Authorized Generic. 4.1. In the event a Third Party, without any cooperation or assistance from Xxxx, Markets a Generic Equivalent in the Territory prior to the License Effective Date, and Shire elects, in its sole discretion, to Market or have Marketed a Generic Product to compete with such Third Party prior to the License Effective Date, then Shire shall appoint Xxxx as the exclusive (even as to Shire [*]) distributor of the Generic Product for a period of at least [*] following the launch of the Generic Product by Xxxx, and as a non-exclusive authorized distributor of the Generic Product thereafter. In the event of such election and appointment by Shire, Xxxx shall have the option, in its sole discretion, to Market AG Product or Xxxx Product. Notwithstanding the provisions of Section 9.1, Xxxx shall pay Shire a royalty of [*] during any period prior to the License Effective Date in which Xxxx is exclusively authorized to Market Generic Product under this Section 4.1. However, this royalty under Section 4.1 shall be [*] if there are two or more Third Parties in addition to Xxxx Marketing a Generic Product.
Authorized Generic. (a) At any time on or after a Third Party Generic Launch with respect to a Product, TRIS shall have the right to manufacture and Market an AG Product of such Product. AYTU is not permitted to Market an AG Product of a Product. If TRIS Markets AG Products during the Term of such Product, it shall pay AYTU on a Fiscal Quarterly basis [**] of TRIS’ Gross Margin for such AG Product for such Fiscal Quarter (the “AG Product Royalty Payment”), and if Gross Margin is negative then AYTU shall pay TRIS [**] of such negative Gross Margin, as more fully set forth in this Section 6.9; provided, however, that if Gross Margin is negative for two consecutive Fiscal Quarters, AYTU may terminate this Agreement by written notice to TRIS on thirty (30) days’ notice delivered within thirty (30) days following delivery of TRIS’ second consecutive AG Quarterly Payment Report showing that AYTU owes amounts to TRIS arising from negative Gross Margin, provided however that if together with such second consecutive AG Quarterly Payment Report, TRIS sends a notice stating that AYTU will no longer be responsible for its share of negative Gross Margin for future quarters, then AYTU may not terminate this Agreement on account of negative Gross Margin.
Authorized Generic. (a) The Parties agree that Purdue and its Affiliates will have the right [***] to enter into an agreement or sublicense with one or more Affiliates or Third Parties that have experience in the commercialization of generic pharmaceutical products, in order to market, advertise, Promote, offer to sell and sell in the U.S. Territory one or more Authorized Generics.
Authorized Generic. (a) The parties agree Vintage (or one of its affiliates) has the exclusive right to manufacture and market an authorized generic version of the Product(s) from time to time after a competing product with identical active ingredients and concentrations has been approved by FDA and has been commercially offered and/or marketed by a competing company. Vintage (or its affiliate) may market an authorized generic sooner if mutually agreed upon in writing. If and when Vintage manufactures and markets an authorized generic version of the Product(s), Vintage and Cornerstone agree to divide the net profits derived from such marketing efforts [***]% due Vintage and [***]% due Cornerstone (the “Profit Split”). Net profits shall be defined as the number of pieces invoiced (and shipped), multiplied by the net dollar amount for which each piece was sold, which shall equal gross dollars, from which shall be deducted: cash discounts, contractual rebates, CMS rebates, returns, chargebacks, and the Product Price (as defined in the Manufacturing Agreement).
Authorized Generic. 4.1 At any time that is prior to the License Effective Date, Impax may elect by providing written notice to Eurand and Anesta to have Eurand supply Impax Authorized ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. Generic Product to Impax for sale in the Territory from and after the applicable License Effective Date subject to all of the terms and conditions of this Agreement. Anything in this agreement to the contrary notwithstanding, [**], Eurand will use [**] supply Impax Authorized Generic Product to Impax by the License Effective Date or as soon thereafter as is reasonably practical.
Authorized Generic. 4.1 At any time that is prior to the License Effective Date, Impax may elect by providing written notice to Eurand and Anesta to have Eurand supply Impax Authorized Generic Product to Impax for sale in the Territory from and after the applicable License Effective Date subject to all of the terms and conditions of this Agreement. Anything in this agreement to the contrary notwithstanding, Eurand has no obligation to deliver Impax Authorized Generic Product to Impax earlier than **** following Eurand’s receipt of written notice of such election from Impax, provided that in the event the License Effective Date is earlier than **** from the date of Impax’s notice, Eurand will use best efforts to supply Impax Authorized Generic Product to Impax by the License Effective Date or as soon thereafter as is reasonably practical.
Authorized Generic. 8.1 * * *.
Authorized Generic. (a) If the First Applicant has not forfeited, relinquished, or otherwise waived its 180-day exclusivity as described in 21 U.S.C. § 355(j)(5)(B)(iv) (as amended or replaced), Perrigo shall be the exclusive distributor of an Authorized Generic supplied by Plaintiffs during the 180-day exclusivity period described in 21 U.S.C. § 355(j)(5)(B)(iv) (as amended or replaced) and Plaintiffs shall not launch a product under the PENNSAID 2% NDA other than the PENNSAID 2% branded product during such 180-day period. For sales of Authorized Generic product made by Perrigo during this period, Plaintiffs shall receive […***…]% of Net Sales and Perrigo shall retain […***…]% of Net Sales. Each payment by Perrigo to Plaintiffs shall be made in U.S. dollars within […***…] calendar days of the end of the Perrigo Fiscal Quarter to which such payment relates. If the First Applicant has forfeited, relinquished, or otherwise waived its 180-day exclusivity as described in 21 U.S.C. § 355(j)(5)(B)(iv) (as amended or replaced) or, if the First Applicant has not forfeited, relinquished, or otherwise waived such exclusivity, upon expiration of such 180-day exclusivity period, Perrigo shall be the non-exclusive distributor of an Authorized Generic supplied by Plaintiffs if, and only if Perrigo does not have approval for the Paddock ANDA or Perrigo has approval for the Paddock ANDA but is unable, despite using commercially reasonable efforts, to manufacture or release Paddock Generic Product for sale. For sales of Authorized Generic product made by Perrigo pursuant to this provision, Plaintiffs shall receive […***…]% of Net Sales and Perrigo shall retain […***…]% of Net Sales. Any payment by Perrigo to Plaintiffs made pursuant to this provision shall be made in U.S. dollars within […***…] ***Confidential Treatment Requested EXECUTION VERSION calendar days of the end of the Perrigo Fiscal Quarter to which such payment relates. Once Perrigo has approval for the Paddock ANDA and is able to manufacture and release Paddock Generic Product for sale to Third Parties, its rights under this Section 7(b) shall be terminated.
Authorized Generic. During the Term, if MEI determines to Develop an Authorized Generic of the Product for the U.S., then MEI shall promptly notify KKC thereof and the Parties shall negotiate exclusively in good faith regarding a potential commercial partnership for [*CONFIDENTIAL*] following such notification.
Authorized Generic. In the event that Cadence Markets (either itself or through an Affiliate) or licenses a Third Party to Market an Authorized Generic before December 6, 2020, then Sandoz’s Entry Date shall automatically be accelerated and amended to be the date on which such Authorized Generic is first Marketed in the Territory. Cadence shall provide Sandoz with notice of any anticipated Marketing of an Authorized Generic within [***] of execution of any agreement that permits the Marketing of an Authorized Generic. (d)
