OR PROPRIETARY INFORMATION AND
MATERIALS, PATENTABLE OR OTHERWISE, IN ANY FORM (WRITTEN, ORAL, PHOTOGRAPHIC,
ELECTRONIC, MAGNETIC, OR OTHERWISE) WHICH IS DISCLOSED TO IT BY THE OTHER PARTY
(THE "DISCLOSING PARTY") INCLUDING, BUT NOT LIMITED TO, ALL INFORMATION
CONCERNING THE PRODUCT, INFORMATION DISCLOSED BY ONE PARTY TO THE OTHER PURSUANT
TO THE CONFIDENTIALITY AGREEMENT, THE CONTENTS OF THIS AGREEMENT AND ANY OTHER
TECHNICAL OR BUSINESS INFORMATION OF WHATEVER NATURE (COLLECTIVELY,
"CONFIDENTIAL INFORMATION").
11.2.
DEVELOPMENT DATA. EXCEPT TO THE EXTENT EXPRESSLY AUTHORIZED
BY THIS AGREEMENT OR OTHERWISE AGREED IN WRITING, THE PARTIES AGREE THAT THEY
SHALL KEEP CONFIDENTIAL AND SHALL NOT PUBLISH OR OTHERWISE DISCLOSE OR USE FOR
ANY PURPOSE OTHER THAN AS PROVIDED FOR IN THIS AGREEMENT ANY DATA, RESULTS,
REPORTS OR OTHER KNOW-HOW DIRECTLY RELATED TO THE PRODUCT WHICH IS GENERATED IN
THE PERFORMANCE OF THE DEVELOPMENTAL STUDIES ("DEVELOPMENT DATA").
11.3.
EXCEPTIONS. NOTWITHSTANDING SECTIONS 11.1 AND 11.2, THE
OBLIGATIONS OF CONFIDENTIALITY SHALL NOT APPLY TO CONFIDENTIAL INFORMATION OR
DEVELOPMENT DATA THAT, IN EACH CASE AS DEMONSTRATED BY COMPETENT EVIDENCE:
(A)
WAS ALREADY KNOWN TO THE RECEIVING PARTY OR ANY AFFILIATE, OTHER
THAN UNDER AN OBLIGATION OF CONFIDENTIALITY, AT THE TIME OF DISCLOSURE;
(B)
WAS GENERALLY AVAILABLE TO THE PUBLIC OR WAS OTHERWISE PART OF THE
PUBLIC DOMAIN AT THE TIME OF ITS DISCLOSURE TO THE RECEIVING PARTY;
CONFIDENTIAL
(C)
BECAME GENERALLY AVAILABLE TO THE PUBLIC OR OTHERWISE PART OF THE
PUBLIC DOMAIN AFTER ITS DISCLOSURE BY THE DISCLOSING PARTY AND OTHER THAN
THROUGH ANY ACT OR OMISSION OF THE RECEIVING PARTY OR ANY AFFILIATE IN BREACH OF
THIS AGREEMENT;
(D)
WAS SUBSEQUENTLY LAWFULLY DISCLOSED TO THE RECEIVING PARTY OR ANY
AFFILIATE BY A PERSON OTHER THAN THE DISCLOSING PARTY, AND WHO, TO THE BEST
KNOWLEDGE OF THE RECEIVING PARTY, DID NOT DIRECTLY OR INDIRECTLY RECEIVE SUCH
INFORMATION FROM THE DISCLOSING PARTY UNDER AN OBLIGATION OF CONFIDENCE; OR
(E)
IS DEVELOPED BY THE RECEIVING PARTY OR ITS AFFILIATE WITHOUT USE
OF OR REFERENCE TO ANY INFORMATION OR MATERIALS DISCLOSED BY THE DISCLOSING
PARTY.
11.4.
PERMITTED DISCLOSURES. NOTWITHSTANDING THE PROVISIONS OF
SECTION 11.1 ABOVE, AND SUBJECT TO SECTIONS 11.5 AND 11.6 BELOW, EACH PARTY
HERETO MAY DISCLOSE CONFIDENTIAL INFORMATION OF THE OTHER PARTY AND DEVELOPMENT
DATA TO ITS AFFILIATES, PERMITTED SUBLICENSEES AND ANY OTHER THIRD PARTIES TO
THE EXTENT SUCH DISCLOSURE: (A) IS FOR THE PURPOSE OF EXERCISING THE RIGHTS
GRANTED TO IT UNDER THIS AGREEMENT; (B) IS REASONABLY NECESSARY TO PROSECUTE OR
DEFEND LITIGATION; (C) IS REASONABLY NECESSARY TO COMPLY WITH APPLICABLE
GOVERNMENTAL LAWS OR REGULATIONS; (D) IS REASONABLY NECESSARY TO SUBMIT
INFORMATION TO TAX OR OTHER GOVERNMENTAL AUTHORITIES; OR (E) IS REASONABLY
NECESSARY TO CONDUCT CLINICAL TRIALS HEREUNDER WITH RESPECT TO THE PRODUCT. IF A
PARTY IS REQUIRED BY LAW OR REGULATIONS TO MAKE ANY SUCH DISCLOSURE OF
CONFIDENTIAL INFORMATION OF THE OTHER PARTY OR DEVELOPMENT DATA, TO THE EXTENT
IT MAY LEGALLY DO SO, IT WILL GIVE REASONABLE ADVANCE NOTICE TO THE OTHER PARTY
OF SUCH DISCLOSURE AND, SAVE TO THE EXTENT INAPPROPRIATE IN THE CASE OF PATENT