By BioCryst. BioCryst will promptly (a) provide Shionogi with all Licensed Product complaints, adverse event information and safety data from clinical studies and Commercialization in its control; and (b) report all such adverse events outside the Territory in accordance with Laws, and provide such information to Shionogi in such a manner and time so as to enable Shionogi to comply with all applicable Laws in the Territory. BioCryst shall, at its own cost, maintain a global adverse event database for the Licensed Products and shall generate adverse event reports outside the Territory for Shionogi’s use. Shionogi shall have free and unfettered access to all data in such database. BioCryst shall be responsible for submitting adverse events reports to the applicable Regulatory Authorities outside the Territory, with respect to which BioCryst shall bear 100% of the costs.
By BioCryst. BioCryst hereby represents and warrants to, and covenants with, Shionogi as follows:
By BioCryst. BioCryst hereby grants to the Roche Group a sole and exclusive (even as to BioCryst), royalty-bearing, worldwide right and license under the BioCryst Patents and BioCryst Know-How to make, have made, use, offer for sale, sell and import Licensed Products in the Field. The foregoing license to the BioCryst Patents and BioCryst Know-How is limited to the exercise of the rights granted under the previous sentence and is sublicensable solely as set forth in Section 2.1(d).
By BioCryst. Subject to the rights retained by BioCryst and its licensors as set forth in Section 2.2, BioCryst grants to Mundipharma an exclusive, royalty-bearing, right and license in the Territory, with the right to sublicense to ***.
By BioCryst. BioCryst will indemnify and hold harmless Torii, its Affiliates, and their directors, officers, employees, successors, heirs and assigns, and agents (individually and collectively, the “Torii Indemnitees”) from and against all Losses incurred in connection with any Third Party Claims to the extent arising from or relating to (a) the Exploitation of the Licensed Product by or on behalf of BioCryst or any of its Affiliates, licensees (not including Torii or its Affiliates, Sublicensees, or its Subcontractors), Sublicensees, or Subcontractors, including product liability claims arising from such Exploitation (including those derived from failure of the Licensed Product Manufactured by or on behalf of BioCryst to conform with the applicable specifications therefor or to be Manufactured in accordance with GMP), and including such Exploitation after the effective date of termination of this Agreement, (b) BioCryst’s actions (or omissions) in the performance of its obligations with respect to Regulatory Submissions or interactions with Regulatory Authorities, in each case, as the Regulatory Responsible Party, (c) the negligence or willful misconduct of BioCryst or any of its Affiliates, licensees (not including Torii or its Affiliates, Sublicensees, or its Subcontractors), Sublicensees, or Subcontractors, (d) BioCryst’s breach of any of its representations, warranties, covenants, or obligations set forth in or entered into pursuant to this Agreement, (e) the failure of BioCryst or any of its Affiliates, licensees (not including Torii or its Affiliates, Sublicensees, or Subcontractors), Sublicensees, or Subcontractors to abide by any Applicable Law, or (f) any claim or demand from any employee or contractor of BioCryst or its Affiliate who is an inventor of any Joint Technology with respect to the ownership thereof, in each case of clauses (a) through (f) above, except to the extent such Third Party Claims arise out of any of a Torii Indemnitee’s negligence or willful misconduct, breach of this Agreement, or failure to abide by any Applicable Law. Certain information has been omitted from this exhibit in places marked “[***]” because it is both not material and would likely cause competitive harm to the registrant if publicly disclosed.
By BioCryst. BioCryst hereby represents and warrants to, and covenants with, CSL as follows:
