Due Diligence Obligations. 3.1 CEREBROTEC shall itself, or through its AFFILIATES or SUBLICENSEES, use its best efforts to develop and make commercially available PRODUCTS for commercial sales and distribution throughout the world in the LICENSE FIELD. Such efforts shall include the following: within twenty-four (24) months after the EFFECTIVE DATE, achieving either (i) the CLOSING OF THE FINANCING; or (ii) entering into a partnering agreement with a SUBLICENSEE under which said SUBLICENSEE agrees to fund research or product development at CEREBROTEC in an amount of at least [*] for at least two years. Within twenty-four (24) months following the EFFECTIVE DATE, GENERAL and CEREBROTEC shall meet to: (i) agree either to adopt further time-limited performance objectives, or to adopt amendments to the annual minimum payments specified in paragraph 5.5, to ensure that CEREBROTEC uses its best efforts to develop and make commercially available PRODUCTS based on PATENT RIGHTS and JOINT PATENT RIGHTS for commercial sales and distribution throughout the world; and (ii) identify such objectives in the event of their necessity. Such objectives may include requirements such as taking the following steps within defined timeframes; to complete all animal toxicity tests required in connection with securing U.S. Food and Drug Administration approval of clinical evaluations thereof; to initiate and thereafter diligently pursue clinical evaluations of a PRODUCT and in connection therewith take all actions reasonably necessary under the Food, Drug and Cosmetic Act (21 USC 301-391); to introduce PRODUCT on a worldwide basis. Provided, however, that GENERAL shall not unreasonably withhold its consent to any revision in any time periods specified herein or established in accordance with this paragraph 3.1 whenever requested in writing by CEREBROTEC and supported by evidence of technical difficulties or delays that the parties could not have reasonably avoided. Failure to achieve any objective within the above stated time periods, or within the time periods established in accordance with this paragraph 3.1 or within any extension granted by GENERAL shall result in GENERAL having the right to cancel upon thirty (30) days notice any exclusive license granted hereunder or convert any exclusive license to a non-exclusive license.
3.2 At intervals no longer than every six (6) months, CEREBROTEC shall report in writing to GENERAL on progress made toward the development and commercialization of PRODUCTS.
Due Diligence Obligations. The Trustee shall not be liable for the Damages incurred by the Trust Property or the Beneficiary that are not due to its willful misconduct or negligence to the extent that the Trustee provides the Trust Administrative Services with the due care of a good manager and in accordance with the provisions of this Agreement.
Due Diligence Obligations. COMPANY shall directly, or through or in collaboration with Affiliates and sublicensees, use its best efforts:
(a) to conduct a research and development program relating to the use of Licensed Products in the Field of Use; and
(b) to diligently pursue Registration of the Licensed Products; and
(c) to effectively market the Licensed Products.
Due Diligence Obligations. The Company shall use diligent efforts, and shall cause its Affiliates and any Sublicensees to use diligent efforts, to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter, the Company and its Affiliates and any Sublicensees shall maximize the commercial sales of such Licensed Products. Specifically, the Company and its Affiliates and any Sublicensees shall fulfill the following obligations:
(a) Within [ *** ] of the Effective Date, the Company shall initiate, defined as first dosing of patient, a trial using a Licensed Product where the primary outcome measure is a statistically significant separation by a Licensed Product from placebo on the positive and negative symptom scale (PANSS) or equivalent scale that has previously been used as a primary endpoint for U.S. Food and Drug Administration registration for the treatment of schizophrenia and the total number of patients that will enroll in the study is greater than [ *** ].
(b) At any time prior to approval of a Licensed Product by the U.S. Food and Drug Administration, the Company shall not, for any consecutive [ *** ] period, fail to initiate, defined as first dosing of patient, a human clinical study with a Licensed Product or make a regulatory submission to the U.S. Food and Drug Administration, the European Medicines Evaluation Agency, or the Japanese Ministry of Health and Welfare seeking the marketing of a License Product for the treatment of a disease.
(c) The Company shall not (i) become insolvent; (ii) make an assignment for the benefit of creditors; (iii) have a bona fide petition in bankruptcy filed for or against it, which petition is withdrawn or dismissed within [ *** ] of its filing; or (iv) cease operations (at an activity level sufficient for the continued development of Products) for more than one [ *** ]. In the event that PureTech determines that the Company (or an Affiliate or Sublicensee) has failed to fulfill its obligations under this Section 2.4, then PureTech may treat such failure as a material breach in accordance with Section 11.2(b).
Due Diligence Obligations. The Company shall use diligent efforts, and shall cause its Affiliates and any Sublicensees to use diligent efforts, to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter, the Company and its Affiliates and any Sublicensees shall maximize the commercial sales of such Licensed Products. Specifically, the Company and its Affiliates and any Sublicensees shall fulfill the following obligations:
Due Diligence Obligations. In Paragraph 3.1, at the end of the first sentence delete “in the LICENSE FIELD” and replace subparagraph (c) with the following new subparagraph (c):
Due Diligence Obligations. 3.1. METASYN, its AFFILIATES and SUBLICENSEES shall use due diligence to develop PRODUCTS for commercial sales and distribution throughout the world and to such end, shall seek to achieve the following objectives in accordance with the following schedule:
(a) initiate Good Manufacturing Practices production of clinical trial quantities of a PRODUCT within [ ]* of the LICENSE EFFECTIVE DATE;
(b) initiate animal toxicity studies of a PRODUCT within [ ]* of LICENSE EFFECTIVE DATE; and
(c) initiate a human clinical study of a PRODUCT within [ ]* of LICENSE EFFECTIVE DATE. In the event any objective identified herein or subsequently designated as provided herein cannot be met for technical or regulatory reasons that the parties could not have reasonably foreseen or that are beyond the reasonable control of METASYN, its AFFILIATES or SUBLICENSEES, GENERAL shall not unreasonably withhold its assent to any revision in the schedule whenever requested in writing by METASYN, its AFFILIATES or SUBLICENSEES and supported by evidence of such technical difficulties or delays in the regulatory process.
3.2. At intervals no longer than every six (6) months, METASYN shall report in writing to GENERAL on progress made toward the objectives designated in accordance with Paragraph 3.1. *Confidential information omitted and filed with the Commission.
Due Diligence Obligations. In the event TDB establishes an account for a foreign legal entity, it shall perform due diligence in order to determine if any substantial U.S. ownership exists. Further, TDB may ask you questions with respect to your U.S. tax payer status and will require you to complete a W-9 or W-8, as applicable. In addition, TDB will inquire as to the nature of your payments (foreign and domestic), the payee, and/or the status of the foreign beneficiary bank / financial institution in order to comply with its obligations under FATCA.
Due Diligence Obligations. (a) ALLERGAN shall use commercially reasonable efforts consistent with its reasonable business judgement to research, develop, manufacture in finished form, and register PRODUCTS and market and sell PRODUCTS in each country of the TERRITORY.
(b) ALLERGAN shall provide written summaries to ENTREMED within thirty (30) days after December 31st of each calendar year concerning the status of PRODUCTS in each country of the TERRITORY. ALLERGAN shall provide ENTREMED with any additional information reasonably requested by ENTREMED in this respect to the degree practicable, as determined by ALLERGAN.
Due Diligence Obligations. We shall perform due diligence in order to determine if you are a U.S. person. Further, we may ask you questions with respect to your U.S. Tax payer status and will require you to complete a W-9 or W-8, as applicable. In addition, we will inquire as to the nature of your payments (foreign and domestic), the payee, and/or the status of the foreign beneficiary bank/financial institution in order to comply with our obligations under FATCA.
