PRODUCT DECISION definition

PRODUCT DECISION means a decision ***************** ******************************************************************************** **************************************** **********************************.
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PRODUCT DECISION means a decision made [***]
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PRODUCT DECISION means a decision made by Lilly's portfolio management committee, or equivalent successor thereof, after completion of Phase II Clinical Trials that the Project Compound (or Post-Project Compound, as the case may be) tested in such trials continues to be a viable pharmaceutical candidate for the treatment of the primary indication and that, therefore, Phase III Clinical Trials on such Project Compound (or Post-Project Compound, as the case may be) are warranted. Irrespective of the decision of the portfolio management committee, or successor thereto, a Product Decision will be deemed to have been achieved should a Project Compound (or Post-Project Compound, as the case may be) enter Phase III Clinical Trials.
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More Definitions of PRODUCT DECISION

PRODUCT DECISION means a decision made at [ * ] discretion after completion of Phase II Clinical Trials that the compound tested in such trials continues to be a viable pharmaceutical candidate for the treatment of Dementia or Obesity and that, therefore, Phase III Clinical Trials on such compound for either or both of such indications are warranted.
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PRODUCT DECISION means approval of the JDC, JCC or JSC (or, if applicable, the Executive Officers pursuant to Section 13.1 or the Expert pursuant to Section 13.3) of (a) a GDP providing for the conduct of Clinical Studies, GLP tox studies or other studies intended to support an IND filing, with respect to any Licensed Compound other than the Existing Compound, or any Product other than the Existing Product, including a Product consisting of a different formulation of the Initial Compound, (b) the Manufacture of any Licensed Compound other than the Existing Compound, or any Product other than the Existing Product, for activities described in the foregoing clause (a), or (c) the Commercialization (or Manufacture for Commercialization) of any Licensed Compound other than the Existing Compound, or any Product other than the Existing Product.
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Related to PRODUCT DECISION

  • 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.

  • Adverse decision means a decision reducing,

  • key decision * means an executive decision which is likely to:

  • Adverse Drug Experience means any of: an “adverse drug experience,” a “life-threatening adverse drug experience,” a “serious adverse drug experience,” or an “unexpected adverse drug experience,” as those terms are defined at either 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80.

  • return decision means an administrative or judicial decision or act, stating or declaring the stay of a third-country national to be illegal and imposing or stating an obligation to return;

  • CPUC Decisions means CPUC Decisions 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000 and any other existing or subsequent decisions, resolutions or rulings related to resource adequacy, as may be amended from time to time by the CPUC.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Informed decision means a decision by a qualified patient, to request and obtain a prescription for medication that the qualified patient may self-administer to end his or her life in a humane and dignified manner, that is based on an appreciation of the relevant facts and after being fully informed by the attending physician of:

  • Recall means any measure aimed at achieving the return of a device that has already been made available to the end user;

  • 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;

  • 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.

  • Feedback means input regarding the SAP Products, services, business or technology plans, including, without limitation, comments or suggestions regarding the possible creation, modification, correction, improvement or enhancement of the SAP Products and/or services, or input as to whether Partner believes SAP’s development direction is consistent with their own business and IT needs.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Product Complaint means any written, verbal or electronic expression of dissatisfaction regarding the Product, including without limitation reports of actual or suspected product tampering, contamination, mislabeling or inclusion of improper ingredients.

  • Proposed decision means the presiding officer’s recommended findings of fact, conclusions of law, decision, and order in a contested case in which the administrator did not preside.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • 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.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • Technical Dispute has the meaning specified in Section 12.2;

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.

  • TO Proposal - Technical means the TO Contractor’s technical response to the CATS II TORFP dateddate of TO Proposal – Technical.

  • JPC means Joint Planning Committee.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • JCC has the meaning set forth in Section 2.1.