Additional indications for conventional Sample Clauses

Additional indications for conventional or innovative epilepsy treatments Some respondents identified as priority areas for clinical trials the exploration of potential additional indications for old-generation AEDs (e.g., carbamazepine for neonatal seizures, phenobarbital for Dravet syndrome); for recently approved AEDs (e.g., topiramate for Dravet syndrome, brivaracetam for juvenile myoclonic epilepsy, perampanel for established status epilepticus, progressive myoclonic epilepsies and refractory absence seizures); for medications used in other conditions but already investigated in epilepsy (e.g. fenfluramine for refractory focal epilepsies; ketamine for encephalopathy associated with CSWS); and for dietary treatments (e.g. the ketogenic diet for eyelid myoclonias with absences and Ring chromosome 20 syndrome).
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  • 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 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, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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.

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  • Billing and Payment Procedure for Forest Products Delivered The State will compute and forward to Purchaser a billing statement of charges for forest products delivered during the billing period at the delivered rate shown in P- 028.2 clause. After receipt of the billing statement, Purchaser’s payment must be received by the Department of Natural Resources on or before the due date shown on the billing statement. Purchaser agrees to make payment, payable to the Department of Natural Resources. Failure to pay on time for forest products delivered is considered a breach of contract. Included with the billing statement will be a summary report for the billing period compiled by the State or their log and load reporting service. The State will adjust final xxxxxxxx to account for any State approved payment reductions. P-080 Payment Account Refund Advance payments made under P-045 or P-045.2 remaining on account above the value for the charges shall be returned to Purchaser within 30 days following the final report of charges. Refunds not made within the 30 day period will accrue interest at the interest rate, as established by WAC 000-000-000, computed on a daily basis until paid.

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