Field Trips Orange COUNTY funds may not be used to support any overnight and/or out of Central Florida travel, unless approved by the COUNTY’S Manager of the CCC or designee in advance. The AGENCY must have on file for field trip(s) that each participant, adult or minor, must have a signed release of liability form releasing the COUNTY from any liability. If the participant is a minor, the release must be signed by a parent/guardian. Central Florida is defined as Orange, Osceola, Seminole, Brevard, Lake, Polk, and Volusia Counties.
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 the U.S. Food and Drug Administration (the “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, 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.
Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.
Other Methods of Procurement of Goods and Works The following table specifies the methods of procurement, other than International Competitive Bidding, which may be used for goods and works. The Procurement Plan shall specify the circumstances under which such methods may be used:
(a) National Competitive Bidding (b) Shopping (c) Direct Contracting
Extra Trips a. Bus Drivers may be absent from driving part and/or all of their regular bus routes to take an extra trip. This will include Kindergarten route, shuttles, and noon Xxxxx Drivers. For Pay purposes the extra trip begins at the end of the driver's regular route.
b. Regular Drivers desiring to take trips shall sign up at first Bus Drivers' Meeting held either prior to or on the opening day of school. Any Driver may join or remove themselves from the list at any time. All extra trips (Educational and Athletic/Group) shall be posted on one (1) list.
c. Eligible Drivers shall be offered trips at a monthly field trip meeting on a seniority rotating basis. Between monthly meetings, trips shall be offered by phone or radio, on a seniority basis.
d. If a Driver cancels a trip they agreed to drive, the trip will be offered to the next driver (who does not have a trip assigned) on a seniority basis from the canceled trip list.
e. Drivers may not exchange trips.
f. Drivers taking a group trip which involves an admission price and/or parking fee shall be covered by the group sponsoring the trip.
g. In the event none of the eligible Drivers on the seniority rotation list are available to take a trip, the Drivers on the as-needed list will be asked. If no regular Drivers are available, then a Sub will be asked. If no Regular or Sub Drivers can take a trip, the Transportation Supervisor will appoint a Driver, starting with the least senior Driver on the DO WANT trips list.
h. The Board may use the radio to contact Drivers for trips. Drivers must make the decision to drive or not to drive the offered trip within two (2) hours.
i. If at all possible, the trips will be scheduled around two (2) weeks in advance.
j. If a Driver shows up for a trip, and has not been notified the trip has been canceled, or a coach/advisor transports students, the Driver will be paid for two (2) regular hours and the driver will not be charged for the trip.
k. If a Driver's trip date is changed, the scheduled Driver will stay on the trip. If the trip is canceled completely, the driver will be inserted next up the seniority rotation. The inserted driver shall not be taken out of rotation for forthcoming trips.
l. If an Athletic Trip is canceled mid-event, the driver will be paid for the actual number of hours on duty; if rescheduled, the rescheduled event will be a new trip on the rotation list and the driver will be paid for the actual number of hours on duty.
m. If a driver is on the insert list and already has a trip on the same day as a newly offered trip, the driver will stay on the insert list until a trip is offered for a day the driver is not already schedule to drive an extra trip.
n. Any driver who cancels an extra trip two (2) or more times in a given month shall be skipped in the next rotation.
o. Pay for extra trips will begin after the driver’s regular route time and will be at the driver’s regular rate of pay for up to two and one-half (2.5) hours for driver time and pre-trip. The remaining portion of the route will be at the Step 0 base rate.
p. Overnight trips shall be considered special trips with reimbursement determined on an individual basis.
q. Drivers on Leaves of Absences are not eligible for extra trips.
r. Drivers are not eligible for extra trips on days on which they have called in and are off.
Particular Methods of Procurement of Goods and Works International Competitive Bidding. Goods and works shall be procured under contracts awarded on the basis of International Competitive Bidding.
Manufacturing Technology Transfer Upon AbbVie’s written request with respect to a given Collaboration CAR-T Product and Licensed Product, Caribou shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party Provider) of all Materials and Know-How Controlled by Caribou relating to the then-current process for the Manufacture of such Collaboration CAR-T Product and any corresponding Licensed Products (each, a “Manufacturing Process”). Caribou shall provide, shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to provide, all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to implement each Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to such Collaboration CAR-T Product and any corresponding Licensed Products. Without limitation of the foregoing, in connection with the Manufacturing Process and related transfer:
(a) Caribou shall, and shall cause its Affiliates to, make available to AbbVie (or its Affiliate or designated Third Party Provider, as applicable), and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Know-How Controlled by Caribou relating to each Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process;
(b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of each Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process;
(c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards);
(d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; and
(e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed Products.
Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.
Technology Upgrades Notwithstanding any other provision of this Agreement, Verizon shall have the right to deploy, upgrade, migrate and maintain its network at its discretion. The Parties acknowledge that Verizon, at its election, may deploy fiber throughout its network and that such fiber deployment may inhibit or facilitate PNG’s ability to provide service using certain technologies. Nothing in this Agreement shall limit Verizon's ability to modify its network through the incorporation of new equipment or software or otherwise. PNG shall be solely responsible for the cost and activities associated with accommodating such changes in its own network.
DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK
