Additional Development Considerations Sample Clauses

Additional Development Considerations. Eisai (or the Eisai Related Party in the applicable country) shall hold the IND and be responsible for executing the Regulatory Strategy for the Products in all countries in the Territory.
Additional Development Considerations. (i) Eisai (or the Eisai Related Party in the applicable country) shall hold the IND and be responsible for executing the Regulatory Strategy for the Products in all countries in the Territory. (ii) Eisai (or the Eisai Related Party in the applicable country) will be responsible for all NDA and other filings for Regulatory Approval (including deciding whether an NDA shall be filed, subject to Section 5.2(a)) for all Products in all countries in the Territory. Eisai (or the Eisai Related Party in the applicable country) shall hold all NDAs and all Regulatory Approvals for all Products in all countries in the Territory. (iii) Eisai (or the Eisai Related Party in the applicable country) shall be responsible for obtaining pricing and reimbursement approvals, as applicable, for all Products in all countries in the Territory at its expense.
Additional Development Considerations. (i) Arena has the right, during a “review period” for each filing of up to three months beginning when a final or substantially mature draft filing is provided to Arena by Eisai, to review and comment on each final or substantially mature draft IND or NDA filing prior to submission by Eisai in a country in the Territory where Eisai has the right to make such filing. After such review period (or earlier if agreed by Arena), Eisai may move forward with the intended filing after good faith consideration of any reasonable Arena comments. (ii) Eisai has the right, during a “review period” for each filling of up to three months beginning when a final or substantially mature draft filing is provided to Eisai by Arena, to review and comment on each final or substantially mature draft IND filing prior to submission by Arena in a country in the Territory where Arena has the right to make such filing. After such review period (or earlier if agreed by Eisai), Arena may move forward with the intended filing after good faith consideration of any reasonable Eisai comments. (iii) Eisai, unless otherwise agreed by the Parties, will use Commercially Reasonable Efforts to obtain any CPP issuable by FDA, EMA or Swissmedic (or other Regulatory Authority) necessary to obtain regulatory approval of the Initial Product in a country in the Additional Territory or New Territory. (iv) The Parties agree to coordinate a joint meeting, and to use Commercially Reasonable Efforts to seek to hold such meeting, with the Committee for Medicinal Products for Human Use in Europe within [...***...] of the 2nd Amendment Effective Date. Eisai agrees to use Commercially Reasonable Efforts to seek to hold a meeting with the Ministry of Health, Labour and Welfare of Japan within [...***...] after such meeting with the Committee for Medicinal Products for Human Use in Europe. (v) The Parties shall discuss in good faith at the JDC, after consideration of the Development Plans for Additional Products, which Party (or its Affiliate or Sub-distributor) should be the Responsible Party to hold an IND and to execute the Regulatory Strategy in a particular country in the Territory relating to the applicable Development Plan for the Initial Product or any Additional Product. Unless otherwise agreed by the JDC (or the JSC or the Senior Executives in accordance with Section 4.1(f)), (A) the Party (or its Affiliate or Sub-distributor) that has final decision-making authority with respect to the Regulatory Strat...

Related to Additional Development Considerations

  • Additional Considerations For FEMA’s Assistance to Firefighters Grant (AFG) Program, recipients must include a penalty clause in all contracts for any AFG-funded vehicle, regardless of dollar amount. In that situation, the contract must include a clause addressing that non-delivery by the contract’s specified date or other vendor nonperformance will require a penalty of no less than $100 per day until such time that the vehicle, compliant with the terms of the contract, has been accepted by the recipient. This penalty clause should, however, account for force majeure or acts of God. AFG recipients should refer to the applicable year’s Notice of Funding Opportunity (NOFO) for additional information, which can be accessed at ▇▇▇▇.▇▇▇.

  • Additional Consideration Retrocessionaire agrees to pay under the Inuring Retrocessions all future premiums Retrocedant is obligated to pay pursuant to the terms of the Inuring Retrocessions to the extent that such premiums are allocable to Retrocessionaire in the manner set forth in Exhibit E hereto, and not otherwise paid by Retrocessionaire and to indemnify Retrocedant for all such premiums paid directly by Retrocedant, net of any ceding commissions and similar amounts paid by Third Party Retrocessionaires to Retrocedant.

  • General Considerations a. All reports, drawings, designs, specifications, notebooks, computations, details, and calculation documents prepared by Vendor and presented to the Board pursuant to this Agreement are and remain the property of the Board as instruments of service. b. All analyses, data, documents, models, modeling, reports and tests performed or utilized by Vendor shall be made available to the Board upon request and shall be considered public records. c. Vendor is required to: (i) keep and maintain public records required by Board; (ii) upon request from Board’ s custodian of public records, provide Board with a copy of the requested records or allow the records to be inspected or copied within a reasonable time at a reasonable or as otherwise provided by law; (iii) ensure that public records that are exempt or, confidential and exempt, from public records disclosure requirements are not disclosed except as authorized by law for the duration of this Agreement and following completion of this Agreement if Vendor does not transfer the records to Board; (iv) upon completion of this Agreement, transfer, at no cost, to Board all public records in possession of Vendor or keep and maintain public records required by Board. d. If Vendor transfers all public records to Board upon completion of this Agreement, Vendor shall destroy any duplicate public records that are exempt or, confidential and exempt, from public records disclosure requirements. If Vendor keeps and maintains public records upon completion of this Agreement, Vendor shall meet all applicable requirements for retaining public records. All records stored electronically must be provided to Board, upon request from Board’s custodian of public records, in a format that is compatible with the information technology systems of Board. e. Vendor shall keep all books, records, files, drawings, plans and other documentation, including all electronically stored items, which concern or relate to the services required hereunder (the “Records”), for a minimum of five (5) years from the date of expiration or suspension of this Agreement, or as otherwise required by any applicable law, whichever date is later. The Board shall have the right to order, inspect, and copy all the Records as often as it deems necessary during any such period-of-time. The right to audit, inspect, and copy Records shall include all of the records of sub-Vendors (if any). f. Vendor shall, at all times, comply with the Florida Public Records Law, the Florida Open Meeting Law and all other applicable laws, rules and regulations of the State of Florida. g. IF THE VENDOR HAS QUESTIONS REGARDING THE APPLICATION OF CHAPTER 119, FLORIDA STATUTES, TO THE VENDORS’ DUTY TO PROVIDE PUBLIC RECORDS RELATING TO THIS AGREEMENT, CONTACT THE CUSTODIAN OF PUBLIC RECORDS AT ▇▇▇-▇▇▇-▇▇▇▇, Sumter County Board of County Commissioners, ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, Wildwood, Florida 34785 or via email at ▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇. h. Vendor shall, at all times, carry General Liability, and Worker’s Compensation Insurance pursuant to the insurance requirements in RFP ▇▇▇-▇-▇▇▇▇/JV, naming Board as both a certificate holder and an additional insured in each such policy. i. Upon Vendor’s written request, the Board will furnish, or cause to be furnished, such reports, studies, instruments, documents, and other information as Vendor and Board mutually deem necessary, and Vendor may rely upon same in performing the services required under this Agreement. j. Vendor is obligated by this agreement to comply with Section 20.055(5), Florida Statutes. k. Any entity or affiliate who has had its Certificate of Qualification suspended, revoked, denied or have further been determined by the Department to be a non-responsive contractor may not submit a bid.

  • Environmental Considerations A. Company, its officers, agents, servants, employees, invitees, independent contractors, successors, and assigns will not discharge or spill any Hazardous Substance, as defined herein, into any component of the storm drainage system or onto any paved or unpaved area within the boundaries of the Premises. In addition, Company will not discharge or spill any Hazardous Substance into any component of the sanitary sewer system without first neutralizing or treating same as required by applicable anti-pollution laws or ordinances, in a manner satisfactory to Authority and other public bodies, federal, state, or local, having jurisdiction over or responsibility for the prevention of pollution of canals, streams, rivers, and other bodies of water. Company’s discharge, spill or introduction of any Hazardous Substance onto the Premises or into any component of Authority’s sanitary or storm drainage systems will, if not remedied by Company with all due dispatch, at the sole discretion of Authority, be deemed a default and cause for termination of this Agreement by Authority, subject to notice and cure. Such termination will not relieve Company of or from liability for such discharge or spill. B. If Company is deemed to be a generator of hazardous waste, as defined by federal, state, or local law, Company will obtain a generator identification number from the U. S. Environmental Protection Agency (EPA) and the appropriate generator permit and will comply with all federal, state, and local laws, and any rules and regulations promulgated thereunder, including but not limited to, ensuring that the transportation, storage, handling, and disposal of such hazardous wastes are conducted in full compliance with applicable law. C. Company agrees to provide Authority, within 10 days after Authority’s request, copies of all hazardous waste permit application documentation, permits, monitoring reports, transportation, responses, storage and disposal plans, material safety data sheets and waste disposal manifests prepared or issued in connection with Company’s use of the Premises. D. At the end of the Agreement, Company will dispose of all solid and hazardous wastes and containers in compliance with all applicable regulations. Copies of all waste manifests will be provided to Authority at least 30 days prior to the end of the Agreement.

  • Special Considerations The Provider position may be abolished at any time by the Collin County Commissioners Court.