Customer Notification of Adverse Reactions Sample Clauses

Customer Notification of Adverse Reactions. In the event that during the course of a preliminary investigation related to a report of any serious adverse reaction associated with Kogenate® or other Product, Bayer obtains preliminary evidence indicating that, according to indications and dosage, the PPF used in the manufacture of such Product may have caused such specific adverse reaction, each Bayer customer that received any such Product shall be notified by Bayer and cautioned that any unused containers of the suspect lots should be withheld from use, pending the outcome of more definitive investigations and evaluations, with a copy of such notice to the applicable Regulatory Authority if required. Bayer shall promptly provide Supplier with a copy of such notice. Any and all of the foregoing actions will be executed with the concurrence of all relevant Regulatory Authority, to the extent required by law.
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Customer Notification of Adverse Reactions. In the event that during the course of a preliminary investigation related to a report of any adverse reaction associated with any Contractual Product or Finished Product Talecris GmbH or Xxxxx obtains preliminary evidence indicating that any Contractual Product or Finished Product may have caused such specific adverse reaction, each Talecris GmbH customer that received any such Contractual Product or Finished Product shall be notified by Talecris GmbH and cautioned that any unused containers of the suspect lots should be withheld from use, pending the outcome of more definitive investigations and evaluations, with a copy of such notice to the applicable Regulatory Authority if required. Talecris GmbH shall promptly provide Xxxxx with a copy of such notice. Any and all of the foregoing actions will be executed with the concurrence of the appropriate Regulatory Authorities, to the extent required by Applicable Law (as defined below).
Customer Notification of Adverse Reactions. In the event that during the course of a preliminary investigation related. to a report of any serious adverse reaction associated with the Products, Purchaser obtains preliminary evidence indicating that, according to indications and dosage, the Inputs used in the manufacture of the Products may have caused such specific adverse reaction, each Purchaser customer that received any such Products shall be notified by Purchaser and cautioned that any unused containers of the suspect lots should be withheld from use, pending the outcome of more definitive investigations and evaluations, with a copy of such notice to the applicable Regulatory Authority, if required. Purchaser shall promptly provide Bayer with a copy of such notice. Any and all of the foregoing actions will be executed with the concurrence of all relevant Regulatory Authority, to the extent required by law.
Customer Notification of Adverse Reactions. In the event during the course of a preliminary investigation related to a report of a serious adverse reaction, preliminary evidence is obtained indicating that the use of Products of certain lots, according to indications and dosage, may have caused specific adverse reactions, each customer that received product from such suspect lots shall be notified by the Party that sold or otherwise provided such Product, itself or through its Affiliates or third parties (other than the other Party) to such customer and cautioned that any unused containers of the suspect lots should be withheld from use, pending the outcome of more definitive investigations and evaluations, with a copy of such notice to the applicable Regulatory Agency if required and to the other Party. Any and all of the foregoing actions will be executed with Regulatory Agency concurrence to the extent required by law.
Customer Notification of Adverse Reactions. In the event that during the course of a preliminary investigation related to a report of any adverse reaction associated with any Product or any other product manufactured using the Products, a Distributor obtains preliminary evidence indicating that the Product or any other product manufactured from the Products, according to indications and dosage, may have caused such specific adverse reaction, each Distributor customer that received any such Product or such other product shall be notified by such Distributor and cautioned that any unused containers of the suspect lots should be withheld from use, pending the outcome of more definitive investigations and evaluations, with a copy of such notice to the applicable Regulatory Authority if required. Each Distributor shall promptly provide Releasor and Newco (if it is not the Releasor) with a copy of such notice. Any and all of the foregoing actions will be executed with the concurrence of Regulatory Authority, to the extent required by law.
Customer Notification of Adverse Reactions. In the event that during the course of a preliminary investigation related to a report of any serious adverse reaction associated with any Customer Products, Customer obtains preliminary evidence indicating that, according to indications and dosage, the Cryo used in the manufacture of such commercial Products may have caused such specific adverse reaction, each customer that received any such commercial Products shall be notified by Customer and cautioned that any unused containers of the suspect lots should be withheld from use, pending the outcome of more definitive investigations and evaluations, with a copy of such notice to the applicable Regulatory Authority if required. Customer shall promptly provide Talecris with a copy of such notice. Any and all of the foregoing actions will be executed with the concurrence of all relevant Regulatory Authority, to the extent required by law.

Related to Customer Notification of Adverse Reactions

  • Notice of Suits, Adverse Events Furnish Agent with prompt notice of (i) any lapse or other termination of any Consent issued to any Borrower by any Governmental Body or any other Person that is material to the operation of any Borrower's business, (ii) any refusal by any Governmental Body or any other Person to renew or extend any such Consent; and (iii) copies of any periodic or special reports filed by any Borrower with any Governmental Body or Person, if such reports indicate any material change in the business, operations, affairs or condition of any Borrower, or if copies thereof are requested by Lender, and (iv) copies of any material notices and other communications from any Governmental Body or Person which specifically relate to any Borrower.

  • Customer Notification By executing this Agreement, the Advisor acknowledges that as required by the Advisers Act the Sub-Advisor has supplied to the Advisor and the Trust copies of the Sub-Advisor’s Form ADV with all exhibits and attachments (including the Sub-Advisor’s statement of financial condition) and will promptly supply to the Advisor copies of all amendments or restatements of such document. Otherwise, the Advisor’s rights under federal law allow termination of this contract without penalty within five business days after entering into this contract. U.S. law also requires the Sub-Advisor to obtain, verify, and record information that identifies each person or entity that opens an account. The Sub-Advisor will ask for the Trust’s legal name, principal place of business address, and Taxpayer Identification or other identification number, and may ask for other identifying information.

  • DISCLOSURE OF TBS ACCESS CODE TO THIRD PARTY (a) The Account Holder must exercise all care to ensure that the TBS Access Code is not disclosed to any person and shall take all steps to prevent forgery or fraud in connection with the use of his TBS Access Code and/or the operation of the TBS. If the TBS Access Code is disclosed to any person, the Account Holder must forthwith give the Bank written notice thereof, thereupon the Account Holder shall immediately cease to use the TBS Access Code. (b) Unless and until the Bank receives such written notice of disclosure, the Account Holder shall be fully liable and be bound by all transactions effected by the use of such TBS, with or without his consent or knowledge.

  • Handling Sensitive Personal Information and Breach Notification A. As part of its contract with HHSC Contractor may receive or create sensitive personal information, as section 521.002 of the Business and Commerce Code defines that phrase. Contractor must use appropriate safeguards to protect this sensitive personal information. These safeguards must include maintaining the sensitive personal information in a form that is unusable, unreadable, or indecipherable to unauthorized persons. Contractor may consult the “Guidance to Render Unsecured Protected Health Information Unusable, Unreadable, or Indecipherable to Unauthorized Individuals” issued by the U.S. Department of Health and Human Services to determine ways to meet this standard. B. Contractor must notify HHSC of any confirmed or suspected unauthorized acquisition, access, use or disclosure of sensitive personal information related to this Contract, including any breach of system security, as section 521.053 of the Business and Commerce Code defines that phrase. Contractor must submit a written report to HHSC as soon as possible but no later than 10 business days after discovering the unauthorized acquisition, access, use or disclosure. The written report must identify everyone whose sensitive personal information has been or is reasonably believed to have been compromised. C. Contractor must either disclose the unauthorized acquisition, access, use or disclosure to everyone whose sensitive personal information has been or is reasonably believed to have been compromised or pay the expenses associated with HHSC doing the disclosure if: 1. Contractor experiences a breach of system security involving information owned by HHSC for which disclosure or notification is required under section 521.053 of the Business and Commerce Code; or 2. Contractor experiences a breach of unsecured protected health information, as 45 C.F.R. §164.402 defines that phrase, and HHSC becomes responsible for doing the notification required by 45 C.F.R. §164.404. HHSC may, at its discretion, waive Contractor's payment of expenses associated with HHSC doing the disclosure.

  • Privacy Notification (1) The authority to request the above personal information from a seller of goods or services or a lessor of real or personal property, and the authority to maintain such information, is found in Section 5 of the State Tax Law. Disclosure of this information by the seller or lessor to the State is mandatory. The principal purpose for which the information is collected is to enable the State to identify individuals, businesses and others who have been delinquent in filing tax returns or may have understated their tax liabilities and to generally identify persons affected by the taxes administered by the Commissioner of Taxation and Finance. The information will be used for tax administration purposes and for any other purpose authorized by law. (2) The personal information is requested by the purchasing unit of the agency contracting to purchase the goods or services or lease the real or personal property covered by this contract or lease. The information is maintained in the Statewide Financial System by the Vendor Management Unit within the Bureau of State Expenditures, Office of the State Comptroller, 000 Xxxxx Xxxxxx, Xxxxxx, Xxx Xxxx 00000.

  • Updated Information Submission by Interconnection Customer The updated information submission by the Interconnection Customer, including manufacturer information, shall occur no later than one hundred eighty (180) Calendar Days prior to the Trial Operation. The Interconnection Customer shall submit a completed copy of the Electric Generating Unit data requirements contained in Appendix 1 to the LGIP. It shall also include any additional information provided to the Participating TO and the CAISO for the Interconnection Studies. Information in this submission shall be the most current Electric Generating Unit design or expected performance data. Information submitted for stability models shall be compatible with the Participating TO and CAISO standard models. If there is no compatible model, the Interconnection Customer will work with a consultant mutually agreed to by the Parties to develop and supply a standard model and associated information.

  • BREACH DISCOVERY AND NOTIFICATION 17 1. Following the discovery of a Breach of Unsecured PHI, CONTRACTOR shall notify 18 COUNTY of such Breach, however both parties agree to a delay in the notification if so advised by a 19 law enforcement official pursuant to 45 CFR § 164.412. 20 a. A Breach shall be treated as discovered by CONTRACTOR as of the first day on which 21 such Breach is known to CONTRACTOR or, by exercising reasonable diligence, would have been 22 known to CONTRACTOR. 23 b. CONTRACTOR shall be deemed to have knowledge of a Breach, if the Breach is 24 known, or by exercising reasonable diligence would have known, to any person who is an employee, 25 officer, or other agent of CONTRACTOR, as determined by federal common law of agency. 26 2. CONTRACTOR shall provide the notification of the Breach immediately to the COUNTY 27 Privacy Officer. CONTRACTOR’s notification may be oral, but shall be followed by written 28 notification within twenty four (24) hours of the oral notification. 29 3. CONTRACTOR’s notification shall include, to the extent possible: 30 a. The identification of each Individual whose Unsecured PHI has been, or is reasonably 31 believed by CONTRACTOR to have been, accessed, acquired, used, or disclosed during the Breach; 32 b. Any other information that COUNTY is required to include in the notification to 33 Individual under 45 CFR §164.404 (c) at the time CONTRACTOR is required to notify COUNTY or 34 promptly thereafter as this information becomes available, even after the regulatory sixty (60) day 35 period set forth in 45 CFR § 164.410 (b) has elapsed, including: 36 1) A brief description of what happened, including the date of the Breach and the date 37 of the discovery of the Breach, if known; 1 2) A description of the types of Unsecured PHI that were involved in the Breach (such 2 as whether full name, social security number, date of birth, home address, account number, diagnosis, 3 disability code, or other types of information were involved); 4 3) Any steps Individuals should take to protect themselves from potential harm 5 resulting from the Breach; 6 4) A brief description of what CONTRACTOR is doing to investigate the Breach, to 7 mitigate harm to Individuals, and to protect against any future Breaches; and 8 5) Contact procedures for Individuals to ask questions or learn additional information, 9 which shall include a toll-free telephone number, an e-mail address, Web site, or postal address. 10 4. COUNTY may require CONTRACTOR to provide notice to the Individual as required in 11 45 CFR § 164.404, if it is reasonable to do so under the circumstances, at the sole discretion of the 12 COUNTY. 13 5. In the event that CONTRACTOR is responsible for a Breach of Unsecured PHI in violation 14 of the HIPAA Privacy Rule, CONTRACTOR shall have the burden of demonstrating that 15 CONTRACTOR made all notifications to COUNTY consistent with this Subparagraph F and as 16 required by the Breach notification regulations, or, in the alternative, that the acquisition, access, use, or 17 disclosure of PHI did not constitute a Breach. 18 6. CONTRACTOR shall maintain documentation of all required notifications of a Breach or 19 its risk assessment under 45 CFR § 164.402 to demonstrate that a Breach did not occur. 20 7. CONTRACTOR shall provide to COUNTY all specific and pertinent information about the 21 Breach, including the information listed in Section E.3.b.(1)-(5) above, if not yet provided, to permit 22 COUNTY to meet its notification obligations under Subpart D of 45 CFR Part 164 as soon as 23 practicable, but in no event later than fifteen (15) calendar days after CONTRACTOR’s initial report of 24 the Breach to COUNTY pursuant to Subparagraph F.2. above. 25 8. CONTRACTOR shall continue to provide all additional pertinent information about the

  • Reporting of Non-Force Majeure Events Each Party (the “Notifying Party”) shall notify the other Parties when the Notifying Party becomes aware of its inability to comply with the provisions of this Agreement for a reason other than a Force Majeure event. The Parties agree to cooperate with each other and provide necessary information regarding such inability to comply, including the date, duration, reason for the inability to comply, and corrective actions taken or planned to be taken with respect to such inability to comply. Notwithstanding the foregoing, notification, cooperation or information provided under this Article shall not entitle the Party receiving such notification to allege a cause for anticipatory breach of this Agreement.

  • LIABILITY FOR UNAUTHORIZED USE-LOST/STOLEN CARD NOTIFICATION You agree to notify Credit Union immediately, orally or in writing at Florida Credit Union, X.X. Xxx 0000, Xxxxxxxxxxx, XX 00000 or telephone (000) 000-0000 twenty four

  • IDENTIFYING INFORMATION AND PRIVACY NOTIFICATION (a) FEDERAL EMPLOYER IDENTIFICATION NUMBER and/or FEDERAL SOCIAL SECURITY NUMBER. As a condition to NYSERDA’s obligation to pay any invoices submitted by Contractor pursuant to this Agreement, Contractor shall provide to NYSERDA its Federal employer identification number or Federal social security number, or both such numbers when the Contractor has both such numbers. Where the Contractor does not have such number or numbers, the Contractor must give the reason or reasons why the payee does not have such number or numbers.

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