ACCURACY OF THE FOREGOING
REPRESENTATION, INCLUDING WITHOUT LIMITATION ANY FDA INVESTIGATIONS OF, OR
DEBARMENT PROCEEDINGS AGAINST, DISTRIBUTOR OR ANY PERSON OR ENTITY PERFORMING
SERVICES OR RENDERING ASSISTANCE, WHICH IS IN ANY WAY RELATED TO ACTIVITIES
UNDERTAKEN PURSUANT TO THIS AGREEMENT.
27
DISTRIBUTOR SHALL IMMEDIATELY NOTIFY COMPANY IN WRITING IF IT, ITS AFFILIATES,
SALES AGENTS OR SUB-DISTRIBUTORS, AT ANY TIME DURING THE TERM OF THIS AGREEMENT,
BECOMES AWARE OF ANY SUCH CIRCUMSTANCES.
11.
LIABILITY AND INSURANCE
11.1.
LIMITATION OF WARRANTIES.
EXCEPT AS MAY BE EXPRESSLY STATED BY
COMPANY ON ANY PRODUCT OR ON COMPANY'S PACKAGING, OR IN COMPANY'S INFORMATION
ACCOMPANYING ANY PRODUCT, COMPANY MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY
KIND WITH RESPECT TO SUCH PRODUCT OR THAT INFORMATION, EXPRESS OR IMPLIED,
INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE.
COMPANY NEITHER ASSUMES NOR AUTHORISES ANYONE, INCLUDING ITS EMPLOYEES
OR REPRESENTATIVES, TO ASSUME FOR IT ANY OBLIGATION OR LIABILITY IN CONNECTION
WITH PRODUCT.
11.2.
PRODUCT CLAIMS.
DISTRIBUTOR AGREES NOT TO MAKE ANY CLAIMS FOR ANY
PRODUCT WHICH ARE NOT INCLUDED IN THE INDICATIONS OR ARE OUTSIDE THE SCOPE OF
THOSE PERMITTED FOR MEDICAL DEVICES OR WOULD PREJUDICE THE MEDICAL DEVICE
CLASSIFICATION OF THE PRODUCT AND DISTRIBUTOR SHALL NOT MAKE ANY REPRESENTATION
OR WARRANTY WITH RESPECT TO THE PRODUCT THAT IS MORE EXTENSIVE THAN, OR
INCONSISTENT WITH ANY REGISTRATION OR PUBLICATIONS OF COMPANY OR THIRD PARTIES
RELATING TO THE PRODUCT.
11.3.
INSURANCE.
THE PARTIES SHALL (AND SHALL CAUSE THEIR RESPECTIVE
AFFILIATES TO), DURING THE TERM, AND FOR A PERIOD OF NOT LESS [***] YEARS
FOLLOWING TERMINATION OR EXPIRATION OF THIS AGREEMENT, MAINTAIN PRODUCT AND
GENERAL LIABILITY INSURANCE (INCLUDING BLANKET CONTRACTUAL LIABILITY) IN A
MINIMUM AMOUNT OF [***] US DOLLARS (US $[***]) FOR EACH CLAIM, AND [***] US
DOLLARS (US $[***]) IN THE AGGREGATE, TO COVER CLAIMS RELATING TO THE PRODUCT.
ALL PARTIES AT THE REQUEST OF ANOTHER SHALL PROVIDE EVIDENCE TO SUCH REQUESTING
PARTY OF COMPLIANCE WITH ITS INSURANCE OBLIGATION (AND THOSE OF ITS AFFILIATES)
UNDER THIS SECTION 11.3 AND EVIDENCE OF RENEWALS OF ANY SUCH POLICY FROM TIME TO
TIME.
THE PARTIES AGREE THAT THE INSURANCE COVERAGE PROVISIONS OF THIS
SECTION 11.3 SHALL BE IN EFFECT NO LATER THAN SIXTY (60) DAYS BEFORE THE LAUNCH
DATE OF THE PRODUCT.
12.
INTELLECTUAL PROPERTY
12.1.
PATENTS.
THE PATENTS ARE OWNED BY THE REGENTS OF THE UNIVERSITY OF
CALIFORNIA ("UCSF"), AND LICENSED TO COMPANY.
COMPANY SHALL HAVE THE SOLE
OBLIGATION TO UCSF FOR ANY AN ALL AMOUNTS DUE IN CONNECTION WITH SUCH LICENSE OF
THE PATENTS AND OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY ASSOCIATED
WITH, COVERING OR CLAIMING THE PRODUCT, OR THE MANUFACTURE, USE OR SALE OF THE
PRODUCT, IN THE TERRITORY.
THE PARTIES RECOGNIZE THAT UCSF HAS CERTAIN AUDIT,
PATENT PROSECUTION, DEFENSE OF INFRINGEMENT, NOTICE AND OTHER RIGHTS IN
CONNECTION WITH COMPANY'S LICENSE OF THE PATENTS FROM UCSF.
DISTRIBUTOR SHALL
USE DILIGENT EFFORTS TO PROVIDE, UNDER APPROPRIATE TERMS OF CONFIDENTIALITY,
INFORMATION IT MAY POSSESS WHICH COMPANY REASONABLY REQUESTS IN ORDER TO COMPLY
WITH COMPANY'S OBLIGATIONS TO