Master Alliance Provisions Guide (MAPGuide)

DNDi Template Development Collaboration and License Agreement

  • Business model | Governance

<p>&#8220;<strong>Collaboration Plansstrong>&#8221; shall mean the Development Plan(s), the Access and Implementation Plan(s) and any other plan(s) mutually agreed by the Parties in connection with this Agreement.p>
<p class=”p1“><span style=”textdecoration: underline;”><strong>3. DEVELOPMENT AND DISTRIBUTION PROGRAMstrong>span>p>
<p><strong>3.4 strong>The Collaboration Plans may be approved and revised by the JDC, at decision points as new data becomes available and inclusive of scientific consultations with the <a href=”#kt“>Regulatory Authoritiesa>, in accordance with the provisions of Article 15.p>
<p><strong>3.5strong> During the Term, each Party shall use <a href=”#kt“>Reasonable Effortsa> to conduct, advance and complete the 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 Collaboration Plans. In particular, the Parties shall use Reasonable Efforts to develop, obtain <a href=”#kt“>Regulatory Approvala>(s) for and, following <a href=”#kt“>Marketing Authorisationa>, use all Reasonable Efforts to provide an adequate supply of Product on an Affordable Basis in the Field in the Territory and provide a strong supply network to support such distribution.p>
<p><span style=”textdecoration: underline;”><strong>5. PARTNERS CONTRIBUTIONS TO THE DEVELOPMENT PLANstrong>span>p>
<p><strong>5.1strong> Partner shall:p>
<p style=”paddingleft: 40px;”>a) carry out the activities assigned to it in the Development Plan and as agreed between the Parties from time to time, mainly: a. &lt; complete &gt;; b. &lt; complete &gt;; andp>
<p style=”paddingleft: 40px;”>b) contribute to the management of the activities by participating to the JDC.p>
<p><strong>5.2strong> Partner shall supply to DNDi, upon request and free of charge, pursuant to <a href=”#kt“>Good Manufacturing Practicea>, <a href=”#kt“>Good Distribution Practicea> and its internal quality guidelines and practices including the requirements of the Quality Agreement, such quantities of Molecule, Product &lt; and comparator products &gt; as deemed necessary for DNDi to perform its activities under the Collaboration Plan(s).p>
<p><span style=”textdecoration: underline;”><strong>6. DNDIS CONTRIBUTIONS TO THE DEVELOPMENT PLANstrong>span>p>
<p><strong>6.1strong> DNDi shall:p>
<p style=”paddingleft: 40px;”>a) coordinate and conduct, through its CSPs, all activities assigned to it in the Development Plan, mainly: a. &lt; complete &gt;; b. &lt; complete &gt;; andp>
<p style=”paddingleft: 40px;”>b) DNDi shall participate in the management of the activities through the JDC.p>
<p><span style=”textdecoration: underline;”><strong>15. GOVERNANCE STRUCTUREstrong>span>p>
<p><em>Project Leaders.em>p>
<p><strong>15.1strongEach Party shall appoint a project leader for the duration of the Collaboration Plans (each, a “<em><strong>Project Leaderstrong>em>”). Each Party may replace its Project Leader from time to time by giving a written notice to the other Party in relation to such change.p>
<p><strong>15.2strong> The Project Leaders shall be responsible for:p>
<p style=”paddingleft: 40px;”>a) being the primary points of contact for the Collaboration Plans;p>
<p style=”paddingleft: 40px;”>b) designing, updating, refining and revising the Collaboration Plans;p>
<p style=”paddingleft: 40px;”>c) facilitating the efficient implementation, coordination and monitoring of the operational activities set out in the Collaboration Plans;p>
<p style=”paddingleft: 40px;”>d) providing information to the Parties with respect to specific activities conducted under the Collaboration Plans; andp>
<p style=”paddingleft: 40px;”>e) assisting with the analysis and interpretation of data resulting from the Collaboration Plans.p>
<p><em>Joint Development Committee.em>p>
<p><strong>15.3strongThe Parties shall set up the JDC within thirty (30) days after the Effective Date.p>
<p><strong>15.4strongThe JDC shall be composed of &lt; the Project Leaders and two (2) permanent representatives of each Party &gt; (each, a “<em><strong>JDC Memberstrong>em>”). Each JDC Member shall have appropriate technical credentials, experience and knowledge. Either Party may replace any or all of its JDC Members at any time upon prior written notice to the other Party. If a Partys JDC Member is unable to attend a meeting, that Party may designate an alternate representative for such particular meeting.p>
<p><strong>15.5strongThe role of the JDC is to serve as an information exchange platform, to leverage the respective competencies and contributions of each Party to optimally conduct the Collaboraton Plans, and to oversee the performance of the Collaboraton Plans. It shall notably:p>
<p style=”paddingleft: 40px;”>a) review and approve any Collaboration Plans, updates and amendments thereto, or the discontinuation thereof;p>
<p style=”paddingleft: 40px;”>b) monitor the workflow and overall progress under the Collaboration Plans;p>
<p style=”paddingleft: 40px;”>c) discuss strategic issues that could influence the implementation of the Collaboration Plans, the Regulatory Strategy and manufacturing and supply strategy; andp>
<p style=”paddingleft: 40px;”>d) take such other actions as are expressly delegated to the JDC in this Agreement or as the Parties may mutually agree in writing.p>
<p>For the avoidance of doubt, the JDC has no authority to amend, or to waive compliance with, any term or condition of this Agreement.p>
<p><strong>15.6strongThe JDC shall be chaired by &lt; &gt; during &lt; add phases &gt; and by &lt; &gt; during &lt; add phases &gt;. The Chair shall be responsible for administering the work of the JDC, including organizing JDC meetings, setting the agenda for such meetings and distributing it to the JDC Members no less than &lt; one (1) week &gt; before any JDC meeting. The Chair shall also be responsible for preparing and circulating draft minutes from each JDC meeting to the JDC Members, facilitating the exchange of information, reviews of results and monitoring the contributions by each Party.p>
<p><strong>15.7strongThe JDC shall meet at such times as are agreed to by the JDC Members, but at least &lt; four (4)&gt; 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 &lt; thirty (30) &gt; days after the Effective Date.p>
<p><strong>15.8strongA quorum of the JDC shall exist whenever at least &lt; one representative appointed by each Party &gt; is present at a meeting.p>
<p><strong>15.9strongThe minutes shall be kept of all JDC meetings and sent to all JDC Members for review and approval within &lt; seven (7) &gt; days after each meeting. Minutes shall be deemed approved unless any JDC Member objects to the accuracy of such minutes by providing written notice to the other JDC Members within &lt; fourteen (14) &gt; days after receipt of the minutes. In the event that any such objection is not resolved by the JDC, such minutes shall be amended to reflect such unresolved dispute.p>
<p><strong>15.10strong> 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 JDC in an advisory capacity within their respective competences as deemed necessary for the advancement of the Collaboration Plans (such additional representative(s), “<em><strong>Guest(s)strong>em>”). For clarity, any Guest(s) shall not vote or otherwise participate in the decision.making process of the JDC. Expenses related to the attendance of any Guest(s) to a JDC meeting shall be borne solely by the Party inviting such Guest(s).p>
<p><strong>15.11strong> For the avoidance of doubt, the Parties may also engage in informal scientific discussions and exchanges of correspondence outside of the scheduled JDC meetings, as needed. Decision.Making.p>
<p><strong>15.12strong> The JDC shall take decision by consensus. Any differences of opinion between the Parties relating to the Collaboration Plans shall be discussed in good faith within the JDC.p>
<p><strong>15.13strongIf the JDC is unable to reconcile the opinions within thirty (30) days, then the Parties shall submit the difference of opinion to each Partys senior executive officer, which, in the case of Partner, shall be &lt; complete &gt;, and, in the case of DNDi, shall be the Executive Director, to enable a compromise between different views with respect to such issue.p>
<p><strong>15.14strongIf such senior executives of the Parties cannot successfully reconcile the difference of opinion within a ten (10) day period after the moment of formal submission to them, then the Party that has been allocated responsibility for the matter at issue will have the final decision, provided that any such decision will not result in an increase of the other Partys financial burden.p>
<p><strong>15.15strong> The Parties acknowledge and agree that the JDC is strictly for the purposes of decisionmaking and governance of the Collaboration Plans. Without limiting the generality of the foregoing, any dispute relating to the interpretation of this Agreement, the performance or alleged non performance of a Partys obligations under this Agreement, or any other alleged breach of this Agreement shall be decided in accordance with the terms of Article 32.p>
<p><span style=”textdecoration: underline;”><strong>32. GOVERNING LAW, DISPUTE RESOLUTION AND EQUITABLE RELIEFstrong>span>p>
<p><strong>32.1strongThis 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.p>
<p><strong>32.2strongExcept as provided in Sections 15.12 to 15.15, 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.p>
<p><strong>32.3strong> 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 31 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 31 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 32.2. Notwithstanding this Section 32.3, each Party shall be free to seek a preliminary injunction in court at any time.p>
<p><strong>32.4strong> Notwithstanding Sections 32.2 and 32.3, 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 nonbreaching 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 32.4 is intended, or shall be construed, to limit the Partiesrights to equitable relief or any other remedy for a breach of any provision of this Agreement.p>