Master Alliance Provisions Guide (MAPGuide)

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

  • Business model | Product supply

7. Manufacture of Product

7.1 Moderna Materials. Within the time period agreed in the relevant Statement of work, Moderna will ensure that LONZA is provided with the materials listed in such Statement of Work required to be supplied by MODERNA for the production of the Product, and any handling instructions, protocols, SOPs and other documentation necessary to maintain the properties of such materials for the performance of the Services (collectively, the “MODERNA Materials”).The MODERNA Materials are the development–agreement–4/” target=”_blank” rel=”noopener“>Confidential Information of MODERNA and shall be used by LONZA solely for purposes of this Agreement and the relevant Statement of Work. MODERNA will promptly inform LONZA of any delays in providing MODERNA Materials that would prevent LONZA from performing the Services or in accordance with the timeline set forth in the relevant Statement of Work, and, in the event of any such delay, LONZA will use commercially reasonable efforts to accommodate any requests by MODERNA to adjust the timeline for the Services to compensate for such delay. LONZA shall ensure that the MODERNA Materials is secure and safe from loss, damage or misuse.

7.2 LONZA Materials. Except for the MODERNA Materials and as otherwise agreed in the relevant Statement of Work, LONZA shall supply, at its sole cost and expense and accordance with the relevant approved specifications, all materials in adequate quantities to be used by LONZA for the Manufacture of the Product and the performance of Services (“LONZA Supplied Materials”). The Parties agree that LONZA is responsible for the procurement of LONZA Supplied Materials, including with respect to transporting, testing, inspecting and storing the LONZA Supplied Materials; maintaining systems for management of LONZA Supplied Materials; and maintaining adequate supplies of LONZA Supplied Materials based on binding forecasts. LONZA shall not be responsible for raw material shortages or supplier delays outside of its control to the extent it diligently complied with its duties to procure and maintain adequate LONZA supplies Supplied Materials.

7.3. Commencement Date. Each Statement of Work governing the Manufacture of Product will include a Commencement Date agreed upon by the Parties. Subject to the terms of the relevant Statement of Work, LONZA will commence Manufacture of the Product on or before the Commencement Date.

7.4. Manufacture by LONZA. During the time period specified in the relevant Statement of Work, LONZA will Manufacture, package, ship, handle quality assurance and quality control for the Product exclusively at the applicable Facility, all as set forth in such Statement of Work, and will deliver to MODERNA the Product requested by MODERNA in such Statement of Work in accordance with the estimated timelines set forth in such Statement of Work, all in accordance with the terms set forth in Section 7.6 below. LONZA shall, at its own cost and expense, ensure that at all times the applicable Facility is in a qualified and validated state appropriate for inclusion as a Manufacturing site for the Products.

17. Additional Covenants

17.2 Business Continuity Plan. LONZA acknowledges the importance to MODERNA of an uninterrupted supply of Products. Based on the information available at the Effective Date, LONZA has, and reasonably expects that despite the COVID–19 Pandemic it will continue to have the available capacity and staff designated “essential workers” under Applicable Laws to perform Services and Manufacture and supply Product under this Agreement. Further, LONZA has a formal business continuity plan detailing LONZA’s plans, procedures and designated resources for timely response to and recovery from potential civil, natural, and physical plant disasters that could reasonably be expected to disrupt LONZA’s performance of services, including Services under this Agreement, and additional plans covering potential disruption that might arise in connection with the COVID–19 Pandemic (“Business Continuity Plans”). During the Term, LONZA will promptly notify MODERNA in writing of any potential disruption to the performance of the Services or the Manufacturing and supply of the Products.