Development and Commercialization Diligence. Xxxxxx shall use Commercially Reasonable Efforts during the Term to Develop Candidates and Commercialize Products in the Field and in the Territory. Without limiting the foregoing, Xxxxxx shall seek Regulatory Approvals for, and Commercialize, each Product in all of the Major Market Countries and in every other country in the Territory identified in the Marketing and Sales Plan. If Enanta at any time believes that Xxxxxx is not meeting its diligence obligations pursuant to this Section 4.3, Enanta may give written notice to Xxxxxx requesting written justification, in the form of detailed reasons, that would support the proposition that Xxxxxx is meeting such diligence obligations. In such event, Xxxxxx shall provide such written justification to Enanta within [*****] days after such notice is given. In the event that Enanta does not receive such justification within such [*****] day period or does not agree with such justification, then Enanta shall have the right, in its sole discretion, to pursue a declaration of breach and seek available remedies under Section 11.3.6 or any or all other rights or remedies that it may have under this Agreement, at law or in equity.
Development and Commercialization Diligence. Merck shall use reasonable efforts, consistent with the usual practice followed by Merck in pursuing the commercialization and marketing of its other pharmaceutical products of a similar commercial value, at its own expense, to develop and commercialize, itself or through Related Parties, as promptly as reasonably practicable, [***] on a commercially reasonable basis in the Major Markets and in such other countries in the Territory where in Merck's reasonable opinion it is commercially viable to do so.
(a) In the event that Merck, except as otherwise excused in accordance with Section 3.5,: (i) is not conducting development or commercialization of [***] in a Major Market in accordance with the first paragraph of this Section 3.3, or (ii) decides that it will not conduct development and commercialization of [***] in a Major Market in accordance with the first paragraph of this Section 3.3, then Merck shall provide Metabasis with prompt written notice thereof.
(b) In addition, if Metabasis in good faith believes that Merck is not meeting its development and commercialization obligations in accordance with the first paragraph of this *** Confidential Treatment Requested
Development and Commercialization Diligence. (a) Taisho shall devote the same degree of attention and diligence to the development and marketing of Products in Japan that it devotes to other compounds and products of its own development. If Taisho fails to use such diligence, Tularik may notify Taisho of such failure and the parties shall meet to discuss such matter. Tularik may request that Taisho propose a detailed plan, with a timeline, for remedying such failure and carrying out further development and marketing with the degree of diligence described above. If requested, such plan shall be submitted to Tularik within [ * ] of the date of Tularik's request. If Tularik determines that such plan provides for the degree of diligence described above, it shall approve the plan. Tularik's approval shall not be unreasonably withheld or delayed. If the plan does not provide for the degree of diligence described above, or if the plan is approved by Tularik but Taisho later fails to carry out development or marketing as provided in the approved plan, then Tularik may terminate this Agreement pursuant to Section 7.3. The requirements for diligent development and commercialization set forth in this Section 3.8 shall in no way be interpreted to modify either party's respective obligations under the Research Program.
(b) Taisho hereby agrees to keep Tularik informed on a reasonable basis of the development of each Compound, including but not limited to periodic written updates on the progress of each filing with MHW or other appropriate regulatory authorities in Japan.
(c) Notwithstanding the foregoing, any failure by Taisho to fulfill the development, commercialization and information obligations set forth in this Section 3.8 with respect to any Compound shall not be deemed a material breach of this Agreement, to the extent that [ * ].
Development and Commercialization Diligence. KHK shall exercise Commercially Reasonable Efforts to develop each Licensed Product in the Field in the Territory, using the level of resources and effort which (a) are necessary to meet the timetable set forth in the Development and Commercialization Plan applicable to such Licensed Product and (b) are at a level that is consistent with those which it would apply to a product of comparable potential resulting from its own programs. KHK will keep DICERNA reasonably informed concerning the status of its development and commercialization of each Licensed Product.
Development and Commercialization Diligence. In addition and without derogating from Section 5.1 above, Company shall use commercially reasonable efforts and shall contractually obligate its Sublicensees to use commercially reasonable efforts to: (a) develop Licensed Products based on the Licensed Technology in accordance with the Development Plan; (b) secure independent financing sufficient to perform the Development Plan, including, without limitation, meeting the Investment Milestones; (c) obtain appropriate regulatory approvals in major markets, (d) introduce Licensed Products into the commercial market; and (e) market Licensed Products following such introduction into the market. In addition, Company, by itself or through its Affiliates or Sublicensees, shall use commercially reasonable efforts to achieve each of the Development Milestones within the time periods specified in Exhibit E (or within the postponement periods pursuant to this Section 5.2 or within the remedy periods pursuant to Section 5.5). The Leading Licensor shall not withhold its consent to the postponement of Development Milestones should the Company be able to demonstrate that it is making ongoing commercially reasonable efforts to reach them and to the extent that they are caused by: (i) the requirements or decisions of a regulatory authority; (ii) force majeure; or (iii) inability or delays (from the scientific side) in being able to achieve the desired research or testing results.
Development and Commercialization Diligence. 6.1.1 After the Closing, Buyer shall be solely responsible for the development and commercialization of the Product, including the conduct of the On-Going Clinical Trials; during the Transition Period, Seller shall provide Product development services to Buyer in accordance with the Transition Services Agreement. After the Closing, Buyer shall bear all costs and expenses incurred in connection with the development and commercialization of the Product (except as expressly provided in the Transition Services Agreement), including the conduct of the On-Going Clinical Trials. Buyer shall use Diligent Efforts to develop and commercialize Products, including obtaining Regulatory Approval for at least one (1) Product, and to achieve the milestone events set forth in Section 2.3.2 [*]. Upon Seller’s reasonable request, Buyer shall inform Seller regarding the development and commercialization of the Product. Buyer’s obligations under this Section 6.1.1 shall terminate and be of no further force or effect upon the seventh (7th) anniversary of the Closing Date. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
6.1.2 If Buyer reasonably determines both that it is unlikely that any Product will receive Regulatory Approval from the FDA and that it is unlikely that any Product will receive Regulatory Approval from the EMA, then Buyer shall have the right, in its sole discretion and upon written notice to Seller, to immediately terminate the development and commercialization of all Products and PARP Development Products at any time. If such termination occurs [*], Buyer shall [*]. Seller’s obligations [*], and, notwithstanding the last sentence of [*]
Development and Commercialization Diligence. ELAN and its Affiliates shall exercise Commercially Reasonable Efforts during the Term to Develop and Commercialize the Product in the United States, Canada and the Major Countries. WARATAH and its Affiliates shall exercise Commercially Reasonable Efforts during the Term to Develop the Product.
Development and Commercialization Diligence. 3.1 Clinical Development and Commercialization of Licensed Products. INmune shall be solely responsible, at its sole cost expense, for conducting all development, manufacturing and commercialization activities for each Licensed Product in the Field, including obtaining and maintaining any Regulatory Approvals which may be necessary and appropriate for the manufacture, use, storage, import, marketing or sale of Licensed Products in the Field. INmune shall conduct all such activities in compliance in all material respects with all applicable laws, including good scientific and clinical practices under the applicable laws.
Development and Commercialization Diligence. (a) As between Gilead and Genelabs, Gilead and its Related Gilead Parties shall be solely responsible for Pre-Clinical Development, clinical development, manufacturing (except as otherwise set forth in the Research Plan), Regulatory Approval, marketing and commercialization of Products licensed to Gilead hereunder. Gilead shall, itself and/or through Related Gilead Parties, at its own expense, use Commercially Diligent Efforts to commercialize Collaboration Compound Products in the HCV Field in [each Major Market]. In the event that Gilead selects more than one Selected Compound, Gilead shall use “Commercially Diligent Efforts” to determine the appropriate number of Selected Compounds [(which may be one or more) for commercial development and the appropriate number of “backup” compounds, based on Gilead’s reasonable judgment about relevant factors (including preclinical and clinical profile, patentability, regulatory pathway, commercial value, and competition)].
Development and Commercialization Diligence. (a) As between Gilead and Genelabs, Gilead and its Related Gilead Parties shall be solely responsible for Pre-Clinical Development, clinical development, manufacturing (except as otherwise set forth in the Research Plan), Regulatory Approval, marketing and commercialization of Products licensed to Gilead hereunder. Gilead shall, itself and/or through Related Gilead Parties, at its own expense, use Commercially Diligent Efforts to commercialize Collaboration Compound Products in the HCV Field in [**]. In the event that Gilead selects more than one Selected Compound, Gilead shall use "Commercially Diligent Efforts" to determine the appropriate number of Selected Compounds [**].
(b) In the event that Gilead, except as otherwise excused in accordance with Section 3.5 irrevocably elects in writing by specific reference to this Section 3.3(b) not to use Commercially Diligent Efforts for any Collaboration Compound Products licensed to Gilead hereunder in the HCV Field in [**] in accordance with Section 3.3(a), then Gilead shall provide Genelabs with prompt written notice thereof, and all rights granted by Genelabs to Gilead under this Agreement to such Collaboration Compound Product in such [**] shall revert back to Genelabs.
(c) If Genelabs in good faith believes that Gilead is not using Commercially Diligent Efforts in accordance with Section 3.3(a) in [**] that is not otherwise excused in accordance with Section 3.5, Genelabs may provide Gilead with written notice thereof, specifying in reasonable details its reasons for its conclusions, in which event Gilead will have sixty ** CONFIDENTIAL TREATMENT REQUESTED (60) days from the date of such notice in which to respond to Genelabs that Gilead is meeting such diligence obligation. If Genelabs believes that such response does not change its view, or if Gilead does not timely respond, then Genelabs may initiate the dispute resolution process set forth in Section 11.6 to seek termination of Gilead's rights to such Collaboration Compound Product in [**].
