Launch Sequence Sample Clauses

Launch Sequence. A list of those countries in the Territory in which Licensee intends to commence Commercialization of the Licensed Product within the first [**] after the Effective Date and timelines reflecting potential date ranges for First Commercial Sale following receipt of Regulatory Approval and Reimbursement Approval (if applicable) in such countries, (the “Launch Sequence” and the countries included in the Launch Sequence, the “Launch Countries”) is made part of this Agreement in Schedule 7.2.1. Licensee will amend or update the Launch Sequence [**] thereafter (without formally amending this Agreement), including updating such sequence with additional countries in the Territory in which Licensee plans to commence Commercialization of the Licensed Product. The Launch Sequence and all amendments and updates thereto will be reviewed and discussed by the JSC.
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Launch Sequence. No later than [**] following Licensee’s submission of the MAA for the Licensed Product to the EMA, Licensee will prepare and submit to the JSC for its review and discussion a list of those countries in the Territory in which Licensee intends to Commercialize the Licensed Product and timelines reflecting the target date of the First Commercial Sale (the “Launch Sequence”, and the countries included in the Launch Sequence, the “Launch Countries”). Licensee will amend or update the Launch Sequence at least [**] thereafter, including updating such sequence so as to provide reasonable prior notice of the target date of the First Commercial Sale in any additional countries in the Territory not included in the initial Launch Sequence. Each amendment and update to the Launch Sequence will be reviewed and discussed by the JSC pursuant to Section 3.4 (Specific Responsibilities of the JSC).
Launch Sequence. No later than [***] following the Effective Date, Licensee will prepare a list of those countries in the Territory in which Licensee intends to commence Commercialization of each Licensed Product within the first [***] after receipt of Regulatory Approval for such Licensed Product from the FDA and the EMA and timelines reflecting potential date ranges for First Commercial Sale following receipt of Regulatory Approval and Reimbursement Approval (if applicable) in such countries, (the “Launch Sequence” and the countries included in the Launch Sequence, the “Launch Countries”). Licensee will amend or update the Launch Sequence [***] thereafter, including updating such sequence with additional countries in the Territory in which Licensee plans to commence Commercialization of a Licensed Product. The Launch Sequence and all amendments and updates thereto will be [***] by the JCC pursuant to Section 3.4.3(a) (Specific Responsibilities of the JCC), and subsequently [***] by the JSC pursuant to Section 3.1.5(n) (Specific Responsibilities of the JSC); provided that if the JSC is unable to [***] the Launch Sequence or any amendment or update thereto, then such matter will not be referred for resolution by the Executive Officers, and instead Licensee’s representatives on the JSC will [***] the Launch Sequence (including the Launch Countries).

Related to Launch Sequence

  • Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.

  • Purchase Order Pricing/Product Deviation If a deviation of pricing/product on a Purchase Order or contract modification occurs between the Vendor and the TIPS Member, TIPS must be notified within five (5) business days of receipt of change order. TIPS reserves the right to terminate this agreement for cause or no cause for convenience with a thirty (30) days prior written notice. Termination for convenience is conditionally required under Federal Regulations 2 CFR part 200 if the customer is using federal funds for the procurement. All purchase orders presented to the Vendor, but not fulfilled by the Vendor, by a TIPS Member prior to the actual termination of this agreement shall be honored at the option of the TIPS Member. The awarded Vendor may terminate the agreement with ninety (90) days prior written notice to TIPS 0000 XX Xxx Xxxxx, Xxxxxxxxx, Xxxxx 00000. The vendor will be paid for goods and services delivered prior to the termination provided that the goods and services were delivered in accordance with the terms and conditions of the terminated agreement. This termination clause does not affect the sales agreements executed by the Vendor and the TIPS Member customer pursuant to this agreement. TIPS Members may negotiate a termination for convenience clause that meets the needs of the transaction based on applicable factors, such as funding sources or other needs. Usually, purchase orders or their equal are issued by participating TIPS Member to the awarded vendor and should indicate on the order that the purchase is per the applicable TIPS Agreement Number. Orders are typically emailed to TIPS at xxxxxx@xxxx-xxx.xxx. • Awarded Vendor delivers goods/services directly to the participating member. • Awarded Vendor invoices the participating TIPS Member directly. • Awarded Vendor receives payment directly from the participating member. • Fees are due to TIPS upon payment by the Member to the Vendor. Vendor agrees to pay the participation fee to TIPS for all Agreement sales upon receipt of payment including partial payment, from the Member Entity or as otherwise agreed by TIPS in writing and signed by an authorized signatory of TIPS.

  • Completion of Work The Contractor agrees to complete the work on, or before October 29, 2021.

  • Milestone Schedule Please state the status and progress of each Milestone and identify any completed Milestone(s) for the previous calendar quarter.

  • Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving (either itself or through the acts of a SUBLICENSEE) the following development milestones in its diligence activities under this AGREEMENT: (a) (b).

  • Project Specific Milestones In addition to the milestones stated in Section 212.5 of the Tariff, as applicable, during the term of this ISA, Interconnection Customer shall ensure that it meets each of the following development milestones: 6.1 Substantial Site work completed. On or before December 31, 2020 Interconnection Customer must demonstrate completion of at least 20% of project site construction. At this time, Interconnection Customer must submit to Interconnected Transmission Owner and Transmission Provider initial drawings, certified by a professional engineer, of the Customer Interconnection Facilities. 6.2 Delivery of major electrical equipment. On or before December 31, 2021, Interconnection Customer must demonstrate that all generating units have been delivered to Interconnection Customer’s project site.

  • CORRECTION OF WORK 13.2.1 The Contractor shall be responsible for correcting all Work which the Architect has found to be defective or which fails to conform to the Contract Documents whether observed be- fore or after Substantial Completion and whether or not fabricated, installed or completed. The Contractor shall bear all costs of correcting such rejected Work, including compensation for the Architect's and the State’s additional services made necessary thereby. 13.2.2 If, within one year after the Date of Substantial Completion of the Work or designated portion thereof or within one year after acceptance by the State of designated equipment or within such longer period of time as may be prescribed by law or by the terms of any applicable special warranty required by the Contract Documents, any of the Work is found to be defective or not in accordance with the Contract Documents, the Contractor shall correct it promptly after receipt of a written notice from the State to do so unless the State has previously given the Contractor a written acceptance of such condition. This obligation shall survive termination of the Contract. The State shall give such notice promptly after discovery of the condition. 13.2.3 The Contractor shall remove from the site all portions of the Work which are defective or non-conforming and which have not been corrected under Subparagraphs 4.5.1, 13.2.1 and 13.2.4 If the Contractor fails to correct defective or nonconforming Work as provided in Subparagraphs 4.5.1, 13.2.1 and 13.2.2, the State may correct it in accordance with Paragraph 13.2.5 If the Contractor does not proceed with the correction of such defective or non- conforming Work within a reasonable time fixed by written notice from the Architect, the State may remove it and may store the materials or equipment at the expense of the Contractor. If the Contractor does not pay the cost of such removal and storage within ten days thereafter, the State may upon ten additional days written notice sell such Work at auction or at private sale and shall account for the net proceeds thereof, after deducting all the costs that should have been borne by the Contractor, including compensation for the Architect's and the State’s additional services and expenses made necessary thereby. If such proceeds of sale do not cover all costs which the Contractor should have borne, the difference shall be charged to the Contractor and an appropriate Change Order shall be issued. If the payments then or thereafter due the Contractor are not sufficient to cover such amount, the Contractor shall pay the difference to the State. 13.2.6 The Contractor shall bear the cost of making good all work of the State or separate contractors destroyed or damaged by such correction or removal. 13.2.7 Nothing contained in this Paragraph 13.2 shall be construed to establish a period of limitation with respect to any other obligation which the Contractor might have under the

  • Project/Milestones Taxpayer provides refrigerated warehousing and logistic distribution services to clients throughout the United States. In consideration for the Credit, Taxpayer agrees to invest in a new refrigeration and distribution facility in the XxXxxxxxx Park area of Sacramento, California, and hire full-time employees (collectively, the “Project”). Further, Taxpayer agrees to satisfy the milestones as described in Exhibit A (“Milestones”) and must maintain Milestones for a minimum of three (3) taxable years thereafter. In the event Taxpayer employs more than the number of full-time employees, determined on an annual full-time equivalent basis, than required in Exhibit A, for purposes of satisfying the “Minimum Annual Salary of California Full-time Employees Hired” and the “Cumulative Average Annual Salary of California Full-time Employees Hired,” Taxpayer may use the salaries of any of the full-time employees hired within the required time period. For purposes of calculating the “Minimum Annual Salary of California Full-time Employees Hired” and the “Cumulative Average Annual Salary of California Full-time Employees Hired,” the salary of any full-time employee that is not employed by Taxpayer for the entire taxable year shall be annualized. In addition, the salary of any full-time employee hired to fill a vacated position in which a full-time employee was employed during Taxpayer’s Base Year shall be disregarded.

  • Commercial Milestones (a) Within [*****] calendar days after the end of the first Calendar Year in which aggregate annual Net Sales for that Calendar Year for the Licensed Product in the Territory reach any threshold indicated in the Commercial Milestone Events listed below, EverInsight shall notify VistaGen of the achievement of such Commercial Milestone Event and VistaGen shall invoice EverInsight for the corresponding non-refundable, non-creditable Milestone Payment set forth below and EverInsight shall remit payment to VistaGen within [*****] Business Days after the receipt of the invoice, as described in Section 8.6 (Currency; Exchange Rate; Payments). Annual Net Sales Milestones for Licensed Product Milestone Payments (in Dollars) (each a “Commercial Milestone Event”): (1). [*****] (2). [*****] (3). [*****] (4). [*****] (5). [*****] (b) For the purposes of determining whether a Net Sales Milestone Event has been achieved, Net Sales of Licensed Product(s) in the Territory shall be aggregated. For clarity, the annual Net Sales Milestone Payments set forth in this Section 8.3 (Commercial Milestones) shall be payable only once, upon the first achievement of the applicable Commercial Milestone Event, regardless of how many times such Commercial Milestone Event is achieved. (c) If a Commercial Milestone Event in Section 8.3 (Commercial Milestones) is achieved and payment with respect to any previous Commercial Milestone Event in Section 8.3 has not been made, then such previous Commercial Milestone Event shall be deemed achieved and EverInsight shall notify VistaGen within fifteen (15) calendar days of such achievement. VistaGen shall then invoice EverInsight for such unpaid previous Commercial Milestone Event(s) and EverInsight shall pay VistaGen such unpaid previous milestone payment(s) within thirty (30) Business Days of receipt of such invoice. (d) In the event that, VistaGen believes any Commercial Milestone Event under Section 8.3(a) has occurred but EverInsight has not given VistaGen the notice of the achievement of such Commercial Milestone Event, it shall so notify EverInsight in writing and shall provide to EverInsight data, documentation or other information that supports its belief. Any dispute under this Section 8.3(d) (Commercial Milestones - subsection (d)) that relates to whether or not a Commercial Milestone Event has occurred shall be referred to the JSC to be resolved in accordance with ARTICLE 3 (Governance) and shall be subject to resolution in accordance with Section 14.10 (Dispute Resolution). The Milestone Payments made for each Commercial Milestone Event shall be non-creditable and non-refundable.

  • 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.

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