| || |
|Customer Materials || || |
means any Raw Materials, components of Product, or other materials of any nature provided by Customer.
|EMA || || |
means the European Medicines Agency, or any successor agency thereto.
|Engineering Batches || || |
means a Batch that is intended to demonstrate the transfer of the Manufacturing Process to the Facility.
|External Laboratories || || |
means any Third Party instructed by Lonza, with Customers prior consent, to conduct any of the activities required to complete the Services.
|Facility || || |
means Lonzas manufacturing facilities in [***] or such other Lonza facility as may be agreed upon by the Parties.
|FDA || || |
means the United States Food and Drug Administration, or any successor agency thereto.
|Governmental Authority || || |
means any Regulatory Authority and any national, multi-national, regional, state or local regulatory agency, department, bureau, or other governmental entity in the U.S. or European Union.
|Intellectual Property || || |
means (i) inventions (whether or not patentable), patents, trade secrets, copyrights, trademarks, trade names and domain names, rights in designs, rights in computer software, database rights, rights in confidential information (including know-how) and any other intellectual property rights, in each case whether registered or unregistered, (ii) all applications (or rights to apply) for, and renewals or extensions of, any of the rights described in the foregoing clause (i) and (iii) and all rights and applications that are similar or equivalent to the rights and application described in the foregoing clauses (i) and (ii), which exist now, or which come to exist in the future, in any part of the world.
|Lonza Information || || |
means all information that is proprietary to Lonza or any Affiliate of Lonza and that is maintained in confidence by Lonza or any Affiliate of Lonza and that is disclosed by Lonza or any Affiliate of Lonza to Customer under or in connection with this Agreement, including without limitation, any and all Lonza know-how and trade secrets.
|Manufacturing Process || || |
means the production process provided by Customer for the manufacture of Product, as such process may be improved or modified from time to time by agreement of the Parties in writing.
|Master Batch Record || || |
means the document, proposed by Lonza and approved by Customer, which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of Product, and which may be amended from time to time by agreement of the Parties in writing.
|New Customer Intellectual Property || || |
has the meaning given in Clause 10.2.