Comparator Drugs Sample Clauses

Comparator Drugs. Each Party conducting clinical trials for the Product shall be responsible for procuring all of its requirements of all comparator drugs or placebos necessary for conducting such clinical trials; provided, however, Affymax shall reasonably cooperate with Takeda for such purposes, which cooperation shall include the transfer to Takeda of technology Controlled by Affymax relating to activities that were conducted by Affymax as of the Effective Date with respect to any such placebo, in connection with the Development of the Product. The costs and expenses incurred by either Party for procuring the comparator drugs or placebos for the U.S. Development shall be included in the Development Expenses.
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Comparator Drugs. Collaborator shall be responsible for obtaining, at its sole expense, all supplies of its requirements of all comparator drugs and/or placebos necessary for conducting clinical trials of the Product in the Licensed Territory, provided, however, Affymax shall reasonably cooperate with Collaborator for such purposes at Collaborator's expense, which cooperation shall include the transfer to Collaborator of technology Controlled by Affymax relating to activities that were conducted by Affymax as of the Effective Date with respect to any such placebo, in connection with the Development of Products.
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Comparator Drugs. Each Party conducting pre-clinical and clinical trials for the Product shall be responsible for procuring all of its requirements of all comparator drugs or placebos necessary for conducting such trials. The costs and expenses incurred by either Party for procuring the comparator drugs or placebos for the Development shall be included in the Development Expenses.
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Comparator Drugs shall be responsible for procuring all comparator drugs or placebos necessary for conducting non-clinical studies and Clinical Trials and the cost of these agents up to the end of the First Step. After which, the costs and expenses related to the Comparator Drugs or placebos for the Development shall be included in the Development Expenses. SECTION 4.01 REGULATORY MATTERS 4.1 Transfer of Data and Regulatory Materials. (a) Existing Data. Within * ( * ) of the Effective Date, NOVIMMUNE shall provide copies of all preclinical, non-clinical data and manufacturing reports (Exhibit G), for Product as a single agent, relevant to an IND or CTA submission. * shall have the full right, without any additional consideration, to use any and all such data and reports to support collaborations on their bispecific antibody platform using their anti-CD47 platform arm. * shall have the full right on behalf of JV, without any additional consideration, to use any and all such data and reports in connection with the Development and/or Commercialization of the Product in the Territory, including the incorporation of such data or reports in any regulatory submissions, including MAA and BLA submissions. (b) Future Data. Novimmune shall, in a timely manner and compliant with requirements of the FDA, the EMA, and any other applicable Regulatory Authority, provide to TGTX copies of all preclinical, non-clinical, analytical, manufacturing, and clinical data relating to the Product either as single agent or in Combination, generated by or on behalf of Novimmune that is related to the Product. TGTX shall provide to Novimmune all completed clinical study reports and Novimmune shall have the right to use these reports solely for the purposes of decision making on Novimmune other programs. Novimmune will treat these reports as TGTX Confidential Information. TGTX shall have the full right, without any additional consideration, to use any and all such data and reports in connection with the Development and/or the Commercialization of the Product in the Territory, including the incorporation of such data or reports in any regulatory submissions including MAA and/or BLA submissions. 4.2 Regulatory Submissions and Approvals. (a) In General. The Parties intend to seek Regulatory Approval in the first instance in the * , * and * thereafter the remainder of the Territory wherein the JSC determines it is worthwhile to Develop and Commercialize the Product. Subject to the terms of this Article 4: (...
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Related to Comparator Drugs

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

  • Specialty Prescription Drugs (+ Prorated copayments for a shorter supply period may apply for network pharmacy only. See Prescription Drug section for details. When purchased at a Specialty Pharmacy (+): For maintenance and non-maintenance prescription drugs, a copayment applies for each 30-day period (or portion thereof) within the prescribeddosing period. Tier 5: $125 Not Covered When purchased at a Retail Pharmacy (+): For maintenance and non-maintenance prescription drugs, a copayment applies for each 30-day period (or portion thereof) within the prescribeddosing period. Specialty Prescription Drugs purchasedat a retail pharmacy will require a significantly higher out of pocket expense than if purchased from a Specialty Pharmacy. Our reimbursement is based on the pharmacy allowance. Tier 5: 50% Not Covered When purchased at a Mail Order Pharmacy: Not Covered Not Covered Infertility Prescription Drugs - Three(3) in-vitro cycles will be covered per plan year with a total of eight (8) in-vitro cycles covered in a member’s lifetime. When purchased at a Specialty, Mail Order, or Retail Pharmacy Tier 1: 20% Not Covered Tier 2: 20% Not Covered Tier 3: 20% Not Covered Tier 4: 20% Not Covered When purchased at a Specialty Pharmacy (+) Tier 5: 20% Not Covered When purchased at a Retail Pharmacy (+): Specialty Prescription Drugs purchased at a retail pharmacy will require a significantly higher out of pocket expense than if purchased from a specialty pharmacy. Tier 5: 20% Not Covered Contraceptive Methods- Preventive Coverage includes barrier method (diaphragmor cervical cap), hormonal method (birth control pill), and emergency contraception. For non-preventive contraceptive prescription drugs and devices, the amount you pay will depend on the tier placement of the contraceptive prescription drug or device. See above for details. When purchased at a Retail Pharmacy: Up to a 365-day supply of contraceptive prescription drugs is available at all network retail pharmacies. For more information about this option, visit our website. Tier 1: $0 Not Covered When purchased at a Mail Order Pharmacy: Up to a 90-day supply. Tier 1: $0 Not Covered

  • Prescription Drug Quantity Limits We limit the quantity of certain prescription drugs that you can get at one time for safety, cost-effectiveness and medical appropriateness reasons. Our clinical criteria for quantity limits are subject to our periodic review and modification. Quantity limits may restrict: • the amount of pills dispensed per thirty (30) day period; • the number of prescriptions ordered in a specified time period; or • the number of prescriptions ordered by a provider, or multiple providers. Our formulary indicates which prescription drugs have a quantity limit. Prescription drugs and diabetic equipment or supplies can be bought from the following types of pharmacies: • Retail pharmacies. These dispense prescription drugs and diabetic equipment or supplies. • Mail order pharmacies. These dispense maintenance and non-maintenance prescription drugs and diabetic equipment or supplies. • Specialty pharmacies. These dispense specialty prescription drugs, defined as such on our formulary. For information about our network retail, mail order, and specialty pharmacies, visit our website or call our Customer Service Department.

  • SHOP DRAWINGS, PRODUCT DATA AND SAMPLES 4.12.1 Shop Drawings are drawings, diagrams, schedules and other, data specially prepared for the Work by the Contractor or any Subcontractor, manufacturer, supplier or distributor to illustrate some portion of the Work. 4.12.2 Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams and other information furnished by the Contractor to illustrate a material, product or system for some portion of the Work. 4.12.3 Samples are physical examples which illustrate materials, equipment or workmanship and establish standards by which the Work will be judged. 4.12.4 The Contractor shall review, approve and submit, with reasonable promptness and in such sequence as to cause no delay in the Work or in the work of the State or any separate contractor, all Shop Drawings, Product Data and Samples required by the Contract Documents. 4.12.5 By approving and submitting Shop Drawings, Product Data and Samples, the Contractor represents that he / she has determined and verified all materials, field measurements, and field construction criteria related thereto, or will do so, and that he / she has checked and coordinated the information contained within such submittals with the requirements of the Work and of the Contract Documents. 4.12.6 The Contractor shall not be relieved of responsibility for any deviation from the requirements of the Contract Documents by the Architect's approval of Shop Drawings, Product Data or Samples under Subparagraph 2.2.7 of these General Conditions unless the Contractor has specifically informed the Architect and the State in writing of such deviation at the time of sub- mission and the Architect and the State has given written approval to the specific deviation. The Contractor shall not be relieved from responsibility for errors or omissions in the Shop Drawings, Product Data or Samples by the Architect's approval thereof. 4.12.7 The Contractor shall direct specific attention, in writing or on resubmitted Shop Drawings, Product Data or Samples, to revisions other than those requested by the Architect on previous submittals. 4.12.8 No portion of the Work requiring submission of a Shop Drawing, Product Data or Sample shall be commenced until the submittal has been approved by the Architect as provided in Subparagraph 2.2.7 of these General Conditions. All such portions of the Work shall be in accordance with approved submittals.

  • DRUG/ALCOHOL TESTING Section 33.1 Drug testing may be conducted on employees during their duty hours upon reasonable suspicion or randomly by computer selection. Alcohol testing will be conducted only upon reasonable suspicion. Reasonable suspicion that an employee used or is using a controlled substance or alcohol in an unlawful or abusive manner may be based upon, but not limited to: A. Observable phenomena, such as direct observation of drug or alcohol use or possession and/or the physical symptoms of being under the influence of a drug or alcohol; B. A pattern or abnormal conduct or erratic behavior, including abnormal leave patterns; C. Arrest or conviction for a drug or alcohol-related offense, or the identification of an employee as the focus of a criminal investigation into illegal drug or alcohol possession, use, or trafficking; D. Information provided either by reliable and credible sources or independently corroborated; E. Evidence that an employee has tampered with a previous drug test; F. Facts or circumstances developed in the course of an authorized investigation of an accident or unsafe working practices. Section 33.2 Drug/alcohol testing shall be conducted solely for administrative purposes and the results obtained shall not be used in criminal proceedings. Under no circumstances may the results of drug/alcohol screening or testing be released to a third party for use in a criminal prosecution against the affected employee. The following procedure shall not preclude the Employer from other administrative action but such actions shall not be based solely upon the initial reagent testing results alone. Section 33.3 All drug screening tests shall be conducted by laboratories meeting the standards of the Substance Abuse and Mental Health Service Administration. No test shall be considered positive until it has been confirmed by a Gas Chromatography/Mass Spectrometry. The procedures utilized by the Employer and testing laboratory shall include an evidentiary chain of custody control and split sample testing. All procedures shall be outlined in writing and this outline shall be followed in all situations arising under this article. Section 33.4 Alcohol testing shall be done in accordance with the law of the State of Ohio to detect drivers operating a motor vehicle under the influence. A positive result shall entitle the Employer to proceed with sanctions as set forth in this Article. Section 33.5 The results of the testing shall be delivered to a specified employee of the Employer with command responsibility and the employee tested. An employee whose confirmatory test result is positive shall have the right to request a certified copy of the testing results in which the vendor shall affirm that the test results were obtained using the approved protocol methods. The employee shall provide a signed release for disclosure of the testing results to the Employer. A representative for the bargaining unit shall have a right of access to the results upon request to the Employer, with the employee’s written consent. Refusal to submit to the testing provided for under this Agreement may be grounds for discipline. A. If a drug screening test is positive, a confirmatory test shall be conducted utilizing the fluid from the primary sample. B. In the event that any confirmation drug test results are positive, the employee is entitled to have the split sample tested by another DHHS-certified lab in the manner prescribed above at the employee’s expense. The employee must request the split sample test within seventy-two (72) hours of being notified of a positive result. The results of this test, whether positive or negative, shall be determinative. Section 33.7 A list of three (3) testing laboratories shall be maintained by the Employer. These laboratories shall conduct any testing directed by the Employer. The Employer shall obtain the approval of the bargaining unit representative as to any laboratories put on this list, which approval shall not be unreasonably withheld. Section 33.8 If after the testing required above has produced a positive result the Employer may require the employee to participate in any rehabilitation or detoxification program that is covered by the employee’s health insurance. Discipline allowed by the positive findings provided for above shall be deferred pending rehabilitation of the employee within a reasonable period. An employee who participates in a rehabilitation or detoxification program shall be allowed to use sick time and vacation leave for the period of the rehabilitation or detoxification program. If no such leave credits are available, the employee shall be placed on medical leave of absence without pay for the period of the rehabilitation or detoxification program. Upon completion of such program and upon receiving results from a retest demonstrating that the employee is no longer abusing a controlled substance/alcohol, the employee shall be returned to his/her former position. Such employee may be subject to periodic retesting upon his/her return to his/her position for a period of one (1) year from the date of his/her return to work. Any employee in a rehabilitation or detoxification program in accordance with this Article will not lose any seniority or benefits, should it be necessary for the employee to be placed on medical leave of absence without pay, for a period not to exceed ninety (90) days. Section 33.9 If the employee refuses to undergo rehabilitation or detoxification, or if he/she tests positive during a retesting within one (1) year after his/her return to work from such a program, the employee shall be subject to disciplinary action, including removal from his/her position and termination of his/her employment. Section 33.10 Costs of all drug screening tests and confirmatory tests shall be borne by the Employer except that any test initiated at the request of the employee shall be at the employee’s expense. Section 33.11 The Employer may conduct four (4) tests of an employee during the one (1) year period after the employee has completed a rehabilitation or detoxification program as provided above. Section 33.12 The provisions of this Article shall not require the Employer to offer a rehabilitation/detoxification program to any employee more than once.