definiens: has the meaning ascribed thereto in Section 5.3 . and shall be similarly defined as of either RB5 Bulk Drug Substance or of Intermediate Drug Product ; means any individual, company, partnership or other entity, which directly or indirectly, at present or in the future, controls, is controlled by or is under common control with a Party . For this purpose shall mean direct or indirect beneficial ownership of at least fifty per cent ( 50 % ) of the voting share capital in such company or other business entity . With respect to [COMPANY] Biologics, in this section shall mean [COMPANY] N.V. of Heerlen, The Netherlands ; means this Development and Manufacturing Agreement, including all the Schedules and annexes hereto ; means a unique specific quantity of materials as defined by and processed according to the requirements of the batch production records and all applicable cGMP requirements during the same cycle of manufacture . The Batch is intended to have homogeneous character and quality, as defined by the approved limits and specification requirements ; means docmnents containing written evidence of the activities that have been executed for the manufacture of a Batch, including materials used and results of in - process testing ; means a [ description of analytical tests, including their standard methods and procedures, which are used to evaluate the quality and consistency of the Process, the criteria for cGMP manufacturing of the Product, and all amendments thereto, to be agreed upon between the Parties ) ; means a [ Contemplated Change Notification initiated by [COMPANY] Biologics upon request of either Party and describing any material deviation from the Project, which notification shall be provided in writing by [COMPANY] Biologics to Palatin prior to any such material deviation and will be effective as of the date of Palatin ' s written approval of the same . The standard format of a CCN is attached hereto as Annex 1 ] ; means the [ cryopreserved murine hybridoma cell line stored at [COMPANY] Biologics that has been engineered to produce the RB5 Bulk Drug Substance ] ; means the [ certificate containing the outcome of selected tests on the RB5 Bulk Drug Product as well as selected tests on the RB5 Intermediate Drug . Product, perfonned according to the Bill of Testing ; in addition the Certificate of Analysis contains outcomes of certain biosafety testing and may include a statement of compliance ] ; means current good manufacturing practices and general biological products standards, including the regulations promulgated under the United States Federal Food Drug and Cosmetic Act, 21 CFR § § 210 et seq ., as amended from time to time, applicable guidance documents issued by the United States Food and Drug Administration ( ), applicable documents developed by the International Conference on Harmonization ( ), and similar requirements of other countries to the extent that they are applicable ;