OFF-LABEL SALES Clause Samples

The Off-Label Sales clause restricts or regulates the sale and promotion of products for uses not approved by relevant regulatory authorities. In practice, this clause typically prohibits a party from marketing or distributing a product for any purpose other than those specifically authorized, such as selling a pharmaceutical drug for an unapproved medical condition. Its core function is to ensure compliance with legal and regulatory requirements, thereby reducing the risk of liability and protecting both parties from potential enforcement actions related to unauthorized product use.
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OFF-LABEL SALES. If Connetics exercises the option set forth in Section 4.1 then: (a) Each Party agrees and shall require its sublicensees, if any, to use commercially reasonable efforts to formulate all Licensed Protein Products developed by such Party or sublicensee thereof in a manner to reduce, to the extent reasonably practicable, the possibility that such Licensed Protein Product can be used in the other Party’s field of use as provided hereunder. If a Party cannot so formulate a particular Licensed Protein Product, then such Party agrees to use its Best Efforts to prevent sales of such Licensed Protein Product for use in the other Party’s field of use, including without limitation instructing its sales forces, and requiring all sublicensees to instruct their sales forces, that such Licensed Protein Product is not to be promoted, marketed or sold for use in the other Party’s field of use. (b) In the event that either Party determines that a Licensed Protein Product sold by a Party or its sublicensees hereunder is being used in a field of use other than one for which such Party has the right to sell such Licensed Protein Product hereunder, the Party making such determination shall immediately inform the other Party. The Parties shall then promptly meet and diligently and in good faith determine a fair and reasonable mechanism for equitable allocation of the sales of such Licensed Protein Product that are used outside the field of use for which the selling Party had the right to sell.
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OFF-LABEL SALES. Each Party (and its Affiliates) shall not knowingly promote or sell (or encourage or facilitate the sale of) any Licensed Product for use outside the approved indications for such Licensed Product, and in all cases, outside any Licensed Indication. Each Party and its Affiliates (and their respective Sublicensees) shall not provide funding to or otherwise support continuing education programs for sales representatives and/or medical professionals in which information is provided about the use of any Licensed Product for use outside the approved indications for such Licensed Product, and in all cases, outside any Licensed Indication, except in accordance with Applicable Law.
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OFF-LABEL SALES. If Connetics exercises the option set forth in Section 4.1 then: (a) Each Party agrees and shall require its sublicensees, if any, to use commercially reasonable efforts to formulate all Licensed Protein Products developed by such Party or sublicensee thereof in a manner to reduce, to the extent reasonably practicable, the possibility that such [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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OFF-LABEL SALES. If a Product of the Collaboration receives Regulatory Approval in the Royalty Territory prior to the receipt by Chiron (or its licensee or joint development partner) of Regulatory Approval in the Royalty Territory of a product containing the same Compound as the Product for an indication outside the Field, then all sales of such Product used for any indication (whether inside or outside the Field) in the Royalty Territory shall be included in the Net Sales used to calculate the royalty payable by Chiron pursuant to Section 8.1. Notwithstanding the foregoing, [CONFIDENTIAL TREATMENT REQUESTED] All sales of the Product used in any indication outside the Field (according to market reports accepted in the industry) in a country in the Royalty Territory shall be excluded for purposes of calculating the royalty payable by Chiron pursuant to Section 8.1 in such country when Chiron (or its licensee or joint development partner) receives Regulatory Approval for an indication outside the Field for such Product either in such country itself or in any country in the Major Markets, whichever occurs first.
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OFF-LABEL SALES. If Connetics exercises the option set forth in Section 4.1 then: (a) Each Party agrees and shall require its sublicensees, if any, to use commercially reasonable efforts to formulate all Licensed Protein Products developed by such Party or sublicensee thereof in a manner to reduce, to the extent reasonably practicable, the possibility that such Licensed Protein Product can be used in the other Party's field of use as provided hereunder. If a Party cannot so formulate a particular Licensed Protein Product, then such Party agrees to use its Best Efforts to prevent sales of such Licensed Protein Product for use in the other Party's field of use, including without limitation instructing its sales forces, and requiring all sublicensees to instruct their sales forces, that such Licensed Protein Product is not to be promoted, marketed or sold for use in the other Party's field of use. (b) In the event that either Party determines that a Licensed Protein Product is being used in a field of use other than for which it was intended, such Party shall immediately inform the other Party. The Parties shall then promptly meet and diligently and in good faith determine a fair and reasonable mechanism for equitable allocation of the sales of such Licensed Protein Product that are used outside the field of use for which they are intended. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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OFF-LABEL SALES. If Cara or its Affiliates Commercialize, or grant a license to Third Party to Commercialize, either (a) a Licensed Product for an Additional I.V. Indication and/or (b) a commercial product that is an oral formulation of the Compound in the United States, then the Parties shall agree in good faith on an effective mechanism to (i) seek to prevent off-label sales in each other’s respective field (for Vifor, in the Field, and for Cara (and its Affiliates and Third Party licensees), outside the Field) in the Licensed Territory of such Licensed Product and (ii) provide adequate compensation to the other Party for off-label sales in its respective field in the Licensed Territory of such Licensed Product. If such an agreement is not reached, the matter will be resolved as provided under Section 11.4. As used herein, an “Additional I.V. Indication” means a therapeutic use of an I.V. Licensed Product relating to the prevention or treatment of acute pain in hospital settings. ​ ​
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Related to OFF-LABEL SALES

  • Product Sales Subject to Sections 10.3(c) and 10.3(d), Licensee agrees that it will not sell, offer for sale, or assist third parties (including Affiliates) in selling Product except for the sale and offer for sale of (A) TAF Product, TAF Combination Product, TDF Product and TDF Combination Product for use in the Field and in the countries of the TDF-TAF Territory, (B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory, and (C) EVG Product, EVG Combination Product and Quad Product for use in the Field and in the countries of the EVG-Quad Territory.‌ (i) Licensee agrees that during the period in which the Patents are valid and enforceable (on a Product-by-Product basis) it will prohibit its Distributors from selling Product (A) to any other wholesaler or distributor, (B) outside the Territory for which Licensee is licensed for sale of such Product pursuant to Section 2.2, or (C) for any purpose outside the Field. (ii) Licensee agrees that it will not administer the TAF Quad to humans, or sell the TAF Quad until Gilead has obtained marketing approval for the TAF Quad from the FDA. Licensee agrees that it will not administer EVG to humans, or sell Products containing EVG until Gilead has obtained marketing approval for an EVG Product from the FDA. Licensee agrees that it will not administer COBI to humans, or sell Products containing COBI until Gilead has obtained marketing approval for a COBI Product from the FDA. Licensee agrees that it will not administer TAF to humans, or sell Products containing TAF until Gilead has obtained marketing approval for a TAF Product from the FDA. If Gilead obtains marketing approval from the FDA for any Quad Product or a Combination Product containing TAF, COBI or EVG (“Approved Combination Product”) prior to obtaining marketing approval for a TAF Product, EVG Product or COBI Product from the FDA, then Licensee will be allowed to administer such Quad Product or such Approved Combination Product to humans, and sell such Quad Product or such Approved Combination Product from and after the date of such marketing approval from the FDA, but will not (A) administer to humans or sell Combination Products containing EVG other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for an EVG Product, or (B) administer to humans or sell Combination Products containing COBI other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for a COBI Product or (C) administer to humans or sell Combination Products containing TAF other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for a TAF Product.

  • Gross Sales Notwithstanding anything in the Lease to the contrary the definition of Gross Sales shall be as follows:

  • Required Vendor Sales Reporting By responding to this Solicitation, you agree to report to TIPS all sales made under any awarded Agreement with TIPS. Vendor is required to report all sales under the TIPS contract to TIPS. If the TIPS Member entity requesting a price from the awarded Vendor requests the TIPS contract, Vendor must include the TIPS Contract number on any communications with the TIPS Member entity. If awarded, you will be provided access to the Vendor Portal. To report sales, login to the TIPS Vendor Portal and click on the PO’s and Payments tab. Pages 3-7 of the Vendor Portal User Guide will walk you through the process of reporting sales to TIPS. Please refer to the TIPS Accounting FAQ’s for more information about reporting sales and if you have further questions, contact the Accounting Team at ▇▇▇▇▇▇▇▇▇▇@▇▇▇▇-▇▇▇.▇▇▇. The Vendor or vendor assigned dealers are responsible for keeping record of all sales that go through the TIPS Agreement and submitting same to TIPS.

  • Net Sales The term “

  • Gross Receipts The entire amount of all receipts, determined on a cash basis, from (a) tenant rentals collected pursuant to tenant leases of apartment units, for each month during the term hereof; provided that there shall be excluded from tenant rentals any tenant security deposits (except as provided below); (b) cleaning, tenant security and damage deposits forfeited by tenants in such period; (c) laundry and vending machines income; (d) any and all other receipts from the operation of the Project received and relating to the period in question; (e) proceeds from rental interruption insurance, but not any other insurance proceeds or proceeds from third-party damage claims, and (f) any other sums and charges collected in connection with termination of the tenant leases. Gross Receipts also does not include the proceeds of (i) any sale, exchange, refinancing, condemnation, or other disposition of all or any part of the Project, (ii) any loans to Owner whether or not secured by all or any part of the Project, (iii) any capital expenditures or funds deposited to cover costs of operations made by Owner, and (iv) any insurance policy (other than rental interruption insurance or proceeds from third-party damage claims).