Costs of Development. Connetics shall be responsible for all aspects and costs of development, regulatory approval and registration of Licensed Products.
Costs of Development. Shire shall bear all expenses that are related to Developing and obtaining Regulatory Approval of Collaboration Products in the ROW Territory, subject to the terms of Section 3.5.1 below. The Parties recognize that Shire may desire to conduct clinical trials of Collaboration Products within the US Territory for the purpose of obtaining Regulatory Approval within the ROW Territory, and agree that, prior to receipt of Regulatory Approval in the US Territory, Shire may conduct such trials with New River’s prior written consent, such consent not to be unreasonably withheld, conditioned, or delayed; provided, that Shire is solely responsible for all costs of conducting any such trials.
Costs of Development. Notwithstanding Section 3.7 below, (a) New River shall bear all Development Expenses that are related to Developing and obtaining Regulatory Approval for the first Collaboration Products for ADHD [*] in the US Territory, (b) New River shall be responsible for all Phase IV and Related Expenses for all activities that are required in connection with receiving Regulatory Approval by FDA or other Governmental Authorities in the US Territory with respect to such Collaboration Products (“Required Studies”), and (c) if there are any additional studies necessary to obtain [*] for the Collaboration Product for ADHD (“[*]”), New River shall be responsible for all such Development Expenses and/or Phase IV and Related Expenses related to such [*].
Costs of Development. All Development Expenses incurred by Alliance for a Product shall be borne by Alliance.
Costs of Development. 25 3.6 Joint Development and Marketing Activities..............................25 3.7 Compliance with Law and Safety and Adverse Event Reporting..............26 3.8
Costs of Development. Dicerna shall be responsible for its own costs and expenses for the Research and Development of the Dicerna Products, and Alnylam shall be responsible for its own costs and expenses for the Research and Development of Alnylam Products.
Costs of Development. Unless otherwise agreed and except as is otherwise provided in Section 2.03(d), all Development Expenses incurred for a Product shall be borne by Alliance; PROVIDED, HOWEVER, that in the event either Schering, in its sole determination, or the Steering Committee determines that additional Development of the Product beyond the scope described in this Agreement and in the Development Plan is necessary and such decision causes a material increase in Development Expenses, then such additional Development Expenses shall be borne by Schering.
Costs of Development. Unless otherwise agreed all -------------------- Development Expenses incurred for Licensed Products shall be borne by CTI. PG- TXL shall not conduct any Development, nor incur Development Expenses, without CTI's prior written consent.
Costs of Development. In case of termination by either party during the development phase, LRE shall use Is best efforts to limit or cancel any outstanding commitments in connection with the development. Subject to paragraphs 2.1 to 2.5(b), BIOSITE shall bear all costs incurred by LRE for all development work performed through the effective termination date, and for all outstanding obligations which were incurred by LRE in good faith in advance and which cannot be canceled.
Costs of Development. All Development expenses shall be borne by OSCIENT; provided that, LGLS shall reimburse OSCIENT for 50% of all amounts paid to Menarini by OSCIENT for all reasonable and verifiable regulatory development expenses incurred by Menarini in the European Territory; provided that in no event such reimbursement payments by LGLS shall exceed $[*] in the aggregate. With respect to any such regulatory development expenses to be reimbursed by LGLS, OSCIENT shall provide LGLS with a copy of the statement prepared by Menarini setting forth in detail such development expenses incurred by Menarini in the relevant quarter and proof of payment of such expenses by OSCIENT, such as receipt or payment slip. LGLS shall reimburse OSCIENT as provided for in this Section 2.5 within thirty (30) days of its receipt of all such statements and proofs. OSCIENT shall cause Menarini to keep complete and accurate books and financial records pertaining to such costs and expenses of regulatory development. LGLS shall have the right, at its discretion, to annually audit all such books and records of OSCIENT and Menarini upon advance notice to OSCIENT, and OSCIENT shall duly cooperate with LGLS. OSCIENT shall also cause Menarini to duly cooperate with LGLS with respect to such audit.
