U.S. Development Expenses definition

U.S. Development Expenses means any amounts payable by a Party for obligations to a Third Party for the U.S. Development performed on or after January 1, 2007, which expenses are generally consistent with the Development Budget. 1. 115 "U.S. Development Plan" means the plan of the U.S. Development. The initial U.S. Development Plan is attached hereto as Exhibit H. Exhibit H may be from time to time added or modified by the JSC. 1. 116 "U.S. Product Profit" means the profits or losses resulting from the Commercialization of the Product in the U.S. and shall be equal to Net Sales of the Product in the U.S., less Commercial Expenses.
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U.S. Development Expenses means any amounts payable by a Party for obligations to a Third Party for the U.S. Development performed on or after January 1, 2007, which expenses are generally consistent with the Development Budget.
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Examples of U.S. Development Expenses in a sentence

  • With respect to the Development and Commercialization of Elected Candidate and Licensed Product for U.S. Administration hereunder, if any payments become due under any Applicable Pre-Existing In-License, Applicable New In-Licenses, Co-Co In-Licenses or Celgene Licensed Product In-License during the CCPS Agreement Term, the contracting Party thereto will pay same and such payment will be treated as U.S. Development Expenses or Allowable Expenses, as appropriate, provided [***].

  • Any Development Expenses to the extent required for the Parties to prepare, submit and maintain all Regulatory Materials in the U.S. (including any materials that are intended for submission to Regulatory Authorities in both the U.S. and Royalty Territory) shall be treated as U.S. Development Expenses.

  • Unless otherwise provided for in this Agreement, any efforts, costs and expenses for the ROW Development shall be borne solely by Takeda and not treated as U.S. Development Expenses.

  • If the JSC elects to proceed pursuant to a unanimous decision, the JSC shall amend the U.S. Development Plan to include the Development activities to be conducted for such Additional Indication (a "Joint Additional Indication") up through Regulatory Approval in the U.S. Unless otherwise agreed by the Parties, the U.S. Development Expenses for such Development of the Product for the Joint Additional Indication shall be deemed Development Expenses.

  • For the avoidance of doubt, U.S. Development Expenses may include expenses related to Clinical Studies performed outside of the United States in support of Regulatory Approval in the United States.

  • If total actual U.S. Development Expenses exceeded budgeted U.S. Development Expenses by more than [**]% for the Calendar Year to date, the reimbursing Party shall first pay the other Party an amount sufficient to cause the reimbursing Party to have borne its stated percentage of [**]% of the budgeted U.S. Development Costs.

  • Prior to the Initiation of the first Phase III Study with respect to each Profit-Sharing Product, each Party has a one-time option to reduce its percentage share of U.S. Development Expenses related to such Profit-Sharing Product ("EXPENSE SHARE REDUCTION OPTION"); provided, however, that in no event will such percentage share be less than [**] percent ([**]%).

  • Subject to the foregoing clause (ii), any proposal to increase U.S. Development Expense for any Calendar Year by more than [**]% of the U.S. Development Expenses budgeted for such Calendar Year, if the Parties are unable to reach consensus on such issue, after referral to the executive officers of the Parties pursuant to Section 13.6.1, shall not be approved.

  • If the JSC elects to proceed pursuant to a unanimous decision, the JSC shall amend the U.S. Development Plan to include the Development activities to be conducted for such Additional Indication (a “Joint Additional Indication”) up through Regulatory Approval in the U.S. Unless otherwise agreed by the Parties, the U.S. Development Expenses for such Development of the Product for the Joint Additional Indication shall be deemed Development Expenses.

  • Actual U.S. Development Expenses in excess of [**]% of budgeted U.S. Development Expenses shall also be reimbursed if (a) both Parties approve the additional U.S. Development Expenses in advance or (b) such excess U.S. Development Expenses are the result of work carried out in response to a governmental requirement to do such work and the Party incurring such excess U.S. Development Expenses has notified the other Party prior to incurring such excess U.S. Development Expenses.