Specific Diligence Requirements Sample Clauses

Specific Diligence Requirements. Notwithstanding the generality of Section 4.8(a), the following shall be considered, without limitation, to represent a failure of Equillium to comply with Section 4.8(a): (i) If, following Stage 2 Study Completion, Equillium fails either (A) within two (2) years to dose the first patient in a PoC Study, and/or (B) to use Commercially Reasonable Efforts to pursue clinical development of Product in at least one Indication for any continuous period greater than three (3) years (subject to extension as described below), Biocon shall have the right to terminate this Agreement in accordance with Section 10.2(b), subject to Section 10.2(c). The two-year and three-year periods in (A) and (B) above shall be extended to the extent of any delays directly attributable to events beyond the reasonable control of Equillium. By way of example and not of limitation, for purposes of this Section 4.8(b)(i), “events beyond the reasonable control of Equillium” include Biocon’s failure to supply Product in accordance with the Clinical Supply Agreement (except to the extent directly attributable to Equillium’s failure to comply with its obligations under the Clinical Supply Agreement), imposition of a clinical hold, Biocon’s failure or delay in performing its obligations under Article 4 that are a prerequisite for Equillium’s clinical development of Product, or delays in receiving required OFAC license(s). However, the foregoing two-year period in (A) and three-year period in (B) above shall not be extended by more than one (1) year in each case by reason of any and all events beyond the reasonable control of Equillium, unless, and only to the extent that, any such delay beyond three (3) years (in the case of (A)) and four (4) years (in the case of (B)) is directly attributable to Biocon’s failure to supply Product in accordance with the Clinical Supply Agreement (except to the extent directly attributable to Equillium’s failure to comply with its obligations thereunder) or Biocon’s failure or delay in performing its obligations under Article 4 that are a prerequisite for Equillium’s clinical development of Product. This Section 4.8(b)(i) and Biocon’s rights hereunder shall automatically terminate and be of no further force or effect upon First US Approval. (ii) If Equillium has not completed one PoC Study of Product in an Indication that is not an Orphan Indication by the seventh (7th) anniversary of Stage 2 Study Completion (subject to extension as described below), then the ...
Sample 1Sample 2
AutoNDA by SimpleDocs
Specific Diligence Requirements. If Anthera or its Affiliates or sublicensees do not [***] for a Licensed Product containing one of the Initial Compounds within [***] after the Effective Date, Shionogi and Lilly shall have the right to terminate Anthera’s license rights with respect to all Licensed Products containing any Initial Compound in accordance with Section 9.2(b). For example, if Anthera [***] of a Licensed Product containing RSC-3388 within [***] after the Effective Date, Anthera shall be deemed to have satisfied the foregoing diligence obligation and shall retain its license rights with respect to Licensed Products containing any of RSC-3388, S-5920/LY315920 or S-3013/LY333013. In addition, if Anthera fails to [***] for the first Licensed Product within [***] after the Effective Date, Shionogi and Lilly shall have the right to terminate this Agreement in accordance with Section 9.2(b). 4.6
Sample 1
Specific Diligence Requirements. 5.4.1. Overall Development. (a) Xxxxxx shall commence Clinical Trials for at least [*] clinical indications in the Field for NEUPREX within [*] years of the Effective Date and shall continue to conduct Clinical Trials of [*] or more Products in at least [*] clinical indications continuously thereafter for a period of at least [*] years following the Effective Date or, if earlier, until [*] or more Products have received Regulatory Approval for a total of [*] different label claims (one of which may be Meningococcemia) from either the FDA or the CEU (e.g., [*] from the FDA and [*] from the CEU). (b) In the event Xxxxxx fails to comply with its obligation in Section 5.4.1 (a) as a result of a Clinical Trial being stopped due to safety concerns, lack of efficacy or other unanticipated circumstances, XOMA Ireland may, at its option, notify Xxxxxx in writing of its intent to terminate the licenses granted to Xxxxxx under this Agreement. Xxxxxx shall have (i) [*] to develop and submit to XOMA Ireland in writing a plan (the "Clinical Plan") describing the steps Xxxxxx intends to take to cure such non-compliance, including a specific time period following submission of the Clinical Plan to XOMA Ireland for commencing one or more additional Clinical Trials and (ii) [*] to commence such Clinical Trial(s) and cure such non-compliance; provided that [*]. In the event such Clinical Trial(s) are not commenced and such compliance is not cured within the time period set forth in the Clinical Plan, the last sentence of Section 5.3 shall apply. (c) In the event Xxxxxx fails to comply with its obligation in Section 5.4.1(a) as a result of a Clinical Plan ending (that is, patient follow-up being completed) in the ordinary course of the conduct of such trial, Xxxxxx shall have a period of (i) [*] to commence the next Clinical Trial of such Product in such indication or file an IND thereby commencing, for purposes hereof, an additional Clinical Trial of a Product in another indication or (ii) [*] to file an IND thereby commencing, for purposes hereof, an additional Clinical Trial of a Product in another indication, before XOMA Ireland shall have the right to terminate the licenses granted hereunder. In the event of any such termination, the last sentence of Section 5.3 shall apply.
Sample 1Sample 2
Specific Diligence Requirements. Subject to Section 4.3, NTI shall, either on its own or through its Affiliates or Sublicensees, (a) * * * within * * * after the termination or expiration of the Research Program Term, (b) * * * within * * * after the termination or expiration of the Research Program Term, (c) * * * within * * * after the termination or expiration of the Research Program Term, and (d) * * * within * * * after the termination or expiration of the Research Program Term.
Sample 1
Specific Diligence Requirements. Licensee shall comply with the requirements set forth in Exhibit G and Exhibit H hereto, and in the event of noncompliance thereof, HGEN may, at its option pursuant to Exhibit G, terminate this Agreement pursuant to Section 13.2.
Sample 1
Specific Diligence Requirements. Pursuant to Section 6.4(c) of the Agreement, HGEN may terminate the Agreement pursuant to Section 13.2 if Licensee does not comply with any of the following requirements:
Sample 1

Related to Specific 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.

  • 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.

  • 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.

  • 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.

  • Due Diligence Review Prior to the filing of the Registration Statement the Company shall make available for inspection and review by the Investor, advisors to and representatives of the Investor, any underwriter participating in any disposition of the Registrable Securities on behalf of the Investor pursuant to the Registration Statement, any such registration statement or amendment or supplement thereto or any blue sky, NASD or other filing, all financial and other records, all SEC Documents and other filings with the SEC, and all other corporate documents and properties of the Company as may be reasonably necessary for the purpose of such review, and cause the Company's officers, directors and employees to supply all such information reasonably requested by the Investor or any such representative, advisor or underwriter in connection with such Registration Statement (including, without limitation, in response to all questions and other inquiries reasonably made or submitted by any of them), prior to and from time to time after the filing and effectiveness of the Registration Statement for the sole purpose of enabling the Investor and such representatives, advisors and underwriters and their respective accountants and attorneys to conduct initial and ongoing due diligence with respect to the Company and the accuracy of the Registration Statement.

  • Diligence Reports Company shall provide all reports with respect to its obligations under Section 3.1 as set forth in Section 5.

  • Notice Requirements A. All notices given by Xxxxxxx shall be in writing, include the Grant Agreement contract number, comply with all terms and conditions of the Grant Agreement, and be delivered to the System Agency’s Contract Representative identified above. B. Grantee shall send legal notices to System Agency at the address below and provide a copy to the System Agency’s Contract Representative: Health and Human Services Commission Attn: Office of Chief Counsel 0000 X. Xxxxxxxxx, Mail Code 1100 Austin, Texas 78751 C. Notices given by System Agency to Grantee may be emailed, mailed or sent by common carrier. Email notices shall be deemed delivered when sent by System Agency. Notices sent by mail shall be deemed delivered when deposited by the System Agency in the United States mail, postage paid, certified, return receipt requested. Notices sent by common carrier shall be deemed delivered when deposited by the System Agency with a common carrier, overnight, signature required. D. Notices given by Grantee to System Agency shall be deemed delivered when received by System Agency. E. Either Party may change its Contract Representative or Legal Notice contact by providing written notice to the other Party.

  • Specific Requirements compensation insurance with statutory limits required by South Dakota law. Coverage B-Employer’s Liability coverage of not less than $500,000 each accident, $500,000 disease-policy limit, and $500,000 disease-each employee.

  • License Requirements The Hotel’s alcoholic beverage license requires that the Hotel shall: (i) request proper identification (photo ID) of any person of questionable age and refuse alcoholic beverage service if the person is either under age or proper identification cannot be produced, and (ii) refuse alcoholic beverage service to any person who, in the Hotel’s judgment, appears to be intoxicated; and (iii) instruct its personnel to avoid encouraging patrons to consume alcoholic beverages (commonly referred to as “over-pouring”).

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!