Sampling The Licensee agrees that the Composition is purchased as a “Work Made for Hire” whereby the clearing of any sampled materials is the responsibility of Licensee.
Screening The Health Plan must work with contracted providers to conduct interperiodic EPSDT screens on RIte Care and all ACA Adult Expansion Population members under age 21 (i.e. 19 and 20-year old under this Agreement) to identify health and developmental problems in conformance with ATTACHMENT ED to this Agreement. Additional screens should be provided as Medically Necessary. At a minimum, these screens must include: • A comprehensive health and developmental history, including health education, nutrition assessment, immunization history, and developmental assessment • Immunizations according to the Rhode Island EPSDT Periodicity Schedule • An unclothed physical examination • Laboratory tests including lead, TB, and newborn screenings as medically indicated • Vision testing • Hearing testing • Dental screening oral examination by PCP as part of a comprehensive examination required before age one (1) • All other medically indicated screening services • And provide EOHHS with a list of established CPT/HCPC codes used to identify all billable services included in the EPSDT schedule.
Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.
Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.
Remediation If Contractor claims that its products or services satisfy the applicable requirements and standards specified in Section 4.2.1 and it is later determined by HCA that any furnished product or service is not in compliance with such requirements and standards, HCA will promptly inform Contractor in writing of noncompliance. Contractor shall, at no additional cost to HCA, repair or replace the non-compliant products or services within the period specified by HCA. If the repair or replacement is not completed within the specified time, HCA may cancel the Contract, delivery, task order, or work order, or purchase line item without termination liabilities or have any necessary changes made or repairs performed by employees of HCA or by another contractor, and Contractor shall reimburse HCA for any expenses incurred thereby.