Common use of Labeling Clause in Contracts

Labeling. Service Providers have identified labeling issues in Section 3.17(d) of the Amendment to the Seller Disclosure Schedule dated September 2, 2010 (the “Disclosure Update”) and have identified Inventory that utilize labels that require revision. Service Providers have developed a corrective action plan to correct the labels utilized on the products, which plan is attached hereto as Exhibit E (the “Corrective Action Plan”). In connection with the correction of the foregoing, the Corrective Action Plan segregates the identified labeling issues between those products and Registrations for which modification of the labels is required before any product can be shipped, which are the first eight registrations on the Corrective Action Plan (the “Eight Registrations”) and the remaining products and Registrations for which products can be shipped and kept in commerce within the meaning of Applicable Law (the “Remaining Registrations”). In connection with the correction of the foregoing and the execution of the Corrective Action Plan: • Service Providers shall use commercially reasonable efforts to complete the Corrective Action Plan in accordance with its terms; • Service Providers shall have identified, segregated and marked all inventory containing labels for products that utilize the Eight Registrations and have been identified as requiring revision pursuant to the Disclosure Update (the “Quarantined Inventory”) so that such Quarantined Inventory is not shipped and is not otherwise in commerce as determined by Applicable Law; • Service Providers shall, as promptly as practicable, prepare new labels for each product that is identified under the Eight Registrations and shall not ship any Quarantined Inventory (or any inventory using any old label for such products) without first having replaced the label and all labeling such that the same complies with Applicable Law; • Service Providers shall, as promptly as practicable prepare new labels for each product that is identified under the Remaining Registrations; • Each such new label shall be submitted to Buyers for Buyers’ review and comment and Buyers’ reasonable changes that are submitted as promptly as practicable shall be incorporated into such labels; • Following Buyers’ review of each label, Service Providers shall promptly submit for approval and/or file all labeling with each applicable Governmental Entity, including each state in which such products are sold or intended to be sold; • With respect to any Registration for which Service Provider is a supplemental registrant, to the extent required pursuant to Applicable Law, Service Provider shall submit to applicable primary registrant for approval any proposed label; • Once approved and available for use on inventory, if relabeling is required, Service Providers shall remove all old labels on all inventory and shall affix on such inventory the new, approved and available labels so that the manufacturing, sale, offering for sale and introduction into commerce of such inventory is, at all times, in compliance, in all material respects, with Applicable Law including with respect to labels and labeling; • Service Providers shall notify Buyers of the re-labeling of any such inventory with new labels in accordance with the foregoing and shall provide Buyers with reasonable advance notice prior to any shipment of such inventory or the movement of Quarantined Inventory from any segregated area of the Service Provider’s locations and enable Buyers to inspect such relabeled inventory; and • Service Providers shall use commercially reasonable efforts to conduct all of the foregoing Services in a manner so as not to disrupt the sale or shipment of any inventory to any customer and Buyers shall exercise its approval rights in a manner so as to avoid any such disruption; Notwithstanding any of the foregoing and any approval by Buyers of the labels or the re-labeled inventory, Service Providers shall at all times during the Transition Period be responsible for compliance, in all material respects, with all Applicable Law with respect to labels and labeling.

Appears in 2 contracts

Samples: Transition Services Agreement, Transition Services Agreement (Zep Inc.)

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Labeling. Service Providers have identified Within thirty (30) days after the Effective Date, Horizon, at its own expense, will provide AHP with Horizon's new labeling issues for the Product (including a new NDC number for each Product) bearing Horizon's corporate name and trade dress. If such labeling is changed in Section 3.17(dany manner other than a new NDC number and Horizon's corporate name and tradedress, such labeling shall be subject to the approval of AHP, which approval will not be unreasonably withheld. AHP agrees to either approve or disapprove such labeling within thirty (30) business days of AHP's receipt thereof from Horizon. AHP, at Horizon's expense, will print, either directly or through a Third Party, labels and other printed material to be included as part of the Amendment finished Product. Product manufactured by AHP after AHP's receipt and approval of Horizon's new labeling for the Product, shall bear such new labeling, provided, however, that AHP shall have no responsibility with respect to the Seller Disclosure Schedule dated September 2content of such labeling, 2010 provided the content of the labeling printed by AHP is the same as the content of the labeling provided by Horizon. Horizon shall reimburse AHP for all reasonable costs incurred (the “Disclosure Update”on a Fully-Absorbed Cost basis) and have identified Inventory that utilize labels that require revisionby AHP in making modifications to labeling, branding or imprinting, packaging and/or manufacturing processes to accommodate Horizon's new labeling or to accommodate any other changes requested by Horizon. Service Providers have developed a corrective action plan Such reimbursement shall be made pursuant to correct the labels utilized on the productsinvoices submitted by AHP to Horizon, which plan is attached hereto as Exhibit E invoices shall be payable within thirty (the “Corrective Action Plan”)30) days after Horizon's receipt thereof. In connection with addition, should such new labeling result in any increase in AHP's cost of manufacturing the correction of Product hereunder, the purchase price for such Product as calculated under Section 5.1 hereof, shall be increased by such additional costs. Notwithstanding the foregoing, the Corrective Action Plan segregates the identified AHP may supply Horizon with Product bearing AHP's labeling issues between those products if such Product was manufactured and Registrations for which modification of the labels is required before any product can be shipped, which are the first eight registrations on the Corrective Action Plan (the “Eight Registrations”) and the remaining products and Registrations for which products can be shipped and kept in commerce within the meaning of Applicable Law (the “Remaining Registrations”). In connection with the correction of the foregoing and the execution of the Corrective Action Plan: • Service Providers shall use commercially reasonable efforts to complete the Corrective Action Plan in accordance with its terms; • Service Providers shall have identified, segregated and marked all inventory containing labels for products that utilize the Eight Registrations and have been identified as requiring revision pursuant labeled prior to the Disclosure Update Closing, it being agreed that Product manufactured from and after the Closing shall bear (the “Quarantined Inventory”i) so that such Quarantined Inventory is not shipped and is not otherwise in commerce as determined by Applicable Law; • Service Providers shall, as promptly as practicable, prepare new labels for each product that is identified under the Eight Registrations and shall not ship any Quarantined Inventory (or any inventory using any old label for such products) without first having replaced the label and all labeling such that the same complies with Applicable Law; • Service Providers shall, as promptly as practicable prepare new labels for each product that is identified under the Remaining Registrations; • Each such new label shall be submitted to Buyers for Buyers’ review and comment and Buyers’ reasonable changes that are submitted as promptly as practicable shall be incorporated into such labels; • Following Buyers’ review of each AHP's label, Service Providers shall promptly submit for approval and/or file all labeling with each applicable Governmental Entity, including each state in which such products are sold or intended to be sold; • With respect to any Registration for which Service Provider is a supplemental registrant, to the extent required pursuant to Applicable Law, Service Provider shall submit to applicable primary registrant for approval any proposed (ii) Horizon's new label; • Once approved and available for use on inventory, if relabeling is required, Service Providers shall remove all old labels on all inventory and shall affix on such inventory the new, approved and available labels so that the manufacturing, sale, offering for sale and introduction into commerce of such inventory is, at all times, in compliance, in all material respects, with Applicable Law including with respect to labels and labeling; • Service Providers shall notify Buyers of the re-labeling of any such inventory with new labels in accordance with the foregoing and shall provide Buyers with reasonable advance notice prior to any shipment of such inventory or the movement of Quarantined Inventory from any segregated area of the Service Provider’s locations and enable Buyers to inspect such relabeled inventory; and • Service Providers shall use commercially reasonable efforts to conduct all of the foregoing Services in a manner so as not to disrupt the sale or shipment of any inventory to any customer and Buyers shall exercise its approval rights in a manner so as to avoid any such disruption; Notwithstanding any of the foregoing and any approval by Buyers of the labels or the re-labeled inventory, Service Providers shall at all times during the Transition Period be responsible for compliance, in all material respects, with all Applicable Law with respect to labels and labeling.

Appears in 2 contracts

Samples: Product Supply Agreement (First Horizon Pharmaceutical Corp), Product Supply Agreement (First Horizon Pharmaceutical Corp)

Labeling. Service Providers 9.1 Licensee agrees that it will cause to appear on or within each Licensed Product manufactured, sold, and/or distributed under this Agreement and on or within all advertising, marketing, promotional, or display material bearing the Licensed Marks, the appropriate trademark and copyright notices, markings, and/or designations, and/or any other notice requested by Licensor. Each Licensed Product that is distributed and/or sold in a carton, container, packing and/or wrapping material bearing the Licensed Marks, shall have identified labeling issues in Section 3.17(dsuch notices appear upon the said carton, container, packing, and/or wrapping material. 9.2 Licensee further agrees that on all descriptive and marketing materials for the Licensed Products, a licensing statement inclusive of Licensor’s web page/site address, and a mission statement, both subject to Licensor’s approval which shall not be unreasonably withheld, and shall appear during the term of this Agreement and any renewal or extension thereof provided that such approvals or disapprovals shall be delivered to Licensee within seven(7) business days following request and if not so delivered shall be deemed approved. A true and correct copy of the Amendment licensing statement and mission statement approved by Licensor is set forth in Exhibit F attached hereto and incorporated by reference herein. Licensor reserves the right to modify, supplement, and/or alter the licensing statement or mission statement in its sole discretion and upon reasonable notice to Licensee. Each Related Material containing any such statements or Licensed Marks, as well as all advertising, marketing, promotional, and/or display material which reference the Licensed Marks and/or relate to the Seller Disclosure Schedule dated September 2Licensed Products, 2010 (the “Disclosure Update”) and have identified Inventory that utilize labels that require revision. Service Providers have developed a corrective action plan to correct the labels utilized on the products, which plan is attached hereto as Exhibit E (the “Corrective Action Plan”). In connection with the correction of the foregoing, the Corrective Action Plan segregates the identified labeling issues between those products and Registrations for which modification of the labels is required before any product can be shipped, which are the first eight registrations on the Corrective Action Plan (the “Eight Registrations”) and the remaining products and Registrations for which products can be shipped and kept in commerce within the meaning of Applicable Law (the “Remaining Registrations”). In connection with the correction of the foregoing and the execution of the Corrective Action Plan: • Service Providers shall use commercially reasonable efforts to complete the Corrective Action Plan in accordance with its terms; • Service Providers shall have identified, segregated and marked all inventory containing labels for products that utilize the Eight Registrations and have been identified as requiring revision pursuant to the Disclosure Update (the “Quarantined Inventory”) so that such Quarantined Inventory is not shipped and is not otherwise in commerce as determined by Applicable Law; • Service Providers shall, as promptly as practicable, prepare new labels for each product that is identified under the Eight Registrations and shall not ship any Quarantined Inventory (or any inventory using any old label for such products) without first having replaced the label and all labeling such that the same complies with Applicable Law; • Service Providers shall, as promptly as practicable prepare new labels for each product that is identified under the Remaining Registrations; • Each such new label shall be submitted to Buyers Licensor for Buyers’ review and comment and Buyers’ reasonable changes that are submitted as promptly as practicable shall be incorporated into such labels; • Following Buyers’ review of each label, Service Providers shall promptly submit for its approval and/or file all labeling with each applicable Governmental Entity, including each state in which such products are sold or intended to be sold; • With respect to any Registration for which Service Provider is a supplemental registrant, to the extent required pursuant to Applicable Law, Service Provider shall submit to applicable primary registrant for approval any proposed label; • Once approved and available for use on inventory, if relabeling is required, Service Providers shall remove all old labels on all inventory and shall affix on such inventory the new, approved and available labels so that the manufacturing, sale, offering for sale and introduction into commerce of such inventory is, at all times, in compliance, in all material respects, with Applicable Law including with respect to labels and labeling; • Service Providers shall notify Buyers of the re-labeling of any such inventory with new labels in accordance with the foregoing and shall provide Buyers with reasonable advance notice prior to any shipment of use by Licensee provided that such inventory approvals or the movement of Quarantined Inventory from any segregated area of the Service Provider’s locations disapprovals shall be delivered to Licensee within seven (7) business days following request and enable Buyers to inspect such relabeled inventory; and • Service Providers if not so delivered shall use commercially reasonable efforts to conduct all of the foregoing Services in a manner so as not to disrupt the sale or shipment of any inventory to any customer and Buyers shall exercise its approval rights in a manner so as to avoid any such disruption; Notwithstanding be deemed approved. 9.3 The Parties further agree that should any of the foregoing Licensed Products be manufactured, distributed, or sold without the appropriate or requested trademark and copyright notices, markings, and/or designations, in addition to any approval by Buyers other rights it may have, Licensor may demand the removal of the labels or offending product from distribution and sale, and may remove that product from the list of Licensed Products. In that event any such product may be re-labeled inventory, Service Providers shall at all times during and packaged to have a different look from the Transition Period be responsible for compliance, in all material respects, with all Applicable Law with respect to labels and labelingprior version of the product.

Appears in 2 contracts

Samples: License Agreement (NuGene International, Inc.), License Agreement (Bling Marketing, Inc.)

Labeling. Service Providers have identified labeling issues in Section 3.17(d) 9.1 Licensee agrees that it will cause to appear on or within each Licensed Product manufactured, sold, and/or distributed under this Agreement and on or within all advertising, marketing, promotional, or display material bearing the Licensed Marks, the appropriate trademark and copyright notices, markings, and/or designations, and/or any other notice requested by Licensor. In the event that any Licensed Product is displayed, distributed and/or sold with any Related Materials, such notices shall also appear upon the Related Materials. 9.2 Licensee further agrees that on all Related Materials for the Licensed Products, a licensing statement inclusive of Licensor’s web page/site address, and a mission statement, both subject to Licensor’s approval, shall appear during the term of this Agreement and any renewal or extension thereof. A true and correct copy of the Amendment licensing statement and mission statement approved by Licensor is set forth in Exhibit E attached hereto and incorporated by reference herein. Licensor reserves the right to modify, supplement, and/or alter the licensing statement or mission statement in its sole discretion and upon reasonable notice to Licensee. All Related Materials containing any such statements or Licensed Marks, as well as all advertising, marketing, promotional, and/or display material which reference the Licensed Marks and/or relate to the Seller Disclosure Schedule dated September 2Licensed Products, 2010 (the “Disclosure Update”) and have identified Inventory that utilize labels that require revision. Service Providers have developed a corrective action plan to correct the labels utilized on the products, which plan is attached hereto as Exhibit E (the “Corrective Action Plan”). In connection with the correction of the foregoing, the Corrective Action Plan segregates the identified labeling issues between those products and Registrations for which modification of the labels is required before any product can be shipped, which are the first eight registrations on the Corrective Action Plan (the “Eight Registrations”) and the remaining products and Registrations for which products can be shipped and kept in commerce within the meaning of Applicable Law (the “Remaining Registrations”). In connection with the correction of the foregoing and the execution of the Corrective Action Plan: • Service Providers shall use commercially reasonable efforts to complete the Corrective Action Plan in accordance with its terms; • Service Providers shall have identified, segregated and marked all inventory containing labels for products that utilize the Eight Registrations and have been identified as requiring revision pursuant to the Disclosure Update (the “Quarantined Inventory”) so that such Quarantined Inventory is not shipped and is not otherwise in commerce as determined by Applicable Law; • Service Providers shall, as promptly as practicable, prepare new labels for each product that is identified under the Eight Registrations and shall not ship any Quarantined Inventory (or any inventory using any old label for such products) without first having replaced the label and all labeling such that the same complies with Applicable Law; • Service Providers shall, as promptly as practicable prepare new labels for each product that is identified under the Remaining Registrations; • Each such new label shall be submitted to Buyers Licensor for Buyers’ review and comment and Buyers’ reasonable changes that are submitted as promptly as practicable shall be incorporated into such labels; • Following Buyers’ review of each label, Service Providers shall promptly submit for its approval and/or file all labeling with each applicable Governmental Entity, including each state in which such products are sold or intended to be sold; • With respect to any Registration for which Service Provider is a supplemental registrant, to the extent required pursuant to Applicable Law, Service Provider shall submit to applicable primary registrant for approval any proposed label; • Once approved and available for use on inventory, if relabeling is required, Service Providers shall remove all old labels on all inventory and shall affix on such inventory the new, approved and available labels so that the manufacturing, sale, offering for sale and introduction into commerce of such inventory is, at all times, in compliance, in all material respects, with Applicable Law including with respect to labels and labeling; • Service Providers shall notify Buyers of the re-labeling of any such inventory with new labels in accordance with the foregoing and shall provide Buyers with reasonable advance notice prior to any shipment of such inventory or the movement of Quarantined Inventory from any segregated area of the Service Provider’s locations and enable Buyers to inspect such relabeled inventory; and • Service Providers shall use commercially reasonable efforts to conduct all of the foregoing Services in a manner so as not to disrupt the sale or shipment of any inventory to any customer and Buyers shall exercise its approval rights in a manner so as to avoid any such disruption; Notwithstanding by Licensee. 9.3 The Parties further agree that should any of the foregoing Licensed Products be manufactured, distributed, or sold without the appropriate or requested trademark and copyright notices, markings, and/or designations, in addition to any approval by Buyers other rights it may have, Licensor may demand the removal of the labels or offending product from distribution and sale, and may remove that product from the re-labeled inventory, Service Providers shall at all times during the Transition Period be responsible for compliance, in all material respects, with all Applicable Law with respect to labels and labelinglist of Licensed Products.

Appears in 1 contract

Samples: License Agreement (House of Taylor Jewelry, Inc.)

Labeling. Service Providers have identified labeling issues 9.1 Licensee agrees that it will cause to appear on or within each Licensed Product manufactured, sold, and/or distributed under this Agreement and on or within all advertising, marketing, promotional, or display material bearing the Licensed Marks, the appropriate trademark and copyright notices, markings, and/or designations, and/or any other notice requested by Licensor. In the event that any Licensed Product is distributed and/or sold in Section 3.17(d) a carton, container, packing and/or wrapping material bearing the Licensed Marks, such notices shall also appear upon the said carton, container, packing, and/or wrapping material. 9.2 Licensee further agrees that on all Related Materials for the Licensed Products, a licensing statement inclusive of Licensor’s web page/site address, and a mission statement, both subject to Licensor’s approval, shall appear during the term of this Agreement and any renewal or extension thereof. A true and correct copy of the Amendment licensing statement and mission statement approved by Licensor is set forth in Exhibit F attached hereto and incorporated by reference herein. Licensor reserves the right to modify, supplement, and/or alter the licensing statement or mission statement in its sole discretion and upon reasonable notice to Licensee. Each Related Material containing any such statements or Licensed Marks, as well as all advertising, marketing, promotional, and/or display material which reference the Licensed Marks and/or relate to the Seller Disclosure Schedule dated September 2Licensed Products, 2010 (the “Disclosure Update”) and have identified Inventory that utilize labels that require revision. Service Providers have developed a corrective action plan to correct the labels utilized on the products, which plan is attached hereto as Exhibit E (the “Corrective Action Plan”). In connection with the correction of the foregoing, the Corrective Action Plan segregates the identified labeling issues between those products and Registrations for which modification of the labels is required before any product can be shipped, which are the first eight registrations on the Corrective Action Plan (the “Eight Registrations”) and the remaining products and Registrations for which products can be shipped and kept in commerce within the meaning of Applicable Law (the “Remaining Registrations”). In connection with the correction of the foregoing and the execution of the Corrective Action Plan: • Service Providers shall use commercially reasonable efforts to complete the Corrective Action Plan in accordance with its terms; • Service Providers shall have identified, segregated and marked all inventory containing labels for products that utilize the Eight Registrations and have been identified as requiring revision pursuant to the Disclosure Update (the “Quarantined Inventory”) so that such Quarantined Inventory is not shipped and is not otherwise in commerce as determined by Applicable Law; • Service Providers shall, as promptly as practicable, prepare new labels for each product that is identified under the Eight Registrations and shall not ship any Quarantined Inventory (or any inventory using any old label for such products) without first having replaced the label and all labeling such that the same complies with Applicable Law; • Service Providers shall, as promptly as practicable prepare new labels for each product that is identified under the Remaining Registrations; • Each such new label shall be submitted to Buyers Licensor for Buyers’ review and comment and Buyers’ reasonable changes that are submitted as promptly as practicable shall be incorporated into such labels; • Following Buyers’ review of each label, Service Providers shall promptly submit for its approval and/or file all labeling with each applicable Governmental Entity, including each state in which such products are sold or intended to be sold; • With respect to any Registration for which Service Provider is a supplemental registrant, to the extent required pursuant to Applicable Law, Service Provider shall submit to applicable primary registrant for approval any proposed label; • Once approved and available for use on inventory, if relabeling is required, Service Providers shall remove all old labels on all inventory and shall affix on such inventory the new, approved and available labels so that the manufacturing, sale, offering for sale and introduction into commerce of such inventory is, at all times, in compliance, in all material respects, with Applicable Law including with respect to labels and labeling; • Service Providers shall notify Buyers of the re-labeling of any such inventory with new labels in accordance with the foregoing and shall provide Buyers with reasonable advance notice prior to any shipment of such inventory or the movement of Quarantined Inventory from any segregated area of the Service Provider’s locations and enable Buyers to inspect such relabeled inventory; and • Service Providers shall use commercially reasonable efforts to conduct all of the foregoing Services in a manner so as not to disrupt the sale or shipment of any inventory to any customer and Buyers shall exercise its approval rights in a manner so as to avoid any such disruption; Notwithstanding by Licensee. -14- Initials: _______ Initials: _______ 9.3 The Parties further agree that should any of the foregoing Licensed Products be manufactured, distributed, or sold without the appropriate or requested trademark and copyright notices, markings, and/or designations, in addition to any approval by Buyers other rights it may have, Licensor may demand the removal of the labels or offending product from distribution and sale, and may remove that product from the re-labeled inventory, Service Providers shall at all times during the Transition Period be responsible for compliance, in all material respects, with all Applicable Law with respect to labels and labelinglist of Licensed Products.

Appears in 1 contract

Samples: License Agreement (Samsara Luggage, Inc.)

Labeling. Service Providers have identified labeling issues TRADE DRESS; NON-PRODUCT 5.1 LABELING, TRADE DRESS AND PACKAGING. The Product will be labeled, prepared and packed for shipment in Section 3.17(d) of the Amendment to the Seller Disclosure Schedule dated September 2, 2010 (the “Disclosure Update”) and have identified Inventory that utilize labels that require revision. Service Providers have developed a corrective action plan to correct the labels utilized on the products, which plan is attached hereto as Exhibit E (the “Corrective Action Plan”). In connection full compliance with the correction of the foregoingNDA, the Corrective Action Plan segregates the identified labeling issues between those products and Registrations for which modification of the labels is required before any product can be shipped, which are the first eight registrations on the Corrective Action Plan (the “Eight Registrations”) cGMP and the remaining products and Registrations for which products can be shipped and kept in commerce within the meaning of Applicable Law (the “Remaining Registrations”). In connection with the correction of the foregoing and the execution of the Corrective Action Plan: • Service Providers shall use commercially reasonable efforts to complete the Corrective Action Plan in accordance with its terms; • Service Providers shall have identified, segregated and marked all inventory containing labels for products that utilize the Eight Registrations and have been identified as requiring revision pursuant to the Disclosure Update (the “Quarantined Inventory”) so that such Quarantined Inventory is not shipped and is not otherwise in commerce as determined by Applicable Law; • Service Providers shall, as promptly as practicable, prepare new labels for each product that is identified under the Eight Registrations and shall not ship any Quarantined Inventory (or any inventory using any old label for such products) without first having replaced the label and all labeling such that the same complies with Applicable Law; • Service Providers shall, as promptly as practicable prepare new labels for each product that is identified under the Remaining Registrations; • Each such new label shall be submitted to Buyers for Buyers’ review and comment and Buyers’ reasonable changes that are submitted as promptly as practicable shall be incorporated into such labels; • Following Buyers’ review of each label, Service Providers shall promptly submit for approval and/or file all labeling with each applicable Governmental Entity, including each state in which such products are sold or intended to be sold; • With respect to any Registration for which Service Provider is a supplemental registrant, to the extent required pursuant to Applicable Law, Service Provider shall submit to applicable primary registrant for approval any proposed label; • Once approved and available for use on inventory, if relabeling is required, Service Providers shall remove all old labels on all inventory and shall affix on such inventory the new, approved and available labels so that the manufacturing, sale, offering for sale and introduction into commerce of such inventory is, at all times, in compliance, in all material respects, with Applicable Law including with respect to labels and labeling; • Service Providers shall notify Buyers of the re-labeling of any such inventory with new labels in accordance with the MRD/Quality Agreement. NEOSAN, at its expense, will provide Lilly with an electronic graphics file for all new or revised printed packaging components to be used in the manufacture of Product. Such artwork will be implemented as soon as practicable after all applicable regulatory requirements with respect thereto have been met and in accordance with the provisions set forth in the MRD/Quality Agreement. Until NEOSAN's initial packaging and labeling materials have been implemented, Product will continue to be labeled and packaged with the labels and packaging being used by Lilly as of the Closing Date. Lilly hereby grants to NEOSAN, for no additional consideration, a non-exclusive license solely to market, sell and promote the Product delivered by Lilly that contains the labels and packaging being used by Lilly as of the Closing Date. The foregoing and shall provide Buyers with reasonable advance notice license will terminate upon the earlier of NEOSAN'S sale of all of such Product, or on the one (1) year anniversary of the Closing Date. Lilly will have no obligation to re-label or over-label any such Product packaged prior to any shipment the implementation of such inventory NEOSAN's labels and packaging. The Parties contemplate that NEOSAN's name (or the movement name of Quarantined Inventory from any segregated area an Affiliate of NEOSAN) will appear as the exclusive distributor of the Service Provider’s locations Product and enable Buyers Lilly's name will appear as the manufacturer of the Product (unless a Third Person manufactures any Product pursuant to inspect Section 4.3, above, in which event such relabeled inventory; Third Person's name will appear as the manufacturer of the Product). All changes made to NEOSAN's initial labeling will be made in accordance with the procedures and • Service Providers shall use timelines set forth in the MRD. NEOSAN will reimburse Lilly for any costs associated with changing to NEOSAN's initial labeling, trade dress and packaging work provided by Lilly hereunder and for any subsequent packaging and labeling change work required or otherwise requested by NEOSAN hereunder, including without limitation, commercially reasonable efforts to conduct all costs associated with the destruction of printed components rendered obsolete as a result of the foregoing Services in a manner so as not to disrupt the sale or shipment of any inventory to any customer and Buyers shall exercise its approval rights in a manner so as to avoid any such disruption; Notwithstanding any of the foregoing and any approval by Buyers of the labels or the re-labeled inventory, Service Providers shall at all times during the Transition Period be responsible for compliance, in all material respects, with all Applicable Law with respect to labels and labelingtransactions contemplated hereby.

Appears in 1 contract

Samples: Manufacturing Agreement (Aaipharma Inc)

Labeling. Service Providers have identified labeling issues 8.1 Licensee agrees that it will cause to appear on or within each Product manufactured, sold, and/or distributed under this Agreement and on or within all advertising, marketing, promotional, or display material bearing the Licensed Marks, the appropriate trademark and copyright notices, markings, and/or designations, and/or any other notice requested by Licensor. In the event that any Product is distributed and/or sold in Section 3.17(d) a carton, container, packing and/or wrapping material bearing the Licensed Marks, such notices shall also appear upon the said carton, container, packing, and/or wrapping material. 8.2 Licensee further agrees that on all hang-tags and packaging materials for the Products, including without limitation cartons, containers, packing, and wrapping materials, if any, a licensing statement inclusive of Licensor’s web page/site address, and subject to Licensor’s approval, shall appear during the term of this Agreement and any renewal or extension thereof. A true and correct copy of the Amendment licensing statement approved by Licensor is set forth in Exhibit E attached hereto and incorporated by reference herein. Licensor reserves the right to modify, supplement, and/or alter the licensing statement in its sole discretion and upon reasonable notice to Licensee. Each and every hang-tag, label, imprint, and/or other material containing any and all such notices, if any, as well as all advertising, marketing, promotional, and/ or display material which reference the Licensed Marks and/or relate to the Seller Disclosure Schedule dated September 2Licensed Products, 2010 (the “Disclosure Update”) and have identified Inventory that utilize labels that require revision. Service Providers have developed a corrective action plan to correct the labels utilized on the products, which plan is attached hereto as Exhibit E (the “Corrective Action Plan”). In connection with the correction of the foregoing, the Corrective Action Plan segregates the identified labeling issues between those products and Registrations for which modification of the labels is required before any product can be shipped, which are the first eight registrations on the Corrective Action Plan (the “Eight Registrations”) and the remaining products and Registrations for which products can be shipped and kept in commerce within the meaning of Applicable Law (the “Remaining Registrations”). In connection with the correction of the foregoing and the execution of the Corrective Action Plan: • Service Providers shall use commercially reasonable efforts to complete the Corrective Action Plan in accordance with its terms; • Service Providers shall have identified, segregated and marked all inventory containing labels for products that utilize the Eight Registrations and have been identified as requiring revision pursuant to the Disclosure Update (the “Quarantined Inventory”) so that such Quarantined Inventory is not shipped and is not otherwise in commerce as determined by Applicable Law; • Service Providers shall, as promptly as practicable, prepare new labels for each product that is identified under the Eight Registrations and shall not ship any Quarantined Inventory (or any inventory using any old label for such products) without first having replaced the label and all labeling such that the same complies with Applicable Law; • Service Providers shall, as promptly as practicable prepare new labels for each product that is identified under the Remaining Registrations; • Each such new label shall be submitted to Buyers Licensor for Buyers’ review and comment and Buyers’ reasonable changes that are submitted as promptly as practicable shall be incorporated into such labels; • Following Buyers’ review of each label, Service Providers shall promptly submit for its written approval and/or file all labeling with each applicable Governmental Entity, including each state in which such products are sold or intended to be sold; • With respect to any Registration for which Service Provider is a supplemental registrant, to the extent required pursuant to Applicable Law, Service Provider shall submit to applicable primary registrant for approval any proposed label; • Once approved and available for use on inventory, if relabeling is required, Service Providers shall remove all old labels on all inventory and shall affix on such inventory the new, approved and available labels so that the manufacturing, sale, offering for sale and introduction into commerce of such inventory is, at all times, in compliance, in all material respects, with Applicable Law including with respect to labels and labeling; • Service Providers shall notify Buyers of the re-labeling of any such inventory with new labels in accordance with the foregoing and shall provide Buyers with reasonable advance notice prior to any shipment of such inventory or use by Licensee. Licensor’s written approval/disapproval will be provided to Licensee not more then ten (10) business days after the movement of Quarantined Inventory from any segregated area submission of the Service Provider’s locations and enable Buyers materials by Licensee. In the event such notice is not given, same shall be deemed disapproved. Licensee shall have the right to inspect such relabeled inventory; and • Service Providers shall use commercially reasonable efforts to conduct utilize the signature of Xxxxxxxxx Xxxxxx on all of the foregoing Services materials referred to in a manner so as this paragraph. Approval by Licensor shall not to disrupt the sale constitute waiver of Licensor's rights or shipment Licensee's duties under any provision of any inventory to any customer and Buyers shall exercise its approval rights in a manner so as to avoid any such disruption; Notwithstanding this Agreement. 8.3 The Parties further agree that should any of the foregoing Licensed Products be manufactured, distributed, or sold without the appropriate or requested trademark and copyright notices, markings, and/or designations, in addition to any approval by Buyers other rights it may have, Licensor may demand the immediate removal of the labels or offending product from distribution and sale, and may remove that product from the re-labeled inventory, Service Providers shall at all times during the Transition Period be responsible for compliance, in all material respects, with all Applicable Law with respect to labels and labelinglist of Licensed Products.

Appears in 1 contract

Samples: License Agreement (House of Taylor Jewelry, Inc.)

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Labeling. Service Providers have identified labeling issues in Section 3.17(d(a) Licensee agrees that it will cause to appear on or within each Licensed Article sold by it under this license and on or within all advertising, promotional or display material bearing the Mark the and the notice as shown on Appendix 2 attached hereto, and where such Licensed Article or advertising, promotional or display material bears a trademark or service mark, appropriate statutory notice of the Amendment to the Seller Disclosure Schedule dated September 2, 2010 (the “Disclosure Update”) and have identified Inventory that utilize labels that require revision. Service Providers have developed a corrective action plan to correct the labels utilized on the products, which plan is attached hereto as Exhibit E (the “Corrective Action Plan”)registration or application for registration thereof. In connection with the correction of event that any article is marketed in a carton, container, packing or wrapping material bearing the foregoingMark, the Corrective Action Plan segregates the identified labeling issues between those products such notice shall also appear upon that carton, container, packing or wrapping material. Each and Registrations for which modification of the labels is required before every tag, label, imprint or other device containing any product can be shipped, which are the first eight registrations on the Corrective Action Plan (the “Eight Registrations”) and the remaining products and Registrations for which products can be shipped and kept in commerce within the meaning of Applicable Law (the “Remaining Registrations”). In connection with the correction of the foregoing and the execution of the Corrective Action Plan: • Service Providers shall use commercially reasonable efforts to complete the Corrective Action Plan in accordance with its terms; • Service Providers shall have identified, segregated and marked all inventory containing labels for products that utilize the Eight Registrations and have been identified as requiring revision pursuant to the Disclosure Update (the “Quarantined Inventory”) so that such Quarantined Inventory is not shipped and is not otherwise in commerce as determined by Applicable Law; • Service Providers shall, as promptly as practicable, prepare new labels for each product that is identified under the Eight Registrations and shall not ship any Quarantined Inventory (or any inventory using any old label for such products) without first having replaced the label notice and all labeling such that advertising, promotional or display material bearing the same complies with Applicable Law; • Service Providers shall, as promptly as practicable prepare new labels for each product that is identified under the Remaining Registrations; • Each such new label Mark shall be submitted to Buyers Licensor for Buyers’ review its written approval prior to use by Licensee. Approval by Licensor shall not constitute a waiver of Licensor’s rights or Licensee's duties under any provision of this Agreement. (b) Licensee agrees to cooperate fully and comment in good faith with Licensor for the purpose of securing and Buyers’ reasonable changes preserving Licensor’s rights in and to the Mark. In the event there has been no previous registration of the Mark and/or articles and/or any material relating thereto, Licensee shall, at Licensor's request and expense, cooperate in the effort to register a copyright, trademark or service mark in the appropriate class in the name of Licensor. It is agreed that are submitted as promptly as practicable nothing contained in this Agreement shall be incorporated into construed as an assignment or grant to the Licensee of any right, title or interest in or to the Mark, it being understood that all rights relating thereto are reserved by Xxxxxxxx, except for the license hereunder to Licensee of the right to use and utilize the Mark only as specifically and expressly provided in this Agreement. Licensee hereby agrees that at the termination or expiration of this Agreement Licensee will be deemed to have assigned, transferred and conveyed to Licensor any rights, equities, goodwill, title or other rights in and to the mark which may have been obtained by Licensee or which may have vested in Licensee in pursuance of any endeavors covered hereby, and that Licensee will execute any instruments requested by Licensor to accomplish or confirm the foregoing. Any such labelsassignment, transfer or conveyance shall be without other consideration than the mutual covenants and considerations of this Agreement (c) Licensee hereby agrees that its every use of the Mark shall inure to the benefit of Licensor and that Licensee shall not at any time acquire any rights in the Mark by virtue of any use it may make of the Mark. (d) Licensee shall not suggest in its labeling, advertising or other promotion of any article subject to this Agreement, that Licensor endorses such product; • Following Buyers’ review of each label, Service Providers shall promptly submit for approval and/or file all labeling with each applicable Governmental Entity, including each state in which such products are sold or intended that Licensor has found the product to be soldfit for consumption by persons afflicted with celiac disease and NCGS; • With respect or make any representation regarding the Mark other than as specifically indicated on Appendix 2 which Is attached to any Registration for which Service Provider is a supplemental registrant, to the extent required pursuant to Applicable Law, Service Provider shall submit to applicable primary registrant for approval any proposed label; • Once approved and available for use on inventory, if relabeling is required, Service Providers shall remove all old labels on all inventory and shall affix on such inventory the new, approved and available labels so that the manufacturing, sale, offering for sale and introduction into commerce of such inventory is, at all times, in compliance, in all material respects, with Applicable Law including with respect to labels and labeling; • Service Providers shall notify Buyers of the re-labeling of any such inventory with new labels in accordance with the foregoing and shall provide Buyers with reasonable advance notice prior to any shipment of such inventory or the movement of Quarantined Inventory from any segregated area of the Service Provider’s locations and enable Buyers to inspect such relabeled inventory; and • Service Providers shall use commercially reasonable efforts to conduct all of the foregoing Services in a manner so as not to disrupt the sale or shipment of any inventory to any customer and Buyers shall exercise its approval rights in a manner so as to avoid any such disruption; Notwithstanding any of the foregoing and any approval by Buyers of the labels or the re-labeled inventory, Service Providers shall at all times during the Transition Period be responsible for compliance, in all material respects, with all Applicable Law with respect to labels and labelingthis Agreement.

Appears in 1 contract

Samples: Trademark License Agreement

Labeling. Service Providers have identified labeling issues TRADE DRESS; NON-PRODUCT 5.1 LABELING, TRADE DRESS AND PACKAGING. The Product will be labeled, prepared and packed for shipment in Section 3.17(d) of the Amendment to the Seller Disclosure Schedule dated September 2, 2010 (the “Disclosure Update”) and have identified Inventory that utilize labels that require revision. Service Providers have developed a corrective action plan to correct the labels utilized on the products, which plan is attached hereto as Exhibit E (the “Corrective Action Plan”). In connection full compliance with the correction of the foregoingsNDAs and cGMP, the Corrective Action Plan segregates the identified labeling issues between those products and Registrations for which modification of the labels is required before any product can be shipped, which are the first eight registrations on the Corrective Action Plan (the “Eight Registrations”) and the remaining products and Registrations for which products can be shipped and kept in commerce within the meaning of Applicable Law (the “Remaining Registrations”). In connection with the correction of the foregoing and the execution of the Corrective Action Plan: • Service Providers shall use commercially reasonable efforts to complete the Corrective Action Plan in accordance with its terms; • Service Providers shall have identified, segregated and marked all inventory containing labels for products that utilize the Eight Registrations and have been identified as requiring revision pursuant to the Disclosure Update (the “Quarantined Inventory”) so that such Quarantined Inventory is not shipped and is not otherwise in commerce as determined by Applicable Law; • Service Providers shall, as promptly as practicable, prepare new labels for each product that is identified under the Eight Registrations and shall not ship any Quarantined Inventory (or any inventory using any old label for such products) without first having replaced the label and all labeling such that the same complies with Applicable Law; • Service Providers shall, as promptly as practicable prepare new labels for each product that is identified under the Remaining Registrations; • Each such new label shall be submitted to Buyers for Buyers’ review and comment and Buyers’ reasonable changes that are submitted as promptly as practicable shall be incorporated into such labels; • Following Buyers’ review of each label, Service Providers shall promptly submit for approval and/or file all labeling with each applicable Governmental Entity, including each state in which such products are sold or intended to be sold; • With respect to any Registration for which Service Provider is a supplemental registrant, to the extent required pursuant to Applicable Law, Service Provider shall submit to applicable primary registrant for approval any proposed label; • Once approved and available for use on inventory, if relabeling is required, Service Providers shall remove all old labels on all inventory and shall affix on such inventory the new, approved and available labels so that the manufacturing, sale, offering for sale and introduction into commerce of such inventory is, at all times, in compliance, in all material respects, with Applicable Law including with respect to labels and labeling; • Service Providers shall notify Buyers of the re-labeling of any such inventory with new labels in accordance with the MRD/Quality Agreement. Xxxxx, at its expense, will provide Lilly with an electronic graphics file for all new or revised printed packaging components to be used in the manufacture of Product. Such artwork will be implemented as soon as practicable after all applicable regulatory requirements with respect thereto have been met and in accordance with the provisions set forth in the MRD/Quality Agreement. Until Galen's initial packaging and labeling materials have been implemented, Product will continue to be labeled and packaged with the labels and packaging being used by Lilly as of the Closing Date. Lilly hereby grants to Xxxxx, for no additional consideration, a non-exclusive license to use (but not modify) the labels and packaging being used by Lilly for the Product as of the Closing Date solely to market, sell and promote the Product delivered by Lilly that contains such labels and packaging being used by Lilly as of the Closing Date. The foregoing license does not xxxxx Xxxxx any rights in the "Lilly" xxxx or name except as it appears in such labels and shall provide Buyers with reasonable advance notice packaging. The foregoing license will terminate upon the earlier of Galen's sale of all of such Product, or on the second (2nd) year anniversary of the Closing Date. Lilly will have no obligation to re-label or over-label any such Product packaged prior to any shipment the implementation of such inventory Galen's labels and packaging. Galen's name (or the movement name of Quarantined Inventory from any segregated area an Affiliate of Xxxxx) will appear as the exclusive distributor of the Service Provider’s locations Product and enable Buyers Lilly's name will appear as the manufacturer of the Product (unless a Third Person manufactures any Product pursuant to inspect Section 4.3, above, in which event such relabeled inventory; Third Person's name will appear as the manufacturer of the Product) unless it is reasonable and • Service Providers shall use allowed under Applicable Laws under the circumstances to delete Lilly's or such Third Person's name. All changes made to Galen's initial labeling will be made in accordance with the procedures and timelines set forth in the MRD. Xxxxx will reimburse Lilly for any costs associated with changing to Galen's initial labeling, trade dress and packaging work provided by Lilly hereunder and for any subsequent packaging and labeling change work required or otherwise requested by Xxxxx hereunder, including without limitation, commercially reasonable efforts to conduct all costs associated with the destruction of printed components rendered obsolete as a result of the foregoing Services in a manner so as not to disrupt the sale or shipment of any inventory to any customer and Buyers shall exercise its approval rights in a manner so as to avoid any such disruption; Notwithstanding any of the foregoing and any approval by Buyers of the labels or the re-labeled inventory, Service Providers shall at all times during the Transition Period be responsible for compliance, in all material respects, with all Applicable Law with respect to labels and labelingtransactions contemplated hereby.

Appears in 1 contract

Samples: Manufacturing Agreement (Galen Holdings PLC)

Labeling. Service Providers have identified labeling issues (a) Customer hereby grants Manufacturer a limited, non-exclusive, non-transferable license as to the Marks for the purpose of allowing Manufacturer to perform its obligations under this Agreement. Manufacturer agrees not to use, directly or indirectly, any other trademarks that are colorable imitations of or confusingly similar to the Marks. Manufacturer agrees that it shall not register the Marks listed on Exhibit B (including any colorable imitations, translations, or transliterations thereof) or participate directly or indirectly in Section 3.17(d) such registration without Customer’s prior written consent. Manufacturer further acknowledges and agrees that if it Confidential Information Redacted Confidential Treatment Requested has obtained or obtains in the future, in any country, a right, title, or interest in the Marks (including any colorable imitations, translations, or transliterations thereof), or in any other trademark or service xxxx owned by Customer, Manufacturer has acted or will act as an agent for the benefit of Customer for the limited purpose of obtaining such registrations and assigning them to Annie’s Homegrown, Inc. Furthermore, Manufacturer agrees that it shall immediately notify customer of any potential infringements of the Amendment Marks as it shall become aware. Manufacturer also agrees that it will not directly or indirectly (by causing others or otherwise) use or take any action challenging or opposing, or raise any questions concerning, the validity of the Marks. The design costs and all costs for prepress chares, including color separations and charges for preparing plates and all other costs related to developing the Marks shall be paid by Customer to the Seller Disclosure Schedule dated September 2provider of such services. Customer shall, 2010 (subject to the “Disclosure Update”) size specification provided by Manufacturer, provide Manufacturer with the design and have identified Inventory that utilize labels that require revision. Service Providers have developed a corrective action plan color specification for the label for each Product covered by this Agreement and for each Xxxx to correct the labels utilized be used on the products, which plan is attached hereto as Exhibit E (the “Corrective Action Plan”). In connection with the correction of the foregoing, the Corrective Action Plan segregates the identified labeling issues between those products and Registrations for which modification of the labels is required before any product can be shipped, which are the first eight registrations on the Corrective Action Plan (the “Eight Registrations”) and the remaining products and Registrations for which products can be shipped and kept in commerce within the meaning of Applicable Law (the “Remaining Registrations”). In connection with the correction of the foregoing and the execution of the Corrective Action Plan: • Service Providers shall use commercially reasonable efforts to complete the Corrective Action Plan in accordance with its terms; • Service Providers shall have identified, segregated and marked all inventory containing labels for products that utilize the Eight Registrations and have been identified as requiring revision pursuant to the Disclosure Update (the “Quarantined Inventory”) so that such Quarantined Inventory is not shipped and is not otherwise in commerce as determined by Applicable Law; • Service Providers shall, as promptly as practicable, prepare new labels packaging for each product that is identified under the Eight Registrations and Product (b) Manufacturer shall not ship any Quarantined Inventory (or any inventory using any old label for such products) without first having replaced the label and all labeling such that the same complies with Applicable Law; • Service Providers shall, as promptly as practicable prepare new labels for each product that is identified under the Remaining Registrations; • Each such new label shall be submitted to Buyers for Buyers’ review and comment and Buyers’ reasonable changes that are submitted as promptly as practicable shall be incorporated into such labels; • Following Buyers’ review of each label, Service Providers shall promptly submit for approval and/or file all labeling with each applicable Governmental Entity, including each state in which such products are sold or intended to be sold; • With respect to any Registration for which Service Provider is a supplemental registrant, to the extent required pursuant to Applicable Law, Service Provider shall submit to applicable primary registrant for approval any proposed label; • Once approved and available for use on inventory, if relabeling is required, Service Providers shall remove all old labels on all inventory and shall affix on such inventory the new, approved and available labels so that the manufacturing, sale, offering for sale and introduction into commerce of such inventory is, at all times, in compliance, in all material respects, with Applicable Law including with respect to labels and labeling; • Service Providers shall notify Buyers of the re-labeling of any such inventory with new labels in accordance with the foregoing and shall provide Buyers with reasonable advance notice prior to any shipment of such inventory or the movement of Quarantined Inventory from any segregated area of the Service Provider’s locations and enable Buyers to inspect such relabeled inventory; and • Service Providers shall use commercially reasonable efforts to conduct all of the foregoing Services in a manner so as not to disrupt the sale or shipment of any inventory to any customer and Buyers shall exercise its approval rights in a manner so as to avoid any such disruption; Notwithstanding any of the foregoing and any approval by Buyers of the labels or the re-labeled inventory, Service Providers shall at all times during the Transition Period be responsible for complianceensuring compliance with the labeling requirements of the Federal Food, in all material respectsDrug, with all Applicable Law with respect to and Cosmetic Act and other applicable federal and state food labeling laws and regulations. (c) Manufacturer shall be responsible for ordering adequate supplies of labels and labelingother packaging materials on behalf of Customer based on forecasts as provided by the Customer. Prior to placing any order for labels or packaging materials, Manufacturer shall deliver to Customer a recommendation as to the quantity of packaging to be ordered based on forecasts as provided by the Customer for Customer’s approval or modification. Manufacturer shall not place any order for labels or packaging materials without Customer’s prior written approval. Customer shall be responsible for any unused labels or packaging materials due to marketing formulation changes, not hitting sales forecast or item discontinuation. Manufacturer shall order [***] impressions of each film item and [***] of each carton. (d) Customer shall apply for and obtain, at Customer’ cost, UPC codes required for labeling of the Products with the Marks. Customer shall supply the UPC codes to Manufacturer for printing on the labels used for the Products. (e) Nothing herein is deemed to grant to Manufacturer any right or license to use the Marks for any purpose other than the labeling of Products for sale by Customer as provided in this Agreement.

Appears in 1 contract

Samples: Contract Manufacturing and Packaging Agreement

Labeling. Service Providers have identified labeling issues (a) Customer hereby grants Manufacturer a limited, non-exclusive, non-transferable license as to the Marks for the purpose of allowing Manufacturer to perform its obligations under this Agreement. Manufacturer agrees not to use, directly or indirectly, any other trademarks that are colorable imitations of or confusingly similar to the Marks. Manufacturer agrees that it shall not register the Marks listed on Exhibit B (including any colorable imitations, translations, or transliterations thereof) or participate directly or indirectly in Section 3.17(d) such registration Confidential Information Redacted Confidential Treatment Requested without Customer’s prior written consent. Manufacturer further acknowledges and agrees that if it has obtained or obtains in the future, in any country, a right, title, or interest in the Marks (including any colorable imitations, translations, or transliterations thereof), or in any other trademark or service xxxx owned by Customer, Manufacturer has acted or will act as an agent for the benefit of Customer for the limited purpose of obtaining such registrations and assigning them to Annie’s Homegrown, Inc. Furthermore, Manufacturer agrees that it shall immediately notify customer of any potential infringements of the Amendment Marks as it shall become aware. Manufacturer also agrees that it will not directly or indirectly (by causing others or otherwise) use or take any action challenging or opposing, or raise any questions concerning, the validity of the Marks. The design costs and all costs for prepress chares, including color separations and charges for preparing plates and all other costs related to developing the Marks shall be paid by Customer to the Seller Disclosure Schedule dated September 2provider of such services. Customer shall, 2010 (subject to the “Disclosure Update”) size specification provided by Manufacturer, provide Manufacturer with the design and have identified Inventory that utilize labels that require revision. Service Providers have developed a corrective action plan color specification for the label for each Product covered by this Agreement and for each Xxxx to correct the labels utilized be used on the products, which plan is attached hereto as Exhibit E (the “Corrective Action Plan”). In connection with the correction of the foregoing, the Corrective Action Plan segregates the identified labeling issues between those products and Registrations for which modification of the labels is required before any product can be shipped, which are the first eight registrations on the Corrective Action Plan (the “Eight Registrations”) and the remaining products and Registrations for which products can be shipped and kept in commerce within the meaning of Applicable Law (the “Remaining Registrations”). In connection with the correction of the foregoing and the execution of the Corrective Action Plan: • Service Providers shall use commercially reasonable efforts to complete the Corrective Action Plan in accordance with its terms; • Service Providers shall have identified, segregated and marked all inventory containing labels for products that utilize the Eight Registrations and have been identified as requiring revision pursuant to the Disclosure Update (the “Quarantined Inventory”) so that such Quarantined Inventory is not shipped and is not otherwise in commerce as determined by Applicable Law; • Service Providers shall, as promptly as practicable, prepare new labels packaging for each product that is identified under the Eight Registrations and Product (b) Manufacturer shall not ship any Quarantined Inventory (or any inventory using any old label for such products) without first having replaced the label and all labeling such that the same complies with Applicable Law; • Service Providers shall, as promptly as practicable prepare new labels for each product that is identified under the Remaining Registrations; • Each such new label shall be submitted to Buyers for Buyers’ review and comment and Buyers’ reasonable changes that are submitted as promptly as practicable shall be incorporated into such labels; • Following Buyers’ review of each label, Service Providers shall promptly submit for approval and/or file all labeling with each applicable Governmental Entity, including each state in which such products are sold or intended to be sold; • With respect to any Registration for which Service Provider is a supplemental registrant, to the extent required pursuant to Applicable Law, Service Provider shall submit to applicable primary registrant for approval any proposed label; • Once approved and available for use on inventory, if relabeling is required, Service Providers shall remove all old labels on all inventory and shall affix on such inventory the new, approved and available labels so that the manufacturing, sale, offering for sale and introduction into commerce of such inventory is, at all times, in compliance, in all material respects, with Applicable Law including with respect to labels and labeling; • Service Providers shall notify Buyers of the re-labeling of any such inventory with new labels in accordance with the foregoing and shall provide Buyers with reasonable advance notice prior to any shipment of such inventory or the movement of Quarantined Inventory from any segregated area of the Service Provider’s locations and enable Buyers to inspect such relabeled inventory; and • Service Providers shall use commercially reasonable efforts to conduct all of the foregoing Services in a manner so as not to disrupt the sale or shipment of any inventory to any customer and Buyers shall exercise its approval rights in a manner so as to avoid any such disruption; Notwithstanding any of the foregoing and any approval by Buyers of the labels or the re-labeled inventory, Service Providers shall at all times during the Transition Period be responsible for complianceensuring compliance with the labeling requirements of the Federal Food, in all material respectsDrug, with all Applicable Law with respect to and Cosmetic Act and other applicable federal and state food labeling laws and regulations. (c) Manufacturer shall be responsible for ordering adequate supplies of labels and labelingother packaging materials on behalf of Customer based on forecasts as provided by the Customer. Prior to placing any order for labels or packaging materials, Manufacturer shall deliver to Customer a recommendation as to the quantity of packaging to be ordered based on forecasts as provided by the Customer for Customer’s approval or modification. Manufacturer shall not place any order for labels or packaging materials without Customer’s prior written approval. Customer shall be responsible for any unused labels or packaging materials due to marketing formulation changes, not hitting sales forecast or item discontinuation. Manufacturer shall order [***] impressions of each film item and [***] of each carton. (d) Customer shall apply for and obtain, at Customer’ cost, UPC codes required for labeling of the Products with the Marks. Customer shall supply the UPC codes to Manufacturer for printing on the labels used for the Products. (e) Nothing herein is deemed to grant to Manufacturer any right or license to use the Marks for any purpose other than the labeling of Products for sale by Customer as provided in this Agreement.

Appears in 1 contract

Samples: Contract Manufacturing and Packaging Agreement (Annie's, Inc.)

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