OF THE ORIGINAL EFFECTIVE DATE OR
WHICH WERE DEVELOPED PRIOR TO THE EFFECTIVE DATE OF THIS RESTATED AGREEMENT
WHICH ARE NECESSARY OR USEFUL FOR USING, OBTAINING REGULATORY APPROVALS FOR, OR
SELLING BESA'S DRUG/POLYMER COMPOSITE FORMULATION, BESA'S POLYMER COATING OR
BIOLIMUS A9 IN CONNECTION WITH XTENT'S STENTS AND XTENT'S STENT SYSTEMS.
LICENSED KNOW-HOW SPECIFICALLY EXCLUDES KNOW-HOW TO THE EXTENT COMPRISED OF OR
DESCRIBING ANY EXCLUDED TECHNOLOGY AND ANY KNOW-HOW RELATED TO THE MANUFACTURING
METHODS OR PROCESSES FOR THE PRODUCTION OF BIOLIMUS A9 OR BESA'S POLYMER
COATING.
3
1.17
"LICENSED PATENTS" MEANS (I) THOSE CERTAIN PATENTS, PATENT APPLICATIONS
AND INVENTION DISCLOSURES OWNED OR CONTROLLED BY BESA OR ANY OF ITS AFFILIATES
AS OF THE ORIGINAL EFFECTIVE DATE OR DURING THE TERM OF THIS RESTATED AGREEMENT,
ANY CLAIMS OF WHICH ARE DIRECTED TO OR COVER BIOLIMUS A9, BESA'S POLYMER
COATING, OR BESA'S DRUG/POLYMER COMPOSITE FORMULATION, OR THE USE THEREOF, ALL
OF WHICH FILED AS OF THE ORIGINAL EFFECTIVE DATE ARE SET FORTH ON EXHIBIT 1.17,
(II) ALL PATENTS THAT ARE CONTINUATIONS-IN-PART, SUBSTITUTIONS, CONFIRMATIONS,
DIVISIONALS, REISSUES, REGISTRATIONS, RE-EXAMINATIONS, REVALIDATIONS,
EXTENSIONS, FOREIGN COUNTERPARTS OR ARE OTHERWISE BASED ON OR CLAIM PRIORITY TO
THE PATENTS, PATENT APPLICATIONS AND INVENTION DISCLOSURES REFERRED TO IN
SUBSECTION (I) HEREINABOVE; AND (III) ALL PATENTS AND PATENT APPLICATIONS
COVERING, DISCLOSING OR DIRECTED TO
THE LICENSED KNOW-HOW, BUT IN THE CASE OF
EACH OF (I) AND (II) ABOVE, ONLY TO THE EXTENT THAT CLAIMS OR PORTIONS OF CLAIMS
COVER OR ARE DIRECTED TO BESA'S DRUG/POLYMER COMPOSITE FORMULATION, BIOLIMUS A9
OR
BESA'S POLYMER COATING
OR THE USE OF ANY OF THE FOREGOING, AND SPECIFICALLY
EXCLUDING ANY EMBODIMENTS OF A PATENTED CLAIM THAT ARE DIRECTED TO OR COVER
EXCLUDED TECHNOLOGY AND ARE NOT DIRECTED TO OR DO NOT COVER
(I) OR (II) ABOVE.
1.18
"LOSSES" MEANS ALL LOSSES, DAMAGES, DEMANDS, CLAIMS, ASSESSMENTS,
LIABILITIES, PAYMENTS AND OBLIGATIONS, AND ALL EXPENSES RELATED THERETO.
LOSSES
WILL INCLUDE ANY REASONABLE LEGAL FEES AND COSTS INCURRED BY AN INDEMNIFIED
PERSON IN DEFENSE OF OR IN CONNECTION WITH ANY ALLEGED OR ASSERTED LIABILITY,
PAYMENT OR OBLIGATION FOR WHICH INDEMNITY IS PROVIDED UNDER ARTICLE IX, WHETHER
OR NOT SUCH INDEMNIFIED PERSON IS MADE OR BECOMES A PARTY TO ANY CLAIM OR LEGAL
ACTION.
1.19
"MATERIAL ADVERSE EFFECT" MEANS ANY CHANGE, EFFECT, FACT, EVENT,
OCCURRENCE, STATE OF FACTS OR DEVELOPMENT THAT, INDIVIDUALLY OR TOGETHER WITH
ANY OTHER CHANGES, EFFECTS, FACTS, EVENTS, OCCURRENCES, STATES OF FACT OR
DEVELOPMENTS WHICH MATERIALLY AND ADVERSELY AFFECTS THE ABILITY OF THE
APPLICABLE PARTY TO PERFORM ITS OBLIGATIONS UNDER THIS RESTATED AGREEMENT.
1.20
"NET SALES" MEANS THE GROSS SALES OF ROYALTY BEARING PRODUCTS BY XTENT,
XTENT'S AFFILIATES AND SUBLICENSEES TO THIRD PARTIES IN A COMMERCIAL SALE,
SPECIFICALLY EXCLUDING TRANSFERS FOR PURPOSES OF CLINICAL TRIALS OR EVALUATION
AND NOT FOR SALE, IN EACH CASE LESS THE AMOUNT ACTUALLY ALLOWED TO SUCH THIRD
PARTIES FOR (A) ALLOWANCES ON ACCOUNT OF THE REJECTION OR RETURN OF PRODUCTS
PREVIOUSLY SOLD, (B) CUSTOMARY TRADE DISCOUNTS AND REBATES TO CUSTOMERS TO THE
EXTENT ACTUALLY ALLOWED AND TAKEN, (C) ACTUAL COST OF TRANSPORTATION, INSURANCE,