Diligence Reporting. Spyre shall use Commercially Reasonable Efforts (a) to Develop and seek Regulatory Approval for at least one Spyre Product in the Field in the United States and at least one other Major Market Country, and (b) upon receipt of Regulatory Approval for a given Spyre Product in a given country, to Commercialize such Spyre Product in such country, in each case ((a) or (b)) either by itself or through its Affiliates or Sublicensees or its or their respective contractors. Additionally, on or before [***] of each year during the Term, Spyre shall deliver to Paragon a report summarizing its material development efforts with respect to the Spyre Products, including a summary of current and anticipated preclinical and clinical activities, a summary of the status of any regulatory filings and any anticipated regulatory filings, and achievement of any Milestones, during the preceding [***]; provided, however, that Spyre may satisfy the reporting obligations set forth in this Section 3.3 by providing Paragon with copies of any annual report or other filings with a securities exchange that include the relevant information. For the avoidance of doubt, if Spyre determines, in its sole discretion, that it is inconsistent with the use of Commercially Reasonable Efforts to pursue Commercialization of a Spyre Product in any country (other than the United States), it will not be considered a material breach of this Agreement to cease Development or Commercialization of such Spyre Product with respect to such country.
Appears in 4 contracts
Sources: License Agreement (Spyre Therapeutics, Inc.), License Agreement (Spyre Therapeutics, Inc.), License Agreement (Spyre Therapeutics, Inc.)
Diligence Reporting. Spyre Oruka shall use Commercially Reasonable Efforts (a) to Develop and seek Regulatory Approval for at least one Spyre Oruka Product in the Field in the United States and at least one other Major Market Country, and (b) upon receipt of Regulatory Approval for a given Spyre Oruka Product in a given country, to Commercialize such Spyre Oruka Product in such country, in each case ((a) or (b)) either by itself or through its Affiliates or Sublicensees or its or their respective contractors. Additionally, on or before [***] of each year during the Term, Spyre Oruka shall deliver to Paragon a report summarizing its material development efforts with respect to the Spyre Oruka Products, including a summary of current and anticipated preclinical and clinical activities, a summary of the status of any regulatory filings and any anticipated regulatory filings, and achievement of any Milestones, during the preceding [***]; provided, however, that Spyre Oruka may satisfy the reporting obligations set forth in this Section 3.3 by providing Paragon with copies of any annual report or other filings with a securities exchange that include the relevant information. For the avoidance of doubt, if Spyre ▇▇▇▇▇ determines, in its sole discretion, that it is inconsistent with the use of Commercially Reasonable Efforts to pursue Commercialization of a Spyre an Oruka Product in any country (other than the United States), it will not be considered a material breach of this Agreement to cease Development or Commercialization of such Spyre Oruka Product with respect to such country.
Appears in 2 contracts
Sources: License Agreement (Oruka Therapeutics, Inc.), Il 17 License Agreement (Oruka Therapeutics, Inc.)