|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.
under applicable Law, to actively participate in, all substantive meetings and interactions with any Regulatory Authority in the Ono Territory; provided that Ono shall not be required to delay the occurrence of any substantive meetings or interactions with any such Regulatory Authority to the extent that Array representatives are not available to attend such substantive meetings or interactions on the date and time the same are scheduled to occur; and in any case, Ono shall keep Array informed as to all material interactions with Regulatory Authorities within the Ono Territory; and
(C) a copy of any material documents, information and correspondence that Ono (or its designee) proposes to submit to a Regulatory Authority in the Ono Territory relating to Regulatory Filings for the Product reasonably in advance of the date on which such documents, information and/or correspondence are proposed to be submitted, together with English translations thereof, if such translations exist. Array shall have the right to consult with, and provide comments to, Ono in connection with (1) any substantive meetings and/or interactions with Regulatory Authorities in the Ono Territory and (2) any material documents, information and correspondence that Ono (or its designee) proposes to submit to any Regulatory Authority in the Ono Territory; and Ono shall consider in good faith all reasonable comments provided by Array with respect to such meetings, interactions, documents, information and/or correspondence. Without limiting the foregoing, Ono shall provide to Array copies of the proposed labeling for the Product in the local language to be filed in the Ono Territory. Additionally, Ono shall provide Array with (1) a copy of the MAA in electronic format provided that in cases where the MAA was not filed electronically, Ono will provide the electronic files used to generate such submission, and (2) copies of the final labeling for the Product in the local language in all countries in the Ono Territory in which Ono obtains Marketing Approvals. Array shall provide to Ono copies of the proposed labeling for the Product in the local language to be filed by Array in USA and by PFM in France, Germany, Italy, Spain and the United Kingdom. Additionally, (1) Array shall provide Ono with a copy of the MAA filed by Array with the FDA and a copy of the MAA filed by PFM with the EMA, in each case in electronic format, provided that in cases where the MAA was not filed electronically, Array will provide the electronic files used to generate such submission, and (2) Array shall provide to Ono copies of the final labeling for the Product in the local language in all countries in the Array Territory in which Array and Array’s Third Party Partners obtains Marketing Approvals.
(ii) The Parties shall cooperate in good faith with respect to Regulatory Authority inspections of any site or facility where Clinical Studies, manufacturing or pharmacovigilance activities with respect to the Product are conducted by or on behalf Ono pursuant to this Agreement, whether such site or facility is Ono’s or its Affiliate’s or Subcontractor’s (each an “Audited Site”). Array shall be given a reasonable opportunity (taking into account the timing and notice provided by the applicable Regulatory Authority) to assist in the preparation of the Audited Sites for inspection, where appropriate, and to attend any inspection by any Regulatory Authority of the Audited Sites, and the summary, or wrap-up, meeting with a Regulatory Authority at the conclusion of such inspection subject to any required