definiens: means that [COMPANY] or any of its Affiliates or Sublicensees ar e engaging in or have engaged within the preceding [ * * * ] in one or more of the following activities for a Compound or Product : pre -clinical research and development ; formulation development ; study / protocol design activity ; protocol preparation ; vendor se lection ; awaiting protocol approval from the applicable institutional review board or Regulatory Authority ; patient recruitment ; patient enrollment ; patient treatment, evaluation and monitoring in Clinical Trials ; data collection and analysis ; auditing of vendors, clinical sites, manufacturing facilities and storage facilities ; report writing for any pre -clinical or clinical study or manufacturing activity ; communicating or negotiating with Regulatory Authorities ; regulatory file(s ) being drafted or pending ( including preparation of one or more applications for Regulatory Approval ) ; awaiting a response from the applicable Regulatory Authorities ( including with respect to pending applications for Regulatory Approval ) ; pricing or reimbursement approvals pendin g ; manufacturing investment work ; packaging development ; manufacturing scale -up and validation ; awaiting go / no go decision from a formal research and development committee within [COMPANY] or such Affiliate or Sublicensee to initiate or continue any of the pre ceding activities ; negotiating contracts with Third Parties to implement any of the foregoing activities ( e.g., clinical trial agreements, services agreements, manufacturing and supply agreements ) ; publication writing ; seeking licensing partners ; endeavori ng to overcome circumstances outside of [COMPANY] ’s or its Affiliate ’s, or Sublicensee ’s reasonable control ( including supply, regulatory and other issues ) that impair the ability of [COMPANY] or its Affiliate or Sublicensee to perform any of the foregoing activit ies ; reasonable, good faith planning or preparation for any of the foregoing activities ; and reasonable, good faith evaluation of the results of any of the foregoing activities with the goal of making a timely recommendation for next steps