Labeling and Artwork. (a) After execution of this Agreement, ABI shall review and comment on any labeling and proposed changes to the labeling of the Product and shall be entitled to participate in discussions with the Governmental Authorities concerning any labeling or proposed labeling change so long as Atrix is purchasing the Product from ABI. Notwithstanding the above, Atrix shall make the final decision with regard to any labeling or labeling revisions.
(b) Both Parties will approve all artwork developed for inclusion in the Product packaging, including carton labels, package inserts, etc., which approval will not be unreasonably withheld, conditioned or delayed by either Party. If Atrix wishes to institute changes in labeling artwork, both Parties will develop a mutually acceptable implementation schedule. The actual cost of implementing such change will be at Atrix's sole cost and **** Indicates that a portion of the text has been omitted Confidential expense, including any materials made obsolete by Atrix's changes to the artwork. Neither Party shall alter, change or in any way modify the artwork, which has previously been approved, for any reason, without prior written authorization from the other Party, which approval will not be unreasonably withheld, conditioned or delayed, and provided that such approved artwork shall conform to all Applicable Laws.
Labeling and Artwork. (a) After execution of this Agreement, CollaGenex shall have the right to review and comment upon any labeling and proposed changes to the labeling of the Products and to participate in discussions with the Governmental Authorities concerning any labeling or proposed labeling change. Notwithstanding the above, Atrix shall make the final decision with regard to any labeling or labeling revisions.
(b) Both Parties will approve all artwork developed for inclusion in the Product packaging, including carton labels, package inserts, etc., which approval will not be unreasonably withheld, conditioned or delayed by either Party. For the avoidance of doubt, Atrix will be solely responsible for the initial conversion of the current artwork to artwork bearing the CollaGenex name and trade dress, as applicable. The Parties acknowledge that other significant changes from currently approved packaging and labeling may require FDA approval prior to marketing. If CollaGenex wishes to institute changes in labeling artwork, after the Parties have agreed to and implemented the first labeling artwork bearing the CollaGenex name and information, both Parties will develop a mutually acceptable implementation schedule. The actual cost of implementing such change will be at CollaGenex's sole cost and expense, including any materials made obsolete by CollaGenex's changes to the artwork. Neither Party shall alter, change or in any way modify the artwork, which has previously been approved, for any reason, without prior written authorization from the other Party, which approval will not be unreasonably withheld, conditioned or delayed, and provided that such approved artwork shall conform to all Applicable Laws.
Labeling and Artwork. Purchaser is responsible for the development and final approval of all Labeling artwork. Manufacturer will provide Purchaser with all necessary documentation to produce packaging artwork, including, but not limited to Specifications, drawings, and bar code details. Manufacturer will provide Purchaser’s Label control department with final printed labels upon first printing and any subsequent request. Manufacturer is responsible for procuring primary packaging and printed Labeling, in accordance with Specifications supplied by Purchaser. Purchaser shall ensure the accuracy of the information contained in all Labeling specifications and will comply with all regulatory standards. Manufacturer will ensure the use of primary packaging materials are in agreement with material specifications referenced in the filing/registration of Product(s). Changes made by Manufacturer to Labeling/artwork shall be pre-approved by Purchaser prior to implementation. Manufacturer will implement version changes to Labeling and packaging in accordance with implementation timelines provided by Purchaser from time to time.
Labeling and Artwork. The Parties agree that the label for Licensed Products in the Territory shall be, and all packaging and presentations concerning the Licensed Products shall display, a Meda label in accordance with Meda’s customary practices and the Parties shall use Commercially Reasonable Efforts to cooperate in gaining Governmental Approval to sell Licensed Products in the Territory under the Meda label. Each Licensed Product Commercialized by Meda or its Affiliates or permitted sublicensees under this Agreement shall be marked (to the extent not prohibited by Applicable Laws and reasonably practical and customary in the pharmaceutical industry) with applicable patent and other intellectual property notices relating to the Licensed Patents in such a manner as may be required by applicable law or reasonably necessary to ensure the availability of all remedies which may be available for infringement of the Licensed Patents. The Commercialization Committee shall be provided with copies of any labeling and proposed changes to the labeling of any Licensed Product for the Commercialization Committee’s review, comment, and approval. Any such labeling or proposed changes thereto shall not be effected by Meda unless approved in advance by the Commercialization Committee. The actual cost of implementing such change will be at Meda’s sole cost and expense, including any materials made obsolete by Meda’s changes to the artwork. All labeling, artwork, and proposed changes thereto shall at all times comply with Applicable Laws.
Labeling and Artwork. Partner shall at least one hundred and fifty (150) days prior to submission of the MAA to the Regulatory Authorities, provide PolyPid with packaging mock-ups and specimen to be submitted to the Regulatory Authorities for approval in compliance with the Packaging Specifications. Should the MAA be submitted via a Centralized Procedure, PolyPid shall effect such filing. Should the MAA be submitted via the Decentralized Procedure, and PolyPid requests that Partner do so, Partner shall file the Regulatory Materials specifically related to the Packaging during the national phase, on PolyPid’s behalf and at PolyPid’s cost (which cost shall be agreed in advance between the Parties), in each country in the Territory for the Packaging Specifications approval; and Partner shall provide PolyPid with assistance with translations as required. PolyPid shall provide Partner with all the necessary powers required for Partner to fulfill this filing obligation. Partner shall be responsible for assuring that packaging and labeling set forth in the Packaging Specifications comply with all Applicable Laws where such Product is to be distributed for sale in the Territory.
Labeling and Artwork. Arius Two shall be provided with copies of any labeling and proposed changes to the labeling of the Fentanyl Product for Arius Two’s review and comment. The actual cost of implementing such change will be at Arius’ sole cost and expense, including any materials made obsolete by Arius’ changes to the artwork.
Labeling and Artwork. BDSI shall be provided with copies of any labeling and proposed changes to the labeling of the Licensed Product for BDSI’s review, comment, and approval; any such labeling or proposed changes thereto shall not be effected by Meda unless approved in advance by BDSI, such approval not to be unreasonably withheld. The actual cost of implementing such change will be at Meda’s sole cost and expense, including any materials made obsolete by Meda’s changes to the artwork. All labeling, artwork, and proposed changes thereto shall at all times comply with Applicable Laws.
Labeling and Artwork. The LICENSOR shall not amend the labeling of the Product for Commercialization in the Territory without IMMEDICA’s prior written approval. In the event that IMMEDICA proposes changes to the labeling of the Product, it shall provide LICENSOR with copies of any labeling and proposed changes to the labeling of the Product for LICENSOR’s review and comment; LICENSOR will have [*] to provide comments on such proposed changes to IMMEDICA, and IMMEDICA will reasonably consider such comments prior to effecting such change. The actual cost of implementing such change will be at IMMEDICA’s sole cost and expense, including any materials made obsolete by IMMEDICA’s changes to the artwork, unless such change was requested by the LICENSOR, in which case such cost and expense shall be at the LICENSOR’s sole cost and expense. All labeling, artwork, and proposed changes thereto shall at all times comply with Applicable Laws. 5. REGULATORY MATTERS
5.1. Marketing Authorization Holder. Subject to IMMEDICA’s obligations upon termination pursuant to Section 15.6, IMMEDICA shall be the holder and owner of all Regulatory Approvals in the Territory.
Labeling and Artwork. Cutter guides (technical drawings of the Artwork mock-ups) will be provided by LICENSOR to IMMEDICA. IMMEDICA shall be responsible for updating the cutter guides and the creation of printer ready labeling mock-ups in the Territory according to local regulations and guidelines. In the event that IMMEDICA proposes changes to the labeling or packaging of the Product, it shall provide LICENSOR with justification for the proposed change, revised mock-ups for printing and clear timelines for the implementation of such updates The actual cost of implementing such change will be at IMMEDICA’s sole cost and expense, including any materials made obsolete by IMMEDICA’s changes to the artwork, unless such change was requested by the LICENSOR, in which case such cost and expense shall be at the LICENSOR’s sole cost and expense. All labeling, artwork, packaging and proposed changes thereto shall at all times comply with Applicable Laws.
Labeling and Artwork. (a) After execution of this Agreement, both Parties will approve all Labeling and any proposed Labeling change. Fujisawa shall have the right to review and comment upon any Labeling and proposed changes to the Labeling and to participate in any discussions or communications with the Competent Authorities concerning any Labeling or proposed Labeling change. []** the Parties shall []** Atrix shall make the final decision with regard to any Labeling or proposed Labeling changes. []** and otherwise in accordance with generally accepted practices in the pharmaceutical industry. Fujisawa shall []** and shall []**
(b) Both Parties will approve all artwork developed for inclusion in the Product Packaging, which approval will not be unreasonably withheld, conditioned or delayed by either Party. If Fujisawa wishes to institute changes in the artwork both Parties will develop a mutually acceptable implementation schedule. The actual cost of implementing such change will be at []**, including any materials made obsolete by Fujisawa's changes to the artwork. Neither Party shall alter, change or in any way modify the artwork, that has previously been approved, for any reason, without prior written authorization from the other Party, which approval will not be unreasonably withheld, conditioned or delayed, and provided that such approved artwork shall conform to all Applicable Laws and Governmental Approvals.
