DSCSA Sample Clauses
The DSCSA clause establishes requirements for compliance with the Drug Supply Chain Security Act, a federal law governing the traceability and safety of prescription drugs in the United States. This clause typically obligates parties involved in the manufacture, distribution, or sale of pharmaceuticals to maintain records, verify trading partners, and ensure proper product tracing and serialization. By mandating adherence to DSCSA standards, the clause helps prevent counterfeit or unsafe drugs from entering the supply chain, thereby protecting public health and ensuring regulatory compliance.
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DSCSA. Seller and Equity Holder agree to provide or to cause to be provided to Buyer all product tracing information that is required in connection with requirements under the Drug Supply Chain Security Act (“DSCSA”) for the prescription merchandise to be purchased by Buyer under Section 1(a)(i) hereof, including, without limitation, transaction histories, transaction statements, and transaction information, for such merchandise (collectively, the “DSCSA Records”). At no additional cost to Buyer, Seller shall cooperate and assist Buyer, at least thirty (30) days prior to the Date of Inventory, in Buyer’s efforts to effect a transfer of the DSCSA Records. Such cooperation shall include Seller taking such acts as may be necessary, including, without limitation, executing a release or authorization for the benefit of any third parties that are maintaining any DSCSA Records on behalf of Seller, as may be necessary to facilitate the transfer of all DSCSA Records to Buyer. The terms and provisions of this Section 2(f) shall survive the Closing.
DSCSA. Sellers agree to provide Buyer with all product tracing information and other information required by the Drug Supply Chain Security Act (“DSCSA”) for the prescription merchandise to be purchased by Buyer under Section 1.1(b)(ii) hereof, including, without limitation, transaction histories, transaction statements, and transaction information, for such merchandise (collectively, the “DSCSA Records”). At no additional cost to Buyer, Sellers shall fully cooperate and assist Buyer, at least thirty (30) days prior to the Closing Date, in Buyer’s efforts to effect a transfer of the DSCSA Records using such means and efforts as determined by Buyer in its sole discretion. Such cooperation shall include Sellers taking such actions as may be necessary, including, without limitation, executing a release or authorization for the benefit of any third parties that are maintaining any DSCSA Records on behalf of Sellers, as may be necessary to facilitate the transfer of all DSCSA Records to Buyer.
DSCSA. Cardinal Health currently has projects and processes in place to comply with the DSCSA guidelines as they pertain to returns. System tools are currently being tested, internally and externally, to ensure that the DSCSA-required data points are recorded accurately. Once the testing is successful, the data elements will act behind the scenes with no inconvenience to our customers.
DSCSA. Wholesaler will retain all 3T Data per the requirements specified by the DSCSA, a minimum of six (6) years, for MMCAP Infuse Members served by the Wholesaler, regardless of whether or not the MMCAP Infuse Members are presently utilizing the Wholesaler for pharmaceutical distribution services. Access to the 3T Data, for the required timeline, will be provided at no charge to MMCAP Infuse Members. Wholesaler access will be consistent with the requirement to allow the MMCAP Infuse Member enough time to respond to the FDA within 48 hours for product inquiries. MMCAP Infuse Participating Facilities will have the responsibility of utilizing the third-party end user agreement to document that the Wholesaler will hold and retain 3T data.
DSCSA. Cardinal Health currently has projects and processes in place to comply with the DSCSA guidelines as they pertain to returns. System tools are currently being tested, internally and externally, to ensure that the DSCSA-required data points are recorded accurately. Once the testing is successful, the data elements will act behind the scenes with no inconvenience to our customers. There are four data elements required by DSCSA as they pertain to returns, so as long as the product is still in saleable condition and as long as the four data elements are present for the return product, there will not be a change in our returns policy. This policy is subject to change without prior notice by Cardinal Health. This policy is further subject to modification as may be deemed necessary or appropriate by Cardinal Health to comply with applicable federal and/or state regulations, FDA guidelines, state law, and other restrictions applicable to returned products. Cardinal Health will use commercially reasonable efforts to notify MMCAP of any change to this policy within ten (10) business days of said change. Caroinal MMS1900113 This Agreement ("MPA") is entered into by the State of New York ("Member") and Cardinal Health 110, LLC and Cardinal Health 112, LLC, whose designated business address is ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇, {"Vendor") and the MMCAP Infuse, an agency of the State of Minnesota {"MMCAP Infuse"), regarding vendor contract MMS1900113 ("Vendor Contract").
DSCSA. Inquire with the Vendor for further information regarding obtaining traceability transaction information. MMCAP resource: ▇▇▇▇://▇▇▇.▇▇▇.▇▇▇▇▇.▇▇▇▇▇.▇▇.▇▇/mmcap/News/DataFile.aspx?fid=2729
DSCSA. Seller and Equity Holder agree to provide Buyer with all product tracing information and other information required by the Drug Supply Chain Security Act (“DSCSA”) for the Inventory to be purchased by Buyer under Section 1(a)(i) hereof, including, without limitation, transaction histories, transaction statements, and transaction information, for such Inventory (collectively, the “DSCSA Records”). At no additional cost to Buyer, Seller shall fully cooperate and assist ▇▇▇▇▇, commencing as of the date hereof, in ▇▇▇▇▇’s efforts to effect a transfer of the DSCSA Records using such means and efforts as determined by ▇▇▇▇▇ in its sole discretion. Such cooperation shall include Seller taking such acts as may be necessary, including, without limitation, executing a release or authorization for the benefit of any third parties that are maintaining any DSCSA Records on behalf of Seller, as may be necessary to facilitate the transfer of all DSCSA Records to Buyer. The terms and provisions of this Section 2(g) shall survive the Closing.