Preview | License Agreement |

THIS LICENSE AGREEMENT (the Agreement) is made as of December 17, 2004 by and between QUARK BIOTECH, INC., a California corporation having its principal place of business at 6536 Kaiser Drive, Fremont CA 94555, U.S.A. (hereinafter referred to as Quark) and SANWA KAGAKU KENKYUSHO CO., LTD., a corporation organized and existing under the laws of Japan and having its principal place of business at 35 Higashisotobori-cho, Higashi-ku, Nagoya 461-8631, Japan (hereinafter referred to as SKK).

SKK and Quark are sometimes referred to herein individually as a party and collectively as the parties.

WHEREAS, Quark, together with its Affiliates (as hereinafter defined), has developed and owns or has the exclusive right to use the Quark Know-How and the Patent Rights relating to the antidyslipidemic compound known as BT16 (as hereinafter defined); and

WHEREAS, SKK, together with its Affiliates (as hereinafter defined) possesses extensive capabilities in the development and commercialization of pharmaceutical products in Japan and in certain countries in Asia; and

WHEREAS, SKK desires to obtain and Quark is willing to grant to SKK, an exclusive license in the Territory under the Patent Rights and the Quark Know-How (as such terms are hereinafter defined), on the terms and conditions set forth herein.

Now, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, SKK and Quark hereby agree as follows:

As used in this Agreement, the following initially capitalized terms, whether used in the singular or plural, shall have the respective meanings set forth below:

1.1 Affiliate shall mean, with respect to either party to this Agreement, any individual or entity directly or indirectly controlled by or under common control with, such party. For purposes of this Agreement, the direct or indirect ownership of fifty percent (50%) or more of the outstanding voting securities of an entity, or the right to receive fifty percent (50%) or more of the profits or earnings of an entity shall be deemed to constitute control. For the avoidance of doubt, [ * ].

[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

1.2 BTI6 shall mean [*].

1.3 [*].

1.4 Calendar Quarter shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31 and such shorter period of time from the later of each of the foregoing dates through the date this Agreement is terminated or expires.

1.5 Calendar Year shall mean each successive period of twelve (12) months commencing on January 1 and ending on December 31, for so long as this Agreement is in effect.

1.6 Development Time Table shall mean that development time table that sets forth the schedule and major milestones for SKK to develop Licensed Products in the Territory as further described in and as may be amended pursuant to Section 2.3.1.

1.7 Effective Date shall mean the next business day following the delivery of full and duly executed counterparts of this Agreement.

1.8 First Commercial Sale shall mean, with respect to any Licensed Product, the first sale of such Licensed Product by SKK, or any Affiliate or SKK Sublicensee, to any third party, in an arms length transaction for use or consumption in a country in the Territory, provided that the First Commercial Sale shall not be deemed to have commenced in any country until the annual Net Sales in that country exceeds [ * ]

1.9 Improvement shall mean any [ * ] for Licensed Products or Licensed Compounds, in each case which is [ * ].

1.10 Licensed Compound shall mean BT16.

1.11 Licensed Product(s) shall mean any form or dosage of pharmaceutical composition or preparation in final form for sale by prescription, over-the-counter or any other method, which contains as an active ingredient the Licensed Compound.

1.12 NDA shall mean a New Drug Application or its equivalent, filed with any regulatory authority in any country in the Territory seeking approval to market and sell a Licensed Product in such country in the Territory.

1.13 Net Sales shall mean the gross invoice prices for all sales of Licensed Product on a country by country basis by SKK, its Affiliates or SKK Sublicensees to an unaffiliated third party, less deductions from such gross amounts for: (i) customary trade, quantity and cash discounts actually taken, (ii) credits, rebates, allowances and adjustments actually granted for rejections, recall or returns, (iii) duties, sales, use, consumption, value-added, excise and similar taxes or duties, (iv) transportation, insurance and other shipping expenses and (v) actual allowances for bad debt or uncollectible amounts, provided that the total amount deducted for items (i) to (v) above shall not exceed [ * ] of the gross invoiced value.

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