Commercialization of the Product Sample Clauses
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Commercialization of the Product. In the event the clinical testing set forth in Section 5 of this Agreement produces favorable results in the reasonable discretion of PathoGenesis, PathoGenesis shall use commercially reasonable efforts to obtain regulatory approval and commercialize the Products in the United States. PathoGenesis may, at its sole discretion, commercialize the Products in any other country in the Territory in accordance with PathoGenesis' other commercial obligations, if any. If any further documentation, agreement or information is necessary to facilitate PathoGenesis' commercialization of the Products in countries other than the United States, the parties agree to cooperate in good faith to effect such documentation or agreement and to provide such information.
Commercialization of the Product. (a) Each Obligor (itself or through one or more Subsidiaries or licensees) shall use Commercially Reasonable Efforts to (i) Develop and obtain Marketing Authorization for Product in the United States, and (ii) Commercialize the Product in each jurisdiction in which Marketing Authorization is obtained. Without limiting the foregoing, each Obligor will use Commercially Reasonable Efforts to prepare, execute, deliver and file any and all agreements, documents or instruments that are necessary to secure and maintain Marketing Authorization in the United States for the Product. No Obligor shall withdraw or abandon, or fail to take any action necessary to prevent the withdrawal or abandonment of, Marketing Authorization in any applicable jurisdiction for the Product once obtained, other than to the extent that such withdrawal is required for safety reasons or otherwise required under applicable Law, or where maintenance of such Marketing Authorization would not constitute Commercially Reasonable Efforts.
(b) Subject to Section 5.06(d), no Obligor shall enter into any Product Agreement unless such Obligor shall have performed reasonable and customary diligence in selecting the applicable counterparty to such Product Agreement and negotiating and agreeing to the terms of such Product Agreement (or any amendment, modification, restatement, cancellation, supplement, termination or waiver of any of the material terms thereof). In addition, if any Product Agreement that is necessary for the Product Commercialization and Development Activities terminates for
(c) Upon the occurrence of a breach of any Product Agreement by any other party thereto where such breach has (or is reasonably likely to have) a Material Adverse Effect, or Product Material Adverse Effect in the event at the time of determination, the Company or any of its Affiliates is Developing or Commercializing one or more Other Products, the Company shall use Commercially Reasonable Efforts to seek to enforce all of its (or its Subsidiary’s) rights and remedies thereunder.
Commercialization of the Product. 4.1 On the Approval Date and throughout the Term of this Agreement, DOBFAR hereby represents, covenants and agrees that it shall certify to SAGENT the following:
4.1.1 DOBFAR is, and will remain, the sponsor and sole owner of the ANDA, that such ANDA has been duly approved by the FDA, that to date DOBFAR has diligently maintained each such ANDA in full force and effect, and that DOBFAR will maintain such ANDA in full force and effect;
4.1.2 DOBFAR has obtained, and will maintain, full approval from the FDA and any other applicable Governmental Authorities permitting the manufacture of the Product and the use, marketing and sale of the Product in the Territory;
4.1.3 The Product and all intermediaries used in the manufacture thereof have been developed in accordance with their respective Specifications, in a good scientific manner, and in compliance in all material respects with all requirements of applicable laws, rules and regulations, and all other requirements of any applicable cGMP, good laboratory practice and current good clinical practice;
4.1.4 The Product has been developed in such a manner such that its manufacture and supply does not infringe, or will not infringe, the intellectual property rights of any Third Party;
4.1.5 The Product has not been recalled, suspended or discontinued as a result of any action by the FDA or any other similar foreign governmental entity, regardless of whether made or sold by DOBFAR or any licensee, distributor or marketer in the Territory or outside of the Territory;
4.1.6 DOBFAR has not received any written notice that the FDA or any other Governmental Authority has commenced, or threatened to initiate, any action to withdraw approval, place marketing or sale restrictions, or request the recall of the Product, or commenced, or threatened to initiate, any action to enjoin or place restrictions on the production, sale, marketing or reimbursement of the Product;
4.1.7 DOBFAR has not used, and will not use at any time during the term of this Agreement, in any capacity, the services of any person debarred under the U.S. Generic Drug Enforcement Act, 21 USC §335a(k)(1) and further has not used, and will not use at any time during the term of this Agreement, any person who has been convicted of a crime as defined under the U. S. Generic Drug Enforcement Act in connection with any of the services provided under this Agreement or the Supply Agreement; and
4.1.8 Performance of any of the terms and conditions of this Agreeme...
Commercialization of the Product. The Parties agree that Xxxxxx Xxxxxxx or its Sublicensee(s) will exclusively Commercialize the Product in the Territory under Xxxxxx Xxxxxxx’x commercial name and trademark. Xxxxxx Xxxxxxx will use Commercially Reasonable Efforts to launch the Product within the shortest period of time in *** after obtaining the Regulatory Approval, and in any event will launch the Product in *** no later than *** after the receipt of the Regulatory Approval and price approval or price reimbursement (if applicable) in the respective country.
Commercialization of the Product. Seller hereby agrees to use its Commercially Reasonable Efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things reasonably necessary to maximize Net Sales of the Product and Commercialize the Product.
Commercialization of the Product. 16 Section 7.01. CollaGenex's Obligations.................................16 Section 7.02. Marketing Advisory Board.................................17 Section 7.03. Co-Promotional Activities of Atrix.......................18
Commercialization of the Product. Following the receipt of a Marketing Authorization in any jurisdiction, each applicable Loan Party shall use Commercially Reasonable Efforts to Commercialize the Product in each jurisdiction in respect of which Marketing Authorization has been received.
Commercialization of the Product. Hikma has and throughout the Term of this Agreement will continue to have the expertise, resources, experience and personnel necessary to obtain Health Registration of Hikma XXXx and market, promote, distribute and sell the Product in the manner contemplated by this Agreement;
Commercialization of the Product. Seller hereby agrees to use its commercially reasonable efforts to promptly Commercialize the Product and use its commercially reasonable efforts to maximize Net Sales of the Product in a manner that would satisfy payments of the Scheduled Quarterly Amounts. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
Commercialization of the Product. Distributor shall use commercially reasonable efforts, comparable to those a similarly situated company would use for a product of comparable commercial opportunity (without reference to any competitive products of Distributor), to (1) cause the Launch Date of the Product to occur within [***] of the Effective Date; provided that the Company can deliver launch quantities of commercially viable Product to Distributor within such time period pursuant to orders placed by Distributor; and (2) sell and distribute the Product in the Territory. Distributor agrees to [***] commencing on the Launch Date for the Product and shall use commercially reasonable efforts to [***] during the first Contract Year.