Clinical Development. (a) Myogen shall use Commercially Reasonable Efforts to develop the Compound in accordance with the Work Plan and not to materially deviate from the time schedule stated therein except as may be dictated by valid scientific, clinical and/or Regulatory circumstances and shall use Commercially Reasonable Efforts to maximize the commercial opportunity of the Compound and Product. Myogen may modify the Work Plan if required to adjust the Work Plan under such circumstances and will communicate such modifications to Abbott. If Myogen requires any other material xodification to the Work Plan, it will so notify Abbott within a reasonable time. Myogen shall have sole responsibility for designing, conducting and paying for the cost of the clinical development of Product and shall use Commercially Reasonable Efforts to conduct such [/\#/\] CONFIDENTIAL TREATMENT REQUESTED 10 [/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. clinical development as set forth below. Abbott hereby agrees that [/\#/\].
(b) In the event Myogen breaches a material obligation under Section 6.3(a) or 6.5(b) of this Agreement, Abbott may then advise Myogen that Abbott believes that Myogen has breached xxxx xaterial obligation and that Abbott is adversely impacted thereby. Upon so xdvising Myogen, either Party may initiate an alternative dispute resolution procedure ("ADR") as set forth in Exhibit D and request the ADR to rule upon whether Myogen has breached any such material obligation. In the event that the neutral conducting such ADR renders a ruling that Myogen has breached such material obligation and that Abbott was adversely impacted thereby, anx Xxxxen fails to comply with the terms of the neutral's ruling within the time specified therein for compliance (which in no event shall be less than ninety (90) days), or if such compliance cannot be fully achieved by such date, Myogen has failed to commence compliance and/or has failed to use diligent efforts to achieve full compliance as soon thereafter as is reasonably possible, then Abbott's sole remedy shall be the right tx xxxxxxate this Agreement and the licenses granted hereunder, and to obtain from Myogen a license to Improvements under Section 15.
Clinical Development. Licensee will have sole responsibility for and sole decision making over the clinical development of any Product arising from the Research Program in the Field. Notwithstanding the foregoing, if Licensee wishes to conduct clinical development of a Development Candidate at Penn and Penn has the clinical expertise, interest and ability to run such a trial as assessed at Penn’s sole discretion, such a study will be conducted under a separate Clinical Trial Agreement to be negotiated by the Parties prior to initiation of such study. Such separate clinical trial agreement will include a detailed clinical development plan, including costs and time lines for conducting the Clinical Trial.
Clinical Development. GSK shall be solely responsible for, and shall use Commercially Reasonable Efforts to conduct and fund [***] of the clinical development of the Compound and any Backup Compound and the development and manufacture of all Products for the Atopic Dermatitis Indication and the Psoriasis Indication in (i) the Ex-China Territory after the First Closing and (ii) if the Second Closing occurs in accordance with this Agreement, the China Territory after the Second Closing. GSK shall, not less than once every [***], provide to Welichem a written report in summary form describing the efforts, and results of its efforts, to develop the Compound in accordance with the Development Plan. Such written report shall include a summary of any material changes made to the Development Plan.
Clinical Development. Copies of the following items that are Controlled by NOVARTIS, its Affiliates or the University of Minnesota (in the case of the University of Minnesota, in NOVARTIS’ possession) in each case below, solely as they relate to the HemOnc IND and the IMD IND:
2.3.3.1. An electronic copy of the then current databases as of the Effective Date, (a) the clinical study database, (b) the safety database, and (c) the PK and biomarker database. In addition, for study 2204, Novartis will refresh the safety database annually, or on an as requested basis, in no case more frequently than on a semi-annual basis; CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
2.3.3.2. material protocols and amendments, study reports and results (including tables, figures and data);
2.3.3.3. All adverse event reports (e.g., Medwatch or equivalent forms);
2.3.3.4. Case Report Forms (CRFs) or equivalents thereof for all completed clinical studies of the Products (i.e., studies with signed-off final clinical study reports);
2.3.3.5. An electronic copy of clinical study raw data from clinical studies included in study databases;
2.3.3.6. all Trial Master Files (TMF’s) or equivalents thereof, to the extent such TMFs are in NOVARTIS’ or its Affiliates’ possession; and
2.3.3.7. To the extent any of the Documentation set forth in Sections 2.3.3.1—2.3.3.6 is in possession of the University of Minnesota as of the Effective Date, then Novartis agrees to notify the University of Minnesota of the license grant under this Agreement and will reasonably cooperate with LICENSEE to request and obtain such Documentation.
Clinical Development. Licensee will have sole responsibility for and sole decision making over the clinical development of the Licensed Products arising from the Research Program or otherwise developed by or on behalf of Licensee or any of its Sublicensees, in each case, in the Field.
Clinical Development. (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.
Clinical Development. DISTRIBUTOR shall not initiate, sponsor or support any structured data collection schemes involving any Product, including but not limited to:
(i) interventional clinical trials; and/or
(ii) non-interventional clinical studies, compassionate use/named subject use programs, or any other subject support programs.
Clinical Development. Except as disclosed in the Registration Statement and the Prospectus, none of the Company’s product candidates have received marketing approval from any Applicable Regulatory Authority. All clinical and pre-clinical studies and trials conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, with respect to the Company’s product candidates, including any such studies and trials that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”), were, and if still pending are, to the Company’s knowledge, being conducted in all material respects in accordance with all applicable Health Care Laws of the Applicable Regulatory Authorities and current Good Clinical Practices and Good Laboratory Practices, standard medical and scientific research procedures and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are being conducted; the descriptions in the Registration Statement and the Prospectus of the results of any Company Trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; the Company has no knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement and the Prospectus; the Company has not received any written notices, correspondence or other communications from the Applicable Regulatory Authorities or any other governmental entity requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement and the Prospectus, no investigational new drug application or comparable submission filed by or on behalf of the Company with the FDA has been terminated or suspended by the FDA or any other Applicable Regulatory Authority. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in a Company Trial. To the Company’s knowledge, none of...
Clinical Development. Aerogen shall use Commercially Reasonable Efforts to manufacture and supply the Device to Dance, its Affiliates, or its Commercialization Partners, at [*] if intended for use during clinical trials by Dance pursuant to Section 3.4.1 (Regulatory Approval of Device, Drug Product or Combination Product by Dance). Aerogen shall use Commercially Reasonable Efforts to provide one hundred percent (100%) of Dance’s, its Affiliates’, or its Commercialization Partners’ requirements for such clinical trials.
Clinical Development. Abbott shall exercise its Reasonable Best Efforts to pursue and shall bear the full cost and expense of the clinical development of the ABT-378, including performing all clinical studies and trials and generating all safety and toxicology data required to pursue Product Approval of the Products in the Territory. Abbott shall keep Triangle generally apprised with respect to the status of its clinical development activities. Abbott shall control all decisions regarding such clinical development activities.
