Company Diligence Obligations. 3.1 COMPANY shall use commercially reasonable efforts, or shall cause its AFFILIATES and SUBLICENSEES to use commercially reasonable efforts, to develop at least one (1) LICENSED PRODUCT or LICENSED PROCESS and to introduce at least one (1) LICENSED PRODUCT or LICENSED PROCESS into the commercial market; thereafter, COMPANY or its AFFILIATES or SUBLICENSEES shall use commercially reasonable efforts to make LICENSED PRODUCTS or LICENSED PROCESSES reasonably available to the public. Specifically, COMPANY or AFFILIATE or SUBLICENSEE shall fulfill the following obligations:
(i) Within [***] months after the EFFECTIVE DATE, COMPANY shall furnish XXXXXXXXX with a written research and development plan describing the major tasks to be achieved in order to bring to market a LICENSED PRODUCT or LICENSED PROCESS, specifying the resources to be devoted to such commercialization effort.
(ii) Within [***] days after [***], COMPANY shall furnish XXXXXXXXX with a written report (consistent with Section 5.1(a)) on the progress of its efforts during [***] to develop and commercialize a LICENSED PRODUCT or LICENSED PROCESS. The report shall also contain a discussion of intended efforts and sales projections for the year in which the report is submitted. At XXXXXXXXX’X request, COMPANY will provide its commercially diligent assessment on embodiments of PATENT RIGHTS.
(iii) Within [***] years after the EFFECTIVE DATE, COMPANY, AFFILIATE, or SUBLICENSEE shall file an IND for a LICENSED PRODUCT. In the event that COMPANY, AFFILIATE, or SUBLICENSEE, alone or together, has not performed Section 3.1(iii), and such failure is because of a bona fide and documented scientific, technical, or regulatory issue, then XXXXXXXXX and COMPANY shall negotiate in good faith a reasonable extension of time for COMPANY, AFFILIATE, or SUBLICENSEE to achieve the specific obligation, and XXXXXXXXX will not unreasonably deny or condition such extension. If the parties are unable to agree on the length of such extension of time, then the matter will be resolved in accordance with Article 14. Subject to the immediately preceding paragraph, in the event that COMPANY, AFFILIATE, or SUBLICENSEE, alone or together, has not performed Sections 3.1(i) through (iii), then XXXXXXXXX may treat such failure as a material breach in accordance with Section 13.3(b).
Company Diligence Obligations. 3.1 COMPANY shall use commercially reasonable efforts, or shall cause one or more of its AFFILIATES and SUBLICENSEES to use commercially reasonable efforts, to develop one or more LICENSED PRODUCTS or LICENSED PROCESSES and to introduce LICENSED PRODUCTS or LICENSED PROCESSES into the commercial market; thereafter, COMPANY or its AFFILIATES or SUBLICENSEES shall make one or more LICENSED PRODUCTS or LICENSED PROCESSES reasonably available to the public. Specifically, COMPANY or any of its AFFILIATES or SUBLICENSEES shall fulfill the following obligations:
(i) Within [***] ([***]) months after the EFFECTIVE DATE, COMPANY shall furnish XXXXXXXXX with a written research and development plan describing the major tasks to be achieved in order to bring to market a LICENSED PRODUCT and/or LICENSED PROCESS, specifying the number of staff and other resources to be devoted to such commercialization effort.
(ii) Within [***] ([***]) days after the end of each calendar year, COMPANY shall furnish XXXXXXXXX with a written report (consistent with Section 5.1(a)) on the progress of its efforts during the immediately preceding calendar year to develop and commercialize LICENSED PRODUCTS and/or LICENSED PROCESSES. The report will also contain a discussion of intended efforts and sales projections for the year in which the report is submitted.
Company Diligence Obligations. 3.1 COMPANY shall use commercially reasonable efforts, or shall cause one or more of its AFFILIATES and SUBLICENSEES to use commercially reasonable efforts, to develop one or more PRODUCTS or LICENSED PROCESSES and to introduce PRODUCTS or LICENSED PROCESSES into the commercial market; thereafter, COMPANY or its AFFILIATES or SUBLICENSEES shall make one or more PRODUCTS or LICENSED PROCESSES reasonably available to the public. Specifically, COMPANY or AFFILIATE or SUBLICENSEE shall fulfill the following obligations:
(i) Within [**] months after the EFFECTIVE DATE, COMPANY shall furnish DFCI with a written research and development plan describing the major tasks to be achieved in order to bring to market a PRODUCT, specifying the number of staff and other resources to be devoted to such development effort.
(ii) Within [**] days after the end of each calendar year, COMPANY shall furnish DFCI with a written report (consistent with Section 5.1 (a)) on the progress of its efforts during the immediately preceding calendar year to develop and commercialize a PRODUCT. The report shall also contain a discussion of intended efforts for the year in which the report is submitted.
Company Diligence Obligations. 3.1 Company shall use best efforts to bring Licensed Products to market through a thorough, vigorous and diligent program for exploitation of the Patent Rights, and continue active, diligent marketing efforts for Licensed Products throughout the Term. Without limiting the foregoing, Company shall meet the performance milestones listed in Appendix B.
3.2 Company shall give NU written notice and evidence within thirty (30) days of the achievement of each of the performance milestones listed in Appendix B.
3.3 Company shall provide to NU the most current updates, if any, to the detailed business plan provided to NU prior to the Effective Date for the development of the Licensed Technology, including relevant information such as schedules of capital investments needed to implement the plan, equipment, facility plans, number and kind of personnel and time planned for each phase of development of the Licensed Technology for a three (3) year period, to the extent formed by Company, the committed management team of Company, and plans to recruit team and management personnel.
3.4 Company shall provide annual reports, pursuant to Article 6, to NU to relay update and status information on Company’s business, research and development progress, including projections of activity anticipated for the next reporting year.
3.5 Company shall be solely responsible, at its sole cost and expense, for securing any necessary governmental or regulatory approvals for development, manufacture, and sale of Licensed Products and shall advise NU, through the annual reports described in Section 3.4 and Article 6, of its program for obtaining said approvals and any such approvals obtained.
3.6 If Company is the subject of a demand, notice, inquiry, or inspection report by a governmental authority or certification agency or any other Third Party in relation to any Licensed Product that (i) by its terms directs or may reasonably be expected to require suspension or cessation of manufacturing, sale, development, or marketing of Licensed Products, (ii) concerns a recall or potential recall of Licensed Products, (iii) concerns a loss of life or material issue of safety, or (iv) may reasonably be expected to prevent Company’s compliance with its diligence obligations, then Company shall provide a copy of the demand, notice, inquiry, or inspection report to NU without delay and keep NU reasonably apprised of its response.
Company Diligence Obligations. 5 4. Royalties and Payment Terms....................................................5 5. Reports and Record keeping.....................................................7
Company Diligence Obligations. Subparagraphs 3.1A, 3.1C, and 3.1D are hereby deleted from the LICENSE thereby eliminating compliance with all such obligations thereunder by COMPANY.
Company Diligence Obligations. The Company agrees to use Reasonable Efforts to further develop and exploit the Product in the Field either itself or with or through third parties, in accordance with the Wellcome Policies, and shall use Reasonable Efforts to take into account (and cause any sublicensee to take into account) Wellcome’s approach to equitable access to healthcare interventions (see xxxxx://xxxxxxxx.xx.xx/wellcomes-approach-equitable-access-healthcare- interventions). The Company shall:
(a) Within six (6) months of completion of the Project provide to Wellcome a development plan for the Product in the Field, including details of any further clinical trials that may be required; and thereafter use Reasonable Efforts to deliver that development plan until the first commercial sale of a Product in the Field anywhere in the world.
(b) Within six (6) months of making an application for marketing approval for the Product in the Field for the commercialization of the Product in the Field, provide to Wellcome a marketing plan setting out the planned activities to make the Product in the Field available to end users reflecting Wellcome Policies, and shall consider in good faith Wellcome’s comments thereto, which plan may include an appropriate and proportionate global access plan that covers registration targets, plans to meet demand, flexible approaches to IPRs and other strategies that reflect ability to pay in particular countries and populations and ensure that economic barriers to access to Products in the Field are low, and thereafter use Reasonable Efforts to deliver that marketing plan until the seventh (7th) anniversary of the date of first commercial sale of a Product in the Field anywhere in the world. (together, the “Company Diligence Obligations”).
Company Diligence Obligations
