1.20 Firm Order means a binding,
non-cancelable agreement to purchase Product as evidenced by a purchase order, sales acknowledgement or other evidence to purchase Product in writing and delivered to CytoDyn by American Regent and accepted by
CytoDyn in accordance with Section 6.2.
1.21 First Commercial Sale means with respect to a Product, the first
commercial sale of the Product by American Regent to a Third Party in the Field in the Territory in final dosage form packaged for use by end-users, other than for testing purposes and/or sale for experimental
purposes, promotional purposes, compassionate use programs, named patient programs, test market purposes, or similar purposes.
current Good Manufacturing Practices or cGMP means at any time the quality systems and good manufacturing practices as set forth in 21 C.F.R. (Parts 210 and 211) and
any other Applicable Laws, directives, rules, regulations, guides and guidance in existence in the Territory at that time.
Intellectual Property means all patents, copyrights, trademarks, service marks, service names, trade names, internet domain names, e-mail addresses, applications or
registrations for any of the foregoing, or extensions, renewals, continuations or re-issues thereof, or amendments or modifications thereto, brandmarks, brand names, trade dress, labels, logos, know-how (including the Product Know-How), show-how, technical and non-technical information,
trade secrets, formulae, techniques, sketches, drawings, models, inventions, designs, specifications, processes, apparatus, equipment, databases, research, experimental work, development, pharmacology and clinical data, software programs and
applications, software source documents, Third Party licenses, and any similar type of proprietary intellectual property right vesting in the owner and/or licensee thereof pursuant to the Applicable Laws of any relevant jurisdiction or under any
applicable license or contract, whether now existing or hereafter created, together with all modifications, enhancements and improvements thereto.
1.24 Latent Defect means a defect that existed at the time that title to Product passed to American
Regent which could not have been detected by American Regent utilizing American Regents usual and customary inspection procedures for incoming finished product intended for distribution in the Territory, which in any event will be in
accordance with American Regents cGMP obligations.
1.25 Losses has the meaning set forth in
1.26 Manufacture means to make Product in compliance with cGMP, including to
process, prepare, make and Test the raw materials used in the preparation of Product and to Test a Product prior to release for Packaging, filling, packaging, labeling, and preparation of Product for shipment, in each case in a finished dosage form
ready for administration to humans, and Manufacturing has a corresponding meaning.
Market means to distribute, market, offer to sell and/or sell for purposes of a commercial sale, and Marketing has a corresponding meaning.