Provision Language
3. Governance
3.1. Joint Steering Committee.
3.1.1 Immediately following the Effective Date, the Parties shall establish a joint steering committee (“JSC”) to oversee, review, approve and coordinate the activities of the Parties under this Agreement, including each Statement of Work. Each Party shall appoint three (3) members to the JSC (each a “Member”). Each Party may change one or more of its Members by written notice to the other Party.
3.1.2. The JSC shall be responsible for: [***]
3.1.3 The JSC shall meet [***]
3.1.4 [***]
3.2 Joint Manufacturing Team.
3.2.1. Within [***] of the Effective Date, the JSC shall establish a joint manufacturing team (the “JMT”) to oversee the Services under each Statement of Work. The JMT shall be composed of a mutually agreed number of members, with an equal number appointed by each of MODERNA and LONZA. The JMT shall include individuals with expertise and responsibilities appropriate (in terms of their seniority, availability, function in their respective organizations, training and experience) for the tasks then being undertaken. Each Party shall designate one of its representatives as its primary contact for JMT matters (such Party’s “Team Co–Leader”). A Party may replace any or all of its representatives (and designated Team Co–Leader) at any time by informing the other Team Co–Leader in advance, in writing (which maybe by email).
3.2.2. The JMT shall be responsible for: [***]
3.2.3. The JMT shall meet [***].
3.2.4. The Parties acknowledge and agree that the JMT is intended to act as a body solely overseeing and deciding upon items within the scope of work defined and agreed upon in writing by the Parties in the relevant SOWs, as well as a discussion forum, and not a decision–making body for any items outside of the agreed upon scope of work. Other than with respect to questions regarding the JMT’s authority to review and approve modifications to Statements of Work within parameters prescribed by the JSC, the JMT’s responsibilities are not subject to the oversight of, or escalation to, the JSC in the event of any dispute or disagreement between the Parties.
3.3 Limitations of Authority. Each Party will retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers, or discretion will be delegated to or vested in the JSC or JMT, unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing. Except as provided in Section 3.1.2 and Section 3.2.2(f), the JSC and the JMT will not have the power to (a) amend, modify or waive compliance with this Agreement, including any Statement of Work, (b) alter, increase or expand the Parties’ rights or obligations under this Agreement, including any Statement of Work, beyond those explicitly set forth in this Agreement, including any Statement of Work, (c) determine that a Party has fulfilled any obligations under this Agreement or that a Party has breached any obligation under this Agreement, including any Statement of Work, or (d) make a decision that is expressly stated to require the mutual agreement of the Parties or for which MODERNA or LONZA have final decision making authority.
18. Miscellaneous
18.14 Dispute Resolution.
18.14.1 Disputes; Dispute Escalation. Except as expressly set forth otherwise in this Agreement, disputes of any nature arising under, relating to, or in connection with this Agreement will be exclusively resolved pursuant to this Section 18.14. If the Parties are unable to resolve a dispute, despite their good faith efforts, either Party may, by written notice to the other, have such dispute referred to the Executive Officers (or their designees, which designee is required to have decision–making authority on behalf of such Party), who will attempt to resolve such dispute by negotiation and consultation for a [***] period following receipt of such written notice. Notwithstanding the dispute resolution procedures set forth in this Section 18, in the event of an actual or threatened breach of this Agreement, the aggrieved Party may seek provisional equitable relief (including restraining orders, specific performance or other injunctive relief), without first submitting to any dispute resolution procedures hereunder.
18.14.2 Full Arbitration. In the event that no agreement is reached by the Executive Officers (or other designees) with respect to a dispute within [***] after its referral to them, either Party may at any time after such [***] period submit such dispute to be finally settled by arbitration administered in accordance with the procedural rules of the American Arbitration Association (“AAA”) in effect at the time of submission, as modified by this Section 18.14. The arbitration will be heard and determined by three (3) arbitrators who are retired judges or attorneys with at least ten (10) years of relevant experience in the pharmaceutical and biotechnology industry, each of whom will be impartial and independent. Each Party will appoint one arbitrator and the third arbitrator will be selected by the two Party–appointed arbitrators, or, failing agreement within [***] following appointment of the second arbitrator, by AAA. The arbitration shall be held in New York, New York. The arbitration proceedings shall be conducted, and the award shall be rendered, in the English language. Fees, costs and expenses of arbitration are to be divided by the Parties in the following manner: [***].
18.14.3 Expedited Arbitration. Notwithstanding Section 18.14.2 the Parties may agree to refer a dispute to expedited arbitration (an “Expedited Dispute”) rather than resolve the same pursuant to Section 18.14.2. Any such Expedited Dispute shall be finally settled by arbitration under the Commercial Arbitration Rules (Expedited Rules) of the American Arbitration Association (“AAA Expedited Rules”). Arbitration will be conducted in New York, New York by one (1) arbitrator who shall be reasonably acceptable to the Parties and who shall be appointed in accordance with the AAA Expedited Rules. If the Parties are unable to select an arbitrator within [***] of the notice that initiated the arbitration, then the arbitrator shall be appointed in accordance with the AAA Expedited Rules. Any arbitrator chosen hereunder shall have educational training and industry experience sufficient to demonstrate a reasonable level of scientific, financial, medical and industry knowledge relevant to the particular dispute. [***].
18.14.4 Arbitration Award. The arbitrator(s) shall issue their decision in writing, setting forth the basis for such decision. The arbitration award so given will be a final and binding determination of the dispute, will be fully enforceable in any court of competent jurisdiction. Except in a proceeding to enforce the results of the arbitration or as otherwise required by law, neither Party nor any arbitrator may disclose the existence, content or results of any arbitration hereunder without the prior written consent of both Parties (each such consent not to be unreasonably withheld, delayed or conditioned).
18.14.5 Tolling. The Parties agree that all applicable statutes of limitation and time–based defenses (such as estoppel and laches) shall be tolled while the dispute resolution procedures set forth in this Section 18.14 are pending, and the Parties shall cooperate in taking all actions reasonably necessary to achieve such a result. In addition, during the pendency of any dispute under this Agreement initiated before the end of the cure period under Section 15.2, this Agreement shall remain in full force and effect, and the time periods for cure under development–agreement–12/” target=”_blank” rel=”noopener“>Section 15.2 shall be tolled. Notwithstanding the dispute resolution procedures set forth in this Section 18.14, in the event of an actual or threatened breach of this Agreement, the aggrieved Party may seek provisional equitable relief (including restraining orders, specific performance or other injunctive relief), without first submitting to any dispute resolution procedures hereunder.
18.14.6 Confidentiality. Any and all activities conducted under this Section 18.14, including any and all non–public proceedings and decisions under Section 18.14.2, will be deemed Confidential Information of each of the Parties, and will be subject to the development–agreement–4/” target=”_blank” rel=”noopener“>terms of 10.