Development Schedule shall have the meaning set forth in Section 1.1.
Clinical categories means the groups into which hospital treatments are categorised by type, e.g., brain and nervous system, kidney and bladder, and digestive system. At the time of writing there were 38 categories in the Medicare clinical categories system.
Additional Indication means any indication other than the Initial Indication.
Supply Price has the meaning set forth in Section 6.2.
Annual Net Sales means, with respect to any Calendar Year, the aggregate amount of the Net Sales for such Calendar Year.
Real-time Prices means the Locational Marginal Prices resulting from the Office of the Interconnection’s dispatch of the PJM Interchange Energy Market in the Operating Day.
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.
Major Market Countries means the United States, Japan, England, Germany, France, Italy and Spain.
Initial Indication means the treatment of Netherton Syndrome in humans in the Territory.
Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.
Data Universal Numbering System +4 (DUNS+4) number means the DUNS number assigned by D&B plus a 4- character suffix that may be assigned by a business concern. (D&B has no affiliation with this 4-character suffix.) This 4-character suffix may be assigned at the discretion of the business concern to establish additional SAM records for identifying alternative Electronic Funds Transfer (EFT) accounts for the same parent concern.
Common Language Location Identifier (CLLI means the codes that provide a unique eleven (11) character representation of a network interconnection point. The first eight (8) characters identify the city, state and building location, while the last three (3) characters identify the network component.
Peak tube potential means the maximum value of the potential difference across the x-ray tube during an exposure.
Research Plan shall have the meaning set forth in Section 2.1.
Batch number means a unique numeric or alphanumeric identifier assigned prior to any testing to allow for inventory tracking and traceability.
Data Universal Number System (DUNS) Number means the 9-digit number assigned by Dun and Bradstreet, Inc. (D&B) to identify unique business entities.
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.
Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.
Channel migration zone (CMZ) means the area where the active channel of a stream is prone to move and this results in a potential near-term loss of riparian function and associated habitat adjacent to the stream, except as modified by a permanent levee or dike. For this purpose, near-term means the time scale required to grow a mature forest. (See board manual section 2 for descriptions and illustrations of CMZs and delineation guidelines.)
Development Milestone Payment shall have the meaning set forth in Section 9.2(a).
geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.
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.
First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.
Location Routing Number (LRN means the ten (10) digit number that is assigned to the network switching elements (Central Office–Host and Remotes as required) for the routing of calls in the network. The first six (6) digits of the LRN will be one of the assigned NPA NXX of the switching element. The purpose and functionality of the last four (4) digits of the LRN have not yet been defined but are passed across the network to the terminating switch.
Development Plan has the meaning set forth in Section 3.2.
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.