|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.
4.5 Right to Conduct Clinical Studies in Other Party’s Territory.
(a) Generally. Neither Party shall conduct Clinical Studies in the other Party’s Territory without the prior written approval of the other Party, except that Array shall be entitled to conduct Declined Clinical Studies utilizing sites within the Ono Territory without obtaining Ono’s consent (but prior notification is required), subject to the following:
(i) Array shall not conduct Clinical Studies for a Product in the Ono Territory with respect to an Indication for which such Product has received Marketing Approval in the Ono Territory if Ono reasonably believes that the conduct of such Clinical Studies is likely to materially adversely affect the commercial value of such Product. In the event of a dispute between the Parties as to whether Ono’s belief regarding the harm to its market is reasonable, the Parties shall promptly resolve such matter in accordance with the provisions of Section 17.2 below; provided that Array shall not conduct such Clinical Studies in the Ono Territory unless and until such matter is resolved in favor of such Clinical Studies proceeding.
(ii) Prior to commencing a Clinical Study in countries of the Ono Territory, Array shall inform and coordinate with Ono regarding the conduct of such Clinical Study. In the event that Array proceeds with a Clinical Study in the Ono Territory without Ono’s participation, then the Parties shall enter into a pharmacovigilance agreement pursuant to which Array shall provide Ono with the safety data.
(b) Combination Studies with [ * ] in the Ono Territory. Without limiting the limitations described in Section 4.5(a), Array further agrees as follows:
(i) Array shall not sponsor any Clinical Studies of Binimetinib and/or Encorafenib in combination with a [ * ] (“Combination Studies”) where the such Clinical Studies are conducted solely for purposes of obtaining Marketing Approval of the studied [ * ] in combination with Binimetinib and/or Encorafenib in the Ono Territory (“Local Studies”); and
(ii) Array shall not supply Binimetinib, Encorafenib or Products to any Third Party for use in the conduct of Local Studies; and
(iii) Array shall not include clinical sites in the Ono Territory in any Combination Study, including but not limited to Phase1/2 studies, sponsored by Array that is intended to support Marketing Approval of the studied [ * ] in combination with Binimetinib and/or Encorafenib in the United States or Europe (“Global Studies”), unless Ono has previously declined a Joint Clinical Study Proposal to conduct a Global Registration Study in the same patient population for a [ * ], Binimetinib and/or Encorafenib combination. For the avoidance of doubt, Array shall make [ * ], Binimetinib and/or