Common use of Licensor Assistance Clause in Contracts

Licensor Assistance. Throughout the Term, Licensor shall be obligated to identify Information that is reasonably necessary for Licensee to Develop the Product or Commercialize the Products in the Field in the Territory in accordance with this Agreement and, at any time that Licensor or Licensee identifies Licensor Know-How relevant for these purposes in the Territory, Licensor shall promptly provide Licensee with copies of such Licensor Know-How free of charge other than any expenses incurred in such provision. Without limiting the foregoing, in order to assist Licensee in the conduct of clinical studies of the Product in or for the Territory during the Term, Licensor shall at the cost of the Licensor, (i) promptly upon Licensee’s request, supply Licensee with Licensor Know-How that is reasonably necessary for Licensee to conduct clinical studies of the Product in or for the Territory and (ii) promptly after the Effective Date, provide Licensee (or its subcontractor), for use in clinical studies of the Product, with materials developed and validated by Licensor in the English language (e.g., patient diary); and (iii) provision of sample and reference Products for clinical Development; and (iv) if reasonably requested by Licensee, implement necessary pre-clinical trials and clinical trials outside the Territory, provided that (a) such trials are required by the Regulatory Authority in the Territory or considered necessary to facilitate Licensee for the application for or maintenance of the Regulatory Approvals in the Territory; (ii) such trials are permitted by the Applicable Law and acceptable for the Regulatory Authority in the Territory; and (iii) the costs and expenses of such trials (including the cost of Products used therein) are borne by Licensee.

Appears in 2 contracts

Samples: License, Collaboration and Distribution Agreement (Midatech Pharma PLC), License, Collaboration and Distribution Agreement (Midatech Pharma PLC)

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Licensor Assistance. Throughout Upon the Termclosing of Tranche 1 Investment pursuant to the Securities Purchase Agreement and upon Licensee’s reasonable request, Licensor shall be obligated agrees to assist to identify Information that is reasonably necessary for Licensee to Develop Localize the Product or Commercialize the Products in the Field in the Territory in accordance with this Agreement andand which is not protected by confidentiality and/or exclusivity agreements applicable outside of the Territory. Throughout the Term, subject to Article 4.2, at any time that Licensor or Licensee identifies Licensor Know-How relevant which is reasonably necessary for these purposes the purpose of the Localization and Commercialization of the Product in the Field in the Territory, Licensor shall promptly provide Licensee with copies of such Licensor Know-How free of charge other than any expenses incurred in such provisioncharge. Without limiting the foregoing, in In order to assist Licensee in the conduct of clinical studies of the Product Products, and obtain or maintain Regulatory Approvals in or for the Territory during the Term, Licensor shall at the cost of the Licensorits own cost, (i) promptly upon Licensee’s request, supply Licensee with Licensor Know-How and Information that is mandatory and/or reasonably necessary for Licensee to conduct clinical studies of the Product (if any) or obtain or maintain Regulatory Approvals in or for the Territory Territory, and (ii) promptly after the Effective Date, provide Licensee (or its subcontractor)Licensee, for use in clinical studies of the ProductProducts (if any) or to obtain or maintain Regulatory Approvals in the Territory, with materials relevant documents and information developed and validated by Licensor in the English language (e.g., patient diarydiaries); and (iii) provision of provide sample and reference Products for clinical Developmentdevelopment (if any) at the expense of the Licensee, provided that Licensor shall inform Licensee in writing and in advance of the related costs and obtain the prior written consent of the Licensee; and (iv) if reasonably requested by Licensee, implement necessary pre-clinical trials and clinical trials outside the Territory, provided that (ax) such trials are required by the Regulatory Authority in the Territory or considered necessary to facilitate Licensee for the application for or maintenance of the Regulatory Approvals in the Territory; and (iiy) such trials are permitted by the Applicable Law and acceptable for the Regulatory Authority in the Territory; and (iiiz) Licensor shall be responsible for collaborating with Licensee to carry out such pre-clinical trials and clinical trials at the costs expense of Licensee, provided further that Licensor shall inform Licensee in writing and expenses in advance of the related parties in charge of such trials and obtain the prior written consent of Licensee and secure for Licensee the right to directly communicate with that party to negotiate the relevant costs. Without limiting the foregoing, in order to assist Licensee in the Commercialization of the Product, and obtain or maintain Regulatory Approvals in or for the Territory during the Term, Licensor shall upon Licensee’s reasonable request, supply Licensee with the Licensor Know-How, training and Information related to the Product (including updates) that is necessary for Licensee to carry out the cost Commercialization of the Products. CONFIDENTIAL License and Distribution Agreement between Axxxxxx and Zylox Licensor agrees to provide source code applicable to use of the Product as may be necessary for the Licensee to Localize, register, or update the Products used therein) are for the purpose of Commercialization of the Products in the Territory. To avoid doubt, the salaries, labor costs, and managerial costs and other costs related to the employment of engineers or other Personnel of or designated by the Licensor in order to fulfill its obligation under this article shall be borne by Licenseethe Licensor, while Licensee will pay reasonable travel and related costs that are incurred within the Territory and pay for pre-approved international travel costs.

Appears in 1 contract

Samples: License and Distribution Agreement (Avinger Inc)

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Licensor Assistance. Throughout the Term, Licensor shall be obligated to identify Information notify Licensee of any new Licensor Know-How that is reasonably necessary for Licensee to Develop the Product or Commercialize the Products in the Field in the Territory in accordance with this Agreement and, at any time that Licensor or Licensee identifies Licensor Know-How relevant for these purposes in the Territorynot previously provided to Licensee, Licensor shall promptly provide Licensee with copies of such Licensor Know-How free of charge other than any expenses incurred in such provisionHow. Without limiting the foregoing, in order to assist Licensee in the conduct of clinical studies of the Product in or the Field in and for the Territory during the Term, Licensor shall at the cost of the Licensor, (ia) promptly upon Licensee’s request, supply Licensee with Licensor Know-How that is reasonably necessary for Licensee to conduct clinical studies of the Product in or for the Territory and not previously provided to Licensee, and (iib) promptly after the Effective Date, provide Licensee (or its subcontractorDesignated Party), for use in clinical studies of the ProductProduct in the Field, with materials patient diary developed and validated used in clinical studies of the Product conducted by Licensor in the English language (e.g., patient diary)language; and (iiic) provision of reasonable amount of sample Products and reference placebo for use in clinical Development (for clarity, excluding Post-Marketing Studies) free of charge; provided that such amount together with the quantity supplied under Article 5.4(a) shall be subject to the Supply Ceiling set forth in Article 7.2(b) and shall not exceed [***] units of Product and [***] units of the placebo during the first five (5) years after the Effective Date and Licensor shall have no obligation to supply such products for free after the fifth anniversary of the Effective Date. Subject to the Supply Ceiling set forth in Article 7.2(b), Licensor shall use Commercially Reasonable Efforts to supply any additional quantity of the Products or placebo for clinical Development; and use in Development (ivfor clarity, excluding Post-Marketing Studies) at a price equal to the Cost of Goods if reasonably required by Licensee. Without limiting the foregoing, promptly upon Licensee’s request, Licensor shall provide Licensee with the Required Information (in the English language) requested by Licensee, implement necessary pre-clinical trials and clinical trials outside Licensee in order to obtain or maintain Regulatory Approvals for the Territory, provided that (a) such trials are required by the Regulatory Authority Product in the Territory or considered necessary to facilitate Licensee for the application for or maintenance of the Regulatory Approvals Field in the Territory; provided, however, that Licensor shall not be obligated to provide the CMC Data to Licensee if such data may be submitted by Licensor to the Regulatory Authorities in the Territory directly. In the event it is not possible for Licensor to submit the CMC Data directly to the Regulatory Authorities, Licensee shall use Commercially Reasonable Efforts to negotiate with the applicable Regulatory Authorities to minimize the CMC Data required to be submitted to the Regulatory Authorities. Licensee shall reimburse Licensor for the pre-agreed cost and expense incurred by Licensor to provide such assistance. For the purpose of this clause, (i) Licensor shall not charge Licensee for any normal occupational activities or behaviors that are supposed to be conducted or performed by its officers, directors, employees or agents in the ordinary business course; and (ii) such trials are permitted by Licensor shall not be obligated to provide the Applicable Law and acceptable for the Regulatory Authority in the Territory; and (iii) assistance set forth herein unless the costs and expenses of such trials (including to be reimbursed by Licensee have been mutually agreed upon by the cost of Products used therein) are borne by LicenseeParties.

Appears in 1 contract

Samples: License, Collaboration and Supply Agreement (Capstar Special Purpose Acquisition Corp.)

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