First Chain API Validation definition

First Chain API Validation means, with respect to a Licensed Compound, the successful Validation and release by Pharmacyclics (or its Affiliate , designated representative or Manufacturing Subcontractor) of a third batch of API of such Licensed Compound using Pharmacyclics’ independent supply chain described in Section 6.1.2(d).

Related to First Chain API Validation

  • Technology Transfer Agreement has the meaning given in Section 2.2(e).

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • Validation as used in WAC 222-20-016, means the department's agreement that a small forest landowner has correctly identified and classified resources, and satisfactorily completed a roads assessment for the geographic area described in Step 1 of a long-term application.

  • Technology Transfer has the meaning set forth in Section 5.2.

  • Medical cannabis card means the same as that term is defined in Section 26-61a-102.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Medical cannabis means the same as that term is defined in Section 26-61a-102.

  • Technology Transfer Plan will have the meaning set forth in Section 4.1.

  • IOSCO means the International Organisation of Securities Commissions.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Serialization within the enterprise identifier means each item produced is assigned a serial number that is unique among all the tangible items produced by the enterprise and is never used again. The enterprise is responsible for ensuring unique serialization within the enterprise identifier.

  • Food-chain crops means tobacco, crops grown for human consumption, and crops grown for feed for animals whose products are consumed by humans.

  • CMC means Comprehensive maintenance Contract (labour, spare and preventive maintenance)

  • Veterinarian means a veterinarian authorized by law to practice veterinary medicine in this State.

  • major non-compliance outcome notification means a notification received by a council under section 19N(3) or (4) of the Food Act 1984, or advice given to council by an authorized officer under that Act, of a deficiency that does not pose an immediate serious threat to public health but may do so if no remedial action is taken

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Autism spectrum disorders means any of the pervasive developmental disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, published by the American Psychiatric Association, including autistic disorder, Asperger's disorder and pervasive developmental disorder not otherwise specified.[PL 2011, c. 420, Pt. A, §26 (RAL).]

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Drug test means a test designed to detect the illegal use of a controlled substance.

  • Commencement of Commercial Production means the first occurrence of Commercial Production in an Area.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Health screening means the use of one or more diagnostic tools to test a person for the presence or precursors of a particular disease.

  • Autism spectrum disorder means a neuro-developmental condition typically appearing in the first three years of life that significantly affects a person's ability to communicate, understand relationships and relate to others, and is frequently associated with unusual or stereotypical rituals or behaviours.

  • Home health aide means an individual employed by a home health agency to provide home health services under the direction of a registered nurse or therapist.