Off Label Use. For purpose of clarity, (a) following the First Commercial Sale of an Oragenics Product, the use by direct or indirect purchasers or other users of Oragenics Products outside the Field (i.e. “off label use”) shall not constitute a breach by Oragenics of the terms of Section 3.3 or 3.4, provided that neither Oragenics nor its Affiliate (nor any Third Party under contract with either of them) marketed or promoted Oragenics Products for such off-label use; and (b) following the First 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 3.4, 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 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. 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. OVERDOSE 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. PRODUCT COMPLAINT 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. RECONCILIATION BETWEEN PV SOURCES 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. RECONCILIATION BETWEEN PARTNER AND BIOCODEX Periodic review between both parts of all pharmacovigilance cases exchanged. RISK MANAGEMENT PLAN 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. RISK MANAGEMENT SYSTEM 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. SERIOUS ADVERSE EVENT (SAE) OR ADVERSE DRUG REACTION An adverse reaction which: Results in death, Is life-threatening, 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. Requires inpatient hospitalisation or prolongation of existing hospitalisation, Results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect, Is an important medical event (an event that jeopardizes the patient or may require intervention to prevent one of the other outcomes listed above) Examples of such events are intensive...
Off Label Use. For purposes of clarity, (a) the use by direct or indirect purchasers or other users of Collaboration Products or Improved Products outside the Field (an “off label use”) shall not constitute a breach by OvaScience of the terms of Section 3.4 , provided that neither OvaScience nor its Affiliate (nor any Third Party under contract with either of them) marketed or promoted Collaboration Products or Improved 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. 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. (a) Notwithstanding anything to the contrary herein and subject to the obligations of PSIVIDA under this Agreement, the Faber Agreement, the BMP Agreement, Sections 2.1.1 and 2.1.2 of the B&L Agreement and Sections 4.1, 5.1, 5.4 and 5.8 of the Alimera Agreement, PSIVIDA shall not have the right under the PSIVIDA Technology, the PSIVIDA Patent Rights, the PSIVIDA Program Technology or the PSIVIDA Program Patent Rights to make, have made, use, sell, import or service products that (A) contain or incorporate (x) a Generic Compound that has been studied in animals pursuant to terms and conditions of the Research Plan unless such Generic Compound was the subject of prior (i.e., before such Generic Compound was studied in animals under the Research Plan) pre-clinical animal studies by PSIVIDA or (y) a PFIZER Proprietary Compound or (B) use a Device that could reasonably be used to deliver a composition of matter into the eye of a patient during an office visit through an incision smaller than that required for a 20 gauge needle. * Confidential information has been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.
Off Label Use. For purposes of clarity, (a) the use by direct or indirect purchasers or other users of Collaboration Products outside the Field (commonly referred to as “off label use”) shall not constitute a breach by Histogenics of the terms of Article 3, provided that neither Histogenics 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 Article 3, 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. **** CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. CONFIDENTIAL
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. During the Term of this Agreement, Alexza shall use Commercially Reasonable Efforts to prevent (as to itself and its Affiliates), and shall include and enforce contractual obligations on its other licensees, sublicensees and distributors of the Product to use Commercially Reasonable Efforts to prevent, any and all off-label uses of the Product or any combination product that is comprised of Loxapine and one or more other APIs delivered by the Device in the Field in the Territory. During the Term of this Agreement, BLS shall use Commercially Reasonable Efforts to prevent (as to itself and its Affiliates), and shall include and enforce contractual obligations for its Sublicensees and Distributors to use Commercially Reasonable Efforts to prevent, any and all off-label uses of the Product outside the Field or outside the Territory.
