Provision Language
Definitions
“Contract Service Provider” or “CSP” shall mean any Third Party service provider or Affiliate contracted by either Party to perform certain aspects of the Research Program.
3. RESEARCH PROGRAM
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3.3 The Research Plan may be approved and revised by the JRC, at decision points as new data becomes available.
3.4 During the Term, each Party shall use Reasonable Efforts to conduct, advance and complete the research activities assigned to it in a timely way and as soon as reasonably practical, including devoting such employees/consultants/CSPs with sufficient skills and experience, and facilities and equipment as are reasonably necessary to complete its obligations under the Research Plan(s).
5. PARTNER’S CONTRIBUTIONS TO THE RESEARCH PROGRAM
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5.2 Partner shall:
a) carry out the activities assigned to it in the Research Plan(s), which may include, without limitation, parasitology, pharmacology, synthetic and medicinal chemistry, ADME and PK, safety and toxicology studies, formulation development, and as agreed between the Parties from time to time;
b) provide expert scientific advice; and
c) contribute to the management of the Research Program by participating to the JRC.
6. DNDI’S CONTRIBUTIONS TO THE RESEARCH PROGRAM
6.1 DNDi shall:
a) coordinate and conduct, through its CSPs, all activities assigned to it in the Research Plan(s); and
b) participate in the management of the Research Program through the Project Leader and the JRC.
12. GOVERNANCE STRUCTURE
12.1 DNDi shall appoint a project leader (“Project Leader”) for the duration of the Agreement. DNDi may replace the Project Leader from time to time.
12.2 The Project Leader shall be responsible for:
a) being the primary point of contact for the Research Program;
b) designing, updating, refining and revising the Research Plan(s);
c) facilitating the efficient implementation, coordination and monitoring of the operational activities set out in the Research Plan(s);
d) providing information to the Parties with respect to specific activities conducted under each Research Plan;
e) assisting with the analysis and interpretation of data resulting from the Research Plan(s); and
f) recommending to the JRC whether: i. any Molecule(s) shall enter into the next stage of the Research Plan; and ii. any Clinical Candidate(s) shall enter into the Development Program.
12.3 The Parties shall set up a Joint Research Committee (“JRC”) within thirty (30) days after the Effective Date.
12.4 The JRC shall be composed of < the Project Leader and two (2) permanent representatives of each Party > (each, a “JRC Member”). Each such JRC Member shall have appropriate technical credentials, experience and knowledge. Either Party may replace any or all of its JRC Members at any time upon prior written notice to the other Party. If a Party’s JRC Member is unable to attend a meeting, that Party may designate an alternate representative for such particular meeting.
12.5 The role of the JRC is to serve as an information exchange platform, to leverage the respective competencies and contributions of each Party to optimally conduct the Research Plan(s), and to oversee the performance of the Research Plan(s). It shall notably:
a) review and approve any Research Plan(s), updates and amendments thereto, or the discontinuation thereof;
b) monitor the workflow and overall progress under the Research Plan(s);
c) consider issues of priority relating to the Research Plan(s);
d) determine whether: i. any Molecule(s) shall enter into the next stage of the Research Plan; or ii. any Clinical Candidate(s) shall enter into the Development Program based on the Project Leader’s recommendation and the business, legal, medical and scientific standards typically used by Partner and DNDi for reviewing molecules of a similar nature and potential; and
e) take such other actions as are expressly delegated to the JRC in this Agreement or as the Parties may mutually agree in writing. For the avoidance of doubt, the JRC has no authority to amend, or to waive compliance with, any term or condition of this Agreement.
12.6 The Project Leader shall serve as the chair of the JRC and shall be responsible for administering the work of the JRC, including organizing JRC meetings, setting the agenda for such meetings and distributing it to the JRC Members no less than < one (1) week > before any JRC meeting. The Chair shall also be responsible for preparing and circulating draft minutes from each JRC meeting to the JRC Member, facilitating the exchange of information, reviews of results and monitoring the contributions by each Party.
12.7 The JRC shall meet at such times as are agreed to by the JRC Members, but at least < four (4)> times per year. Such meetings may be held in person or by means of telecommunication (telephone, video, or web conferences) at a mutually agreed time and place. The first meeting shall take place within < thirty (30) > days after the Effective Date.
12.8 A quorum of the JRC shall exist whenever at least < one representative appointed by each Party > is present at a meeting.
12.9 The JRC shall take decision by consensus. In case of a disagreement within the JRC, the issue shall be brought to senior executives of Partner and DNDi (as designated by each Party) to attempt to reach a consensus with respect to such issue. If the senior executives cannot reach an agreement within thirty (30) days of such escalation, the Party that is incurring the larger financial burden with respect to the specific issue in disagreement will have the final decision, provided that any such decision will not result in an increase of the other Party’s financial burden. The Parties acknowledge and agree that the JRC is strictly for the purposes of decision making and governance of the Research Program. Without limiting the generality of the foregoing, any dispute relating to the interpretation of this Agreement, the performance or alleged non–performance of a Party’s obligations under this Agreement, or any other alleged breach of this Agreement shall be decided in accordance with the terms of Article 29.
12.10 The minutes shall be kept of all JRC meetings and sent to all JRC Members for review and approval within < seven (7) > days after each meeting. Minutes shall be deemed approved unless any JRC Member objects to the accuracy of such minutes by providing written notice to the other JRC Members within < fourteen (14) > days after receipt of the minutes. In the event that any such objection is not resolved by the JRC, such minutes shall be amended to reflect such unresolved dispute.
12.11 The Parties may invite, from time to time, guests (from either Party as well as external consultants or advisors), who shall be under an obligation of confidentiality no less stringent than the terms set forth in this Agreement, to attend any meeting of the JRC in an advisory capacity within their respective competences as deemed necessary for the advancement of the Research Program (such additional representative(s), “Guest(s)”). For clarity, any Guest(s) shall not vote or otherwise participate in the decision.making process of the JRC. Expenses related to the attendance of any Guest(s) to a JRC meeting shall be borne solely by the Party inviting such Guest(s).
12.12 For the avoidance of doubt, the Parties may also engage in informal scientific discussions and exchanges of correspondence outside of the scheduled JRC meetings, as needed.
29. GOVERNING LAW, DISPUTE RESOLUTION AND EQUITABLE RELIEF
29.1 This Agreement shall be governed by, subject to, construed and enforced in accordance with the laws of Switzerland, without giving effect to any conflicts of law rules.
29.2 Except as provided in Section 12.9, any disputes arising between the Parties in connection with the validity, interpretation, performance or termination of this Agreement shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by one or more arbitrators appointed in accordance with such rules. The place of arbitration shall be Geneva, Switzerland and the language of the proceedings shall be English.
29.3 Prior to initiating arbitration, the Parties shall make a good faith attempt to resolve amicably any dispute arising under this Agreement. The contact persons indicated in Article 28 shall first attempt to resolve the matter by negotiation, and shall attend to at least one meeting for this purpose. In case this effort is unsuccessful, within fifteen (15) calendar days from the first discussion, the Parties shall each designate a person senior to the contact persons indicated in Article 28 to make a further attempt to resolve the dispute. If the dispute is not resolved within fifteen (15) calendar days thereafter, either Party may, by written notice to the other Party, initiate arbitration proceedings as provided in Section 29.2. Notwithstanding this Section 29.3, each Party shall be free to seek a preliminary injunction in court at any time.
29.4 Notwithstanding Sections 29.2 and 29.3, a breach by either Party of this Agreement may cause irreparable damage and the non‐breaching Party may not be adequately compensated by monetary damages. In the event of a breach, or threatened breach, the non‐breaching Party shall be entitled to seek from any court of competent jurisdiction equitable relief, whether preliminary or permanent, without the need to show irreparable harm or the inadequacy of monetary damages as a remedy and without the requirement of having to post a bond or other security. Nothing in this Section 29.4 is intended, or shall be construed, to limit the Parties’ rights to equitable relief or any other remedy for a breach of any provision of this Agreement.