For CCX282 Clause Samples

For CCX282. Notwithstanding the foregoing Section 4.2.1, a new and different PoC Trial Report for CCX282 shall be delivered to GSK within sixty (60) days of the JSC having determined that CCX282 meets the PoC Criteria and has successfully met the endpoints for the PoC Trial in each of the following situations: (a) the PROTECT-1 Induction Phase, (b) the PROTECT-1 Maintenance Phase, and (c) the Asthma CCR9 PoC Trial, and each such PoC Trial Report shall include all the preclinical and clinical data showing that the clinical endpoints have been achieved demonstrating the successful outcome of the respective portion of the PROTECT-1 Trial or the Asthma CCR9 PoC Trial, as the case may be.
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For CCX282. Unless and until GSK exercises its Product Option with respect to CCX282, promptly after the conduct of each of the following (a) the PROTECT-1 Induction Phase, (b) the PROTECT-1 Maintenance Phase, and (c) the Asthma CCR9 PoC Trial, as applicable, if ChemoCentryx determines that CCX282 meets the PoC Criteria therefor, ChemoCentryx shall promptly notify GSK, in writing, of such event. The JSC will, at a special ad hoc meeting to be scheduled, confirm that CCX282 meets such PoC Criteria and that the PoC Trial has successfully met the relevant endpoints. Following such confirmation, GSK shall have the right to exercise its Product Option with respect to CCX282 in accordance with Section 4.3.1(b) and Article 4. Where GSK does not so elect to exercise its Product Option at the timepoint referenced in clause (a) above, as provided in Section 4.3, then following the time point referenced in clause (b) or (c), if ChemoCentryx again determines that CCX282 meets the PoC Criteria, ChemoCentryx shall promptly notify GSK, in writing, of such event. The JSC will, a special ad hoc meeting to be scheduled, confirm that CCX282 meets such PoC Criteria. Following such confirmation, GSK shall again have the right to exercise its Product Option with respect to CCX282 in accordance with Article 4 and Section 4.3.1(b). Such process shall again continue with respect to all three (3) time points described in clauses (a), (b) and (c) above, as and to the extent ChemoCentryx conducts such PoC Trials, and CCX282 meets the PoC Criteria with respect to the PoC Trial referenced therein, GSK shall thus have a total of up to three (3) opportunities to exercise its Product Option with respect to CCX282 in accordance with Section 4.3.1(b), and the failure by GSK to exercise any of such opportunities shall not count against GSK’s Product Options, unless and until all of such opportunities with respect to CCX282 arising hereunder are declined by GSK.
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For CCX282. Unless and until GSK exercises its Product Option with respect to CCX282 or a CCX282 Back-up Compound, promptly after the conduct of each of the following (a) the PROTECT-1 Induction Phase, (b) the PROTECT-1 Maintenance Phase,
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Related to For CCX282

  • 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 or have been submitted to FDA or other comparable governmental entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, applicable Authorizations, and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and, for studies submitted to regulatory authorities for approval, in all material respects, 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 and fairly present the data derived from such studies and trials in all material respects; 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 materially 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 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.

  • Random Testing Notwithstanding any provisions of the Collective Agreement or any special agreements appended thereto, section 4.6 of the Canadian Model will not be applied by agreement. If applied to a worker dispatched by the Union, it will be applied or deemed to be applied unilaterally by the Employer. The Union retains the right to grieve the legality of any imposition of random testing in accordance with the Grievance Procedure set out in this Collective Agreement.

  • Drug Testing (A) The state and the PBA agree to drug testing of employees in accordance with section 112.0455, F.S., the Drug-Free Workplace Act. (B) All classes covered by this Agreement are designated special risk classes for drug testing purposes. Special risk means employees who are required as a condition of employment to be certified under Chapter 633 or Chapter 943, F.S. (C) An employee shall have the right to grieve any disciplinary action taken under section 112.0455, the Drug-Free Workplace Act, subject to the limitations on the grievability of disciplinary actions in Article 10. If an employee is not disciplined but is denied a demotion, reassignment, or promotion as a result of a positive confirmed drug test, the employee shall have the right to grieve such action in accordance with Article 6.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Product Testing No later than [**] prior to a scheduled Delivery ARIAD US shall send to ARIAD SWISSCO the Delivery Documents for review. Following such review, unless within [**] of receipt of the Delivery Documents ARIAD SWISSCO gives written notice of rejection of the Product to be delivered, stating the reasons for such rejection, the Delivery shall proceed, and both Parties shall organize the same. Upon arrival at ARIAD SWISSCO nominated site it shall visually inspect the shipment of the Product to identify any damage to the external packaging. ARIAD SWISSCO may reject any shipment (or portion thereof) of the Product that is damaged by providing to ARIAD US reasonable evidence of damage within [**] after Delivery of such Product. If ARIAD SWISSCO does not so reject any shipment (or portion thereof) of the Product within [**] of Delivery of such Product, ARIAD SWISSCO shall be deemed to have accepted such shipment of the Product; provided, however, that in the case of the Product having any Latent Defect, ARIAD SWISSCO shall notify ARIAD US promptly once it becomes aware that a Product contains a Latent Defect and subsequently may reject such Product by giving written notice to ARIAD US of ARIAD SWISSCO’s rejection of such Product and shipping a representative sample of such Product or other evidence of Non-Conformance to ARIAD US within [**] after becoming aware of such Latent Defect, which notice shall include a description of the Latent Defect.