definiens: means a Product m anufactured ( or to be manufactured, as the context requires ) under cGMP conditions ; means any pharmaceutical or biotechnology company with ( i ) an active Adeno -associated virus based programme of research or clinical development, or ( ii ) one o r more products, whether in development or available on the market, which compete with those of CUSTOMER as may be the case from time to time during the Term ; means any and all commercial and technical information, and whether p atented or unpatented, including but not limited to documents, strategies, methods, procedures, know -how, trade secrets, pre - clinical and clinical test -data, or technical or marketing information regardless of method of storage, and copies thereof, disclos ed by or on behalf of one Party ( ) to the other Party ( ) pursuant to this Agreement . The Product and ( save to the extent containing Confidential information of NOVASEP ) Work Plans shall be deemed the Confidential information of CUSTOMER ; means all data, CUSTOMER ’s Confidential Information, methods, substances, samples and Materials provided to NOVASEP by or on behalf of CUSTOMER pursuant to this Agreement ; / has the meaning given in Section 3.3 of this Agreement ; means the formulated Drug Substance in association with none, one or more other ingredients sterile filtered and aseptically filled into vials suitable for use as a medicinal product ; means the active component in solution in bulk form in a suitable container for frozen storage ; means the date mentioned on top of the first page of this Agreement ; means those pieces of equipment described in a Work Plan and required or used by NOVASEP to produce the Product, including, without limitation, the related documentation regarding the design, validation, operation, calibration and maintenance of such equi pment . Components of the Equipment shall also be deemed Equipment . and shall be as defined in Section 2.4 of this Agreement ; shall mean NOVASEP ’s development and manufacturing facility(ies ) where the Wor k will be carried out, as agreed between the Parties and set out in the relevant Work Plan ; means any and all uses of Adeno -associated virus constructs ; has the meaning given in Section 14 of this Agreement ; mean s the [COMPANY] Foreground IPR, the CUSTOMER Foreground IPR and/or the Jointly Owned Foreground IPR as the case may be ; means the degree of skill, care prudence, knowledge and foresight which would reasonably and ordinarily be expec ted of a skilled, professional, competent and experienced contract manufacturing organisation engaged in the development of manufacturing processes for, and the cGMP manufacture of products at a similar or equivalent stage of development or approval to the Product ; [ * * ] 4 Certain confidential information contained in this document, marked by [ * * ], has been omitted because the information ( i ) is not material and ( ii ) would likely cause competitive harm to the Company if publicly disclosed