Diligence; Compliance Sample Clauses

Diligence; Compliance. Each Party shall use Diligent Efforts to carry out the tasks assigned to it under the Joint Medical Affairs Plan in a timely and effective manner and in compliance with Applicable Law and applicable industry codes, including the PhRMA Code.
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Diligence; Compliance. CPP shall use Commercially Reasonable Efforts to conduct and complete the FAP Pivotal Trial and other development activities for the Products in the Territory in accordance with the applicable development plan. CPP shall comply with all applicable laws, rules, regulations and guidances in connection with its development of the Products.
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Diligence; Compliance. Each Party shall carry out the tasks assigned to it under the Medical Affairs Plans in a timely and effective manner and in compliance with Applicable Laws and applicable industry compliance standards.
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Diligence; Compliance. Esperion shall use Commercially Reasonable Efforts to undertake and complete Development for each Licensed Product, in each case pursuant to the applicable Esperion Global Development Plan for such Licensed Product (including, for clarity, pursuing Regulatory Approval of the Licensed Products in the DSE Territory). Esperion shall conduct all Development activities in good scientific manner and in compliance with applicable Law, using sufficient effort and resources, and with personnel with sufficient skills and experience and sufficient equipment to efficiently and expeditiously carry out its obligations pursuant to any such Esperion Global Development Plan. The Esperion Global Development Plan shall be updated from time-to-time to remain an accurate reflection of all planned Development activities for each Licensed Product. Any Development activities set forth in each Esperion Global Development Plan shall at all times be designed to be in compliance with all applicable Laws and in accordance with professional and ethical standards customary in the pharmaceutical industry.
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Diligence; Compliance. (a) Following the Effective Date, each Party will use Commercially Reasonable Efforts to undertake Development of Licensed Product in all indications agreed to by the Parties in each Party’s portion of the Territory in the manner contemplated in this Agreement. Without limiting the foregoing, Bayer will endeavor to file a Drug Approval Application with respect to obtaining Regulatory Approval of a first indication for Licensed Product in Europe and Canada within [ * ] after the date that Nuvelo files a Drug Approval Application in the United States for that same indication and both Parties will thereafter use Commercially Reasonable Efforts to obtain Regulatory Approval for the Licensed Product in such countries. (b) To the extent applicable, Bayer agrees to maintain all regulatory and governmental permits, licenses and approvals and to comply with all Bayer Territory Drug Laws that are applicable to its activities in each country in the Bayer Territory and the particular stage of Development of Licensed Product in such country in the Bayer Territory. In addition, to the extent applicable, Bayer will comply with good laboratory practices (“GLP”), good clinical practices (“GCP”) and good manufacturing practices (“GMP”) as these standards are defined in accordance with the applicable guidance and regulations including the International Conference of Harmonization (ICH). To the extent applicable, Nuvelo agrees to maintain all regulatory and governmental permits, licenses and approvals and to comply with all US Drug Laws that are applicable to its activities in the Nuvelo Territory and the particular stage of Development of Licensed Product in the Nuvelo Territory. In addition, to the extent applicable, Nuvelo will comply with GLP, GCP and GMP as these standards are defined in accordance with the applicable FDA rules and regulations.
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Diligence; Compliance. Subject to Section 3.3 (Subcontracting), Catalyst will perform all Catalyst Research Activities. As between the Parties, Biogen will be responsible for performing all Biogen Research Activities, at its own cost and expense. All such activities shall be performed by the applicable Party using reasonable care and skill, in accordance with all Applicable Laws, and in accordance with the Work Plan and otherwise in accordance with this Agreement. Catalyst will not perform any activities with respect to a Compound that are not set forth in the Work Plan.
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Related to Diligence; Compliance

  • Due Diligence Cooperation The Company will cooperate with any reasonable due diligence review conducted by the Agent or its representatives in connection with the transactions contemplated hereby, including, without limitation, providing information and making available documents and senior corporate officers, during regular business hours and at the Company’s principal offices, as the Agent may reasonably request.

  • Inspection; Compliance The Contractor understands its, and its subcontractors (if any), duty, pursuant to section 20.055(5), F.S., to cooperate with the Inspector General in any investigation, audit, inspection, review, or hearing. Upon request of the Department’s Inspector General, or other authorized State official, the Contractor shall provide any type of information the State official deems relevant to the Contractor’s integrity or responsibility. Such information may include the Contractor’s business or financial records, documents, or files of any type or form that refer to or relate to the Term Contract. The Contractor agrees to reimburse the State for the reasonable costs of investigation incurred by the Inspector General or other authorized State official for investigations of the Contractor’s compliance with the terms of the Term Contract or any other agreement between the Contractor and the State which results in the suspension or debarment of the Contractor. Such costs will include salaries of investigators, including overtime; travel and lodging expenses; and expert witness and documentary fees. The Contractor shall not be responsible for any costs of investigations that do not result in the Contractor’s suspension or debarment.

  • Diligence Requirements Company shall use diligent efforts or shall cause its Affiliates or Sublicensees to use diligent efforts to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates or Sublicensees shall fulfill the following obligations: (a) Within ninety (90) days after the Effective Date, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed Products. (b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year. (c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of Combination Product and Licensed Product. Specifically, Company shall: (i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”); (ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product; (iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.; and (iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement. (d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000). (e) In addition to the obligations set forth above, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored research by Company or its Affiliates or Sublicensees at the Medical School) an aggregate of not less than {***} per calendar year for the development of Combination Product and/or Licensed Product commencing with the year 2004. Company shall have the responsibility to finance its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to Company in this regard. In the event that Medical School determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School shall furnish Company with written notice of such determination. Within sixty (60) days after receipt of such notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the right, immediately upon written notice to Company, to terminate this Agreement.

  • Due Diligence Session Upon commencement of the offering of the Shares under this Agreement (and upon the recommencement of the offering of the Shares under this Agreement following the termination of a suspension of sales hereunder lasting more than 30 Trading Days), and at each Representation Date, the Company will conduct a due diligence session, in form and substance, reasonably satisfactory to the Manager, which shall include representatives of management and Accountants. The Company shall cooperate timely with any reasonable due diligence request from or review conducted by the Manager or its agents from time to time in connection with the transactions contemplated by this Agreement, including, without limitation, providing information and available documents and access to appropriate corporate officers and the Company’s agents during regular business hours, and timely furnishing or causing to be furnished such certificates, letters and opinions from the Company, its officers and its agents, as the Manager may reasonably request. The Company shall reimburse the Manager for Manager’s counsel’s fees in each such due diligence update session, up to a maximum of $2,500 per update, plus any incidental expense incurred by the Manager in connection therewith.

  • Environmental Compliance and Reports Borrower shall comply in all respects with any and all Environmental Laws; not cause or permit to exist, as a result of an intentional or unintentional action or omission on Borrower’s part or on the part of any third party, on property owned and/or occupied by Borrower, any environmental activity where damage may result to the environment, unless such environmental activity is pursuant to and in compliance with the conditions of a permit issued by the appropriate federal, state or local governmental authorities; shall furnish to Lender promptly and in any event within thirty (30) days after receipt thereof a copy of any notice, summons, lien, citation, directive, letter or other communication from any governmental agency or instrumentality concerning any intentional or unintentional action or omission on Borrower’s part in connection with any environmental activity whether or not there is damage to the environment and/or other natural resources. Additional Assurances. Make, execute and deliver to Lender such promissory notes, mortgages, deeds of trust, security agreements, assignments, financing statements, instruments, documents and other agreements as Lender or its attorneys may reasonably request to evidence and secure the Loans and to perfect all Security Interests.