definiens: means the activities as undertaken by [COMPANY] which relate to non - cGMP manufacturing of the Product which areperformed in the laboratory facilities and include technology transfer and any kind of development, scaling - up, validation and testing activitiesincluding toxicology batches and engineering batches ; means the documents on the basis of which a Batch of Product is released by [COMPANY] which include but may not be limited to : theCertificate of Analysis, Statement of Compliance, production and testing records, analytical test data for release tests of the Bulk HarvestProduct, Batch dossier summary and deviation reports as agreed upon in the Quality Agreement ; means the development and production facilities of [COMPANY] located at [ * * * ] and [ * * * ] ; means the European Medicines Agency ; means the date indicated on the first page of this Agreement ; means the U.S. Food and Drug Administration ; shall mean an audit to address a Major cGMP Deviation resulting in a failure of Product to meet Specification due toDSM ’s material breach of its obligations under this Agreement