results, manufacturing procedures, test procedures and purification and isolation techniques, and any tangible embodiments of any of the foregoing, and any scientific, manufacturing, marketing and business plans, any financial and personnel matters relating to a Party or its present or future products, sales, suppliers, customers, employees, investors or business, that has been disclosed by or on behalf of such Party or such Partys Affiliates to the other Party or the other Partys Affiliates either in connection with the discussions and negotiations pertaining to this Agreement or in the course of performing this Agreement.
Customer Intellectual Property Rights means Intellectual Property rights and Customer Know-How owned by Customer or licensed to Customer by a third party covering any aspect of the Services or materials, techniques or processes used in the Services.
Customer Know-How means all information, techniques and technical information owned or controlled by Customer in connection with the Cell Line, Customer Materials or Process.
Customer Materials means the Cell Line, vectors, plasmids and all other materials supplied by Customer, its Affiliate or agent to CMC or made available to CMC by Customer including, without limitation, those described in the Work Statement.
Deliverables means the data, results and materials generated from the performance of the Services including Drug History Record and Product.
Drug History Record means all lot disposition documentation relevant to a cGMP Batch to be provided to Customer with the Product from that cGMP Batch as described in the Work Statement, including a Certificate of Analysis.
Drug Substance means the biological or chemical entities described or classified in the Work Statement expressed by the Cell Line and harvested in bulk from a fermentation run pursuant to the applicable Process.
Intellectual Property means all intellectual property rights, including patents, supplementary protection certificates, utility models, trademarks, database rights, rights in designs, copyrights (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 and confidential 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 together with any renewals or extensions.
Non-Fault Delay means a delay in the Services caused by (a) the acts or omissions of Customer or its representatives, including errors or defects in the Customer Materials or (b) inability to source, though no act or omission of CMC, materials used exclusively in the manufacture of the Product and not used by CMC in the manufacture of other products.
Objective means the desired outcome of the Services as described in the Work Statement.
Permitted Recipients means the directors, officers, employees, Testing Laboratories or professional advisers who are required, on a need-to-know basis, in the course of their duties to receive and consider the Confidential Information for the purpose of enabling the relevant party to perform its obligations under this agreement; provided, that those persons are under obligations of confidence substantially similar to those set out in Section 9 imposed on the Recipient Party.
Price means the price for the Services (or any part or Stage of the Services as context requires) as defined in the Work Statement and itemized on a Stage by Stage basis.
Process means the method for manufacture, harvesting and purification of the Product.