PRODUCT HAVE BEEN FILED.
1.18
"IMPROVEMENT" MEANS ALL IMPROVEMENTS, ENHANCEMENTS, ADDITIONS AND
ADAPTATIONS TO THE LICENSED SUBJECT MATTER CONCEIVED OR CREATED BY EITHER PARTY
OR ANY OF THEIR RESPECTIVE AFFILIATES THAT ARE SUFFICIENTLY DIFFERENT TO BE
SEPARATELY PATENTABLE.
1.19
"IND" MEANS AN INVESTIGATIONAL NEW DRUG APPLICATION FILED WITH THE FDA
AS MORE FULLY DEFINED IN 21 C.F.R. § 312.3 OR ITS EQUIVALENT IN ANY
JURISDICTION.
1.20
"JOINT COLLABORATION INVENTION" MEANS A COLLABORATION INVENTION CREATED
OR CONCEIVED JOINTLY BY AVANT AND SELECT.
1.21
"KNOW-HOW" MEANS ALL INFORMATION AND DATA, TECHNICAL INFORMATION, TRADE
SECRETS, SPECIFICATIONS, INSTRUCTIONS, PROCESSES, FORMULAE, EXPERTISE AND
INFORMATION RELATING TO LICENSED PRODUCTS INCLUDING, WITHOUT LIMITATION: (I)
BIOLOGICAL, CHEMICAL, PHARMACOLOGICAL, BIOCHEMICAL, TOXICOLOGICAL,
PHARMACEUTICAL, PHYSICAL AND ANALYTICAL, SAFETY, QUALITY CONTROL, MANUFACTURING,
3
PRECLINICAL AND CLINICAL DATA, INSTRUCTIONS, PROCESSES, FORMULAE, EXPERTISE AND
INFORMATION INCLUDING TECHNOLOGY RIGHTS THAT ARE RELEVANT TO THE MANUFACTURE,
USE OR SALE OR AND /OR WHICH MAY BE USEFUL IN STUDYING, TESTING, DEVELOPING,
PRODUCING, FORMULATING OR USING THE LICENSED PRODUCTS; AND (II) COPIES OF ANY
IND OR NDA OR OTHER HEALTH REGISTRATION DOCUMENTS AND AMENDMENTS OR SUPPLEMENTS
THERETO FILED WITH THE FDA OR OTHER GOVERNMENTAL, REGULATORY AUTHORITY OR HEALTH
AUTHORITY IN THE LICENSED TERRITORY AND ALL CORRESPONDENCE TO
AND FROM SUCH
AGENCY RELEVANT TO THE LICENSED PRODUCTS WHICH IS KNOWN TO AND/OR POSSESSED AND
/OR ACQUIRED BY A PARTY OR ITS AFFILIATES.
1.22
"LICENSED FIELD" MEANS THE DEVELOPMENT AND COMMERCIALIZATION OF VACCINE
PRODUCTS FOR HUMAN THERAPEUTIC AND PROPHYLACTIC USE.
1.23
"LICENSED PRODUCT" MEANS A VACCINE PRODUCT THAT (I) IS COVERED BY OR
MADE USING LICENSED SUBJECT MATTER AND (II) CONTAINS A TARGET ANTIGEN RELATED TO
A TARGET DISEASE.
1.24
"LICENSED SUBJECT MATTER" MEANS THE (I) SELECT KNOW-HOW, (II) SELECT
PATENTS, AND (III) SELECT'S INTEREST IN ANY JOINT COLLABORATION INVENTIONS.
1.25
"LICENSED TERRITORY" MEANS WORLDWIDE.
1.26
"NDA" MEANS A NEW DRUG APPLICATION AND ALL SUPPLEMENTS FILED PURSUANT TO
THE REQUIREMENTS OF THE FDA, INCLUDING ALL DOCUMENTS, DATA AND OTHER INFORMATION
WHICH ARE NECESSARY FOR, OR INCLUDED IN, FDA APPROVAL TO MARKET A LICENSED
PRODUCT AS MORE FULLY DEFINED IN 21 C.F.R. § 314.50 ET. SEQ, OR ITS EQUIVALENT
IN ANY JURISDICTION..
1.27
"NET SALES" MEANS, WITH RESPECT TO ANY LICENSED PRODUCT, THE GROSS
REVENUES RECEIVED FROM THE SALE OF LICENSED PRODUCTS BY AVANT AND ITS AFFILIATES
FOR BONA FIDE SALES OF SUCH LICENSED PRODUCT TO A THIRD PARTY (OTHER THAN
SUBLICENSEES AND AVANT'S AFFILIATES BUT INCLUDING DISTRIBUTORS FOR RESALE), LESS
DISCOUNTS (INCLUDING CASH, QUANTITY AND PATIENT PROGRAM DISCOUNTS), RETROACTIVE
PRICE REDUCTIONS, CHARGE-BACK PAYMENTS AND REBATES GRANTED TO MANAGED HEALTH
CARE ORGANIZATIONS OR TO FEDERAL, STATE AND LOCAL GOVERNMENTS, THEIR AGENCIES,
AND PURCHASERS AND REIMBURSERS OR TO TRADE CUSTOMERS; CREDITS OR ALLOWANCES
ACTUALLY GRANTED UPON CLAIMS, DAMAGED GOODS OR REJECTIONS OF SUCH LICENSED
PRODUCT, FREIGHT OUT, POSTAGE, SHIPPING AND INSURANCE CHARGES FOR DELIVERY OF
SUCH LICENSED PRODUCT; AND SALES AND/OR USE TAXES ACTUALLY PAID, INCLUDING
VALUE-ADDED TAXES, OR OTHER GOVERNMENTAL CHARGES OTHERWISE IMPOSED UPON THE
BILLED AMOUNT, AS ADJUSTED FOR REBATES AND REFUNDS, TO THE EXTENT NOT PAID BY
THE