before receipt thereof under this Agreement; (b) is disclosed to the receiving party by a third person who is under no obligation of confidentiality to the disclosing party with respect to such information and who otherwise has a right to make such disclosure; (c) is or becomes generally known in the public domain through no fault of the receiving party; or (d) is independently developed by the receiving party, as evidenced by the receiving partys written records, without access to the other Partys Confidential Information.
1.24 Conforming Drug Substance means Drug Substance that conforms to all of the warranties set forth in Section 14.2.1.
1.25 Consumable means all bags, liners and other single use or regularly replaced materials that are required to perform the Manufacturing Process (excluding Raw Materials, Resins and Wearables).
1.26 Control or Controlled means, with respect to any Intellectual Property, the possession (whether by ownership, license, or other agreement or arrangement existing now or after the Effective Date, other than pursuant to this Agreement) by a Party or an Affiliate thereof of the right to grant to the other Party a license as provided herein under such Intellectual Property without violating (a) any law or governmental regulation applicable to such license or sublicense or (b) the terms of any agreement or other arrangement with any Third Party that exists as of the Effective Date or, if such right is acquired after the Effective Date, as of the date the Party or an Affiliate thereof first gained possession of such right.
1.27 Decision Request has the meaning ascribed to it in Section 3.1.2.
1.28 Designated Carrier means the common carrier selected by PROTEON to take delivery of Drug Substance at the LONZA Facility.
1.29 Drug Substance means API in bulk form that has been manufactured by LONZA pursuant to this Agreement.
1.30 Effective Date has the meaning ascribed to it in the Recitals.
1.31 EMEA means the European Medicines Agency, or any successor agency thereto.
1.32 Engineering Batch means a Batch produced from an Engineering Run.
1.33 Engineering Run means a Run used for process demonstration and engineering of some or all of the Manufacturing Process steps.
1.34 EXW means Ex Works (named place), as that expression is defined in Incoterms 2000, ICC Publishing S.A.
1.35 FDA means the United States Food and Drug Administration, or any successor agency thereto.
* 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.