OTHERWISE TO ACHIEVE MARKETING APPROVAL OF ANY
PRODUCT, EXCLUDING (A) SETTLEMENT COSTS WITH RESPECT THERETO, AND (B) AMOUNTS
RELATING TO ACHIEVING LEGAL CLEARANCE FOR THE LOVENOX-REFERENCED PRODUCT IN THE
U.S. TERRITORY.
1.70.
"LEGAL COSTS".
LEGAL COSTS MEANS, WITH RESPECT TO A PRODUCT, ANY
LIABILITIES PAID OR INCURRED BY EITHER PARTY WITH RESPECT TO THIRD PARTY CLAIMS
AGAINST ANY SANDOZ INDEMNIFIED PARTY OR MOMENTA INDEMNIFIED PARTY, OF THE TYPE
DESCRIBED IN SECTION 12.1(C), (D) OR (E) (REGARDLESS OF WHETHER SUCH CLAIM HAS
BEEN MADE AGAINST OR NAMING ANY MOMENTA INDEMNIFIED PARTY) WITH RESPECT TO SUCH
PRODUCT, INCLUDING SETTLEMENT COSTS, BUT EXPRESSLY EXCLUDING ALL LEGAL CLEARANCE
COSTS.
1.71.
"LEGAL EXPENSES".
LEGAL EXPENSES MEANS, WITH RESPECT TO A PRODUCT
IN THE RELEVANT TERRITORY:
(A) LEGAL CLEARANCE COSTS; (B) LEGAL COSTS; AND (C)
MOMENTA'S FTE COSTS
12
WITH RESPECT TO LEGAL ACTIVITIES FOR THE GLYCOPROTEIN PRODUCTS, WHICH COSTS ARE
INCURRED IN ACCORDANCE WITH THE RELEVANT ANNUAL COLLABORATION PLAN; BUT (D) NOT
INCLUDING MOMENTA'S FTE COSTS WITH RESPECT TO THE LEGAL ACTIVITIES FOR THE
COLLABORATION PRODUCTS.
NOTWITHSTANDING THE FOREGOING, LEGAL EXPENSES HEREUNDER
EXCLUDES SUCH AMOUNTS RELATING TO THE LOVENOX-REFERENCED PRODUCT IN THE U.S.
TERRITORY.
1.72.
"LOVENOX-EQUIVALENT PRODUCT".
LOVENOX-EQUIVALENT PRODUCT MEANS
(A)
LOVENOX® IN INJECTABLE FORM SOLD AS A BRAND, INCLUDING LOVENOX® SOLD BY
SANOFI-AVENTIS USING CLEXANE®, KLEXANE® OR ANOTHER TRADENAME (COLLECTIVELY,
"BRANDED CLEXANE"), OR (B) ANY INJECTABLE PRODUCT SOLD IN THE EUROPEAN TERRITORY
(OTHER THAN BRANDED CLEXANE) THAT IS A GENERIC A-RATED THERAPEUTICALLY
EQUIVALENT, OR THE EU EQUIVALENT THEREOF, TO LOVENOX®, CLEXANE® OR KLEXANE® IN
INJECTABLE FORM.
FOR THE AVOIDANCE OF DOUBT, LOVENOX-EQUIVALENT PRODUCT
EXCLUDES ANY NEW CHEMICAL ENTITIES.
1.73.
"LOVENOX-REFERENCED PRODUCT".
LOVENOX-REFERENCED PRODUCT MEANS
INJECTABLE (SYRINGE AND VIAL) ENOXAPARIN FOR WHICH THE REFERENCE LISTED DRUG IS
LISTED IN US NEW DRUG APPLICATION NO. 020164, FOR WHICH AN APPLICATION COULD BE
APPROVED BY THE RELEVANT REGULATORY AUTHORITY.
FOR THE AVOIDANCE OF DOUBT,
LOVENOX-REFERENCED PRODUCT EXCLUDES ANY NEW CHEMICAL ENTITIES.
1.74.
"MARKETING APPROVAL".
MARKETING APPROVAL MEANS, WITH RESPECT TO A
PRODUCT IN A COUNTRY OR REGION, THE APPROVAL OF THE RELEVANT REGULATORY
AUTHORITY NECESSARY AND SUFFICIENT FOR THE MARKETING AND FIRST COMMERCIAL SALE
OF SUCH PRODUCT IN SUCH COUNTRY OR REGION.
1.75.
"MIT".
MIT MEANS MASSACHUSETTS INSTITUTE OF TECHNOLOGY.
1.76.
"MIT AGREEMENT".
MIT AGREEMENT MEANS THE AMENDED AND RESTATED
EXCLUSIVE PATENT LICENSE AGREEMENT BY AND BETWEEN MIT AND MOMENTA, DATED AS OF
NOVEMBER 1, 2002, AND AS AMENDED BY A FIRST AMENDMENT DATED NOVEMBER 15, 2002,
LETTER AGREEMENTS DATED SEPTEMBER 12, 2003 AND OCTOBER 22, 2003, A SECOND
AMENDMENT DATED NOVEMBER 19, 2003, A THIRD AMENDMENT DATED APRIL 2, 2004, A
FOURTH AMENDMENT WITH AN EFFECTIVE DATE OF JULY 17, 2004, A FIFTH AMENDMENT
DATED AUGUST 5, 2006, A SIXTH AMENDMENT DATED JANUARY 10, 2007 AND LETTER
AGREEMENTS DATED AUGUST 10, 2006 AND OCTOBER 18, 2006, AS THE SAME MAY BE
AMENDED FROM TIME TO TIME.
1.77.
"MOMENTA COLLABORATION KNOW-HOW".
MOMENTA COLLABORATION KNOW-HOW
MEANS (A) ALL KNOW-HOW (OTHER THAN WORKS OF AUTHORSHIP) WHICH IS CONCEIVED, OR,
SOLELY WITH RESPECT TO WORKS OF AUTHORSHIP, AUTHORED, SOLELY