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.
4.2. [*]. Should Shire: (i) [*], (ii) Market the [*], and (iii) choose, in Shire’s sole discretion, to Market or authorize a Third Party to Market [*] then Shire agrees that it shall inform Xxxx of such decision and shall afford Xxxx the opportunity, at Xxxx’x discretion, to exclusively [*]. Xxxx shall notify Shire within [*] of notice of Shire’s decision to Market such AG New Product of Xxxx’x decision as to whether it desires to Market the [*]. If Xxxx so notifies Shire of its desire to Market the [*], Shire and Xxxx shall negotiate in good faith an agreement with respect to such [*], such agreement to be on terms similar to the terms contained in this Agreement, except that Shire and Xxxx shall share the [*] from the sale of such [*] to each Party. For purposes of clarity, Shire is under no obligation to choose to Market [*] and may do so in its sole discretion.
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 […***…] 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.
(b) The parties will enter into a formal supply agreement (“Supply Agreement”) to memorialize the details of Plaintiff’s supply of and Xxxxxxx’x distribution of the Authorized Generic. The Supply Agreement will, in addition to the preceding “key terms”, contain commercially reasonable terms and conditions. The Supply Agreement will be entered into at least […***…] months prior to the anticipated launch date of the Authorized Gen...
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.
(b) Purdue may, in its reasonable discretion after consultation with the JCC, launch or authorize the launch of any Authorized Generic in the U.S. Territory, upon either (i) [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. final FDA approval of a Generic Product or (ii) [***]. Purdue will have the right, in its sole discretion after consultation with the JCC, to terminate the distribution of any Authorized Generic at any time. Except as set forth above and subject to Purdue’s obligations to its Affiliates and Third Parties, Purdue shall provide that any right or sublicense to market, advertise, Promote, offer to sell or sell in the U.S. Territory any Authorized Generic shall apply only during such time that there is a Generic Product in the distribution and supply chain in the U.S. Territory. Purdue shall provide Transcept with written notification of a launch of an Authorized Generic by, or on the authorization of, Purdue within twenty-four (24) hours after such launch.
Authorized Generic. 4.1. At any time that is prior to the issuance of any tentative or final approval for the Impax ANDA and also prior to the License Effective Date, Impax may elect by providing written notice to Shire to have Shire supply AG 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, including Section 5 below. Anything in this agreement to the contrary notwithstanding, Shire have no obligation to deliver AG Product to Impax earlier than ninety days following Shire’s receipt of written notice of such election from Impax.
4.2. If, prior to the License Effective Date, Shire determines, in its sole discretion, to Launch an authorized generic Adderall XR product then Shire shall supply Impax with AG Product, for Marketing in the Territory. Impax shall Launch such AG Product only on or after a date chosen by Shire, in its sole discretion, and such date shall be deemed a License Effective Date solely with respect to the Authorization and License under Section 2.2.
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. CONFIDENTIALITY
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).
(b) Cornerstone shall have the right for two (2) years after any payment from the Profit Split resulting from the genericization of products (or, in the event of a dispute involving in any way those books of account and records with respect to a Profit Split, for two (2) years after the dispute is resolved), on reasonable notice to Vintage, to inspect and examine the appropriate Vintage affiliate’s books of account and records and other documents (including, without limitation, vouchers, records, purchase orders, sales orders and re-orders) relating to the Net Profit Payments to the extent necessary to verify the accuracy of the Profit Split made under this Agreement.
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.
Authorized Generic drug defined. For the purposes of this subpart, an au- thorized generic drug means any drug sold, licensed, or marketed under an NDA approved by the FDA under sec- tion 505(c) of the FFDCA; and mar- keted, sold, or distributed under a dif- ferent labeler code, product code, trade name, trademark, or packaging (other than repackaging the listed drug for use in institutions) than the brand drug.
Authorized Generic. In the event Kos obtains rights to Distribute an Authorized Generic in the Territory and Kos desires to be supplied with an Authorized Generic, Kos shall notify BPI in writing of its request to purchase supply of an Authorized Generic for Distribution in the Territory from BPI, which request shall include a forecast of Kos's demand for the Authorized Generic for the first eighteen (18) months from launch. BPI may, (i) from and after the Effective Date through the end of the Threshold Purchases Term, in BPI's sole discretion and (ii) after the end of the Threshold Purchases Term to the end of the Term, in BPI's reasonable discretion (which discretion shall not take into account the supply price financial terms, which shall be set forth in Section 5.1.2), and in each case after discussions with its Affiliates, within thirty (30) Business Days of Kos's written request, notify Kos whether it agrees to supply Kos with Product for use as an Authorized Generic on the terms of this Agreement, mutatis, mutandis (except as otherwise set forth in Section 5.1.2) and thereafter, such Authorized Generic shall be included as a "Product" under this Agreement.
