I STUDY, A PHASE II STUDY, A PHASE
IIB STUDY, A PHASE III STUDY, A PHASE IV STUDY OR A COMBINATION OF TWO (2) OF
ANY OF THE FOREGOING STUDIES.
1.8
"COMMERCIALIZATION" OR "COMMERCIALIZE" MEANS ANY ACTIVITIES
DIRECTED TO OBTAINING PRICING AND/OR REIMBURSEMENT APPROVALS, MARKETING,
PROMOTING, DISTRIBUTING, IMPORTING, OFFERING TO SELL, AND/OR SELLING A PRODUCT
(INCLUDING ESTABLISHING THE PRICE FOR SUCH PRODUCT).
1.9
"COMMERCIALLY REASONABLE EFFORTS" OF A PARTY MEANS, WITH RESPECT
TO AN OBJECTIVE, THE REASONABLE, DILIGENT, GOOD FAITH EFFORTS OF A PARTY,
(INCLUDING THE EFFORTS OF ITS AFFILIATES, AND SUBLICENSEES) OF THE TYPE TO
ACCOMPLISH SUCH OBJECTIVE AS A SIMILARLY SITUATED (WITH RESPECT TO SIZE, STAGE
OF DEVELOPMENT, AND ASSETS) BIOTECHNOLOGY OR PHARMACEUTICAL COMPANY, AS THE CASE
MAY BE, WOULD NORMALLY USE TO ACCOMPLISH A SIMILAR OBJECTIVE UNDER SIMILAR
CIRCUMSTANCES, IT BEING UNDERSTOOD AND AGREED THAT, WITH RESPECT TO EFFORTS TO
BE EXPENDED IN RELATION TO A PRODUCT (INCLUDING IMPLEMENTATION OF DEVELOPMENT
AND COMMERCIALIZATION STRATEGIES TO SUPPORT THE PURSUIT OF MULTIPLE INDICATIONS
IN ACCORDANCE WITH EXHIBIT C), SUCH EFFORTS SHALL BE SUBSTANTIALLY EQUIVALENT TO
THOSE EFFORTS AND RESOURCES THAT A SIMILARLY SITUATED BIOTECHNOLOGY OR
PHARMACEUTICAL COMPANY, AS THE CASE MAY BE, WOULD TYPICALLY DEVOTE TO ITS OWN
INTERNALLY DISCOVERED COMPOUND OR PRODUCT, WHICH COMPOUND OR PRODUCT IS AT A
SIMILAR STAGE IN ITS DEVELOPMENT OR PRODUCT LIFE AND IS OF SIMILAR MARKET AND
ECONOMIC POTENTIAL AS PRODUCTS EXPECTED TO RESULT FROM THE LICENSED COMPOUNDS AT
A SIMILAR STAGE IN THEIR DEVELOPMENT OR PRODUCT LIFE, TAKING INTO ACCOUNT THE
RISKS OF DEVELOPMENT, THE COMMERCIAL POTENTIAL FOR THE PRODUCT, ITS PROPRIETARY
POSITION AND OTHER RELEVANT FACTORS.
1.10
"CONFIDENTIAL INFORMATION" MEANS (A) ALL CONFIDENTIAL OR
PROPRIETARY INFORMATION RELATING TO LICENSED COMPOUNDS, AND (B) ALL OTHER
CONFIDENTIAL OR PROPRIETARY DOCUMENTS, TECHNOLOGY, KNOW-HOW OR OTHER INFORMATION
(WHETHER OR NOT PATENTABLE) ACTUALLY DISCLOSED BY ONE PARTY TO THE OTHER
PURSUANT TO THIS AGREEMENT OR THE PRIOR CONFIDENTIALITY AGREEMENT.
1.11
"CONTROL" OR "CONTROLLED" MEANS, WITH RESPECT TO ANY (A) MATERIAL,
DOCUMENT, ITEM OF INFORMATION, METHOD, DATA OR OTHER KNOW-HOW OR (B) PATENT
RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS, THE POSSESSION BY A PARTY OR ITS
AFFILIATES (WHETHER BY OWNERSHIP OR LICENSE (OTHER THAN BY A LICENSE GRANTED
UNDER THIS AGREEMENT)), OF THE ABILITY TO GRANT TO THE OTHER PARTY ACCESS, A
LICENSE AND/OR A SUBLICENSE AS PROVIDED HEREIN WITHOUT REQUIRING THE CONSENT OF
A THIRD PARTY OR VIOLATING THE TERMS OF ANY AGREEMENT OR OTHER ARRANGEMENT WITH
ANY THIRD PARTY, IN EACH
2
*** Confidential material redacted and filed separately with the Commission.
CASE AS OF THE EFFECTIVE DATE, OR IF ANY OF THE SAME ARE ACQUIRED OR CREATED
AFTER THE EFFECTIVE DATE, AT THE DATE IT IS ACQUIRED OR CREATED BY THE RELEVANT
PARTY OR ITS AFFILIATE.
1.12
"COVER", "COVERING" OR "COVERED" WITH RESPECT TO A PRODUCT,
TECHNOLOGY, PROCESS OR METHOD, MEANS THAT, BUT FOR A LICENSE GRANTED TO A PERSON
UNDER A VALID CLAIM INCLUDED IN THE PATENT RIGHTS UNDER WHICH SUCH LICENSE IS
GRANTED, THE DEVELOPMENT, MANUFACTURE, COMMERCIALIZATION AND/OR OTHER USE