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.
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: (...
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.

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.

  • 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.

  • Combination Product The term “

  • 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.

  • Safety Glasses Section 1. The City shall supply prescription safety glasses with plastic lenses to employees who are required to wear safety glasses and who are members of the classifications contained in Appendix C to this contract. Safety glasses which are authorized must be industrial grade safety glasses which meet or exceed the requirements of ANSI Specification Z87. 1. All employees who are required to wear safety glasses shall also be required to wear side xxxxxxx, either permanent or snap-on, whenever an eye hazard exists. Solid tinted glasses will not be approved unless required by prescription. Photogray, progressive, scratch coating and/or anti-glare lenses may be considered for those employees who primarily work outdoors or as prescribed. In the event that additional classes are identified as needing either prescription safety glasses or protective eyewear, such classes may be added to the classification list in Appendix C upon approval of PAGE and the City. Section 2. The City agrees to pay the full cost of required prescription safety glasses, with frames not to exceed $75.00. This excludes the cost of the eye examination which will be the responsibility of the employee. The effected employees will be allowed one (1) replacement of safety glasses every two (2) years. In the event the safety glasses become lost, unserviceable, or broken on the job, the employee must present a written request for replacement to the Department Head and Human Resources Director. If the employee breaks his safety glasses while on the job, the Department shall replace the glasses at no cost to the employee. The replacement of lost glasses or glasses that are broken off the job will be at the discretion of the Department Head and Human Resources Director. If an employee has been provided safety glasses by the City, the employee shall be permitted to retain possession of the glasses after separation from the City without reimbursing the City for any costs associated with the glasses. Section 3. An employee who is required to wear prescription safety glasses must present a written request to his department head or designated representative. Section 4. The employee must obtain a current prescription and the employee is authorized the use of sick leave not to exceed two (2) hours to accomplish this examination. The employee will obtain a purchase order from the Department Head prior to ordering the safety glasses. The employee will present the purchase order to the appropriate vendor when ordering. The vendor will contact the appropriate Department Head when the glasses are ready for delivery. The Department Head will then notify the employee who will present himself at the vendor for fitting and pickup. Section 5. In the event a probationary employee has been issued safety glasses and terminates his employment with the City for any reason during the probationary period, he shall be required to reimburse the City for any expenses incurred in the purchase of safety glasses.

  • Prescription Drugs The agreement may impose a variety of limits affecting the scope or duration of benefits that are not expressed numerically. An example of these types of treatments limit is preauthorization. Preauthorization is applied to behavioral health services in the same way as medical benefits. The only exception is except where clinically appropriate standards of care may permit a difference. Mental disorders are covered under Section A. Mental Health Services. Substance abuse disorders are covered under

  • Mileage Measurement Where required, the mileage measurement for LIS rate elements is determined in the same manner as the mileage measurement for V&H methodology as outlined in NECA Tariff No. 4.

  • Power Factor Design Criteria Developer shall design the Large Generating Facility to maintain an effective power delivery at demonstrated maximum net capability at the Point of Interconnection at a power factor within the range established by the Connecting Transmission Owner on a comparable basis, until NYISO has established different requirements that apply to all generators in the New York Control Area on a comparable basis. The Developer shall design and maintain the plant auxiliary systems to operate safely throughout the entire real and reactive power design range. The Connecting Transmission Owner shall not unreasonably restrict or condition the reactive power production or absorption of the Large Generating Facility in accordance with Good Utility Practice.

  • Combination Products If a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENT.

  • Unbundled Channelization (Multiplexing) 5.7.1 To the extent NewPhone is purchasing DS1 or DS3 or STS-1 Dedicated Transport pursuant to this Agreement, Unbundled Channelization (UC) provides the optional multiplexing capability that will allow a DS1 (1.544 Mbps) or DS3 (44.736 Mbps) or STS-1 (51.84 Mbps) Network Elements to be multiplexed or channelized at a BellSouth central office. Channelization can be accomplished through the use of a multiplexer or a digital cross-connect system at the discretion of BellSouth. Once UC has been installed, NewPhone may request channel activation on a channelized facility and BellSouth shall connect the requested facilities via COCIs. The COCI must be compatible with the lower capacity facility and ordered with the lower capacity facility. This service is available as defined in NECA 4. 5.7.2 BellSouth shall make available the following channelization systems and interfaces: 5.7.2.1 DS1 Channelization System: channelizes a DS1 signal into a maximum of twenty- four (24)

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