Authorized Generic Sample Clauses
The Authorized Generic clause defines the terms under which a brand-name drug manufacturer permits a third party, often a generic drug company, to market a generic version of its branded product, typically under the original New Drug Application (NDA). This arrangement allows the generic to be sold without the brand name but with the same formulation, often during the period of market exclusivity or patent protection. The core function of this clause is to clarify the rights and obligations regarding the distribution and marketing of authorized generics, helping to manage competition and potentially lower drug prices while maintaining some control for the original manufacturer.
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Authorized Generic. 4.1. In the event a Third Party, without any cooperation or assistance from ▇▇▇▇, 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 ▇▇▇▇ 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 ▇▇▇▇, and as a non-exclusive authorized distributor of the Generic Product thereafter. In the event of such election and appointment by Shire, ▇▇▇▇ shall have the option, in its sole discretion, to Market AG Product or ▇▇▇▇ Product. Notwithstanding the provisions of Section 9.1, ▇▇▇▇ shall pay Shire a royalty of [*] during any period prior to the License Effective Date in which ▇▇▇▇ 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 ▇▇▇▇ 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 ▇▇▇▇ of such decision and shall afford ▇▇▇▇ the opportunity, at ▇▇▇▇’▇ discretion, to exclusively [*]. ▇▇▇▇ shall notify Shire within [*] of notice of Shire’s decision to Market such AG New Product of ▇▇▇▇’▇ decision as to whether it desires to Market the [*]. If ▇▇▇▇ so notifies Shire of its desire to Market the [*], Shire and ▇▇▇▇ 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 ▇▇▇▇ 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) 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. 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. (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.
(b) For each Fiscal Quarter during the Term of this Agreement commencing with the first Fiscal Quarter which includes TRIS’ launch of an AG Product TRIS shall calculate the Gross Margin from the sale of each AG Product in the Territory. Each such calculation shall be conducted in a manner consistent with the definition of “Net Sales” (as revised in the definition of Gross Margin) contained herein and shall be in accordance with GAAP.
(c) Within forty-five (45) calendar days (sixty (60) days in the case of the last Fiscal Quarter in a calendar year) after the last day of each Fiscal Quarter of each calendar year during the Term commencing with the Fiscal Quarter of TRIS’ launch of an AG Product, TRIS shall furnish to AYTU a written report (the “AG Quarterly Payment Report”) setting forth for such Fiscal Quarter, (i) the Net Sales of each Product (including the number of units shipped times the invoiced price per unit and the details of all deductions from gross sales to arrive at Net Sales, with Net Sales determined as in the definition of Gross Margin); (ii) the date of TRIS’ launch of such Product during such period (if applicable), (iii) the amount of the AG Product Royalty Payment to be made to AYTU, together with reasonable supporting d...
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. CONFIDENTIALITY
Authorized Generic. At the request of a Party from time to time during the Term (with respect to the Marketed Product), the Parties shall meet to discuss the possibility of partnering with a Third Party for the purpose of Distributing an Authorized Generic for sale in the Territory and agree on a plan of execution with respect to such Authorized Generic. Thereafter, in the event Kos desires to so Distribute an Authorized Generic, Kos shall notify BLS in writing of its request to Distribute an Authorized Generic in the Territory, which request shall include a forecast of Kos's demand for the Authorized Generic for the first eighteen (18) months from launch. BLS may, (i) from and after the Effective Date through ****, in BLS's sole discretion and (ii) after **** to the end of the Term (with respect to the Marketed Product), in BLS's reasonable discretion (which discretion shall not take into account the supply price financial terms), within thirty (30) Business Days of Kos's written request, notify Kos whether it agrees to grant rights to Kos to Distribute an Authorized Generic on the terms of this Agreement, mutatis, mutandis and thereafter (x) such Authorized Generic shall be included as a "Marketed Product" under this Agreement and (y) Kos hereby agrees that it shall only order Authorized Generic for Distribution in the Territory from BLS or on behalf of BLS from an Authorized Supplier.
Authorized Generic. If Kura develops, itself or through or with its Affiliate or any Third Party, an Authorized Generic which could be used in the Field in the U.S. Territory, Kura will notify KKC in writing promptly following the submission of any application to the Regulatory Authority in the U.S. Territory for such Authorized Generic. KKC shall have [***] Business Days following receipt of such notice (the “Authorized Generic Election Period”) to elect to negotiate with ▇▇▇▇ the terms of a potential commercial partnership with respect to such Authorized Generic in the Territory by providing written notice to ▇▇▇▇ (such notice, an “Authorized Generic Election Notice”). Following ▇▇▇▇’s receipt of the Authorized Generic Election Notice, Kura and KKC shall negotiate in good faith the terms for such commercial partnership for a period of [***] days (or such longer period as may be mutually agreed by the Parties) (the “Authorized Generic Negotiation Period”). If KKC does not provide Kura with an Authorized Generic Election Notice within the Authorized Generic Election Period or if the Parties do not enter into a definitive agreement with respect to such Authorized Generic prior to the expiration of the Authorized Generic Negotiation Period, [***]. For clarity, nothing in this Section 2.9 obligates either Party to enter into a definitive agreement with respect to such Authorized Generic.
Authorized Generic. (a) Lupin shall be the exclusive distributor of an Authorized Generic supplied by Plaintiff for a […***…] day period following […***…], and Plaintiff shall not sell an Original Generic during such […***…]-day period. […***…] For sales made by Lupin of Authorized Generic product during this period, Plaintiff shall receive […***…] and Lupin shall retain […***…]. Each payment by Lupin to Plaintiff shall be made in U.S. dollars within […***…] calendar days of the end of the Lupin Fiscal Quarter to which such payment relates.
(b) Upon expiration of such […***…]-day period described in Section 8(a), Lupin shall be the non-exclusive distributor of an Authorized Generic supplied by Plaintiff if, and only if, Lupin does not have approval for the Lupin ANDA or Lupin has approval for the Lupin ANDA but is unable, despite using commercially reasonable efforts, to manufacture or release Lupin Generic Product for sale. For sales of Authorized Generic product made by Lupin pursuant to this provision, Plaintiff shall receive […***…] and Lupin shall retain […***…]. Any payment by Lupin to Plaintiff made pursuant to this provision shall be made in U.S. dollars within […***…] calendar days of the end of the Lupin Fiscal Quarter to which such payment relates. Once Lupin has approval for the Lupin ANDA and is able to manufacture and release Lupin Generic Product for sale to Third Parties, its rights under this Section 8(b) shall be terminated.
(c) The parties will enter into a formal supply agreement (“Supply Agreement”) to memorialize the details of Plaintiff’s supply of and Lupin’s 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 within […***…] months of the Effective Date unless extended by mutual agreement. In the event the parties cannot agree to any of the other terms of the Supply Agreement, the “key terms” in this Section 8 shall be binding and not negotiable and the parties shall utilize binding arbitration or mediation to resolve any terms in dispute.
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.