Common use of Due Diligence Obligations Clause in Contracts

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. 3.1 CEREBROTEC COMPANY shall itself, or through its AFFILIATES or SUBLICENSEES, use its best commercially reasonable efforts to develop and make commercially available PRODUCTS for commercial sales and distribution throughout the world in the LICENSE FIELD. Such efforts shall include consist of achieving the following: following objectives 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 time period designated below following the EFFECTIVE DATE: (a) GENERAL acknowledges that COMPANY represents that it is developing the drug ganaxolone for indications other than migraine headaches, GENERAL and CEREBROTEC shall meet to: COMPANY therefore agrees that it will commence a Phase II clinical trial of a PRODUCT comprising ganaxolone (i"GANAXOLONE PRODUCT") agree either to adopt further time-limited performance objectivesfor an indication within the LICENSE FIELD within twelve (12) months, or to adopt amendments to the annual minimum payments specified in paragraph 5.5, to ensure and that CEREBROTEC uses its best efforts to develop and make commercially available PRODUCTS based on PATENT RIGHTS and JOINT PATENT RIGHTS it will thereafter diligently pursue clinical evaluations of a GANAXOLONE PRODUCT for commercial sales and distribution throughout the world; and (ii) identify such objectives an indication in the event of their necessity. Such objectives may include requirements such LICENSE FIELD as taking long as a GANAXOLONE PRODUCT continues to show clinical efficacy against an indication in the following steps LICENSE FIELD; (b) 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 of a PRODUCT not comprising ganaxolone ("SECOND GENERATION PRODUCT"). * Confidential treatment requested. 5. (c) within [ * ], initiate and thereafter diligently pursue clinical evaluations of a SECOND GENERATION PRODUCT and in connection therewith take all actions reasonably necessary under the Food, Drug and Cosmetic Act (21 USC 301-391); (d) within [ * ], determine whether to manufacture either a GANAXOLONE PRODUCT or a SECOND GENERATION PRODUCT for commercial sale and to inform GENERAL of such determination; (e) as a result of the determination in (d) above, either introduce a GANAXOLONE PRODUCT in the United States, Europe and Japan within [ * ] of the EFFECTIVE DATE or introduce a SECOND GENERATION PRODUCT in the United States, Europe and Japan within [ * ] of the EFFECTIVE DATE; to introduce and (f) within [ * ], announce and market for general commercial sale either a GANAXOLONE PRODUCT or a SECOND GENERATION PRODUCT on a worldwide basis. Provided; provided, however, that GENERAL shall not unreasonably withhold its consent to any revision in any such time periods specified herein or established in accordance with this paragraph 3.1 whenever requested in writing by CEREBROTEC COMPANY and supported by evidence of technical difficulties or delays in clinical studies or regulatory processes that the parties could not have reasonably avoided. Failure to achieve any objective one or more of the above objectives 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 sixty (3060) 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 twelve (612) months, CEREBROTEC COMPANY shall report in writing to GENERAL on progress made toward the development and commercialization of PRODUCTSforegoing objectives.

Due Diligence Obligations. 3.1 CEREBROTEC PALOMAR shall itself, or through its AFFILIATES or SUBLICENSEES, use its best reasonable efforts to develop and make commercially available PRODUCTS for commercial sales and distribution throughout the world in the LICENSE FIELD. Such efforts shall include consist of: (a) Entering into the following: Clinical Trial Agreement with General attached hereto as Exhibit A and providing the funding specified in said Agreement; (b) Commencing the commercial sale of the PRODUCT or SERVICES outside the United States within twenty-four three (243) months after tests on a normal mode ruby laser have been completed and approval has been received from the EFFECTIVE DATE, achieving either Principal Investigator (isee Clinical Trial Agreement) that such laser works acceptably; (c) Filing with 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 for a 510(k) on any PRODUCT within three (3) months of receipt of clinical evaluations thereof; data from GENERAL sufficient for such filing, it being understood that GENERAL is providing such data to initiate PALOMAR pursuant to the Clinical Trial Agreement. In the event that GENERAL fails to provide such data, GENERAL and thereafter diligently pursue clinical evaluations of PALOMAR shall confer to establish a PRODUCT reasonable procedure and schedule to secure approval for such PRODUCT, and in connection therewith take all actions reasonably necessary under the Foodevent that GENERAL and PALOMAR cannot agree on such procedure and schedule they shall resolve this issue in accordance with the dispute resolution provisions of paragraph 10.9; (d) Commencing the commercial sale of the PRODUCT or SERVICES within the United States within six (6) months after FDA clearance is received. However, 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 such time periods specified herein or established in accordance with this paragraph 3.1 whenever requested in writing by CEREBROTEC PALOMAR and supported by evidence of technical difficulties or delays in clinical studies or regulatory processes that the parties could not have reasonably avoided. Failure to achieve any objective one or more of the above objectives 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 PALOMAR shall report in writing to GENERAL on progress made toward the development and commercialization of PRODUCTSforegoing objectives.