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

Term & termination | Effects of termination

Summary of Approaches

What are the effects of termination or withdrawal by a party?
- Following termination, each party remains entitled to any rights that have accrued to its benefit.
- Lonza is entitled to any cancellation fees provided for in outstanding statements of work. In the case of Moderna’s material breach, all work is deemed cancelled.
- Obligations that survive the termination of the agreement include: a prohibition on Lonza using non-commercially available IP in connection with its services for Moderna without Moderna’s approval; confidential information provisions; provisions governing Lonza’s use of Moderna equipment; certain provisions governing cancellation fees; recordkeeping requirements; manufacturing disclaimers, including that Lonza did not invent any Moderna product; provisions governing regulatory approvals, inspections, actions and other complaints; certain payment provisions, intellectual property provisions; representations and warranties; disclaimers, liability limitations; termination; indemnification and insurance; non-solicitation obligations; and miscellaneous provisions, including dispute resolutions procedures.
- Each party may require the other to return or destroy the party’s confidential information. However, the exceptions are that (a) each party may retain samples and standards of each product as required by law to determine its rights under the Agreement; (b) Moderna may retain Lonza confidential information for use in regulatory filings, and as required by law; and (c) each party may retain a single copy of the other’s confidential information for documentation purposes.

Annotations

This Global Long Term Agreement (“Agreement”) between Lonza Ss Ltd. and Lonza Sales (collectively, “Lonza”) and ModernaTX, Inc. (“Moderna”)is effective from May 1, 2020. The Agreement is a ten-year contract that governs Lonza’s manufacturing work on behalf of Moderna, which principally involves the development of additional manufacturing know-how for Moderna’s mRNA Products (including the mRNA-1273 COVID-19 vaccine), and the actual production of mRNA vaccines and drugs, or their components. Moderna and Lonza have signed several related agreements, including a “Strategic Collaboration Agreement,” “Quality Agreement” and statements of work that detail the parties’ rights and obligations under the Agreement with respect to specific streams of work. The Agreement is heavily redacted, especially governance, pricing, key IP terms, and an exclusivity provision.

Under the agreement, Moderna grants Lonza a license to the background IP necessary for the performance of the Agreement, and Lonza grants Moderna a license to sell the products that are manufactured. The parties grant foreground IP licenses to each other. The Agreement contemplates that Moderna personnel will work onsite at Lonza facilities to assist with initial technology transfer and manufacturing, and for ongoing consultations. Moderna also agrees to provide the raw materials and other items needed to manufacture its product. The Confidential Information provisions require Lonza to protect Moderna’s manufacturing know-how in perpetuity with the same degree of care that Lonza protects its own confidential manufacturing information.

Note: there appears to be an error with the sequential section numbering in the SEC-filed version of this document. The section references used in the MAPGuide have been corrected by GHIAA based on section cross-referencing in the agreement and the order in which the sections appear.

Provision Language

15. Term and Terminationb>span>p>
15.5 Effects of Terminationb>p>
15.5.1. span>Accrued Rights.span>span> Termination of this Agreement or any SOW for any reason will be without prejudice to any rights that will have accrued to the benefit of a Party prior to such termination. Such termination will not relieve a Party of obligations that are expressly indicated to survive the termination of this Agreement or such SOW. Without limitation of the foregoing, in the event of termination of this Agreement or an SOW, LONZA shall be compensated for any Cancellation Fees (if any) in accordance with the relevant Statements of Work. In the case of termination by LONZA for MODERNA’s material breach in accordance with Section 15.2, all scheduled Services and Batches shall be deemed cancelled by MODERNA, and Cancellation Fees set forth in the relevant Statements of Work shall be calculated as of the date of written notice of termination.span>p>
15.5.2. span>Disposition of Remaining MODERNA Property and Confidential Information.span>span> Upon termination or expiration of this Agreement, LONZA will, at MODERNA’s option, return or destroy any MODERNA <a href=”https://ghiaa.org/provision_document/moderna–lonza–covid–19–mrna–vaccine–therapies–manufacturing–process–development –agreement–4/” target=”_blank” rel=”noopener“>Confidential Informationspan>a> in the possession or control of LONZA. Likewise, MODERNA will, at LONZA’s option, return or destroy any LONZA Confidential Information in the possession or control of MODERNA. Notwithstanding the foregoing provisions: (i) LONZA may retain and preserve, in a secure manner, at its sole cost and expense, samples and standards of each Product following termination or expiration of this Agreement as required by Applicable Law solely for use in determining LONZA’s rights and obligations hereunder; (ii) MODERNA may retain and preserve, in a secure manner, any LONZA Confidential Information following termination or expiration of this Agreement (A) for use in determining MODERNA’s rights and obligations hereunder, (B) as necessary, in connection with MODERNA’s regulatory filings or Regulatory Approvals , or (C)as required by Applicable Law and (iii) each Party may retain a single copy of the other Party’s Confidential Information for documentation purposes only and which shall remain subject to the obligations of nonuse and confidentiality set forth in this Agreement.span>p>
15.5.3 span>Survival.span>span> span>Sections 1, 4.2, 4.5, 4.6, 5.1, 7.8, 7.10, 7.13, 8.2, 8.4, 8.5, 8.6, 8.7, 9.4, 9.5, 9.6, 10, 11, 13, 14, 15, 16, 17.1 and 18 of this Agreement, together with any appendices referenced therein, will survive any expiration or termination of this Agreementspan>p>

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