Quality Control and No Diversion Sample Clauses

Quality Control and No Diversion. Once the sublicense agreement becomes effective, the licensees take full control of the development, registration, importation, manu- facturing, and marketing of the licensed products.247 Therefore, Pfizer only plays a limited supporting role at this stage. Upon the licensee’s request through MPP, Pfizer provides a discrete data package related to the licensed products on a confidential basis. It has the discretion to limit the contents of the package.248 The agreement does not require Pfizer to provide any technical support or assistance to the licensees.249 During the development process, the licensee may also conduct clinical trials or other studies with the licensed products.250 Pfizer re- tains the right to review the licensee’s “study design, specifications, protocol and related materials of any proposed studies.”251 Even if Pfizer approves the studies proposed by the licensee, it will not be- come a sponsor or hold regulatory responsibility unless otherwise specified in the agreement.252 Pfizer is not responsible for any liabili- ties incurred during the studies or trials conducted by the licensee. However, Pfizer may request to use the data free of charge in the same manner that it uses any improvements made by licensees.253 244. Id. 245. Id. §4.2. 246. Id. §4.4. 247. Id. at Exhibit D, §3.1. 248. Id. at Exhibit D, §3.2. 249. Id. 250. Id. at Exhibit D, §3.3. 251. Id. 252. Id. 253. Id. at Exhibit D, §3.4. 2022] BEYOND COMPULSORY LICENSING 35 In the manufacturing process, the licensee must comply either with the WHO prequalification standards or with the standards of the country where the manufacture is located. The licensee must observe all the laws and regulations in the jurisdiction, as well as standard manufacturing practices in the industry.254 Without either WHO prequalification or the government ap- proval, the licensee is prohibited from marketing the licensed prod- ucts.255 While the licensee is solely responsible for seeking regulatory approvals, Pfizer will facilitate the application process to the extent necessary.256 Like the TRIPS Agreement Article 31bis, the Pfizer-MPP Agree- ment sets forth measures to prevent market diversion.257 Licensees are not permitted to market, distribute, or donate the licensed products outside the authorized territory except as expressly permitted in the agreement.258 The prohibition includes when a licensee “knows, be- lieves or ought reasonably to suspect” the licensed products will enter unauthorized terri...
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Related to Quality Control and No Diversion

  • Quality Control A. Controlled Affiliate agrees to use the Licensed Marks and Name only in connection with the licensed services and further agrees to be bound by the conditions regarding quality control shown in attached Exhibit A as they may be amended by BCBSA from time-to-time.

  • Quality Control Program The Contractor shall describe the Quality Control Program in a written document which shall be reviewed by the Engineer prior to the start of any production, construction, or off-site fabrication. The written Quality Control Program shall be submitted to the Engineer for review at least ten (10) calendar days before the start of construction. The Quality Control Program shall be organized to address, as a minimum, the following items:

  • Quality control system (i) The Contractor shall establish a quality control mechanism to ensure compliance with the provisions of this Agreement (the “Quality Assurance Plan” or “QAP”).

  • Quality Control Plan Within forty five (45) days after the design development documents are approved, the Design-Builder shall develop a quality control plan for the Project (the “Quality Control Plan”). A draft of the Quality Control Plan shall be submitted to the Department and shall be subject to the Department’s review and approval. The Quality Control Plan shall be tailored to the specific products/type of construction activities contemplated by the GMP Basis Documents, and in general, shall include a table of contents, quality control team organization, duties/responsibilities of quality control personnel, submittal procedures, inspection procedures, deficiency correction procedures, documentation process, and a list of any other specific actions or procedures that will be required for key elements of the Work.

  • Commodity Compliance and Compatibility It is the Contractor’s responsibility to ensure that the Commodities supplied are compliant with the Contract requirements, specifications, terms, and conditions. Additionally, the Contractor shall ensure that all Commodities ordered by the Customer are fully compatible with each other and with any associated pre-existing Commodity possessed by the Customer and disclosed to the Contractor by the Customer. The Contractor’s acceptance of the Customer’s order shall indicate that the Contractor agrees to deliver a Commodity that is fully compliant and compatible with the Customer’s order requirements, specifications, terms, and conditions. In the event any ordered Base Equipment, OEM and Non-OEM Option(s), Part(s), Accessory(ies), and Implement(s); and their respective features, equipment, and components are found by the Customer to be missing, incorrect, defective, damaged, non- compatible, or non-compliant, the Contractor shall, at the Customer’s discretion, be required to complete one of the following: • Install or repair the Base Equipment, OEM and Non-OEM Option(s), Part(s), Accessory(ies), and Implement(s), and their respective features, equipment, and components; • Replace the Base Equipment, OEM and Non-OEM Option(s), Part(s), Accessory(ies), and Implement(s); and their respective features, equipment, and components; • Refund the purchase price of the Base Equipment, OEM and Non-OEM Option(s), Part(s), Accessory(ies), and Implement(s); and their respective features, equipment, and components to the Customer. Any changes necessary after the delivery of the Customer’s order that are required to bring a Commodity into compliance or compatibility due to an incorrect order fulfillment by the Contractor shall be accomplished at the Contractor’s expense.

  • Data Integrity Control Personal Data will remain intact, complete and current during processing activities.

  • Supervisory Control and Data Acquisition (SCADA) Capability The wind plant shall provide SCADA capability to transmit data and receive instructions from the ISO and/or the Connecting Transmission Owner for the Transmission District to which the wind generating plant will be interconnected, as applicable, to protect system reliability. The Connecting Transmission Owner for the Transmission District to which the wind generating plant will be interconnected and the wind plant Developer shall determine what SCADA information is essential for the proposed wind plant, taking into account the size of the plant and its characteristics, location, and importance in maintaining generation resource adequacy and transmission system reliability in its area.

  • Quality control records and Documents The Contractor shall hand over a copy of all its quality control records and documents to the Authority’s Engineer before the Completion Certificate is issued pursuant to Clause 12.2. The Contractor shall submit Road Signage Plans to the Authority Engineer for approval at least 6 (six) months prior to expected completion of Project Highway.

  • Quality Assurance/Quality Control Contractor shall establish and maintain a quality assurance/quality control program which shall include procedures for continuous control of all construction and comprehensive inspection and testing of all items of Work, including any Work performed by Subcontractors, so as to ensure complete conformance to the Contract with respect to materials, workmanship, construction, finish, functional performance, and identification. The program established by Contractor shall comply with any quality assurance/quality control requirements incorporated in the Contract.

  • Department of Health and Human Services An employee notified of a positive controlled substance or alcohol test result may request an independent test of their split sample at the employee’s expense. If the test result is negative, the Employer will reimburse the employee for the cost of the split sample test. An employee who has a positive alcohol test and/or a positive controlled substance test may be subject to disciplinary action, up to and including dismissal, based on the incident that prompted the testing, including a violation of the drug and alcohol free work place rules.

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