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) The Company itself or through one or more Subsidiaries or Licensees, shall use Commercially Reasonable Efforts to Develop and Commercialize the Product. Without limiting the foregoing, the Company will use Commercially Reasonable Efforts to prepare, execute, deliver and file any and all agreements, documents or instruments that are necessary or desirable to secure and maintain Marketing Authorization in the United States for the Product. The Company shall not withdraw or abandon, or fail to take any action necessary to prevent the withdrawal or abandonment of, Marketing Authorization in the United States for the Product once obtained, other than to the extent that such withdrawal is required for safety reasons or otherwise required under applicable Law. The Company shall use Commercially Reasonable Efforts, itself or through one or more Subsidiaries or Licensees, to Commercialize the Product in each jurisdiction in which Marketing Authorization is obtained.
(b) The Company shall not enter into any Material Contract related to the Product unless the Company shall have performed reasonable and customary diligence in selecting the applicable counterparty to such Material Contract and negotiating and agreeing to the terms of such Material Contract (or any amendment, modification, restatement, cancellation, supplement, termination or waiver of any of the material terms thereof). In addition, if any Material Contract related to the Product terminates for any reason whatsoever, the Company shall use Commercially Reasonable Efforts to enter into a replacement Material Contract to the extent the relevant rights under such terminated Material Contract are required for the ongoing Development and Commercialization of the Product by the Company in accordance with its express obligations set forth in Section 5.16(a).
(c) The Company shall, and shall cause its Subsidiaries to, comply with all material terms and conditions of and fulfill all material obligations under each Material Contract (including, without limitation, each License Agreement) related to the Product to which any of them is party. Upon the occurrence of a material breach of any such Material Contract by any other party thereto where such material breach has (or could reasonably likely to have) a material adverse effect on the Included Product Revenue, the Company shall provide written notice of such breach to Purchaser, describing in reasonable detail the relevant breach and use Commercially Reasona...
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. 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. 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. (a) Distributor Responsibilities. Distributor shall have the exclusive right to market, promote, sell, offer for sale, import, package and otherwise Commercialize the Product in the Field in the Territory, at its sole cost and expense, in accordance with Applicable Laws and the Commercialization Plan and subject to the terms and conditions of this Agreement. Without limiting the foregoing, Distributor will have the exclusive right and responsibility in the Field in the Territory for the following:
(i) designing the Commercialization strategy and tactics for the Product, subject to JSC approval of the Commercialization Plan;
(ii) undertaking all promotional activities for the Product; US-DOCS\105216871.19
(iii) establishing and implementing post-marketing surveillance studies for the Product in the Territory as required or recommended by a Regulatory Authority;
(iv) receiving, accepting and filling orders for the Product from customers;
(v) warehousing and distributing the Product to customers;
(vi) controlling invoicing, order processing and collection of accounts receivable for sales of the Product;
(vii) recording sales of the Product in the Territory in its books of account for sales; and
(viii) providing results of sales of the Product in the Territory for purposes of periodic safety reports and exposure estimates. Distributor shall provide updates regularly to the JSC relating to Commercialization activities for the Product in the Field in the Territory.
Commercialization of the Product. Outside the Field by Medarex. ------------------------------------------------------------- If Medarex intends to itself develop or commercialize the Product for the treatment of an autoimmune disorder outside the Field, it shall notify Centeon. In such event, Centeon may notify Medarex it wishes to negotiate an agreement regarding co-development and commercialization of the Products for such indication, and the parties shall negotiate the terms of such an agreement in good faith. If Medarex and Centeon fail to enter into a written letter of intent for such an agreement within ninety (90) days from Medarex' notice to Centeon, or such longer period as the parties may agree, then Medarex shall be free to conduct any such activities, itself or with a third party, and Centeon shall have no rights with respect thereto.
