IND Ready Criteria definition

IND Ready Criteria means objective specifications defining ex vivo primary pharmacodynamic and biophysical characteristics that will be agreed upon between the Parties for an Antibody against a Sucampo Target. The IND Ready Criteria shall be included in each Research Plan. IND Ready Criteria shall be defined such that it supports subsequent preclinical development including current Good Manufacturing Practice (cGMP) manufacturing process development and preclinical safety and toxicology studies to satisfy the Investigational New Drug (IND) requirements for biologics in accordance with the US Food and Drug Administration (FDA) or other regulatory authority current regulations and/or guidance. Finally, Antibodies produced in a generic lab scale process according to Section 3.9.2 could possibly be used for non-Good Laboratory Practice (GLP) in vitro and animal studies to assess pharmacokinetic and pharmacology.
Sample 1

Examples of IND Ready Criteria in a sentence

  • In the presence of these instabilities, the driven system becomes a kind of time quasicrystal, with macroscopic occupation of a magnon state results of these simulations show that there is first a tran,sition from the expected vtrans ∼ bz bRwhose frequency and momentum are incommensurate with the driving frequency ω and lattice momentum q, respectively.

  • The Success Fee for Discovery Project No. 1 shall be payable within thirty (30) days of receipt by Sucampo of an invoice from Numab, which invoice will be issued promptly after the achievement of the IND Ready Criteria for Part A of Discovery Project No. 1 has been accepted by Sucampo pursuant to Section 3.9.3. For the performance […***…] FTE Rate.

  • The IND Ready Criteria will be agreed upon prior to the initiation of the Discovery Project.

  • Upon exercise of a Target Option, the Parties shall through the JSC use good faith efforts to agree upon IND Ready Criteria with respect to the applicable Sucampo Target(s).

  • IND Ready Criteria for each Antibody and Compound shall be in writing and shall be attached hereto as an appendix and shall be deemed a part of this Agreement.

Related to IND Ready Criteria

  • ASAM criteria means the most current edition of the American Society of Addiction Medicine's published criteria for admission to treatment, continued services, and discharge.

  • Review Criteria has the meaning assigned to that term in Section 12.02(b)(i).

  • Business Criteria means any one or any combination of Income before Taxes, Net Income, Return on Equity, Return on Assets, Pre-tax Margin, Free Cash Flow, Valuation or EPS.

  • Investment Criteria The criteria specified in Section 12.2(a).

  • Evaluation Criteria means the criteria set out under the clause 27 (Evaluation Process) of this Part C, which includes the Qualifying Criteria, Functional Criteria and Price and Preferential Points Assessment.

  • Selection Criteria means and includes all of the requirements, considerations,

  • Qualifying Criteria means the criteria outlined in Section 3 and which is used to determine whether an individual is eligible to receive criminal Legal Aid;

  • Nomination Criteria means the criteria made up of the Over-Riding Nomination Criteria andthe Specific Nomination Factors, and is also referred to as “this Criteria”.

  • Fitch Criteria means the Collateral Amount shall equal the sum of (i) the product of A multiplied by the xxxx-to-market value of the outstanding Transactions determined by Party A in good faith from time to time, and (ii) the product of B multiplied by the current aggregate notional amount of the outstanding Transactions, where:

  • Criteria means one of the eight (8) state defined categories to be scored.

  • Eligibility Criteria means the legal criteria as specified in the Clause 5 of this E- Auction Process Information Document;

  • Over-Riding Nomination Criteria means the criteria set out in clause 4.2.

  • Functional Criteria means the criteria set out in clause 27 of this Part C.

  • Eligibility and selection criteria means criteria for determining:

  • Direct Award Criteria means the award criteria to be applied for the award of Call-Off Contracts for Standard Services set out in Part 1 of Schedule 6 (Award Criteria) of this Framework Agreement;

  • Award Criteria means the award criteria to be applied for the direct award of Call Off Agreements for Goods and/or Services set out in Part A of Framework Schedule 6 (Award Criteria); Dispute means any dispute, difference or question of interpretation arising out of or in connection with this Framework Agreement, including any dispute, difference or question of interpretation relating to the Goods and/or Services, failure to agree in accordance with the procedure for variations in Clause 16.1(Variation Procedure) or any matter where this Framework Agreement directs the Parties to resolve an issue by reference to the Dispute Resolution Procedure;

  • Acceptance Criteria means the Specifications, goals, performance measures, testing results and/or other criteria designated by the Agency and against which the Deliverables may be evaluated for purposes of Acceptance or Non-acceptance thereof.

  • Applicable Servicing Criteria With respect to the Servicer, the Special Servicer or any Servicing Function Participant, the Servicing Criteria applicable to it, as set forth on Exhibit L attached hereto. For clarification purposes, multiple parties can have responsibility for the same Applicable Servicing Criteria and with respect to a Servicing Function Participant engaged by the Servicer or the Special Servicer, the term “Applicable Servicing Criteria” may refer to a portion of the Applicable Servicing Criteria applicable to the Servicer or the Special Servicer, as the case may be.

  • Rating Criteria with respect to any Person, means that (i) the short-term unsecured debt obligations of such Person are rated at least “A-1” by S&P, “P-1” by Xxxxx’x and “F-1” by Fitch, if deposits are held by such Person for a period of less than one month, or (ii) the long-term unsecured debt obligations of such Person are rated at least “AA-” by S&P, “Aa3” by Xxxxx’x and “AA-” by Fitch, if deposits are held by such Person for a period of one month or more.

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

  • Performance Criteria means the criteria (and adjustments) that the Committee selects for an Award for purposes of establishing the Performance Goal or Performance Goals for a Performance Period, determined as follows:

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Servicing Criteria The "servicing criteria" set forth in Item 1122(d) of Regulation AB, as such may be amended from time to time.

  • Design Criteria Package means concise, performance-oriented drawings or specifications for a public construction project. The purpose of the Design Criteria Package is to furnish sufficient information to permit Design-Build Firms to prepare a bid or a response to the District’s Request for Proposals, or to permit the District to enter into a negotiated Design- Build Contract. The Design Criteria Package must specify performance- based criteria for the public construction project, including the legal description of the site, survey information concerning the site, interior space requirements, material quality standards, schematic layouts and conceptual design criteria of the project, cost or budget estimates, design and construction schedules, site development requirements, provisions for utilities, stormwater retention and disposal, and parking requirements applicable to the project. Design Criteria Packages shall require firms to submit information regarding the qualifications, availability, and past work of the firms, including the partners and members thereof.

  • Qualifying Performance Criteria means any one or more of the following performance criteria, either individually, alternatively or in any combination, applied to either the Company as a whole or to a business unit, Parent, Subsidiary or business segment, either individually, alternatively or in any combination, and measured either annually or cumulatively over a period of years, on an absolute basis or relative to a pre-established target, to previous years’ results or to a designated comparison group, and on a pre-tax or after-tax basis, in each case as specified by the Committee in the Award: (i) cash flow (including operating cash flow or free cash flow); (ii) earnings (including gross margin, earnings before interest and taxes, earnings before taxes, and net earnings); (iii) earnings per share; (iv) growth in earnings or earnings per share; (v) stock price; (vi) return on equity or average stockholders’ equity; (vii) total stockholder return; (viii) return on capital; (ix) return on assets or net assets; (x) return on investment; (xi) revenue; (xii) income or net income; (xiii) operating income or net operating income; (xiv) operating profit or net operating profit; (xv) operating margin; (xvi) return on operating revenue; (xvii) market share; (xviii) contract awards or backlog; (xix) overhead or other expense reduction; (xx) growth in stockholder value relative to the moving average of the S&P 500 Index or a peer group index; (xxi) credit rating; (xxii) strategic plan development and implementation (including individual performance objectives that relate to achievement of the Company’s or any business unit’s strategic plan); (xxiii) improvement in workforce diversity; (xxiv) expenses; (xxv) economic value added; (xxvi) product quality; (xxvii) number of customers; (xxviii) objective customer indicators; (xxix) customer satisfaction; (xxx) new product invention or innovation; (xxxi) profit after taxes; (xxxii) pre-tax profit; (xxxiii) working capital; (xxxiv) sales; (xxxv) advancement of the Company’s product pipeline; (xxxvi) consummation of strategic transactions; (xxxvii) reduction in cash utilization; and (xxxviii) addition of technologies and products. The Committee may appropriately adjust any evaluation of performance under a Qualifying Performance Criteria to exclude any of the following events that occurs during a performance period: (A) asset write-downs; (B) litigation or claim judgments or settlements; (C) the effect of changes in tax law, accounting principles or other such laws or provisions affecting reported results; (D) accruals for reorganization and restructuring programs; and (E) any gains or losses classified as extraordinary or as discontinued operations in the Company’s financial statements.

  • Peer support specialist means an individual who has experienced a severe and persistent mental illness and who has successfully completed standardized training to provide peer support services through the medical assistance program or the Iowa Behavioral Health Care Plan.