Critical Matters definition

Critical Matters means (A) all decisions made by the CRC, JSC and JPTs that, in the reasonable opinion of either Party, are likely to have any of the following impacts: (i) [*] under a Development Plan or Brand Plan; (ii) a change to a Development Plan or Brand Plan that results in the lesser of (a) an increase of [*] or more (provided, that such amount is at least [*]) and (b) [*] or more, in each case, to the then-current budgeted amount of Development Costs and/or General Costs for any specific calendar year under the applicable Development Budget, Operations Budget or Commercialization Budget or the amounts estimated under Sections 7.2.1 (Partner Costs) and 7.2.2 (Amgen Costs); (iii) a change to a Development Plan or Brand Plan that results in a decrease of [*] (provided, that such amount is at least [*]) or more to the then-current budgeted amount of Development Costs and/or General Costs for any specific calendar year under the applicable Development Budget, Operations Budget or Commercialization Budget or the amounts estimated under Sections 7.2.1 (Partner Costs) and 7.2.2 (Amgen Costs); or (iv) a change to a Development Plan (including any plans with respect to a contemplated Regulatory Approval set forth therein) or Brand Plan that would, based upon [*], result in [*] of a Product for any specific calendar year under the applicable Development Plan or Brand Plan; (B) agreement of the initial Commercialization Budget for each Product; (C) agreement of the initial Brand Plan (or material updates thereto reflecting the launch of a new indication), Global Payer Plan and any Access and Pricing Plan for each Product; and (D) deadlocks with respect to the approval of an annual Development Budget, Operations Budget or Commercialization Budget as provided for under Section 7.7 (Budget Deadlocks).
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Critical Matters means, with respect to a decision of the Parties, JSC or JAC, (i) decisions that are likely to [*]; (ii) decisions that are likely to [*]; (iii) decisions with respect to the approval (or amendment) of [*] for each Product; (iv) decisions to approve [*] for each Product, [*] and any changes to [*]; and (v) decisions that are reasonably likely to [*] for any Product [*].
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Critical Matters means any decision of the Parties or any Committee: […***…].
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Examples of Critical Matters in a sentence

  • Data regarding representative exchange rates, the consumer price index, and their rates of change are set out below: Rate of change 2012201120102012 Accounting Policies on Critical Matters and Critical Accounting EstimatesWorldReginfo - f5fe760c-cdf6-43cc-95f4-ba6e66f9c662The financial statements of the Bank are prepared in accordance with accounting principles and rules, the main points of which are described in Note 1 to the Financial Statements.

  • All such Critical Matters so escalated to the Executive Officers [*].

  • For clarity, resolution of JRC matters pertaining or relating to Critical Matters shall require mutual agreement of the Executive Officers acting in compliance with applicable Law.

  • The CRC will be responsible for (i) providing general oversight of the collaboration; (ii) resolving any matters specifically designated to it under this Agreement; and (iii) resolving any Critical Matters escalated to it from the JSC.

  • If a dispute (originating at either the USCT or the JUSLT) arises on a Critical Matter which cannot be resolved within the JUSLT within [*] Business Days following referral to the JUSLT, the Co-Chair of either Party may cause such dispute to be referred to the Alliance Managers for escalation to the JSC for Critical Matters that are strategic or scientific issues, or to the United States Senior Officers for all other Critical Matters (including budget or resource allocation issues).

  • Additionally, either Party may request a meeting of the CRC to resolve any Critical Matters requiring resolution.

  • With respect to any Critical Matters not referred to Expedited Arbitration in accordance with Section 9.7.3.1 (Referral to Expedited Arbitration), including all Candidate Category 1 Target Development Critical Matters, no changes will be adopted.

  • These objectives will remain mere pipe dreams as long as the North continues to use the WTO and allied institutions as instruments of trade and financial imperialism against the South.B. Critical Matters to be AddressedThe present writer believes that the WTO might be able to realize parts of its visions if it changes its methodology for delivery and if, more especially, it allows developing countries, which form two-thirds of its current membership, to have a sense of ownership in the free trade agenda.

  • Table 2 – Response and Rectification Times – Offsite Category Call Type Description Initial Attendance Interim Solution (if applicable) Completion Due A Critical Matters giving rise to an immediate health and safety, business critical or security risk.

  • Subject to the authority of the JPT with respect to Critical Matters, during the Company Development Period, Company shall reasonably consult with, and consider in good faith any input provided by, Amgen regarding any material plans or decisions regarding the Company Development Activities.


More Definitions of Critical Matters

Critical Matters means: (a) [*****]; (b) [*****]; (c) [*****]; and (d) [*****].
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Critical Matters means: (i) agreement of the initial versions of each of the [***], (ii) any material updates or changes to [***], (iii) decisions that would reasonably be expected to: [***], (iv) a decision to conduct [***] and (v) any material decision with respect to [***].
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Related to Critical Matters

  • Legal Matters In the opinion of Xxxxxx Xxxxxxx, General Counsel of Prospect Administration, administrator for Prospect Capital Corporation, a Maryland corporation (the “Company”), the certificates evidencing the Notes (the “Note Certificates”) constitute the valid and binding obligations of the Company, entitled to the benefits of the Indenture and enforceable against the Company in accordance with their terms under the laws of the State of New York subject to applicable bankruptcy, insolvency and similar laws affecting creditors’ rights generally, concepts of reasonableness and equitable principles of general applicability (including, without limitation, concepts of good faith, fair dealing and the lack of bad faith), provided that such counsel expresses no opinion as to the effect of fraudulent conveyance, fraudulent transfer or similar provision of applicable law on the conclusions expressed above. This opinion is given as of the date hereof and is limited to the law of the State of New York as in effect on the date hereof. In addition, this opinion is subject to the same assumptions and qualifications stated in the letter of Skadden, Arps, Slate, Xxxxxxx & Xxxx, LLP dated March 8, 2012, filed as Exhibit (l)(5) to the Company’s registration statement on Form N-2 (File No. 333-176637) and to the further assumptions that (i) the Note Certificates have been duly authorized by all requisite corporate action on the part of the Company and duly executed by the Company under Maryland law, and (ii) they were duly authenticated by the Trustee and issued and delivered by the Company against payment therefor in accordance with the terms of the Amended and Restated Selling Agent Agreement and the Indenture. Capitalized terms used in this paragraph without definition have the meanings ascribed to them in the accompanying prospectus supplement.

  • Environmental Matters means any matter arising out of or relating to health and safety, or pollution or protection of the environment or workplace, including any of the foregoing relating to the presence, use, production, generation, handling, transport, treatment, storage, disposal, distribution, discharge, release, control or cleanup of any Hazardous Substance.

  • transitional matter means a matter that needs to be dealt with for the purpose of effecting the transition from the provisions of the Acts amended by this Act as in force before this Act comes into operation to the provisions of those Acts as in force after this Act comes into operation.

  • staff matters means the remuneration, conditions of service, promotion, conduct, suspension, dismissal or retirement of staff;

  • Environmental Matter means any past, present or future activity, event or circumstance in respect of the environment, health or safety including the Release of any Hazardous Substance including any substance which is hazardous to Persons, animals, plants, or which has a detrimental effect on the soil, air or water, or the generation, treatment, storage, use, manufacture, holding, collection, processing, treatment, presence, transportation or disposal of any Hazardous Substances.

  • Academic and professional matters means the following policy development and implementation matters:

  • Critical control point means a point, step, or procedure in a food proc- ess at which control can be applied, and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.

  • Critical Component means, in respect of a weapons system referred to in the definition of Prohibited Defense Contract, a component used specifically in the production of the weapon system or plays a direct role in the lethality of the weapon system.

  • Material Compliance Matter has the same meaning as the term defined in Rule 38a-1, and includes any compliance matter that involves: (1) a violation of the federal securities laws by Distributor (or its officers, directors, employees, or agents); (2) a violation of Distributor's Rule 38a-1 policies and procedures; or (3) a weakness in the design or implementation of Distributor's Rule 38a-1 policies and procedures.

  • Critical (C) means any equipment, medications or supplies critical for lifesaving patient care and which by its absence would jeopardize patient care.

  • Critical habitat - means the following river reaches and their 100 year floodplains: the Gunnison River downstream of the Uncompahgre River confluence, the Colorado River downstream of the exit 90 north bridge from I-70, the White River downstream of Rio Blanco Dam, the Green River downstream of the Yampa River confluence, and the Yampa River downstream of the Colo 394 bridge.

  • Critical Path means those Trade Contractor Work activities identified on the Construction Schedule which, if delayed, will cause a corresponding Delay in the Substantial Completion Date.

  • Excluded Matters has the meaning given in Section 6.3.

  • Critical group means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

  • ABS Informational and Computational Material means any written communication as defined in Item 1101(a) of Regulation AB under the 1933 Act and the 1934 Act, as may be amended from time to time.

  • Clinical experience means providing direct services to individuals with mental illness or the provision of direct geriatric services or special education services. Experience may include supervised internships, practicums, and field experience.

  • Debilitating medical condition means one or more of the following:

  • Qualifying medical condition means seizure disorder,

  • Business Critical means any function identified in any Statement of Work as Business Critical.

  • Critical Illness or “CI” means Diagnosis of any of the following Covered Conditions which occur directly as a result of illness, and first occur after the Effective Date of Insurance:

  • Pre-existing Medical Condition means any condition which:

  • Least developed country construction material means a construction material that—

  • Disclosed Matters means the actions, suits and proceedings and the environmental matters disclosed in Schedule 3.06.

  • Adverse System Impact means a negative effect that compromises the safety or reliability of the electric distribution system or materially affects the quality of electric service provided by the electric distribution company (EDC) to other customers.

  • Electronic and Information Resources Accessibility Standards means the accessibility standards for electronic and information resources contained in 1 Texas Administrative Code Chapter 213.

  • Emergency medical condition means a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) so that a prudent layperson, who possesses an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in a condition described in clause (i), (ii), or (iii) of section 1867(e)(1)(A) of the Social Security Act (42 U.S.C. 1395dd(e)(1)(A)). In that provision of the Social Security Act, clause (i) refers to placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy; clause (ii) refers to serious impairment to bodily functions; and clause (iii) refers to serious dysfunction of any bodily organ or part.