fixed in a tangible medium of expression as part of or based upon or related to activities undertaken as part of the Project whether: (a) solely by one or more employees or agents or Subcontractors of LONZA; (b) solely by one or more employees or agents of PROTEON; or (c) jointly by one or more employees or agents or Subcontractors of LONZA and one or more employees or agents of PROTEON.
1.61 Project Manager has the meaning ascribed to it in Section 3.2.2.
1.62 Project Plan means the scope of work for technology transfer, process development, process implementation, manufacturing and overall project scope, attached as Exhibit A hereto and hereby incorporated into this Agreement by reference.
1.63 Project Rates means the applicable rates at which LONZA will charge PROTEON for the various Additional Services performed hereunder, if any, which shall be comparable to the rates utilized by LONZA to price the Project as of the Effective Date.
1.64 PROTEON has the meaning ascribed to it in the Recitals.
1.65 PROTEON Credit has the meaning ascribed to it in Section 6.1.
1.66 Quality Agreement means the quality agreement between the Parties. The Quality Agreement will be negotiated and entered into by the Parties within thirty (30) days following the Effective Date and will be attached as Exhibit C hereto and incorporated into this Agreement by reference.
1.67 Quality Review and Approval means LONZAs review and approval, by LONZAs quality assurance department, of a Clinical Batch and the associated Batch Disposition Documentation.
1.68 Raw Material means all ingredients, solvents and other components of the Drug Substance required to perform the Manufacturing Process (excluding any Consumables, Resins and Wearables).
1.69 Recall has the meaning ascribed to it in Section 11.1.
1.70 Reference Materials means Drug Substance that is generated from a Run that is well characterized, packaged and stored in a controlled manner, and used as a standard or reference for analytical testing purposes.
1.71 Registration has the meaning ascribed to it in Section 8.1.
1.72 Regulatory Authority means the FDA or the EMEA, or both of the foregoing, as the case requires.
1.73 Regulatory Filing means any or all applications, including but not limited to the NDA, submitted to Regulatory Authorities for the purpose of registering the Product or the Manufacturing Process as required by statute, and any amendments or supplements 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.