definiens: means all Intellectual property rights, including ( without limitation ) patents, rights in patents, supplementary protection certificates, petty patents, utility models, trade marks, database rights, rights in designs, copyrig hts ( whether or not any of these are registered or capable of being registered ) and including all applications and the right to apply for registered protection of the foregoing and all inventions, trade secrets, know how, techniques, rights in Confidential Information and other proprietary knowledge and information, and all rights and forms of protection of a similar nature or having equivalent or similar effect to any of these which may subsist anywhere in the World, in each case for their full term and to gether with any renewals or extensions ; means the document, proposed by NOVASEP and subsequently approved in writing by CUSTOMER and which specifies the Raw Materials with their quantities and the packaging materials, together w ith a detailed description of the procedures and precautions required to produce a specified quantity of an intermediate, bulk or finished product as well as the processing instructions, including the in -process controls ; means materials, Raw Materials, compounds or Intermediates supplied by or on behalf of CUSTOMER to NOVASEP or its Affiliates under Section 2.7 of this Agreement or procured by NOVASEP in accordance with Section 2.6 of this Agreement ; has the meaning given in Section 2.1 of this Agreement ; has the meaning given in Section 2.1 of this Agreement ; has the meaning given in Recital ( i ) to this Agreement ; has the meaning given in Section 2.4 of this Agreement ; means the team established by the Parties per Work Plan, in advance of commencement of the Work, and detailed in a Work Plan, responsible for ( without limitation ) the management of the Work on a day -to - day basis and which will consist of include one project manager from each of NOVASEP and CUSTOMER to act as the primary day -to - day point of contact for the Parties in respect of a Work Plan ( each a ) ; means the agreement between the Parties, to be entered into on or within thirty ( 30 ) calendar days of the Effective Date, defining ( without limitation ) the quality and cGMP responsibilities regarding the performance of the Work and quality aspects of the manufacture of the Product, and will inc lude any further quality agreements to be entered into between the Parties in respect of any other Work Plan ; in the format of the template quality agreement at Part 4 of this Agreement ; media, resins, catalysts, raw materials, solvents, f ilters, membranes, disposable analytical test kits, disposable bags, and other items consumed during or for the performance of the Work ; shall mean using all reasonable care and skill and resources but having regard to the fact tha t the Work, including without limitation the method of manufacture of the Product, is experimental in nature and NOVASEP can not be considered liable for issues ( including without limitation those causing delays ) arising for causes which could not reasonabl y have been known to NOVASEP at the relevant time ; means any or all applications, submitted to regulatory authorities for the purpose of seeking and obtaining marketing approval for the Product, and/or of the method of production of t he Product as required by statute and any amendments or supplements thereto, and any other filings required by the regulatory authorities relating to the manufacture, testing, sale or distribution of any Product, including, without limitation, an NDA or BL A ; 5 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