Product Shortage definition

Product Shortage means a circumstance, whether or not the result of a force majeure, in which VIVUS is unable to supply Product to Purchaser in compliance with the terms and conditions of this Agreement in the quantities sufficient to meet Purchaser’s requirements of Product as set forth in outstanding Purchase Orders and/or the Binding Forecast.
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Product Shortage means any calendar quarter in which Supplier fails to supply, for any reason except for Force Majeure, at least [ ]* of all firm orders of a Product (the "Orders") for such calendar quarter, but if and only if such Orders (i) do not exceed the most recent forecast for such calendar quarter, (ii) are no greater than the level required to fill Product prescriptions dispensed in the Territory during such calendar quarter. If, however, Supplier fills all pending and new Orders which have been placed in accordance with the terms of this Agreement during the calendar quarter immediately following the calendar quarter in which such Product Shortage occurred, Supplier shall be deemed to have remedied the Product Shortage and no change in the Net Distribution Margin percentages will occur with respect to such Product Shortage. However, the first calendar quarter for which the Parties shall apply the Product Shortage test shall be the third calendar quarter after the calendar quarter in which the Launch Date for such Product occurs.
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Product Shortage means a circumstance that is not the result of a force majeure in which Vivus is unable to supply Product to Purchaser in compliance with the terms and conditions of this Agreement in the quantities sufficient to meet Purchaser’s requirements of Product as set forth in outstanding Purchase Orders and/or the Forecast.
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Examples of Product Shortage in a sentence

  • The comment suggested that within 1 year of implementation of the final rule, FDA can assess whether overnotification has occurred and can revise the draft guidance for industry entitled "Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage" to include additional examples of products that are or are not likely to fall within the scope of products subject to the notification provision.

  • The creation of Field Management Directive (FMD) #15, Product Shortage Communication, in July 2012, established a mutual understanding of communication roles, responsibilities, and expectations involving both potential and current product shortage situations between ORA and the centers.

  • There is a marked difference in resource levels geographically with northern Africa, for example, being exposed to more than twice the level of solar energy as northern Europe; implying that for the same size panel the electrical output could be doubled in the former location.

  • An IVIG Product Shortage extenuating circumstance is when a prior- authorization/ pre-certification was obtained from the carrier for a specific IVIG product, without any approval of an alternate IVIG product, before the provider or health plan knew of or experienced any impact due to the product’s shortage.

  • A Review of FDA’s Approach to Medical Product Shortage, October 31, 2011, available athttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm275051.htm, accessed December 2011.

  • These are circumstances where the provider organization, due a recent Product Shortage, could not obtain the Physician Administered Drug or the Dosage Vial of the Physician Administered Drug that was pre-authorized for the patientNote: This extenuating circumstance is a “one-time” situation when a product shortage is discovered by the provider and continuity in patient treatment does not allow sufficient time to get an alternative drug pre-authorized by the health plan.

  • CBER’s Product Shortage Coordinator The Product Shortage Coordinator within CBER’s Office of Compliance and Biologics Quality, Immediate Office of the Director, is the primary contact for potential or actual shortages of biologics regulated by CBER.

  • A Review of FDA’s Approach to Medical Product Shortage, October 31, 2011, available at http://www.fda.gov/AboutFDA/ ReportsManualsForms/Reports/ ucm275051.htm, accessed December 2011.

  • The CBER Product Shortage Coordinator is generally in close communication with other Department of Health and Human Services agencies, including the Biomedical Advanced Research and Development Authority (BARDA)27 and the CDC.

  • Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage This guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on this topic.


More Definitions of Product Shortage

Product Shortage shall have the meaning assigned to such term in Section 8.2. 1.39 "PURCHASE ORDER" shall have the meaning assigned to such term in Section 4.3. 1.40 "QC" shall mean quality control. 1.41 "QUALITY AGREEMENT" shall have the meaning assigned to such term in Section 3.10. 1.42 "REGULATORY APPROVAL" shall mean (i) in the United States, approval by the FDA of an NDA or equivalent and satisfaction of any related applicable FDA registration and notification requirements, and (ii) any equivalent approval in any country other than the United States. 1.43 "REGULATORY AUTHORITIES" shall mean foreign counterparts of the FDA in the Territory, and other government agencies in the Territory charged with enforcing laws, rules or regulations governing the manufacture, sale and/or marketing of pharmaceuticals. 1.44 "REMAINING SHELF-LIFE" shall have the meaning assigned to such term in Section 3.4. 1.45 "REQUIRED CHANGE" shall mean any proposed changes to the Specifications or the manufacturing procedures for either API or Filled Product made by either Party that is required by any regulatory agency or law or regulation of any jurisdiction inside or outside the Territory. 1.46 "REQUIRED CHANGE COSTS" shall have the meaning assigned to such term in Section 3.2(c). 1.47 "ROLLING FORECAST" shall have the meaning assigned to such term in Section 4.2. 1.48 "SPECIFICATIONS" shall mean API Specifications, Filled Product Specifications and Packaging Specifications. 1.49 "TERM" shall mean the term of this Supply Agreement as specified in Section 11.1. 1.50 "TRANSFER PRICE" shall have the meaning assigned to such term in Section 7.1(a). * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION 5 <Page> ARTICLE 2 SUPPLY; PLANNING 2.1.
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Product Shortage means a circumstance that is not the result of a force majeure in which SWI is unable to supply Product to Purchaser in compliance with the terms and conditions of this Agreement in the quantities sufficient to meet Purchaser’s requirements of Product as set forth in outstanding Purchase Orders and/or the Binding Forecast.
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Product Shortage. A Product Shortage shall mean the occurrence of any of the following events at any time during which Dyax is Manufacturing Drug Substance for Cubist in accordance with Section 6.2:
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Product Shortage shall have the meaning assigned to such term in Section 8.2.
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Product Shortage has the meaning set forth in Section 6.9.
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Related to Product Shortage

  • Shortage means that a grain dealer does not have a sufficient amount of farm produce by class and quality to cover the grain dealer's outstanding warehouse receipt obligations for that farm produce.

  • Product Backlog means a list of those Stories that do not form part of the current Sprint Plan at that time and which are to form the subject of a future Sprint, either in the current Release at that time or a subsequent Release;

  • fuel supplier means an entity supplying fuel to the market that is responsible for passing fuel through an excise duty point or, in the case of electricity or where no excise is due or where duly justified, any other relevant entity designated by a Member State;

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Routine Patient Costs means all health care services that are otherwise covered under the Group Contract for the treatment of cancer or other Life-threatening Condition that is typically covered for a patient who is not enrolled in an Approved Clinical Trial.

  • Special food product means a food product that is all of the following:

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Product Group or “the Group” means a group of lotteries that has joined together to offer a product pursuant to the terms of the Multi-State Lottery Agreement and the Product Group’s own rules.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Defective Product has the meaning set forth in Section 5.2.

  • Raw material means any unprocessed material in its raw or natural state that is intended to become part of the components of a cannabis product.

  • Material Suppliers has the meaning set forth in Section 3.15(b).

  • Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

  • Manufacturing Site means a location where a manufacturing

  • Routine patient care costs means Covered Medical Expenses which are typically provided absent a clinical trial and not otherwise excluded under the Policy. Routine patient care costs do not include:

  • Special form radioactive material means radioactive material that satisfies the following conditions:

  • Material Supplier has the meaning set forth in Section 3.20.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

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

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Clinical Supply Agreement shall have the meaning set forth in Section 7.2.

  • Tobacco products means cigars, cigarettes, cheroots, stogies, periques, granulated, plug cut, crimp cut, ready rubbed, and other smoking tobacco, snuff, snuff flour, moist snuff, cavendish, ping and twist tobacco, fine-cut and other chewing tobaccos, shorts, refuse scraps, clippings, cuttings and sweepings of tobacco, and other kinds and forms of tobacco, prepared in such manner as to be suitable for chewing or smoking in a pipe or otherwise, or both for chewing and smoking.

  • Distillery manufacturing license means a license issued in accordance with

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • Manufacturing Cost means [***].