Master Alliance Provisions Guide (MAPGuide)

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

  • Intellectual Property | Exploitation of results
  • Intellectual Property | Ownership of background IP
  • Intellectual Property | Ownership of results
  • Intellectual Property | Use of background IP

Definitions

“Lonza Improvement” means all Technology conceived, discovered, invented, developed, created, made or reduced to practice in connection with this Agreement that is [***].

LONZA Technology ” 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 confidential information of MODERNA (including the MODERNA Manufacturing Know-How, Products (or components thereof) or any manufacturing equipment for the Products (or components thereof)).

MODERNA Improvement” means all Technology conceived, discovered, invented, developed, created, made or reduced to practice in connection with this Agreement [***].

MODERNA Manufacturing Know-How” means Know-How Controlled by MODERNA or its Affiliates, which is maintained in confidence by MODERNA or its Affiliates, relating to the manufacturing of a given Product, including documentation constituting material support, performance advice, shop practice, specifications as to materials to be used, control methods, standard operating procedures, protocols, descriptions of the manufacturing process and related know-how, development reports, analytical methods, equipment size/name/customizations/components, validation reports, cleaning methods and batch records and any other information, in each case, that is (a) necessary or reasonably useful to manufacture such Product in accordance with the applicable Specifications or (b) disclosed to LONZA or its Affiliates by or on behalf of MODERNA or its Affiliates in connection with this Agreement, including any Statement of Work.

MODERNA Technology” 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.

11. Intellectual Property

11.1 Ownership

11.1.1  Except as expressly otherwise provided herein, neither Party will, as a result of this Agreement, acquire any right, title, or interest in any Technology of the other Party.

11.1.2  Subject to LONZA’s right, title and interest in and to any and all LONZA Improvements, MODERNA shall own all right, title, and interest in and to any and all MODERNA Improvements. LONZA hereby assigns to MODERNA (or its designee), without additional compensation, all of LONZA’s right, title and interest in and to such MODERNA Improvements. LONZA shall promptly disclose to MODERNA in writing all MODERNA Improvements. LONZA shall execute, and shall require its personnel as well as its Affiliates, or other contractors or agents and their personnel involved in the performance of this Agreement to execute, any documents reasonably required to confirm MODERNA’s ownership of MODERNA Improvements, and any documents required to apply for, maintain and enforce any patent or other right in the MODERNA Improvements. Notwithstanding the foregoing, and subject to the license granted in Section 11.2.2, LONZA shall own all right, title and interest in and to any and all LONZA Improvements

11.2 License Grants

11.2.1.  During the Term, MODERNA hereby grants to LONZA a fully paid-up, non- exclusive license, without the right to grant sublicenses, under any and all MODERNA Technology, MODERNA Manufacturing Know-How, and MODERNA Improvements that are necessary for LONZA to perform its obligations under this Agreement for the sole and limited purpose of LONZA’s performance of its obligations under this Agreement and the relevant Statements of Work, including, without limitation, the development of the Process (if and to the extent applicable in the relevant Statements of Work) and the Manufacture of Product for MODERNA as set forth in the relevant Statements of Work. 

11.2.2. LONZA hereby grants to MODERNA a non-exclusive, world-wide, fully paid-up, perpetual, transferable (subject to the assignment provisions) license, including the right to grant sublicenses, under the LONZA Technology and LONZA Improvements, to use, sell, offer to sell, import and export the Product Manufactured under this Agreement, including any Statement of Work. 

In the event and to the extent that the Services or the Process incorporates, uses or contains non-commercially available LONZA Technology or LONZA Improvements that are not specifically agreed to by MODERNA in the relevant Statement of Work and that would be necessary for MODERNA or a Third Party contract manufacturer to Manufacture Products or would otherwise require MODERNA to obtain a license to the non-commercially available LONZA Technology or LONZA Improvements , LONZA hereby grants to MODERNA and its Affiliates a non-exclusive, worldwide, fully paid-up, perpetual, irrevocable, transferable license (subject to the assignment provisions), including the right to grant sublicenses, under such non- commercially available LONZA Technology or LONZA Improvements that are incorporated, used or contained in the Services or Process to Manufacture (or have Manufactured) Products (but no other products). 

For clarity LONZA will use its operating documents and standard operating procedures (“LONZA Operating Documents”) in performing the Services but LONZA Operating Documents are not necessary for MODERNA or a third party contract manufacturer to manufacture Product as it is assumed that MODERNA or a third party contract manufacturer would have its own operating documents and standard operating procedures. LONZA Operating Documents will not be provided in a technology transfer to MODERNA or a third party contract manufacturer for manufacturing Product. 

11.3 Further Assurances

Each Party agrees to take all necessary and proper acts, and will cause its employees, Affiliates, contractors, and consultants to take such necessary and proper acts, to effectuate the ownership provisions set forth in this Article 11.