Initial Regular Permit definition

Initial Regular Permit means an Edwards Aquifer Authority Groundwater Withdrawal Permit issued by the Edwards Aquifer Authority under Subsection 1.16(d) of the Edwards Aquifer Authority Act.
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Examples of Initial Regular Permit in a sentence

  • In conjunction with such lease, Consenting Party hereby consents to and agrees to allow the review and copying by SAWS of any and all EAA records relating to Consenting Party and the Consenting Party’s EAA Initial Regular Permit No(s).

  • On , Lessor and Lessee entered into a Lease of Groundwater (the "Lease") of the Water Rights described below: The Water Rights consist of the Lessor’s groundwater rights and Lessor’s permit rights from the Xxxxxxx Aquifer Authority (“EAA”) to withdraw acre-feet of unrestricted Xxxxxxx Aquifer groundwater per annum, under EAA Initial Regular Permit recorded as Document No. in Volume , Page of the Official Public Records of County, Texas (the “Groundwater Withdrawal Permit”) (the “Water Rights”).

  • Lessor leases to Lessee the Lessor’s groundwater rights and Lessor’s permit rights from the Xxxxxxx Aquifer Authority (“EAA”) to withdraw acre-feet of unrestricted Xxxxxxx Aquifer groundwater per annum, under EAA Initial Regular Permit recorded as Document No. in Volume , Page of the Official Public Records of County, Texas (the “Groundwater Withdrawal Permit(s)”) (the “Water Rights”).

  • On , Lessor and Lessee entered into a Lease of Groundwater (the "Lease") of the Water Rights described below: The Water Rights consist of the Lessor’s groundwater rights and Lessor’s permit rights from the Xxxxxxx Aquifer Authority (“EAA”) to withdraw acre-feet of unrestricted Xxxxxxx Aquifer groundwater per annum, under EAA Initial Regular Permit County, Texas (the “Groundwater Withdrawal Permit”) (the “Water Rights”).

  • Lessor leases to Lessee the Lessor’s groundwater rights and Lessor’s permit rights from the Xxxxxxx Aquifer Authority (“EAA”) to withdraw acre-feet of unrestricted Xxxxxxx Aquifer groundwater per annum, under EAA Initial Regular Permit recorded as Document No. of the Official Public Records of County, Texas (the “Groundwater Withdrawal Permit(s)”) (the “Water Rights”).

Related to Initial Regular Permit

  • Title V Permit means an operating permit under Title V of the Act.

  • Title V operating permit means a permit issued under Chapter 3745-77 of the Administrative Code.

  • Required Permit means a Permit (a) issued or required under Laws applicable to the business of Borrower or any of its Subsidiaries or necessary in the manufacturing, importing, exporting, possession, ownership, warehousing, marketing, promoting, sale, labeling, furnishing, distribution or delivery of goods or services under Laws applicable to the business of Borrower or any of its Subsidiaries or any Drug Application (including without limitation, at any point in time, all licenses, approvals and permits issued by the FDA or any other applicable Governmental Authority necessary for the testing, manufacture, marketing or sale of any Product by any applicable Borrower(s) as such activities are being conducted by such Borrower with respect to such Product at such time), and (b) issued by any Person from which Borrower or any of their Subsidiaries have received an accreditation.

  • National Pollutant Discharge Elimination System Permit or “NPDES” means a permit issued by the MPCA as required by federal law for the purpose of regulating the discharge of pollutants from point sources into waters of the United States from concentrated animal feeding operations (CAFOs) as defined by federal law

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Principal Regulator means the body or person appointed as the Principal Regulator under the Charities Act 2011;

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Conditional Use Permit or “CUP” means a conditional use permit issued under this chapter.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • the principal Regulations means the Building Regulations 2010 ;

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Land use permit means a permit issued by a land use authority.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • PAL permit means the construction permit issued by the Department that establishes a Plantwide Applicability Limitation (PAL) for a major stationary source.

  • Proposed permit means the version of an Oregon Title V Operating Permit that DEQ or LRAPA proposes to issue and forwards to the Administrator for review in compliance with OAR 340-218-0230.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • General air quality operating permit or "general permit" means an air quality operating permit that meets the requirements of ARM 17.8.1222, covers multiple sources in a source category, and is issued in lieu of individual permits being issued to each source.