UNDER SIMILAR CIRCUMSTANCES FOR ITS OWN BUSINESS AND (II) WITH RESPECT
TO THE EFFORTS TO BE EXPENDED BY ANY PERSON WITH RESPECT TO RESEARCH,
DEVELOPMENT, MANUFACTURE, SUPPLY, INSTALLATION, SERVICE, SUPPORT, AND
COMMERCIALIZATION OF A
7
PRODUCT, EFFORTS AND RESOURCES NORMALLY USED OR WHICH HAVE BEEN USED BY SUCH
PERSON WITH RESPECT TO A MEDICAL DEVICE PRODUCT OWNED BY SUCH PERSON WHICH IS OF
SIMILAR MARKET POTENTIAL AT A SIMILAR STAGE IN THE DEVELOPMENT OR LIFE OF SUCH
PRODUCT, TAKING INTO ACCOUNT ISSUES OF SAFETY, EFFICACY, PRODUCT PROFILE, THE
COMPETITIVENESS OF THE MARKETPLACE, THE PROPRIETARY POSITION OF THE PRODUCT, THE
REGULATORY STRUCTURE INVOLVED, PROFITABILITY OF THE PRODUCT AND OTHER RELEVANT
COMMERCIAL FACTORS. FOR CLARITY, THE REASONABLENESS OF ACCURAY'S EFFORTS IN
PERFORMING DEVELOPMENT, MANUFACTURE, AND SUPPLY FOR CYBERHEART SHALL BE ASSESSED
UNDER (I) AND (II) ABOVE AS IF ACCURAY WAS PERFORMING DEVELOPMENT FOR ITSELF AND
ITS OWN PRODUCT; AND THE CYBERHEART PRODUCTS SHALL BE DEEMED TO BE OF SIMILAR
MARKET POTENTIAL AND PROFITABILITY AS CYBERKNIFE SYSTEMS FOR PURPOSES OF THE
FOREGOING.
1.39
"REGULATORY AGENCY" MEANS ANY NATIONAL (E.G., THE FDA),
SUPRA-NATIONAL (E.G., THE EUROPEAN COMMISSION, THE COUNCIL OF THE EUROPEAN UNION
("EMEA")), OR OTHER GOVERNMENTAL ENTITY WITH AUTHORITY OVER THE DEVELOPMENT,
MANUFACTURE, USE, MARKETING, SALE, OR PRICING OF ANY CYBERHEART PRODUCT OR
CYBERKNIFE SYSTEM IN ANY JURISDICTION.
1.40
"REGULATORY APPROVAL" MEANS THE NATIONAL OR MULTINATIONAL APPROVAL
NECESSARY TO MARKET, USE, OR SELL A NEW MEDICAL DEVICE PRODUCT TO THE PUBLIC AT
LARGE IN A PARTICULAR COUNTRY OR MULTI-NATIONAL GROUP OF COUNTRIES INCLUDING
WITHOUT LIMITATION THROUGHOUT THE EUROPEAN UNION.
1.41
"REGULATORY FILING" MEANS ANY APPLICATION OR NOTIFICATION REQUIRED
TO BE FILED WITH A REGULATORY AGENCY IN ORDER TO GAIN REGULATORY APPROVAL IN A
COUNTRY, INCLUDING WITHOUT LIMITATION A PREMARKET APPROVAL APPLICATION OR
PREMARKET NOTIFICATION FILED UNDER SECTION 515 OR SECTION 510(K) OF THE U.S.
FEDERAL FOOD, DRUG AND COSMETIC ACT, 21, U.S.C. §§ 360E, 360(K), RESPECTIVELY,
AS AMENDED OR ITS SUPRANATIONAL EQUIVALENT.
1.42
"SPECIFICATIONS" MEANS THE CHARACTERISTICS, FEATURES, STANDARDS,
AND OTHER REQUIREMENTS FOR EACH OF THE DELIVERABLES PROVIDED HEREUNDER AS
(I) SET FORTH IN EACH STATEMENT OF WORK, (II) REQUIRED BY APPLICABLE LAW, OR
(III) OTHERWISE AGREED UPON BY THE PARTIES IN WRITING. FOR THE AVOIDANCE OF
DOUBT, EITHER PARTY MAY PROPOSE SPECIFICATIONS TO THE OTHER PARTY, BUT BOTH
PARTIES MUST AGREE TO SUCH SPECIFICATIONS.
1.43
"STATEMENT OF WORK" HAS THE MEANING ASSIGNED TO SUCH TERM UNDER
SECTION 3.1.
1.44
"TECHNOLOGY" MEANS ANY AND ALL TECHNOLOGY, TECHNICAL INFORMATION,
CONFIDENTIAL INFORMATION, SOFTWARE, WORKS OF AUTHORSHIP, KNOW-HOW, INVENTIONS,
PROCESSES, PROCEDURES, COMPOSITIONS, METHODS, FORMULAE, PROTOCOLS, TECHNIQUES,
DESIGNS, DRAWINGS, DATA, AND OTHER TECHNICAL SUBJECT MATTER, DOCUMENTS, AND
MATERIALS.
1.45
"TERM" HAS THE MEANING ASSIGNED TO SUCH TERM UNDER SECTION 11.1.
8
2.
ACCURAY TECHNOLOGY DELIVERY AND GRANT OF RIGHTS AND LICENSE BACK.
2.1
DELIVERY.
PROMPTLY FOLLOWING THE EFFECTIVE DATE, ACCURAY SHALL
DELIVER TO CYBERHEART, OR OTHERWISE PROVIDE SUFFICIENT ACCESS TO MEET ITS
OBLIGATIONS OR EXERCISE ITS RIGHTS UNDER THIS AGREEMENT, THE ACCURAY TECHNOLOGY
SET FORTH IN EXHIBIT B IN A FORMAT AND LOCATION MUTUALLY AGREED