Off Label Use Sample Clauses

Off Label Use. For purpose of clarity, (a) following the Commercial Sale of a Fibrocell Product or Improved Product, the use by direct or indirect purchasers or other users of Fibrocell Products or Improved Products outside the Field (i.e. “off label use”) shall not constitute a breach by Fibrocell of the terms of Section 3.3, 3.4 or 3.5, provided that neither Fibrocell nor its Affiliate (nor any Third Party under contract with either of them) marketed or Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. promoted Fibrocell Products or Improved Products for such off-label use; and (b) following the Commercial Sale of a product by Intrexon, an Intrexon Affiliate, or a Third Party sublicensee, collaborator, or partner of Intrexon, the use by direct or indirect purchasers or other users of such products in the Field (i.e. “off label use”) shall not constitute a breach by Intrexon of the terms of Section 3.5, provided that neither Intrexon nor its Affiliate (nor any Third Party under contract with either of them) marketed or promoted such products for such off-label use.

Off Label Use. Both parties shall not in any way position and use all reasonable efforts to avoid off-label usage. Should either party identify that there is off-label usage of a Product, it shall immediately notify the other party of this usage. The party selling the Product will take all reasonable steps to minimize this off-label usage and pay the other party a royalty to compensate for lost sales. If the parties cannot agree on the amount of the royalty, both agree to submit to binding arbitration.

Off Label Use. An off-label use is any use of the product in a way that is not in accordance with the labeled directions. Please see below for examples of off-label comments that must be reported: O Life tip (?): 1 glass of wine, 2 homemade margaritas & 1 shot of @brand makes you fall asleep even faster! Goodnight fam 💫 O I drank a full bottle of @brand today and feel no different O At least I can take my near-lethal dose of @brand and go to bed at a normal time tonight. #Canes

Off Label Use. Except as provided in this Agreement, Corvas shall not, during the term of this Agreement, grant any license or sublicense to any third party to make, use, sell, offer for sale or import an HCV Activity Compound in the Territory under Corvas Patent Rights or Corvas Know-How if at the time of such grant Corvas has information from which it could reasonably be concluded that any products to be based on such HCV Activity Compound will be used for the treatment of Hepatitis C.

Off Label Use. Situations where a medicinal product is intentionally used for a medical purpose not in accordance with the authorized product information. Administration of a quantity of a medicinal product given per administration or cumulatively which is above the maximum recommended dose according to the authorized product information. Communication that contains any allegation, written, electronic or oral, expressing concern with the quality of a product that could be related to good manufacturing practice or good distribution practice. Periodic review of all sources of safety data to be sure that no potential PV case is missing. Source of data included at least quality complaint, medical inquiries and literature search. Periodic review between both parts of all pharmacovigilance cases exchanged. The risk management plan established by the marketing authorisation holder shall contain the following elements: (a) an identification or characterisation of the safety profile of the medicinal product(s) concerned; (b) an indication of how to characterise further the safety profile of the medicinal product(s) concerned; (c) a documentation of measures to prevent or minimise the risks associated with the medicinal product, including an assessment of the effectiveness of those interventions; (d) a documentation of post-authorisation obligations that have been imposed as a condition of the marketing authorization. A set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions. Note: The term "life-threatening" refers to a reaction in which the patient was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if more severe. Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; or development of drug dependency or drug abuse. Any suspected transmission via a medicinal product of an infectious agent is also considered a serious adverse reaction. All cases linked to an AE/ADR to drugs or dietary supplements, special situation, medical device incident. Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known associati...

Off Label Use. May prescribe as long as:

Off Label Use. For purposes of clarity, (a) the use by direct or indirect purchasers or other users of Collaboration Products outside the Field (an “off label use”) shall not constitute a breach by OvaXon of the terms of Section 3.4 , provided that neither OvaXon nor its Affiliate (nor any Third Party under contract with either of them) marketed or promoted Collaboration Products for such off-label use; and (b) an “off-label use by any direct or indirect purchasers or other users of products sold by Intrexon, an Intrexon Affiliate, or a Third Party sublicensee, collaborator, or partner of Intrexon shall not constitute a breach by Intrexon of the terms of Section 3.4, provided that neither Intrexon nor its Affiliate (nor any Third Party under contract with either of them) marketed or promoted such products for such off-label use.

Off Label Use. For purpose of clarity, (a) following the Commercial Sale of a BioLife Product, the use by direct or indirect purchasers or other users of BioLife Products outside the Field (i.e. “off label use”) shall not constitute a breach by BioLife of the terms of Section 3.3, 3.4 or 3.5, provided that neither BioLife nor its Affiliate (nor any Third Party under contract with either of them) marketed or promoted BioLife Products for such off-label use; and (b) following the Commercial Sale of a product by Intrexon, an Intrexon Affiliate, or a Third Party sublicensee, collaborator, or partner of Intrexon, the use by direct or indirect purchasers or other users of such products in the Field (i.e. “off label use”) shall not constitute a breach by Intrexon of the terms of Section 3.5, provided that neither Intrexon nor its Affiliate (nor any Third Party under contract with either of them) marketed or promoted such products for such off-label use.

Off Label Use. Off label use, unless We must cover the use by law or if We approve it. Oral Appliances for Snoring. Medical and surgical treatment for snoring, except when provided as a part of treatment for documented obstructive sleep apnea. Orthodontic Services. We do not provide benefits for procedures, equipment, services, supplies or charges for the following: • Monthly treatment visits that are inclusive of treatment cost; • Repair or replacement of lost/broken/stolen appliances; • Orthodontic retention/retainer as a separate service; • Retreatment and/or services for any treatment due to relapse; • Inpatient or Outpatient Hospital expenses (please refer to Your medical coverage to determine if this is a covered medical service); and • Provisional splinting, temporary procedures or interim stabilization of teeth. Orthotic Devices. We do not provide benefits for procedures, equipment, services, supplies or charges for the following: • Repair and replacement due to misuse, malicious breakage or gross neglect. • Replacement of lost or stolen items. Outdoor Treatment Camps and/or Programs and/or Wilderness Programs. Over-the-Counter. For drugs, devices, products, or supplies with over-the-counter equivalents and any drugs, devices, products, or supplies that are therapeutically comparable to an over-the-counter drug device, product, or supply, except as specified as a Covered Service in this Contract or as required by law. Personal Care, Convenience and Mobile/Wearable Devices. For personal hygiene, environmental control, or convenience items including, but not limited to: • Air conditioners, humidifiers, air purifiers; • Health club membership, and physical fitness equipment such as a treadmill or exercise cycles; charges from a physical fitness instructor or personal trainer, or any other charges for activities, equipment, or facilities used for developing or maintaining physical fitness, even if ordered by a doctor. This exclusion also applies to health spas or similar Facility. • Special exercise testing or equipment solely to evaluate exercise competency or assist in an exercise program; • Charges from a health spa or similar Facility; • Personal comfort and convenience items during an Inpatient stay, including, but not limited to, daily television rental, telephone services, cots or visitor’s meals; • Charges for non-medical self-care except as otherwise stated; • Purchase or rental of supplies for common household use, such as water purifiers; • Allergenic pill...