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
Sources: Transition Services Agreement, Transition Services Agreement (Zep Inc.)
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
Sources: License Agreement (NuGene International, Inc.), License Agreement (Bling Marketing, Inc.)
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
Sources: Product Supply Agreement (First Horizon Pharmaceutical Corp), Product Supply Agreement (First Horizon Pharmaceutical Corp)
Labeling. Service Providers (a) All labels for Products shall use the Sagent name and the Sagent NDC number. Gland shall be permitted to use such labels only on Products delivered to Sagent hereunder. Sagent shall provide in a timely manner the camera-ready artwork for labeling for the containers, package inserts and shipping containers in the form specified by Gland at Sagent’s cost. Sagent shall have identified approved all such labeling issues in Section 3.17(d) writing in advance of initial printing. From time to time, Sagent may request Gland modify the artwork or Labeling. Sagent and Gland shall mutually develop the timeline for implementation of the Amendment to the Seller Disclosure Schedule dated September 2, 2010 (the “Disclosure Update”) and have identified Inventory that utilize labels that require revisionrevised labeling. 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 Gland shall use commercially make all reasonable efforts to complete implement 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 revised Labeling in accordance with the foregoing Sagent schedule. Unless otherwise agreed, labeling approved by Sagent shall be the only labeling used by Gland for Products, provided that any labels and package inserts shall provide Buyers be consistent with reasonable advance notice prior FDA and Gland’s requirements with regard to any shipment physical dimensions and specifications relating to the methods of such inventory handling and affixing on container. Gland may modify artwork as necessary to meet its requirements or the movement print vendor requirements and equipment design specifications; however, in such cases, Gland will submit final proofs of Quarantined Inventory from artwork and labeling to Sagent for final approval. Sagent shall have approved all such Labeling in writing in advance of initial printing and Gland shall have a system for control of master labeling. Any label artwork preparation and setup charge shall be billed to Sagent on a pass through cost basis. In addition, all costs associated with any segregated area of labeling changes required by Sagent or required by the Service Provider’s locations FDA, including the costs associated with any labeling or packaging rendered obsolete by such changes, shall be borne by Sagent.
(b) All code or product specific printed material or labeling, excluding promotional and enable Buyers to inspect such relabeled inventory; and • Service Providers advertising material, shall use commercially reasonable efforts to conduct all of the foregoing Services in a manner so as not to disrupt the sale be 100% electronically verified or shipment of any inventory to any customer and Buyers printed on line. Gland 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 compliancethe appropriate barcoding per cGMP requirements.
(c) Gland will monitor the Reference Listed Drug package insert text. Gland and Sagent will consult from time to time on the need for changes in prescribing information (package insert) or in the labeling of packaging and containers of the Products or in the Product information supplied to customers, in all material respects, the medical profession or patients. Gland and Sagent will comply with all Applicable Law with respect to labels regulatory requirements.
(d) The shipping label shall be in Healthcare Distribution Management Association (HDMA) format and labeling.shall include the following information: • Name and address of Company • NDC number • Lot number • Lot Expiration Date • Quantity • Storage and special transportation conditions
Appears in 2 contracts
Sources: Development and Supply Agreement (Sagent Holding Co.), Development and Supply Agreement (Sagent Holding Co.)
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 ▇▇▇▇ 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 ▇▇▇▇ 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
Sources: Contract Manufacturing and Packaging Agreement (Annie's, Inc.)
Labeling. Service Providers have identified Trademarks. Diamond shall affix labeling issues to all Products, such --------------------- labeling to bear one or more Distributor trademarks, as specified in Section 3.17(d) writing by Distributor. Nothing contained herein shall give Diamond any right to use any Distributor trademark except on all Products manufactured and delivered for Distributor. Diamond shall not obtain any right; title or interest in any Distributor trademark by virtue of the Amendment this Agreement Distributor shall not use, nor shall Distributor obtain any right, title or interest in, any Diamond trademark or any [ *** ] trademark, including without limitation "Pneumo-Star," "Somnu-Star" and "Somnu-Star ----------- ---------- ---------- PH." All Product labeling shall in addition to the Seller Disclosure Schedule dated September 2Distributor trademark, 2010 (-- contain the “Disclosure Update”) notation "Manufactured by Diamond Animal Health, Inc." with its address, or such similar notation as may be necessary or advisable under applicable law, and have identified Inventory that utilize labels that require revisionshall contain the notation "Distributed by Agri Laboratories, Inc.," with its address. Service Providers have developed a corrective action plan Distributor shall cause All Product labeling to correct contain only such claims as are permitted under applicable Licenses for such Products and to otherwise comply with applicable law. All labeling and packaging of All Products shall be subject to the labels utilized on the productsprior written approval of both parties, 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 be unreasonably withheld. Diamond will order quantities of labeling 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 packaging sufficient to perform its obligations hereunder in its reasonable discretion. Distributor 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 compliancethe costs of developing and changing packaging for All Products, in all material respectsincluding costs of obsolete labeling and packaging due to changes requested by Distributor but only those occurring after initial License for the same. Furthermore, with all Applicable Law with respect to labels and labelingDiamond shall be responsible for the cost occasioned by any changes required by a government agency.
Appears in 1 contract
Labeling. Service Providers have identified labeling issues in Section 3.17(d(a) If, at the time of submission of the Amendment to the Seller Disclosure Schedule dated September 2Regulatory Approval Application for a MacroGenics Combination Regimen, 2010 (the “Disclosure Update”) and have identified Inventory there is no Monotherapy Regimen, Incyte Combination Regimen or Collaborator Combination Regimen that utilize labels that require revision. Service Providers have developed a corrective action plan to correct the labels utilized on the productshas received Regulatory Approval, 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 Incyte shall use commercially reasonable efforts to complete the Corrective Action Plan Commercially Reasonable Efforts to, contemporaneously and in accordance coordination with its terms; • Service Providers shall have identifiedMacroGenics, 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 seek Regulatory Approval of a label for such productsLicensed Compound as a component of a MacroGenics Combination Regimen that, if such Licensed Compound label is approved, will sufficiently enable Commercialization by MacroGenics of the applicable MacroGenics Pipeline Asset as a component of a MacroGenics Combination Regimen and Commercialization by Incyte of the Licensed Compound as a component of a MacroGenics Combination Regimen (provided that, Incyte shall have no right to conduct any Medical Affairs Activities or activities directed to marketing, detailing, promoting, educating or any Phase IV Studies with respect to the Licensed Compound as a component of a MacroGenics Combination Regimen other than MacroGenics Combination Regimen Detailing).
(b) without first having replaced For each Regulatory Approval of a MacroGenics Pipeline Asset as a component of a MacroGenics Combination Regimen, MacroGenics shall have the right to determine in its sole discretion, whether to include the Regulatory Approval for the MacroGenics Combination Regimen in its label for the applicable MacroGenics Pipeline Asset included in such MacroGenics Combination Regimen.
(c) Without limiting Incyte’s obligations under Section 5.8(a), Incyte may, at its discretion, reference all Regulatory Documentation and other Information submitted by MacroGenics to the applicable Regulatory Authority as required by Incyte for the purposes of (i) seeking Regulatory Approval of the Licensed Compound as a component of a MacroGenics Combination Regimen and expanding the label of the Licensed Compound to include such Regulatory Approval as a component of a MacroGenics Combination Regimen or (ii) exercising its rights under Section 3.1(c). Notwithstanding anything to the contrary herein, the rights granted to Incyte in this Section 5.8(c) to include in the label for the Licensed Compound newly-generated Regulatory Documentation and all labeling such other Information submitted by MacroGenics to the applicable Regulatory Authority shall immediately terminate on a going-forward basis (but, for clarity, the right of Incyte to continue to exercise its rights under Section 3.1(c) shall continue) upon the following: (A) after any Change of Control of Incyte, except that the same complies right of Incyte to include in the label for the Licensed Compound newly-generated Regulatory Documentation and other Information submitted by MacroGenics to the applicable Regulatory Authority shall continue 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 Regulatory Documentation and other Information submitted by MacroGenics in connection with a Pivotal Study by MacroGenics (or an Acquirer of MacroGenics) that was Initiated prior to date upon which the Change of Control of Incyte was publicly announced; or (B) on a MacroGenics Combination Regimen-by-MacroGenics Combination Regimen basis, in the event that the then-current label of the Licensed Compound includes a Regulatory Approval for an Indication Population based on a Combination Study, other than a Combination Study conducted by MacroGenics, that is the same Indication Population for which Service Provider is a supplemental registrant, to MacroGenics seeks Regulatory Approval for 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 labelingMacroGenics Combination Regimen.
Appears in 1 contract
Sources: Global Collaboration and License Agreement (Macrogenics 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 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. ▇▇▇▇▇, 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 ▇▇▇▇▇, 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 ▇▇▇▇▇ ▇▇▇▇▇ any rights in the "Lilly" ▇▇▇▇ 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 ▇▇▇▇▇) 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. ▇▇▇▇▇ 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 ▇▇▇▇▇ 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
Labeling. Service Providers have identified labeling issues in Section 3.17(d) of All GSK Supplied Products shall bear a generic label specifying PAR as the Amendment distributor and displaying the logo PAR artwork supplied by PAR to GSK, and as agreed by GSK pursuant 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”remainder of this Section 4.2(e). In connection The label shall also include any references to Spectrum as conveyed by PAR and Spectrum to GSK in accordance with the correction of the foregoingApplicable Law, 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[***]. All GSK Supplied Product Labels, 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 packaging or trade dress [***] shall comply with Applicable Law (including the “Remaining Registrations”). In connection with the correction terms of the foregoing and applicable NDA), and, subject to the execution first sentence 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 identifiedthis Section 4.2(f), segregated and marked all inventory containing labels for products that utilize the Eight Registrations and have been identified as requiring revision [***]. Should PAR or GSK desire or be required pursuant to Applicable Law to make any change in any such Labels or Labeling, GSK shall be responsible for procuring the Disclosure Update (the “Quarantined Inventory”) so that updating of all artwork and text associated with such Quarantined Inventory is not shipped change and is not otherwise in commerce as determined providing such changes to PAR. Upon approval by Applicable Law; • Service Providers GSK, GSK shall make all necessary arrangements for such changed Labels or Labeling to be printed and shall provide to PAR agreed artwork documents for PAR’s review. PAR shall, as promptly as practicablewithin one (1) week of receipt of agreed artwork documents, prepare new labels for each product either provide GSK any necessary corrections thereto or notify GSK of its approval of such agreed artwork documents. [***] If a change of Labels or Labeling 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 shallwas requested by PAR, 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 or due to an assignment of this Agreement by Spectrum pursuant to Section 9.1 results in obsolete inventory of former Labels or Labeling that GSK cannot otherwise use, [***]. PAR shall submit to applicable primary registrant for approval any proposed label; • Once approved supply GSK with all of PAR’s necessary artwork, text, SKU numbers and available for use on inventoryother necessary items by the dates reasonably requested by GSK, 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 GSK can prepare the manufacturingLabels and packaging for the Initial Quantity. GSK’s obligations to supply PAR and its Affiliates with GSK Supplied Product, saleincluding the Initial Quantity by the specified delivery date, 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 Providerbe contingent upon GSK’s locations and enable Buyers to inspect such relabeled inventory; and • Service Providers shall use commercially reasonable efforts to conduct all timely receipt of the foregoing Services in a manner so as not to disrupt the sale or shipment of any inventory to any customer artwork, text, SKU and Buyers shall exercise its approval rights in a manner so as to avoid any such disruption; Notwithstanding any of the foregoing NDC numbers 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 labelingother necessary items from PAR.
Appears in 1 contract
Sources: Supply and Distribution Agreement (Spectrum Pharmaceuticals Inc)
Labeling. Service Providers have identified BSC will be responsible at its own expense for determining the 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 requirements for each product that is identified under country in 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 Territory in which such products are sold or intended BSC wishes to be sold; • With respect to any Registration for which Service Provider is a supplemental registrantsell the relevant Product(s), 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 other than with respect to labels and labeling; • Service Providers shall notify Buyers (i) labeling requirements of the re-U.S. Food and Drug Administration (the "FDA"), (ii) the CE Mark ▇▇▇hin the EU and (iii) the labeling requirements for Japan, for each of any which the Company will be responsible, and BSC will timely and promptly provide the Company, in reasonable detail, with such inventory requirement information. Provided BSC has timely and fully informed the Company of the relevant labeling requirements (except with new respect to FDA, CE Mark ▇▇▇ Japanese product labeling requirements, for each of which the Company will be responsible), the Company will provide BSC, at BSC's expense directly or reimbursed to the Company, and in time for the Company to meet its delivery dates to BSC of the relevant Product(s) pursuant to accepted orders, the labels, necessary translations and instructions as to placement of labels on such product(s), prior to their shipment into countries in accordance with the Territory. Notwithstanding 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 inventorysentence, Service Providers shall at all times during the Transition Period BSC will be responsible for informing the Company of any additional labeling or over-labeling requirements in the EU or in Japan related solely to BSC's distribution and not to product labeling for regulatory compliance). The Products will be labeled with the Company's name as the manufacturer, and will (at BSC's expense for any additional labeling or over-labeling that is not incorporated into the Company's manufacturing process) have BSC named as a distributor in those jurisdictions within the Territory (a) where such denomination of BSC is required by law, in all material respectswhich case such label content, with all Applicable Law with respect configuration, size and placement on the products will be approved by the Company, which approval the Company will not unreasonably withhold, or (b) as to labels which the Company has approved such labeling at BSC's written request as appropriate and labelingdesirable to BSC as a distributor hereunder, based upon custom and usage in such jurisdiction or where deemed advisable by BSC, which approval the Company will not unreasonably withhold.
Appears in 1 contract
Sources: International Distribution Agreement (Cardiogenesis Corp)
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 ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ 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
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
Labeling. Service Providers (i) Within [**] Business Days after execution of this Agreement, Supplier shall provide the package inserts, labeling, and packaging materials (collectively, “Labeling”) for the Brand Product.
(ii) Not less than [**] months prior to the Launch Date, Distributor will provide Supplier with recommended changes to the Labeling which are in compliance with Applicable Law and which changes are limited to those that reflect that the product is the Authorized Generic Product and not the Brand Product.
(iii) Distributor and Supplier will mutually agree on the changes to Labeling that are appropriate for the Authorized Generic Product. Supplier will provide Distributor a proof of such Labeling for its review and approval at least [**] months prior to the Launch Date. Distributor shall have identified labeling issues [**] Business Days to review and either comment upon, or approve, such Labeling materials. If approval of, or comments to, the Labeling materials is not provided within such [**] Business Day period, then the Labeling materials shall be considered approved. If comments are provided by Distributor, the Parties will work in Section 3.17(d) good faith to resolve such comments within [**] Business Days, with Supplier possessing final decision-making authority in respect of such Labeling materials, should resolution not occur within such period. Notwithstanding the timelines set forth herein, in the event of any change to the Labeling of the Amendment Brand Product, the Parties shall work in good faith to discuss revisions 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 Labeling of the foregoing, the Corrective Action Plan segregates the identified labeling issues between those products and Registrations for which modification Authorized Generic Product so as not to delay Distributor’s planned launch of the labels is required before any product can be shippedAuthorized Generic Product or, 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 if launched, so as to promptly update Labeling 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 registrantAuthorized Generic Product, to the extent required pursuant required.
(iv) Supplier will be responsible for procuring all Labeling necessary to Applicable Lawenable it to perform its obligations under this Agreement, Service Provider shall submit subject to applicable primary registrant for approval any proposed label; • Once approved Distributor providing Supplier with the artwork, design 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 other content of the re-labeling of any such inventory with new labels Labeling in accordance with the foregoing timelines set forth herein. Supplier or its Third Party designee shall maintain complete 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 accurate records of the Service Provider’s locations usage and enable Buyers disposal of all Labeling related to inspect such relabeled inventory; and • Service Providers shall use commercially reasonable efforts to conduct all the Manufacture of the foregoing Services in a manner so as not to disrupt the sale Authorized Generic Product(s) for Distributor. Supplier makes no representations 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 warranties with respect to labels and labelingthe content of the Labeling of the Authorized Generic Product to the extent determined by Distributor (artwork, design, etc.).
Appears in 1 contract
Sources: Authorized Generic Product Supply Agreement (Alkermes Plc.)
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 ▇▇▇▇▇▇▇▇, 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
Sources: Trademark License Agreement