Validation Plan. Within [***] days following the Effective Date, the Parties, through the Joint Steering Committee, shall prepare and approve a plan for a program to produce ADCs directed to [***] Targets to be identified in such plan (each, a “Validation Program Target”), which ADCs shall combine Selected Antibodies with drug payloads selected by Mersana and reasonably acceptable to Adimab via [***], which plan shall include the elements set forth in Exhibit B and such other elements as the Parties may mutually agree from time to time, and which plan will be thereafter attached to this Agreement as Exhibit C (the “Validation Plan”). Each Party shall use Commercially Reasonable Efforts to carry out the activities assigned to such Party in the Validation Plan, in accordance with the applicable timelines set forth in the Validation Plan and the terms and conditions of this Agreement.
Validation Plan. Promptly after Fusion’s receipt of a Nomination Notice for a given Combination Collaboration Target, the Parties (through the JRC) will prepare and submit to the JSC for approval a plan (each a “Combination Collaboration Validation Plan”) for the conduct of pre-clinical studies by Fusion that are sufficient in scope to enable AstraZeneca, upon receipt of a data package indicating the results of such studies prepared by Fusion in accordance with parameters set forth in the applicable Combination Collaboration Validation Plan (each a “Combination Collaboration Pre-Clinical Data Package”), to make an informed decision on the viability of further studying the combination of a compound in the AstraZeneca Pipeline modulating such Combination Collaboration Target with FPI1434 (or, if mutually agreed by the Parties, another compound in the Fusion Pipeline). Upon approval by the JSC, the JSC will amend the Combination Collaboration Plan to incorporate such Combination Collaboration Validation Plan and Fusion will use its Commercially Reasonable Efforts to undertake such agreed pre-clinical activities and generate the Combination Collaboration Pre-Clinical Data Package in accordance with the timelines and budget set forth in the applicable Combination Collaboration Validation Plan.
Validation Plan. (a) Without limiting clause 7.1, the Registrar must prepare and send to auDA for approval, within 6 months following the Commencement Date, a Validation Plan that sets out the Registrar's processes and procedures to validate the identity and Australian Presence of a Registrant, including the specific Reliable and Independent Electronic Data or identity documents that will be used by the Registrar for those purposes, in respect of the validation process set out in clause 7.1, for the Term.
(b) auDA will, within a reasonable period of time (not to exceed 30 Days), review the Validation Plan and either notify the Registrar in writing that the Validation Plan is approved, or of any changes to the Validation Plan that are required by auDA.
(c) The Registrar must make any changes to the Validation Plan that are required by auDA pursuant to clause 7.2(b) within 7 Days of receipt of auDA's written notification requiring such changes, and submit the updated Validation Plan to auDA for approval.
(d) If auDA does not approve the Validation Plan (or any updated Validation Plan pursuant to clause 7.2(f)(iii)) following the process in clauses 7.2
(a) to 7.2(c) (inclusive) due to the Registrar failing to take the necessary steps to change the Validation Plan as required by auDA pursuant to clauses 7.2(b) and 7.2(c) (inclusive), auDA may suspend the Registrar from access to the Registry (or any part of it) in accordance with clause 13.1(e).
(e) The Registrar must implement and maintain the Validation Plan once it is approved in writing by auDA.
Validation Plan. A Validation Plan shall be developed to provide the evidence needed for final evaluation of the system performance. The selected validation methods shall be specified as activities in the Validation Plan. A validation method shall be described in sufficient detail to carry out the activities and obtain reliable evidence. These activities provide evidence to document compliance with the validation requirements. The Validation Plan consists of activities which are categorized in four categories: validation of the hardware safety, validation of the system functionalities (first validation trial), validation of the overall system in real life scenarios (second validation trial) and validation of the human machine interface and ergonomics. The description of each activity is given in the following sections.
Validation Plan. 14 Protocol number Process Validation Protocol-PLECONARIL-DATE The objective of this Protocol is to describe the commercial manufacturing process for the production of pleconaril drug substance at the 600 kg scale. It also defines the requirements for process validation and the acceptance criteria for this process validation. The successful completion of this Protocol will provide assurance that the commercial manufacturing process for pleconaril will consistently produce material that meets the Specifications for pleconaril, including polymorph form (Form III), and is, therefore, validated.
Validation Plan. The PARTIES shall agree on a VALIDATION plan which shall establish the priorities and timetable for validating all critical systems, processes, tests and equipment, among other things. Consideration shall be given to whether currently validated systems, processes and tests need to be re-validated by BI AUSTRIA. Based on the VALIDATION plan, individual VALIDATION protocols shall be created.
