Provision Language
Definitions
“Alliance Manager” means a single individual appointed by each Party to assist in the administration of the Agreement and to oversee the timing of events as described herein take place when and how defined.
“Program Manager” means the representative from DNDi responsible for managing the R&D Plan.
“Project Team” means a team composed of adequately qualified representatives of both Parties which shall be responsible for managing and guiding the research and development activities conducted under this Agreement, under the direction of the Program Manager.
2. RESEARCH AND DEVELOPMENT PROGRAM
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2.2 Joint Research Committee
(a) Formation; Composition. Promptly after the Effective Date, the Parties will appoint a joint research committee consisting of two (2) representatives from each Party (the “Joint Research Committee” or “JRC”). Either Party may change its appointed JRC members upon written notice to the other Party. The JRC will construct the R&D Plan and appoint the necessary Project Team. The JRC will oversee the activities of the Project Team including the review and approval of the Project Plan and any modifications. The JRC will continue to operate for as long as CAMB is being developed under this Agreement.
(b) Duties. The JRC will (a) oversee the conduct of the R&D Plan, (b) serve as an information–sharing forum between the Parties regarding the R&D Plan, (c) design, manage and organize clinical trials, data storage and access, (d) approve Project Plans detailing the conduct of the Project Team and the Parties’ research activities, (e) review the results of the R&D Plan, including the results of on–going clinical trials, on a regular basis (to be agreed upon by the JRC), and (f) propose to the Parties modifications to the R&D Plan as appropriate. The JRC will have only those powers set forth in this Section 2.2 and will have no power to amend or waive compliance with this Agreement.
(c) Meetings. Within thirty (30) days after the Effective Date, the JRC will meet, in person or by video or teleconference to discuss and approve a Project Plan for the Parties’ initial activities under this Agreement, and to finalize within 60 days of the Effective Date a complete R&D Plan to constitute the Annex A of the present Agreement. Thereafter, the JRC will meet regularly as determined by its members, in person or by video or teleconference. The JRC will be chaired by a representative of DNDi. The JRC is required to and will keep complete and accurate detailed minutes of its meetings, including any decisions made. The chair (or his or her designee) shall prepare and circulate an agenda ten (10) business days before each meeting of the JRC and meeting minutes after each meeting for review and approval by the JRC. In all cases the JRC will comply with the timings described in this section and provide the Alliance Managers with all dates and times for meetings and all minutes described in this section.
(d) Decision–Making. The JRC representatives of each Party will each have one (1) vote in the JRC. The JRC will make all decisions by majority vote and in case of deadlock the JRC shall refer the matter to the Alliance Managers who will attempt to resolve the deadlock. The Alliance Managers shall consult with each Parties executive management and attempt to resolve the dispute. For the avoidance of doubt, DNDi shall have the final decision in any matter regarding the funding of clinical trials. Should the Alliance Managers with the input of the Parties executive management be unable to resolve the dispute, the matter shall be handled as defined in Section 11.
2.3 Project Team. The JRC will establish a Project Team responsible for day–to–day management of all activities under the R&D Plan and Project Plans. The purpose of the Project Team will be to facilitate the efficient conduct of the R&D Plan, to provide information and assistance with respect to specific activities conducted under the R&D Plan, and to assist with data analysis and interpretation. It is possible that members of the Project Team could also be members of the JRC.
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2.5 DNDi’s Performance of the R&D Plan
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(b) Program Manager. DNDi will be responsible for the overall management of the R&D Plan through the Program Manager and the other representatives of the JRC and Project Team. DNDi, promptly after the Effective Date will appoint a Program Manager and will advise BDSI in writing of the name and qualifications of the appointed Program Manager. The Program Manager maybe removed from such appointment by a majority vote of the JRC. Should the Program Manager be removed DNDi will appoint a new Program Manager according to this section.
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(d) Scientific Advisory Committee. BDSI acknowledges that DNDi’s continued performance of the R&D Plan is subject to review by DNDi’s Scientific Advisory Committee, which may recommend to terminate DNDi’s performance of the R&D Plan at any time.
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2.7 Data and Reports
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(b) Reports. For so long as a Party has obligations to conduct research or development activities under the R&D Plan, such Party will provide written quarterly reports to the JRC, and additional updates as requested by the JRC, summarizing all Program Data created in the preceding quarter by such Party, including a description of any inventions made, developed, conceived or reduced to practice by such Party. The purpose of these reports is to ensure the continuous sharing between the Parties of information regarding results achieved under the R&D Plan and to enable any Party to take prompt action to file any patent applications covering the Collaboration IP. In addition, each Party will submit to the JRC semi–annual written reports outlining the milestones achieved by such Party, key decisions made, and progress toward achieving the objectives set forth in the R&D Plan. The JRC will provide to the Alliance Managers copies of all reports required under this section and it will be the responsibility of the Alliance Managers to assure the JRC and their respective Party complies with all responsibilities under this section in a timely manner.
11. MISCELLANEOUS
11.1 Dispute Resolution. Unless otherwise set forth in this Agreement, in the event of a dispute arising under this Agreement between the Parties, either Party shall have the right to refer such dispute to their Alliance Managers, respective chief executive officers, their designees (or equivalent), and such officers shall attempt in good faith to resolve the dispute. If the Parties are unable to resolve a given dispute pursuant to this Section 11.1 within sixty (60) calendar days of referring such dispute to the chief executive officers, their designees (or equivalent), either Party may have the dispute settled by binding arbitration pursuant to Section 11.2.
11.2 Arbitration. If a Party intends to initiate arbitration to resolve a dispute arising under this Agreement, such Party shall provide written notice (the “Arbitration Request”) to the other Party of its intention and the issues for resolution. From the date of the Arbitration Request until such time as the dispute has become finally settled, the running of the time periods as to which a Party must cure a breach of this Agreement becomes suspended as to any breach that is the subject matter of the dispute.
(a) Arbitration of Patent/Confidentiality Issues. Unless otherwise agreed by the Parties, disputes arising between the Parties relating to Patents and non–disclosure, non–use and maintenance of Confidential Information shall be settled by arbitration under the Rules of Arbitration of the World Intellectual Property Organization by three (3) arbitrators appointed and acting in accordance with such Rules. Arbitration proceedings shall be conducted in the English language in Geneva, Switzerland.
(b) Arbitration Procedure. All disputes arising between the Parties other than those defined in paragraph (a) above will be finally settled by arbitration under the Rules of the International Chamber of Commerce by three (3) arbitrators appointed and acting in accordance with such Rules. Arbitration proceedings shall be conducted in the English language in Paris, France.
(c) Fees. Each Party shall bear its own attorneys’ fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the arbitrators.