Master Alliance Provisions Guide (MAPGuide)

Moderna – Lonza, COVID-19 mRNA Vaccine & Therapies, Manufacturing & Process Development Agreement

  • Consortium structure & management | Roles & Responsibilities

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.