Labeling. Within thirty (30) days after the Effective Date, Horizon, at its own expense, will provide AHP with Horizon's new labeling 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 any 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 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 content of such labeling, 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 (on a Fully-Absorbed Cost basis) by 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. Such reimbursement shall be made pursuant to invoices submitted by AHP to Horizon, which invoices shall be payable within thirty (30) days after Horizon's receipt thereof. In addition, should such new labeling result in any increase in AHP's cost of manufacturing the 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, AHP may supply Horizon with Product bearing AHP's labeling if such Product was manufactured and labeled prior to the Closing, it being agreed that Product manufactured from and after the Closing shall bear (i) AHP's label, or (ii) Horizon's new label.
Appears in 2 contracts
Sources: Product Supply Agreement (First Horizon Pharmaceutical Corp), Product Supply Agreement (First Horizon Pharmaceutical Corp)
Labeling. Within thirty (30) days after 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 Effective DateLicensed Marks, Horizonthe appropriate trademark and copyright notices, at its own expensemarkings, will provide AHP with Horizon's new labeling 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 such 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 Product (including Licensed Products, a new NDC number for each Product) bearing Horizon's corporate name licensing statement inclusive of Licensor’s web page/site address, and trade dress. If such labeling is changed in any manner other than a new NDC number and Horizon's corporate name and tradedressmission statement, such labeling shall be both subject to the Licensor’s approval of AHP, which approval will shall not be unreasonably withheld. AHP agrees , 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 either approve or disapprove such labeling Licensee within thirty (30seven(7) business days of AHP's receipt thereof from Horizonfollowing request and if not so delivered shall be deemed approved. AHP, at Horizon's expense, will print, either directly or through a Third Party, labels A true and other printed material to be included as part correct copy of the finished Productlicensing statement and mission statement approved by Licensor is set forth in Exhibit F attached hereto and incorporated by reference herein. Product manufactured by AHP after AHP's receipt Licensor reserves the right to modify, supplement, and/or alter the licensing statement or mission statement in its sole discretion and approval of Horizon's new labeling for 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 Product, shall bear such new labeling, provided, however, that AHP shall have no responsibility with respect Licensed Marks and/or relate to the content of such labeling, 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 (on a Fully-Absorbed Cost basis) by 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. Such reimbursement shall be made pursuant to invoices submitted by AHP to Horizon, which invoices shall be payable within thirty (30) days after Horizon's receipt thereof. In addition, should such new labeling result in any increase in AHP's cost of manufacturing the Product hereunder, the purchase price for such Product as calculated under Section 5.1 hereofLicensed Products, shall be increased by such additional costs. Notwithstanding the foregoing, AHP may supply Horizon with Product bearing AHP's labeling if such Product was manufactured and labeled submitted to Licensor for its approval prior to any use by Licensee 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.
9.3 The Parties further agree that should any of the ClosingLicensed Products be manufactured, it being agreed that Product manufactured from and after the Closing shall bear (i) AHP's labeldistributed, or (ii) Horizon's new labelsold without the appropriate or requested trademark and copyright notices, markings, and/or designations, in addition to any other rights it may have, Licensor may demand the removal of the 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 and packaged to have a different look from the prior version of the product.
Appears in 2 contracts
Sources: License Agreement (NuGene International, Inc.), License Agreement (Bling Marketing, Inc.)
Labeling. Within thirty Service Providers have identified labeling issues in Section 3.17(d) of the Amendment to the Seller Disclosure Schedule dated September 2, 2010 (30the “Disclosure Update”) days after and have identified Inventory that utilize labels that require revision. Service Providers have developed a corrective action plan to correct the Effective Datelabels utilized on the products, Horizonwhich 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 its own expenseall times, will provide AHP in compliance, in all material respects, with Horizon's new labeling for the Product (Applicable Law including a new NDC number for each Product) bearing Horizon's corporate name and trade dress. If such labeling is changed in any 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 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 labels and labeling; • Service Providers shall notify Buyers of the content 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 labeling, provided inventory or the content movement of Quarantined Inventory from any segregated area of the labeling printed by AHP is the same as the content 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 labeling provided 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 Horizon. Horizon Buyers of the labels or the re-labeled inventory, Service Providers shall reimburse AHP at all times during the Transition Period be responsible for compliance, in all reasonable costs incurred (on a Fully-Absorbed Cost basis) by AHP in making modifications material respects, with all Applicable Law with respect to labels and labeling, branding or imprinting, packaging and/or manufacturing processes to accommodate Horizon's new labeling or to accommodate any other changes requested by Horizon. Such reimbursement shall be made pursuant to invoices submitted by AHP to Horizon, which invoices shall be payable within thirty (30) days after Horizon's receipt thereof. In addition, should such new labeling result in any increase in AHP's cost of manufacturing the 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, AHP may supply Horizon with Product bearing AHP's labeling if such Product was manufactured and labeled prior to the Closing, it being agreed that Product manufactured from and after the Closing shall bear (i) AHP's label, or (ii) Horizon's new label.
Appears in 2 contracts
Sources: Transition Services Agreement, Transition Services Agreement (Zep Inc.)
Labeling. Within thirty (30) days after 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 Effective DateLicensed Marks, Horizonthe appropriate trademark and copyright notices, at its own expensemarkings, will provide AHP with Horizon's new labeling and/or designations, and/or any other notice requested by Licensor. In the event that any Licensed Product is distributed and/or sold in 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 Product (including Licensed Products, a new NDC number for each Product) bearing Horizon's corporate name licensing statement inclusive of Licensor’s web page/site address, and trade dress. If such labeling is changed in any manner other than a new NDC number and Horizon's corporate name and tradedressmission statement, such labeling shall be both subject to Licensor’s approval, shall appear during the approval term of AHP, which approval will not be unreasonably withheldthis Agreement and any renewal or extension thereof. 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 A true and other printed material to be included as part correct copy of the finished Productlicensing statement and mission statement approved by Licensor is set forth in Exhibit F attached hereto and incorporated by reference herein. Product manufactured by AHP after AHP's receipt Licensor reserves the right to modify, supplement, and/or alter the licensing statement or mission statement in its sole discretion and approval of Horizon's new labeling for 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 Product, shall bear such new labeling, provided, however, that AHP shall have no responsibility with respect Licensed Marks and/or relate to the content of such labeling, 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 (on a Fully-Absorbed Cost basis) by 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. Such reimbursement shall be made pursuant to invoices submitted by AHP to Horizon, which invoices shall be payable within thirty (30) days after Horizon's receipt thereof. In addition, should such new labeling result in any increase in AHP's cost of manufacturing the Product hereunder, the purchase price for such Product as calculated under Section 5.1 hereofLicensed Products, shall be increased by such additional costs. Notwithstanding the foregoing, AHP may supply Horizon with Product bearing AHP's labeling if such Product was manufactured and labeled submitted to Licensor for its approval prior to any use by Licensee. -14- Initials: _______ Initials: _______
9.3 The Parties further agree that should any of the ClosingLicensed Products be manufactured, it being agreed that Product manufactured from and after the Closing shall bear (i) AHP's labeldistributed, or (ii) Horizon's new labelsold without the appropriate or requested trademark and copyright notices, markings, and/or designations, in addition to any other rights it may have, Licensor may demand the removal of the offending product from distribution and sale, and may remove that product from the list of Licensed Products.
Appears in 1 contract
Labeling. Within thirty (30) days after TRADE DRESS; NON-PRODUCT
5.1 LABELING, TRADE DRESS AND PACKAGING. The Product will be labeled, prepared and packed for shipment in full compliance with the Effective DatesNDAs and cGMP, Horizonand in accordance with the MRD/Quality Agreement. ▇▇▇▇▇, at its own expense, will provide AHP Lilly with Horizonan 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 new 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 (including a new NDC number for each Product) bearing Horizon's corporate name as of the Closing Date solely to market, sell and trade dress. If promote the Product delivered by Lilly that contains such labeling is changed in any 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 packaging being used by Lilly as part of the finished ProductClosing Date. Product manufactured by AHP after AHPThe foregoing license does not ▇▇▇▇▇ ▇▇▇▇▇ any rights in the "Lilly" ▇▇▇▇ or name except as it appears in such labels and packaging. The foregoing license will terminate upon the earlier of Galen's receipt and approval sale of Horizon's new labeling for the all of such Product, shall bear such new labeling, provided, however, that AHP shall or on the second (2nd) year anniversary of the Closing Date. Lilly will have no responsibility with respect obligation to the content of such labeling, 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 (on a Fullyre-Absorbed Cost basis) by AHP in making modifications to labeling, branding label or imprinting, packaging and/or manufacturing processes to accommodate Horizon's new labeling or to accommodate over-label any other changes requested by Horizon. Such reimbursement shall be made pursuant to invoices submitted by AHP to Horizon, which invoices shall be payable within thirty (30) days after Horizon's receipt thereof. In addition, should such new labeling result in any increase in AHP's cost of manufacturing the 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, AHP may supply Horizon with Product bearing AHP's labeling if such Product was manufactured and labeled packaged prior to the Closingimplementation of Galen's labels and packaging. Galen's name (or the name of an Affiliate of ▇▇▇▇▇) will appear as the exclusive distributor of the Product and Lilly's name will appear as the manufacturer of the Product (unless a Third Person manufactures any Product pursuant to Section 4.3, above, in which event such Third Person's name will appear as the manufacturer of the Product) unless it being agreed that Product manufactured from is reasonable and after allowed under Applicable Laws under the Closing shall bear (i) AHPcircumstances to delete Lilly's labelor 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 (ii) Horizon's new labelotherwise requested by ▇▇▇▇▇ hereunder, including without limitation, commercially reasonable costs associated with the destruction of printed components rendered obsolete as a result of the transactions contemplated hereby.
Appears in 1 contract
Labeling. Within thirty (30) days after 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 Effective DateLicensed Marks, Horizonthe appropriate trademark and copyright notices, at its own expensemarkings, will provide AHP 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 Horizon's new labeling any Related Materials, such notices shall also appear upon the Related Materials.
9.2 Licensee further agrees that on all Related Materials for the Product (including Licensed Products, a new NDC number for each Product) bearing Horizon's corporate name licensing statement inclusive of Licensor’s web page/site address, and trade dress. If such labeling is changed in any manner other than a new NDC number and Horizon's corporate name and tradedressmission statement, such labeling shall be both subject to Licensor’s approval, shall appear during the approval term of AHP, which approval will not be unreasonably withheldthis Agreement and any renewal or extension thereof. 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 A true and other printed material to be included as part correct copy of the finished Productlicensing statement and mission statement approved by Licensor is set forth in Exhibit E attached hereto and incorporated by reference herein. Product manufactured by AHP after AHP's receipt Licensor reserves the right to modify, supplement, and/or alter the licensing statement or mission statement in its sole discretion and approval of Horizon's new labeling for 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 Product, shall bear such new labeling, provided, however, that AHP shall have no responsibility with respect Licensed Marks and/or relate to the content of such labeling, 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 (on a Fully-Absorbed Cost basis) by 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. Such reimbursement shall be made pursuant to invoices submitted by AHP to Horizon, which invoices shall be payable within thirty (30) days after Horizon's receipt thereof. In addition, should such new labeling result in any increase in AHP's cost of manufacturing the Product hereunder, the purchase price for such Product as calculated under Section 5.1 hereofLicensed Products, shall be increased by such additional costs. Notwithstanding the foregoing, AHP may supply Horizon with Product bearing AHP's labeling if such Product was manufactured and labeled submitted to Licensor for its approval prior to any use by Licensee.
9.3 The Parties further agree that should any of the ClosingLicensed Products be manufactured, it being agreed that Product manufactured from and after the Closing shall bear (i) AHP's labeldistributed, or (ii) Horizon's new labelsold without the appropriate or requested trademark and copyright notices, markings, and/or designations, in addition to any other rights it may have, Licensor may demand the removal of the offending product from distribution and sale, and may remove that product from the list of Licensed Products.
Appears in 1 contract
Labeling. Within thirty (30) days after TRADE DRESS; NON-PRODUCT
5.1 LABELING, TRADE DRESS AND PACKAGING. The Product will be labeled, prepared and packed for shipment in full compliance with the Effective DateNDA, Horizonand cGMP and in accordance with the MRD/Quality Agreement. NEOSAN, at its own expense, will provide AHP Lilly with Horizonan 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 new 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 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 the implementation of NEOSAN's labels and packaging. The Parties contemplate that NEOSAN's name (or the name of an Affiliate of NEOSAN) will appear as the exclusive distributor of the Product and Lilly's name will appear as the manufacturer of the Product (including a new NDC number for each Product) bearing Horizon's corporate name and trade dress. If such labeling is changed in any 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 unless a Third PartyPerson manufactures any Product pursuant to Section 4.3, labels and other printed material to be included above, in which event such Third Person's name will appear as part the manufacturer of the finished Product). Product manufactured by AHP after AHPAll changes made to NEOSAN's receipt initial labeling will be made in accordance with the procedures and approval of Horizontimelines set forth in the MRD. NEOSAN will reimburse Lilly for any costs associated with changing to NEOSAN's new labeling for the Product, shall bear such new initial labeling, providedtrade dress and packaging work provided by Lilly hereunder and for any subsequent packaging and labeling change work required or otherwise requested by NEOSAN hereunder, howeverincluding without limitation, that AHP shall have no responsibility commercially reasonable costs associated with respect to the content destruction of such labeling, provided the content printed components rendered obsolete as a result 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 (on a Fully-Absorbed Cost basis) by 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. Such reimbursement shall be made pursuant to invoices submitted by AHP to Horizon, which invoices shall be payable within thirty (30) days after Horizon's receipt thereof. In addition, should such new labeling result in any increase in AHP's cost of manufacturing the 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, AHP may supply Horizon with Product bearing AHP's labeling if such Product was manufactured and labeled prior to the Closing, it being agreed that Product manufactured from and after the Closing shall bear (i) AHP's label, or (ii) Horizon's new labeltransactions contemplated hereby.
Appears in 1 contract
Labeling. (i) Within thirty [**] Business Days after execution of this Agreement, Supplier shall provide the package inserts, labeling, and packaging materials (30collectively, “Labeling”) days after for the Effective Brand Product.
(ii) Not less than [**] months prior to the Launch Date, Horizon, at its own expense, Distributor will provide AHP Supplier with Horizon's new labeling 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 Product (including Authorized Generic Product. Supplier will provide Distributor a new NDC number proof of such Labeling for each Product) bearing Horizon's corporate name its review and trade dressapproval at least [**] months prior to the Launch Date. Distributor shall have [**] 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 labeling is changed in any manner other than a new NDC number and Horizon's corporate name and tradedress[**] Business Day period, such labeling then the Labeling materials shall be considered approved. If comments are provided by Distributor, the Parties will work in 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 Brand Product, the Parties shall work in good faith to discuss revisions to the Labeling of the Authorized Generic Product so as not to delay Distributor’s planned launch of the Authorized Generic Product or, if launched, so as to promptly update Labeling of the Authorized Generic Product, to the extent required.
(iv) Supplier will be responsible for procuring all Labeling necessary to enable it to perform its obligations under this Agreement, subject to Distributor providing Supplier with the approval of AHPartwork, 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 design and other printed material to be included as part content of the finished ProductLabeling in accordance with the timelines set forth herein. Product manufactured by AHP after AHP's receipt Supplier or its Third Party designee shall maintain complete and approval accurate records of Horizon's new labeling the usage and disposal of all Labeling related to the Manufacture of Authorized Generic Product(s) for the Product, shall bear such new labeling, provided, however, that AHP shall have Distributor. Supplier makes no responsibility representations or warranties with respect to the content of such labeling, provided the content Labeling 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 (on a Fully-Absorbed Cost basis) by 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. Such reimbursement shall be made pursuant to invoices submitted by AHP to Horizon, which invoices shall be payable within thirty (30) days after Horizon's receipt thereof. In addition, should such new labeling result in any increase in AHP's cost of manufacturing the Authorized Generic 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, AHP may supply Horizon with Product bearing AHP's labeling if such Product was manufactured and labeled prior to the Closingextent determined by Distributor (artwork, it being agreed that Product manufactured from and after the Closing shall bear (i) AHP's labeldesign, or (ii) Horizon's new labeletc.).
Appears in 1 contract
Sources: Authorized Generic Product Supply Agreement (Alkermes Plc.)
Labeling. Within thirty (30a) days after Customer hereby grants Manufacturer a limited, non-exclusive, non-transferable license as to the Effective Date, Horizon, at its own expense, will provide AHP with Horizon's new labeling Marks for the Product 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 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 new NDC number 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 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 provider of such services. Customer shall, subject to the size specification provided by Manufacturer, provide Manufacturer with the design and color specification for the label for each Product covered by this Agreement and for each ▇▇▇▇ to be used on the packaging for each Product
(b) bearing Horizon's corporate name and trade dress. If such labeling is changed in any manner other than a new NDC number and Horizon's corporate name and tradedress, such labeling Manufacturer shall be subject to responsible for ensuring compliance with the approval labeling requirements of AHPthe Federal Food, which approval will not Drug, and Cosmetic Act and other applicable federal and state food labeling laws and regulations.
(c) Manufacturer shall be unreasonably withheld. AHP agrees to either approve or disapprove such labeling within thirty (30) business days responsible for ordering adequate supplies 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 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 included ordered based on forecasts as part 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 finished ProductProducts with the Marks. Product manufactured by AHP after AHP's receipt and approval of Horizon's new labeling Customer shall supply the UPC codes to Manufacturer for printing on the labels used for the Product, shall bear such new labeling, provided, however, that AHP shall have no responsibility with respect Products.
(e) Nothing herein is deemed to grant to Manufacturer any right or license to use the content of such labeling, provided the content of Marks for any purpose other than the labeling printed of Products for sale by AHP is the same Customer as the content of the labeling provided by Horizon. Horizon shall reimburse AHP for all reasonable costs incurred (on a Fully-Absorbed Cost basis) by 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. Such reimbursement shall be made pursuant to invoices submitted by AHP to Horizon, which invoices shall be payable within thirty (30) days after Horizon's receipt thereof. In addition, should such new labeling result in any increase in AHP's cost of manufacturing the 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, AHP may supply Horizon with Product bearing AHP's labeling if such Product was manufactured and labeled prior to the Closing, it being agreed that Product manufactured from and after the Closing shall bear (i) AHP's label, or (ii) Horizon's new labelthis Agreement.
Appears in 1 contract
Labeling. Within thirty (30a) days after 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 Effective DateMark the and the notice as shown on Appendix 2 attached hereto, Horizonand where such Licensed Article or advertising, at its own expensepromotional or display material bears a trademark or service mark, will provide AHP with Horizon's new labeling appropriate statutory notice of registration or application 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 any 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 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 content of such labeling, 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 (on a Fully-Absorbed Cost basis) by 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. Such reimbursement shall be made pursuant to invoices submitted by AHP to Horizon, which invoices shall be payable within thirty (30) days after Horizon's receipt registration thereof. In additionthe event that any article is marketed in a carton, should container, packing or wrapping material bearing the Mark, such new labeling result in notice shall also appear upon that carton, container, packing or wrapping material. Each and every tag, label, imprint or other device containing any increase in AHP's cost of manufacturing such notice and all advertising, promotional or display material bearing the Product hereunder, the purchase price for such Product as calculated under Section 5.1 hereof, Mark shall be increased by such additional costs. Notwithstanding the foregoing, AHP may supply Horizon with Product bearing AHP's labeling if such Product was manufactured and labeled submitted to Licensor for 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 in good faith with Licensor for the Closingpurpose of securing and 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 nothing contained in this Agreement shall be construed as an assignment or grant to the Licensee of any right, title or interest in or to the Mark, it being agreed understood that Product manufactured from all rights relating thereto are reserved by ▇▇▇▇▇▇▇▇, except for the license hereunder to Licensee of the right to use and after utilize the Closing 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 assignment, transfer or conveyance shall bear be without other consideration than the mutual covenants and considerations of this Agreement
(ic) AHP's labelLicensee 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 (ii) Horizon's new labelother promotion of any article subject to this Agreement, that Licensor endorses such product; that Licensor has found the product to be fit for consumption by persons afflicted with celiac disease and NCGS; or make any representation regarding the Mark other than as specifically indicated on Appendix 2 which Is attached to this Agreement.
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Sources: Trademark License Agreement
Labeling. Within thirty 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 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 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 Licensed Products, shall be submitted to Licensor for its written approval prior to any use by Licensee. Licensor’s written approval/disapproval will be provided to Licensee not more then ten (3010) business days after the Effective Datesubmission of the materials by Licensee. In the event such notice is not given, Horizon, at its own expense, will provide AHP with Horizon's new labeling 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 any manner other than a new NDC number and Horizon's corporate name and tradedress, such labeling same shall be subject deemed disapproved. Licensee shall have the right to utilize the approval signature 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 ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ on all of the finished Productmaterials referred to in this paragraph. Product manufactured Approval by AHP after AHPLicensor shall not constitute waiver of Licensor's receipt and approval rights or Licensee's duties under any provision of Horizon's new labeling for the Product, shall bear such new labeling, provided, however, this Agreement.
8.3 The Parties further agree that AHP shall have no responsibility with respect to the content of such labeling, provided the content should any of the labeling printed by AHP is Licensed Products be manufactured, distributed, or sold without the same as appropriate or requested trademark and copyright notices, markings, and/or designations, in addition to any other rights it may have, Licensor may demand the content immediate removal of the labeling provided by Horizon. Horizon shall reimburse AHP for all reasonable costs incurred (on a Fully-Absorbed Cost basis) by AHP in making modifications to labelingoffending product from distribution and sale, branding or imprinting, packaging and/or manufacturing processes to accommodate Horizon's new labeling or to accommodate any other changes requested by Horizon. Such reimbursement shall be made pursuant to invoices submitted by AHP to Horizon, which invoices shall be payable within thirty (30) days after Horizon's receipt thereof. In addition, should such new labeling result in any increase in AHP's cost and may remove that product from the list of manufacturing the 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, AHP may supply Horizon with Product bearing AHP's labeling if such Product was manufactured and labeled prior to the Closing, it being agreed that Product manufactured from and after the Closing shall bear (i) AHP's label, or (ii) Horizon's new labelLicensed Products.
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