CHANGE TO PRODUCTION PROCEDURE ETC Sample Clauses

CHANGE TO PRODUCTION PROCEDURE ETC. The parties recognize that in order to optimize the production procedure for commercial purposes, changes and modifications are expected to be required during the Clinical Development phase. It is further acknowledged that it is the parties' intention that the manufacturing production process for commercial purposes should be formalized [*]. If ImmunoGen decides that any change or modification of the production procedure of the Licensed Compound is necessary during the term for any reason or if any changes to manufacturing facilities, equipment (except to the extent that changes are made as a result of routine maintenance) or quality control procedures are proposed, ImmunoGen shall promptly notify BB in writing of the need for such change or modification. To the extent that any change or modification is material, ImmunoGen shall not implement such change or modification to the actual production procedure without BB's prior written consent, which shall not be unreasonably withheld and shall be deemed given unless ImmunoGen is otherwise notified in writing by BB within [*] of ImmunoGen's corresponding notice. It is agreed that it shall be reasonable for BB to withhold its consent to any changes which may materially impact on BB's ability to apply for Regulatory Approvals in the Territory or which would result in a material interruption in the supply of Licensed Compound or Product. To the extent that any material changes are made to the manufacturing process, ImmunoGen shall carry out, [*], all necessary pre-clinical work to minimize the need for clinical comparability studies to be conducted, provided always that in the event that the Regulatory Authorities require any such clinical comparability studies to be so conducted, these shall be conducted [*]t. Furthermore, in the event that any changes result [*].
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Related to CHANGE TO PRODUCTION PROCEDURE ETC

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  • Project Plan Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s “A multi-center, randomized, double-blind, double-dummy, vehicle-controlled sequential cohort study to determine the safety of PEP005 0.025% and 0.05% topical gel in patients with actinic keratoses” (hereinafter “the Project”) and associated costs. Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to the Project costs.

  • BUSINESS CONTINUITY/DISASTER RECOVERY In the event of equipment failure, work stoppage, governmental action, communication disruption or other impossibility of performance beyond State Street’s control, State Street shall take reasonable steps to minimize service interruptions. Specifically, State Street shall implement reasonable procedures to prevent the loss of data and to recover from service interruptions caused by equipment failure or other circumstances with resumption of all substantial elements of services in a timeframe sufficient to meet business requirements. State Street shall enter into and shall maintain in effect at all times during the term of this Agreement with appropriate parties one or more agreements making reasonable provision for (i) periodic back-up of the computer files and data with respect to the Trusts; and (ii) emergency use of electronic data processing equipment to provide services under this Agreement. State Street shall test the ability to recover to alternate data processing equipment in accordance with State Street program standards, and provide a high level summary of business continuity test results to the Trusts upon request. State Street will remedy any material deficiencies in accordance with State Street program standards. Upon reasonable advance notice, and at no cost to State Street, the Trusts retain the right to review State Street’s business continuity, crisis management, disaster recovery, and third-party vendor management processes and programs (including discussions with the relevant subject matter experts and an on-site review of the production facilities used) related to delivery of the service no more frequently than an annual basis. Upon reasonable request, the State Street also shall discuss with senior management of the Trusts any business continuity/disaster recovery plan of the State Street and/or provide a high-level presentation summarizing such plan.”

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