|ARRAY BIOPHARMA INC filed this Form 10-K on 08/11/2017|
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(e) to Array’s knowledge, none of the issued Array Patents are invalid or unenforceable;
(f) the Array Patents in the Ono Territory listed on Exhibit 1.5 constitute a true, accurate and complete list of all Patents in the Ono Territory in existence as of the Effective Date that are Controlled by Array and relate to the Products, indicating the owner, licensor and/or co-owner(s) thereof if any such Array Patent is not, solely owned by Array;
(g) to Array’s knowledge, Array and its Affiliates (i) have generated, prepared, and maintained all material Regulatory Filings in the Ono Territory in accordance with applicable Law and (ii) have conducted (and each of their respective Subcontractors and consultants have conducted) all Development of the Products in the Ono Territory in accordance with applicable Law;
(h) to Array’s knowledge, all material information with respect to the safety and efficacy of Encorafenib and Binimetinib has been provided or made available to Ono prior to the Effective Date through on site due diligence, in the electronic data room to which access was provided to Ono in connection with the negotiation of this Agreement or by other means. In addition, to Array’s knowledge, there are no, and there have been no, material safety issues relating to Encorafenib or Binimetinib as of the Effective Date that have been provided or made available to Ono prior to the Effective Date through on site due diligence, in the electronic data room to which access was provided to Ono in connection with the negotiation of this Agreement or by other means. With respect to any information provided by Array to Ono prior to the Effective Date relating to the on-going Clinical Studies, Ono acknowledges and agrees that such information is partial, preliminary, and will not be finalized until the completion of data analysis, lock and transfer. Array is not aware of any fact or circumstance that would reasonably be expected to materially adversely affect the acceptance or the subsequent approval, by any Regulatory Authority of any filing, application or request for Marketing Approval;
(i) Array and its Affiliates, and to Array’s knowledge, its Subcontractors and PFM, have conducted all Development of the Products in accordance with applicable Law, including where required by applicable Law, in accordance good laboratory and clinical practice; and
(j) Array is the sole and exclusive owner, the co-owner, or exclusive licensee with respect to the Products of all of the Array Patents listed in Exhibit 1.5, or the Product Trademarks listed on Exhibit 1.56 free from encumbrances and, with respect to Patents owned or co-owned by Array, is, listed in the records of the appropriate Governmental Authorities as the sole and exclusive owner or the co-owner of the Array Patents and has the right to grant to Ono the rights granted herein with the respect to the Array Know-How.
15.3 Additional Covenants: Each Party hereby covenants as of the Effective Date, as follows: