Common use of Development and Commercialisation Clause in Contracts

Development and Commercialisation. 4.1 Cyclacel shall use commercially reasonable endeavours to pursue the development and commercialisation of Product. For the purposes of this Clause 4 such reasonable endeavours shall mean those efforts to develop and commercialise Product which are at least the same as the efforts used by Cyclacel in relation to the development and commercialisation of other Cyclacel pharmaceutical products under similar commercial circumstances that have similar commercial value and development status to the Product. Cyclacel shall carry out such development in accordance with the key elements of the Development Plan which plan may be updated and/or amended from time to time by Cyclacel and Cyclacel shall provide Sankyo with a copy of any such updated or amended plan. 4.2 Without limiting the generality of the foregoing Cyclacel shall use its reasonable endeavours [*] If Cyclacel, its Affiliates or Cyclacel Licensees have not [*] then provided such failure is not due to an Exceptional Cause Sankyo shall be entitled to notify Cyclacel that it intends to terminate this Agreement, Cyclacel shall have sixty (60) days to reply to Sankyo’s notification and demonstrate that such failure was due to an Exceptional Cause. In the event that the Parties agree that no such Exceptional Cause has been demonstrated then Sankyo will have the right to terminate this Agreement upon thirty (30) days written notice. [*] The Parties shall, no later the fifth (5th) anniversary of the Commencement Date discuss, in good faith and review such time periods and, if appropriate, extend such period to [*] 4.3 Cyclacel shall within thirty (30) days of each anniversary of the Commencement Date provide Sankyo with a written summary of the progress which Cyclacel, its Affiliates and/or Cyclacel Licensees has made against the Development Plan in the previous twelve (12) month period. In addition, Cyclacel shall provide Sankyo within seven (7) months of each annual written report with a brief update of such progress, which update may be given in writing by facsimile or by e-mail. 4.4 In the event that Cyclacel decides to appoint a Third Party, or if Cyclacel receives an offer from a Third Party, in either case to develop and/or commercialise Product solely in Japan or in Japan as part of a multi-territory sub-licence, it shall so notify Sankyo which notification shall not be made prior to the first Successful Completion of a [*] Clinical Trial or the decision by Cyclacel or a Cyclacel Licensee to initiate [*] Clinical Trials and shall be accompanied by (i) details of the terms upon which Cyclacel is prepared to offer for the appointment of a Third Party licensee and (ii) the data and evidence on which Cyclacel or Cyclacel Licensee made such decision. Sankyo shall notify Cyclacel within [*] of receipt of the Cyclacel notification whether Sankyo wishes to develop and/or commercialise Product in Japan. If Sankyo notifies Cyclacel that it does wish to develop and/or commercialise Product in Japan the Parties shall meet and negotiate in good faith the terms of appointment of Sankyo as Cyclacel Licensee in Japan. If Sankyo notifies Cyclacel that it does not wish to develop and/or commercialise Product in Japan or, in the case where Sankyo has notified Cyclacel that it does wish to develop and/or commercialise Product in Japan but the Parties have failed to agree terms within [*] of commencing negotiations, then Cyclacel shall be free to appoint a Third Party to develop and/or commercialise Product in Japan provided that such appointment shall be on terms no more favourable than those terms which Cyclacel was prepared to offer Sankyo. For the avoidance of doubt if Cyclacel receives an offer at any time by a Third Party to commercialise Product on a worldwide basis, Cyclacel shall notify such Third Party that Sankyo has a first refusal right of Marketing in Japan and Cyclacel shall propose to such Third Party to accept such condition. In such case, the conditions imposed under this Clause will be accelerated and Cyclacel will serve notification to Sankyo who will respond in accordance with the provisions herein. [*]

Development and Commercialisation. 4.1 Cyclacel shall use commercially reasonable endeavours 8.1. The Initial Development Program is attached hereto as Appendix F. The Company will submit to pursue Yeda copies of all additional or amended Development Programs for the development and commercialisation of Product. For Products as approved by the purposes Company’s board of this Clause 4 such reasonable endeavours shall mean those efforts to develop and commercialise Product which are at least the same as the efforts used by Cyclacel in relation to the development and commercialisation of other Cyclacel pharmaceutical products under similar commercial circumstances that have similar commercial value and development status to the Product. Cyclacel shall carry out such development in accordance with the key elements of the Development Plan which plan may be updated and/or amended directors from time to time by Cyclacel and Cyclacel shall provide Sankyo with following the date hereof, as soon as practicable after the date of approval (each such Development Program a copy of any such updated or amended plan. 4.2 Without limiting “Development Program”). The foregoing notwithstanding, the generality Company undertakes to submit copies of the foregoing Cyclacel shall use its reasonable endeavours [*] If Cyclacel, its Affiliates or Cyclacel Licensees have not [*] then provided such failure is not due to an Exceptional Cause Sankyo shall be entitled to notify Cyclacel that it intends to terminate this Agreement, Cyclacel shall have sixty (60) days to reply to Sankyo’s notification and demonstrate that such failure was due to an Exceptional Cause. In the event that the Parties agree that no such Exceptional Cause has been demonstrated then Sankyo will have the right to terminate this Agreement upon thirty (30) days written notice. [*] The Parties shall, no later the fifth (5th) anniversary of the Commencement Date discuss, in good faith and review such time periods and, if appropriate, extend such period to [*] 4.3 Cyclacel shall within thirty (30) days of each anniversary of the Commencement Date provide Sankyo with a written summary of the progress which Cyclacel, its Affiliates and/or Cyclacel Licensees has made against the following Development Plan in the previous twelve (12) month period. In addition, Cyclacel shall provide Sankyo within seven (7) months of each annual written report with a brief update of such progress, which update may be given in writing by facsimile or by e-mail. 4.4 In the event that Cyclacel decides to appoint a Third Party, or if Cyclacel receives an offer from a Third Party, in either case to develop and/or commercialise Product solely in Japan or in Japan as part of a multi-territory sub-licence, it shall so notify Sankyo which notification shall not be made prior to the first Successful Completion of a [*] Clinical Trial or the decision by Cyclacel or a Cyclacel Licensee to initiate [*] Clinical Trials and shall be accompanied by Programs: (i) details of during the terms upon which Cyclacel is prepared to offer for Incubator Period, such development programs as are filed with the appointment of a Third Party licensee OCS, and (ii) the data and evidence on which Cyclacel or Cyclacel Licensee made such decision. Sankyo shall notify Cyclacel within [*] of receipt of the Cyclacel notification whether Sankyo wishes to develop and/or commercialise Product in Japan. If Sankyo notifies Cyclacel that it does wish to develop and/or commercialise Product in Japan the Parties shall meet and negotiate in good faith the terms of appointment of Sankyo as Cyclacel Licensee in Japan. If Sankyo notifies Cyclacel that it does not wish to develop and/or commercialise Product in Japan or, in the case where Sankyo has notified Cyclacel that it does wish to develop and/or commercialise Product in Japan but the Parties have failed to agree terms within [**] of commencing negotiationsthe end of the Incubator Period, a Development Program covering the period up to the end of Phase I clinical studies for at least [***] Products, to include milestones at intervals of no more than [***]. 8.2. The Company is of the opinion that the Existing Know-How is revolutionary and that to the best of its knowledge, no product containing phages has been approved as a therapeutic to date. As the scientific, technical and regulatory hurdles that will be encountered in developing, producing, testing and registering Licensed Products cannot be assessed at present, the Company cannot commit to carrying out the Development Programs within set time frames. The Company does undertake, however, at its own expense, to use commercially reasonable efforts to expedite the commencement of the commercial sale of the Products (compliance with such obligation will be evaluated on the basis of current industry standards for research and development activities applicable to companies of similar size as the Company as generally applied to products of similar potential at similar stages in their life cycles), and to make commercially reasonable efforts to raise sufficient funds to carry out the Development Programs. The Company further undertakes to continue with development and/or commercialisation of at least [***] Products diligently throughout the period of the Licence. 8.3. During the Incubator Period, the Company shall provide Yeda with copies of the reports that it submits to the OCS. Thereafter, on [***] of each calendar year, the Company shall provide Yeda with written progress reports (“Progress Reports”) which shall include descriptions of the progress and results, if any, of: (i) the tests and trials (if applicable) conducted and all other actions taken by the Company pursuant to the Initial Development Program or any other Development Program; (ii) manufacturing, sublicensing, marketing and sales; (iii) the Company’s plans in respect of the testing, undertaking of trials (if applicable) or commercialisation of Products; and (v) the amount of money invested in the Company during the preceding [***]. If the Company has provided a Development Program for more than 1 (one) Product, then Cyclacel such Progress Report shall be free provide such information separately for each such Product. The Company shall also provide any reasonable additional data that Yeda requires to appoint a Third Party to develop and/or commercialise Product in Japan provided that such appointment shall be on terms no more favourable than those terms which Cyclacel was prepared to offer Sankyoevaluate the performance of the Company hereunder. 8.4. For the avoidance of doubt if Cyclacel receives doubt, without derogating from the remaining provisions of this clause 8 or of clause 13.2 below, nothing contained in this Agreement shall be construed as a warranty by the Company that any Development Program to be carried out by it as aforesaid will actually achieve its aims and the Company makes no warranties whatsoever as to any results to be achieved in consequence of the carrying out of any such Development Program. 8.5. The Company shall mark, and cause all its Sublicensees and Distributors to mark, all Products (including any Companion Diagnostic Kits of any Products) that are manufactured or sold under this Agreement with the number or numbers of each Patent applicable to such Product (or Companion Diagnostic Kit, as applicable). 8.6. Without derogating from the aforegoing in this clause 8, the Company undertakes that an offer at any time average of [***], calculated on a [***] rolling basis (meaning, in respect of [***]), (but no less than [***]) will be invested (by the Company and/or by a Third Party to commercialise Product on Sublicensee, if a worldwide basisSublicence has been entered into) in the development of Products, Cyclacel shall notify such Third Party that Sankyo has a first refusal right of Marketing in Japan and Cyclacel shall propose to such Third Party to accept such condition. In such case, the conditions imposed under this Clause will be accelerated and Cyclacel will serve notification to Sankyo who will respond in accordance with the provisions herein. [***].