“MODERNA Equipment” means all equipment or machinery designated by the Parties as “MODERNA Equipment” in the relevant Statement of Work or other written agreement by the Parties, or in the list of equipment maintained by the JMT as set forth in Section 3.2.2(f).
“Materials” means all raw materials, components (including packaging materials), and other potential materials, supplies, consumables or similar items reasonably necessary for, or otherwise used in, the Manufacture of Product.
“Project Documentation” means the compilation of documentation generated or to be generated by LONZA in preparation of and during the performance of the relevant Statement of Work, including, without limitation, executed Batch Records, component records, test records and test record forms, Certificates of Analysis, Certificate of Testing, release documentation, study protocols, study summary reports, deviation reports, laboratory investigations, environment excursions, formulation records, and other related documents, which show that the Product was Manufactured in accordance with the Quality Agreement, Applicable Law and the Specifications, or that Services were otherwise performed in accordance with the requirements of this Agreement.
“Technology Transfer” means the transfer of Know-How, documentation, specifications, SOPs, analytical methods and process validation documents related to MODERNA’s Process or Product by MODERNA to LONZA for the development of the Project Documentation for the Manufacture of the Product specifically for MODERNA or its Affiliates.
2. Statements Of Work – Process And Product Development; Process Or Product Manufacture; Flow-Down provisions; Quality Agreement
2.1 Statement of work Prior to performing any Process or Product development, Technology Transfer, or Product Manufacture, the Parties will collaborate to prepare a Statement of Work describing the activities to be performed by the Parties (or to be subcontracted by LONZA to one or more Third Parties in accordance with Section 2.5). In the event of a conflict between the terms and conditions of this Agreement and any Statement of Work, the terms and conditions of this Agreement shall control.
4. Technology Transfer
4.1. Based on the information provided by MODERNA and including process definition or changes mutually agreed by the Parties pursuant to the relevant Statement of Work, LONZA will prepare the Project Documentation for the applicable Process in accordance with the schedule set forth in the relevant Statement of Work and the Specifications, the LONZA Operating Documents and any written instructions provided by MODERNA (provided that LONZA shall be required to comply with such written instructions only if such instructions comply with cGMP requirements, data integrity specifications or commitments made by MODERNA to the applicable Regulatory Authorities). MODERNA will inform LONZA of any specific requirements MODERNA may have relating to the Project Documentation, including, without limitation, any information or procedures MODERNA wishes to have incorporated therein. The applicable Project Documentation, as set forth in the relevant Statement of Work, shall be completed and delivered by LONZA at completion of a Batch
5. MODERNA Equipment
5.1. Relevant Terms. Each Statement of Work shall include the terms and conditions applicable to the MODERNA Equipment to be used by LONZA to perform the Services set forth in such Statement of Work.
7. Manufacture of Product
7.1 Moderna Materials. Within the time period agreed to 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 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.
7.11.1 Moderna Access. Pursuant to and as set forth further in the applicable Statement of Work, [***] MODERNA’s employees, consultants and agents (including its independent contractors or designees) (collectively, “MODERNA Personnel”) in each Facility may participate in the Manufacture of the Product only in such capacities as set forth in the relevant Statement of Work or as may be approved in writing in advance by LONZA, such approval not to be unreasonably withheld, conditioned or delayed; provided, however, that, upon [***] prior written notice to LONZA, MODERNA Personnel shall have the right to be present at the Facility to observe the Manufacture of Product or performance of Services and for quality or technical reference purposes. MODERNA Personnel working at the Facility are required to comply with LONZA’s Operating Documents and any other applicable LONZA cGMP or safety policies. LONZA shall make available office space to the MODERNA Personnel on-site at the applicable Facility, and shall also provide any reasonable and customary related office resources and support services for such on-site MODERNA Personnel. For the avoidance of doubt, unless otherwise agreed to by LONZA, following completion of technology transfer and stabilization of Manufacturing activities, MODERNA Personnel may not physically participate in the production or Manufacture of any Product that may be used in or on humans.
11.2 License Grants
11.2.2 […] 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.