Termination for Safety Concern Sample Clauses

Termination for Safety Concern. On a Licenced Product-by-Licenced Product basis, the Company may, at its election, terminate this Agreement with respect to such Licenced Product immediately upon written notice to the University as a result of a safety concern, toxicity or drug safety issue or a serious adverse event reasonably related to or observed in connection with the development or commercialization activities relating to and arising from use of a Licenced Product.
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Termination for Safety Concern. (a) If Servier wishes to terminate this Agreement with respect to a Product for a safety concern that does not rise to the level of a safety issue as set forth in Section 12.2.5, then Servier shall be permitted to do so under the terms and conditions of a termination for convenience by Servier under Sections 12.2.3 and with the effects described under Section 12.3.1 except that (i) Servier’s obligation to provide continued supply of the Product for [***] under Section 12.3.1.(g) and (ii) Servier’s obligation to continue and fund or co-fund ongoing Clinical Studies and ongoing Manufacturing campaigns for [***] under Section 12.3.1.(e) shall not apply. Instead, the Parties shall discuss and agree in good faith on an appropriate amount of time for continued supply, continuation of ongoing Clinical Studies and ongoing Manufacturing campaigns and funding of continued development in order to permit an orderly transition of the Product to Pieris so that it may continue Development of such Product, depending on the circumstances and nature of the safety concern. Such agreement shall also include appropriate indemnification provisions for Servier.
Sample 1
Termination for Safety Concern. (a) If Servier wishes to terminate this Agreement with respect to a Product for a safety concern that does not rise to the level of a safety issue as set forth in Section 12.2.5, then Servier shall be permitted to do so under the terms and conditions of a termination for convenience by Servier under Sections 12.2.3 and with the effects described under Section 12.3.1 except that (i) Servier’s obligation to provide continued supply of the Product for [***] under Section 12.3.1.(g) and (ii) Servier’s obligation to continue and fund or co-fund ongoing Clinical Studies and ongoing Manufacturing campaigns for [***] under Section 12.3.1.(e) shall not apply. Instead, the Parties shall discuss and agree in good faith on an appropriate amount of time for continued supply, continuation of ongoing Confidential Clinical Studies and ongoing Manufacturing campaigns and funding of continued development in order to permit an orderly transition of the Product to Pieris so that it may continue Development of such Product, depending on the circumstances and nature of the safety concern. Such agreement shall also include appropriate indemnification provisions for Servier. (b) If Pieris wishes to terminate this Agreement with respect to the Lead or a CoDev Product for a safety concern that does not rise to the level of a safety issue as set forth in Section 12.2.5, then Pieris shall be permitted to do so under the terms and conditions with the effects described under Sections 12.3.1(b), (c), and (e)–(j) applied to Pieris mutatis mutandis except that (i) Pieris’s obligation to provide continued supply of the Product for [***] under Section 12.3.1.(g) and (ii) Pieris’s obligation to continue and fund or co-fund ongoing Clinical Studies and ongoing Manufacturing campaigns for [***] under Section 12.3.1.(e) shall not apply. Instead, the Parties shall discuss and agree in good faith on an appropriate amount of time for continued supply, continuation of ongoing Clinical Studies and ongoing Manufacturing campaigns and funding of continued development in order to permit an orderly transition of the Product to Servier so that it may continue Development of such Product, depending on the circumstances and nature of the safety concern. Such agreement shall also include appropriate indemnification provisions for Pieris.
Sample 1
Termination for Safety Concern. Either Party may terminate this Agreement immediately upon written notice to the other party if the terminating Party determines in good faith, based on a review of the Clinical Data or other Study-related Know-How or information, that the Study may adversely affect patient safety due to the existence of a Material Safety Issue that warrants termination of the Study; provided that prior to delivery of such notice of termination, such Party shall notify the other Party, and within [***] hours of such notice, the Parties shall discuss whether an amendment to the Protocol for the Study would be reasonably likely to address the issue; provided further that if the Parties are unable to agree on such an amendment to the Protocol for the Study, then this Agreement shall terminate upon the end of such [***] hour period.
Sample 1
Termination for Safety Concern. A Party may terminate this Agreement immediately upon written notice to the other Party if the terminating Party determines in good faith, based on a review of the Study Data or other Study-related know-how or information, that the Study may unreasonably (e.g. seriously and unexpectedly) affect patient safety, or for a similar medical, scientific, or legal concern. If requested by the other Party, the Parties shall discuss such concerns and whether the same can be reasonably addressed without termination.
Sample 1

Related to Termination for Safety Concern

  • Termination for Catastrophe In event of Catastrophic Damage, this contract may be modified un- der B8.32, following rate redetermination under B3.32, or terminated under this Subsection. Such termination shall not be considered a termination under B8.34.

  • Termination for continuing Force Majeure Event Either Party may, by written notice to the other, terminate this Framework Agreement if a Force Majeure Event endures for a continuous period of more than one hundred and twenty (120) Working Days.

  • Contractor Responsibility for System Agency’s Termination Costs If the System Agency terminates the Contract for cause, the Contractor shall be responsible to the System Agency for all costs incurred by the System Agency and the State of Texas to replace the Contractor. These costs include, but are not limited to, the costs of procuring a substitute vendor and the cost of any claim or litigation attributable to Contractor’s failure to perform any Work in accordance with the terms of the Contract.

  • Promotion to a Higher Classification An employee who is promoted to a higher rated classification within the bargaining unit will be placed in the range of the higher rated classification so that he shall receive no less an increase in wage rate than the equivalent of one step in the wage rate of his previous classification (provided that he does not exceed the wage rate of the classification to which he has been promoted).

  • CFR PART 200 Procurement of Recovered Materials A non-Federal entity that is a state agency or agency of a political subdivision of a state and its contractors must comply with section 6002 of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act. The requirements of Section 6002 include procuring only items designated in guidelines of the Environmental Protection Agency (EPA) at 40 CFR part 247 that contain the highest percentage of recovered materials practicable, consistent with maintaining a satisfactory level of competition, where the purchase price of the item exceeds $10,000 or the value of the quantity acquired during the preceding fiscal year exceeded $10,000; procuring solid waste management services in a manner that maximizes energy and resource recovery; and establishing an affirmative procurement program for procurement of recovered materials identified in the EPA guidelines. Does vendor certify that it is in compliance with the Solid Waste Disposal Act as described above? Yes

  • Performing Agency Responsibility for System Agency’s Termination Costs If the System Agency terminates the Contract for cause, the Performing Agency shall be responsible to the System Agency for all costs incurred by the System Agency and the State of Texas to replace the Performing Agency. These costs include, but are not limited to, the costs of procuring a substitute vendor and the cost of any claim or litigation attributable to Performing Agency’s failure to perform any Work in accordance with the terms of the Contract.

  • Additional Requirements for Sleeping Rooms The Contractor shall provide departing Attendees a secured area for storing belongings.

  • Payment of Sales, Use or Similar Taxes All sales, use, transfer, intangible, recordation, documentary stamp or similar Taxes or charges, of any nature whatsoever, applicable to, or resulting from, the transactions contemplated by this Agreement shall be borne by the Sellers.

  • Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract. a. The contractor shall notify all potential subcontractors and suppliers and lessors of their EEO obligations under this contract. b. The contractor will use good faith efforts to ensure subcontractor compliance with their EEO obligations.

  • Modification for Catastrophe In event of Catastrophic Damage, Forest Service, in consultation with Purchaser, shall outline on Sale Area Map: (a) Any areas of catastrophe-affected live and dead timber meeting Utilization Standards and having undesignated timber so situated that it should be logged with the designated timber; (b) If needed, any such areas where the damaged undesignated timber can reasonably be logged separately; and (c) Areas of affected or unaffected timber that are to be eliminated from Sale Area. Forest Service shall locate and post the boundaries of all such areas, as needed. After Sale Area Map has been outlined under this Subsection, Forest Service may propose contract modification to permit the harvest of catastrophe-affected timber. If Purchaser accepts Forest Service proposed modifications, this contract shall be modified to include rates redetermined under B3.32 and other related revisions as necessary, such as revision of Operating Schedule to ensure prompt removal of affected timber when necessary to avoid further loss and provision for additional contract time, if needed.

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