1.13 Change Order means a document mutually approved in writing by both Parties in accordance with the procedures set forth in Section 3.4 that describes in reasonable detail an amendment or modification to the Project and/or the Project Plan.
1.14 PROTEON Change Request has the meaning ascribed to it in Section 3.4.
1.15 LONZA Change Request has the meaning ascribed to it in Section 3.4.
1.16 PROTEON Confidential Information means any Manufacturing Documentation provided by PROTEON to LONZA, and all elements of the Manufacturing Process provided by PROTEON to LONZA, clinical data and information, business plans, regulatory and Product information, Product strategies and all technical and other information, whether patented or unpatented, relating to PROTEON Product processes, test methods, operations, technologies, forecasts and business information that is disclosed or supplied to LONZA by or on behalf of PROTEON pursuant to this Agreement. PROTEON Confidential Information shall also include the Master Production Record, the Materials Specifications, and the Manufacturing Documentation.
1.17 PROTEON Equipment means those certain pieces of equipment described in the Project Plan used to produce the Product that are purchased by PROTEON or for which PROTEON reimburses LONZA, including, without limitation, the related documentation regarding the design, validation, operation, calibration and maintenance of such equipment.
1.18 PROTEON Intellectual Property means all Intellectual Property owned or Controlled by PROTEON that are conceived, discovered, developed, generated, created, made or reduced to practice or fixed in a tangible medium of expression at any time prior to the Effective Date or after the Effective Date if such Intellectual Property rights are not based upon or related to the performance of the Project.
1.19 Clinical Batch means a Batch produced from a Clinical Run.
1.20 Clinical Run means a Run manufactured in accordance with the Master Production Record and is used to create Drug Substance for clinical use.
1.21 Commercially Reasonable Efforts means with respect to any objective of a Party, diligent, good faith efforts to accomplish such objective, to be undertaken in accordance with such Partys reasonable business, legal and scientific judgment, consistent with the effort a reasonably comparable biological development company (in the case of PROTEON) or biopharmaceutical contract manufacturer (in the case of LONZA) would normally use to accomplish a similar objective under similar circumstances.
1.22 Confidentiality Agreement means the Reciprocal Confidentiality Agreement between PROTEON and Lonza Biologics, Inc., dated May 20th, 2009.
1.23 Confidential Information means PROTEON Confidential Information and/or LONZA Confidential Information, as the context requires, except any portion thereof which: (a) is known to the receiving party, as evidenced by the receiving partys prior written records,
* 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.