Uncertainty In Development. With respect to the development of Licensed Products and efforts to obtain Regulatory Approval, each of the Parties agrees as follows: (a) Drug product research and development is uncertain and has many risks and potential problems (including efficacy and toxicity issues), and that the development program on Licensed Products may produce no results, or unpredictable or inaccurate results, or results that cannot support Regulatory Approval or further development or commercial activity; (b) Neither Party gives to the other any warranty or assurance that the development program for Licensed Products will have any particular result, that Regulatory Approval(s) will be obtained, or that such product development or Commercialization will be successful; (c) ProNAi’s research and development program is dependent upon ProNAi’s receipt of adequate funding for such projects, from sources that may include federal and other grants, foundations, partners or private capital. The availability of such financing is uncertain and ProNAi makes no warranty or assurance that such attempts will be successful; (d) For the avoidance of doubt, deviations from or changes to the development program on Licensed Product due to unexpected, unpredictable, inaccurate, or otherwise undesirable results as described in this Section 3.3 (including, without limitation, results indicating toxicity issue or a lack of efficacy) shall not be considered a failure of ProNAi to meet its obligations hereunder and it shall not be deemed a material breach to this Agreement per Section 10.2(c) of this Agreement.
Appears in 3 contracts
Sources: Exclusive License Agreement (ProNAi Therapeutics Inc), Exclusive License Agreement (ProNAi Therapeutics Inc), Exclusive License Agreement (Marina Biotech, Inc.)