Conduct of the Development Program Sample Clauses

Conduct of the Development Program. From the date hereof until the Closing Date, Aradigm shall conduct the Development Program in accordance with the Development and License Agreement in the ordinary course consistent with past practices and shall use its best efforts to preserve intact the business organizations and relationships with third parties relevant to the Development Program and to keep available the services of the Development Program Employees. Without limiting the generality of the foregoing, from the date hereof until the Closing Date, Aradigm will not: (a) with respect to the Development Program acquire a material amount of assets from, or enter into any license agreement with, any other Person; (b) sell, lease, license or otherwise dispose of any Transferred Assets except (i) pursuant to existing contracts or commitments and (ii) in the ordinary course consistent with past practices; (c) agree or commit to do any of the foregoing; or (d) (i) take or agree or commit to take any action that would make any representation or warranty of Aradigm hereunder inaccurate in any respect at, or as of any time prior to, the Closing Date or (ii) knowingly omit or agree or commit to omit to take any action reasonably necessary to prevent any such representation or warranty from being inaccurate in any respect at any such time.
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Conduct of the Development Program. With respect to each Licensed Compound, Dainippon will conduct a Development Program designed to obtain Regulatory Approval in the Territory.
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Conduct of the Development Program. 2.2.1. As between the Parties, subject to Section 2.2.2 and Section 2.2.3, unless otherwise agreed by the Parties in writing, Xxxxxxx shall be the Party conducting the Development Program. Xxxxxxx shall: (a) use Commercially Reasonable Efforts to conduct the Development Program, at its sole cost and expense, under the oversight of the JDC, in accordance with the Initial Development Plan (including the timelines set forth therein); and (b) conduct the Development Program in good scientific manner and in compliance, in all material respects, with all Applicable Law. Without limiting the foregoing, Xxxxxxx shall comply with its Sponsor Responsibilities in connection with the Xxxxxxx Study and nothing in this Agreement shall be construed to prohibit any such compliance. 2.2.2. Xxxxxxx shall consider in good faith any reasonable request by Forest that Forest or one of its Affiliates perform specified activities with respect to the Development Program. The performance of any such activities by Forest or its Affiliate would be subject to a separate agreement between Xxxxxxx and Forest (or its applicable Affiliate) governing the terms and conditions under which Forest or its Affiliate would perform such activities. 2.2.3. If, in Forest’s good faith belief, Xxxxxxx is performing the Development Program in a manner that could reasonably be expected to adversely and materially impact: (a) the timelines for the Xxxxxxx Study set forth in the Initial Development Plan; (b) the likelihood of the Xxxxxxx Study [*] as set forth in the then-current Initial Development Plan; (c) Xxxxxxx’x compliance with any Applicable Law; or (d) the [*] with respect to the Development Program, Forest may raise any such concerns through the JDC or to Xxxxxxx directly. If Xxxxxxx fails to take appropriate steps to remedy such concern within [*] days of Forest first raising such concern to the JDC or Xxxxxxx, as applicable, or such shorter period of time as is necessary to [*] in the [*] or to [*] with any [*], then Forest shall have the right, at Forest’s sole election, and without limitation to any other right or remedy available to Forest, to assume and complete some or all of the applicable activities with respect to the Development Program by notifying Xxxxxxx in writing of such election within [*] days after the end of such [*]-day (or shorter, if applicable) period (any such assumed activities specified by Forest in its notice to Xxxxxxx, the “Assumed Development Program Activities”). ...
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Conduct of the Development Program. Each of the parties shall use commercially reasonable efforts to perform its obligations under each Development Plan, including allocation of sufficient time, effort, equipment and facilities necessary to perform its obligations under such Development Plan and use of personnel with sufficient skills and experience as are required to accomplish such party's responsibilities under such Development Plan. Each party shall conduct its responsibilities under such Development Plan in good scientific manner, and in compliance in all material respects with all requirements of applicable laws, rules and regulations and all applicable good laboratory practices. Each party shall immediately notify the other in writing of any deviations by such party from applicable regulatory or legal requirements in the course of performing its responsibilities under such Development Plan. Each party hereby covenants to the other that neither such party nor any of its employees or contractors who perform any services under such Development Plan will have been debarred, or convicted of a crime for which a person can be debarred, under 21 U.S.
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Conduct of the Development Program. (a) Xxxxxxx will conduct the Development Program under the direction of the Steering Committee. Xxxxxxx shall keep the Steering Committee fully informed on a reasonable basis of the development of the Product, including but not limited to periodic written updates on the progress of each filing with a Regulatory Authority. (b) In performing the Development Program, Xxxxxxx shall devote the same degree of attention, resources and diligence to the preclinical and clinical development of the Product as it devotes to its own high priority compounds and products. In particular, Xxxxxxx undertakes to diligently conduct clinical trials and to apply for Regulatory Approval of the Product in each country of the Territory within [ * ] from the Effective Date. If Xxxxxxx has not filed an NDA or its foreign equivalent in a country of the Territory within [ * ] from the Effective Date, Xxxxxxx' option granted under Section 4.1 shall be deemed to
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Conduct of the Development Program. (a) Robexxx xxxl conduct the Development Program under the direction of the Steering Committee. Robexxx xxxll keep the Steering Committee fully informed on a reasonable basis of the development of the Product, including but not limited to periodic written updates on the progress of each filing with a Regulatory Authority. (b) In performing the Development Program, Robexxx xxxll devote the same degree of attention, resources and diligence to the preclinical and clinical development of the Product as it devotes to its own high priority compounds and products. In particular, Robexxx xxxertakes to diligently conduct clinical trials and to apply for Regulatory Approval of the Product in each country of the Territory within [ * ] from the Effective Date. If Robexxx xxx not filed an NDA or its foreign equivalent in a country of the Territory within [ * ] from the Effective Date, Robexxx' xxtion granted under Section 4.1 shall be deemed to * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
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Conduct of the Development Program 
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Related to Conduct of the Development Program

  • Development Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones) B. Estimated total development time

  • Conduct of Research Each Party will perform its Research Activities diligently and in good scientific manner, in compliance with all Applicable Laws, including cGMP, GLP, and GCP, as applicable. Each Party will devote the efforts of suitably qualified and trained employees and research assistants capable of carrying out the Research Activities set forth under the Research Plan to a professional workmanlike standard.

  • Conduct of the Study 3.1 Athenex shall act as the sponsor of the Study and shall hold the IND/CTA relating to the Study; provided, however, that in no event shall Athenex file a separate IND/CTA for the Study unless required by Regulatory Authorities to do so. If a Regulatory Authority requests a separate IND/CTA for the Study the Parties will meet and mutually agree on an approach to address such requirement. 3.2 Athenex shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP. 3.3 Athenex shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Further, Athenex shall ensure that all Regulatory Approvals from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are obtained prior to initiating performance of the Study. Athenex shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that Lilly shall have the right (but no obligation) to participate in any discussions with a Regulatory Authority, and prior review and approval of any written communications with a Regulatory Authorty, regarding matters related to the Lilly Compound. 3.4 Athenex shall maintain reports and all related documentation (paper or electronic versions as applicable) in good scientific manner and in compliance with Applicable Law. Athenex shall provide any Study information and documentation reasonably requested to enable Lilly to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, in each case, to the extent related to the Study or such the Lilly Compound, (ii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iii) to determine whether the Study has been performed by Athenex in accordance with this Agreement. 3.5 Athenex shall ensure that all patient authorizations and consents, and all consents from other data subjects, for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and any other similar Applicable Law in connection with the Study, permit the use and sharing of the Clinical Data as set forth in this Agreement, including the sharing of Clinical Data with Lilly. 3.6 All Clinical Data, including raw data and results, generated under this Agreement, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically for use in connection with the Study and related to the Lilly Compound, shall be jointly owned by Lilly and Athenex.

  • Professional Development Program (a) The parties agree to continue a Professional Development Program for the maintenance and development of the faculty members' professional competence and effectiveness. It is agreed that maintenance of currency of subject knowledge, the improvement of performance of faculty duties, and the maintenance and improvement of professional competence, including instructional skills, are the primary professional development activities of faculty members. (b) Information collected as part of this program shall be the sole property of the faculty member. This information or any judgments arising from this program shall not be used to determine non-renewal or termination of a faculty member's contract, suspension or dismissal of a faculty member, denial of advancement on the salary scale, nor affect any other administrative decisions pertaining to the promotion or employment status of the faculty member. (c) A joint advisory committee consisting of three regular faculty members who shall be elected by and are P.D. Committee Chairpersons and three administrators shall make recommendations for the operation, financing and management of the Professional Development Program.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Research Use The Requester agrees that if access is approved, (1) the PI named in the DAR and (2) those named in the “Senior/Key Person Profile” section of the DAR, including the Information Technology Director and any trainee, employee, or contractor1 working on the proposed research project under the direct oversight of these individuals, shall become Approved Users of the requested dataset(s). Research use will occur solely in connection with the approved research project described in the DAR, which includes a 1-2 paragraph description of the proposed research (i.e., a Research Use Statement). Investigators interested in using Cloud Computing for data storage and analysis must request permission to use Cloud Computing in the DAR and identify the Cloud Service Provider (CSP) or providers and/or Private Cloud System (PCS) that they propose to use. They must also submit a Cloud Computing Use Statement as part of the DAR that describes the type of service and how it will be used to carry out the proposed research as described in the Research Use Statement. If the Approved Users plan to collaborate with investigators outside the Requester, the investigators at each external site must submit an independent DAR using the same project title and Research Use Statement, and if using the cloud, Cloud Computing Use Statement. New uses of these data outside those described in the DAR will require submission of a new DAR; modifications to the research project will require submission of an amendment to this application (e.g., adding or deleting Requester Collaborators from the Requester, adding datasets to an approved project). Access to the requested dataset(s) is granted for a period of one (1) year, with the option to renew access or close-out a project at the end of that year. Submitting Investigator(s), or their collaborators, who provided the data or samples used to generate controlled-access datasets subject to the NIH GDS Policy and who have Institutional Review Board (IRB) approval and who meet any other study specific terms of access, are exempt from the limitation on the scope of the research use as defined in the DAR.

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK

  • Research Program The term “

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Research Matters By entering into this Agreement, the Placement Agent does not provide any promise, either explicitly or implicitly, of favorable or continued research coverage of the Company and the Company hereby acknowledges and agrees that the Placement Agent’s selection as a placement agent for the Offering was in no way conditioned, explicitly or implicitly, on the Placement Agent providing favorable or any research coverage of the Company. In accordance with FINRA Rule 2711(e), the parties acknowledge and agree that the Placement Agent has not directly or indirectly offered favorable research, a specific rating or a specific price target, or threatened to change research, a rating or a price target, to the Company or inducement for the receipt of business or compensation.