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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