General Diligence Requirements Sample Clauses

General Diligence Requirements. COMPANY shall use diligent efforts, or shall cause its AFFILIATES and SUBLICENSEES to use diligent efforts, to develop LICENSED PRODUCTS or LICENSED PROCESSES and to introduce LICENSED PRODUCTS or LICENSED PROCESSES into the commercial market; thereafter, COMPANY or its AFFILIATES or SUBLICENSEES shall make LICENSED PRODUCTS or LICENSED PROCESSES reasonably available to the public. Specifically, COMPANY or an AFFILIATE or SUBLICENSEE shall fulfill the following obligations: (i) Within six (6) months after the EFFECTIVE DATE, COMPANY shall furnish M.I.T. with a written research and development plan describing the major tasks to be achieved in order to bring to market a LICENSED PRODUCT or a LICENSED PROCESS, specifying the number of staff and other resources to be devoted to such commercialization effort. (ii) Within sixty (60) days after the end of each calendar year, COMPANY shall furnish M.I.T. with a written report (consistent with Section 5.1(a)) on the progress of its efforts during the immediately preceding calendar year to develop and commercialize LICENSED PRODUCTS or LICENSED PROCESSES. The report shall also contain a discussion of intended efforts and sales projections for the year in which the report is submitted. (iii) COMPANY shall expend (either directly or through AFFILIATES or SUBLICENSEES) at least the amounts set forth below on research toward the development of LICENSED PRODUCTS or LICENSED PROCESSES in each calendar year (pro-rated for partial years) beginning in 2013 and ending with the first commercial sale of a LICENSED PRODUCT. 2013 [**] [**] [**] [**] 2016 $1,200,000 2017 and every year thereafter $1,500,000 (iv) By the [**] anniversary of the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall [**].
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General Diligence Requirements. NTI covenants to Institute that it, either on its own or through its Affiliates or Sublicensees, shall, at its own expense, use Commercially Reasonable Efforts to develop, seek Marketing Authorization for, and commercialize at least one Product worldwide. As between the Parties, NTI shall be responsible, at its expense, for all development and manufacturing activities, for the preparation, filing, and maintenance of NDAs for Products in each country worldwide, and commercializing Products. By January 31 of each calendar year for the term of this Agreement, NTI shall provide Institute a written report of its activities in this regard during the preceding calendar year, and a summary of any such activities for the upcoming year.
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General Diligence Requirements. Anthera shall have sole responsibility for all aspects of developing, obtaining Regulatory Approval for, and commercializing Licensed Products in the Territory. Anthera, either on its own or through its Affiliates or sublicensees, shall, at its own expense, use Commercially Reasonable Efforts to undertake all Development Work necessary to obtain Regulatory Approval for [***]. Notwithstanding the foregoing, in the event that Anthera, either on its own or through its Affiliates or sublicensees, develops a particular Licensed Product for the purpose of seeking Regulatory Approval of such product as an Orphan Drug and obtains Regulatory Approval of such Licensed Product in the United States, Anthera shall have no obligation to seek Regulatory Approval for such Licensed Product in any other Major Market. In such event, Anthera shall not be deemed to have breached its obligations under this Section 4.5(a), regardless of whether Anthera is able to obtain Regulatory Approval of [***]. In addition, Anthera shall use Commercially Reasonable Efforts to promote, market, and sell Licensed Products for which Regulatory Approval has been obtained with the goal of maximizing the profit from sales of Licensed Products as early as reasonably practical and maintaining such sales for as long as commercially reasonable. Anthera will report to Lilly and Shionogi on its development progress from time to time, but no less frequently than semi-annually in order for Shionogi and Lilly to confirm the status of development of Licensed Products. If Lilly and Shionogi believe that Anthera is not using Commercially Reasonable Efforts hereunder, Lilly and Shionogi will notify Anthera in writing detailing their specific concerns and recommendations, and the Parties will discuss and agree upon what steps should be taken by Anthera in order to fulfill its obligations hereunder, including a commercially reasonable period of time for Anthera to fulfill such obligations. If the Parties cannot agree on such time period, an independent research and development organization located in the Territory with good reputation in the pharmaceutical industry selected unanimously by the Parties shall establish a commercially reasonable time period. Thereafter, Anthera shall use Commercially Reasonable Efforts to take such steps in order to fulfill its obligations within the period of time agreed to by the Parties or established by the independent research and development organization.
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Related to General Diligence Requirements

  • 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.

  • Time Requirements The Independent Contractor will not be required to follow or establish a regular or daily work schedule, but shall devote during the term of this Agreement the time, energy and skill as necessary to perform the services of this engagement and shall, periodically or at any time upon the request of the Company, submit information as to the amount of time worked and scope of work performed.

  • Notice and Evidence Requirements (a) An Employee must give at least 10 weeks written notice of the intention to take parental leave, including the proposed start and end dates. At this time, the Employee must also provide a statutory declaration stating: (i) that the Employee will become either the Primary Carer or non- Primary Carer of the Child, as appropriate; (ii) the particulars of any parental leave taken or proposed to be taken or applied for by the Employee’s Spouse; and (iii) that for the period of parental leave the Employee will not engage in any conduct inconsistent with their contract of employment. (b) At least four weeks before the intended commencement of parental leave, the Employee must confirm in writing the intended start and end dates of the parental leave, or advise the Employer of any changes to the notice provided in subclause 80.6(a) , unless it is not practicable to do so. (c) The Employer may require the Employee to provide evidence which would satisfy a reasonable person of: (i) in the case of birth-related leave, the date of birth of the Child (including without limitation, a medical certificate or certificate from a registered midwife, stating the date of birth or expected date of birth); or (ii) in the case of adoption-related leave, the commencement of the placement (or expected day of placement) of the Child and that the Child will be under 16 years of age as at the day of placement or expected day of placement. (d) An Employee will not be in breach of this clause if failure to give the stipulated notice is occasioned by the birth of the Child or placement occurring earlier than the expected date or in other compelling circumstances. In these circumstances the notice and evidence requirements of this clause should be provided as soon as reasonably practicable.

  • Insurance Requirements Vendor agrees to maintain the following minimum insurance requirements for the duration of this Agreement. All policies held by Vendor to adhere to this term shall be written by a carrier with a financial size category of VII and at least a rating of “A‐” by A.M. Best Key Rating Guide. The coverages and limits are to be considered minimum requirements and in no way limit the liability of the Vendor(s). Any immunity available to TIPS or TIPS Members shall not be used as a defense by the contractor's insurance policy. Only deductibles applicable to property damage are acceptable, unless proof of retention funds to cover said deductibles is provided. "Claims made" policies will not be accepted. Vendor’s required minimum coverage shall not be suspended, voided, cancelled, non‐renewed or reduced in coverage or in limits unless replaced by a policy that provides the minimum required coverage except after thirty (30) days prior written notice by certified mail, return receipt requested has been given to TIPS or the TIPS Member if a project or pending delivery of an order is ongoing. Upon request, certified copies of all insurance policies shall be furnished to the TIPS or the TIPS Member. Vendor agrees that when Vendor or its subcontractors are liable for any damages or claims, Vendor’s policy, shall be primary over any other valid and collectible insurance carried by the Member or TIPS.

  • Training Requirements Grantee shall: A. Authorize and require staff (including volunteers) to attend training, conferences, and meetings as directed by DSHS; B. Appropriately budget funds in order to meet training requirements in a timely manner, and ensure that staff and volunteers are trained as specified in the training requirements listed at xxxxx://xxx.xxxx.xxxxx.xxx/hivstd/training/ and as otherwise specified by DSHS. Grantee shall document that these training requirements are met; and C. Ensure that staff hired for HIV and syphilis testing are trained to perform blood draws within three (3) months of employment.

  • Coverage Requirements (08/19) Contractor shall comply with the following insurance requirements:

  • Compliance Requirements A. Nondiscrimination. The Contractor agrees to comply, and to require its subcontractor(s) to comply, with the nondiscrimination provisions of MCL 37.2209. The Contractor further agrees to comply with the provisions of Section 9:158 of Chapter 112 of the Xxx Arbor City Code and to assure that applicants are employed and that employees are treated during employment in a manner which provides equal employment opportunity.

  • Conference requirement and procedure (i) The Employer, or the Employer’s representative, shall, when requested by the Employees or their Employee Representative/ Union Delegate, confer (within a reasonable period of time which should not exceed 1/2 hour) for the purpose of determining whether or not conditions are inclement. (ii) Provided that if the Employer or the Employers’ representative refuses to confer within such reasonable period, Employees shall be entitled to cease work for the rest of the day and be paid inclement weather.

  • Quality Assurance Requirements There are no special Quality Assurance requirements under this Agreement.

  • CONTRACT COMPLIANCE REQUIREMENT The HUB requirement on this Contract is 0%. The student engagement requirement of this Contract is 0 hours. The Career Education requirement for this Contract is 0 hours. Failure to achieve these requirements may result in the application of some or all of the sanctions set forth in Administrative Policy 3.10, which is hereby incorporated by reference.

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