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

Intellectual Property | Protection of IP

Summary of Approaches

Who has the decision-making authority and responsibility for patent prosecution, maintenance and enforcement? How should IP protection expenses be allocated between the parties?
- Each party has the sole right and discretion to prosecute and maintain patent claims relating to the party’s own background and foreground technology at the party’s own expense.
Is there a mechanism for information sharing and cooperation between the parties in relation to patent prosecution, maintenance and enforcement activities?
- Lonza is required to cooperate with Moderna when Moderna prosecutes or maintains patent claims.

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

“Lonza Improvement”b> means all <a href=”#kt“>Technologya>span> conceived, discovered, invented, developed , created, made or reduced to practice in connection with this Agreement that is [***].span>p>
“span>LONZA Technology b>” means all Technology of LONZA (a) existing prior to the effective date of this Agreement; or (b) developed or obtained by or on behalf of LONZA independent of this Agreement and without the use or reference to any <a href=”https://ghiaa.org/provision_document/moderna–lonza–covid–19–mrna–vaccine–therapies–manufacturing–process–development –agreement–4/” target=”_blank” rel=”noopener“>confidential informationa> of MODERNA (including the MODERNA Manufacturing Know-How span>, Products (or components thereof) or any manufacturing equipment for the Products (or components thereof)).span>p>
“span>MODERNA Improvementb>” means all Technology conceived, discovered, invented, developed , created, made or reduced to practice in connection with this Agreement [***].span>p>
“span>MODERNA Technologyb>” means all Technology Controlled by MODERNA or its Affiliates (a) existing prior to the effective date of this Agreement; or (b) developed or obtained by or on behalf of MODERNA or its Affiliates independent of this Agreement and without the use or reference to any confidential information of LONZA. For clarity, the MODERNA Technology includes (i) the Product and any Product–intermediates, components or derivatives of Product, (ii) starting materials and any intermediates, components or derivatives of starting materials, (iii) Specifications,(iv) Test Methods and (v) Process.span>p>
11. Intellectual Propertyb>span>p>
11.4 Prosecution of Patents b>p>
11.4.1 LONZA will have the sole right and discretion to file, prosecute and maintain patent applications and patents claiming LONZA Technology or LONZA Improvements at LONZA’s expense.span>p>
11.4.2. MODERNA will have the sole right and discretion to file, prosecute and maintain patent applications and patents claiming MODERNA Technology or MODERNA Improvements at MODERNA’s expense. LONZA will cooperate with MODERNA to file, prosecute and maintain patent applications and patents claiming MODERNA Technology or MODERNA Improvements .span>p>

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

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

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