Clinical and Regulatory Activities definition

Clinical and Regulatory Activities means any clinical drug or biological development activities occurring after Development, including test method development and stability testing, toxicology, formulation, quality assurance/quality control development, statistical analysis, as needed for Clinical Trials and to obtain Regulatory Approvals, Pricing and Reimbursement Approvals and Regulatory Exclusivity.
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Clinical and Regulatory Activities means any clinical drug or biological development activities occurring after Development, including test method development and stability testing, toxicology, formulation, quality assurance/quality control
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Clinical and Regulatory Activities has the meaning set forth in Section 4.2 hereof.
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Examples of Clinical and Regulatory Activities in a sentence

  • This notification shall be accompanied by a Development Plan that includes, at a minimum, a description of the proposed Clinical and Regulatory Activities, a projected budget for the contemplated Development Work and a timeline for achieving FDA Approval.

  • With respect to each Initial Product and upon mutual agreement of the Parties with respect to the Additional Products, Flame!, or one of its Affiliates or subcontractors, will be responsible for performing all clinical studies, including any bio-equivalence studies, and for making the Regulatory Filing and obtaining approval of the Regulatory Filing (collectively, the "Clinical and Regulatory Activities").

  • To effect the transition of the Commercial Manufacturing Scale-Up Activities to Etan, Flamel, or one of its Affiliates or subcontractors, will transfer to Elan all Flamel Know How for that Product obtained in performing the Laboratory Development Activities and the Clinical and Regulatory Activities (the "Technology Transfer").

  • Without limiting the terms of Section 4.1 (iBio Diligence Obligations), iBio will be obligated to, at its sole expense, itself or through Sublicensees, use Commercially Reasonable Efforts to complete such further Development, conduct Clinical and Regulatory Activities, and obtain Marketing Approval, for at least one (1) Collaboration Product per Program in the Field in each of the Major Markets.

  • With respect to the Initial Products and upon mutual agreement of the Parties with respect to each Additional Product, Flame!, or one of its Affiliates or subcontractors, will also be responsible for scaling up such Product for commercial production, manufacturing exhibit batches for pivotal studies (conducted by Flame! as part of the Clinical and Regulatory Activities) and producing exhibit batches for stability testing (the "Commercial Manufacturing Scale-Up Activities").

  • Effective and contingent upon the applicable Option Exercise Date, iBio shall use Commercially Reasonable Efforts to (i) Develop the Selected Compounds for use in the Collaboration Product(s), (ii) Develop the Collaboration Product(s), (iii) perform Clinical and Regulatory Activities for the Collaboration Product(s), (iv) Manufacture and Commercialize the Collaboration Product(s), in each case of (i)-(v) in the Field and Territory.

  • To effect the transition of the Commercial Manufacturing Scale-Up Activities to Elan, Flamel, or one of its Affiliates or subcontractors, will transfer to Elan all Flamel Know How for that Product obtained in performing the Laboratory Development Activities and the Clinical and Regulatory Activities (the “Technology Transfer”).

  • With respect to the Initial Products and upon mutual agreement of the Parties with respect to each Additional Product, Flamel, or one of its Affiliates or subcontractors, will also be responsible for scaling up such Product for commercial production, manufacturing exhibit batches for pivotal studies (conducted by Flamel as part of the Clinical and Regulatory Activities) and producing exhibit batches for stability testing (the “Commercial Manufacturing Scale-Up Activities”).


More Definitions of Clinical and Regulatory Activities

Clinical and Regulatory Activities has the meaning set forth in Section 4.2 hereof. "Coated AP[" has the meaning set forth in Section 5.5 hereof. "Coated AP[ Agreement" has the meaning set forth in Section 5.5 hereof. "Commercial Manufacturing Scale-Up Activities" has the meaning set forth in Section 4.3 hereof. "Commercial Launch Date" means, with respect to each Product, the date of Elan's first sale of such Product to Third Parties on a commercial basis in the Territory, which date shall be no later than (i) sixty (60) days following delivery to Elan of the commercial launch quantities of the Ibuprofen Product; and (ii) sixty (60) days after FDA approval of the Regulatory Filing for the Guaifenesin Product and each Additional Product. "Competing Product" means, with respect to any Product, any extended release liquid product containing the same active pharmaceutical ingredient, in the same strength as such Product in the case of monotherapy products or the same combination of active pharmaceutical ingredients as such Product in the case of combination therapy products such that such product would reasonably be considered as substitutable for such Product. "Confidential Information" means all proprietary materials, data or other information (whether or not patentable) regarding a Person's knowhow, products, business information or objectives, that are designated as confidential in writing by the disclosing party, whether by letter or by the use of an appropriate stamp or legend, prior to or at the time any such material, data or other information is disclosed by such Person to the recipient. Notwithstanding the foregoing, materials, data or other information that are disclosed by a Person in writing without an appropriate letter, stamp or legend, or that are orally, electronically or visually disclosed by a Person, also constitute Confidential [nformation of such Person if (i) within thirty (30) calendar days after such disclosure, such Person delivers to the recipient a written document or documents describing the materials, data or other information indicating that such materials, data or other information constitute Confidential Information, and referencing the place and date of such oral, 2 CHICAGO\4542184.8 ID\SDS - I 00827\000009
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Related to Clinical and Regulatory Activities

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Development Work means the conduct of preclinical and clinical trials, the compilation of the regulatory dossier concerning Licensed Products and the conduct of other work necessary or useful for obtaining Regulatory Approval of Licensed Products.

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • 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.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Manufacturing Site means a location where a manufacturing

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Commercial cannabis activity means the production, cultivation,

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Economic activities shall in principle include activities of an industrial, commercial and professional character and activities of craftsmen;

  • Regulatory Action means an administrative, regulatory, or judicial enforcement action, proceeding, investigation or inspection, FDA Form 483 notice of inspectional observation, warning letter, untitled letter, other notice of violation letter, recall, seizure, Section 305 notice or other similar written communication, injunction or consent decree, issued by the FDA or a federal or state court.

  • Development Works means the external development works and internal development works on immovable property;

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • 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.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • licensed activities means things authorised to be done by the licence

  • Extracurricular activities means: a voluntary activity sponsored by the school or local education agency or an organization sanctioned by the local education agency. Extracurricular activities include, but are not limited to, preparation for and involvement in public performances, contests, athletic competitions, demonstrations, displays, and club activities.