definiens: means, for all studies or activities performed --------------------by or on behalf of either Party or any of its Affiliates to the extent providedfor in an approved U.S. Development Plan or otherwise approved in advance by theJoint Development Committee or Joint Steering Committee, including withoutlimitation Phase III Studies, that are relevant to the Development ofCollaboration Products for Commercialization in the United States : 1.42.1 * * costs and expenses incurred ( i.e., paid or accrued ) to a * *, in connection with all Development activities performed in accordance with theU.S. Development Plan ; 1.42.2 the cost of clinical supplies for such studies or activities asagreed in the U.S. Development Plan, which costs shall be comprised of ( i ) thecost of clinical and pre - clinical supplies, including Compound, utilized inDevelopment, ( ii ) out - of - pocket costs and expenses incurred in purchasingcomparator drug and in packaging comparator drug and/or the CollaborationProducts, shipping clinical supplies to centers or disposal of clinicalsupplies, and ( iii ) actual costs of packaging comparator if done by a Party