Drug Supply Chain Security Act Sample Clauses

Drug Supply Chain Security Act. The Parties agree to strictly comply with the Drug Supply Chain Security Act, and all other laws related to the subject matter of this Agreement.
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Drug Supply Chain Security Act. (1) Capitalized terms used in this Section 11.14 will have the meanings set forth in the Drug Supply Chain Security Act of 2013, 21 U.S.C. Section 360eee, et seq., and the rules, regulations and guidance thereunder, all as amended from time to time (collectively, the “DSCSA”). (2) Each Party agrees to comply with all provisions of the DSCSA applicable to such Party. Upon any amendment of the DSCSA or the issuance of rules, regulation or guidance thereunder, the Parties will reasonably cooperate with each other to amend this Agreement, as necessary, in order to permit each Party to comply with its obligations pursuant to the DSCSA. (3) With respect any Product provided by ANXXXXXX xnder this Agreement, ANXXXXXX xill provide to Eton, in such form and format as Eton shall reasonably request from time to time, any information required by Eton to complete and provide, in accordance with the DSCSA, Transaction Information and Transaction History for such Product (including, without limitation, lot-level information and, when required under DSCSA, Product Identifier information). (4) ANXXXXXX, through CMO, will affix or imprint a Product Identifier to each package and homogenous case of Product provided by ANXXXXXX xnder this Agreement. In connection with ANXXXXXX’x xerformance pursuant to this Section 11.14(4), ANXXXXXX xill reasonably cooperate with Eton (including, without limitation, cooperating to implement Product Identifiers and related information technology that are compatible with Eton’s systems and industry standards, and that comply with the DSCSA). (5) ANXXXXXX, through CMO, will implement and have in place systems to enable ANXXXXXX, through CMO, to engage in the actions and perform the procedures set forth in 21 U.S.C. Section 360eee-1(b)(4) and Section 360eee-1(g)(1) and the rules, regulations and guidance thereunder (all as amended from time to time) to the same extent as if ANXXXXXX xere the manufacturer referred to therein. Upon Eton’s request, ANXXXXXX, through CMO, will engage in such actions and perform such procedures and will, as reasonably requested by Eton, cooperate with Eton and Eton’s designees in connection therewith (such cooperation to include, without limitation, providing any additional requested information). (6) ANXXXXXX xcknowledges that the DSCSA may require that Eton provide information to the FDA, other government agencies or Trading Partners within twenty-four (24) hours after the occurrence of events specified in the DSCS...
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Drug Supply Chain Security Act. (a) Capitalized terms used in this Section 5.5 will have the meanings set forth in the Drug Supply Chain Security Act of 2013, 21. U.S.C. Section 360eee, et seq., and the rules, regulations and guidance there-under, all as amended and in effect from time to time (collectively, the “DSCSA”). (b) Ingenus will affix or imprint a Product Identifier to each package, each homogenous case and each pallet of Product provided by Ingenus under this Agreement and these Product Identifiers (serial numbers) will be fully aggregated and communicated electronically in EPCIS format in GS1 EPCIS 1.1 standard. (c) Each Party will keep and maintain records of its performance under this Section 5.5 for not less than Three (3) years after such records are generated or such longer period as may be required under the DSCSA.
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Drug Supply Chain Security Act. The provision of doses of the Protoype Project will be compliant with applicable provisions of the Drug Supply Chain Security Act (DSCSA) Sections 581-585 of PL 113-54 (Nov 27, 2013), taking into account FDA’s regular guidance for the public health response.
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Drug Supply Chain Security Act. From and after the Closing Date, the Seller shall maintain product serialization data related to the Products sold by the Seller prior to the Closing or during the TSA Period in Seller’s label for so long as is required by applicable Law. From and after the Closing Date, the Purchaser shall maintain product serialization data related to the Products sold by the Purchaser after the Closing in Seller’s label for so long as is required by applicable Law. The Seller shall field serialization inquiries and promptly communicate all such inquiries in writing to the Purchaser. The Purchaser shall be responsible for payment of the costs and for investigating and responding to serialization inquiries, providing a written copy of all such investigations and responses to the Seller.
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Drug Supply Chain Security Act. Effective July 1, 2015, Section 582 (d) (1)(A) of the Drug Supply Chain Security Act (“DSCSA”) requires pharmacies (“Dispensers”) to capture and transmit the transaction history, transaction information and transaction statement (collectively “Transaction Data”) for pharmaceutical products received from an authorized wholesaler(s). Subject to the termination provisions below, and subject to Retailer’s signature of agreement to the terms and conditions of the Drug Supply Chain Security Act Agreement to Maintain Transaction Data attached as Exhibit “4” of this Agreement (“Data Maintenance Agreement”), Company agrees to confidentially maintain for six (6) years, beginning on the date of a transaction, the Transaction Data required to be maintained by Retailer under subsection 582(d) of the DSCSA at no additional charge to Retailer . Retailer may access the Transaction Data at Company’s proprietary website xxxx://xxx.xxxxxxxxxxxx.xxx. Only Transaction Data for products sold to Retailer by Company will be maintained. Retailer agrees that it is responsible to maintain for six (6) years the transactional data required by the DSCSA for product it receives direct from the manufacturer (e.g., by drop shipment) or from any sources other than Company.
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Related to Drug Supply Chain Security Act

  • Supply Chain Security Supplier shall implement and maintain a written security program that consists of physical and procedural controls: to (a) prevent unauthorized access to Supplier’s facilities; (b) prevent finished goods or equipment from being tampered with, stolen or damaged prior to Supplier’s delivery in accordance with the terms of this Order; and (c) detect when malicious activity has occurred (the “Supply Chain Security Program”). Supplier’s Supply Chain Security Program shall align to the World Customs Organization’s SAFE Framework of Standards to Secure and Facilitate Global Trade (“SAFE Framework”) or other global security programs recognized by the World Customs Organization. Supplier shall flow down and verify the requirements of its Supply Chain Security Program to its sub-tier suppliers, if applicable. Supplier shall test its Supply Chain Security Program at least annually or whenever there are material changes in Supplier’s operations, risks or business practices. Upon Buyer’s written and reasonable request, Supplier shall provide Buyer with: (i) a copy of Supplier’s Supply Chain Security Program; (ii) an executive summary of test results and a report of corrective actions (including the timing for implementation) to be taken to remedy any deficiencies identified by such testing; and (iii) any audit results or findings resulting from Supplier’s periodic audit or testing of its sub-tier suppliers’ security programs.

  • Procurement of Goods Part A: General Goods shall be procured in accordance with the provisions of Section I of the "Guidelines for Procurement under IBRD Loans and XXX Credits" published by the Bank in January 1995 and revised in January 1996 (the Guidelines) and the following provisions of this Section, as applicable. Part B: International Competitive Bidding

  • Procurement of Goods and Services (a) If the HSP is subject to the procurement provisions of the BPSAA, the HSP will abide by all directives and guidelines issued by the Management Board of Cabinet that are applicable to the HSP pursuant to the BPSAA. (b) If the HSP is not subject to the procurement provisions of the BPSAA, the HSP will have a procurement policy in place that requires the acquisition of supplies, equipment or services valued at over $25,000 through a competitive process that ensures the best value for funds expended. If the HSP acquires supplies, equipment or services with the Funding it will do so through a process that is consistent with this policy.

  • Alcohol and Drug Testing Employee agrees to comply with and submit to any Company program or policy for testing for alcohol abuse or use of drugs and, in the absence of such a program or policy, to submit to such testing as may be required by Company and administered in accordance with applicable law and regulations.

  • National Treatment and Most-favoured-nation Treatment (1) Each Contracting Party shall accord to investments of investors of the other Contracting Party, treatment which shall not be less favourable than that accorded either to investments of its own or investments of investors of any third State. (2) In addition, each Contracting Party shall accord to investors of the other Contracting Party, including in respect of returns on their investments, treatment which shall not be less favourable than that accorded to investors of any third State. (3) The provisions of paragraphs (1) and (2) above shall not be construed so as to oblige one Contracting Party to extend to the investors of the other the benefit of any treatment, preference or privilege resulting from: (a) Any existing or future free trade area, customs unions, monetary union or similar international agreement or other forms of regional cooperation to which one of the Contracting Parties is or may become a party, or (b) Any matter pertaining wholly or mainly to taxation.

  • Regulatory Applications (a) Western and PNB and their respective Subsidiaries shall cooperate and use their respective reasonable best efforts to prepare all documentation, to effect all filings and to obtain all permits, consents, approvals and authorizations of all third parties and Governmental Authorities necessary to consummate the transactions contemplated by this Agreement. Western and PNB shall use their reasonable best efforts to make all required bank regulatory filings, including the appropriate filing with the Regulatory Authorities. Each of Western and PNB shall have the right to review in advance, and to the extent practicable each will consult with the other, in each case subject to applicable laws relating to the exchange of information, with respect to all material written information submitted to any third party or any Governmental Authority in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto agrees to act reasonably and as promptly as practicable. Each party hereto agrees that it will consult with the other party hereto with respect to the obtaining of all material permits, consents, approvals and authorizations of all third parties and Governmental Authorities necessary or advisable to consummate the transactions contemplated by this Agreement and each party will keep the other party appraised of the status of material matters relating to completion of the transactions contemplated hereby. (b) Each party agrees, upon request, to furnish the other party with all information concerning itself, its Subsidiaries, directors, officers and shareholders and such other matters as may be reasonably necessary or advisable in connection with any filing, notice or application made by or on behalf of such other party or any of its Subsidiaries to any third party or Governmental Authority.

  • Anti-Money Laundering and Red Flag Identity Theft Prevention Programs The Trust acknowledges that it has had an opportunity to review, consider and comment upon the written procedures provided by USBFS describing various tools used by USBFS which are designed to promote the detection and reporting of potential money laundering activity and identity theft by monitoring certain aspects of shareholder activity as well as written procedures for verifying a customer’s identity (collectively, the “Procedures”). Further, the Trust and USBFS have each determined that the Procedures, as part of the Trust’s overall Anti-Money Laundering Program and Red Flag Identity Theft Prevention Program, are reasonably designed to: (i) prevent each Fund from being used for money laundering or the financing of terrorist activities; (ii) prevent identity theft; and (iii) achieve compliance with the applicable provisions of the Bank Secrecy Act, Fair and Accurate Credit Transactions Act of 2003 and the USA Patriot Act of 2001 and the implementing regulations thereunder. Based on this determination, the Trust hereby instructs and directs USBFS to implement the Procedures on the Trust’s behalf, as such may be amended or revised from time to time. It is contemplated that these Procedures will be amended from time to time by the parties as additional regulations are adopted and/or regulatory guidance is provided relating to the Trust’s anti-money laundering and identity theft responsibilities. USBFS agrees to provide to the Trust: (a) Prompt written notification of any transaction or combination of transactions that USBFS believes, based on the Procedures, evidence money laundering or identity theft activities in connection with the Trust or any Fund shareholder; (b) Prompt written notification of any customer(s) that USBFS reasonably believes, based upon the Procedures, to be engaged in money laundering or identity theft activities, provided that the Trust agrees not to communicate this information to the customer; (c) Any reports received by USBFS from any government agency or applicable industry self-regulatory organization pertaining to USBFS’ Anti-Money Laundering Program or the Red Flag Identity Theft Prevention Program on behalf of the Trust; (d) Prompt written notification of any action taken in response to anti-money laundering violations or identity theft activity as described in (a), (b) or (c) immediately above; and (e) Certified annual and quarterly reports of its monitoring and customer identification activities pursuant to the Procedures on behalf of the Trust. The Trust hereby directs, and USBFS acknowledges, that USBFS shall (i) permit federal regulators access to such information and records maintained by USBFS and relating to USBFS’ implementation of the Procedures, on behalf of the Trust, as they may request, and (ii) permit such federal regulators to inspect USBFS’ implementation of the Procedures on behalf of the Trust.

  • Supply of Goods 6.1 In consideration of UKRI’s agreement to pay the Charges, the Supplier shall supply all Goods in accordance with the Agreement and any Contract. In particular, the Supplier warrants that the Goods shall: (a) conform with their description in the specifications (including the Specification), drawings, descriptions given in quotations, estimates, brochures, sales, marketing and technical literature or material (in whatever format made available by the Supplier) supplied by, or on behalf of, the Supplier; (b) be of satisfactory quality (within the meaning of the Sale of Goods Act 1979) and fit for any purpose held out by the Supplier or made known to the Supplier by UKRI, expressly or by implication, and in this respect UKRI relies on the Supplier's skill and judgement. The Supplier acknowledges and agrees that the approval by UKRI shall not relieve the Supplier of any of its obligations under this sub-clause; (c) where applicable, be free from defects (manifest or latent), in materials and workmanship and remain so for 12 months after Delivery; (d) be free from design defects; (e) comply with all applicable statutory and regulatory requirements relating to the manufacture, labelling, packaging, storage, handling and delivery of the Goods; (f) be supplied in accordance with all applicable legislation in force from time to time; and (g) be destined for supply into, and fully compliant for use in, the United Kingdom (unless specifically stated otherwise in the Specification). 6.2 In supplying the Goods, the Supplier shall co-operate with UKRI in all matters relating to the supply of the Goods and comply with all of UKRI’s instructions. 6.3 The Supplier shall ensure that at all times it has and maintains all the licences, permissions, authorisations, consents and permits that it needs to carry out its obligations under the Agreement. 6.4 UKRI and its representatives shall have the right to inspect and test the Goods at any time before Delivery. 6.5 If following such inspection or testing UKRI considers that the Goods do not conform or are unlikely to comply with the Supplier's undertakings at clause 6.1, UKRI shall inform the Supplier and the Supplier shall immediately take such remedial action as is necessary to ensure compliance. 6.6 Notwithstanding any such inspection or testing, the Supplier shall remain fully responsible for the Goods and any such inspection or testing shall not reduce or otherwise affect the Supplier's obligations under this Agreement, and UKRI shall have the right to conduct further inspections and tests after the Supplier has carried out its remedial actions. 6.7 UKRI’s rights under the Agreement are without prejudice to and in addition to the statutory terms implied in favour of UKRI under the Sale of Goods Act 1979, the Supply of Goods and Services Act 1982 and any other applicable legislation as amended.

  • Musculoskeletal Injury Prevention and Control The hospital in consultation with the Joint Health and Safety Committee (JHSC) shall develop, establish and put into effect, musculoskeletal prevention and control measures, procedures, practices and training for the health and safety of employees.

  • Manufacturing Standards All forest products except poles, produced and sold under this contract will be manufactured to maximize the amount of logs meeting preferred log lengths and to achieve the average log length listed. 97318 3 WS "WS" indicates that west side scaling rules apply. Minimum trim is 8 inches per scaling segment for west side scaling rules. "ES" indicates that east side scaling rules apply. Minimum trim is 4 inches per scaling segment for east side scaling rules. Poles produced under this contract will be manufactured to ANSI specifications (American National Standard Specifications and Dimensions for Wood Poles), in force at the time of signing this contract. a. Sweep will be limited to within the bole of the log as measured using a tape stretched between the centers of each end of the log. b. Logs approved by the state for peelers shall be chuckable with no more than a 2 inch diameter area of rot within a 5 inch diameter circle located at the center of either end of the log. c. Limbs and knots shall be cut flush, with no more than 15 percent of a log having limbs or knots over 2 inches in diameter extending more than 2 inches above the surface of the log.

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