Product Development Costs definition

Product Development Costs means all external costs, including external product development costs, incurred by Centocor and Schering-Plough after the Effective Date in connection with the clinical development (including pre-clinical, toxicology, pharmacology and pharmacodynamic studies and clinical trials, except as limited by the last sentence of this definition) and clinical support of regulatory filings with respect to the Product. "Product Development Costs" also includes the cost of goods for material used in clinical trials, which cost will be calculated based on Centocor's Cost of Goods Sold, or, if Centocor contracts with a third party for manufacture of the Product, will be the actual cost paid by Centocor to that third party. "Product Development Costs" also includes such costs of the development of improvements of manufacturing and control processes as are incurred after the Product has received a first EMEA Approval. All internal costs of Centocor or Schering-Plough, including but not limited to salaries, payroll taxes, bonuses and benefits incurred with respect to their employees and office, administration and overhead expenses, are specifically excluded from the definition of "Product Development Costs," unless otherwise agreed by the parties. Excluded from "Product Development Costs" are costs incurred with respect to clinical trials or other studies undertaken solely to support applications for Regulatory Approval outside the Territory.

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Product Development Costs means those out-of-pocket costs approved by the Development Committee incurred in connection with Product Development Activities defined in Section 5.4. Product Development Costs do not include any expenditures for studies commenced prior to the approval of the NDA unless specifically approved by DuPont. The amounts and reimbursement of Product Development Costs shall be determined in accordance with Sections 5.4 and 5.5.

Product Development Costs. ("PDC") is defined in Section 2.3(c) below.

Examples of Product Development Costs in a sentence

Each party will have the right, upon forty-five (45) days prior written notice and during normal business hours, through an independent third party representative (who will agree to be bound by confidentiality provisions to review and inspect the other party's books and records which relate to such other parties's operations under this Agreement including, but not limited to, records concerning Commercial Sales, Net Sales, Product Development Costs, sales presentations, and other costs.
To the extent that either party exceeds the agreed upon budgeted Product Development Costs for such activities without the prior written approval of the Product Committee, such party shall be solely responsible for such excess expenditures which shall be excluded from Product Development Costs.
To the extent that either party exceeds the agreed upon budgeted Product Development Costs for such activities without the prior written approval of the Product Committee, such party shall be solely responsible for such excess expenditures which shall be excluded from the calculation of any Excess Amount under Section 6.3(c).
The Development Subcommittee shall review and make recommendations to the Steering Committee whether to approve any proposals by one Party to modify clinical trials being planned by the other Party, as described in Section 3.4 and prepare initial estimates and budgets for shared Incremental Product Development Costs as may be required under Section 3.4.
Further, all cost directly related to [****] shall be considered Shared ANG2 Product Development Costs.
Bioject shall complete true and accurate books of accounts and records of the Aject Development Costs and AngioSense Product Development Costs incurred for the Aject Development and AngioSense Product Development hereunder.
The parties further agree that, subject to variances in patient accrual rates, the anticipated budget for Product Development Costs in calendar year 1999 for the clinical trials already in progress or ready to be started and for the ACCENT study is estimated at [***].
Schering-Plough's obligation to pay for Product Development Costs incurred during 1998 and 1999 with respect to such studies shall be capped, unless the Product Committee elects to initiate additional clinical studies during such calendar years or the Product Committee otherwise approves additional Product Development Costs to be incurred in such calendar years.
If the total of both parties' Product Development Costs is [***] or less and [***] of the Excess Amount is less than [***], then (1) if Schering-Plough would otherwise be the Paying Party as defined above, Schering-Plough shall make no payment to Centocor and Centocor shall pay Schering-Plough the amount by which [***] exceeds [***] of the Excess Amount; and (2) if Centocor is the Paying Party as defined above, Centocor shall pay Schering-Plough [***] plus [***] of the Excess Amount.
In the event that (i) the indication in the approved NDA is substantially narrower than that approved for Kos' Niaspan(R) product, or (ii) a generic version of niacin plus lovastatin is approved by the FDA, then the Parties shall promptly negotiate in good faith revisions with respect to the Parties' obligations for Product Development Costs and Copromotion Activities and the Term of the Agreement.

More Definitions of Product Development Costs

Product Development Costs mean direct costs incurred by MSU in developing the Accessor.

Product Development Costs means, in respect of any relevant testing period, the amount shown in respect of product development costs in the balance sheet comprising part of the Combined Pro-forma Accounts as at 31st December 1994;

Product Development Costs as used herein refers to any cost incurred from activities related to Product Development.

Product Development Costs means all external costs, including external product development costs, incurred by Centocor and Schering-Plough after the Effective Date in connection with the clinical development (including pre-clinical, toxicology, pharmacology and pharmacodynamic studies and clinical trials, except as limited by the last CONFIDENTIAL TREATMENT REQUESTED. sentence of this definition) and clinical support of regulatory filings with respect to the Product. "Product Development Costs" also includes the cost of goods for material used in clinical trials, which cost will be calculated based on Centocor's Cost of Goods Sold, or, if Centocor contracts with a third party for manufacture of the Product, will be the actual cost paid by Centocor to that third party. "Product Development Costs" also includes such costs of the development of improvements of manufacturing and control processes as are incurred after the Product has received a first EMEA Approval. All internal costs of Centocor or Schering-Plough, including but not limited to salaries, payroll taxes, bonuses and benefits incurred with respect to their employees and office, administration and overhead expenses, are specifically excluded from the definition of "Product Development Costs," unless otherwise agreed by the parties. Excluded from "Product Development Costs" are costs incurred with respect to clinical trials or other studies undertaken solely to support applications for Regulatory Approval outside the Territory.

Product Development Costs means costs incurred for sample books, studio strike offs, design acquisition and development, printing cylinders, engraving and analogous items.