DP 5 Decision Point definition

DP 5 Decision Point means the later of (a) the date that BMS’ Brand Development Operating Committee, or any successor thereto, approves BMS’ internal recommendations to invest resources in Phase III Clinical Trials for an Indication for a Product and (b) the date that BMS notifies Medarex in writing of such approval. Typically, the information considered by BMS’ Brand Development Operating Committee in connection with such DP 5 Decision Point shall include the following: (i) clinical proof-of-principle achieved, (ii) safety, tolerability, pharmacokinetic and clinical data in patients that meets predetermined criteria, (iii) manufacturing assessment and initial manufacturing plan have been completed, (iv) end of Phase II meeting with FDA (if any) has been held and relevant advice incorporated into the clinical plan, and (v) market research, market dynamics analysis, pricing/reimbursement sensitivity analysis, and financial modeling completed and early commercial assessment have been completed.

Related to DP 5 Decision Point

  • key decision * means an executive decision which is likely to:

  • Interconnection Point means the point(s) of connection(s) at which the project is connected to the grid i.e. it shall be at 11 / 22 kV bus bar level of substation of MSEDCL.

  • Major Decision means:

  • Connection Point means an exit point or an entry point or a bidirectional point identified or to be identified as such in an access contract.

  • Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.

  • Network Termination Point (NTP) means the physical point at which a subscriber is provided with access to a public communications network; in the case of networks involving switching or routing, the NTP is identified by means of a specific network address, which may be linked to a subscriber number or name;

  • Quality factor (Q) means the modifying factor, listed in Tables I and II of 38.4(4), that is used to derive dose equivalent from absorbed dose.

  • Proposed decision means the presiding officer’s recommended findings of fact, conclusions of law, decision, and order in a contested case in which the administrator did not preside.

  • return decision means an administrative or judicial decision or act, stating or declaring the stay of a third-country national to be illegal and imposing or stating an obligation to return;

  • Major Decision Reporting Package With respect to any Major Decision, (a) a written report prepared by the Special Servicer describing in reasonable detail (i) the background and circumstances requiring action of the Special Servicer, (ii) the proposed course of action recommended, and (iii) information regarding any direct or indirect conflict of interest in the subject action, and (b) all information in the Special Servicer’s possession that is reasonably requested by the party receiving such Major Decision Reporting Package in order for such party to exercise any consultation or consent rights available to such party under this Agreement.

  • Wind-Down Budget means a budget to be prepared by the Debtors, and reasonably acceptable to the Deerfield Requisite Supporting Noteholders, the Unaffiliated Requisite Supporting Noteholders, and the Committee, which shall be filed with the Court as part of the Plan Supplement, and which may be amended from time to time after entry of the Confirmation Order, subject to the consent of the Oversight Committee, which consent shall not be unreasonably withheld, and which shall estimate the funds necessary to administer the Plan and wind down the Debtors’ affairs, including the costs of holding and liquidating the Estates’ remaining property, objecting to Claims, making the Distributions required by the Plan, prosecuting claims and Causes of Action that may be held by the Estates against third parties that are not released, waived or transferred pursuant to the Plan (including pursuant to Article X) or otherwise, paying Taxes, filing Tax returns, paying professionals’ fees and expenses, paying the fees and expenses of the Oversight Committee, funding payroll and other employee costs, providing for the purchase of errors and omissions insurance and/or other forms of indemnification for the Plan Administrator, and for all such items and other costs of administering the Plan, the Estates and the Liquidating Debtors (other than the Administrative and Priority Claims Reserve, the Disputed Claims Reserve, and the Professional Fee Reserve).

  • Demarcation Point means the point where Qwest owned or controlled facilities cease, and CLEC, End User Customer, premises owner or landlord ownership or control of facilities begin. "Designed, Verified and Assigned Date" or "DVA" means the date on which implementation groups are to report that all documents and materials have been received and are complete.

  • Unilateral Change Order (ULCO means a Change Order issued by Owner without the complete agreement of Contractor, as to cost and/or time.

  • Valuation Point means such time as shall be specified in the relevant Supplement for each Fund.

  • Certified Remanufacture System or Verified Engine Upgrade means engine upgrades certified or verified by EPA or CARB to achieve a reduction in emissions.

  • Summary Subcontract Report (SSR) Coordinator, as used in this clause, means the individual at the department or agency level who is registered in eSRS and is responsible for acknowledging or rejecting SSRs in eSRS for the department or agency.

  • Planned External Financed Generation Capacity Resource means a Planned External Generation Capacity Resource that, prior to August 7, 2015, has an effective agreement that is the equivalent of an Interconnection Service Agreement, has submitted to the Office of the Interconnection the appropriate certification attesting achievement of Financial Close, and has secured at least 50 percent of the MWs of firm transmission service required to qualify such resource under the deliverability requirements of the Reliability Assurance Agreement.

  • Development Location Point means a single point selected by the Applicant on the proposed Development site that is located within 100 feet of a residential building existing or to be constructed as part of the proposed Development. For a Development which consists of Scattered Sites, this means a single point on the site with the most units that is located within 100 feet of a residential building existing or to be constructed as part of the proposed Development.

  • Yearly (1/Year) sampling frequency means the sampling shall be done in the month of September, unless specifically identified otherwise in the effluent limitations and monitoring requirements table.

  • Yearly (1/Year) sampling frequency means the sampling shall be done in the month of September, unless specifically identified otherwise in the effluent limitations and monitoring requirements table.

  • Collection Point means the collection point for the Vehicle specified in the Confirmation and/or Rental Agreement;

  • Adequacy Decision means a decision issued by the European Commission that a country or region or a category of recipients in such country or region is deemed to provide an “adequate” level of data protection.

  • Generation Interconnection Feasibility Study means a study conducted by the Transmission Provider (in coordination with the affected Transmission Owner(s)) in accordance with Tariff, Part IV, section 36.2.

  • Construction Change Directive means a written order prepared by Owner Parties and signed by Owner directing Contractor to perform a change in the Work prior to agreeing to a change, if any, to the Contract Time, schedule of performance of the Work, Contract Sum, or Contractor’s compensation.

  • Adverse decision means a decision reducing,

  • Final Decision means a final action of the commission determining the legal rights, duties, or privileges of any person. “Final decision” does not include preliminary, procedural, or intermediate actions by the commission, actions regulating the internal administration of the commission, or actions of the commission to enter into or refrain from entering into contracts or agreements with vendors to provide goods or services to the commission.