Commercialisation Reports Sample Clauses

Commercialisation Reports. Without prejudice to the generality of the Licensee’s obligations under clause 5.1, the Licensee shall send CE within [**] of each Anniversary an updated, written commercialisation report, covering [**]. The report shall include: (a) an up to date list of all the patents or patent applications as defined in the Patents, including the following details: territory, patent type, application number, application date and status, (grant number and grant date if applicable); (b) the projected or actual dates of grant of Marketing Authorisation of a Royalty Product; (c) Milestone progression (dates for projected and achieved Milestones); and (d) a brief summary of activities (i) taken by the Licensee in the previous [**] and (ii) to be taken in the next [**], to bring Royalty Products to market and to seek to maximise the sale of Royalty Products in the Territory. CE’s receipt or approval of any such report shall not be taken to waive or qualify the Licensee’s obligations under clause 5.1.
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Commercialisation Reports. Within thirty (30) days following the close of each calendar quarter following the completion of the R&D Programme and exercise of the Further Development Option, Pacific will provide IntelGenx with a quarterly report with respect to activities and progress regarding its responsibilities, the commercialisation, sublicensing, and government approvals of Product.
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Commercialisation Reports sanofi pasteur shall keep Emergent reasonably informed of the progress of sanofi pasteur’s efforts to Commercialise any Product in the Field in the Territory through semi-annual reports, which reports shall summarise sanofi pasteur’s efforts to Commercialise such Product in accordance with the Commercialisation Plan for such Product.
Sample 1
Commercialisation Reports. Without prejudice to the generality of the Licensee’s obligations under clause 5.1, the Licensee shall send CE within 30 days of each Anniversary an updated, written commercialisation report, covering as a minimum the 12 months preceding the Anniversary and the 12 months following it. The report shall include: (a) the prior year’s past, current and projected activities taken or to be taken in the following year by the Licensee to bring Licensed Products to market and promote the sale of Licensed Products in the Territory; (b) Milestone progression (dates for projected and achieved Milestones); (c) an up to date list of all the patents or patent applications as defined in the Patents, including the following details: territory, patent type, application number, application date and status, (grant number and grant date if applicable); (d) the projected and actual dates of first sale of a Licensed Product; (e) Planned Sales during the period covered by the report; (f) sub-licences granted during the period covered by the report; (g) any Other Income invoiced or received during the period covered by the report; (h) any publication of any results achieved through use of the Data; (i) the commercial and public benefit which the Licensed Technology has created or stimulated; and (j) certification of insurance cover maintained (types and levels). CE’s receipt or approval of any such report shall not be taken to waive or qualify the Licensee’s obligations under clause 5.1.
Sample 1
Commercialisation Reports. Following completion of the Overall Project, Benitec will provide Biomics with an annual Commercialisation report outlining:
Sample 1
Commercialisation Reports. Without prejudice to the generality of the Licensee’s obligations under clause 5.1, the Licensee shall send CE within [####] of each Anniversary an updated, written commercialisation report, (which constitutes Licensee Confidential Information), covering as a minimum the [####] preceding the Anniversary and the [####] following it. The report shall include: (a) all activities conducted under this Agreement since the Commencement Date or the date of the previous Commercialisation Report provided under this clause 5.2; (b) milestone progression (dates for projected and achieved Milestones); (c) all past, current and projected activities taken or to be taken by the Licensee to exploit the Licensed Technology; (d) details of any sub-licences granted or rights granted to Affiliates under the Licensed Technology during the period covered by the report; (e) details of the commercial and public benefit which the Licensed Technology has created or stimulated; and (f) details of certification of insurance cover maintained (types and levels). CE’s receipt or approval of any such report shall not be taken to waive or qualify the Licensee’s obligations under clause 5.1.
Sample 1
Commercialisation Reports. Within 60 days after the end of each Income Period, the Licensee must provide a report, in the form provided in SCHEDULE 2, to the Licensor summarising the following matters in respect of the Income Period which has just ended: (a) all executed sub-licence agreements; (b) audited accounts of all Income received and all Commercialisation Costs incurred; (c) the Commercialisation Activities undertaken by the Licensee (including any such activities undertaken by any permitted sub-licensees); (d) progress of Commercialisation Activities, including: (i) achievement of Key Performance Indicators; (ii) any potential reduction in the adoption of Licensed Project Outputs; (iii) any potential delay in the release of Licensed Project Outputs to Australian grain growers; and (iv) any potential delays to the realisation of Income; (e) Income forecasts for the next Income Period; (f) any other matter provided for in the form provided in Schedule 2; and (g) any other matter the Licensor reasonably requests, (Commercialisation Report).
Sample 1
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Commercialisation Reports. Within thirty (30) days following the close of each calendar quarter following the completion of the R&D Programme and exercise of the Further Development Option, Pacific will provide Globe with a quarterly report with respect to activities and progress regarding its responsibilities, the commercialisation, sublicensing, and government approvals of Product.
Sample 1
Commercialisation Reports. Without prejudice to the generality of the Licensee’s obligations under Clause 5.1, the Licensee shall send CE within [####] of each Anniversary an updated, written commercialisation report (which constitutes Licensee Confidential Information), covering as a minimum the [####] preceding the Anniversary and the [####] following it. The report shall include: (a) the projected and actual dates of first sale of a Licensed Product; (b) Planned Sales during the period covered by the report; (c) Milestone progression; (d) a summary of activities taken by the Licensee in the last [####], and to be taken in the next [####], to develop and commercially exploit the Licensed Technology ; (e) sub-licences granted and rights granted to Affiliates during the period covered by the report; (f) any other income invoiced or received during the period covered by the report; (g) the commercial and public benefit which the Licensee believes that the Licensed Technology has created or stimulated; and (h) certification of insurance cover maintained (types and levels). CE’s receipt or approval of any such report shall not be taken to waive or qualify the Licensee’s obligations under Clause 5.1.
Sample 1

Related to Commercialisation Reports

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Regulatory Applications (a) Western and PNB and their respective Subsidiaries shall cooperate and use their respective reasonable best efforts to prepare all documentation, to effect all filings and to obtain all permits, consents, approvals and authorizations of all third parties and Governmental Authorities necessary to consummate the transactions contemplated by this Agreement. Western and PNB shall use their reasonable best efforts to make all required bank regulatory filings, including the appropriate filing with the Regulatory Authorities. Each of Western and PNB shall have the right to review in advance, and to the extent practicable each will consult with the other, in each case subject to applicable laws relating to the exchange of information, with respect to all material written information submitted to any third party or any Governmental Authority in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto agrees to act reasonably and as promptly as practicable. Each party hereto agrees that it will consult with the other party hereto with respect to the obtaining of all material permits, consents, approvals and authorizations of all third parties and Governmental Authorities necessary or advisable to consummate the transactions contemplated by this Agreement and each party will keep the other party appraised of the status of material matters relating to completion of the transactions contemplated hereby. (b) Each party agrees, upon request, to furnish the other party with all information concerning itself, its Subsidiaries, directors, officers and shareholders and such other matters as may be reasonably necessary or advisable in connection with any filing, notice or application made by or on behalf of such other party or any of its Subsidiaries to any third party or Governmental Authority.

  • Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

  • Research Reports Distributor acknowledges that Dealer may prepare research reports relating to the Fund that are not to be used for marketing purposes (“Research Reports”). Distributor hereby authorizes Dealer to use the name of the Fund, Distributor and BREDS in Research Reports.

  • Regulatory Materials (a) On a Program-by-Program basis, commencing on the Effective Date until the Regulatory Transfer Date, Prothena shall have the right, in consultation with Celgene, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”), and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategy. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, and maintain such Program Regulatory Materials, and to interact with Regulatory Authorities in connection with the Development and, as applicable, Manufacture of such Collaboration Candidates and Collaboration Products for such Program in accordance with the terms and conditions of Section 2.5. Additionally, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall apply.

  • Trials The Ship shall run the following test and trials: (1) Harbour Acceptance Tests, including setting to work of the various equipment;

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