Clinical Trial Costs definition

Clinical Trial Costs means the direct and indirect costs incurred by one or both Parties and any licensees thereof in connection with a particular Clinical Trial, including, without limitation, fees paid to clinical sites, fees paid to human subjects participating in such Clinical Trial, and FTE and other overhead expenses, if any, directly attributable to such Clinical Trial.

Clinical Trial Costs means the direct and indirect costs incurred by one or both Parties and any Affiliates or Licensees thereof in connection with a particular Clinical Trial, including, without limitation, fees paid to clinical sites, clinical research organizations (“CRO’s”), patients or volunteers participating in such Clinical Trials and other overhead expense, if any, directly attributable to such Clinical Trial;

Clinical Trial Costs means actual financial obligations incurred to Third Parties (e.g., costs of sample acquisition, patient recruitment and follow-up, and data analysis) necessarily incurred by BMX, or for its account, for any clinical trial of any Initial VIDAS Product.

Examples of Clinical Trial Costs in a sentence

• Within [*****] days following the JSC’s receipt of such written reports, the JSC shall prepare and submit to each Party a written report setting forth in reasonable detail the calculation of the net amount owed by a Party to the other Party in order to ensure the appropriate sharing of the Shared Clinical Trial Costs [*****].

• Shared Development Costs and the Excluded Clinical Trial Costs shall initially be borne by the Party (or its Affiliate) incurring such cost or expense.

• Each Party (the "Auditing Party") shall have the right, upon prior written notice to the other Party (the "Audited Party") and at the Auditing Party's cost, to have the certified public accountants of the Auditing Party's choice, bound by confidentiality and reasonably acceptable to the Audited Party, audit the Audited Party's books and records to verify the Audited Party's calculations of any Clinical Trial Costs of which the Auditing Party is obligated to pay a percentage.

• Shared Development Costs and Excluded Clinical Trial Costs shall be calculated, recorded and reported under this Agreement in accordance with the last updated IFRS and in Euros.

• In the case of Shared Development Costs and Excluded Clinical Trial Costs which are initially incurred in a currency other than Euros, exchange conversion of such amounts into Euros shall be made on a [***] basis and shall be made consistent with the incurring Party’s normal practices used to prepare its audited financial statements for internal and external reporting purposes, which uses a widely accepted source of published exchange rates.

More Definitions of Clinical Trial Costs

Clinical Trial Costs means the [*] incurred by a Party or its Affiliates that is specifically attributable or reasonably allocable to the conduct of clinical trials, and which is payable (a) in the case of such clinical trials conducted by a clinical research organization (“CRO”) or other Third Party on behalf of a Party or its Affiliates, as an out-of-pocket expense to such a CRO, or (b) in the case of such clinical trials conducted by a Party or its Affiliates, at such Party’s or its Affiliate’s actual cost including internal costs and direct expenses.

Clinical Trial Costs means the costs incurred by ASLAN, as from the Effective Date up till the date of ASLAN’s Buy-Back Notice (as defined in Section 15.2), of carrying out clinical trials and clinical studies for the Product, such trials or studies being additional or supplementary to the Ongoing Clinical Trials as listed and defined and in Schedule 2; including, without limitation, costs of clinical research organisations, payments to clinical trial centres, and costs of Regulatory Filings.

Clinical Trial Costs shall have the meaning specified in the Development Agreement.

Clinical Trial Costs means site contract fees, investigator fees, IRB fees, patient laboratory costs, other protocol-directed costs and the costs of contract research organizations, and all other external study costs relating to the Clinical Development of Products. The term “Clinical Trial Costs” also includes all external costs approved by the JSC and incurred by BSC relating to Pre-Clinical Development of Products.

Clinical Trial Costs means all costs directly associated with the clinical trials that are necessary in order to obtain Approvals from the FDA for the Indications described in Section 4, which costs shall include, but not be limited to, those costs set forth on Schedule 1(a) hereto; provided, however, that “Clinical Trial Costs” shall in no event include either party’s overhead or indirect costs associated with its performance hereunder.

Clinical Trial Costs means FTE Costs and Out of Pocket Costs incurred for Clinical Trials in accordance with the Development Plan.

Clinical Trial Costs means the FTE Costs and Third Party Costs incurred in conducting a Clinical Trial, including, without limitation, the costs to prepare and file an IND (as applicable to each Party under the terms of this Agreement), and the fees paid to Third Party investigators, consultants, and contract research organizations; provided, however, that the term does not include the costs of cGMP manufacturing of Licensed Product, manufacturing scale-up, engineering or other costs to enable cGMP manufacturing of larger volumes of Licensed Product, or Regulatory Filings or Regulatory Approvals associated with the manufacture of Licensed Product incurred through the Completion of Phase II Clinical Trials for such Licensed Product.