Common use of Licensors Obligations Clause in Contracts

Licensors Obligations. (a) At Licensee’s request, Licensor shall, at its sole expense, provide to Licensee any information in Licensor's possession or control as to the contents of the Compound or any other information in Licensor's possession or control required by any governmental authorities in any Territory. Licensor shall provide documentation and other information reasonably requested by Licensee in support of Licensee’s application, if any, for USP certification of the Products. Licensee shall be solely responsible for any USP certification application, including the information contained in such application. (b) Licensor shall be responsible for the proper and lawful acquisition, maintenance, storage and handling of the ingredients and components of the Compound and all Compound-related inventory while in Licensor's possession and control. (c) Licensor shall manufacture or have manufactured, package, label, supply and deliver the Compound in accordance with the highest standards of the nutritional supplement industry and in strict compliance with (i) all applicable regulatory requirements, and (ii) Licensee’s current “Supplier Shipping & Compliance Guide,” a copy of which is attached as Schedule G. Licensor shall deliver to Licensee all documentation necessary to adequately document the safety, quality and quantity of all ingredients contained therein and the efficacy of the Compound. Such documentation shall also include, without limitation, a Certificate of Analysis which provides qualitative and quantitative confirmation of the active ingredient content of the Compound and the accompanying laboratory results for each and every lot of the Compound. Licensee may rely on the content of the Certificate of Analysis for any purposes. Failure to provide Compound of suitable quality conforming to the Compound’s Specifications or documentation set forth in this Section 8 in support thereof shall be grounds for rejection of the Compound by the Licensee and a material breach of this Agreement which, if not cured within sixty (60) days, shall provide Licensee with the right to terminate this Agreement. The Property shall not infringe upon or misappropriate the intellectual property or other rights of any third party. (d) Licensor shall materially comply with applicable laws, regulations, rules and orders applicable in the United States, including, without limitation, those of the U.S. Federal Food and Drug Administration (the “FDA”) and those relating to the Dietary Supplements and Health Education Act of 1994, as amended. The Compound is guaranteed by Licensor to be not adulterated or misbranded within the meaning of the Federal Food, Drug and Cosmetic Act, and not an article which may not, under such Act, be introduced into interstate commerce. The Compound shall be merchantable and fit for the intended use by Licensee and the purchasers of the Products. Licensor shall promptly notify Licensee if any audit is conducted by the FDA while any of the Compound is being manufactured. If the FDA pulls a sample of a lot of the Compound, Licensor shall immediately send a matching sample to Licensee. Licensor shall promptly notify Licensee of any customer or other complaints, governmental inquiries, quality issues or product liability issues relating to the Compound or any of its components. (e) Licensor shall use its best efforts to (i) at Licensee’s written request, challenge on the basis of prior art a third party patent application that seeks to patent the Compound in Territories where Costco operates and Licensor does not hold a patent; and (ii) prosecute all pending patent applications with the appropriate governmental authorities in the Territories in order to obtain the issuance of the Patent registrations contemplated hereunder. (f) Licensor shall use reasonable commercial efforts to promptly provide Licensee the results of any clinical studies relating to the Compound in Licensor's possession or control. (g) Licensor represents and warrants that it has provided to Licensee all results of each clinical study in Licensor's possession or control performed by or at the request of Licensor on the Compound to date, and that such results have not been changed, summarized or altered in any way. Licensor further represents and warrants that, to the best of its knowledge after due inquiry, that the results of all clinical studies provided to Licenses are complete and accurate.

Appears in 1 contract

Sources: License Agreement (Schiff Nutrition International, Inc.)

Licensors Obligations. (a) At Licensee’s request, Licensor shall, at its sole expense, shall provide to Licensee a copy of Licensor’ s detailed SOPs and all other Licensed IP for any information in Licensor's possession or control as to the contents and all aspects of the Compound or any other information in Licensor's possession or control required by any governmental authorities in any Territory. Licensor shall provide documentation and other information reasonably requested by Licensee in support of Licensee’s applicationproduction, if anymanufacture, & quality assurance, for USP certification of the Licensed Products. Licensee shall be solely responsible for any USP certification application, including the information contained in such application. (b) Licensor shall be responsible for the proper and lawful acquisition, maintenance, storage and handling of the ingredients and components of the Compound provide to Licensee at no costs any and all Compound-Intellectual Property related inventory while to the Licensed Products and their packaging, labeling, and advertising as is reasonably necessary to allow Licensee to produce, package, advertise and/or sell the Licensed Products in Licensor's possession accordance with Licensee’s obligations under this Agreement and controlApplicable Law. (c) Licensor shall manufacture or have manufactured, package, label, supply print and deliver the Compound in accordance with the highest standards of the nutritional supplement industry and in strict compliance with (i) all applicable regulatory requirements, and (ii) Licensee’s current “Supplier Shipping & Compliance Guide,” a copy of which is attached as Schedule G. Licensor shall deliver to Licensee all documentation necessary to adequately document the safety, quality and quantity of all ingredients contained therein and the efficacy of the Compound. Such documentation shall also include, without limitation, a Certificate of Analysis which provides qualitative and quantitative confirmation of the active ingredient content of the Compound and the accompanying laboratory results for each and every lot of the Compound. Licensee may rely on the content of the Certificate of Analysis for any purposes. Failure to provide Compound of suitable quality conforming to the Compound’s Specifications or documentation set forth in this Section 8 in support thereof shall be grounds for rejection of the Compound by the Licensee and a material breach of this Agreement which, if not cured within sixty (60) days, shall provide Licensee with the right all Point-of-Sale displays, with such displays to terminate this Agreementbe reviewed and approved by Licensee for compliance with Applicable Law. The Property shall not infringe upon or misappropriate the intellectual property or other rights of any third party. (d) Licensor shall materially comply with applicable laws, regulations, rules provide to Licensee a list of (i) required equipment for the production and orders applicable in the United States, including, without limitation, those packaging of the U.S. Federal Food and Drug Administration Licensed Products (the FDARequired Equipment); (ii) and those relating to the Dietary Supplements and Health Education Act of 1994, as amended. The Compound is guaranteed by Licensor to be not adulterated or misbranded within the meaning of the Federal Food, Drug and Cosmetic Act, and not an article which may not, under such Act, be introduced into interstate commerce. The Compound shall be merchantable and fit requirements for the intended safety, use by Licensee and the purchasers operation of the Products. Licensor shall promptly notify Licensee if any audit is conducted by the FDA while any of the Compound is being manufactured. If the FDA pulls a sample of a lot of the Compound, Licensor shall immediately send a matching sample to Licensee. Licensor shall promptly notify Licensee of any customer or other complaints, governmental inquiries, quality issues or product liability issues relating to the Compound or any of its componentsRequired Equipment; and (iii) all required raw material. (e) Licensor shall use its best efforts provide to (i) at Licensee’s written request, challenge on Licensee a floor plan and facility layout specific to the basis of prior art a third party patent application that seeks to patent the Compound in Territories where Costco operates processing and Licensor does not hold a patent; and (ii) prosecute all pending patent applications with the appropriate governmental authorities in the Territories in order to obtain the issuance of the Patent registrations contemplated hereunder.manufacturing premises. ​ (f) Prior to the commencement of any production of the Licensed Products and as may be required by change in Applicable Law, Licensor shall use reasonable commercial efforts design the packaging for the Licensed Products and submit packaging designs to promptly provide Licensee. Licensee shall review such designs to determine such packaging complies with Applicable Law. Upon approval of the results final design by both Parties, Licensee shall thereafter inform Licensor of any clinical studies relating change to Applicable Law affecting the packaging, within thirty (30) days of the implementation of said change, as well as recommend changes to the Compound in Licensor's possession or control.existing packaging to conform to and comply with Applicable Law. ​ (g) Where state law allows, Licensor represents may dedicate a mutually agreed-upon number of ▇▇▇▇ ▇▇▇▇▇▇ brand ambassadors to the Territory. ​ (h) Where state law allows, Licensor agrees to share in the cost of promotional discounts offered by licensed retail establishments to customers, on a pro rata basis proportionate to the revenue share percentages described in Exhibit B. (i) Upon approval of such budget by Licensor’ s management team, Licensor shall provide Licensee with an annual sales and warrants that it has provided marketing budget for the Territory. Licensor shall also provide a mid-year reforecast of the sales and marketing budget for the Territory, based upon year-to-date sales performance and market conditions. Prior to any finalization of such budget, Licensor shall first receive approval from the Licensee all results of each clinical study in Licensor's possession or control performed by or at the request of Licensor on the Compound amount and use of spend. (j) Licensor shall have final approval on all marketing materials and press releases prior to date, and that such results have not been changed, summarized or altered in any wayrelease. Licensor further represents and warrants that, to the best of its knowledge after due inquiry, that the results of all clinical studies provided to Licenses are complete and accurate.

Appears in 1 contract

Sources: License and Manufacturing Agreement (Medicine Man Technologies, Inc.)

Licensors Obligations. (a) At Licensee’s request, Licensor shall, at its sole expense, provide to Licensee any information in Licensor's possession or control as to the contents of the Compound or any other information in Licensor's possession or control required by any governmental authorities in any Territory. Licensor shall provide documentation and other information reasonably requested by Licensee in support of Licensee’s application, if any, for USP certification of the Products. Licensee shall be solely responsible for any USP certification application, including the information contained in such application. (b) Licensor shall be responsible for the proper and lawful acquisition, maintenance, storage and handling of the ingredients and components of the Compound and all Compound-related inventory while in Licensor's possession and controlinventory. (c) Licensor shall manufacture or have manufactured, package, label, supply and deliver the Compound in accordance with the highest standards of the nutritional supplement industry and in strict compliance with (i) all applicable regulatory requirements, and (ii) Licensee’s current “Supplier Shipping & Compliance Guide,” a copy of which is attached as Schedule G. ”. Licensor shall deliver to Licensee all documentation necessary to adequately document the safety, quality and quantity of all ingredients contained therein and the efficacy of the Compound. Such documentation shall also include, without limitation, a Certificate of Analysis which provides qualitative and quantitative confirmation of the active ingredient content of the Compound and the accompanying laboratory results for each and every lot of the Compound. Licensee may rely on the content of the Certificate of Analysis for any purposes. Failure to provide Compound of suitable quality conforming to the Compound’s Specifications or documentation set forth in this Section 8 in support thereof shall be grounds for rejection of the Compound by the Licensee and a material breach of this Agreement which, if not cured within sixty (60) days, shall provide Licensee with the right to terminate this Agreement. The Property shall not infringe upon or misappropriate the intellectual property or other rights of any third partyparty and shall be of acceptable style, appearance and quality to Licensee. (d) Licensor shall materially comply with applicable laws, regulations, rules and orders applicable in the United States, including, without limitation, those of the U.S. Federal Food and Drug Administration (the “FDA”) and those relating to the Dietary Supplements and Health Education Act of 1994, as amended. The Compound is guaranteed by Licensor to be not adulterated or misbranded within the meaning of the Federal Food, Drug and Cosmetic Act, and not an article which may not, under such Act, be introduced into interstate commerce. The Compound shall be merchantable and fit for the intended use by Licensee and the purchasers of the Products. Licensor shall promptly notify Licensee if any audit is conducted by the FDA while any of the Compound is being manufactured. If the FDA pulls a sample of a lot of the Compound, Licensor shall immediately send a matching sample to Licensee. Licensor shall promptly notify Licensee of any customer or other orother complaints, governmental inquiries, quality issues or product liability issues relating to the Compound or any of its components. (e) Licensor shall use its best efforts to (i) at Licensee’s written request, challenge on file all applications for Patents and Trademarks in the basis of prior art a third party patent application that seeks to patent the Compound in Territories where Costco operates and Licensor does they have not hold a patentalready been filed; and (ii) prosecute all pending patent applications with the appropriate governmental authorities in the Territories in order to obtain the issuance of the Patent and Trademark registrations contemplated hereunder. (f) Licensor shall use reasonable commercial efforts to promptly provide Licensee the results of any clinical studies relating to the Compound in Licensor's possession or controlCompound. (g) Licensor represents and warrants that it has provided to Licensee all results of each clinical study in Licensor's possession or control performed by or at the request of Licensor on the Compound to date, and that such results have not been changed, summarized or altered in any way. Licensor further represents and warrants that, to the best of its knowledge after due inquiry, that the results of all clinical studies provided to Licenses are complete and accurate.

Appears in 1 contract

Sources: License and Product Supply Agreement (Schiff Nutrition International, Inc.)

Licensors Obligations. Except where expressly permitted by Article 28 (a3a) At of the GDPR, Licensor shall process data subjects’ Data only within the scope of the statement of work and the instructions issued by Licensee. Where Licensor believes that an instruction would be in breach of applicable law, Licensor shall notify Licensee of such belief without undue delay. Licensor shall be entitled to suspending performance on such instruction until Licensee confirms or modifies such instruction. Licensor shall, within Licensor’s scope of responsibility, organize Licensor’s internal organization so it satisfies the specific requirements of data protection. Licensor shall implement technical and organizational measures to ensure the adequate protection of Licensee’s requestData, which measures shall fulfil the requirements of the GDPR and specifically its Article 32. Licensor shall implement technical and organizational measures and safeguards that ensure ongoing confidentiality, integrity, availability and resilience of processing systems and services. Licensee is familiar with these technical and organizational measures, and it shall be Licensee’s responsibility that such measures ensure a level of security appropriate to the risk. Licensor shall support Licensee, insofar as is agreed upon by the parties, and where possible for Licensor, in fulfilling data subjects’ requests and claims, as detailed in chapter III of the GDPR and in fulfilling the obligations enumerated in Articles 33 to 36 of the GDPR. Licensor warrants that all employees involved in Contract Processing of Licensee’s Data and other such persons as may be involved in Contract Processing within Licensor’s scope of responsibility shall be prohibited from processing Data outside the scope of the instructions. Furthermore, Licensor warrants that any person entitled to process Data on behalf of Controller has undertaken a commitment to secrecy or is subject to an appropriate statutory obligation to secrecy. All such secrecy obligations shall survive the termination or expiration of such Contract Processing. Licensor shall notify Licensee, without undue delay, if Licensor becomes aware of breaches of the protection of personal data within Licensor’s scope of responsibility. Licensor shall implement the measures necessary for securing Data and for mitigating potential negative consequences for the data subject; the Licensor shall coordinate such efforts with Licensee without undue delay. Licensor shall notify to Licensee the point of contact for any issues related to data protection arising out of or in connection with the Agreement. Licensor warrants that Licensor fulfills its obligations under Article 32 (1)(d) of the GDPR to implement a process for regularly testing, assessing and evaluating the effectiveness of technical and organizational measures for ensuring the security of the processing. Licensor shall correct or erase Data if so instructed by Licensee and where covered by the scope of the instructions permissible. Where an erasure, consistent with data protection requirements, or a corresponding restriction of processing is impossible, Licensor shall, at its sole expensebased on Licensee’s instructions, provide and unless agreed upon differently in the Agreement, destroy, in compliance with data protection requirements, all carrier media and other material or return the same to Licensee any information In specific cases designated by Licensee, such Data shall be stored or handed over. The associated remuneration and protective measures shall be agreed upon separately, unless already agreed upon in Licensor's possession or control as to the contents of the Compound or any other information in Licensor's possession or control required by any governmental authorities in any TerritoryAgreement. Licensor shall provide documentation shall, upon termination of Contract Processing and upon Licensee’s instruction, return all Data, carrier media and other information reasonably requested by materials to Licensee in support of Licensee’s application, if any, for USP certification of or delete the Productssame. Licensee shall be solely responsible for bear any USP certification application, including the information contained extra cost caused by deviating requirements in such application. (b) Licensor shall be responsible for the proper and lawful acquisition, maintenance, storage and handling of the ingredients and components of the Compound and all Compound-related inventory while in Licensor's possession and control. (c) Licensor shall manufacture returning or have manufactured, package, label, supply and deliver the Compound deleting data. Where a data subject asserts any claims against Licensee in accordance with the highest standards Article 82 of the nutritional supplement industry and in strict compliance with (i) all applicable regulatory requirements, and (ii) Licensee’s current “Supplier Shipping & Compliance Guide,” a copy of which is attached as Schedule G. Licensor shall deliver to Licensee all documentation necessary to adequately document the safety, quality and quantity of all ingredients contained therein and the efficacy of the Compound. Such documentation shall also include, without limitation, a Certificate of Analysis which provides qualitative and quantitative confirmation of the active ingredient content of the Compound and the accompanying laboratory results for each and every lot of the Compound. Licensee may rely on the content of the Certificate of Analysis for any purposes. Failure to provide Compound of suitable quality conforming to the Compound’s Specifications or documentation set forth in this Section 8 in support thereof shall be grounds for rejection of the Compound by the Licensee and a material breach of this Agreement which, if not cured within sixty (60) days, shall provide Licensee with the right to terminate this Agreement. The Property shall not infringe upon or misappropriate the intellectual property or other rights of any third party. (d) Licensor shall materially comply with applicable laws, regulations, rules and orders applicable in the United States, including, without limitation, those of the U.S. Federal Food and Drug Administration (the “FDA”) and those relating to the Dietary Supplements and Health Education Act of 1994, as amended. The Compound is guaranteed by Licensor to be not adulterated or misbranded within the meaning of the Federal Food, Drug and Cosmetic Act, and not an article which may not, under such Act, be introduced into interstate commerce. The Compound shall be merchantable and fit for the intended use by Licensee and the purchasers of the Products. Licensor shall promptly notify Licensee if any audit is conducted by the FDA while any of the Compound is being manufactured. If the FDA pulls a sample of a lot of the CompoundGDPR, Licensor shall immediately send a matching sample to Licensee. Licensor shall promptly notify support Licensee of any customer or other complaintsin defending against such claims, governmental inquiries, quality issues or product liability issues relating to the Compound or any of its componentswhere possible. (e) Licensor shall use its best efforts to (i) at Licensee’s written request, challenge on the basis of prior art a third party patent application that seeks to patent the Compound in Territories where Costco operates and Licensor does not hold a patent; and (ii) prosecute all pending patent applications with the appropriate governmental authorities in the Territories in order to obtain the issuance of the Patent registrations contemplated hereunder. (f) Licensor shall use reasonable commercial efforts to promptly provide Licensee the results of any clinical studies relating to the Compound in Licensor's possession or control. (g) Licensor represents and warrants that it has provided to Licensee all results of each clinical study in Licensor's possession or control performed by or at the request of Licensor on the Compound to date, and that such results have not been changed, summarized or altered in any way. Licensor further represents and warrants that, to the best of its knowledge after due inquiry, that the results of all clinical studies provided to Licenses are complete and accurate.

Appears in 1 contract

Sources: Patent License Agreement