Recalls Procedures Sample Clauses

Recalls Procedures. Dyax shall promptly notify US Bio of any recalls or market withdrawals initiated by Dyax or required by the FDA or any other governmental agency. US Bio shall notify Dyax immediately of any event or circumstance that US Bio reasonably believes may necessitate a recall or market withdrawal. Upon receipt of notice of a recall or market withdrawal from Dyax, US Bio shall administer such recall or market withdrawal under the direction of Dyax, including promptly notifying the affected Specialty Pharmacy Customers of US Bio in accordance with Dyax’s instructions. Dyax shall provide US Bio with a form letter to be used in connection with notice of any recall or market withdrawal, and shall, to the extent practicable, provide US Bio the opportunity to review and comment on such letter. Dyax shall be responsible for the mailing, shipping, and reasonable administrative expenses incurred by US Bio in connection with the recall or market withdrawal, plus a reasonable service fee as mutually agreed upon in advance by the parties as well as the cost of replacement Product for US Bio’s Specialty Pharmacy Customers. Notwithstanding the foregoing, to the extent that such recall or market withdrawal arises or results from (i) the negligence or intentional misconduct of US Bio or any of its permitted agents or employees or (ii) the breach by US Bio of this Agreement, US Bio shall bear and be responsible for all such costs as well as the reasonable, documented, out-of-pocket expenses of Dyax incurred in connection with such recall or market withdrawal.
Recalls Procedures. Dyax shall promptly notify ASD of any recalls or market withdrawals initiated by Dyax or required by the FDA or any other governmental agency. ASD shall notify Dyax immediately of any event or circumstance that ASD reasonably believes may necessitate a recall or market withdrawal. Upon receipt of notice of a recall or market withdrawal from Dyax, ASD shall administer such recall or market withdrawal under the direction of Dyax, including promptly notifying the affected Wholesale Customers of ASD in accordance with Dyax's instructions. Dyax shall provide ASD with a form letter to be used in connection with notice of any recall or market withdrawal, and shall, to the extent practicable, provide ASD the opportunity to review and comment on such letter. Dyax shall be responsible for the mailing, shipping, and reasonable administrative expenses incurred by ASD in connection with the recall or market withdrawal, plus a reasonable service fee as mutually agreed upon in advance by the parties as well as the cost of replacement Product for ASD's Wholesale Customers, except to the extent that such recall or market withdrawal arises or results from (i) the negligence or intentional misconduct of ASD or any of its permitted agents or employees or (ii) the breach by ASD of this Agreement, in which event ASD shall bear and be responsible for such costs as well as the reasonable, documented, out-of-pocket expenses of Dyax incurred in connection with such recall or market withdrawal.

Related to Recalls Procedures

  • New Procedures New procedures as to who shall provide certain of these services in Section 1 may be established in writing from time to time by agreement between the Fund and the Transfer Agent. The Transfer Agent may at times perform only a portion of these services and the Fund or its agent may perform these services on the Fund's behalf;

  • Safety Procedures The Contractor shall: (a) comply with all applicable safety regulations according to Attachment H; (b) take care for the safety of all persons entitled to be on the Site; (c) use reasonable efforts to keep the Site and Works clear of unnecessary obstruction so as to avoid danger to these persons; (d) provide fencing, lighting, guarding and watching of the Works until completion and taking over under clause 10 [Employer's Taking Over]; and (e) provide any Temporary Works (including roadways, footways, guards and fences) which may be necessary, because of the execution of the Works, for the use and protection of the public and of owners and occupiers of adjacent land.

  • Reply Procedures In connection with any Auction, each Lender holding the relevant Term Loans subject to such Auction may, in its sole discretion, participate in such Auction and may provide the Auction Agent with a notice of participation (the “Return Bid”) which shall be in a form reasonably acceptable to the Auction Agent, and shall specify (i) a discount to par (that must be expressed as a price at which it is willing to sell all or any portion of such Term Loans) (the “Reply Price”), which (when expressed as a percentage of the par principal amount of such Term Loans) must be within the Discount Range and (ii) a principal amount of such Term Loans, which must be in whole increments of $1,000,000 (or, in any case, such lesser amount of such Term Loans of such Lender then outstanding or which is otherwise reasonably acceptable to the Auction Agent) (the “Reply Amount”). Lenders may only submit one Return Bid per Auction, but each Return Bid may contain up to three bids only one of which may result in a Qualifying Bid. In addition to the Return Bid, the participating Lender must execute and deliver, to be held in escrow by the Auction Agent, an Assignment and Assumption with the dollar amount of the Term Loans to be assigned to be left in blank, which amount shall be completed by the Auction Agent in accordance with the final determination of such Lender’s Qualifying Bid pursuant to clause (c) below. Any Lender whose Return Bid is not received by the Auction Agent by the Auction Response Date shall be deemed to have declined to participate in the relevant Auction with respect to all of its Term Loans.

  • Grievance Procedures The AGENCY agrees to establish a formal written grievance process with procedures through which clients and recipients of services may present grievances to the governing authority of the AGENCY regarding services being provided under this Contract. Additionally, the AGENCY agrees to establish fair hearing procedures that ensure all persons will be advised of their rights to a fair hearing to appeal a denial or exclusion from services and/or the failure of staff to take into account the individual’s choice of service. The AGENCY’S internal grievance procedure must document and include, at a minimum, the following: date of grievance, a written response to the applicant sent within thirty (30) days, and the opportunity for the applicant to meet with the AGENCY Executive Director or designee. Upon request by the COUNTY, the AGENCY shall provide a written report as to the grievance outcome within five (5) normal COUNTY working days. The AGENCY will maintain these documents on file for review by the COUNTY.

  • Review Procedures a. In consultation with the Illinois SHPO, NRCS shall identify those undertakings with little to no potential to affect historic properties and list those undertakings in Appendix A. Upon the determination by the CRS that a proposed undertaking is included in Appendix A, the NRCS is not required to consult further with the SHPO for that undertaking. A list of undertakings with the potential to affect historic properties comprises Appendix B. b. The lists of undertakings provided in Appendices A and B may be modified through consultation and written agreement between the NRCS State Conservationist and the SHPO without requiring an amendment to this Illinois Prototype Agreement. The NRCS State Office will maintain the master list and will provide an updated list to all consulting parties with an explanation of the rationale for classifying the practices accordingly. c. Undertakings identified in Appendix B shall require further review as outlined in Stipulation V. a. The NRCS shall consult with the SHPO to define the undertaking’s APE, identify and evaluate historic properties that may be affected by the undertaking, assess potential effects, and identify strategies for resolving adverse effects prior to implementing the undertaking. 1) NRCS may provide its proposed APE, identification of historic properties and/or scope of identification efforts, and assessment of effects in a single transmittal to the SHPO, provided this documentation meets the substantive standards in 36 CFR Part 800.4-5 and 800.11. 2) The NRCS shall attempt to avoid adverse effects to historic properties whenever possible; where historic properties are located in the APE, NRCS shall describe how it proposes to modify, buffer, or move the undertaking to avoid adverse effects to historic properties. 3) Where the NRCS proposes a finding of "no historic properties affected" or "no adverse effect" to historic properties, the SHPO shall have 30 calendar days from receipt of this documented description and information to review it and provide comments. The NRCS shall take into account all timely comments. i. If the SHPO, or another consulting party, disagrees with NRCS' findings and/or determination, it shall notify the NRCS within the thirty (30) calendar daytime period. The NRCS shall consult with the SHPO or other consulting party to attempt to resolve the disagreement. If the disagreement cannot be resolved through this consultation, NRCS shall follow the dispute resolution process in Stipulation VIII below. ii. If the SHPO does not respond to the NRCS within the thirty (30) calendar day period and/or the NRCS receives no objections from other consulting parties, or if the SHPO concurs with the NRCS' determination and proposed actions to avoid adverse effects, the NRCS shall document the concurrence/lack of response within the review time noted above and may move forward with the undertaking. 4) Where a proposed undertaking may adversely affect historic properties, NRCS shall describe proposed measures to minimize or mitigate the adverse effects, and follow the process in 36 CFR Part 800.6, including consultation with other consulting patties and notification to the ACHP, to develop a Memorandum of Agreement to resolve the adverse effects. Should the proposed undertaking have the potential to adversely affect a known NHL, the NRCS shall, to the maximum extent possible, undertake such planning and actions that may be necessary to minimize harm to the NHL in accordance with 54 U.S.C. § 306107 of the NHPA and 36 CFR Part 800.6 and 800.10, including consultation with the ACHP and respective National Park Service, Regional National Historic Landmark Program Coordinator, to develop a Memorandum of Agreement. d. NRCS will conduct archaeological surveys and will submit reports and other documentation to SHPO for review and comment. When no archaeological sites have been located by the archaeological survey, NRCS may proceed with the proposed undertaking. Reports for negative surveys must be submitted to SHPO on a quarterly basis. All positive and negative reports submitted to SHPO will be sent digitally for submission to the Inventory of Illinois Archaeological Sites (IAS) data file maintained by staff at the Illinois State Museum (ISM) housed under the Illinois Department of Natural Resources (IDNR). The NRCS further agrees that access to specific site location data will be restricted to the CRS, the NRCS field personnel installing conservation practices adjacent to the cultural resource, and the landowner. Specific site location information for individual projects will be maintained in a secure cultural resources file kept in the field offices and will not be available to the public. e. Curation: NRCS personnel will not collect artifactual material during routine field inspections. However, if a professional survey, evaluation testing, or mitigation is required, NRCS shall ensure that all materials and records resulting from cultural resources surveys or data recovery activities on federal or state property are curated by the Illinois State Museum. The NRCS shall ensure that all records resulting from cultural resource surveys or data recovery activities on private property are curated by the Illinois State Museum or an equivalent curation facility in accordance with 36 CFR Part 79. Subject to the landowner's permission, all objects resulting from cultural resources surveys or data recovery activities are maintained by the Illinois State Museum or equivalent research institution until their analysis is complete and they are returned to their owner(s). Although landowners will be encouraged to donate artifactual material, it is understood that objects collected on private land remain the property of the landowner(s) unless the landowner(s) donates the material to the Illinois State Museum or equivalent research institution. This excludes burial goods, as stipulated by ▇▇▇▇▇▇.