Diligence Requirements. Company shall use diligent efforts or shall cause its Affiliates or Sublicensees to use diligent efforts to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates or Sublicensees shall fulfill the following obligations:
(a) Within ninety (90) days after the Effective Date, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed Products.
(b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
(c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of Combination Product and Licensed Product. Specifically, Company shall:
(i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”);
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.; and
(iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000).
(e) In addition to the obligations set forth above, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored research by Company or its Affiliates or Sublicensees at the Medical School) an aggregate of not less than {***} ...
Diligence Requirements. Company shall use, and shall cause its Affiliates and Sublicensees, as applicable, to use, best efforts to develop and make available to the public Products and Processes throughout the License Territory in the License Field. Such efforts shall include achieving the following objectives within the time periods designated below following the Effective Date:
Diligence Requirements. COMPANY shall use diligent efforts to develop LICENSED PRODUCTS or LICENSED PROCESSES and to introduce LICENSED PRODUCTS or LICENSED PROCESSES into the commercial market; thereafter, COMPANY shall make LICENSED PRODUCTS or LICENSED PROCESSES reasonably available to the public. Specifically, COMPANY shall fulfill the following obligations:
(a) Within four (4) months after the EFFECTIVE DATE, COMPANY shall furnish MIT with a written research and development plan describing the major tasks to be achieved in order to bring to market a LICENSED PRODUCT or a LICENSED PROCESS or LICENSED SERVICE specifying the number of staff and other resources to be devoted to such commercialization effort.
(b) Within sixty (60) days after the end of each calendar year, COMPANY shall furnish MIT with a written report on the progress of its efforts during the immediately preceding calendar year to develop and commercialize LICENSED PRODUCTS or LICENSED PROCESSES, with specific reference to the diligence obligations required under this Section 3.1. The report shall also contain a discussion of intended efforts and sales projections for the year in which the report is submitted.
(c) COMPANY shall permit an in-plant inspection by MIT at regular intervals with at least six (6) months between each such inspection.
(d) All LICENSED PRODUCTS shall be subject to stringent quality control testing to ensure product performance in accordance with stated product specifications. Any time after first commercial sale, MIT reserves the right to test LICENSED PRODUCTS at random intervals to assure that quality standards have been maintained.
(e) COMPANY shall make a first commercial sale of a LICENSED PRODUCT and/or a first commercial performance of a LICENSED PROCESS on or before September 30, 2018.
(f) COMPANY shall make NET SALES according to the following schedule: 2018 $100,000; 2019 $500,000; 2020 $1,000,000 2020 and each year thereafter $1,500,000. In the event that MIT determines that COMPANY (or an AFFILIATE) has failed to fulfill any of its obligations under this Section 3.1, then MIT may treat such failure as a material breach in accordance with Section 12.3(b).
Diligence Requirements. Company shall use diligent efforts or cause its Affiliates and Sublicensees to use diligent efforts to develop Licensed Products and to introduce Licensed Products into the commercial market. Thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company shall fulfill the following obligations:
Diligence Requirements. COMPANY shall use diligent efforts, or shall cause its AFFILIATES to use diligent efforts, to develop LICENSED PRODUCTS or LICENSED PROCESSES to identify DISCOVERY PRODUCTS and to introduce THERAPEUTIC PRODUCTS into the commercial market; thereafter, COMPANY or its AFFILIATES shall make THERAPEUTIC PRODUCTS reasonably available to the public. Specifically, COMPANY or AFFILIATE shall fulfill the following obligations:
(a) Within **** months after the EFFECTIVE DATE, COMPANY shall furnish THE PARTIES with a written research and development plan describing the major tasks to be achieved in order to bring to develop a SCREENING ASSAY, specifying the number of staff and other resources to be devoted to such commercialization effort.
(b) Within **** days after the end of each calendar year, COMPANY shall furnish M.I.T. 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 DISCOVERY PRODUCTS and THERAPEUTIC PRODUCTS using LICENSED PRODUCTS and/or LICENSED PROCESSES in the SCREENING ASSAY. The report shall also contain a discussion of intended efforts and sales projections for THERAPEUTIC PRODUCTS for the year in which the report is submitted.
(c) For each year following the EFFECTIVE DATE, COMPANY or AFFILIATES or SUBLICENSEES shall expend at least the amounts set forth below on research using LICENSED PRODUCT and/or LICENSED PROCESS in the SCREENING ASSAY. Such amounts may be expended by COMPANY or AFFILIATES or SUBLICENSEES, or by research partners. 2013 $100,000 2014 $600,000 2015 $850,000 2016 $1,000,000 and every year thereafter until the initiation of a clinical trial - $2,000,000
(d) By **** months after the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall have a working model of a SCREENING ASSAY using LICENSED PRODUCT and/or LICENSED PROCESS.
(e) By **** years after the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall identify a DISCOVERY PRODUCT.
(f) Prior to the end of 20**, COMPANY shall advance at least **** new DISCOVERY PRODUCT to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology studies in support of an Investigational New Drug application (“IND”) (or equivalent) for human studies. Furthermore, prior to the end of 20**, COMPANY shall advance at least **** additional new DISCOVERY CANDIDATES to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology studies in support of ...
Diligence Requirements. COMPANY shall use diligent efforts, or shall cause its AFFILIATES and SUBLICENSEES to use diligent efforts, to develop one or more LICENSED PRODUCTS and to introduce one or more LICENSED PRODUCTS into the commercial market; thereafter, COMPANY or its AFFILIATES or SUBLICENSEES shall make LICENSED PRODUCTS reasonably available to the public. Specifically, COMPANY or AFFILIATE or SUBLICENSEE shall fulfill the following obligations:
(a) Within [***] months after the EFFECTIVE DATE, COMPANY shall furnish M.I.T. with a written research and development plan describing the major tasks to be achieved in order to bring to market a LICENSED PRODUCT, specifying the number of staff and other resources to be devoted to such commercialization effort. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(b) Within sixty (60) days after the end of each calendar year, COMPANY shall furnish M.I.T. 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. The report shall also contain a discussion of intended efforts and sales projections for the year in which the report is submitted.
(c) COMPANY shall raise at least [***] dollars ([***]) by [***] from a corporate collaborative agreement(s) and/or the sale of Company’s equity securities for its own account.
(d) In the aggregate, COMPANY shall raise at least [***] dollars [***] by [***] from a combination of one or more of the following: (i) the sale of COMPANY’s equity securities for its own account, (ii) research and development funds, license fees and/or other payments from corporate partners, AFFILIATES or SUBLICENSEES and (iii) grants from government and non-government sources.
(e) COMPANY or an AFFILIATE or SUBLICENSEE shall begin and continue a FULLY FUNDED PROJECT relating to any disease in any DISEASE FIELD within two (2) years after the EFFECTIVE DATE.
(f) COMPANY or an AFFILIATE or SUBLICENSEE shall begin and continue a FULLY FUNDED PROJECT relating to a second disease in any DISEASE FIELD (including the DISEASE FIELD funded in Section 3.1 (d)) within [***] years after the EFFECTIVE DATE.
(g) If, at any time following [***] years after the EFFECTIVE DATE, M.I.T. or COMPANY receives a serious inquiry from a commercial entity seeking a license under the PATENT RIGHTS to devel...
Diligence Requirements. Company shall use diligent efforts or cause its Affiliates and Sublicensees to use diligent efforts to develop Licensed Products and to introduce Licensed Products into the commercial market. Thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company shall fulfill the following obligations:
(a) Financing the Company. On or before March 31, 2007, Company shall raise at least Fifteen Million Dollars ($15,000,000) from investors which may include CytRx Corporation (the “Initial Financing”) or this Agreement automatically terminates, and Company shall pay University Seventy-Five Thousand Dollars ($75,000) due April 1, 2007 (payable only once under the Companion UMass License Agreements). However, if Company demonstrates to the reasonable satisfaction of University that, on March 31, 2007, investors are performing due diligence for, or, in the case of CytRx Corporation, is otherwise taking actions that are reasonably likely to result in, the financing of Company of at least $15,000,000, University grants Company a thirty (30) day extension from March 31, 2007, to fulfill the financing obligation set forth in this Subsection 3.1(a). If Company can demonstrate to the reasonable satisfaction of University that investors are performing due diligence for, or, in the case of CytRx Corporation, is otherwise taking actions that are reasonably likely to result in, the financing of Company of at least $15,000,000, Company shall be granted up to two additional thirty (30) day extensions to fulfill the financing obligation by paying to University Twenty-Five Thousand Dollars ($25,000) each on the last day of the previous extension. The extension fees are non-refundable but creditable to the upfront license fee.
Diligence Requirements. Company shall use, and shall cause its Affiliates and Sublicensees, as applicable, to use, commercially reasonable efforts to develop and make available to the public Products and Processes throughout the License Territory in the License Field. Such efforts shall include achieving the following objectives within the time periods designated below following the Effective Date:
(a) Pre-Sales Requirements for Product and/or Processes using Hospital Patent Rights and/or Technological Information:
(i) Company shall use commercially reasonable efforts to carry out development of Products and/or Processes in accordance with development plans mutually agreed by the Parties through their Steering Committee representatives.
(ii) Company shall secure venture capital or other equity financing of at least $[**] within [**] months following the Effective Date.
(iii) Company shall identify one or more study site(s) for a Clinical Proof of Concept study with [**] months following the Effective Date.
(iv) Provide written report to Hospital detailing regulatory strategy for developing a Product or Process within [**] months following the Effective Date.
(v) Enroll the first patient in a Clinical Proof of Concept study within [**] months following the Effective Date.
(vi) Complete a Clinical Proof of Concept study within [**] months following the Effective Date; provided that this milestone shall be deemed achieved by the completion of a study prospectively intended to demonstrate Clinical Proof of Concept whether or not Clinical Proof of Concept is achieved with such study.
(vii) Achieve a First Commercial Sale as it relates to Hospital Patent Rights or Technological Information within [**] months following the Effective Date.
Diligence Requirements. 3.2.1. Of the Company. The Company will use Commercially Reasonable Efforts to conduct all Development necessary to obtain all Regulatory Approvals for HMPL¬004 and/or Products in the jurisdictions within the Territory and maintain any Regulatory Approvals obtained by the Company for a Product for which the Company (or an Affiliate of the Company) has obtained Regulatory Approval in the Field in the jurisdictions within the Territory. The Company will perform, and will ensure that its Affiliates and Sublicensees perform, all activities required of it hereunder with respect to HMPL-004 and the Products, including the Development of HMPL-004 and such Products, in accordance with and pursuant to all Governing Agreements and any other applicable agreements entered into by, on the one hand, the Company, its Affiliates or Sublicensees, and, on the other hand, Nestlé, Xxxxxxxxx and/or their respective Affiliates.
Diligence Requirements. If, in any calendar year, COMPANY, AFFILIATE, or SUBLICENSEE, alone or together, has performed any one of the following with respect to a LICENSED PRODUCT, then COMPANY shall be deemed to have complied with COMPANY’S obligations under this Section 3.2 with respect to a LICENSED PRODUCT:
(i) has expended a minimum of [***] for research, development, manufacture or commercialization of a LICENSED PRODUCT annually;
(ii) is actively conducting a PHASE I TRIAL, Phase II trial, and/or PHASE III TRIAL with respect to a LICENSED PRODUCT;
(iii) is preparing or has prepared documents for filing an NDA with respect to a LICENSED PRODUCT within [***] years of completion of a PHASE III TRIAL;
(iv) has filed or is pursuing an NDA for MARKETING APPROVAL for a LICENSED PRODUCT;
(v) has received MARKETING APPROVAL for a LICENSED PRODUCT; or
(vi) a LICENSED PRODUCT is launched or is being sold. In the event that COMPANY, AFFILIATE, or SUBLICENSEE, alone or together, has not performed at least one of Sections 3.2(i) through (vi) during such calendar year with respect to a LICENSED PRODUCT, then, subject to COMPANY’S rights in the second paragraph of Section 3.1, XXXXXXXXX may treat such failure as a material breach in accordance with Section 13.3(b).
