Product Commercialization. Par shall, in its sole discretion, determine the timing of the Commercial Launch of each Product taking into consideration the expected timing of the Regulatory Approval of such Product, availability of supply of such Product, and intellectual property and regulatory risks associated with such launch. Upon the Commercial Launch of a Product, Par will promote, market and sell such Product, from Par's Spring Valley facility or such other Par or Third Party facility as Par may elect in its sole discretion, under Par's label in a manner consistent with Par's normal practices with respect to its other generic products.
Product Commercialization. 6.3.1 Unless otherwise agreed by the parties, all production PRODUCTS purchased by AURORA from PACKARD shall be sold by PACKARD ***
6.3.2 PACKARD will have responsibility for distribution, installation, and service support for all production PRODUCTS in line with PACKARD's customary practice in territories where PACKARD has a subsidiary as of the Effective Date, or as otherwise mutually agreed. The parties agree that PACKARD shall have responsibility for such activities in Korea. *** CONFIDENTIAL TREATMENT REQUESTED
Product Commercialization. None of the Company products is subject (and none has been subject since July 2021) to any material recall, market withdrawal, removal or discontinuation (other than for commercial or other business reasons), whether such action was ordered by a Governmental Authority or undertaken voluntarily. Neither the Company nor any of its suppliers has received, nor is the Company aware of facts that could give rise to, any complaint from a third party regarding the safety, quality or labeling compliance of any Company product or any claim that the Company or one of its suppliers has adulterated, misbranded, mispackaged or mislabeled any Company product or engaged in misleading advertising for any Company product, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change.
Product Commercialization. 7 PUBLICITY.........................................................................................................7 CONFIDENTIALITY...................................................................................................7
Product Commercialization. 3.2.2.1 Within […***…] from the date of compound selection for each Selected Compound, Firmenich shall submit a Strategic Marketing Plan to the Steering Committee for Products containing such Selected Compound, which will be incorporated into the minutes of the Steering Committee; however, […***…] Firmenich will update such Strategic Marketing Plan on a […***…] basis and such updates shall be provided to the Steering Committee and incorporated into the minutes of the Steering Committee. The Strategic Marketing Plan will […***…] and neither Firmenich nor any of its Affiliates […***…] In addition, Firmenich will use reasonable commercial efforts to develop Product prototypes/formulations and present such samples to […***…] for the […***…] product categories as identified in the Strategic Marketing Plan within […***…] from the first Regulatory Approval Date for each Selected Compound. Firmenich will provide the Steering Committee with […***…] updates on such efforts.
3.2.2.2 Within […***…] from each Regulatory Approval Date for each Selected Compound […***…], Firmenich shall use reasonable commercial efforts to commence commercial sale of […***…] containing such Selected Compound […***…]. To the extent Firmenich does not commence commercial sale of […***…] containing such Selected Compound within within […***…] of such date […***…], then Senomyx may, at its sole discretion and upon […***…] advance written notice to Firmenich, terminate the rights granted to Firmenich in Section 8 or reduce the license granted to a non-exclusive license for the Territory or Fields as a whole or applicable portions, and the definitions of Territory and/or Field shall be deemed modified accordingly in respect of such Selected Compound […***…].
3.2.2.3 Within […***…] from each Regulatory Approval Date for each Selected Compound […***…], Firmenich shall use reasonable commercial efforts to commence commercial sale of […***…] containing such Selected Compound that will be incorporated into an end product of Firmenich’s customer sold […***…]. To the extent Firmenich does not commence commercial sale of …***…] containing such Selected Compound within […***…], then Senomyx may, at its sole option and upon […***…] advance written notice to Firmenich, terminate the rights granted to Firmenich in Section 8 or reduce the license granted to a non-exclusive license for the Territory or Fields as a whole or applicable portions, and the definitions of Territory and/or Field shall be deemed mo...
Product Commercialization. 3.4.1 EVL shall exercise its Commercially Reasonably Efforts to Commercialize the Product. Subject to complying with its obligations under the preceding sentence, EVL shall have the sole and exclusive right to make determinations regarding the Commercialization of the Product in the Territory, including the timing of the Commercial Launch and responsibility for all sales/marketing and promotional activities.
3.4.2 Upon the Commercial Launch, EVL (or its Affiliate) will market and sell the Product, from the EVL Facility or such other facility as EVL may elect in its sole discretion, under EVL’s (or its Affiliate’s) label in a manner consistent with EVL’s normal practices with respect to its other Drug Products.
Product Commercialization. Within [***] of the completion of the Product Development plan, Kraft will prepare a plan for Product Commercialization for approval by the Steering Committee, which will be attached as Appendix D to this Agreement, and incorporated into the Agreement by reference. Kraft will perform the Product Commercialization outlined in Appendix F.
Product Commercialization. 9.1 Unless otherwise agreed by the Parties and subject to the remainder of this Article 9.1, Evonik shall have the right to manufacture clinical and commercial supplies of Product and supply polymer materials utilized in such manufacture as set forth below. Such rights would be set forth in manufacturing and supply sections of any license and supply agreement negotiated by the Parties in good faith on reasonable commercial terms and conditions (such agreement(s), the “License and Supply Agreement(s)”), which terms and conditions shall:
(i) provide that Evonik shall manufacture commercial Product ***;
(ii) provide that Evonik shall be the exclusive manufacturer of commercial Products (“Exclusive Manufacturer”) on behalf of Customer and, subject to the rights referenced in Article 9.1 (iii) below, Customer will purchase and Evonik will supply one hundred percent (100%) of Customer’s volume for commercial Products from the Evonik Primary Site and Evonik Backup Site ***;
(iii) include rights that in the event Evonik fails to ***;
(iv) provide that Evonik shall be the exclusive manufacturer of clinical supplies of Product on behalf of Customer and Evonik will supply one hundred percent (100%) of Customer’s clinical Product requirements unless ***; and
(v) provide that Evonik shall be the exclusive manufacturer and/or supplier of all polymer materials utilized in the manufacture of Product ***,
(vi) provide Customer with timely and reasonable access to *** including any information, documents and data related thereto, to the extent necessary for the preparation of regulatory filings and correspondence with regulatory or governmental agencies. Evonik shall further provide reasonable assistance to Customer, at Customer’s expense, for such matters in a timely manner. For clarity, none of the terms above are designed to be actual language to be included in future Supply Agreement(s) and are not final language. Any and all such language is subject to further drafting and negotiation between the Parties. Furthermore, the Parties are to negotiate all of the above listed manufacturing and License and Supply Agreement(s) in good faith and in no event shall be obligated to enter into one (1) or more of the above agreements if either Party is not satisfied with the form or result of all of the agreements.
9.2 The Parties acknowledge and agree that the rights and obligations of each Party with respect to the commercialization of a Product, *** shall be set forth in a separa...
Product Commercialization. 3.2.2.1 Within […***…] from the date of compound selection for each Selected Compound, Firmenich shall submit a Strategic Marketing Plan to the Steering Committee for Products containing such Selected Compound, which will be incorporated into the minutes of the Steering Committee; however, […***…] Firmenich will update such Strategic Marketing Plan on a […***…] basis and such updates shall be provided to the Steering Committee and incorporated into the minutes of the Steering Committee. The Strategic Marketing Plan […***…] and neither Firmenich nor any of its Affiliates […***…] in the Strategic Marketing Plan will be achieved.
3.2.2.2 [RESERVED]
3.2.2.3 [RESERVED]
3.2.2.4 For the avoidance of doubt, Firmenich will be responsible for […***…].
3.2.2.5 In accordance with the efforts and resources Firmenich would use for […***…], which is […***…] as the applicable Selected Compound, Firmenich will […***…] at any time during which it has exclusive rights for such Selected Compound under this Agreement.
Product Commercialization. Sinotau shall be responsible, at its expense, for the promotion, sale and distribution of the Product in the Field and Territory, including storage, shipment, transportation, invoicing of customers and obtaining Reimbursement Approvals in the Field and Territory. Sinotau shall store and handle all Product Precursor and Product Precursor Kit in accordance with the applicable storage and handling requirements as provided by FluoroPharma and in compliance with Applicable Laws. FluoroPharma or its designated representatives may inspect Sinotau’s storage, warehouse and distribution facilities during regular business hours upon reasonable notice to ensure Sinotau’s compliance with this Section 7.2 at FluoroPharma’s expense. Sinotau shall not, and shall ensure that the CardioPET Manufacturer shall not, sell any Product with an expired shelf life and shall dispose of any Product with an expired shelf life in the manner required by FluoroPharma and in accordance with all Applicable Laws. Such disposal of expired Product shall be at Sinotau’s expense. Sinotau shall maintain, at all times, a reasonable safety stock of Product Precursor and/or Product Precursor Kit, in accordance with industry standards, in order to limit any interruption of the distribution of the Product to customers. Sinotau shall notify FluoroPharma, as promptly as possible, of any matter that is reasonably likely to materially or significantly affect sales of the Product.
