1.48 Manufacturing Documentation means all documents and records describing or otherwise related to the Manufacturing Process, other than those embodied in the Master Production Record.
1.49 Manufacturing Process means the production process for the manufacture of Drug Substance, as such process may be changed from time to time in accordance with this Agreement.
1.50 [ ]*
1.51 Master Production Record or MPR means the document, proposed by LONZA and approved by PROTEON, that defines the manufacturing methods, test methods, specifications, materials, and other procedures, directions and controls associated with the manufacture and testing of Drug Substance. The Master Production Record shall also include or incorporate by reference, without limitation, such information as Materials Specifications, in process and final Drug Substance sampling standards, equipment and instrumentation specifications and standard operating procedures, including, without limitation, standard operating procedures for in-process quality control testing.
1.52 Materials Specification or MS means a document detailing the specifications for each Raw Material, Resin or Consumable, each as mutually approved by the Parties.
1.53 NDA means a new drug application for the Product, or any equivalent filing thereto, filed with the FDA, and any supplements or amendments to any of the foregoing.
1.54 Non-Conforming Drug Substance means Drug Substance that fails to conform to all of the warranties set forth in Section 14.2.1.
1.55 PAI has the meaning ascribed to it in Section 4.6.
1.56 Patents shall mean, with respect to an invention, any patent or patent application, and any patent issuing there from, together with any extensions, reissues, reexaminations, substitutions, renewals, divisions, continuations and continuations-in-part thereof, and any patent or patent application claiming priority to any application in common with any such patent containing a disclosure substantially similar to that of any such patent, all to the extent the foregoing contain claims covering such invention.
1.57 Product means the final dosage form of the Drug Substance.
1.58 Project means the full range of development and manufacturing services to be provided under this Agreement as more fully described in the Project Plan.
1.59 Project Administration has the meaning ascribed to it in Section 3.3.1.
1.60 Project Intellectual Property means, individually and collectively, all Intellectual Property conceived, created, discovered, developed, generated, made or reduced to practice or
* CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.