Diligence Efforts. The Parties shall use Commercially Reasonable Efforts to execute and to perform, or cause to be performed, in a good scientific manner and in compliance with Applicable Law, the Research activities assigned to them, respectively, in each Workplan.
Diligence Efforts. 5.2.1 Intrexon shall [*****] to [*****] and following such approval, [*****] to [*****]. For purposes of this Section 5.2, [*****].
5.2.2 Neither Intrexon nor any of its Affiliates shall develop itself, or obtain a license from or otherwise collaborate with a third party to develop an Intrexon Subcutaneous Product.
5.2.3 If Intrexon permanently abandons, or permanently ceases, development, use or commercialization of, the Product in any indication within the Licensed Field, then Intrexon shall promptly deliver written notice to Halozyme of its decision therefore, and the parties shall remove such indication from the Licensed Field. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.
Diligence Efforts. Bayer, acting itself and/or through its Sublicensee, will use Commercially Reasonable Efforts to develop and commercialize [***] Project Product [***]. Bayer shall provide Recursion with annual written reports summarizing Bayer’s, its Affiliates and its Sublicensee’s development and commercialization of Licensed Project Compounds, Derivatives, and Products, including a summary of the development and commercialization activities and progress of such development. Without limiting the foregoing, such reports shall contain sufficient detail to enable Recursion to assess Bayer’s compliance with its obligations hereunder. The reports shall also contain sufficient detail to enable Recursion to assess whether Achievement of Development Candidate Criteria has occurred with respect to any Licensed Project Compound or Derivative or any Product is otherwise selected as a Development Candidate.
Diligence Efforts. 5.2.1 ViroPharma shall *** to *** and following such approval *** to ***. Subject to Section 5.2.2, ViroPharma shall satisfy the foregoing obligation by *** and to ***.
5.2.2 If, during the term of this Agreement, Halozyme determines in good faith that there exists sufficiently supported, published scientific literature that demonstrates a reasonable scientific basis for application of the ViroPharma Biologic (as it exists as of the Effective Date) for use in an indication other than HAE (an “Expanded Indication”), then it may notify ViroPharma of such Expanded Indication and include a reference to the supporting scientific literature. Within *** (***) days of receipt of such notice, ViroPharma shall determine whether (i) there is reasonable scientific basis for the Expanded Indication, (ii) administration of the Product in such Expanded Indication would be commercially viable as a subcutaneous administration and (iii) pre-clinical and clinical development, manufacturing, seeking regulatory approval and commercialization of the Product for such Expanded Indication would be commercially reasonable when the Product development, manufacturing, regulatory and commercialization strategy is taken as a whole (collectively with (i) and (ii), the “Expanded Indication Criteria”). If the Expanded Indication Criteria are satisfied, ViroPharma shall *** and, following receipt ***. If ViroPharma determines that the Expanded Indication for the Product does not satisfy the Expanded Indication Criteria, then the parties shall attempt to resolve the issue through good faith discussions. If a mutually acceptable resolution is not reached after *** (***) days, then Halozyme shall have the right to seek a declaratory judgment under this Agreement that the Expanded Indication for the Product satisfies the Expanded Indication Criteria. If (a) Halozyme receives a final, non-appealable judgment (or if such judgment is not appealed by ViroPharma within the allotted time) that the Expanded Indication for the Product satisfies the Expanded Indication Criteria and (b) ViroPharma does not commence development or regulatory activities for the Expanded Indication within *** (***) days of such final, non-appealable judgment, as Halozyme’s sole and exclusive remedy therefor, the Expanded Indication shall be automatically removed from the Licensed Field; provided however, that in the event that the foregoing clause (a) is met and ViroPharma notifies Halozyme that it intends to use commercia...
Diligence Efforts. Sublicensee hereby acknowledges the terms of Article VIII of the Merger Agreement and agrees to act, as “Buyer” thereunder, to comply, in the manner contemplated therein, with the diligence requirements contemplated thereby with respect to the Program Asset Products.
Diligence Efforts. Licensee shall (and shall require its sublicensees to) use Commercially Reasonable Efforts to, as promptly as is reasonably commercially feasible, (i) develop and commercialize one or more Licensed Products in each of the Oncology Field and the Non-Oncology Field, (ii) commence and continue preclinical studies and clinical trials of Licensed Products in each of the Oncology Field and the Non-Oncology Field in the United States and such other worldwide markets as Licensee elects to commercialize the Licensed Products, (iii) obtain such approvals as may be necessary for the sale of Licensed Products in each of the Oncology Field and the Non-Oncology Field in the United States and such other worldwide markets as Licensee elects to commercialize the Licensed Products, and (iv) fulfill market demand and achieve maximum sales of Licensed Products in each of the Oncology Field and the Non-Oncology Field in the United States and such other worldwide markets as Licensee elects to commercialize the Licensed Products. Without limiting the generality of the foregoing, Licensee shall commence and complete the following as promptly as is reasonably commercially feasible:
1. The following Phase III Clinical Trial of a Licensed Product in the Oncology Field: A multi-center Phase III Double-blind, Randomized and Controlled Clinical Trial of XL647 versus Erlotinib in subjects with non-small cell lung cancer that have progressed after first line or second line chemotherapy. The primary endpoint of this trial will be median overall survival assessed by the number of endpoints (deaths) that occur in order to give 80% power to detect an approximate 2.8 month increase in survival with 95% sensitivity. This trial will enroll all second and third line NSCLC patients, which is the group for which Erlotinib (Tarceva) was licensed in 2005 and will be a global trial carried out in both Europe and the United States.
2. A Phase II Clinical Trial of a Licensed Product in the PKD Field.
Diligence Efforts. Until the first commercial sale of the first Licensed Product, VGX will commit financial resources to the development and commercialization of Licensed Products in amounts not less that specified below (“Development Expenditures”) in each 12 month period following the Effective Date. Development Expenditures shall include all monies spent directly for development of Licensed Product by VGX, its subsidiaries, sub-licensees, business partners and independent contractors in any given year and shall be applied as a credit against due diligence fees due at the end of the year. In the event that VGX’s total Development Expenditures for Licensed Products in any such 12 month period do not meet or exceed the required minimum, then VGX will pay to Penn the amount of the shortfall. Year 1 $ 200,000 Year 2 $ 250,000 Year 3 $ 300,000 All years thereafter $ 400,000 3 FEES AND ROYALTIES
Diligence Efforts. Licensor shall have all responsibility for the filing, prosecution, protection and maintenance of the Patent Rights. Licensor shall use good faith, reasonable efforts (consistent with Licensor’s customary practices) to diligently and timely prosecute and maintain the Patent Rights in the United States, and in such other countries as are reasonably designated by Licensee, using counsel reasonably acceptable to Licensee; provided, that Licensee timely reimburses Licensor for [***]. Licensee may suspend its obligations under this Section 6.1 if Licensee fails to timely reimburse Licensor for [***].
Diligence Efforts. Licensee shall use its commercially reasonable efforts (whether alone or with or through its Affiliates) to conduct such research, development and preclinical and human clinical trials as Licensee determines are necessary or desirable to obtain regulatory approval to manufacture and market such Products and Services as Licensee determines are commercially feasible, and shall use its commercially reasonable efforts to obtain regulatory approval to market, and (upon approval) to commence marketing and market each such Product in such countries as Licensee determines are commercially feasible.
Diligence Efforts. 3.7.1 OPIANT shall use Commercially Reasonable Efforts (defined below) to obtain regulatory approval for the Product and to thereafter maximize sales of the Product in the Territory.
3.7.2 The term “Commercially Reasonable Efforts” shall mean that level of effort that a biotechnology or pharmaceutical company of comparable size, capabilities and financials would normally apply in the United States and the EU, as applicable, in pursuing the development and commercialization of a pharmaceutical product with a similar efficacy and safety profile to the Product (taking into account at all times the relevant patent, medical/scientific, technical, regulatory, development cost, market potential, or commercial profile of same), subject to intervening Regulatory Authority actions or requests, new legislation, any breach of the AEGIS’ obligations under this License Agreement and/or Supply Agreement or any other third-party action not within the reasonable control of OPIANT.
