Clinical Trial Completion Sample Clauses

Clinical Trial Completion. Upon termination of the Agreement in its entirety or with respect to a TAK-385 Licensed Compound in the Men’s Health Field for any reason listed in this Section 13.9.2 (Certain Termination Events) other than pursuant to Section 13.4 (Termination for Safety Reasons), if such termination occurs prior to receipt of the first Regulatory Approval of a TAK-385 Licensed Compound in the Men’s Health Field in Japan, then Licensee must either (A) reimburse Takeda for Takeda’s out of pocket costs and expenses directly incurred in connection with Takeda’s completion of the TAK-385 Development Plan in the Men’s Health Field, up to a maximum total reimbursement of seventy million dollars ($70,000,000) (such amount, the “Reimbursed Expenses”); provided that if Licensee validly terminates this Agreement pursuant to Section 13.5 (Termination for Commercial Viability), then Takeda will pay to Licensee an [***] royalty on Net Sales of the applicable Terminated Product, up to a maximum total amount equal to the Reimbursed Expenses or (B) complete the conduct of any Clinical Trials of the TAK-385 Licensed Products in the Men’s Health Field that are ongoing as of the effective date of such termination as set forth in the then-current TAK-385 Development Plan, at its cost and expense. If Takeda undertakes to complete the TAK-385 Development Plan pursuant to clause (A) above, then Takeda will invoice Licensee following the end of each Calendar Quarter for the costs and expenses incurred by Takeda during such Calendar Quarter, and will provide supporting documentation as reasonably requested by Licensee. Licensee will have the right to audit Takeda’s records relating to such costs and expenses in accordance with Section 9.6 (Audit). [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
Sample 1
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Clinical Trial Completion. Upon termination of the Agreement in its entirety or with respect to a TAK-385 Licensed Compound in the Men’s Health Field for any reason listed in this Section 13.9.2 (Certain Termination Events) other than pursuant to Section 13.4 (Termination for Safety Reasons), if such termination occurs prior to receipt of the first Regulatory Approval of a TAK-385 Licensed Compound in the Men’s Health Field in Japan, then Licensee must either (A) [***] (such amount, the “Reimbursed Expenses”); provided that if Licensee validly terminates this Agreement pursuant to Section 13.5 ([***] or (B) [***]. If Takeda undertakes [***]. [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
Sample 1

Related to Clinical Trial Completion

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company 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.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • Project Completion Within five (5) days after the delivery by Supplier to Purchaser of a Commissioning Certificate for the Project’s final Turbine, Supplier shall also deliver to Purchaser a completion certificate for all Turbines in the Project (the “Project Completion Certificate”), in the form attached hereto as Exhibit N, together with a list of any remaining Punch List Work on any Turbine, a schedule for completing the Punch List Work and an estimate of the cost of each item of Punch List Work. Supplier shall thereafter promptly complete all Punch List Work.

  • Feasibility Study Buyer is granted the right to conduct engineering and/or market and economic feasibility studies of the Property and a physical inspection of the Property, including studies or inspections to determine the existence of any environmental hazards or conditions (collectively, the “Feasibility Study”) during the period (the “Feasibility Period”) commencing on the Effective Date and ending at 5:00 p.m., Central Time, on the June 3, 2010. With Seller’s permission, after Seller has received advance notice sufficient to permit it to schedule in an orderly manner Buyer’s examination of the Property and to provide at least 24-hours’ advance written notice to any affected tenants, Buyer or its designated agents may enter upon the Property during normal business hours for purposes of analysis or other tests and inspections which may be deemed necessary by Buyer for the Feasibility Study. Buyer or its designated representative must be accompanied by a designated representative of Seller or have received Seller’s written permission prior to entering upon the Property in connection with Buyer’s Feasibility Study; provided, however, Buyer may not enter into any space leased by any tenant without being accompanied by a designated representative of Seller. Seller agrees to make its representative reasonably available during normal business hours. Buyer will not alter the physical condition of the Property or conduct invasive testing without notifying Seller of its requested tests, and obtaining the written consent of Seller to any physical alteration of the Property or invasive testing. Buyer will utilize commercially reasonable diligence to conduct or cause to be conducted all inspections and tests in a manner and at times which will not unreasonably interfere with any tenant’s use and occupancy of the Property. If Buyer determines, in its sole judgment, that the Property is not suitable for any reason for Buyer’s intended use or purpose, or is not in satisfactory condition, then Buyer may terminate this Contract by written notice to Seller prior to expiration of the Feasibility Period, in which case the Xxxxxxx Money (other than the Option Money) will be returned to Buyer, and neither party shall have any further right or obligation hereunder other than as set forth herein with respect to rights or obligations which survive termination. If this Contract is not terminated pursuant to this Section 5(a), then after expiration of the Feasibility Period, after Seller has received advance notice sufficient to permit it to schedule in an orderly manner Buyer’s examination of the Property and to provide at least 24-hours’ advance written notice to any affected tenants, Buyer or its designated agents may enter upon the Property during normal business hours. Buyer or its designated representative must be accompanied by a designated representative of Seller or have received Seller’s written permission prior to entering upon the Property; provided, however, Buyer may not enter into any space leased by any tenant without being accompanied by a designated representative of Seller. If this Contract is not timely terminated pursuant to this Section 5(a), Buyer’s right to terminate this Contract pursuant to this Section 5(a) and any and all objections with respect to the Feasibility Study will be deemed to have been waived by Buyer for all purposes.

  • Development Milestones Subject to the terms and conditions of this Agreement, no later than [**] following the first occurrence of each event described below (each, a “Development Milestone”), on Product-by-Product basis Moderna shall pay Carisma the non-refundable and non-creditable amounts set forth below for each Product to achieve such event (each, a “Development Milestone Payment”): ​ Development MilestoneDevelopment Milestone Payment (in US$ millions) [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] ​ Moderna shall provide written notice to Carisma of the achievement of each Development Milestone within [**] after such achievement. If a Development Milestone for a Product is achieved without the preceding Development Milestone(s) having been achieved for such Product, then the Development Milestone Payment for such preceding Development Milestone(s) shall be paid by Moderna to Carisma together with ​ ​ the Development Milestone Payment for the Development Milestone that was achieved. For example, if the [**] Development Milestone [**] in the table above is achieved for a Product but the [**] Development Milestone [**] in the table above had not been achieved for such Product, then Moderna would pay the Development Milestone Payment for both such [**] Development Milestone and [**] Development Milestone upon achievement of the [**] Development Milestone. Each of the Development Milestone Payments set forth above shall be payable one time only per Product. If Moderna or its Affiliates or Sublicensees Develops a Product that has achieved at least one Development Milestone and subsequently discontinues Development of such Product and Develops a different Product incorporating or directed to the same combination of Collaboration Targets (whether one Collaboration Target or multiple Collaboration Targets), then Moderna shall be required to pay Development Milestone Payments for such different Product only for Development Milestones that had not been achieved by such discontinued Product.

  • Substantial Completion The Tenant Improvements shall be deemed to be “Substantially Completed” on the date that (i) the Tenant Improvements are essentially and satisfactorily completed in accordance with the Final Plans to the extent that the Leased Premises may be occupied by Tenant for its Approved Use, subject only to completion of minor finishing, adjustment of equipment, and other minor construction aspects (“punch list items”) which do not, in the aggregate, cause interference (other than minor inconvenience) with the use and occupancy of the Leased Premises for the Approved Use, and (ii) a certificate of occupancy, whether conditional or final, has been issued by the proper governmental authority. Landlord shall give Tenant at least 30 days prior notice (written or oral) of Landlord’s reasonable estimate of the date of Substantial Completion of the Tenant Improvements. Tenant shall schedule with Landlord a mutually acceptable date, which will not be later than 3 business days after the date of Substantial Completion (but in no event earlier than the Landlord’s estimated date of Substantial Completion), for a walk-through inspection of the Leased Premises. In such walk-through, Landlord and Tenant will mutually and reasonably agree upon a punch list, and subject to Tenant Delay, Landlord will use reasonable efforts to cause such punch list work to be completed within 30 days after such walk-through. Landlord hereby warrants to Tenant, which warranty shall survive for one year following the date of Substantial Completion of the Tenant Improvements, that (a) the materials and equipment furnished by Landlord and Landlord’s contractors in the completion of the Tenant Improvements will be of good quality and new, and (b) such materials and equipment and the work of such contractors shall be free from defects not inherent in the quality required or permitted hereunder. This warranty shall exclude damages or defects caused by Tenant, its agents, employees or contractors, improper or insufficient maintenance, improper operation or normal wear and tear under normal usage. Landlord shall use diligent and good faith efforts to cause the Tenant Improvements for the Fifth Floor Premises to be Substantially Completed by November 1, 2018. Subject only to Force Majeure (as defined in §11 hereof) and Tenant Delay, and provided that Landlord, using good faith efforts, obtains all required construction permits for the Tenant Improvements (the “Construction Permits”) by not later than June 30, 2018, then in the event that Landlord fails to cause the Tenant Improvements for the Fifth Floor Premises to be Substantially Completed on or before December 1, 2018, (the “Fifth Floor Substantial Completion Date”), Tenant shall be entitled to a day-for-day credit of Base Rent due as of the Commencement Date, for each day after the Fifth Floor Substantial Completion Date that the Tenant Improvements for the Fifth Floor Premises are not Substantially Completed; provided, however, that, for every day of delay which results from a Tenant Delay or a Force Majeure, the Fifth Floor Substantial Completion Date shall be moved back on a day-for-day basis. Such day-for-day credit of Base Rent shall commence upon the Commencement Date and shall continue until applied in full; provided that at no time may Tenant offset more than 50% of the Base Rent amount due each month until such abatement has been completed. Landlord shall use diligent and good faith efforts to cause the Tenant Improvements for the Fourth Floor Premises to be Substantially Completed by February 1, 2019. Subject only to Force Majeure (as defined in §11 hereof) and Tenant Delay, and provided that Landlord, using good faith efforts, obtains all required construction permits for the Tenant Improvements (the “Construction Permits”) by not later than June 30, 2018, then in the event that Landlord fails to cause the Tenant Improvements for the Fourth Floor Premises to be Substantially Completed on or before March 1, 2019, (the “Fourth Floor Substantial Completion Date”), Tenant shall be entitled to a day-for-day credit of Base Rent due as of the Commencement Date, for each day after the Fourth Floor Substantial Completion Date that the Tenant Improvements for the Fourth Floor Premises are not Substantially Completed; provided, however, that, for every day of delay which results from a Tenant Delay or a Force Majeure, the Fourth Floor Substantial Completion Date shall be moved back on a day-for-day basis. Such day-for-day credit of Base Rent shall commence upon the June 1, 2019, and shall continue until applied in full; provided that at no time may Tenant offset more than 50% of the Base Rent amount due each month until such abatement has been completed. Subject only to Force Majeure and Tenant Delay, and provided that Landlord, using good faith efforts, obtains all required Construction Permits by not later than June 30, 2018, if the Tenant Improvements for the Leased Premises are not Substantially Completed on or before April 1, 2019 (“Outside Completion Date”), then Tenant shall have the one-time right by not later than 10 days after the Outside Completion Date to terminate this lease by delivering written notice to Landlord, which notice shall be hand delivered to 0000 Xxxx Xxxxx Xxxxx, Xxxxxxxx, Xxxx 00000, Attention: Xxxxxx X. Xxxxx, Xx., and upon hand delivery of such termination notice to said address, this lease shall be deemed null and void and the parties shall have no further rights or obligations hereunder, except those that specifically survive the expiration or earlier termination of this lease. Landlord and Tenant acknowledge and agree that Tenant’s damages as a result of Landlord’s failure to cause the Tenant Improvements for the Fifth Floor Premises to be Substantially Completed by not later than the Fifth Floor Substantial Completion Date or the Fourth Floor Premises to be Substantially Completed by not later than the Fourth Floor Substantial Completion Date are difficult to ascertain, that such amounts set forth above are a reasonable pre-estimate of Tenant’s probable loss as a result thereof and that such damages constitute reasonable liquidated damages for Tenant’s loss and not a penalty.

  • Development Work Do, or cause to be done, such development and other work as may be reasonably necessary to protect from diminution and production capacity of the Mortgaged Property and each producing well thereon.

  • Regulatory Milestones Celgene shall make the following approval milestone payments to Jounce that are set forth below upon the first achievement by or on behalf of Celgene, its Affiliates or Sublicensees of the regulatory milestone events (“Regulatory Milestone Events”) set forth below with respect to the first Co-Co Product that achieves such event. For clarity, each milestone set forth below shall be due and payable one time only (regardless of the number of Co-Co Products to achieve any such Regulatory Milestone Event). CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Regulatory Milestone Event (For the first Co-Co Product that achieves such event) Milestone Payments (in $ millions) [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] For each of Paragraphs (1) - (3) of this Exhibit C-1, the Parties understand and agree that in no event will more than one (1) milestone payment be paid with respect to any specific event triggering a payment under this Jounce Lead Co-Co Agreement.

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