Provision Language
4. Joint Steering Committee (JSC)
4.1 Purpose of the JSC. The Parties shall form a Joint Steering Committee (JSC) to oversee the progress of the Development of the SIIPL Product based on the SIIPL Development Plan, such SIIPL Development Plan setting forth inter alia timelines for the Technology Transfer of the Licensed Technology, for the conduct of Clinical Trials (if any), and submission(s) of marketing authorization(s) and WHO prequalification.
4.2 Composition of the JSC. The JSC shall be composed of up to 4 (four) members of each Party, respectively, no later than [***] after the Effective Date. The chairperson of the JSC shall be designated annually on an alternating basis between the Parties. The initial chairperson shall be selected by VALNEVA. Each Party shall designate as its representatives’ individuals who have the requisite experience, knowledge and seniority to be able to make decisions on behalf of the Party designating such individual.
4.3 Meetings of the JSC. The Joint Steering Committee shall meet at least quarterly and at such other times as the Parties may agree or may be necessary under this Agreement or the Project Agreements. The first meeting of the Joint Steering Committee shall be held as soon as reasonably practicable, but in no event later than [***] after the Effective Date. Meetings shall be held by teleconference or videoconference; provided, however, that there shall be at least [***] face-to-face meeting per calendar year, unless the Parties agree otherwise. Face-to-face meetings shall alternate between the principal business locations of the Parties or be held at such other location as may be mutually agreed upon by the Parties. Meetings may also be called by either Party, on ten (10) days written notice to the other.
4.4 At least [***] prior to each meeting of the JSC, SIIPL shall submit to VALNEVA an updated report on the status of activities under the SIIPL Development Plan.
4.5 All decisions of the JSC shall be made by unanimous consent of the members present in person or by telephone or teleconferences/videoconferences at any meeting, with SIIPL members cumulatively having one (1) vote and VALNEVA members cumulatively having one (1) vote. A quorum for a meeting shall require at least one (1) representative from SIIPL and at least one (1) representative from VALNEVA. In the event that unanimity cannot be reached by the JSC with respect to a matter that is subject to its decision-making authority, then the matter shall be referred for further review and resolution to the CEO of VALNEVA or such other similar position designated by VALNEVA from time to time, and the CEO of SIIPL, or such other similar position designated by SIIPL from time to time. The designated persons at each Party shall use reasonable efforts to resolve the matter within [***] after the matter is referred to them. In the event that the designated officers fail to resolve the matter, the Parties agree to submit the matter to be resolved to a suitably qualified independent individual acceptable to both Parties. In the event that the matter can still not be resolved within thirty (30) days of its referral to the independent person jointly approved by both Parties, the dispute resolution provisions according to Section 20.5 shall apply.
4.6 Within [***] following the meeting of the Joint Steering Committee, the JSC chair will circulate among the JSC members the meeting minutes, including any decisions made by the JSC and any action items to be completed.
4.7 The Joint Steering Committee shall not have the authority to amend, modify or waive compliance with any term or condition of, or take any action inconsistent with or in violation of this Agreement and the Project Agreements or any Applicable Law.
4.8 The JSC shall be entitled to appoint subcommittees, specifically for the clinical development and the Technology Transfer.
4.9 Costs. The Parties agree that the costs incurred by each Party in connection with its participation in the Joint Steering Committee shall be borne solely by such Party.
6. Development Plan, Regulatory Activities, Diligence, and potential Clinical Trials
6.1 The Parties agree to form a Development Committee to oversee the Development Plan and the Development activities performed by SIIPL under this Agreement and the Project Agreements. The Parties acknowledge that development oversight is necessary solely for proper reporting by both VALNEVA and SIIPL to CEPI on the progress of the SIIPL Product to be accessible to the public health market in the SIIPL Territory, at an affordable price.
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6.3 Development Committee. The Parties shall appoint a development committee of equal number of members designated by VALNEVA and SIIPL, respectively, no later than [***]after the Effective Date (“Development Committee”). The members from each Party collectively will have one (1) vote. The function of the Development Committee shall be to: (i) review and comment upon updates and changes to the SIIPL Development Plan; (ii) advise on the Development of the SIIPL Product generally; (iii) review the progress of the SIIPL Development Plan and any related activities; (iv) appoint subcommittees (with equal participation by the Parties) and set forth the applicable procedures of operation for such subcommittees, and (v) otherwise oversee the SIIPL Development Plan. The Development Committee shall hold meetings at least quarterly and at such other times as the Parties may agree or may be necessary. Meetings shall be held by teleconference or videoconference; provided, however, that there shall be at least [***] per calendar year, unless the Parties agree otherwise. Face-to-face meetings shall alternate between the principal business locations of the Parties or be held at such other location as may be mutually agreed upon by the Parties. Within [***] following the meeting of the Development Committee, SIIPL will provide VALNEVA with the draft meeting minutes for review, including any decisions made by the Development Committee and any action items to be completed. Each Party shall bear its own costs and expenses incurred in connection with such meetings.
11. Payment Terms.
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11.5 Any disputes with respect to any amount due under Section 11.4 may be referred by either Party for dispute resolution in accordance with Section 20.5 (Negotiation; Resolution).
11.6 Payment Dispute. Either Party shall promptly notify the other Party about any dispute on any Payment due under this Agreement. The paying Party shall pay any uncontested amount in accordance with the terms agreed herein and shall not withhold any uncontested portion of the due Payment. The Parties shall consult in good faith to promptly resolve any disputed amount hereunder within [***] following the original due date. Any amounts subsequently resolved shall be due and payable within ten (10) Business Days of such resolution. Any disputes with respect to any amount due which cannot be resolved between the Parties may be referred by either Party for dispute resolution in accordance with Section 20.5 (Negotiation; Resolution) hereof.
20. General Provisions
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20.5 Governing Law, Dispute Resolution and Jurisdiction. The Parties agree to settle their disputes amicably and in good faith. If the executives dealing with the subject matter of this Agreement cannot settle the dispute among themselves then the matter will be referred to the Managing Director / Chief Executive Officer of the respective Parties who shall discuss the dispute and try to arrive at an amicable solution. In the event the Parties are unable to resolve the disputes as mentioned above then this Agreement, and the obligations contained herein, shall be governed by and interpreted in accordance with the laws of the State of New York, USA and the Parties irrevocably submit to the exclusive jurisdiction of the courts of New York, USA, without giving effect to the conflicts of law provisions thereof.