Provision Language
Definitions
“LONZA Equipment” means all equipment and machinery for which LONZA or its Affiliates shall hold title and that is used by LONZA or its Affiliates to (or otherwise necessary for), directly or indirectly, Manufacture Product or perform any Services.
“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 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.
13. Representations, Warranties And Covenants
13.1. By MODERNA. MODERNA hereby represents and warrants to LONZA as of the Effective Date that, to the best of its knowledge, (a) it has the requisite intellectual property related to the MODERNA Technology and MODERNA Manufacturing Know-How to enable the performance of LONZA’s obligations under this Agreement, and (b) the performance of the Services and the production by LONZA of the Product as contemplated in this Agreement will not infringe the intellectual property rights of any Third Party. Such representation and warranty will not apply to any LONZA Equipment to the extent that such LONZA Equipment is the sole basis for the infringement of the intellectual property rights of a Third Party.
13.2. By LONZA
13.2.1 LONZA hereby represents and warrants to MODERNA that, to the best of its knowledge, as of the Effective Date (a) it or its Affiliates have the requisite intellectual property rights in LONZA Equipment and Facility and the LONZA Technology to be able to perform its obligations under this Agreement, and (b) that LONZA’s or its Affiliates’ use of the LONZA Equipment, Facility and the LONZA Technology as contemplated in this Agreement and independent of any infringement caused solely by the use of such LONZA Equipment, Facility and the LONZA Technology in combination with the MODERNA Technology, MODERNA Manufacturing Know-How and Product, will not infringe the intellectual property rights of any Third Party.
13.2.2 LONZA further represents and warrants that it has not and will not to its knowledge use in any capacity in connection with this Agreement the services of any individual, corporation, partnership, or association which has been debarred, excluded, or disqualified by the FDA or any other applicable Regulatory Authority. In the event that LONZA receives notice of the debarment or threatened debarment, exclusion or disqualification or threatened disqualification, of any individual, corporation, partnership or association providing services to LONZA, which relate to its activities under this Agreement, including any Statement of Work, LONZA shall notify MODERNA in writing as soon as practicable.
13.2.3 LONZA represents, warrants and covenants that, save for security interests expressly given in favor of MODERNA or its Affiliates, it will have good and marketable title, free and clear of any pledge, lien, restriction, claim, charge, security interest and/or other encumbrance, to all Product to be delivered under this Agreement (including any Statement of Work), and all Product supplied to MODERNA shall be free and clear of all pledges, liens, restrictions, claims, charges, security interests and/or other encumbrances at the time of delivery
7. Manufacture of Product
7.13. Disclaimers. The LONZA Parties will not engage in any Product improvement, modification or refinement, or Manufacturing or development of the Product, other than as expressly set forth in this Agreement and each relevant Statement of Work. Except as set forth in a relevant Statement of Work, each Party acknowledges and agrees that the LONZA Parties have not participated in the invention or testing of any Product, and have not evaluated its safety or suitability for use in humans or otherwise.