remedy between the Parties regarding any claims, counterclaims, issues, or accounting presented to the arbitrator(s). Judgment upon the award may be entered in any court having jurisdiction. Any costs or fees (including attorneys’ fees and expenses) incident to enforcing the award will be charged against the Party resisting such enforcement. By agreeing to arbitration, the Parties do not intend to deprive any court of its jurisdiction to issue a pre-arbitral injunction, pre-arbitral attachment, or other order in aid of arbitration proceedings and the enforcement of any award. Without prejudice to such provisional remedies as may be available under the jurisdiction of a court, the arbitral tribunal will have full authority to grant provisional remedies and to direct the Parties to request that any court modify or vacate any temporary or preliminary relief issued by such court, and to award damages for the failure of a Party to respect the arbitral tribunal’s orders to that effect. The Parties hereby submit to the exclusive jurisdiction of the federal and state courts located in New York County, New York, for the purpose of an order to compel arbitration, for preliminary relief in aid of arbitration, or for a preliminary injunction to maintain the status quo or prevent irreparable harm prior to the appointment of the arbitrators, and to the non-exclusive jurisdiction of such courts for the enforcement of any award issued hereunder. The Parties hereby agree to accept service of process pursuant to the notice provisions of this Agreement.