Exhibit 10.11


 


REDACTED COPY


 


DEVELOPMENT
AND COMMERCIALIZATION AGREEMENT


 


by
and between


 


WYETH


acting
through its Wyeth Pharmaceuticals Division


 


and


 


ADVANCED
LIFE SCIENCES HOLDINGS, INC.


 


September 29,
2008


 

















 


REDACTED COPY


 


TABLE OF CONTENTS


 


	
   

  	
   

  	
   

  	
  Page

  
	
   

  	
   

  	
   

  	
   

  
	
  1.

  	
  DEFINITIONS

  	
   

  	
  1

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.1.

  	
  ABBOTT AGREEMENT

  	
   

  	
  1

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.2.

  	
  ADDITIONAL THIRD PARTY
  LICENSE

  	
   

  	
  1

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.3.

  	
  ADLS INDEMNIFIED PARTY

  	
   

  	
  1

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.4.

  	
  ADLS KNOW-HOW

  	
   

  	
  1

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.5.

  	
  ADLS LICENSEE

  	
   

  	
  1

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.6.

  	
  ADLS PATENT RIGHTS

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.7.

  	
  ADLS PRODUCT DATA OR
  FILINGS

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.8.

  	
  ADLS STUDY

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.9.

  	
  ADLS TECHNOLOGY

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.10.

  	
  ADLS THIRD PARTY
  AGREEMENT(S)

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.11.

  	
  AFFILIATE(S)

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.12.

  	
  BANKRUPTCY CODE

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.13.

  	
  CALENDAR QUARTER

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.14.

  	
  CALENDAR YEAR

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.15.

  	
  CAP

  	
   

  	
  3

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.16.

  	
  CHANGE OF CONTROL

  	
   

  	
  3

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.17.

  	
  [***] STUDY

  	
   

  	
  3

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.18.

  	
  COMBINATION PRODUCT

  	
   

  	
  3

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.19.

  	
  COMBINATION SALE

  	
   

  	
  3

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.20.

  	
  COMMERCIAL EVENTS

  	
   

  	
  3

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.21.

  	
  COMMERCIALIZATION

  	
   

  	
  3

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.22.

  	
  COMMERCIALLY REASONABLE
  EFFORTS

  	
   

  	
  3

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.23.

  	
  COMMERCIAL PAYMENT

  	
   

  	
  4

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.24.

  	
  COMPETING PRODUCT

  	
   

  	
  4

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.25.

  	
  COMPOUND

  	
   

  	
  4

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.26.

  	
  CONFIDENTIAL INFORMATION

  	
   

  	
  4

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.27.

  	
  CONTINUING PARTY

  	
   

  	
  4

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.28.

  	
  CONTROL

  	
   

  	
  5

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.29.

  	
  CONTROL LIMITATION AGREEMENT

  	
   

  	
  5

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.30.

  	
  CURRENT PRODUCT

  	
   

  	
  5

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.31.

  	
  DEBTOR

  	
   

  	
  5

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.32.

  	
  DECLINING PARTY

  	
   

  	
  5

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.33.

  	
  DEVELOP

  	
   

  	
  5

  



 


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  1.34.

  	
  DEVELOPMENT PROGRAM

  	
   

  	
  5

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.35.

  	
  DISCLOSING PARTY

  	
   

  	
  5

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.36.

  	
  DIVESTED ASSET

  	
   

  	
  5

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.37.

  	
  EFFECTIVE DATE

  	
   

  	
  5

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.38.

  	
  EXECUTIVE OFFICERS

  	
   

  	
  6

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.39.

  	
  FDA

  	
   

  	
  6

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.40.

  	
  FD&C ACT

  	
   

  	
  6

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.41.

  	
  FIRST COMMERCIAL SALE

  	
   

  	
  6

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.42.

  	
  FIRST PARTY

  	
   

  	
  6

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.43.

  	
  GAAP

  	
   

  	
  6

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.44.

  	
  GENERIC PRODUCT

  	
   

  	
  6

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.45.

  	
  GLOBAL DEVELOPMENT PLAN

  	
   

  	
  6

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.46.

  	
  IND

  	
   

  	
  6

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.47.

  	
  INDEMNIFIED PARTY

  	
   

  	
  6

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.48.

  	
  INDEMNIFYING PARTY

  	
   

  	
  6

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.49.

  	
  JOINT INVENTION(S)

  	
   

  	
  6

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.50.

  	
  JOINT KNOW-HOW

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.51.

  	
  JOINT PATENT RIGHT(S)

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.52.

  	
  JOINT TECHNOLOGY

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.53.

  	
  KNOW-HOW

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.54.

  	
  LABEL

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.55.

  	
  LAUNCH EVENTS

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.56.

  	
  LAUNCH PAYMENT

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.57.

  	
  LEADING PARTY

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.58.

  	
  LIABILITY

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.59.

  	
  LICENSED RIGHTS

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.60.

  	
  LICENSEE TRADEMARK

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.61.

  	
  MAJOR MARKET

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.62.

  	
  MANUFACTURING

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.63.

  	
  NET COMBINATION SALE
  AMOUNT

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.64.

  	
  NET SALES

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.65.

  	
  NON-DISCLOSURE AGREEMENT

  	
   

  	
  10

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.66.

  	
  OFFER

  	
   

  	
  10

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.67.

  	
  PATENT RIGHTS

  	
   

  	
  10

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.68.

  	
  PERMITTED DEDUCTIONS

  	
   

  	
  10

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.69.

  	
  PERSON

  	
   

  	
  10

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.70.

  	
  PRODUCT

  	
   

  	
  11

  



 


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  1.71.

  	
  PRODUCT DATA OR FILING

  	
   

  	
  11

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.72.

  	
  PRODUCT IMPROVEMENT

  	
   

  	
  11

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.73.

  	
  PRODUCT TRADEMARK

  	
   

  	
  11

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.74.

  	
  PROSECUTING PARTY

  	
   

  	
  11

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.75.

  	
  RECALL

  	
   

  	
  11

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.76.

  	
  RECEIVING PARTY

  	
   

  	
  11

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.77.

  	
  REGULATORY APPROVAL

  	
   

  	
  12

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.78.

  	
  REGULATORY AUTHORITY

  	
   

  	
  12

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.79.

  	
  REGULATORY MARKETING
  APPROVAL

  	
   

  	
  12

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.80.

  	
  REGULATORY MARKETING
  APPROVAL APPLICATION

  	
   

  	
  12

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.81.

  	
  REGULATORY PRICING
  APPROVAL

  	
   

  	
  12

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.82.

  	
  RIGHT OF FIRST OFFER

  	
   

  	
  12

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.83.

  	
  RIGHT OF REFERENCE

  	
   

  	
  12

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.84.

  	
  [***]

  	
   

  	
  12

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.85.

  	
  ROYALTY RATE

  	
   

  	
  12

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.86.

  	
  ROYALTY TERM

  	
   

  	
  12

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.87.

  	
  SECOND PARTY

  	
   

  	
  13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.88.

  	
  SELLING PERSON

  	
   

  	
  13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.89.

  	
  STEERING COMMITTEE

  	
   

  	
  13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.90.

  	
  STOCK PURCHASE AGREEMENT

  	
   

  	
  13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.91.

  	
  SUED PARTY

  	
   

  	
  13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.92.

  	
  SUPPLY AGREEMENT

  	
   

  	
  13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.93.

  	
  TERM

  	
   

  	
  13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.94.

  	
  TERRITORY

  	
   

  	
  13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.95.

  	
  TERRITORY PATENT RIGHT

  	
   

  	
  13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.96.

  	
  THIRD PARTY

  	
   

  	
  13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.97.

  	
  THIRD PARTY IP RIGHTS

  	
   

  	
  13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.98.

  	
  TRADEMARK

  	
   

  	
  13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.99.

  	
  TRANSITION DATE

  	
   

  	
  14

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.100.

  	
  VALID CLAIM

  	
   

  	
  14

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.101.

  	
  WHOLESALE ACQUISITION COST

  	
   

  	
  14

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.102.

  	
  WYETH INDEMNIFIED PARTY

  	
   

  	
  14

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.103.

  	
  WYETH MANUFACTURING COST

  	
   

  	
  14

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.104.

  	
  WYETH PRODUCT IMPROVEMENT

  	
   

  	
  14

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.105.

  	
  WYETH SUBLICENSEE

  	
   

  	
  14

  



 


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  2.

  	
  LICENSES AND RELATED GRANTS OF
  RIGHTS

  	
   

  	
  14

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  2.1.

  	
  LICENSES GRANTED TO WYETH

  	
   

  	
  14

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  2.2.

  	
  RIGHTS OF REFERENCE

  	
   

  	
  16

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  2.3.

  	
  TECHNOLOGY TRANSFER

  	
   

  	
  16

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  2.4.

  	
  LICENSES GRANTED TO ADLS

  	
   

  	
  16

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  2.5.

  	
  JOINT TECHNOLOGY

  	
   

  	
  17

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  2.6.

  	
  365(N) OF U.S.
  BANKRUPTCY CODE

  	
   

  	
  17

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  2.7.

  	
  NO IMPLIED RIGHTS

  	
   

  	
  18

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.

  	
  DECISION MAKING AND DISPUTE
  RESOLUTION

  	
   

  	
  18

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.1.

  	
  STEERING COMMITTEE

  	
   

  	
  18

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.2.

  	
  OTHER COMMITTEES

  	
   

  	
  19

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.3.

  	
  DECISION MAKING

  	
   

  	
  19

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.4.

  	
  ALLOCATION OF FINAL
  DECISION MAKING AUTHORITY

  	
   

  	
  20

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.5.

  	
  ALLIANCE MANAGERS

  	
   

  	
  22

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4.

  	
  PRODUCT DEVELOPMENT, REGULATORY
  MATTERS, DATA SHARING AND CROSS REFERENCE RIGHTS, MANUFACTURING, SUPPLY AND
  COMMERCIALIZATION

  	
   

  	
  22

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  4.1.

  	
  GENERAL

  	
   

  	
  22

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  4.2.

  	
  GLOBAL DEVELOPMENT PLAN

  	
   

  	
  22

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  4.3.

  	
  INITIAL GLOBAL DEVELOPMENT
  PLAN

  	
   

  	
  23

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  4.4.

  	
  DATA SHARING

  	
   

  	
  23

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  4.5.

  	
  DEVELOPMENT DILIGENCE

  	
   

  	
  25

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  4.6.

  	
  REGULATORY APPROVALS

  	
   

  	
  25

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  4.7.

  	
  REGULATORY REPORTING

  	
   

  	
  26

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  4.8.

  	
  PHARMACOVIGILANCE AND
  PRODUCT LABELING

  	
   

  	
  27

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  4.9.

  	
  MANUFACTURE AND SUPPLY OF
  PRODUCTS

  	
   

  	
  29

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  4.10.

  	
  COMMERCIALIZATION

  	
   

  	
  29

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  4.11.

  	
  PRODUCT RECALLS

  	
   

  	
  30

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5.

  	
  CONSIDERATION

  	
   

  	
  30

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  5.1.

  	
  EQUITY INVESTMENT

  	
   

  	
  30

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  5.2.

  	
  MILESTONE PAYMENTS

  	
   

  	
  30

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  5.3.

  	
  ROYALTIES

  	
   

  	
  31

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  5.4.

  	
  REPORTS AND PAYMENTS

  	
   

  	
  33

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  5.5.

  	
  MAINTENANCE OF RECORDS; AUDITS

  	
   

  	
  35

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6.

  	
  INTELLECTUAL PROPERTY

  	
   

  	
  36

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.1.

  	
  INVENTIONS

  	
   

  	
  36

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.2.

  	
  PATENT RIGHTS

  	
   

  	
  37

  



 


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  6.3.

  	
  RECORDING

  	
   

  	
  43

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  6.4.

  	
  TRADEMARKS

  	
   

  	
  43

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7.

  	
  CONFIDENTIALITY

  	
   

  	
  43

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  7.1.

  	
  CONFIDENTIALITY

  	
   

  	
  43

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  7.2.

  	
  AUTHORIZED DISCLOSURE AND
  USE

  	
   

  	
  44

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  7.3.

  	
  SEC OR SIMILAR FILINGS

  	
   

  	
  45

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  7.4.

  	
  PUBLIC ANNOUNCEMENTS;
  PUBLICATIONS

  	
   

  	
  45

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  7.5.

  	
  TERMINATION OF PRIOR
  NON-DISCLOSURE AGREEMENT

  	
   

  	
  46

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  8.

  	
  REPRESENTATIONS, WARRANTIES AND
  COVENANTS

  	
   

  	
  47

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  8.1.

  	
  REPRESENTATIONS,
  WARRANTIES AND COVENANTS OF EACH PARTY

  	
   

  	
  47

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  8.2.

  	
  ADDITIONAL
  REPRESENTATIONS, WARRANTIES AND COVENANTS OF ADLS

  	
   

  	
  47

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  8.3.

  	
  REPRESENTATION BY LEGAL
  COUNSEL

  	
   

  	
  50

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  8.4.

  	
  NO INCONSISTENT AGREEMENTS

  	
   

  	
  50

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  8.5.

  	
  DISCLAIMER

  	
   

  	
  50

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  9.

  	
  TERM AND TERMINATION

  	
   

  	
  51

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  9.1.

  	
  TERM

  	
   

  	
  51

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  9.2.

  	
  TERMINATION BY EITHER
  PARTY FOR CAUSE

  	
   

  	
  51

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  9.3.

  	
  TERMINATION BY WYETH AT
  WILL OR FOR SAFETY

  	
   

  	
  51

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  9.4.

  	
  TERMINATION ON INSOLVENCY
  OF ADLS

  	
   

  	
  52

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  9.5.

  	
  EFFECTS OF TERMINATION

  	
   

  	
  53

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  9.6.

  	
  SURVIVAL OF CERTAIN
  OBLIGATIONS

  	
   

  	
  56

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  10.

  	
  LIABILITY, INDEMNIFICATION AND
  INSURANCE

  	
   

  	
  56

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  10.1.

  	
  LIABILITY

  	
   

  	
  56

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  10.2.

  	
  INDEMNIFICATION BY WYETH

  	
   

  	
  57

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  10.3.

  	
  INDEMNIFICATION BY ADLS

  	
   

  	
  57

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  10.4.

  	
  PROCEDURE

  	
   

  	
  57

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  10.5.

  	
  INSURANCE

  	
   

  	
  58

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  11.

  	
  DISPUTE RESOLUTION

  	
   

  	
  58

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  11.1.

  	
  GENERAL

  	
   

  	
  58

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  11.2.

  	
  FAILURE OF OFFICERS TO
  RESOLVE DISPUTE

  	
   

  	
  59

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  12.

  	
  MISCELLANEOUS

  	
   

  	
  59

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.1.

  	
  ASSIGNMENT

  	
   

  	
  59

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.2.

  	
  FURTHER ACTIONS

  	
   

  	
  59

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.3.

  	
  FORCE MAJEURE

  	
   

  	
  59

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.4.

  	
  CORRESPONDENCE AND NOTICES

  	
   

  	
  60

  



 


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  12.5.

  	
  AMENDMENT

  	
   

  	
  61

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.6.

  	
  WAIVER

  	
   

  	
  61

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.7.

  	
  SEVERABILITY

  	
   

  	
  61

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.8.

  	
  DESCRIPTIVE HEADINGS

  	
   

  	
  61

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.9.

  	
  GOVERNING LAW; VENUE

  	
   

  	
  61

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.10.

  	
  ENTIRE AGREEMENT OF THE
  PARTIES

  	
   

  	
  62

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.11.

  	
  INDEPENDENT CONTRACTORS

  	
   

  	
  62

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.12.

  	
  COUNTERPARTS

  	
   

  	
  62

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.13.

  	
  INTERPRETATION

  	
   

  	
  62

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.14.

  	
  CHANGE OF CONTROL OF ADLS

  	
   

  	
  63

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.15.

  	
  RIGHT OF FIRST OFFER

  	
   

  	
  64

  



 


	
  EXHIBITS

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  EXHIBIT 1.6

  	
  ADLS PATENT RIGHTS

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  EXHIBIT 1.8

  	
  ADLS STUDY

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  EXHIBIT 1.10

  	
  ADLS THIRD PARTY AGREEMENTS

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  EXHIBIT 1.17

  	
  [***] STUDY

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  EXHIBIT 1.25

  	
  COMPOUND

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  EXHIBIT 1.90

  	
  STOCK PURCHASE AGREEMENT

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  EXHIBIT 4.3

  	
  INITIAL GLOBAL DEVELOPMENT
  PLAN

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  EXHIBIT 4.9.1

  	
  KEY TERMS OF THE SUPPLY
  AGREEMENT

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  EXHIBIT 7.4.3

  	
  ADLS PRESS RELEASE

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  EXHIBIT 8.2(a)

  	
  INFORMATION RELATED TO
  ADLS IP

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  EXHIBIT 8.2(c)

  	
  THIRD PARTY RIGHTS RELATED
  TO ADLS IP

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  EXHIBIT 8.2(e)

  	
  GOVERNMENT FUNDING

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  EXHIBIT 8.2(o)

  	
  CONTROL LIMITATION
  AGREEMENTS

  	
   

  	
   

  



 


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DEVELOPMENT AND COMMERCIALIZATION AGREEMENT


 


This
Development and Commercialization Agreement (the “Agreement”) is entered into as of September 29, 2008 (the
“Effective Date”), by and between
Wyeth, a corporation organized and existing under the laws of the State of
Delaware and having a place of business at 500 Arcola Road, Collegeville,
Pennsylvania 19426 (“Wyeth”),
acting through its Wyeth Pharmaceuticals Division, and Advanced Life Sciences
Holdings, Inc., a corporation organized and existing under the laws of the
State of Delaware and having a principal place of business at  1440 Davey Road, Woodridge, Illinois 60517  (“ADLS”).  Wyeth and ADLS may each be referred to herein
individually as a “Party” and
collectively as the “Parties”.


 


WHEREAS, Wyeth
is engaged in the research, development and commercialization of pharmaceutical
and health care products;


 


WHEREAS, ADLS
controls proprietary rights related to cethromycin, an antibiotic from the
ketolide class;


 


WHEREAS, Wyeth
and ADLS desire to collaborate to develop, manufacture and commercialize
products for the Territory (as defined below) based on cethromycin, as
described herein;


 


NOW THEREFORE,
in consideration of the mutual promises and covenants set forth below and other
good and valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the Parties hereby agree as follows:


 


1.                                      DEFINITIONS.


 


1.1.         Abbott Agreement.  “Abbott Agreement”  shall have the meaning set forth in Section 5.3.2
hereof.


 


1.2.         Additional Third Party License.  “Additional Third Party License”  shall have the meaning set forth in Section 5.3.4
hereof.


 


1.3.         ADLS Indemnified Party.  “ADLS Indemnified Party”  shall have the meaning set forth in Section 10.2
hereof.


 


1.4.         ADLS Know-How.  “ADLS Know-How” shall mean any Know-How,
other than the Joint Know-How, that (i) ADLS or any of its Affiliates
Controls as of the Effective Date or that comes into the Control of ADLS or any
of its Affiliates during the Term (other than through the grant of a license by
Wyeth) and (ii) is necessary or useful in the discovery, synthesis,
research, use, Development, Manufacture or Commercialization of any Compound or
any Product.


 


1.5.         ADLS Licensee.  “ADLS Licensee”  or  “Licensee” shall mean any Person who
receives or has received, directly or indirectly, from ADLS, a license or 


 


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sublicense of
any right to Develop, Manufacture or Commercialize any Compound or Product.


 


1.6.         ADLS Patent Rights.  “ADLS
Patent Rights” shall mean any Patent Right, other than any Joint
Patent Right, that (i) ADLS or any of its Affiliates Controls as of the
Effective Date or that comes into the Control of ADLS or any of its Affiliates
during the Term (other than through the grant of a license by Wyeth) and (ii) is
necessary or useful in the discovery, synthesis, research, use, Development,
Manufacture or Commercialization of any Compound or any Product.  Those ADLS Patent Rights existing as of the
Effective Date include without limitation those set forth on Exhibit 1.6
attached hereto.


 


1.7.         ADLS Product Data or
Filings.  “ADLS Product Data or Filings” shall have
the meaning set forth in Section 4.4.1.


 


1.8.         ADLS Study.  “ADLS Study”
shall mean [***].


 


1.9.         ADLS Technology.  “ADLS Technology” shall mean, collectively,
the ADLS Patent Rights and ADLS Know-How.


 


1.10.       ADLS Third Party Agreement(s).  “ADLS Third Party Agreement(s)” shall mean
any agreement between ADLS and any Third Party under which ADLS obtains rights
in or to any Licensed Right.  Those ADLS
Third Party Agreement(s) in existence as of the Effective Date are listed
on Exhibit 1.10.


 


1.11.       Affiliate(s).  “Affiliate(s)”  shall mean, with respect to any Person or entity, any other
Person or entity that controls, is controlled by or is under common control
with such Person or entity.  A Person or
entity shall be regarded as in control of another entity if it owns or controls
more than fifty percent (50%) of the equity securities of the subject entity
entitled to vote in the election of directors (or, in the case of an entity
that is not a corporation, for the election of the corresponding managing
authority), provided, however, that the term “Affiliate” shall not include
subsidiaries or other entities in which a Party or its Affiliates owns a
majority of the ordinary voting power necessary to elect a majority of the
board of directors or other managing authority, but is restricted from electing
such majority by contract or otherwise, until such time as such restrictions
are no longer in effect.


 


1.12.       Bankruptcy Code.  “Bankruptcy Code”  shall have the meaning set forth in Section 2.6 hereof.


 


1.13.       Calendar Quarter.  “Calendar Quarter”  shall mean the respective periods of three (3) consecutive
calendar months ending on March 31, June 30, September 30 or December 31,
for so long as this Agreement is in effect.


 


1.14.       Calendar Year.  “Calendar Year” shall mean each successive
period of twelve (12) months commencing on January 1 and ending on December 31.


 


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1.15.       CAP. 
“CAP”
shall mean community acquired pneumonia.


 


1.16.       Change of Control.  “Change of Control” shall mean, with respect
to a Party, (i) a merger, reorganization or consolidation of such Party
with a Third Party which results in the voting securities of such Party
outstanding immediately prior thereto ceasing to represent at least fifty
percent (50%) of the combined voting power of the surviving entity immediately
after such merger, reorganization or consolidation, (ii) a Third Party
becoming the beneficial owner of fifty percent (50%) or more of the combined
voting power of the outstanding securities of such Party or (iii) the sale
or other transfer of all or substantially all of such Party’s business or
assets to which this Agreement relates to a Third Party.


 


1.17.       [***] Study.  “[***] Study” shall mean [***].


 


1.18.       Combination Product.  “Combination Product”  shall mean any Product containing as
active ingredients both (a) any Compound and (b) one or more other
pharmaceutically active compounds or substances, in the same formulation.


 


1.19.       Combination Sale.  “Combination Sale”  shall have the meaning set forth in Section 1.64 hereof.


 


1.20.       Commercial Events.  “Commercial Events”  shall have the meaning set forth in Section 5.2
hereof.


 


1.21.       Commercialization.  “Commercialization”  or  “Commercialize” shall mean to use, have
used, offer for sale, have offered for sale, sell, have sold, import, have
imported and otherwise commercialize a product, including activities directed
to obtaining pricing and reimbursement approvals for, marketing, promoting or
distributing a product. 
Commercialization shall not include any activities related to
Manufacturing or Development.


 


1.22.       Commercially Reasonable Efforts.  “Commercially Reasonable Efforts” shall
mean, with respect to the efforts to be expended by a Party with respect to any
objective, those reasonable, diligent, good faith efforts to accomplish such
objective as such Party would normally use to accomplish a similar objective
under similar circumstances.  With
respect to any objective relating to the Development, Manufacture or
Commercialization of a Product by Wyeth, generally or with respect to any
particular country in the Territory, “Commercially Reasonable Efforts” shall
mean those efforts and resources normally used by Wyeth, in the Territory or in
such country, as the case may be, with respect to a product owned or controlled
by Wyeth, or to which Wyeth has similar rights, which product is of similar
market potential in the Territory or in such country, as the case may be, and
is at a similar stage in its development or life as is such Product, taking into
account issues of safety, efficacy, product 


 


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profile, the
likelihood of obtaining regulatory approvals, including satisfactory
reimbursement or pricing approvals for such product in the Territory or such
country, as the case may be, and the timing of such approvals, the current and
projected competitiveness of the marketplace for such product in the Territory
or in such country, as the case may be, the proprietary position and
anticipated exclusivity of such product in the Territory or in such country, as
the case may be, the existing or projected sales and profitability of such product
in the Territory or such country, as the case may be, and other relevant
commercial factors.  To the extent that
the performance of a Party’s obligations hereunder is adversely affected by the
other Party’s failure to perform its obligations hereunder, the impact of the
failing Party’s failure shall be taken into account in determining whether the
other Party has used its Commercially Reasonable Efforts to perform any such
affected obligations.


 


1.23.       Commercial Payment.  “Commercial Payment” shall have the meaning
set forth in Section 5.2.3.


 


1.24.       Competing Product.  “Competing Product” shall mean, with respect
to any Product, any product that contains an active ingredient that is
substantially the same as a Compound (or any analog or other pharmaceutically
acceptable form of a Compound, including, without limitation, any isomer,
metabolite, hydrate, solvate, salt form or polymorph of a Compound).  For the avoidance of doubt, an active
ingredient shall not be considered to be separate, distinct and different from
a Compound solely on the basis of its method of production, method of delivery
or dosage level.


 


1.25.       Compound. 
“Compound”  means the compound set forth on Exhibit 1.25
attached hereto, also known as cethromycin, or any prodrug or other pharmaceutically
acceptable form of such compound, including, without limitation, any isomer,
metabolite, hydrate, solvate, salt form or polymorph of any of the foregoing.


 


1.26.       Confidential Information.  “Confidential Information” of a Party shall
mean all Know-How or other information, including, without limitation,
proprietary information and materials (whether or not patentable) regarding
such Party’s technology, products, business or objectives that is communicated
in any way or form by the Disclosing Party to the Receiving Party, either prior
to or after the Effective Date of this Agreement, and whether or not such
Know-How or other information is identified as confidential at the time of
disclosure.  Subject to Section 7.3
below, the terms and conditions of this Agreement shall be considered
Confidential Information of each Party.


 


1.27.       Continuing Party.  “Continuing Party”  shall have the meaning set forth in Section 6.2.1(b) hereof.


 


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1.28.       Control. 
“Control”  or  “Controlled” shall mean with respect to any
intellectual property right (including, without limitation, any Know-How, Patent
Right or right regarding access or reference to Product Data or Filings or
other data or information), possession of the ability (whether by sole or joint
ownership, license or otherwise, other than pursuant to this Agreement) to
grant, without violating the terms of any Control Limitation Agreement, a
license, access or other right in, to or under such intellectual property
right.


 


1.29.       Control Limitation Agreement.  “Control Limitation Agreement”  shall mean any agreement or arrangement
which limits the ownership rights of a Person with respect to, or limits the
ability of a Person to grant a license, sublicense or other right in, to or
under, any intellectual property right.


 


1.30.       Current Product.  “Current Product”  shall mean the Product the formulation of which is described
in IND number 57836.


 


1.31.       Debtor. 
“Debtor”
shall have the meaning set forth in Section 9.4.


 


1.32.       Declining Party.  “Declining Party” shall have the meaning set
forth in Section 6.2.1(b) hereof.


 


1.33.       Develop. 
“Develop”
shall mean shall mean to discover, research or develop a product, including the
use of any licensed right for the purpose of conducting any such discovery,
research or development.  When used as a
noun, “Development” shall mean any and all activities involved in
Developing.  Develop and Development
shall include, without limitation, conducting non-clinical and clinical
research and development activities such as toxicology, pharmacology and other
discovery efforts, test method development and stability testing, process
development, formulation development, delivery system development, quality
assurance and quality control development, statistical analysis, clinical
studies (including pre- and post-approval studies), regulatory affairs,
pharmacovigilance and all activities directed to obtaining any Regulatory
Approval.


 


1.34.       Development Program.  “Development Program”  shall mean the Development of Products
pursuant to the Global Development Plan.


 


1.35.       Disclosing Party.  “Disclosing Party”  shall have the meaning set forth in Section 7.1 hereof.


 


1.36.       Divested Asset.  “Divested Asset”  shall have the meaning set forth in Section 12.14.2
hereof.


 


1.37.       Effective Date.  “Effective Date” shall have the meaning set
forth in the first paragraph of this Agreement.


 


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1.38.       Executive Officers.  “Executive Officers” shall mean an
appropriate senior level executive designated by Wyeth (or an executive of
Wyeth or an Affiliate of Wyeth designated by such senior level executive) and
the President of ADLS (or an officer of ADLS or an Affiliate of ADLS designated
by such President).


 


1.39.       FDA. 
“FDA”
shall mean the United States Food and Drug Administration or any successor
agency thereto.


 


1.40.       FD&C Act.  “FD&C Act” shall mean the United States
Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended, and the rules and
regulations promulgated thereunder.


 


1.41.       First Commercial Sale.  “First Commercial Sale” shall mean, with
respect to any Product and any country of the Territory and any indication, the
first sale of such Product under this Agreement by Wyeth, its Affiliates or its
Sublicensees to a Third Party in such country, after such Product has been
granted Regulatory Marketing Approval and Regulatory Pricing Approval for such
indication by the competent Regulatory Authorities in such country.  When used without reference to a specified
indication, First Commercial Sale shall mean the First Commercial Sale for any
indication.


 


1.42.       First Party.  “First Party” shall have the meaning set forth
in Section 6.2.1(c).


 


1.43.       GAAP.  “GAAP”
shall mean then current United States generally accepted accounting principles,
consistently applied.


 


1.44.       Generic Product.  “Generic
Product” shall mean any product containing Compound as as an active
ingredient.


 


1.45.       Global Development Plan.  “Global Development Plan” shall have the
meaning as set forth in Section 4.2.


 


1.46.       IND. 
“IND”  shall mean an Investigational New Drug
Application, as defined in the FD&C Act, that is required to be filed with
the FDA before beginning clinical testing of a Product in human subjects, or an
equivalent foreign filing.


 


1.47.       Indemnified Party.  “Indemnified Party”  shall have the meaning set forth in Section 10.4
hereof.


 


1.48.       Indemnifying Party.  “Indemnifying Party”  shall have the meaning set forth in Section 10.4
hereof.


 


1.49.       Joint Invention(s).  “Joint Invention(s)” shall have the meaning
set forth in Section 6.1 hereof.


 


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1.50.       Joint Know-How.  “Joint Know-How” shall have the meaning set
forth in Section 6.1 hereof.


 


1.51.       Joint Patent Right(s).  “Joint Patent Right(s)” shall have the meaning set forth in Section 6.1
hereof.


 


1.52.       Joint Technology.  “Joint Technology” shall mean, collectively,
the Joint Patent Rights, the Joint Inventions and the Joint Know-How.


 


1.53.       Know-How. 
“Know-How”
shall mean non-public, proprietary inventions, discoveries, data, information,
processes, methods, techniques, materials, technology, results or other
know-how, whether or not patentable.


 


1.54.       Label. 
“Label”
shall mean product labeling in accordance with all applicable Regulatory
Approvals.


 


1.55.       Launch Events.  “Launch Events”  shall have the meaning set forth in Section 5.2 hereof.


 


1.56.       Launch Payment.  “Launch Payment” shall have the meaning set
forth in Section 5.2.1(a).


 


1.57.       Leading Party.  “Leading Party” shall have the meaning set
forth in Section 6.2.2(c).


 


1.58.       Liability.  “Liability”
shall have the meaning set forth in Section 10.2 hereof.


 


1.59.       Licensed Rights.  “Licensed Rights” shall mean the interest of
ADLS or any of its Affiliates in the ADLS Patent Rights, the ADLS Know-How and
the Joint Technology.


 


1.60.       Licensee Trademark.  “Licensee Trademark”  shall have the meaning set forth in Section 2.1.3
hereof.


 


1.61.       Major Market.  “Major Market” shall mean [***].


 


1.62.       Manufacturing.  “Manufacturing”  or  “Manufacture”  shall mean activities directed to producing, manufacturing,
processing, filling, finishing, packaging, labeling, quality assurance testing
and release, shipping and storage of a product.


 


1.63.       Net Combination Sale Amount.  “Net Combination Sale Amount”  shall have the meaning set forth in Section 1.64
hereof.


 


1.64.       Net Sales.  “Net Sales”
shall mean the gross amount actually received for any sale of any Product by
Wyeth, any Wyeth Affiliate or any Wyeth


 


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Sublicensee,
as appropriate (a “Selling Person”),
to a non-Affiliate of the Selling Person, less the following deductions, in
each case to the extent specifically related to the Product and taken by the
Selling Person or otherwise paid for or accrued by the Selling Person (“Permitted Deductions”):


 


(i)         trade, cash, promotional
and quantity discounts and wholesaler fees;


 


(ii)        taxes on sales (such as
excise, sales or use taxes or value added taxes) to the extent imposed upon and
paid directly with respect to the sales price (and excluding national, sales or
local taxes based on income);


 


(iii)       freight, insurance, packing
costs and other transportation charges to the extent included in the invoice
price to the buyer;


 


(iv)       amounts repaid or credits
taken by reason of damaged goods, rejections, defects, expired dating, recalls
or returns or because of retroactive price reductions;


 


(v)        charge back payments and
rebates granted to (a) managed healthcare organizations, (b) federal,
state or provincial or local governments or other agencies, (c) purchasers
and reimbursers, or (d) trade customers, including wholesalers and chain
and pharmacy buying groups; and


 


(vi)       documented custom duties
actually paid by the Selling Person.


 


Such Permitted
Deductions shall be determined in accordance with GAAP.


 


Sales of
Products between Wyeth, its Affiliates or Sublicensees for resale, or for use
in the production or manufacture of Products, shall not be included within Net
Sales; provided, however, that any subsequent sale of such Product (or Products
produced or manufactured using such Product) by Wyeth or its Affiliate or
Sublicensee to a non-Affiliate Third Party shall be included within Net Sales.


 


If a Product
is sold as part of a Combination Product (in each case, a “Combination Sale”), the Net Sales amount
for the Product sold in such a Combination Sale shall be that portion of the
gross amount actually received for such Combination Sale (less all Permitted
Deductions) determined as follows:


 


Except as
provided below, the Net Sales amount for a Combination Product shall equal the
gross amount actually received for the Combination Sale, reduced by the
Permitted Deductions (the “Net Combination
Sale Amount”), multiplied by the fraction A/(A+B), where:


 


A
is the Wholesale Acquisition Cost, in the country
where such Combination Sale occurs, of the Product contained in the Combination
Product, if sold as a separate Product in such country by the Selling Person,
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Wholesale
Acquisition Cost(s), in such country, of such other products or active
ingredients/components, as the case may be, included in the Combination Product
if sold separately in such country by the Selling Person.


 


In the event that the Selling Person sells the Product included in a
Combination Product as a separate Product in a country, but does not separately
sell all of the other products or active ingredients/components, as the case
may be, included in such Combination Product in such country, the calculation
of Net Sales resulting from such Combination Sale shall be determined by
multiplying the Net Combination Sale Amount by the fraction A/C where:


 


A is the Wholesale
Acquisition Cost, in the country where such Combination Sale occurs, of the
Product contained in such Combination Product when sold as a separate Product
by the Selling Person, and C is
the Wholesale Acquisition Cost, in such country, charged by the Selling Person
for the entire Combination Product.


 


In the event that the Selling Person does not sell the Product included
in a Combination Product as a separate Product in the country where such
Combination Sale occurs, but does separately sell all of the other products or
active ingredients/components, as the case may be, included in the Combination
Product in such country, the calculation of Net Sales resulting from such
Combination Sale shall be determined by multiplying the Net Combination Sale
Amount by the fraction (C-D)/C,
where:


 


C
is the Wholesale Acquisition Cost, in such country, charged by the Selling
Person for the entire Combination Product, and D is the Wholesale Acquisition Cost, in such country, charged
by the Selling Person for the other products or active ingredients/components,
as the case may be, included in the Combination Product.


 


Where active
ingredient portions of a Combination Product are sold separately as other
products but in different dosage strengths than are in the Combination Product,
the calculation of the Net Sales amount for such Combination Product shall be
based on appropriate proration of the amounts of each active ingredient
component included therein when applying the formulas set forth above.


 


Where the
calculation of Net Sales resulting from a Combination Sale in a country cannot
be determined by any of the foregoing methods, the calculation of Net Sales for
such Combination Sale shall be that portion of the Net Combination Sale Amount
reasonably determined in good faith by Wyeth in consultation with ADLS as
properly reflecting the value of the Product included in the Combination
Product.


 


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If a Product is sold as part of a bundle of distinct products (i.e.,
one price is charged for a number of distinct products that are not (i) packaged
together with another Product or (ii) in a Combination Product form
alone), the Net Sales for such Product shall be based on the ratio of the
Wholesale Acquisition Cost for such Product to the sum of the Wholesale
Acquisition Costs for each product in such bundle.  By way of example, if the Wholesale
Acquisition Cost for such Product when sold separately is $10, and the sum of
the Wholesale Acquisition Costs for each product in such bundle when sold
separately if $40, then the Net Sales attributable to the Product when sold as
part of the bundle would be twenty-five percent (25%) of the Net Sales of the
bundle of products sold by the Selling Person.


 


Notwithstanding
the foregoing, Net Sales shall not include any consideration received by Wyeth,
its Affiliates or its Sublicensees in respect of the sale, use or other
disposition of a Product in a country as part of a clinical trial prior to the
receipt of all Regulatory Marketing Approvals required to commence commercial
sales of such Product in such country.


 


Products
provided by Wyeth, its Affiliates or Sublicensees free of charge, as samples,
for administration to patients enrolled in clinical trials or distributed through
a not-for-profit foundation or other compassionate use program at no charge to
eligible patients, shall not be included in Net Sales, provided that Wyeth, its
Affiliates or Sublicensees receive no cash consideration from such samples,
clinical trials, not-for-profit foundation or program.


 


1.65.       Non-Disclosure Agreement.  “Non-Disclosure Agreement” shall have the
meaning specified in Section 7.5.


 


1.66.       Offer. 
“Offer”
shall have the meaning specified in Section 12.15.


 


1.67.       Patent Rights.  “Patent Rights” shall mean any and all (a) patents,
(b) pending patent applications, including, without limitation, all
provisional applications, substitutions, continuations, continuations-in-part,
divisions and renewals, and all patents granted thereon, (c) all patents-of-addition,
reissues, reexaminations and extensions or restorations by existing or future
extension or restoration mechanisms, including, without limitation,
supplementary protection certificates or the equivalent thereof, (d) inventor’s
certificates, (e) any other form of government-issued right substantially
similar to any of the foregoing; and (f) all United States and foreign
counterparts of any of the foregoing.


 


1.68.       Permitted Deductions.  “Permitted Deductions”  shall have the meaning set forth in Section 1.64
hereof.


 


1.69.       Person. 
“Person”
shall mean an individual, sole proprietorship, partnership, limited
partnership, limited liability partnership, corporation, limited liability
company, business trust, joint stock company, trust, incorporated 


 


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association,
joint venture or similar entity or organization, including a government or
political subdivision or department or agency of a government.


 


1.70.       Product. 
“Product”  shall mean any pharmaceutical product
containing a Compound, including, but not limited to, any formulation of any
Compound (including, but not limited to, oral formulations, oral suspension
formulations and intravenous formulations) and any Product Improvement.  “Product” includes, without limitation, any
Combination Product but does not include any separately formulated
pharmaceutical product not containing a Compound, even if such product is sold
together with a Product.


 


1.71.       Product Data or Filing.  “Product Data or Filing”  shall mean (i) any pre-clinical or
clinical data (including data from post-approval studies), clinical protocol,
study, other data, information or result regarding any Compound or Product or
the composition of or any method of making or using any Compound or Product or (ii) any
IND, Regulatory Marketing Approval Application, Regulatory Marketing Approval
or other regulatory filing regarding any Compound or Product.


 


1.72.       Product Improvement.  “Product Improvement” shall mean any
alternative or improved dosage form of a Compound (e.g., a different dosage
strength or a novel formulation technology) that ADLS may develop or license
for a Compound.


 


1.73.       Product Trademark.  “Product Trademark” shall mean (i) any
Trademark Controlled by ADLS and used by ADLS or its Affiliates anywhere in the
world in connection with the Commercialization of Products, other than any
corporate name or corporate logo of ADLS or its Affiliates or any Trademark
used by ADLS or its Affiliates to identify products other than Products, or (ii) any
Licensee Trademark.


 


1.74.       Prosecuting Party.  “Prosecuting Party” shall have the meaning
set forth in Section 6.2.1(b).


 


1.75.       Recall. 
“Recall”  shall mean, with respect to any
pharmaceutical product, a “recall,” “product withdrawal,” “stock recovery,”
“seizure” or any similar term as utilized by any Regulatory Authority under
such Regulatory Authority’s procedures regarding the recall of pharmaceutical
products, as the same may be amended from time to time, and shall include any
related post-sale warning or mailing of information regarding such product,
including any warnings or mailings described in the Regulatory Authority’s
product recall procedures.


 


1.76.       Receiving Party.  “Receiving Party”  shall have the meaning set forth in Section 7.1 hereof.


 


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1.77.       Regulatory Approval.   “Regulatory
Approval”  means any
technical, medical, scientific or other license, registration, authorization or
approval of any Regulatory Authority regarding the research, development,
clinical testing, commercial manufacture, distribution, marketing, pricing,
reimbursement, promotion, offer for sale, use, import, export or sale of any
pharmaceutical product or proposed pharmaceutical product.


 


1.78.       Regulatory Authority.  “Regulatory Authority” shall mean, with
respect to any national, supra-national, regional, state or local regulatory
jurisdiction, any agency, department, bureau, commission, council or other
governmental entity involved in the granting of a Regulatory Approval for such
jurisdiction.


 


1.79.       Regulatory Marketing Approval.  “Regulatory Marketing Approval” shall mean,
with respect to any Product in any regulatory jurisdiction and for any
indication, Regulatory Approval authorizing the marketing of such Product in
such jurisdiction for such indication.


 


1.80.       Regulatory Marketing Approval
Application.  “Regulatory Marketing Approval Application”
shall mean, with respect to any Product in any regulatory jurisdiction for any
indication, an application submitted to the appropriate Regulatory Authority
for such regulatory jurisdiction seeking Regulatory Marketing Approval of such
Product for use in such indication in such regulatory jurisdiction.


 


1.81.       Regulatory Pricing Approval.  “Regulatory Pricing Approval”  shall mean, with respect to any Product in
any regulatory jurisdiction, and for any indication, the achievement of all
applicable pricing and reimbursement approvals with respect to such Product in
such jurisdiction and for such indication.


 


1.82.       Right of First Offer.  “Right of First Offer” shall have the
meaning specified in Section 12.15.


 


1.83.       Right of Reference.  “Right of Reference” shall mean a “Right of
Reference,” as that term is defined in 21 C.F.R. § 314.3(b) and any
comparable right existing under the laws or regulations of any foreign country.


 


1.84.       [***].


 


1.85.       Royalty Rate.  “Royalty Rate”  shall have the meaning set forth in Section 5.3.2.


 


1.86.       Royalty Term.  “Royalty Term” shall mean, on a
country-by-country and Product-by-Product (but not indication-by-indication)
basis, the period from the date of the First Commercial Sale of the Product in
a country for any indication until the latest of (i) the end of any
regulatory data exclusivity period


 


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for such
Product in such country or (ii) the date on which there is no Valid Claim
of any ADLS Patent Right which covers the use or sale of the Product in such
country or (iii) ten (10) years after such First Commercial Sale of
such Product in such Country.


 


1.87.       Second Party.  “Second Party” shall have the meaning set
forth in Section 6.2.1(c).


 


1.88.       Selling Person.  “Selling Person”  shall have the meaning set forth in Section 1.64 hereof.


 


1.89.       Steering Committee.  “Steering Committee”  shall have the meaning set forth in Section 3.1.1
hereof.


 


1.90.       Stock Purchase Agreement.  “Stock Purchase Agreement” shall mean the
Stock Purchase Agreement dated as of the Effective Date by and between Wyeth
and ADLS in the form attached hereto as Exhibit 1.90.


 


1.91.       Sued Party.  “Sued Party”  shall have the meaning set forth in Section 6.2.3(c) hereof.


 


1.92.       Supply Agreement.  “Supply Agreement” shall have the meaning
set forth in Section 4.9.1 hereof.


 


1.93.       Term. 
“Term”
shall have the meaning set forth in Section 9.1.


 


1.94.       Territory.  “Territory” shall mean China, South Korea,
Taiwan, Hong Kong, Afghanistan, Bangladesh, Bhutan, Brunei, Darussalam,
Cambodia, Indonesia, Laos, Macau, Malaysia, Maldives, Mongolia, Myanmar, Nepal,
North Korea, Pakistan, the Philippines, Singapore, Sri Lanka, Thailand, Vietnam
and, if Wyeth accepts an Offer pursuant to Section 12.15, [***].


 


1.95.       Territory Patent Right.  “Territory Patent Right” shall have the
meaning set forth in Section 6.2.1(a).


 


1.96.       Third Party.  “Third Party” shall mean any Person other
than Wyeth, ADLS and their respective Affiliates.


 


1.97.       Third Party IP Rights.  “Third Party IP Rights”  shall have the meaning set forth in Section 6.2.3(b) hereof.


 


1.98.       Trademark.  “Trademark” shall mean any trademark, trade
dress, design, logo, slogan, house mark or name used in connection with the
marketing of a product, including, without limitation, any registration or
application for registration of any of the foregoing.


 


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1.99.       Transition Date.  “Transition Date”  shall
have the meaning set forth in Section 5.3.2 hereof.


 


1.100.     Valid Claim.  “Valid Claim” shall mean a claim of any unexpired issued patent
that shall not have been dedicated to the public, disclaimed nor held invalid
or unenforceable by a court or government agency of competent jurisdiction in
an unappealed or unappealable decision.


 


1.101.     Wholesale Acquisition Cost.  “Wholesale Acquisition Cost” for any product shall mean the
list price for wholesalers, distributors and other direct accounts before any
rebates, discounts, allowances or other price concessions that might be offered
by the supplier of the product.


 


1.102.     Wyeth Indemnified Party.  “Wyeth Indemnified Party”  shall
have the meaning set forth in Section 10.3 hereof.


 


1.103.     Wyeth Manufacturing Cost.  “Wyeth Manufacturing Cost” shall have the meaning set forth in Section 5.4.2.


 


1.104.     Wyeth Product Improvement.  “Wyeth Product Improvement”  shall
mean any Know-How (other than the Joint Know-How) Controlled by Wyeth or any of
its Affiliates during the Term (other than through the grant of a license by
ADLS) pertaining to the composition of, or any method of making or using, or
any Patent Right (other than a Joint Patent Right) Controlled by Wyeth or any
of its Affiliates during the Term (other than through the grant of a license by
ADLS) that covers or claims, any alternative or improved dosage form of a
Compound (e.g., a different dosage strength or a novel formulation technology)
that Wyeth may Develop under this Agreement.


 


1.105.     Wyeth Sublicensee.  “Wyeth Sublicensee” or “Sublicensee” shall mean any Person who has
received, directly or indirectly, from Wyeth, a sublicense of any right
licensed to Wyeth by ADLS hereunder.


 


2.                                    LICENSES AND RELATED GRANTS OF RIGHTS.


 


2.1.        Licenses
Granted to Wyeth.


 


2.1.1.      Licenses for Compounds and Products.  Subject to the terms and conditions of this
Agreement, ADLS, effective as of the Effective Date, hereby grants to Wyeth
under the Licensed Rights, with the right to grant sublicenses as set forth in Section 2.1.2,
the following licenses:


 


(a)           A non-exclusive
license to Develop and have Developed, in all countries throughout the world,
Compounds and Products for Commercialization in the Territory, and to
Manufacture and have Manufactured, in all countries throughout the world, any
such Compound or Product for use in such Development.


 


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(b)           An exclusive
license (exclusive even as to ADLS and its Affiliates except as necessary to
fulfill their obligations under this Agreement) to Commercialize Compounds and
Products in the Territory and, subject to the obligation to purchase Product
from ADLS pursuant to the Supply Agreement contemplated by Exhibit 4.9.1,
to Manufacture and have Manufactured, in all countries throughout the world,
Compounds and Products solely for use or sale in the Territory as part of such
Commercialization.


 


2.1.2.      Sublicenses.  Wyeth may grant and authorize sublicenses
within the scope of the rights conveyed to Wyeth pursuant to Section 2.1.1.  Wyeth shall give ADLS prompt written notice
of each such sublicense, identifying the applicable Sublicensee, Products
sublicensed, territory and scope of rights granted.  Wyeth shall be responsible to ensure that
each Sublicensee complies with all applicable terms and conditions of this
Agreement.


 


2.1.3.      Trademark License.  Subject to the terms and
conditions of this Agreement, ADLS, effective as of the Effective Date, hereby
grants to Wyeth an exclusive, royalty-free license to use any Product Trademark(s) solely
in connection with Commercialization of Products in the Territory.  With respect to any Trademark Controlled by a
Licensee and used by such Licensee in connection with the Commercialization of
Products in the United States or Europe, other than any corporate name or
corporate logo of such Licensee or any Trademark used by such Licensee to
identify products other than Products (each, a “Licensee Trademark”), ADLS shall use Commercially Reasonable
Efforts to obtain from such Licensee a written agreement confirming ADLS’ right
to include such Trademark in the Product Trademarks licensed to Wyeth as
provided in this Section 2.1.3.


 


2.1.4.      Direct Licenses to Affiliates.  Wyeth may at any time request and authorize
ADLS to grant licenses directly to Affiliates of Wyeth by giving written notice
designating to whom a direct license is to be granted.  Upon receipt of any such notice, ADLS shall
enter into and sign a separate agreement with such designated Affiliate of
Wyeth conveying such direct license for so long as such Affiliate remains an
Affiliate of Wyeth.  All such direct
license agreements shall be consistent with the terms and conditions of this
Agreement, except for such modifications as may be required by the laws and
regulations in the country in which the direct license will be exercised.  In countries where validity of the direct
license agreement requires prior government approval or registration, such
direct license agreement shall not become binding between the parties thereto
until such approval or registration is granted, which approval or registration
shall be obtained by Wyeth.  All
out-of-pocket costs incurred in granting a direct license, including ADLS’
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under this Section 2.1.4
shall be borne by Wyeth.  Wyeth shall
cause any such Affiliate to make all payments required to be made to ADLS and
to satisfy all other obligations of such Affiliate to ADLS under any such
agreement and shall remain directly liable to ADLS for any breaches of any such
agreement by its Affiliate.  In the event
that any such direct license results in the imposition on ADLS of any taxes in excess
of those that would be imposed if Wyeth had granted a sublicense to such
Affiliate, Wyeth shall be obligated to pay to ADLS such amounts as may be
necessary to “gross up” payments to ADLS to account for such additional
taxes.  Any progress reports and royalty
statements to be provided under this Agreement shall be consolidated by Wyeth
to one single report and statement for all Affiliates of Wyeth.


 


2.2.         Rights of
Reference.  ADLS and
Wyeth shall have Rights of Reference as set forth in Section 4.4.


 


2.3.         Technology Transfer.  ADLS shall provide reasonable assistance to
Wyeth, as requested by Wyeth and at no additional cost to Wyeth, to effect the
timely and orderly transfer of the ADLS Know-How to Wyeth in order for Wyeth to
be able to Develop and Commercialize Compounds and Products as contemplated by
this Agreement.  All Know-How and other
materials provided by or on behalf of ADLS may be subject to the obligations
set forth in Section 7, and shall be used by Wyeth and its Affiliates and
Sublicensees solely for the Development, Manufacture and Commercialization of
Products for the Territory pursuant to the licenses set forth in Section 2.1.1
above.


 


2.4.         Licenses
Granted to ADLS.


 


2.4.1.      License for Compounds and Products.  Subject to the terms and conditions of this
Agreement, Wyeth, effective as of the Effective Date, hereby grants to ADLS
under any Wyeth Product Improvement, with the right to grant sublicenses as and
to the extent provided in Section 2.4.2, the following royalty-free
licenses:


 


(a)         A non-exclusive
license to Develop and have Developed, in all countries throughout the world,
Products for future Commercialization outside the Territory, and to Manufacture
and have Manufactured, in all countries throughout the world, any such Product
for use in such Development.


 


(b)         A non-exclusive license to
Commercialize Products outside the Territory and to Manufacture and have
Manufactured, in all countries throughout the world, Products solely for use or
sale outside the Territory as part of such Commercialization.


 


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2.4.2.      ADLS’ Ability to Sublicense.  Subject to the terms of this Agreement, ADLS
may sublicense any right licensed to ADLS by Wyeth in Section 2.4.1 to any
ADLS Licensee.  ADLS shall give Wyeth
prompt written notice of each such sublicense, identifying the applicable ADLS
Licensee, Products sublicensed, territory and scope of rights granted.  ADLS shall ensure that each such ADLS
Licensee complies with all applicable terms and conditions of this Agreement.


 


2.5.         Joint
Technology.  The Parties
may exploit Joint Technology as provided in Section 6.1.


 


2.6.         365(n) of U.S. Bankruptcy Code.   All rights and licenses now or hereafter
granted by ADLS to Wyeth under or pursuant to any Section of this
Agreement, including, without limitation, Sections 2.1, 2.2, 2.3 and 2.4
hereof, are rights to “intellectual property” (as defined in Section 101(35A)
of Title 11 of the United States Code, as amended (such Title 11, the “Bankruptcy Code”).  ADLS hereby grants to Wyeth and its
Affiliates a right to access and to obtain possession of and to benefit from
and, in the case of any biological material or other tangible item of which
there is a fixed or limited quantity, to obtain a pro rata portion of, each of
the following to the extent related to any Compound or Product, or otherwise
related to any right or license granted under or pursuant to this Agreement: (i) copies
of pre-clinical and clinical research data and results, (ii) all of the
following (to the extent that any of the following are so related): cell lines,
antibodies, assays, reagents and other biological materials, (iii) product
samples and inventory, (iv) ADLS Technology, (v) laboratory notes and
notebooks, (vi) data and results related to clinical trials, (vii) Product
Data or Filings, and (viii) Rights of Reference in respect of regulatory
filings and approvals, all of which constitute “embodiments” of intellectual
property pursuant to Section 365(n) of the Bankruptcy Code, and (xi)
all other embodiments of such intellectual property, whether any of the
foregoing are in ADLS’ possession or control or in the possession and control
of any Third Party but which ADLS has the right to access or benefit from and
to make available to Wyeth.  ADLS shall
not interfere with the exercise by Wyeth or its Affiliates of rights and
licenses to intellectual property licensed hereunder and embodiments thereof in
accordance with this Agreement and agrees to use Commercially Reasonable
Efforts to assist Wyeth and its Affiliates to obtain such intellectual property
and embodiments thereof in the possession or control of Third Parties as
reasonably necessary or desirable for Wyeth or its Affiliates to exercise such
rights and licenses in accordance with this Agreement.  The Parties hereto acknowledge and agree that
the payments provided for under Section 5.2, and all other payments by
Wyeth to ADLS hereunder, other than royalty payments pursuant to Section 5.3,
do not constitute royalties within the meaning of Section 365(n) of
the Bankruptcy Code or relate to licenses of intellectual property hereunder.


 


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2.7.         No Implied Rights.  Except as expressly provided in this
Agreement, neither Party shall be deemed by estoppel or implication to have
granted the other Party any license or other right with respect to any
intellectual property of such Party.


 


3.                                    DECISION MAKING AND DISPUTE RESOLUTION.


 


3.1.        Steering
Committee.


 


3.1.1.      Formation of the Steering Committee.  ADLS and Wyeth shall
establish a “Steering Committee”
to facilitate communications regarding the Development of Products by the
Parties and to oversee, direct and coordinate the activities of the Parties
under this Agreement in regard to the Development Program.  The Steering Committee shall also serve as a
forum to facilitate communications between the Parties regarding Development
activities and Development of Products worldwide.  The Steering Committee shall be comprised of
up to four (4) representatives from each Party as appointed by such
Party.  The Steering Committee may change
its size from time to time by mutual consent of its members.  A Party may replace one or more of its
representatives from time to time upon written notice to the other Party.  Each Party, respectively, shall designate its
initial members of the Steering Committee within thirty (30) days after the
Effective Date.  The Steering Committee
shall exist until the completion of the ADLS Study, the [***] Study and any
other studies included under the Global Development Plan, unless the Parties
otherwise agree in writing.  Following
termination of the Steering Committee, each Party shall continue to have an
approval right with respect to matters specified to be decided by the Steering
Committee under this Agreement.  In such
event, if the Parties are unable to reach agreement on a matter specified in
this Agreement to have been decided by the Steering Committee, the matter shall
be resolved in accordance with Section 3.3.3 below.


 


3.1.2.      Chairperson; Secretary of the Steering
Committee.  The
chairperson and secretary of the Steering Committee shall rotate on an annual
basis between the Parties.  The
chairperson and secretary shall not be from the same Party at the same time.  The first chairperson shall be designated by
Wyeth.  The chairperson shall be
responsible for scheduling meetings of the Steering Committee, preparing
agendas for meetings and sending to all Steering Committee members notices of
all regular meetings and agendas for such meetings at least five (5) business
days before such meetings.  The
chairperson shall solicit input from both Parties regarding matters to be
included on the agenda, and any matter either Party desires to have included on
the agenda shall be included for discussion. 
Nothing herein shall be construed to prohibit the Steering Committee
from discussing or acting on matters not included on the applicable
agenda.  


 


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The secretary shall record
the minutes of the meeting, circulate copies of meeting minutes to the Parties
and each Steering Committee member promptly following the meeting for review,
comment and approval by the Steering Committee members and finalize approved
meeting minutes.  The chairperson shall
be a member of the Steering Committee but the secretary need not be a member of
the Steering Committee.


 


3.1.3.      Meetings.  It is currently contemplated that the Steering
Committee shall meet at least once each Calendar Quarter until it has been
terminated in accordance with Section 3.1.1 at dates and times mutually
agreed by the Steering Committee, unless otherwise mutually agreed by the
Parties.  The initial meeting of the
Steering Committee shall be held within ninety (90) days after the Effective
Date.  Either Party may call a special
meeting of the Steering Committee on fifteen (15) days written notice to the
other Party’s members of the Steering Committee (or upon such shorter notice as
exigent circumstances may require).  Such
written notice shall include an agenda for the special meeting.  In-person meetings, including, without
limitation, special meetings, of the Steering Committee shall alternate between
the offices of the Parties, unless otherwise agreed upon by the members of the
Steering Committee.  Meetings of the
Steering Committee may be held telephonically or by video conference; provided
however, that at least one (1) meeting per year shall be held
in-person.  Meetings of the Steering
Committee shall be effective only if at least one (1) representative
of each Party is in attendance or participating in the meeting.  Members of the Steering Committee shall have
the right to participate in and vote at meetings held by telephone or video
conference.  In addition, the Steering
Committee may act on any matter or issue without a meeting if it is documented
in a written consent signed by each member of the Steering Committee.


 


3.2.         Other
Committees.  The Steering
Committee may establish additional committees to oversee specific projects or
activities or to perform certain other functions under this Agreement, and such
committees shall always include equal representation from each Party.


 


3.3.        Decision
Making.


 


3.3.1.      Decisions by Consensus.  All decisions of the Steering Committee and
all other committees established under this Agreement shall be made by
unanimous agreement of both Parties’ representatives.  If the Steering Committee cannot or does not
reach unanimous agreement on a matter within the purview of the Steering Committee,
then such matter may be referred for resolution as set forth in Section 3.3.3
below.


 


3.3.2.      Lower Committee Escalation to Steering Committee.  If any other committee established by the
Steering Committee cannot reach a 


 


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decision on a matter, the
lower committee shall refer the matter to the Steering Committee for
resolution. A matter shall be considered referred to the Steering Committee as
of the date that the lower committee or either Party provides each Steering
Committee member a written description of the disputed matter.  The Party referring such disputed matter to
the Steering Committee shall use reasonable efforts to include in the written
description the positions taken by each Party’s members of the lower committee
as to such matter, all other material information relevant to such matter and a
copy of the minutes (if any) of the applicable lower committee meeting(s) at
which such matter was discussed.  Within
fifteen (15) days after such matter is so presented to the Steering Committee,
the Steering Committee shall meet to discuss and try to resolve the matter.


 


3.3.3.      Steering Committee Dispute Resolution.  If the Steering Committee cannot resolve any
matter within its purview by unanimous agreement, the matter may be referred by
either Party to the Executive Officers, who shall meet promptly (and in any
event within ten (10) days after such matter is referred to the
Executive Officers) in an effort to resolve the matter.  If, after discussion, the Executive Officers
are unable to reach consensus on the matter, any matter as to which one Party
has final decision making authority (as described below in Section 3.4)
may thereafter be resolved as determined by such Party and any other matter may
thereafter be resolved in accordance with Section 11.2 below.


 


3.4.         Allocation of Final Decision Making Authority.  Final decision making authority shall be
allocated to ADLS and Wyeth in regard to certain matters, to the extent such
matters are within the purview of the Steering Committee, as described below.  Such final decision making authority may be
exercised only after discussion by the Executive Officers as described in Section 3.3.3,
in order to encourage the Parties to reach consensus on decisions at the
Steering Committee level or lower committee levels.  Each Party shall exercise its final decision
making authority described herein in a manner consistent with the terms and
conditions of this Agreement.


 


3.4.1.      ADLS.  To the extent decisions regarding any of the
following fall within the purview of the Steering Committee, ADLS shall have
final decision making authority as described in this Section 3.4 with
respect to the following matters:


 


(a)           Any decision
involving Development of any Compound or Product for use or sale outside the
Territory;


 


(b)           Any decision regarding any
filing related to any Compound or Product with any Regulatory Authority outside
the Territory (other than filings related to Manufacture outside the Territory
of Compounds or Products for use or sale in the Territory);


 


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(c)           Any decision relating to
Commercialization of any Product outside the Territory;


 


(d)           Any decision regarding the Manufacture
of any Product for use or sale solely outside the Territory or in any clinical
study undertaken for the sole purpose of obtaining any Regulatory Approval
outside the Territory, except as otherwise provided in the Supply Agreement;
and


 


(e)           Any decision involving the
Label for a Product outside the Territory. 
ADLS will reasonably consider, but shall have no obligation to accept or
act on, requests from Wyeth to modify the Label for a Product outside the Territory.


 


3.4.2.      Wyeth.  Wyeth shall have final decision making
authority as described in this Section 3.4 with respect to the following
matters:


 


(a)           Any decision
regarding the Development of any Compound or Product for use or sale in the
Territory;


 


(b)           Any decision regarding any
filing related to any Compound or Product with any Regulatory Authority in the
Territory (other than filings related to Manufacture in the Territory of
Compounds or Products for use or sale outside the Territory);


 


(c)           Any decision relating to
Commercialization of any Product in the Territory;


 


(d)           Any decision regarding the
Manufacture by or on behalf of Wyeth or its Affiliate or Sublicensee of any
Product for use or sale in the Territory or in any clinical study undertaken
for the purpose of obtaining any Regulatory Approval in the Territory (other
than Manufacture by ADLS or its Affiliate or suppliers of ADLS or its Affiliate
of Compounds or Products, if any, to be supplied to Wyeth or its Affiliate,
which supply, if any, shall be governed by the Supply Agreement); and


 


(e)           Any decision involving the
Label for a Product inside the Territory. 
Wyeth will reasonably consider, but shall have no obligation to accept
or act on, requests from ADLS to modify the Label for a Product inside the Territory.


 


3.4.3.      Limitation on Deciding Vote.  Notwithstanding Sections 3.4.1 and 3.4.2
above, (i) neither Party shall have the right to exercise its final
decision making authority as described herein to obligate the other Party to
expend money or undertake activities unless the other Party agrees in writing,
and (ii) neither Party may exercise its final decision making 


 


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authority in a manner
inconsistent with this Agreement, including the Global Development Plan, or to
amend the provisions of this Agreement or the Global Development Plan, or to
convey licenses or rights to such Party beyond those rights and licenses
expressly set forth in this Agreement.


 


3.5.         Alliance
Managers.  In addition
to the foregoing governance provisions, each of the Parties shall appoint a
single individual to serve as that Party’s Alliance Manager.  The role of each Alliance Manager shall be to
facilitate the relationship between the Parties as established by this
Agreement.  The Alliance Managers shall
attend meetings of the Steering Committee and support the chairperson of such
committee in the discharge of his or her responsibilities.  Unless otherwise determined by the Steering
Committee, a Party’s Alliance Manager shall serve as secretary at each meeting
of such committee for which the chairperson is a representative of the other
Party.  Alliance Managers shall be
non-voting participants in such committee meetings.  A Party may replace its Alliance Manager from
time to time upon written notice to the other Party.


 


4.                                    PRODUCT DEVELOPMENT, REGULATORY MATTERS, DATA SHARING AND CROSS REFERENCE
RIGHTS, MANUFACTURING, SUPPLY AND COMMERCIALIZATION.


 


4.1.         General.  Subject to the terms and conditions of this
Agreement (including the Parties’ responsibilities under the Global Development
Plan and Wyeth’s responsibilities under Section 4.5.1 below), Wyeth shall
have the sole authority and the exclusive right to undertake the Development of
Compounds and Products for use or sale in the Territory.  Subject to the terms and conditions of this
Agreement (including the Parties’ responsibilities under the Global Development
Plan and ADLS’ responsibilities under Section 4.5.2 below), ADLS shall
have the sole authority and the exclusive right to undertake the Development of
Compounds and Products for use or sale outside the Territory, provided,
however, that, in connection with such activities, ADLS shall take into account
their potential impact on Wyeth’s Development and Commercialization of
Compounds and Products for use or sale in the Territory.  Except as expressly provided in this
Agreement, each Party shall be solely responsible for the expenses of conducting
such Development.


 


4.2.         Global Development Plan.  From time to time, in order
to facilitate the Development of Products on a worldwide basis, a Party, acting
through its representatives on the Steering Committee, may propose that certain
Development activities be performed in coordination between the Parties in
accordance with a written plan (the “Global
Development Plan”).  If
approved by the Steering Committee for inclusion in the Global Development
Plan, such Development activities shall be incorporated in appropriate detail
into a written amendment of the Global Development Plan.  If not approved by the Steering Committee for
inclusion in the Global Development Plan, such Development 


 


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activities may be performed
by a Party to the extent in accordance with Section 4.1 above.  Except as expressly provided in this Agreement
or agreed in writing by the Parties, each Party shall be solely responsible for
the expenses of performing its responsibilities under the Global Development
Plan.


 


4.2.1.      In addition, if
ADLS or a Licensee decides to conduct any clinical studies with respect to any
proposed future Product, ADLS shall give written notice of such decision to
Wyeth with a brief description of the proposed Product and clinical
studies.  If, after receipt of such
notice, Wyeth notifies ADLS that Wyeth has a good faith interest in Developing
and Commercializing such Product in the Territory, then such clinical studies
shall be added to the Global Development Plan pursuant to an amendment of the
Global Development Plan to be approved by the Steering Committee in accordance
with this Agreement.


 


4.2.2.      During the Term, the Global
Development Plan may be updated from time to time as deemed necessary by the
Steering Committee.


 


4.2.3.      Each Party shall provide to
the other Party or the Steering Committee, as appropriate, such information in
its Control and relevant to the Development of Products as may be necessary or
appropriate in connection with updating the Global Development Plan.  Each modification or update of the Global
Development Plan shall be subject to review and approval of the Steering
Committee.


 


4.3.         Initial Global Development Plan.  The initial Global Development Plan, which
shall initially consist of the ADLS Study and the [***] Study, is attached
hereto as Exhibit 4.3.


 


4.3.1.      [***].


 


4.3.2.      [***].


 


4.4.        Data
Sharing.


 


4.4.1.      ADLS shall promptly disclose
to and share with, or cause to be disclosed to and shared with, Wyeth, at no
cost to Wyeth, each Product Data or Filing generated by or otherwise coming
into the ownership or Control of ADLS, any of its Affiliates or any ADLS
Licensee in connection with the Development, Manufacture or Commercialization
of Compounds or Products worldwide (the “ADLS
Product Data or Filings”). 
ADLS shall require each ADLS Licensee to allow ADLS to include in the
ADLS Product Data or Filings to be provided to Wyeth under this Section 4.4.1
any Product Data or Filing generated by or otherwise coming into the ownership
or Control of such ADLS Licensee in connection with the Development,
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of Compounds or
Products.  Upon request, ADLS shall
promptly assign and transfer, or cause to be assigned and transferred, to Wyeth
any ADLS regulatory filing filed with any Regulatory Authority in the
Territory.


 


4.4.2.      Wyeth shall promptly disclose to and share
with, or cause to be disclosed to and shared with, ADLS, at no cost to ADLS,
all Product Data or Filings generated by or otherwise coming into the ownership
or Control of Wyeth, any its Affiliates or any Wyeth Sublicensee in connection
with the Development, Manufacture or Commercialization of Compounds or Products
pursuant to this Agreement.


 


4.4.3.      Subject to Sections 4.3.1
and 8.1(e), each Party disclaims any representation or warranty that Product
Data or Filings provided as set forth in this Section 4.4 will meet the
requirements of any particular country, or that such Product Data or Filings will
be adequate or usable by the other Party in connection with seeking any
Regulatory Marketing Approval in any particular country.


 


4.4.4.      Subject to Section 4.4.5, each Party
and its Affiliates and Sublicensees or Licensees, as the case may be, shall have
the right as set forth in this Section 4.4.4 to use, without additional
payment, any and all Product Data or Filings provided pursuant to Section 4.4.1
or Section 4.4.2 to support any regulatory filings for Compounds or
Products (i) in the Territory, in the case of Wyeth and its Affiliates and
Wyeth Sublicensees, or (ii) outside the Territory, in the case of ADLS and
its Affiliates and ADLS Licensees.


 


(a)           ADLS hereby grants to Wyeth
and its Affiliates a Right of Reference, for regulatory filings in the
Territory (or for Manufacture, in countries outside the Territory, of Compounds
or Products for sale in the Territory, or for clinical trials related to
supporting or obtaining any Regulatory Approval in the Territory), to any ADLS
Product Data or Filing to be provided or disclosed by ADLS or its Affiliates or
Licensees pursuant to Section 4.4.1, and ADLS shall, and shall require its
Affiliates and Licensees to, provide a signed statement to this effect, if
requested by Wyeth.  Wyeth may sublicense
the Right of Reference set forth in this Section 4.4.4(a) to its
Sublicensees in the Territory.


 


(b)           Wyeth hereby grants to ADLS
and its Affiliates a Right of Reference, for regulatory filings outside the
Territory (or for Manufacture in the Territory of Compounds or Products for
sale outside the Territory, or for clinical trials related to supporting or
obtaining any Regulatory Approval outside the Territory) to any Product Data or
Filing to be provided or disclosed by Wyeth or 


 


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any of its Affiliates or
Sublicensees pursuant to Section 4.4.2, and Wyeth shall, and shall require
its Affiliates and Sublicensees to, provide a signed statement to this effect,
if requested by ADLS.  ADLS may
sublicense the Right of Reference set forth in this Section 4.4.4(b) to
its Licensees solely for use in connection with the Development, Manufacture
and Commercialization of Products outside the Territory.


 


4.4.5.      Wyeth shall obtain from each
Wyeth Sublicensee (i) an obligation by the Sublicensee to disclose to and
share with Wyeth (for disclosure to and sharing with ADLS as set forth in Section 4.4.2)
any and all Product Data or Filings generated by or otherwise coming into the
ownership or Control of such Sublicensee, and (ii) the right of ADLS, its
Affiliates and Licensees to disclose and to use such Product Data or Filings as
set forth in Section 4.4.4(b).


 


4.4.6.      ADLS shall obtain from each ADLS Licensee (i) an
obligation by such Licensee to disclose to and share with ADLS (for disclosure
to and sharing with Wyeth as set forth in Section 4.4.1) any and all
Product Data or Filings generated by or otherwise coming into the ownership or
Control of such Licensee, and (ii) the right of Wyeth, its Affiliates and
Sublicensees to disclose and to use such Product Data or Filings as set forth
in Section 4.4.4(a).  Commencing
upon the Effective Date, it shall be a condition to any Person becoming an ADLS
Licensee that such Person agree in writing to the obligation and grant of
rights by such ADLS Licensee as set forth in this Section 4.4.6.


 


4.5.        Development
Diligence.


 


4.5.1.      Wyeth shall use Commercially
Reasonable Efforts to Develop and obtain Regulatory Marketing Approval for the
Current Product in each Major Market, provided that ADLS has successfully
completed all Development activities to be performed by ADLS with respect to
such Product pursuant to Section 4.5.2.  In addition, Wyeth shall use Commercially
Reasonable Efforts to perform its obligations under the Global Development Plan
[***].  Wyeth shall have no diligence
obligation, express or implied, with respect to the Development of Products
except as provided in this Section 4.5.1.


 


4.5.2.      ADLS shall use Commercially
Reasonable Efforts to perform its obligations under the Global Development Plan
[***].


 


4.6.        Regulatory
Approvals.


 


4.6.1.      Subject to ADLS’ obligations
under Section 4.5.2, Wyeth shall file, in its own name and at its own
expense, all applications for Regulatory 


 


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Approval in the Territory
for Products where Wyeth, in its sole discretion (subject to Section 4.5.1),
elects to do so, and all other applications for any approvals required for any
clinical study or other study or action necessary or desirable to obtain such
Regulatory Approval.  Wyeth shall have
the sole responsibility for communicating with any Regulatory Authority in the
Territory regarding any application for Regulatory Approval or any Regulatory
Approval once granted or any such other applications.


 


4.6.2.      Subject to its diligence obligations under
Section 4.5.2, ADLS shall have the sole right, in its sole discretion, to
file and maintain, in its own name, all applications for Regulatory Approval
outside the Territory for Products. 
Notwithstanding the foregoing, ADLS shall, or ADLS shall cause its
Licensee to, as applicable, use Commercially Reasonable Efforts to obtain
Regulatory Marketing Approval for the Current Product, and ADLS shall, or ADLS
shall cause its Licensee to, as applicable, use Commercially Reasonable Efforts
to maintain such Regulatory Marketing Approval for the Current Product, as well
as any Regulatory Marketing Approval obtained from the FDA for any other
Product.  If ADLS or its Licensee, as
applicable, elects not to continue to maintain any such Regulatory Marketing
Approval, ADLS shall provide Wyeth with prompt written notice of the decision
not to continue the maintenance of such Regulatory Marketing Approval in
sufficient time to allow Wyeth to continue the maintenance of such Regulatory Marketing
Approval in a timely manner.  In such
event, at Wyeth’s request in its sole discretion, ADLS shall, or ADLS shall
cause its Licensee to, as applicable, execute such documents and perform such
acts, at no cost to Wyeth, as may be reasonably necessary (i) to assign
and transfer to Wyeth all of the right, title and interest of ADLS or its
Licensee, as applicable, in and to such Regulatory Marketing Approval and
related files and (ii) to permit Wyeth to continue the maintenance of such
Regulatory Marketing Approval.  If Wyeth
elects to obtain such assignment and/or continue the maintenance of such
Regulatory Marketing Approval, Wyeth may deduct from any payment to be made to
ADLS hereunder any expenses incurred by Wyeth in connection therewith, provided
that such deductions in aggregate shall not exceed the aggregate payments to be
made to ADLS hereunder.  In addition,
ADLS shall, or shall cause its Licensee to, consult with Wyeth in regard to,
and provide Wyeth with copies of all regulatory correspondence and meeting
minutes pertaining to, all regulatory filings relating to this Section 4.6.2.


 


4.7.         Regulatory
Reporting.  Wyeth shall
be responsible for filing, at its own expense, all reports required to be filed
in order to maintain any Regulatory Approvals granted for Products in the
Territory.


 


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4.8.        Pharmacovigilance
and Product Labeling.


 


4.8.1.      Definitions.  Unless
otherwise defined herein, the terms used surrounding adverse experiences will
have the meaning set forth in U.S. Code of Federal Regulations (CFR), title 21
parts 312 and 314 and the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human Use E2A as
stated now and as may be revised in the future.


 


4.8.2.      Pharmacovigilance.   Wyeth
shall be solely responsible for all of the following in the Territory:  adverse experience reports;  literature review and associated reports;
adverse experience follow-up reports; preparation and submission of all safety
reports to the Regulatory Authorities as required; maintaining information
regarding Compounds and Products for inclusion in the global safety database;
all interactions with relevant Regulatory Authorities and investigators;
periodic submissions; risk management; safety monitoring, signal detection and
safety measures (e.g., clinical holds and restriction on distribution).


 


ADLS shall be solely
responsible for all of the following outside the Territory or in connection
with its clinical studies:  adverse
experience reports; literature review and associated reports; adverse
experience follow-up reports; preparation and submission of all safety reports
to the Regulatory Authorities as required; maintaining information regarding
Compounds and Products for inclusion in the global safety database; all
interactions with relevant Regulatory Authorities and investigators; periodic
submissions; risk management; safety monitoring, signal detection and safety
measures (e.g., clinical holds and restriction on distribution).


 


Notwithstanding the
foregoing and until such time as a pharmacovigilance agreement is executed as
provided in Section 4.8.4, to the extent either Party has or receives any
information regarding any adverse experience which may be related to the use of
the Compounds and Products, the Parties shall promptly forward such information
as follows:


 


·                  Fatal or life-threatening
serious adverse events/adverse drug reactions judged by either the investigator
or sponsor to be reasonably related to the Compounds, Products or protocol
shall be transmitted to the other Party within two (2) calendar days from
the date received by the receiving Party.


 


·                  All other serious adverse
events/adverse drug reactions not fatal or life-threatening but judged by
either the investigator or sponsor to be reasonably related to the Compounds,
Products or 


 


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protocol shall be
transmitted to the other Party within five (5) calendar days from the date
received by the receiving Party.


 


If
to Wyeth:


 


Facsimile:  610-989-5544


or


Overnight courier to:


Global
Safety Surveillance Epidemiology & Labeling


Wyeth
Research


GSSEL
Triage Unit


Dock E


500 Arcola Road


Collegeville, PA  19426


 


If
to ADLS:


 


Facsimile:  630-739-6754


or


Overnight courier to:


Advanced Life Sciences Holdings, Inc.


1440 Davey Road


Woodridge, IL 
60517


Attn:  Director
of Regulatory Affairs


 


4.8.3.      Product
Labeling.    Wyeth shall be solely
responsible for the administrative aspects of preparing, updating and
maintaining product labeling in connection with Commercialization of Product(s) in
the Territory (and related Manufacturing of such Products, subject to ADLS’
obligations under the Supply Agreement). 
Such labeling may include but is not limited to text and graphical
contents of printed labels and labeling components, including but not limited
to healthcare professional leaflets or inserts, patient leaflets or inserts and
cartons.


 


ADLS shall be solely
responsible for the administrative aspects of preparing, updating and
maintaining product labeling in connection with Commercialization of Product(s) outside
of the Territory (and related Manufacturing of such Products).  Such labeling may include but is not limited to
text and graphical contents of printed labels and labeling components,
including but not limited to healthcare professional leaflets or inserts,
patient leaflets or inserts and cartons.


 


The Parties agree to jointly
develop the Developmental Core Data Sheet and Core Data Sheet for the Products
in order to achieve global labeling consistency.


 


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4.8.4.      Pharmacovigilance Agreement.  The Parties agree to meet promptly after the
Effective Date to establish (if such agreement is mutually agreed to be
necessary) a detailed pharmacovigilance agreement containing reasonable and
customary terms that are mutually acceptable, outlining the responsibilities of
each Party in connection with the collection and reporting of adverse
experiences and Product labeling which will supersede this Section 4.8.


 


4.9.        Manufacture
and Supply of Products.


 


4.9.1.      Supply
Agreement.  Within [***]
after the Effective Date, the Parties shall negotiate, draft, execute and
deliver, and the Parties shall thereafter perform their respective obligations
under, a supply agreement
pursuant to which ADLS shall supply or have supplied Wyeth’s clinical and
commercial requirements for Products in bulk (tablet or other) form and
containing the key terms set forth in Exhibit 4.9.1 attached
hereto, as well as other reasonable and customary terms for an agreement of
such type (the “Supply Agreement”).


 


4.9.2.      Final Labeling and Packaging of Products.  Wyeth shall be responsible for the final
labeling and packaging of Products supplied to Wyeth under the Supply Agreement
for sale in the Territory.


 


4.10.       Commercialization.  Subject to the terms and conditions of this
Agreement, Wyeth shall have the sole authority and the exclusive right in the
Territory, at its expense, to Commercialize Products itself or through one or
more Affiliates or Third Parties selected by Wyeth and shall have sole
authority and responsibility in all matters relating to the Commercialization
of Products in the Territory, including but not limited to:  booking sales of all Products in the
Territory, making decisions with respect to the pricing of each Product in each
country in the Territory and making all decisions regarding marketing of and
post-approval clinical studies for any Product in the Territory, provided,
however, that prior to commencing any such post-approval clinical study, Wyeth
shall consult with ADLS in regard to the development of such study.  Wyeth shall use Commercially Reasonable
Efforts to Commercialize the Current Product in each Major Market where Wyeth
has obtained Regulatory Marketing Approval for such Product, provided that ADLS
has successfully completed all Development activities to be performed by ADLS
with respect to such Product pursuant to Section 4.5.2.  Except for the foregoing, Wyeth shall have no
other diligence obligations, express or implied, with respect to the
Commercialization of Products.  ADLS
shall have the sole authority and the exclusive right outside the Territory, at
its expense, to Commercialize Products itself or through one or more Affiliates
or Third Parties selected by ADLS and shall have sole authority and responsibility
in all matters relating to the Commercialization of Products outside the
Territory, including but not limited to booking sales of all Products outside
the Territory, making decisions with respect to the pricing of each 


 


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Product in each country
outside the Territory and making all decisions regarding marketing of and
post-approval clinical studies for any Product outside the Territory.


 


4.11.       Product Recalls.  Wyeth shall be solely responsible for all
contact with Regulatory Authorities relating to any Recall of any Product in
the Territory and ADLS shall be solely responsible for all contact with
Regulatory Authorities related to any Recall of any Product outside of the
Territory.  The responsible Party shall
be solely responsible for implementing, directing and administering any Recall
of any such Product required or recommended by any Regulatory Authority or
court of competent jurisdiction, or determined by the responsible Party, in its
sole discretion, to be necessary or advisable. 
Wyeth shall be responsible for the cost of any Recall of any Product in
the Territory and ADLS shall be responsible for the cost of any Recall of any
Product outside of the Territory, except as otherwise provided in the Supply
Agreement.


 


5.                                    CONSIDERATION.


 


5.1.         Equity
Investment.  Upon the
Effective Date, Wyeth and ADLS shall each execute, deliver and consummate the
purchase by Wyeth and sale by ADLS of shares of ADLS’ common stock pursuant to
the terms and conditions of the Stock Purchase Agreement, and thereafter Wyeth
and ADLS shall perform their respective obligations thereunder.


 


5.2.         Milestone Payments.  In partial consideration of
ADLS’ contributions to the development of data useful for the Development of
Products in the Territory, Wyeth shall be obligated to make a one-time,
non-refundable payment upon the achievement of each of the applicable events
described in Section 5.2.2 (the “Launch
Events”) and Section 5.2.3 (the “Commercial Events”) by Wyeth or any Wyeth Affiliate or
Sublicensee.


 


5.2.1.     Timing
of Payment.


 


(a)           Wyeth shall
promptly notify ADLS in writing of the achievement of each Launch Event, and
Wyeth shall have thirty (30) business days following achievement of any Launch
Event in which to pay the corresponding amount to ADLS (each, a “Launch Payment”).


 


(b)           Each Commercial Payment
payable as provided below shall be payable with the royalty due for the fourth
Calendar Quarter of the Calendar Year for which the Commercial Payment is
earned.


 


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(c)           Each Launch Payment and
Commercial Payment shall be payable one time only even if multiple Products
achieve such event.


 


5.2.2.     Launch Payments.


 


	
  Launch Event

  	
   

  	
  Launch

  Payment

  	
   

  
	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  



 


5.2.3.      Commercial Payments.  If the Net Sales of all Products within the
Territory in any Calendar Year reach any of the following levels within the
time period specified for such level, Wyeth shall make the one-time payment
indicated below for achievement of such Commercial Event (each, a “Commercial Payment”).  Each Commercial Payment set forth herein for
Commercial Event shall be payable only once. 
If Net Sales of all Products within the Territory in an eligible
Calendar Year exceed more than one level of Net Sales, a Commercial Payment
shall be payable for each Commercial Event achieved during such Calendar
Year.  For avoidance of doubt, should Net
Sales of Products first achieve any applicable Commercial Event in any Calendar
Year ending after the applicable time period specified for achievement of such
Commercial Event, under no circumstances shall any Commercial Payment be
payable with respect to such achievement.


 


	
  Commercial Event

  	
   

  	
  Commercial

  Payment

  	
   

  
	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  



 


5.3.        Royalties.


 


5.3.1.      Product Royalties.  In consideration for the licenses granted to
Wyeth under Section 2.1 hereof, Wyeth shall pay to ADLS royalties during
the Royalty Term for the applicable Product in the applicable country as set
forth in Section 5.3.2 below, subject to the adjustments provided in
Sections 5.3.4 and 5.4.2 below.


 


5.3.2.      Royalty Rates.  Except as provided in
Sections 5.3.4 and 5.4.2 below, Wyeth shall pay to ADLS royalties on a
Product-by-Product and country-by-country basis in the amount of the applicable
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obtained by Wyeth, its
Affiliates or its Sublicensees from the sale of each Product in the Territory
during the Royalty Term for such Product:


 


	
   

  	
   

  	
  Royalty Rate

  (% of Net Sales)

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  



 


“Transition Date” shall mean [***] or, if later, the last date
upon which there exists a Valid Claim, covering the use or sale of the
applicable Product in the applicable country, under the ADLS Patent Rights
licensed to ADLS pursuant to that certain License Agreement dated December 13,
2004 between ADLS and Abbott Laboratories, as amended (the “Abbott Agreement”), with respect to which
ADLS is obligated to pay royalties under the Abbott Agreement, provided that
ADLS shall have delivered written evidence of such later date to Wyeth at least
thirty (30) days prior to [***].


 


Further, if, during the
Royalty Term for a Product in any country within the Territory, (i) a
Third Party commences commercial sales of a Generic Product in such country or (ii) there
is no Valid Claim of any ADLS Patent Right which covers the use or sale of such
Product in such country, then the Royalty Rate for such Product in such country
shall be [***], effective for all Net Sales of such Product in such country
during the Royalty Term for such Product in such country occurring on or after (a) the
date of the first commercial sale of such Generic Product in such country (for
so long as any Generic Product continues to be sold in such country) or (b) the
first date upon which there is no such Valid Claim in such country (for so long
as there is no such Valid Claim in such country).


 


5.3.3.      Expiration of Royalty Term.  After expiration of the
Royalty Term for any Product in any country in the Territory, no further
royalties shall be payable in respect of Net Sales of such Product in such
country, and the licenses granted to Wyeth under Section 2.1 with respect
to such Product in such country shall thereafter become fully paid-up,
perpetual, irrevocable, royalty-free licenses.


 


5.3.4.      Royalty Adjustments for Additional Third
Party Licenses.  In the event
Wyeth determines, after good faith consultation with ADLS, that it is necessary
to obtain a license under any intellectual property right from any Third Party
in order to research, Develop, Manufacture or Commercialize any Compound or
Products pursuant to rights granted to Wyeth under this Agreement (an “Additional Third Party License”), Wyeth
shall be solely responsible for negotiating and obtaining any such Additional
Third Party License, but shall not be obligated to do so.  Wyeth shall use Commercially Reasonable
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regarding whether Wyeth
should obtain such rights as part of an agreement through which ADLS or its
licensee obtains similar rights, provided, however, that Wyeth shall have no
obligation to do so.  Wyeth may deduct from
the royalties payable under Section 5.3.2 on the Net Sales of any Product
[***], provided that such deduction shall not reduce the royalties payable
under Section 5.3.2 to less than [***] of the amount that would otherwise
be payable to ADLS.  [***].  Except for any permitted deduction described
in this Section 5.3.4, Wyeth shall be solely responsible for all costs of
any such Additional Third Party Licenses.


 


5.3.5.      Other Third Party Agreements.  ADLS shall be solely responsible for all
payment obligations related to the ADLS Technology under its licenses and other
agreements with Third Parties that are in effect as of the Effective Date,
including, without limitation, those obligations arising under the ADLS Third
Party Agreements.  If after the Effective
Date ADLS enters into any license or other agreement with a Third Party
relating to any Compound or Product, ADLS shall use Commercially Reasonable
Efforts to obtain in such license or other agreement the right to sublicense
the rights granted under such license or other agreement to Wyeth under this
Agreement.  ADLS shall use Commercially
Reasonable efforts to consult with Wyeth prior to entering into any such
license or agreement and to allow Wyeth to obtain such rights either through
ADLS or directly from such Third Party. 
Any payment made to such a Third Party or any additional payment made to
ADLS in order to obtain such rights shall be treated as a payment made for an
Additional Third Party License pursuant to Section 5.3.4.


 


5.3.6.      [***]


 


5.4.        Reports
and Payments.


 


5.4.1.      Cumulative Royalties.  The obligation to pay royalties under Section 5.3
above shall be imposed only once with respect to Net Sales of any single unit
of a Product regardless of how many applicable Valid Claims included within the
ADLS Patent Rights cover the Product in the applicable country.


 


5.4.2.      Royalty Statements and Payments.  Within [***] after the end of each Calendar
Quarter [***], Wyeth shall deliver to ADLS a report setting forth for such
Calendar Quarter the following information, on a country-by-country basis: (a) the
Net Sales of each Product in each country, (b) the basis for any
adjustments to the royalty payable for the sale of each Product, (c) the
royalty due hereunder for the sale of each Product and the resulting total
royalty due for the sale of all Products during such Calendar Quarter, in each
case prior to the application of the provisions of this Section 5.4.2, (d) the
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Exhibit 4.9.1 attached
hereto) paid by Wyeth to ADLS for the supply of Products under the Supply
Agreement during such Calendar Quarter and any Wyeth Manufacturing Cost
incurred during such Calendar Quarter, (e) [***] and (f) the
withholding taxes, if any, required by law to be deducted in respect of the
royalties payable to ADLS after giving effect to the provisions of this Section 5.4.2.  The total royalty due for the sale of
Products during any Calendar Quarter shall be reduced by [***].  No report shall be required with respect to
any Calendar Quarter in which both (x) there are no Net Sales of Products
in the Territory and (y) there is no transfer price paid or payable by
Wyeth to ADLS for the supply of Products under the Supply Agreement or Wyeth
Manufacturing Cost incurred by Wyeth. 
The royalty due for the sale of Products during any Calendar Quarter,
determined in accordance with this Section 5.4.2, shall be remitted at the
time the royalty report for such Calendar Quarter is delivered.


 


5.4.3.      Taxes and Withholding.  All payments under this Agreement shall be
made in full without any deduction or withholding for or on account of any tax
unless such deduction or withholding is required by applicable laws or
regulations.  If Wyeth is so required to
deduct or withhold, Wyeth will (a) promptly notify ADLS of such
requirement, (b) pay to the relevant authorities the full amount required
to be deducted or withheld promptly upon the earlier of determining that such
deduction or withholding is required or receiving notice that such amount has
been assessed against ADLS, (c) promptly forward to ADLS an official
receipt (or certified copy) or other documentation reasonably acceptable to
ADLS evidencing such payment to such authorities and (d) cooperate
reasonably, as ADLS may request (at ADLS’ expense), in efforts of ADLS to
obtain a refund or otherwise recover such withheld taxes.


 


5.4.4.      Currency.  All amounts payable and all calculations made
hereunder shall be paid and made in United States dollars.  As applicable, Net Sales and any royalty
deductions shall be converted into United States dollars in accordance with
Wyeth’s customary and usual currency conversion procedures, consistently
applied.


 


5.4.5.      Method of Payment.  All payments by one Party to the other Party
under this Agreement shall be made by wire transfer in immediately available
funds to such account as the receiving Party shall designate before such
payment is due (which account the receiving Party may from time to time change
upon written notice to the paying Party).


 


5.4.6.      Additional Provisions Relating to
Royalties.  Each Party
acknowledges and agrees that nothing in this Agreement (including, without
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as representing an estimate
or projection of either (a) the number of Products that will or may be
successfully Developed or Commercialized by either Party or (b) the
anticipated sales or the actual value of any Product, and that the figures set
forth in Section 5.2.3 or elsewhere in this Agreement or the exhibits
hereto or that have otherwise been discussed by the Parties are merely intended
to define Wyeth’s payment obligations to ADLS in the event such sales
performance is achieved.  NEITHER PARTY
MAKES ANY REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED, THAT WYETH
WILL BE ABLE TO SUCCESSFULLY DEVELOP OR COMMERCIALIZE ANY PRODUCT OR, IF
COMMERCIALIZED, THAT WYETH WILL ACHIEVE ANY PARTICULAR SALES LEVEL OF SUCH
PRODUCT(S).


 


5.5.        Maintenance
of Records; Audits.


 


5.5.1.      Record
Keeping.  Wyeth shall keep complete and
accurate books and accounts of record in connection with the sale of Products,
in sufficient detail to permit accurate determination of all figures and other information
necessary for verification of royalties and other amounts to be paid
hereunder.  Wyeth shall maintain such
books and records for a period of at least three (3) years  after the end of the Calendar Year in
which they were generated.


 


5.5.2.      Audits.  Upon thirty (30) days prior written notice
from ADLS, Wyeth shall permit an independent certified public accounting firm
of nationally recognized standing selected by ADLS and reasonably acceptable to
Wyeth to examine, at ADLS’ sole expense, the relevant books and records of
Wyeth and Wyeth’s Affiliates as may be reasonably necessary to verify the
accuracy of the reports submitted by Wyeth in accordance with Section 5.4
and the payment of royalties and Commercial Payments hereunder based on Net
Sales.  An examination by ADLS under this
Section 5.5.2 shall occur not more than once in any Calendar Year and
shall be limited to the pertinent books and records for any Calendar Year
ending not more than three (3) years before the date of the request.  The accounting firm shall be provided access
to such books and records at Wyeth’s and Wyeth’s Affiliate’s facility(ies)
where such books and records are normally kept and such examination shall be
conducted during Wyeth’s and Wyeth’s Affiliate’s normal business hours.  Wyeth may require the accounting firm to sign
a standard non-disclosure agreement before providing the accounting firm access
to Wyeth’s and Wyeth’s Affiliate’s facilities or books and records.  Upon completion of the audit, the accounting
firm shall provide both Wyeth and ADLS a written report disclosing whether the
reports submitted by Wyeth are correct or incorrect, whether the royalties and
other amounts paid hereunder are correct or incorrect and, in each case, the
amount of any discrepancies and specific details concerning each such
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5.5.3.      Underpayments/Overpayments.  If such accounting firm correctly concludes
that additional royalties or Commercial Payment(s) were due to ADLS, Wyeth
shall pay to ADLS such additional royalties or Commercial Payment(s) (together
with applicable interest at [***]) within thirty (30) days of the date Wyeth
receives such accountant’s written report so concluding.  In the case of such an underpayment, if such
audit determines that the amount due is at least [***] more than the amount
actually paid for the applicable period audited, Wyeth also shall reimburse
ADLS for the out-of-pocket expenses incurred in conducting the audit.  If such accounting firm concludes that Wyeth
overpaid royalties or Commercial Payment(s) to ADLS, ADLS, within thirty
(30) days of the date it receives such accountant’s report so concluding, will
refund such overpayments to Wyeth.


 


5.5.4.      Confidentiality.  All financial information of Wyeth which is
subject to review under this Section 5.5 shall be deemed to be Wyeth’s
Confidential Information subject to the provisions of Section 7 hereof,
and ADLS shall not disclose such Confidential Information to any Third Party or
use such Confidential Information for any purpose other than verifying payments
to be made by Wyeth to ADLS hereunder, provided, however, that such Confidential Information may
be disclosed by ADLS to Third Parties to the extent (but only to the extent)
necessary to enforce ADLS’ rights under this Agreement.


 


6.                                    INTELLECTUAL PROPERTY.


 


6.1.         Inventions.  Subject to the provisions of Section 2.1
hereof, any invention or Know-How made jointly by employees of both Parties (a “Joint Invention” or “Joint Know-How”) and any Patent Right
claiming any such Joint Invention or Joint Know-How (a “Joint Patent Right”) shall be jointly owned
by the Parties.  All inventions and
Know-How made solely by one or more employees of a Party shall be solely owned
by such Party.  All determinations of inventorship
under this Agreement shall be made in accordance with the patent law of the
United States.  ADLS shall promptly
disclose to Wyeth any invention or any newly acquired or licensed Patent Right
or Know-How that is or may become a Licensed Right.  Any Joint Invention or any Joint Know-How,
including any resulting Joint Patent Right, shall be treated as Joint
Technology under this Agreement.


 


During the Term and after
termination of this Agreement, either Party may exploit and grant licenses
under such Party’s interest in any Joint Technology without accounting to or
obtaining consent from the other Party, subject to the rights and obligations
of the Parties with respect to Joint Technology under this Agreement,
including the licenses of ADLS’ interest under the Joint Technology
granted by ADLS to Wyeth under Section 2.1.1.


 


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6.2.        Patent
Rights.


 


6.2.1.     Filing,
Prosecution and Maintenance of Patent Rights.


 


(a)           ADLS
Patent Rights.  ADLS, at
its expense, shall have the sole right but not the obligation to prepare, file,
prosecute and maintain, throughout the world, all ADLS Patent Rights other than
Territory Patent Rights using counsel of its choice.  ADLS shall have the first right but not the
obligation to file or continue prosecution or maintenance of any application
for an ADLS Patent Right in the Territory (a “Territory
Patent Right”) using patent counsel selected by ADLS and reasonably
acceptable to Wyeth.  Before filing any
Territory Patent Right, ADLS shall give Wyeth a reasonable opportunity to
review and comment upon the text of the application.  ADLS shall consult with Wyeth with respect to
any such application, shall not unreasonably refuse to address any of Wyeth’s
comments with respect to such application and shall supply Wyeth with a copy of
each such application as filed, together with notice of its filing date and
serial number.  ADLS shall also keep
Wyeth advised of the status of prosecution of all such patent applications
included within the ADLS Patent Rights and shall reasonably consider timely
comments of Wyeth with respect thereto, and provide Wyeth with a reasonable
opportunity to comment on all material correspondence received from and all
material submissions to be made to any government patent office or authority
with respect to any such patent application or patent.  In addition, if ADLS elects not to file in
any country in the Territory a patent application on ADLS Know-How that, if
filed, would be a Territory Patent Right, or to cease the prosecution or
maintenance of any Territory Patent Right in the Territory, ADLS shall provide
Wyeth with prompt written notice upon the decision to not file or continue the
prosecution of such patent application or maintenance of such patent in
sufficient time to allow Wyeth to file, continue prosecution of such
application or maintain such patent in a timely manner.  In such event, ADLS shall permit Wyeth, at
Wyeth’s sole discretion, to file or continue prosecution or maintenance of such
Territory Patent Right in the applicable country on ADLS’ behalf and at Wyeth’s
own expense.  If Wyeth elects to make
such filing and/or continue such prosecution or maintenance, Wyeth may deduct
from any payment to be made to ADLS hereunder any expenses incurred by Wyeth in
connection therewith.


 


(b)           Joint Patent Rights.  In the event the Parties make any Joint
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determine, based on the
advice of patent counsel selected jointly by the Parties, whether to seek
patent protection thereon.  If the
Parties jointly decide to seek patent protection on a Joint Invention, the
Parties shall jointly appoint one of the Parties (the “Prosecuting Party”) to have the obligation
(subject to the opt out provisions of this Section 6.2.1(b)), to prepare,
file, prosecute and maintain any Joint Patent Right throughout the world to the
extent determined jointly by the Parties, using patent counsel selected by
jointly the Parties.  The Prosecuting
Party shall give the other Party a reasonable opportunity to review the text of
any application with respect to such Joint Patent Right before filing, shall
consult with such other Party with respect thereto, shall not unreasonably
refuse to address any timely comments of such other Party with respect to such
application and shall supply such other Party with a copy of the application as
filed, together with notice of its filing date and serial number.  The Prosecuting Party shall keep the other
Party advised of the status of the actual and prospective patent filings (including,
without limitation, the grant of any Joint Patent Rights), and shall provide
such other Party with advance copies of any material official correspondence
related to the filing, prosecution and maintenance of such patent filings.  Subject to the opt-out provisions below, the
Party other than the Prosecuting Party shall reimburse the Prosecuting Party
for [***] of the out-of-pocket costs incurred by the Prosecuting Party in
preparing, filing, prosecuting and maintaining such Joint Patent Rights, which
reimbursement will be made pursuant to invoices submitted by the Prosecuting
Party to the other Party no more often than once per Calendar Quarter.  If either Party (the “Declining Party”) at any time declines to
share in the costs of filing, prosecuting and maintaining any such Joint Patent
Right, on a country-by-country basis, the Declining Party shall provide the
other Party (the “Continuing Party”)
with thirty (30) days prior written notice to such effect, in which event the
Declining Party shall (i) have no responsibility for any expenses incurred
in connection with such Joint Patent Right in the applicable country after the
end of such thirty (30) day period and (ii) if the Continuing Party elects
to continue prosecution or maintenance, the Declining Party, upon the
Continuing Party’s request, shall execute such documents and perform such acts,
at the Continuing Party’s expense, as may be reasonably necessary (x) to
assign to the Continuing Party all of the Declining Party’s right, title and
interest in and to such Joint Patent Right and (y) to permit the
Continuing Party to file, prosecute and/or maintain such Joint Patent
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Joint Patent Right and shall
become a Patent Right of the Continuing Party.


 


(c)           No liability.  Neither Party (the “First Party”) shall have any liability to
the other Party (the “Second Party”)
for any actions taken or not taken after exercising any right granted to the
First Party under the provisions of this Section 6.2.1 to file a patent
application or to assume or continue the prosecution or maintenance of a Patent
Right which (in the case of any such patent application or Patent Right) the
Second Party has elected not to file or not to prosecute or maintain or, in the
case of any Joint Patent Right, not to pay for.


 


6.2.2.     Enforcement
of Patent Rights.


 


(a)           Notice.  If either Wyeth or ADLS becomes aware of any
infringement, anywhere in the world, of any issued patent within the ADLS
Patent Rights or Joint Patent Rights, it will promptly notify the other Party
in writing to that effect.


 


(b)           Patent Rights
in the Territory.  In all cases
where such infringement occurs in the Territory or represents infringement of
any Territory Patent Right or Joint Patent Right in the Territory, except in
cases where any existing ADLS Third Party Agreement grants the first or sole
right to prosecute such infringement to a Third Party, Wyeth shall have the
first right, but not the obligation, to take action to obtain a discontinuance
of infringement or bring suit against a Third Party infringer of such Patent
Rights within [***] from the date of notice given pursuant to Section 6.2.2(a) and,
with ADLS’ consent or if ADLS is a necessary and indispensable party, to join
ADLS as a party plaintiff.  Wyeth shall
bear all the expenses of any suit brought by it claiming infringement of any
such Patent Rights.  ADLS will cooperate
with Wyeth in any such suit and shall have the right to consult with Wyeth and
to participate in and be represented by independent counsel in such litigation
at its own expense.  Wyeth shall incur no
liability to ADLS as a consequence of such litigation or any unfavorable
decision resulting therefrom, including any decision holding any of such Patent
Rights invalid or unenforceable.  If,
after the expiration of the foregoing [***] period (or, if earlier, the date
upon which Wyeth provides written notice that it does not plan to seek a
discontinuance or bring suit), Wyeth has not obtained a discontinuance of
infringement of such Patent Rights or filed suit against any such Third Party
infringer of such Patent Rights, then ADLS shall have the right, but not the
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Patent
Rights and to join Wyeth as a party plaintiff, provided that ADLS shall bear
all the expenses of such suit.  Wyeth
will cooperate with ADLS in any such suit for infringement of such Patent
Rights brought by ADLS against a Third Party, and shall have the right to
consult with ADLS and to participate in and be represented by independent
counsel in such litigation at its own expense. 
ADLS shall incur no liability to Wyeth as a consequence of such litigation
or any unfavorable decision resulting therefrom, including any decision holding
any of such Patent Rights invalid or unenforceable.  Neither Party shall have the right to settle
any patent infringement litigation under this Section 6.2.2(b)  in a
manner that diminishes the rights or interests of the other Party without the
prior written consent of such other Party, such consent not to be unreasonably
withheld, conditioned or delayed.  Any
recoveries obtained by either Party as a result of any proceeding against a
Third Party infringer (where the infringement relates to the Manufacture,
importation, use, offer for sale or sale of any Product) shall be allocated as
follows:


 


(i)                                    Such recovery
shall first be used to reimburse each Party for all out-of-pocket costs in
connection with such litigation paid by that Party;


 


(ii)                                [***];


 


(iii)         [***].


 


(c)           Joint Patent Rights Outside the
Territory.  With
respect to any notice of a Third Party infringer of the Joint Patent Rights
outside the Territory, the Parties shall meet as soon as reasonably practicable
to discuss such infringement and determine an appropriate course of action,
including an initial allocation of the fees and expenses of such course of
action.  The Parties jointly shall
appoint one of the Parties (the “Leading
Party”) to bring an action against such Third Party infringer or
otherwise address such alleged infringement within [***] from the date of
notice and to control such litigation or other means of addressing such
infringement.  The other Party shall
cooperate with the Leading Party in any such suit brought by the Leading Party
and shall have the right to consult with the Leading Party and participate in
and be represented by independent counsel in such litigation at its own
expense. The Leading Party shall not have the right to settle any patent
infringement litigation under this Section 6.2.2(c) in a manner that
diminishes the rights or interests of the other Party without the prior written
consent of such other Party, such 


 


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consent not to be
unreasonably withheld or delayed.  Any
recoveries obtained by either Party shall be allocated as in Section 6.2.2(b).


 


6.2.3.     Infringement
and Third Party Licenses.


 


(a)           Notice of
Potential Infringement of Third Party Rights.  If the making, having made, importing,
exporting, using, distributing, marketing, promoting, offering for sale or
selling of any Product is alleged by a Third Party to infringe a Third Party’s
patent or other intellectual property rights, the Party becoming aware of such
allegation shall promptly notify the other Party.  Additionally, if either Party determines that,
based upon the review of a Third Party’s patent or patent application or other
intellectual property rights, it may be desirable to obtain a license from such
Third Party with respect thereto, such Party shall promptly notify the other
Party of such determination.


 


(b)           Option to
Negotiate.  In the
event that a Party determines that it may be desirable to obtain a license
under one or more patents or patent applications or other intellectual property
rights Controlled by a Third Party (collectively, “Third Party IP Rights”), which Third Party IP Rights (i) relate
to any Compound or any Product and (ii) if valid and issued, may, in the
absence of a license from such Third Party, be infringed by the Development,
Manufacture, use or Commercialization of any Compound or Product by or on
behalf of Wyeth or any of its Affiliates or Sublicensees in the Territory or
outside of the Territory pursuant to the exercise of rights granted by ADLS to
Wyeth hereunder, such Party shall have the right, but not the obligation, to
negotiate and enter into an agreement with such Third Party, whereby such Party
is granted a license under such Third Party IP Rights permitting such Party to
practice such Third Party IP Rights in connection with the Development,
Manufacture, use or Commercialization of any Compounds or Products and the
performance of any of its obligations or the exercise of any of its rights
under this Agreement; provided, however, that if such Party proceeds in
negotiating and entering into such license agreement with such Third Party,
then (a) if such Party is Wyeth, and the license agreement with such Third
Party includes the grant of rights outside of the Territory, Wyeth shall use
Commercially Reasonable Efforts to obtain the right under such license
agreement to sublicense such Third Party IP Rights outside of the Territory to
ADLS, and (b) if such Party is ADLS, and the license agreement with such
Third Party includes the grant of rights in the Territory, ADLS shall use
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Reasonable
Efforts to obtain the right under such license agreement to sublicense such
Third Party IP Rights in the Territory to Wyeth.  The provisions of this Section 6.2.3(b) are
subject to the provisions of Sections 5.3.4 and 5.3.5.


 


(c)           Third
Party Infringement Suit.  If a
Third Party sues Wyeth or any of Wyeth’s Affiliates or Sublicensees (the “Sued Party”) alleging that the Sued Party’s
practice of any right granted by ADLS to Wyeth hereunder through the
Development, Manufacture, use or Commercialization of any Compound or Product
pursuant to this Agreement infringes or will infringe such Third Party’s
intellectual property, then, upon the Sued Party’s request and in connection
with the Sued Party’s defense of any such Third Party infringement suit, ADLS
shall provide reasonable assistance to the Sued Party for such defense at the
Sued Party’s expense.  The Sued Party
shall be solely responsible for expenses incurred in defending against any such
suit and for payment of any damages or other rewards that may result therefrom,
subject to Section 10.


 


6.2.4.      Patent Certifications.  Each Party shall immediately give written
notice to the other of any certification of which it becomes aware filed
pursuant to any statutory or regulatory requirement in any country in the
Territory similar to 21 U.S.C. § 355(b)(2)(A) or § 355(j)(2)(A)(vii) (or
any amendment or successor statute thereto) claiming that any ADLS Patent Right
or Joint Patent Right covering any Compound or Product is invalid or that
infringement will not arise from the Development, Manufacture, use or
Commercialization in the Territory of such Compound or Product by a Third
Party.  Upon the giving or receipt of
such notice, Wyeth shall have the first right, but not the obligation, to bring
an infringement action against such Third Party.  In such a case, Wyeth shall notify ADLS at
least ten (10) days prior to the date set forth by statute or regulation
of its intent to exercise, or not exercise, this right.  Any infringement action against a Third Party
arising under this Section 6.2.4 shall be governed by the provisions of Section 6.2.2(b) hereof.


 


6.2.5.      Patent Term Restoration.  During the Term, the Parties shall reasonably
cooperate with each other in obtaining patent term restoration in any country
in the Territory under any statute or regulation equivalent or similar to 35
U.S.C. § 156, where applicable to the ADLS Patent Rights and Joint Patent
Rights.  If any election with respect to
seeking such patent term restoration is to be made in any country in the
Territory during the Term with respect to such country, Wyeth shall make such
election (including, without limitation, by filing supplementary protection
certificates and any other extensions that are now or in the future become
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reasonably
requested by the Wyeth, in connection with the foregoing (including, without
limitation, by providing appropriate information and executing appropriate
documents).


 


6.3.         Recording.  If Wyeth deems it necessary or desirable to
register or record this Agreement or evidence of this Agreement with any patent
office or other appropriate government authorities in one or more jurisdictions
in the Territory, ADLS shall reasonably cooperate to execute and deliver to
Wyeth any documents accurately reflecting or evidencing this Agreement that are
necessary or desirable, in Wyeth’s reasonable judgment, to complete such
registration or recordation.  Wyeth shall
reimburse ADLS for all reasonable out-of-pocket expenses, including attorneys’
fees, incurred by ADLS in complying with the provisions of this Section 6.3.


 


6.4.         Trademarks.  Wyeth shall, in its sole discretion, select
and own all product-related Trademarks and related copyrights to be used in
connection with the Commercialization of any Product hereunder in the
Territory, except to the extent that Wyeth in its discretion may determine to
exercise the right granted to Wyeth by ADLS under the Trademark license
provided for in Section 2.1.3.  ADLS
shall neither use nor seek to register, anywhere in the world, any Trademark
which is confusingly similar to any Trademark used by or on behalf of Wyeth or
its Affiliates or Sublicensees in connection with any Product commercialized
hereunder (other than any Trademark rights to which were obtained by Wyeth from
ADLS under Section 2.1.3; provided, however, that nothing in this Section 6.4
shall be construed to prevent ADLS from enforcing its own Trademark rights.


 


7.                                    CONFIDENTIALITY.


 


7.1.         Confidentiality.  Except to the extent expressly authorized by
this Agreement or otherwise agreed in writing by the Parties, for the Term and
for [***] thereafter, each Party (the “Receiving
Party”) receiving any Confidential Information of the other Party
(the “Disclosing Party”) hereunder
shall keep such Confidential Information confidential and shall not publish or
otherwise disclose or use such Confidential Information for any purpose other
than as provided for in this Agreement except for Confidential Information that
the Receiving Party can establish:


 


(a)           was already
known by the Receiving Party (other than under an obligation of
confidentiality) at the time of disclosure by the Disclosing Party and such Receiving
Party has documentary evidence to that effect;


 


(b)           was generally available to
the public or otherwise part of the public domain at the time of its disclosure
to the Receiving Party;


 


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(c)           became
generally available to the public or otherwise part of the public domain after
its disclosure to the Receiving Party, and other than through any act or
omission of the Receiving Party in breach of this confidentiality obligation;


 


(d)           was
disclosed to the Receiving Party, other than under an obligation of
confidentiality, by a Third Party who had no obligation to the Disclosing Party
not to disclose such information to others; or


 


(e)           was
independently discovered or developed by or on behalf of the Receiving Party
without the use of or reference to the Confidential Information belonging to
the Disclosing Party and the Receiving Party has documentary evidence to that
effect.


 


7.2.         Authorized
Disclosure and Use.


 


7.2.1.      Disclosure.  Notwithstanding the foregoing Section 7.1,
the Receiving Party may disclose Confidential Information belonging to the
Disclosing Party to the extent such disclosure is reasonably necessary to:


 


(a)           file or
prosecute patent applications which the Receiving Party is authorized to file
or prosecute hereunder, if the Disclosing Party consents to such disclosure
(such consent not to be unreasonably withheld or delayed); provided that a
disclosure of the Disclosing Party’s Confidential Information under this Section 7.2.1(a) shall
be treated as a publication under Section 7.4.4, and shall be subject to
the requirements of advance notice, a review period and an opportunity to file
patent application(s), as set forth in Section 7.4.4;


 


(b)           prosecute or
defend litigation;


 


(c)           exercise
rights hereunder provided such disclosure is covered by terms of
confidentiality similar to those set forth herein;


 


(d)           facilitate
discussions with prospective licensees and sublicensees of the Receiving Party,
subject to appropriate confidentiality agreements;


 


(e)           facilitate
discussions with potential financial investors in connection with an investment
in or acquisition of the Receiving Party, subject to appropriate
confidentiality agreements; or


 


(f)            comply with
applicable governmental laws, regulations and orders.


 


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In the event
that the Receiving Party shall reasonably deem it necessary to disclose,
pursuant to Section 7.2.1(b) or 7.2.1(f), Confidential Information
belonging to the Disclosing Party, the Receiving Party shall to the extent
possible give reasonable advance notice of such disclosure to the Disclosing
Party and take reasonable measures to ensure confidential treatment of such
information.


 


7.2.2.      Use.  Notwithstanding the foregoing Section 7.1,
each Party shall have the right to use Confidential Information of the other
Party in Developing, Manufacturing and Commercializing Compounds and Products
as provided in this Agreement.


 


7.3.         SEC or Similar Filings.  Either Party may disclose the terms of this
Agreement and events related to the Development or Commercialization of
Products (including the achievement of Launch Events and Commercial Events and
the payment and amount of corresponding payments, as well as the equity
purchase described in Section 5.1) to the extent reasonably required to
comply with applicable laws, rules and regulations, including, without
limitation, the rules and regulations promulgated by the United States
Securities and Exchange Commission, comparable foreign regulatory organizations
and self-regulatory organizations (such as securities exchanges).  Subject to the foregoing, before disclosing
this Agreement or any of the terms hereof pursuant to this Section 7.3,
the Parties will reasonably consult with one another on the terms of this
Agreement to be redacted in making any such disclosure.  If a Party discloses this Agreement or any of
the terms hereof in accordance with this Section 7.3, such disclosing
Party agrees, at its own expense, to seek confidential treatment of portions of
this Agreement, or such terms, as may be reasonably and timely requested by the
other Party.


 


7.4.         Public
Announcements; Publications.


 


7.4.1.      Coordination.  The Parties agree on the importance of
coordinating their public announcements respecting this Agreement and the
subject matter thereof (other than academic, scientific or medical publications
that are subject to the publication provision set forth below).  Subject to Section 7.3, ADLS and Wyeth
shall, from time to time, and at the request of the other Party, discuss and
agree on the general information content relating to this Agreement which may
be publicly disclosed (including, without limitation, by means of any printed
publication or oral presentation).


 


7.4.2.      Announcements.  Except as may be expressly permitted under
Sections 7.3, 7.4.3 and 7.4.4, or as may be appropriate for either Party to
make in connection with its Development or Commercialization activities as
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Party will
make any public announcement regarding this Agreement or the Development,
Manufacturing or Commercialization of any Product without the prior written
approval of the other Party.


 


7.4.3.      Press Releases.  Each Party may issue, if it determines to do
so, a press release reasonably approved by the other Party, announcing the
execution of this Agreement.  Such press
release to be issued by ADLS shall be in the form of Exhibit 7.4.3
attached hereto.


 


7.4.4.      Publications.  During the Term, each Party will submit to
the other Party for reasonable prior review and approval all proposed academic,
scientific and medical publications and public presentations relating to the
Development, Manufacture or Commercialization of any Product, or any proposed
disclosure under Section 7.2.1(a) (but excluding marketing, sales and
promotional materials and presentations used for Commercialization), for review
in connection with preservation of Patent Rights or to determine whether any of
such other Party’s Confidential Information should be modified or deleted.  Without limiting the foregoing, if such
proposed publication or presentation contains information or data that should
reasonably be reviewed for the preservation of Patent Rights, written copies of
such proposed publication or presentation shall be submitted to the
non-publishing Party no later than sixty (60) days before submission for
publication or presentation and the non-publishing Party shall provide its
comments with respect to such publication or presentation within thirty (30)
business days of its receipt of such written copy.  The review period may be extended for an
additional ninety (90) days in the event the non-publishing Party can
demonstrate reasonable need for such extension, including, but not limited to,
the preparation and filing of patent applications.  By mutual agreement, this period may be
further extended.  Wyeth and ADLS will
each comply with standard academic practice regarding authorship of scientific
publications and recognition of the contribution of other parties in any
publications relating to the Development, Manufacture or Commercialization of
any Product.


 


7.5.         Termination
of Prior Non-Disclosure Agreement.  This Agreement supersedes the Non-Disclosure
Agreement between the Parties dated July 18, 2007 (the “Non-Disclosure Agreement”), including any
amendments thereto, provided, however, that the foregoing shall not limit any
remedies available to either Party with respect to any breach of the
Non-Disclosure Agreement which occurred prior to the Effective Date.  All Information (as defined in the
Non-Disclosure Agreement) exchanged between the Parties under the Non-Disclosure
Agreement shall be deemed to be Confidential Information under this Agreement
and shall be subject to the terms of this Section 7.


 


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8.                                    REPRESENTATIONS,
WARRANTIES AND COVENANTS.


 


8.1.         Representations,
Warranties and Covenants of Each Party.  Each of ADLS and Wyeth hereby represents,
warrants and covenants to the other Party as follows:


 


(a)           it
is a corporation duly organized and validly existing under the laws of the
state of its incorporation;


 


(b)           the
execution, delivery and performance of this Agreement by such Party has been
duly authorized by all requisite corporate action and does not require any
stockholder action or approval;


 


(c)           it has the
power and authority to execute and deliver this Agreement and to perform its
obligations hereunder;


 


(d)           the
execution, delivery and performance by such Party of this Agreement and its
compliance with the terms and provisions hereof does not and will not conflict
with or result in a breach of any of the terms and provisions of or constitute
a default under (i) a loan agreement, guaranty, financing agreement,
agreement affecting a product or other agreement or instrument binding or
affecting it or its property; (ii) the provisions of its certificate of
incorporation or bylaws; or (iii) any order, writ, injunction or decree of
any court or governmental authority entered against it or by which any of its
property is bound;


 


(e)           it shall use
Commercially Reasonable Efforts to conduct all human clinical trials of
Products in accordance with current Good Clinical Practices, as defined by
regulations promulgated by the FDA and corresponding ICH Guidelines, and shall
use Commercially Reasonable Efforts to cause its Affiliates and Licensees (in
the case of ADLS) and Sublicensees (in the case of Wyeth) to conduct such
clinical trials in such manner; and


 


(f)            it shall at
all times comply in all material respects with all laws and regulations
applicable to its activities under this Agreement.


 


8.2.         Additional
Representations, Warranties and Covenants of ADLS.  In addition to the representations,
warranties and covenants made by ADLS elsewhere in this Agreement, ADLS hereby
represents, warrants and covenants to Wyeth that:


 


(a)           except as
disclosed in Exhibit 8.2(a), as of the Effective Date, the ADLS
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existing and,
to its knowledge, are not invalid or unenforceable, in whole or in part;


 


(b)           it has the
full right, power and authority to grant the licenses granted or to be granted
to Wyeth under this Agreement;


 


(c)           except as
disclosed in Exhibit 8.2(c) attached hereto, as of the
Effective Date, no Third Party has any right, title or interest in or to any of
the ADLS Patent Rights or ADLS Know-How or any of ADLS’ interest in the Joint
Know-How or Joint Patent Rights that would preclude the grant to Wyeth of the
licenses set forth herein;


 


(d)           except as
disclosed in Exhibit 8.2(c) attached hereto, ADLS is the sole
and exclusive owner of the ADLS Patent Rights listed on Exhibit 1.6
attached hereto and the ADLS Know-How existing as of the Effective Date, all of
which are free and clear of any liens, charges or encumbrances;


 


(e)           except as
set forth in Exhibit 8.2(e) attached hereto, no ADLS Patent
Right and no portion of the ADLS Know-How existing as of the Effective Date and
relating to any Compound or Product is subject to any funding agreement with
the United States government or any of its agencies;


 


(f)            to its
knowledge, as of the Effective Date, neither the Development, Manufacture, use
or Commercialization of any Compound or Product infringes or would infringe any
existing issued patent owned or possessed by any Third Party;


 


(g)           to its
knowledge, as of the Effective Date, there are no Third Party pending patent
applications which are not included in the ADLS Patent Rights and, if issued,
would cover the Development, Manufacture, use or Commercialization of any
Compound or Product;


 


(h)           to its
knowledge, as of the Effective Date, there are no claims, judgments or
settlements against or owed by ADLS or any of its Affiliates, or pending or
threatened claims or litigation, in each case relating to the ADLS Patent
Rights listed in Exhibit 1.6 attached hereto or the ADLS Know-How;


 


(i)            during the
Term, ADLS will use diligent efforts not to diminish the rights under the ADLS
Patent Rights or the ADLS Know-How granted to Wyeth hereunder, including,
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omissions
which would cause ADLS to breach any ADLS Third Party Agreement; ADLS will
provide Wyeth promptly with written notice of any such breach or any allegation
of any such breach; and as of the Effective Date, ADLS is in compliance in all
respects with each ADLS Third Party Agreement;


 


(j)            the ADLS Third Party
Agreements are in full force and effect; to ADLS’ knowledge, as of the
Effective Date, no other party to such agreements is in breach or default
thereunder; and ADLS has not waived or allowed to lapse or terminate any of its
rights relating to any Compound or Product under the ADLS Third Party
Agreements;


 


(k)           ADLS has provided a
true and complete copy of each ADLS Third Party Agreement to Wyeth, including
any amendment(s) thereto;


 


(l)            ADLS will not during
the Term amend such ADLS Third Party Agreements in a manner that would
adversely affect the rights, obligations or economic interests of Wyeth under
this Agreement without Wyeth’s prior written consent;


 


(m)          ADLS shall furnish Wyeth
with copies of all notices received by ADLS relating to any alleged breach or
default by ADLS under ADLS Third Party Agreements within five (5) business
days after ADLS’ receipt thereof.  In the
event ADLS does not resolve any such alleged breach, it shall notify Wyeth
within a sufficient period of time before the expiration of the cure period for
such breach under such ADLS Third Party Agreement such that Wyeth, in its sole
discretion, is able to cure or otherwise resolve such alleged breach.  If Wyeth makes any payments to a Third Party
in connection with the cure or other resolution of such alleged breach of ADLS,
then Wyeth may credit the amount of such payments against any royalties or
other payments payable to ADLS pursuant to this Agreement;


 


(n)           ADLS shall promptly
furnish Wyeth with copies of all (i) amendments of the ADLS Third Party
Agreements and (ii) correspondence (or in the case of oral discussions, a
summary of such discussions) with or from and reports received from or provided
to licensors under the ADLS Third Party Agreements to the extent material to
Wyeth or its rights granted under this Agreement;


 


(o)           except as disclosed in Exhibit 8.2(o) attached
hereto, as of the Effective Date, ADLS is not a party to or otherwise subject
to


 


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any Control
Limitation Agreement limiting Wyeth’s access to or rights with respect to any
Licensed Right or any other intellectual property right that would, but for
such Control Limitation Agreement, be included in the Licensed Rights;


 


(p)           except as may otherwise
be expressly permitted by the terms of this Agreement, during the Term, ADLS
will not enter into or otherwise allow itself to be subject to any Control
Limitation Agreement limiting Wyeth’s access to or rights with respect to any
Licensed Right or any other intellectual property right that would, but for
such Control Limitation Agreement, be included in the Licensed Rights;


 


(q)           as of the Effective
Date, there are no ADLS Licensees, and ADLS will provide Wyeth promptly with
written notice in the event that any Person becomes an ADLS Licensee and a copy
of any document pursuant to which such Person is granted a license or
sublicense of any right to Develop, Manufacture or Commercialize any Compound
or Product, which copy may be redacted with respect to financial terms;


 


(r)           it has complied with
the “Right of First Negotiation” as defined in Section 5.6 of the Abbott
Agreement, including the notice and negotiation provisions thereof, with
respect to the transactions contemplated by this Agreement;


 


(s)           [***]; and


 


(t)            [***].


 


8.3.         Representation
by Legal Counsel. 
Each Party hereto represents that it has been represented by legal
counsel in connection with this Agreement and acknowledges that it has
participated in the drafting hereof.  In
interpreting and applying the terms and provisions of this Agreement, the
Parties agree that no presumption shall exist or be implied against the Party
which drafted such terms and provisions.


 


8.4.         No Inconsistent Agreements.  Neither Party has in effect and after the Effective
Date neither Party shall enter into any oral or written agreement or
arrangement that would be inconsistent with its obligations under this
Agreement.


 


8.5.         Disclaimer.  EXCEPT AS OTHERWISE EXPRESSLY SET FORTH
HEREIN, THE PARTIES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY
KIND, EITHER EXPRESS OR IMPLIED, AND PARTICULARLY THAT PRODUCTS WILL BE
SUCCESSFULLY


 


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DEVELOPED
HEREUNDER, AND IF PRODUCTS ARE DEVELOPED, WITH RESPECT TO SUCH PRODUCTS, THE PARTIES
DISCLAIM ALL IMPLIED WARRANTIES OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE.


 


9.                                    TERM
AND TERMINATION.


 


9.1.         Term.  The term of this Agreement (the “Term”) will commence on the Effective Date and shall extend,
unless this Agreement is terminated earlier in accordance with this Section 9,
on a Product-by-Product and country-by-country basis until such time as the
Royalty Term with respect to the sale of such Product in such country expires.


 


9.2.         Termination by Either Party for Cause.  Either Party may terminate this Agreement, in
its entirety or, at the terminating Party’s option, on a Product-by-Product and
country-by-country basis, at any time during the Term by giving written notice
to the other Party in the event that the other Party commits a material breach
of its obligations under this Agreement and such breach remains uncured for
[***] (or [***] in the case of the breach of a payment obligation, other than
any payment obligation that the payor is disputing in good faith), measured
from the date written notice of such breach is given to the breaching Party;
provided, however, that if such breach is not susceptible of cure within the
stated period and the breaching Party uses active and continuous, diligent,
good faith efforts to cure such breach, the stated period will be extended by
an additional [***].  Notwithstanding the
foregoing, a Party shall not have the right to terminate this Agreement in part
pursuant to this Section 9.2 with respect to an individual Product or
country unless the other Party’s material breach giving rise to such
termination right specifically relates to such Product or country, as
applicable.


 


9.3.         Termination
by Wyeth At Will or For Safety.


 


9.3.1.      Termination
At Will.  Wyeth
shall have the right, exercisable upon [***] prior written notice to ADLS, to
terminate this Agreement either (a) in its entirety or (b) on a
Product-by-Product basis. 
Notwithstanding the foregoing, in no event shall such termination at
will by Wyeth relieve it of its obligation to fully satisfy its payment
obligations under this Agreement, to the extent accrued prior to such termination,
and stock purchase obligations under Section 5.1.


 


9.3.2.      Termination for a Material Safety Issue.  Wyeth shall have the right to terminate this
Agreement, at any time, either in its entirety or on a Product-by-Product and
country-by-country basis, by giving [***] prior written notice to ADLS in the
event of any safety issue that would reasonably be expected to have a material
adverse effect on Wyeth’s ability to Develop, Manufacture or Commercialize any
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Product, as
determined in Wyeth’s reasonable judgment and according to Wyeth’s standard
internal procedures for evaluating such safety issues.


 


9.4.         Termination
on Insolvency of ADLS.  ADLS shall be
deemed a “Debtor” under this
Agreement if, at any time during the Term (i) a case is commenced by or
against ADLS under the Bankruptcy Code, (ii) ADLS files for or is subject
to the institution of bankruptcy, reorganization, liquidation or receivership
proceedings (other than a case under the Bankruptcy Code), (iii) ADLS
assigns all or a substantial portion of its assets for the benefit of
creditors, (iv) a receiver or custodian is appointed for ADLS’ business or
(v) a substantial portion of ADLS’ business is subject to attachment or
similar process; provided, however, that in the case of any involuntary case
under the Bankruptcy Code, ADLS shall not be deemed a Debtor if the case is
dismissed within [***] after the commencement thereof.  In the event that ADLS is deemed a Debtor,
Wyeth may terminate this Agreement by providing written notice to ADLS.  In accordance with Section 2.6 above,
all licenses granted under this Agreement are deemed to be, for purposes of Section 365(n) of
the Bankruptcy Code, licenses of rights to “intellectual property” as defined
in Section 101 of the Bankruptcy Code, and Wyeth shall have such rights as
are provided under the Bankruptcy Code in the event of the bankruptcy of ADLS.


 


9.4.1.      Licenses.
 If a case is
commenced under the Bankruptcy Code by or against ADLS, ADLS (in any capacity,
including debtor-in-possession) and its successors and assigns (including a
trustee) shall:


 


(a)                                  as
Wyeth may elect in a written request, immediately upon such request:


 


(i)            perform
all of the obligations provided in this Agreement to be performed by ADLS,
including, where applicable, providing to Wyeth portions of intellectual
property licensed hereunder (including embodiments thereof) held by ADLS and/or
such successors and assigns or otherwise available to them; or


 


(ii)           provide to
Wyeth all such intellectual property (including all embodiments thereof) held
by ADLS and/or such successors and assigns or otherwise available to them; and


 


(b)                                  not
interfere with Wyeth’s rights under this Agreement, or any agreement
supplemental hereto, to such intellectual property (including such
embodiments), including any right to obtain such intellectual property (or such
embodiments) from another entity, to the extent provided in Section 365(n) of
the Bankruptcy Code.


 


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9.4.2.      Rights
to Intellectual Property.  If (i) a case under the
Bankruptcy Code is commenced by or against ADLS, (ii) this Agreement is
rejected as provided in the Bankruptcy Code and (iii) Wyeth elects to
retain its rights hereunder as provided in Section 365(n) of the
Bankruptcy Code, then ADLS (in any capacity, including debtor-in-possession)
and its successors and assigns (including any trustee) shall provide to Wyeth
all intellectual property licensed hereunder (including all embodiments
thereof) held by ADLS and/or such successors and assigns, or otherwise
available to them, immediately upon Wyeth’s written request.  Whenever ADLS or any of its successors or
assigns provides to Wyeth any of the intellectual property licensed hereunder
(or any embodiment thereof) pursuant to this Section 9.4.2, Wyeth shall
have the right to perform the obligations of ADLS hereunder with respect to
such intellectual property, but neither such provision nor such performance by
Wyeth shall release ADLS from liability resulting from rejection of the license
or the failure to perform such obligations.


 


9.4.3.      Additional
Rights.  All rights, powers and remedies of Wyeth
provided herein are in addition to and not in substitution for any and all
other rights, powers and remedies now or hereafter existing at law or in equity
(including the Bankruptcy Code) in the event of the commencement of a case
under the Bankruptcy Code.  The Parties
agree that they intend the following rights to extend to the maximum extent
permitted by law, and to be enforceable under Bankruptcy Code Section 365(n):


 


(a)           the
right of access to any intellectual property (including all embodiments
thereof) of ADLS, or any Third Party with whom ADLS contracts to perform an
obligation of ADLS under this Agreement, and, in the case of the Third Party,
which is necessary for the Development, Manufacture, Commercialization or use
of Products; and


 


(b)           the right to
contract directly with any Third Party to complete the contracted work.


 


9.5.         Effects
of Termination.


 


9.5.1.      Effect of Termination by Wyeth for Cause.  If Wyeth terminates this Agreement with
respect to any one or more Products in any one or more countries pursuant to Section 9.2
(Termination by either Party for Cause):


 


(a)           All licenses
conveyed by ADLS to Wyeth with respect to the applicable terminated Product in
the applicable terminated country shall become irrevocable and perpetual, Wyeth’s
rights under Sections 4.4, 4.6.2, 6.2.1(a), 6.2.2(a) and (b), 6.2.4, 6.2.5


 


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and 8.2(i),
(l), (m), (n), (p) and (q) with respect to such Product shall remain
in effect and Wyeth shall have no further obligations to ADLS under this
Agreement with respect to such Product in such country other than (i) an
obligation to pay royalties with respect to Net Sales of such Product in such
country in an amount equal to [***] of the amount that would otherwise have
been payable under this Agreement, such amount to be paid in accordance with
and subject to the other terms of this Agreement governing the payment of
royalties, and (ii) those obligations that expressly survive termination
in accordance with Section 9.6 hereof;


 


(b)           Such
termination shall not be construed to limit ADLS’ right to receive payments
that accrued before the effective date of such termination;


 


(c)           Wyeth shall
have the right to offset, against any payment owing to ADLS as provided for
under Section 9.5.1(a), any damages found or agreed by the Parties to be
owed by ADLS to Wyeth;


 


(d)           For the
avoidance of doubt, all licenses and other rights granted by Wyeth to ADLS
under Sections 2.4 and 4.4, and any rights granted by ADLS under such rights to
any Affiliate or ADLS Licensee, with respect to such Product(s) shall
terminate as of the effective date of such termination; and


 


(e)           Nothing in
this Section 9.5.1 shall limit any other remedy Wyeth may have for ADLS’
breach of this Agreement.


 


9.5.2.      Effect of Termination by Wyeth on
Insolvency of ADLS. 
If Wyeth terminates this Agreement pursuant to Section 9.4
(Termination on Insolvency of ADLS):


 


(a)           All licenses
granted to Wyeth shall become irrevocable and perpetual, Wyeth’s rights under
Sections 4.4, 4.6.2, 6.2.1(a), 6.2.2(a) and (b), 6.2.4, 6.2.5 and 8.2(i),
(l), (m), (n), (p) and (q) shall remain in effect and Wyeth shall
have no further obligations to ADLS under this Agreement other than (i) those
obligations that expressly survive termination in accordance with Section 9.6
hereof and (ii) an obligation to pay royalties with respect to Net Sales
of Products in an amount equal to [***] of the amount that would otherwise have
been payable under this Agreement, such amount to be paid in accordance with
and subject to the other terms of this Agreement governing the payment of
royalties;


 


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(b)           Such
termination shall not be construed to limit ADLS’ right to receive payments
that accrued before the effective date of such termination;


 


(c)           Wyeth shall
have the right to offset, against any payment owing to ADLS as provided for under
Section 9.5.2(a), any damages found or agreed by the Parties to be owed by
ADLS to Wyeth;


 


(d)           For the
avoidance of doubt, all licenses and other rights granted by Wyeth to ADLS
under Sections 2.4 and 4.4, and any rights granted by ADLS under such rights to
any Affiliate or ADLS Licensee, shall terminate as of the effective date of
such termination; and


 


(e)           Nothing in
this Section 9.5.2 shall limit any other remedy Wyeth may have for any
breach by ADLS of this Agreement.


 


9.5.3.      Effect of Termination by ADLS for Cause or
by Wyeth At Will or For Safety.


 


(a)           If ADLS
terminates this Agreement in its entirety pursuant to Section 9.2
(Termination by Either Party for Cause), or if Wyeth terminates this Agreement
in its entirety pursuant to Section 9.3 (Termination by Wyeth At Will or
For Safety), then the following shall apply:


 


(i)            All
licenses granted by ADLS to Wyeth shall automatically terminate; and


 


(ii)           Such
termination shall not be construed to limit ADLS’ right to receive payments
that accrued before the effective date of such termination.


 


(b)           If this
Agreement is not terminated in its entirety, but (i) ADLS terminates this
Agreement with respect to any one or more Products in any one or more countries
pursuant to Section 9.2, (ii) Wyeth terminates this Agreement
pursuant to Section 9.3.1 with respect to any one or more Products or (iii) Wyeth
terminates this Agreement pursuant to Section 9.3.2 with respect to any
one or more Products in any one or more countries, then the following shall
apply:


 


(i)            All
licenses granted by ADLS to Wyeth under Section 2.1 with respect to such
Product(s) in such countr(y/ies) shall terminate, provided that the
licenses to


 


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Wyeth with
respect to all remaining Products and in all other countries in the Territory
shall remain in effect; and


 


(ii)           Such
termination shall not be construed to limit ADLS’ right to receive payments
that accrued before the effective date of such termination.


 


(c)           Nothing in
this Section 9.5.3 shall limit any other remedy ADLS may have for Wyeth’s
breach of this Agreement.


 


9.5.4.      Disposition of Inventories of Products.  Following termination of this Agreement with
respect to one or more Products by ADLS pursuant to Section 9.2, or by
Wyeth pursuant to Section 9.3.1, ADLS shall have the right but not the
obligation to purchase from Wyeth, at Wyeth’s cost, Wyeth’s then existing
inventory of such Product or Products. 
Wyeth, its Affiliates and its Sublicensees shall have the right to
continue to sell in the Territory any amounts of their existing inventories of
such Products that ADLS does not elect to purchase as described in this Section 9.5.4
for a period not to exceed [***] after the effective date of any such
termination of this Agreement with respect to one or more Products, and Wyeth
shall pay any royalties payable in connection with such sales in accordance
with Sections 5.3 and 5.4. and, if applicable, any Commercial Payment
payable with respect to such sales in accordance with Section 5.2.3.


 


9.6.         Survival of Certain Obligations.  Expiration or termination of this Agreement
shall not relieve the Parties of any obligation accrued prior to such
expiration or termination.  The following
provisions shall survive expiration or termination of this Agreement:  Section 1 (Definitions) (to the extent
definitions are embodied in the following Sections); Section 4.7
(Regulatory Reporting); Section 4.8.2 (Pharmacovigilance); Section 4.11
(Product Recalls) (solely with respect to Products sold prior to such
expiration or termination); Section 5.5 (Maintenance of Records; Audits); Section 6.1
(Inventions); Section 7 (Confidentiality); Section 10 (Liability,
Indemnification and Insurance); Section 11 (Dispute Resolution); and Section 12
(Miscellaneous) (other than Sections 12.14 (Change of Control of ADLS) and
12.15 (Right of First Offer)).


 


10.                               LIABILITY,
INDEMNIFICATION AND INSURANCE.


 


10.1.       Liability.  Except with respect
to liability arising from a breach of Section 6 or 7, from any
willful misconduct or intentionally wrongful act, or to the extent such Party
may be required to indemnify the other Party under this Section 10, neither
Party nor its respective Affiliates shall be liable to the other for special,
punitive or consequential damages, whether based on contract or tort, or
arising under applicable law or otherwise, in connection with this Agreement.


 


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10.2.       Indemnification by Wyeth.  Wyeth will indemnify, defend and hold harmless
ADLS and its Affiliates, Licensees and each of their respective employees,
officers, directors and agents (each, an “ADLS
Indemnified Party”) from and against any and all liability, loss,
damage, expense (including reasonable attorneys’ fees and expenses) and cost
(collectively, a “Liability”) that
the ADLS Indemnified Party may be required to pay to one or more Third Parties
to the extent resulting from or arising out of (i) any claims of any
nature, including product liability claims, arising out of the Development,
Manufacture or Commercialization of Compounds or Products by, on behalf of or
under the authority of Wyeth (other than by ADLS, its Affiliates or Licensees
or any of their respective employees, officers, directors and agents), or (ii) any
breach by Wyeth of any representation, warranty or covenant set forth in this
Agreement, except, in each case, to the extent caused by the negligence or
willful misconduct of ADLS or any ADLS Indemnified Party or any breach by ADLS
of any representation, warranty or covenant set forth herein.


 


10.3.       Indemnification by ADLS.  ADLS will indemnify, defend and hold harmless
Wyeth and its Affiliates, Sublicensees and distributors and each of its and
their respective employees, officers, directors and agents (each, a “Wyeth Indemnified Party”) from and against
any and all Liabilities that the Wyeth Indemnified Party may be required to pay
to one or more Third Parties to the extent resulting from or arising out of (i) any
claims of any nature, including product liability claims, arising out of the
Development, Manufacture or Commercialization of any Compound or Product by, on
behalf of or under the authority of ADLS (other than by Wyeth, its Affiliates
or Sublicensees or any of their respective employees, officers, directors and
agents), or (ii) any breach by ADLS of any representation, warranty or
covenant set forth in this Agreement, except, in each case, to the extent
caused by the negligence or willful misconduct of Wyeth or any Wyeth
Indemnified Party or any breach by Wyeth of any representation, warranty or
covenant set forth herein.


 


10.4.       Procedure.  Each Party will notify the other promptly in
the event it becomes aware of a claim for which indemnification may be sought
hereunder.  In furtherance and not in
limitation of the preceding sentence, in case any proceeding (including any
governmental investigation) shall be instituted involving any Wyeth Indemnified
Party or ADLS Indemnified Party in respect of which indemnity may be sought
pursuant to this Section 10, ADLS (if such proceeding is initiated against
an ADLS Indemnified Party) or Wyeth (if such proceeding is initiated against a
Wyeth Indemnified Party) (such Party referred to as the “Indemnified Party”) shall promptly notify
the other Party (the “Indemnifying Party”)
in writing within fifteen (15) days after the Indemnified Party first becomes
aware of such proceeding and the Indemnifying Party and Indemnified Party shall
then promptly meet to discuss how to respond to any claims that are the subject
matter of such proceeding.  The
Indemnifying Party shall have the right to assume the defense of any Third
Party claim subject to indemnification obligations hereunder.  The Indemnifying Party, upon assuming


 


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the defense of
the claim, shall retain counsel reasonably satisfactory to the Indemnified
Party to conduct the defense of the claim and shall pay the fees and expenses
of such counsel related to such proceeding. 
The Indemnified Party agrees to cooperate fully with the Indemnifying
Party in the defense of any such claim, action or proceeding, or any litigation
resulting from any such claim.  In any
such proceeding, the Indemnified Party shall have the right to retain its own
counsel, but the fees and expenses of such counsel shall be at the expense of
the Indemnified Party unless (a) the Indemnifying Party and the
Indemnified Party shall have mutually agreed to the retention of such counsel
or (b) the named parties to any such proceeding (including any impleaded
parties) include both the Indemnifying Party and the Indemnified Party and
representation of both Parties by the same counsel would be inappropriate due
to actual or potential differing interests between them.  All such fees and expenses shall be
reimbursed as they are incurred.  The
Indemnifying Party shall not be liable for any settlement of any proceeding
effected without its written consent, but if settled with such consent, the
Indemnifying Party agrees to indemnify the Indemnified Party from and against
any loss or liability by reason of such settlement.  The Indemnifying Party shall not, without the
written consent of the Indemnified Party, effect any settlement of any pending
or threatened proceeding in respect of which the Indemnified Party is, or
arising out of the same set of facts could have been, a party and indemnity
could have been sought hereunder by the Indemnified Party, unless such settlement
includes an unconditional release of the Indemnified Party from all liability
on claims that are the subject matter of such proceeding.


 


10.5.       Insurance.  ADLS shall obtain and maintain, during the
Term, commercial general liability insurance, including products liability
insurance, with reputable and financially secure insurance carriers to cover
its indemnification obligations under Section 10.3, with limits of not
less than [***] per occurrence and in the aggregate.  Insurance shall be procured with carriers
having an A.M. Best Rating of A-VII or better.


 


11.                               DISPUTE
RESOLUTION


 


11.1.       General.  Any controversy, claim or dispute arising out
of or relating to this Agreement shall be settled, if possible, through good
faith negotiations between the Parties. 
However, subject to Section 3.3 with respect to decisions of the
Steering Committee and other committees established under this Agreement, if
the Parties are unable to settle such dispute after good faith negotiations,
the matter shall be referred to the Executive Officers (having authority to
bind the Parties with respect to such dispute, subject to obtaining any
necessary corporate or management approvals) to be resolved by negotiation in
good faith as soon as is practicable but in no event later than thirty (30)
days after referral.  The resolution, if
any, of a referred matter shall be reduced to writing signed by such Executive
Officers and thereafter shall be final and binding on the Parties.


 


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11.2.       Failure of Officers to Resolve Dispute.  If the Executive Officers are unable to
settle the dispute after good faith negotiation in the manner set forth above,
either Party may seek resolution of the dispute through any remedies available
at law or in equity from any court of competent jurisdiction as provided in Section 12.9
below.


 


12.                               MISCELLANEOUS.


 


12.1.       Assignment.  Neither this Agreement nor any interest
hereunder shall be assignable by either Party, without the prior written
consent of the other Party, which consent shall not be unreasonably withheld,
conditioned or delayed, except a Party may make an assignment of its entire
interest in this Agreement without the other Party’s consent to an Affiliate or
to a successor to all or substantially all of the business of such Party to
which this Agreement relates, whether by merger, sale of stock, sale of assets,
exclusive transfer of technology or other transaction, provided that, in the
case of assignment to an Affiliate, the assigning Party shall guarantee the
performance of this Agreement by such Affiliate.  Each successor or permitted assign shall
promptly provide the other Party written notice of its agreement to be bound by
the terms and conditions of this Agreement. 
This Agreement shall be binding upon the successors and permitted
assigns of the Parties, and the name of a Party appearing herein shall be
deemed to include the names of such Party’s successors and permitted assigns to
the extent necessary to carry out the intent of this Agreement.  Any assignment not in accordance with this Section 12.1
shall be void.  In addition, ADLS shall
not assign any interest in the Licensed Rights to any Third Party or Affiliate
unless such assignee agrees in writing that such assignment is subject to the
terms and conditions of this Agreement and the rights granted to Wyeth
hereunder.


 


12.2.       Further Actions.  Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of the
Agreement.


 


12.3.       Force Majeure.  Neither Party shall be liable to the other
for delay or failure in the performance of the obligations on its part
contained in this Agreement if and to the extent that such failure or delay is
due to circumstances beyond its control which it could not have avoided by the
exercise of reasonable diligence.  Such
Party shall notify the other Party promptly should such circumstances arise,
giving an indication of the likely extent and duration thereof, and shall use
all Commercially Reasonable Efforts to resume performance of its obligations as
soon as practicable, provided, however, that neither Party shall be required to
settle any labor dispute or disturbance.


 


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12.4.    Correspondence
and Notices.


 


12.4.1.    Ordinary Notices.  Subject to Section 12.4.2,
correspondence, reports, documentation and any other communication in writing
between the Parties in the course of ordinary implementation of this Agreement
shall be delivered by hand, sent by facsimile transmission (receipt verified),
sent by registered or certified mail (return receipt requested) postage prepaid
or sent using a nationally recognized express courier service, in each case to
the employee or representative of the other Party who is designated by such
other Party to receive such written communication.


 


12.4.2.    Extraordinary Notices.  Any notice or notification required or
permitted to be provided pursuant to the terms and conditions of this Agreement
(including, without limitation, any notice of force majeure, breach,
termination, change of address, etc.) shall be in writing and shall be deemed
given upon receipt if delivered personally or by facsimile transmission
(receipt verified), five (5) days after deposited in the mail if
mailed by registered or certified mail (return receipt requested) postage
prepaid, or on the next business day if sent by overnight delivery using a
nationally recognized express courier service and specifying next business day
delivery (receipt verified), to the Parties at the following addresses or
facsimile numbers (or at such other address or facsimile number for a Party as
shall be specified by like notice, provided, however, that notices of a change of address shall be effective
only upon receipt thereof):


 


All
correspondence to Wyeth shall be addressed as follows:


 


Wyeth


500 Arcola Road


Collegeville, Pennsylvania 19426


Attn:  Senior Vice President, Corporate Business
Development


Fax:  (484) 865-6476


 


with a copy
to:


 


Wyeth


5 Giralda
Farms


Madison, New
Jersey 07940


Attn:  Executive Vice President and General Counsel


Fax:  (973) 660-7156


 


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All
correspondence to ADLS shall be addressed as follows:


 


Advanced Life
Sciences Holdings, Inc.

1440 Davey Road

Woodridge, IL  60517


Attn:  Chief Legal Counsel


Fax:  (630) 739-6754


 


with a copy to:


 


Winston &
Strawn LLP

35 West Wacker Drive

Chicago, IL  60601


Attn:  R. Cabell Morris, Jr.


Fax:  (312) 558-5700


 


12.5.       Amendment.  No amendment, modification or supplement of
any provision of this Agreement shall be valid or effective unless made in writing
and signed by a duly authorized officer of each Party.


 


12.6.       Waiver.  No provision of this Agreement shall be
waived by any act, omission or knowledge of a Party or its agents or employees
except by an instrument in writing expressly waiving such provision and signed
by a duly authorized officer of the waiving Party.  The waiver by either of the Parties of any
breach of any provision hereof by the other Party shall not be construed to be
a waiver of any succeeding breach of such provision or a waiver of the
provision itself.


 


12.7.       Severability.  If any clause or portion thereof in this
Agreement is for any reason held to be invalid, illegal or unenforceable, the
same shall not affect any other portion of this Agreement, as it is the intent
of the Parties that this Agreement shall be construed in such fashion as to
maintain its existence, validity and enforceability to the greatest extent
possible.  In any such event, this
Agreement shall be construed as if such clause of portion thereof had never
been contained in this Agreement, and there shall be deemed substituted
therefor such provision as will most nearly carry out the intent of the Parties
as expressed in this Agreement to the fullest extent permitted by applicable
law.


 


12.8.       Descriptive Headings.  The descriptive headings of this Agreement
are for convenience only and shall be of no force or effect in construing or
interpreting any of the provisions of this Agreement.


 


12.9.       Governing Law; Venue.  This Agreement shall be governed by and
interpreted in accordance with the substantive law of the state of New York,
without regard to conflict of law principles thereof.  Subject to Section 11 hereof, any action
based upon a controversy, claim or dispute arising out of or relating to this
Agreement shall be brought only in a federal court of competent


 


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jurisdiction
(or a state court if no federal court has jurisdiction) located in New York,
New York and the Parties hereby submit to the exclusive jurisdiction and venue
of such courts.


 


12.10.          Entire
Agreement of the Parties.  This Agreement constitutes and contains the
complete, final and exclusive understanding and agreement of the Parties
respecting the subject matter hereof and cancels and supersedes any and all
prior negotiations, correspondence, understandings and agreements, whether oral
or written, among the Parties respecting the subject matter hereof.


 


12.11.          Independent
Contractors. 
Both Parties are independent contractors under this Agreement.  Nothing herein contained shall be deemed to
create an employment, agency, joint venture or partnership relationship between
the Parties or any of their agents or employees, or any other legal arrangement
that would impose liability upon one Party for the act or failure to act of the
other Party.  Neither Party shall have
any express or implied power to enter into any contracts or commitments or to
incur any liabilities in the name of, or on behalf of, the other Party, or to
bind the other Party in any respect whatsoever.


 


12.12.          Counterparts.  This Agreement may be executed in two
counterparts, each of which need not contain the signature of more than one
Party but all such counterparts taken together shall constitute one and the
same agreement.


 


12.13.          Interpretation.  Except where the context requires otherwise, (a) the
use of any gender herein shall be deemed to encompass references to either or
both genders, and the use of the singular shall be deemed to include the plural
(and vice versa), (b) the words “include”, “includes” and “including”
shall be deemed to be followed by the phrase “without limitation,” (c) the
word “will” shall be construed to have the same meaning and effect as the word “shall,”
(d) any definition of or reference to any agreement, instrument or other
document herein shall be construed as referring to such agreement, instrument
or other document as from time to time amended, supplemented or otherwise
modified (subject to any restrictions on such amendments, supplements or
modifications set forth herein), (e) any reference herein to any Person
shall be construed to include the Person’s successors and assigns, (f) the
words “herein”, “hereof” and “hereunder”, and words of similar import, shall be
construed to refer to this Agreement in its entirety and not to any particular
provision hereof, (g) all references herein to Sections or Exhibits shall
be construed to refer to Sections or Exhibits of this Agreement, and references
to this Agreement include all Exhibits hereto, (h) the word “notice” shall
mean notice in writing (whether or not specifically stated) and shall include
notices, consents, approvals and other written communications contemplated
under this Agreement, (i) provisions that require that a Party, the
Parties or any committee hereunder “agree,” “consent” or “approve” or the like
shall require that such agreement, consent or approval be specific and in writing,
whether by written agreement, letter, approved minutes or otherwise (but
excluding e-mail and instant messaging),


 


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and (j) references
to any specific law, rule or regulation, or article, section or other
division thereof, shall be deemed to include the then-current amendments
thereto or any replacement or successor law, rule or regulation thereof.


 


12.14.          Change
of Control of ADLS.


 


12.14.1.           Change
of Control Notice. 
ADLS shall notify Wyeth in writing promptly (and in any event within two
(2) business days) following the entering into of a definitive agreement
with respect to a Change of Control of ADLS.


 


12.14.2.           Disposition
Upon Divestiture. 
If, in connection with any Change of Control of ADLS, any governmental
agency requires ADLS (including, but not limited to, pursuant to a consent
decree) to divest its interest in any Product or this Agreement (the “Divested Asset(s)”), Wyeth shall have the
right to purchase ADLS’ interest in the Divested Asset(s) for fair
consideration.  ADLS shall propose in
writing a purchase price for the Divested Asset(s) within [***] after
receiving notice of such divestiture requirement.  Wyeth shall have [***] after receipt of such
written proposal to accept or reject the proposed price for the Divested
Asset(s).  If Wyeth rejects the proposed
price, ADLS shall be free to offer the Divested Asset(s) for sale to a
Third Party for [***].  If no sale to a
Third Party is consummated within such [***] period, the provisions of this Section 12.14.2
requiring ADLS to first offer the Divested Assets to Wyeth shall again apply.


 


12.14.3.           Right
to Terminate if Confirmation of Continued Priority Not Received.  Wyeth may terminate this Agreement in its
entirety or with respect to any one or more Product(s) upon any Change of
Control of ADLS unless, within [***] following the closing of such Change of
Control, Wyeth has received from ADLS, and any Third Party who is acquiring or
has acquired control of ADLS, written confirmation reasonably satisfactory to
Wyeth to the effect that (i) after such Change of Control, the
Development, Manufacture and Commercialization of Products as contemplated by
this Agreement will have a priority for ADLS or its successor following such
Change of Control which is equal to or greater than the priority that such
Development, Manufacture and Commercialization had for ADLS prior to such
Change of Control; and (ii) ADLS will continue to meet all of its
obligations under this Agreement following such Change of Control.  Any termination by Wyeth under this Section 12.14.3
shall be treated as a termination for cause under Section 9.2.


 


12.14.4.           Rights
if Acquiror Has Competing Product.  Furthermore, in the event that a Change of
Control of ADLS results in ADLS or any Affiliate of ADLS having, immediately
following the


 


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Change of
Control, marketing or royalty rights to, or any other substantial financial
interest in, any Competing Product, Wyeth may, in its sole discretion,
regardless of any assurances provided by ADLS, terminate this Agreement in its
entirety or with respect to any one or more Product(s).  Any termination by Wyeth under this Section 12.14.4
shall be treated as a termination for cause under Section 9.2.


 


12.14.5.           No
Relief from Obligation.  Nothing
in this Section 12.14 shall relieve ADLS of any of its obligations under
this Agreement.


 


12.15.             Right
of First Offer. 
Wyeth is hereby granted a Right of First Offer (as hereinafter defined)
to Develop and Commercialize Products in [***]. 
The “Right of First Offer”
shall mean a written offer (the “Offer”)
presented by ADLS to Wyeth to exclusively Develop and Commercialize Products in
[***].  The Offer shall be presented to
Wyeth before any such rights to Develop and Commercialize Products in [***] are
offered or granted by or on behalf of ADLS to any Third Party.  The Offer shall disclose the proposed terms
and conditions of the arrangement and any other material facts relating to the
Offer.  Wyeth shall have [***] after
receipt of the Offer to accept or reject it in writing.  In the event that Wyeth accepts such Offer,
the Parties shall negotiate in good faith and enter into a written agreement
containing the terms of such Development and Commercialization in [***].  Except for any terms and conditions expressly
set forth in the Offer, such agreement between the Parties for [***] shall be
substantially on the terms and conditions of this Agreement.  If Wyeth rejects the Offer, ADLS shall be
free to make similar offers to Third Parties for a period of [***] on terms and
conditions, on the whole, no less favorable to ADLS than those offered to
Wyeth.  If, after such [***] period, ADLS
has not entered into a written agreement with a Third Party granting to such
Third Party rights to Develop and Commercialize Products in [***], ADLS shall
not offer or grant to a Third Party any rights to Develop or Commercialize
Products in [***] without again complying with the provisions of this Section 12.15.


 


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IN
WITNESS WHEREOF, duly authorized representatives of
the Parties have duly executed this Agreement to be effective as of the
Effective Date.


 


 


	
  WYETH,

  	
   

  	
  ADVANCED LIFE SCIENCES

  
	
   

  	
   

  	
  HOLDINGS, INC.

  
	
  acting through its

  	
   

  	
   

  
	
  Wyeth Pharmaceuticals Division

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
         /s/ Theodore R. Kozial

  	
   

  	
  By:

  	
           /s/
  Michael T. Flavin

  
	
  Name:

  	
    Theodore R. Kozial

  	
   

  	
  Name:

  	
    Michael T. Flavin, Ph.D.

  
	
  Title:

  	
    Vice President

  	
   

  	
  Title:

  	
    Chief Executive Officer

  
							



 


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EXHIBIT 1.6


 


ADLS PATENT RIGHTS


 


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EXHIBIT 1.8


 


ADLS STUDY


 


[***]


 


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EXHIBIT 1.10


 


ADLS THIRD PARTY AGREEMENT(S)


 


1.             License Agreement, dated December 13,
2004, by and between Abbott Laboratories and Advanced Life Sciences Holdings, Inc.


 


2.             First Amendment to License
Agreement, dated April 27, 2005, by and between Abbott Laboratories and
Advanced Life Sciences Holdings, Inc.


 


3.             Second Amendment to License
Agreement, dated August 2, 2005 by and between Abbott Laboratories and
Advanced Life Sciences Holdings, Inc.


 


4.             Third Amendment to License
Agreement, dated August 10, 2005, by and between Abbott Laboratories and
Advanced Life Sciences Holdings, Inc.


 


5.             Fourth Amendment to License
Agreement dated as of November 13, 2007 by and between Abbott Laboratories
and Advanced Life Sciences, Inc.


 


6.             Fifth Amendment to License
Agreement expected to be executed on or around September 30, 2008 by and
between Abbott Laboratories and Advanced Life Sciences, Inc.


 


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EXHIBIT 1.17


 


[***] STUDY


 


[***]


 


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EXHIBIT 1.25


 


COMPOUND


 


Structural Formula


 





 


Chemical
Name


 


[3aS,4R,7R,9R,10R,11R,13R,15R,15aR]-4-ethyloctahydro-3a,7,9,11,13,15-hexamethyl-11-[[3-(3-quinolinyl)-2E-propenyl]oxy]-10-[[3,4,6-trideoxy-3-(dimethylamino)-b-D-xylo-hexopranosyl]oxy]-2H-oxacyclotetradecino
[4,3-d] oxazole-2,6,8,14(1H,7H,9H)-tetrone.


 


Molecular
Formula


 


C42H59N3O10


 


Molecular
Weight


 


765.93


 


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EXHIBIT 1.90


 


STOCK PURCHASE AGREEMENT


 


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EXHIBIT 4.3


 


INITIAL GLOBAL DEVELOPMENT PLAN


 


[***].


 


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EXHIBIT 4.9.1


 


KEY TERMS OF THE SUPPLY AGREEMENT


 


1.                                       Rolling
Forecasts.  [***].


 


2.                                       Inventory;
Launch.  ADLS shall at all times
maintain an inventory of each Product (in bulk tablet form) equal to [***] of
the estimate provided to ADLS under Section 1 above for the next
[***].  ADLS shall at all times maintain
an inventory of the API for each Product, and/or such Product in bulk tablet
form, sufficient to support supply of [***] of the estimate for such Product
provided to ADLS under Section 1 above for the next [***].  Such inventory shall be maintained by ADLS at
no charge to Wyeth.  The Supply Agreement
shall also contain appropriate provisions with respect to launch quantities of
Products.


 


3.                                       Shelf
Life.  Each shipment of Products
shall have, as of the date of receipt by Wyeth, at least [***] of remaining
shelf life.


 


4.                                       Third
Party Manufacturers.  At all times
during the Term and as provided in Section 9 below, ADLS shall satisfy its
supply obligations to Wyeth hereunder through binding written agreements with
qualified Third Parties engaged to perform services or supply facilities or
goods in connection with the Manufacture of Products, provided that ADLS shall
not enter into any such agreement unless prior thereto ADLS shall have given
Wyeth a written summary identifying the proposed manufacturer and the principal
terms of such proposed agreement and Wyeth shall not have reasonably objected
thereto in writing within ten (10) days after receipt of such
summary.  Upon reasonable request, ADLS
shall permit and arrange for Wyeth to conduct due diligence inspections of any
proposed Third Party manufacturers.


 


5.                                       Changes.  Except as otherwise permitted under the
change control procedures to be specified in the Supply Agreement, ADLS shall
not modify or change the process, specifications, materials, suppliers,
facilities or analytical testing methods used in connection with the
Manufacture of Products, regardless of whether such modification or change
requires the approval of any Regulatory Authority, without the prior written
consent of Wyeth, which consent shall not be unreasonably withheld.  ADLS shall provide Wyeth with a written
summary of all proposed modifications or changes and must receive the written
approval of Wyeth prior to the implementation thereof, which approval shall not
be unreasonably withheld.  The detailed
provisions reflecting this Section 5 shall be set forth in a quality
agreement on reasonable and customary terms, and complying with applicable
regulatory requirements, to be negotiated and entered into by the Parties in
connection with the Supply Agreement (the “Quality
Agreement”).


 


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6.                                       Failure
to Supply.  ADLS shall give Wyeth
prompt written notice if ADLS becomes aware that it will not be able to satisfy
Wyeth’s requirements for Products in any material way.  In such event, or in the event that, without
such prior notice, ADLS actually fails to materially satisfy Wyeth’s
requirements for Products, Wyeth and ADLS shall promptly work together, in good
faith, to devise and implement measures to cure such failure to supply or to
identify an appropriate alternative source of Products.  In addition, in the event of an uncured
failure to supply, if Wyeth determines to utilize an alternative source of
Products, at Wyeth’s request, ADLS shall promptly transfer to Wyeth or its
designee, at no cost to Wyeth, all Know-How and other technical information
necessary or useful to permit Wyeth to make or have made Products, provided
that, pending the full transfer of supply to an alternative source, ADLS shall
use best efforts to continue to supply Wyeth’s requirements for Products until
such time as Wyeth determines, in its sole reasonable discretion, that such
alternative supplier is fully able to supply all such requirements.  Until such time, available quantities of
Products shall be allocated pro-rata among Wyeth’s requirements hereunder for
the Territory and ADLS’ requirements for outside the Territory based upon their
relative sales of the applicable Products for the immediately preceding [***]
period, or if such shortages occur during or prior to the first [***] period of
sales for a Product, then such pro-rata allocation shall be based upon the
Parties’ then current relative annualized projected requirements for such
Product.


 


7.                                       Transfer
Price.  The transfer price for
commercial supplies of the Current Product purchased by Wyeth during the
Royalty Term shall be [***].  The
transfer price for commercial supplies of other Products purchased by Wyeth
during the Royalty Term shall be as mutually agreed by the Parties, but shall
in no event exceed [***].


 


8.                                       Inspection
and Other Rights.  Wyeth shall have
reasonable and customary (a) rights to routinely inspect the facilities
(including with respect to compliance with applicable regulatory requirements)
and books and records of ADLS and its Third Party manufacturers relating to
Products and (b) rights to information, consultation and participation
with respect to regulatory inspections of ADLS and its Third Party
manufacturers relating to Products.


 


9.                                       Survival.  In the event that Wyeth terminates the Agreement
with respect to any Product pursuant to Section 9.2 or 9.4 of the
Agreement, at Wyeth’s option the Supply Agreement shall remain in effect with
respect to any such Product until such time as ADLS and Wyeth are able to
transfer all Third Party supply arrangements relating to such Product directly
to Wyeth and, pending such transfer, ADLS shall use best efforts to ensure
Wyeth’s continued supply of any such Product from any applicable Third Party
manufacturer(s).


 


10.                                 Qualification
of Back-Up Manufacturers.  Wyeth
shall have the right to qualify potential back-up manufacturers (for both API
and Products) for use in the event that Wyeth elects to Manufacture or have
Manufactured any Product due to a failure by ADLS to supply or have supplied
such Product to Wyeth.


 


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11.                                 Stability
Studies.  ADLS, at its expense, shall
perform stability studies with respect to each Product in accordance with ICH
Guidelines and meeting the requirements of Regulatory Authorities in the
Territory, as applicable, as necessary to establish a shelf life of at least
[***] for each Product in a final packaged form (as will be agreed upon and set
forth in further detail in the Supply Agreement or the Quality Agreement).  The detailed provisions reflecting this Section 11
shall be set forth in the Quality Agreement.


 


12.                                 Term.  The Supply Agreement shall remain in effect
with respect to each Product supplied thereunder during the Royalty Term for
such Product.


 


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EXHIBIT 7.4.3


 


ADLS PRESS RELEASE


 


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EXHIBIT 8.2(a)


 


INFORMATION RELATED TO ADLS IP


 


[***]


 


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EXHIBIT 8.2(c)


 


THIRD PARTY RIGHTS RELATED TO ADLS IP


 


Please refer to Exhibit 1.10.


 


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EXHIBIT 8.2(e)


 


GOVERNMENT FUNDING


 


None.


 


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EXHIBIT 8.2(o)


 


CONTROL LIMITATION AGREEMENTS


 


Please refer to Exhibit 1.10.


 


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