time.
"VRE" means the Vitrea® volume rendering engine with respect to a specified
platform, e.g., IGS O2 or Windows® software platform, as the same exists on the
date hereof or as is otherwise agreed in the applicable Product Plan.
"VTAL" means Vital Images, Inc. and its Affiliates.
1.2
MEANING OF "SALE".
IN ADDITION TO THE FOREGOING,
TERMS SUCH AS
"SALE" AND "PURCHASE" AND VARIANTS AND SYNONYMS THEREOF WHEN USED WITH REFERENCE
TO THE SUPPLY OF ANY SOFTWARE PRODUCT ARE USED HEREIN FOR CONVENIENCE ONLY AND
REFER TO TRANSACTIONS INVOLVING THE GRANT OF A SOFTWARE LICENSE FOR PRODUCT.
1.3
OTHER TERMS.
OTHER TERMS MAY BE DEFINED ELSEWHERE IN THE TEXT OF
THIS AGREEMENT AND SHALL HAVE THE MEANING INDICATED THROUGHOUT THIS AGREEMENT.
1.4
DEFINITIONAL PROVISIONS.
THE TERM "PERSON" INCLUDES ANY
INDIVIDUAL, PARTNERSHIP, JOINT VENTURE, CORPORATION, TRUST, UNINCORPORATED
ORGANIZATION OR GOVERNMENT OR ANY DEPARTMENT OR AGENCY THEREOF.
ARTICLE 2
DEVELOPMENT OF PRODUCTS
2.1
DEVELOPMENT EFFORTS.
VTAL AND SNT WILL WORK TOGETHER TO DEVELOP
PRODUCTS ACCORDING TO EACH PRODUCT PLAN ATTACHED HERETO OR ADDED FROM TIME TO
TIME.
4
2.2
PRODUCT PLANS.
PRODUCT PLANS PRODUCTS MAY BE EXECUTED FROM TIME
TO TIME
BY THE PARTIES AS AND WHEN THEY REACH AGREEMENT THEREON.
EACH PRODUCT
PLAN, WHEN SIGNED BY BOTH PARTIES, SHALL BE SUBJECT TO THE GENERAL TERMS AND
PROVISIONS OF THIS AGREEMENT; PROVIDED THAT TO THE EXTENT OF ANY CONFLICT
BETWEEN THE TERMS HEREOF AND THE TERMS OF A PRODUCT PLAN, THE TERMS OF THE
PRODUCT PLAN WILL CONTROL.
THE PARTIES AFFIRM THEIR INTENTION TO ENTER INTO A
PRODUCT PLAN WITH RESPECT TO EACH PROPOSED PRODUCT, BUT NO PROPOSED PRODUCTS
SHALL BE A PRODUCT UNLESS AND UNTIL A PRODUCT PLAN WITH RESPECT THERETO IS
EXECUTED BY THE PARTIES.
2.3
REPORTS AND RECORDS.
WITHIN FIFTEEN (15) DAYS AFTER THE END OF
EACH MONTH, VTAL SHALL PROVIDE TO SNT A REASONABLY DETAILED REPORT SETTING FORTH
A SUMMARY OF THE DEVELOPMENT ACTIVITIES OF VTAL UNDER EACH PRODUCT PLAN DURING
SUCH MONTH AND THE STATUS OF DEVELOPMENT OF EACH PRODUCT AS OF THE END OF SUCH
MONTH.
2.4
REGULATORY.
(A)
VTAL SHALL, AT ITS COST AND EXPENSE, USE COMMERCIALLY REASONABLE
EFFORTS TO ENSURE THAT EACH PRODUCT IS PRODUCED AND PACKAGED IN ACCORDANCE WITH
ALL APPLICABLE REGULATIONS IN THE USA, CANADA AND THE COUNTRIES OF THE EUROPEAN
UNION AS CONSTITUTED ON THE DATE HEREOF, INCLUDING WITHOUT LIMITATION THE FDA
AND CE MARK PER MEDICAL DEVICE DIRECTIVE (MDD 93/42/EEC), AND SHALL BEAR ALL
COSTS RELATED TO SUCH COMPLIANCE.
RESPONSIBILITY FOR PRODUCTION COMPLIANCE WITH
THE REGULATIONS OF ANY OTHER GOVERNMENTAL UNIT AND PAYING THE COST THEREOF SHALL
BE AGREED TO AND ALLOCATED AS SET FORTH IN THE APPLICABLE PRODUCT PLAN.
(B)
SNT SHALL BE RESPONSIBLE FOR OBTAINING ALL OTHER REGULATORY
APPROVALS FOR THE COMMERCIAL SALE OF PRODUCTS, INCLUDING THE PREPARATION OF THE
CLINICAL STUDY PROTOCOLS, SELECTION OF INVESTIGATIONAL SITES, PREPARATION OF THE
INVESTIGATOR'S BROCHURES, INSTRUCTION AND TRAINING OF CLINICAL INVESTIGATORS,
MONITORING THE PERFORMANCE OF CLINICAL TRIALS, DATA COLLECTION AND ANALYSIS,
REPORTING OF ADVERSE EVENTS, PREPARATION AND PROSECUTION OF REGULATORY