Labeling Changes. With respect to changes to the Printed Matter, the Parties shall cooperate in making such changes promptly and Allendale shall, unless otherwise agreed, reimburse NPI for all remaining obsolete stock of Products, all inventory of Printed Matter (at NPI actual acquisition cost plus 15%) and all remaining obsolete work in process of Products resulting from any such change or amendment to the Printed Matter. Allendale may, at any time during the Supply Term, change or amend any item of the labeling by notice hereunder, such change or amendment to be effective after appropriate advance written notice hereof.
Labeling Changes. Without admitting wrongdoing or liability and solely to avoid the cost and disruption of further litigation, Perrigo agrees that for a period of twenty four (24) months commencing nine (9) months after the Effective Date, Perrigo will (i) include the language “individual results may vary” on the labels of the Covered Products and/or any other Perrigo- manufactured glucosamine and/or chondroitin products offered for resale, and (ii) will remove references to “rebuilding,” “renewing” “regrowing,” “growing,” “adding” or “regenerating” cartilage on the labels of the Covered Products and any other Perrigo-manufactured glucosamine and/or chondroitin products offered for resale.
(a) The labeling changes described in this Paragraph are not an admission by Defendants regarding the claims in the Litigation or the propriety of statements used or omitted on other versions of the packaging of the Covered Products.
(b) Perrigo shall have nine (9) months from the Effective Date to begin shipping Covered Products with labels and/or packaging that conform to the terms of the Settlement.
(c) Neither Perrigo nor any of the Retailers nor any Person in the chain of distribution of the Covered Products shall be required to recall, remove from shelves or pull from distribution or inventory any Covered Products that have been shipped by Perrigo prior to the date commencing nine (9) months after the Effective Date.
(d) If, after the date of Final Approval, Perrigo becomes aware of additional evidence substantiating that the Covered Products rebuild, renew, regrow, grow, add to or regenerate cartilage, Perrigo may seek the agreement of Settlement Class Counsel to modify Paragraph 10 of the Settlement Agreement. If the Parties are not able to agree, Perrigo may seek relief from the Court.
Labeling Changes. Should Xxxxxxx request or be required to make any modifications to Product labeling and packaging, it shall submit a written change order to Pfizer containing the requested or required modifications, together with any documentation specifying the content of the new labeling and packaging, including all necessary photo-ready art (or its substantial equivalent). Pfizer shall promptly provide Xxxxxxx with a statement of estimated charges for the work to be performed based on its per/person, per/hour rates then in effect, and its estimated timeline for implementing the changes. Upon written approval by Xxxxxxx, which approval shall not be unreasonably withheld, Pfizer will perform all requested or required labeling and packaging work. Xxxxxxx shall pay Pfizer for the work performed, in addition to reimbursing Pfizer for the cost of any existing labeling and packaging that has become obsolete as a result of such changes; provided, however, that such labeling and packaging shall not exceed the quantity of labeling and packaging required for the Product forecasted by Xxxxxxx for manufacture in the relevant Firm Order Period.
Labeling Changes. In the event either Party seeks to change a label and/or package insert for a Special Product due to safety or efficacy concerns, the Party seeking to make the change shall notify the other Party and provide the other Party with applicable data for its review and evaluation. The Parties may discuss in good faith and endeavor to agree upon all proposed significant safety or efficacy changes to the labeling and/or package inserts for Special Products. Each Party agrees to consider all comments of the other in good faith. Notwithstanding any good faith discussions, Abbott shall have the right to file for such labeling change as it reasonably deems appropriate in the Abbott Territory and AbbVie shall have the right to file for such labeling change as it reasonably deems appropriate in the AbbVie Territory, as applicable.
Labeling Changes a. Without admitting liability and solely to avoid the cost and disruption of further litigation, Defendant, as defined in the release set forth in this Agreement, agrees that, commencing after the Effective Final Judgment Date, it will not make the following statements, or statements conveying the same messages, on Direct Digital’s packaging and labeling, or in promotional materials under Direct Digital’s direct control, on product internet websites under Direct Digital’s direct control, or in any other advertising media under Direct Digital’s direct control, pertaining to the formulation of Instaflex, or any other identical or substantially similar joint health benefit product Direct Digital manufactures or offers for sale under any different product name: (i) that any such product provides joint support;
Labeling Changes. With respect to changes to the Printed Matter, the Parties shall cooperate in making such changes promptly and JDS shall, unless otherwise agreed, reimburse NPI for all remaining obsolete stock of Products, all inventory of Printed Matter (at NPI actual acquisition cost plus 15%) and all remaining obsolete work in process of Products resulting from any such change or amendment to the Printed Matter as long as the amount of material does not exceed 125% of the most recent forecast. JDS may, at any time during the Supply Term, change or amend any item of the labeling by notice hereunder, such change or amendment to be effective after appropriate advance written notice hereof. Under no circumstances may NPI make changes to the Printed Matter without the express written permission of JDS.
Labeling Changes. Should Omeros request or be required to make any modifications to Product labeling and packaging, it shall submit a written change order to Hospira containing the requested or required modifications, together with any documentation specifying the content of the new labeling and packaging, including all necessary photo-ready art (or its substantial equivalent). Hospira shall promptly provide Omeros with a statement of charges for the work to be performed based on its per/hour, per/person rates then in effect and its estimated timeline for implementing the changes. Upon written approval by Omeros, which approval shall be at Omeros’ sole discretion, Hospira shall perform such requested or required labeling and packaging work. Omeros shall pay Hospira for the work performed, in addition to reimbursing Hospira for the reasonable cost of any existing labeling and packaging that has become obsolete as a result of such changes.
Labeling Changes. Upon reasonable prior written notice to Manufacturer, Customer may, in its sole discretion, make changes to labels, product inserts and other SC1:4529841.10 [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions. Labeling for the Product, which changes shall be submitted by Customer to all applicable Regulatory Authorities responsible for the approval of the Product, if required.
Labeling Changes. In the event either Party seeks to change a core label and/or core package insert (e.g., the CCDS, MasterSmPC, core PIL, US PI or its equivalent) for a Special Product due to safety or efficacy concerns, the Party seeking to make the change shall notify the other Party and provide the other Party with applicable data for its review and evaluation within thirty (30) days of compiling such data. The Parties may discuss in good faith and endeavor to agree upon all proposed significant safety or efficacy changes to the labeling and/or package inserts for Special Products in Major Jurisdictions. Each Party agrees to consider all comments of the other in good faith. Notwithstanding any good faith discussions, Abbott shall have the right to file for such labeling change as it reasonably deems appropriate in the Abbott Territory and AbbVie shall have the right to file for such labeling change as it reasonably deems appropriate in the AbbVie Territory, as applicable.
