**Exhibit 10.11**

 

REDACTED COPY

 

DEVELOPMENTAND COMMERCIALIZATION AGREEMENT

 

byand between

 

WYETH

actingthrough its Wyeth Pharmaceuticals Division

 

and

 

ADVANCEDLIFE 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 |

 

[***]Confidential Treatment Requested

Confidentialportion omitted and filed separately with the Commission

 

i

----

 

REDACTED COPY

 
|   | 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     |

 

[***]Confidential Treatment Requested

Confidentialportion omitted and filed separately with the Commission

 

ii

----

 

REDACTED COPY

 
|   | 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     |

 

[***]Confidential Treatment Requested

Confidentialportion omitted and filed separately with the Commission

 

iii

----

 

REDACTED COPY

 
| **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 |

 

[***]Confidential Treatment Requested

Confidentialportion omitted and filed separately with the Commission

 

iv

----

 

REDACTED COPY

 
|    | 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     |

 

[***]Confidential Treatment Requested

Confidentialportion omitted and filed separately with the Commission

 

v

----

 

REDACTED COPY

 
|   | 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**

 

ThisDevelopment and Commercialization Agreement (the “**Agreement**”) is entered into as of September 29, 2008 (the“**Effective Date**”), by and betweenWyeth, a corporation organized and existing under the laws of the State ofDelaware and having a place of business at 500 Arcola Road, Collegeville,Pennsylvania 19426 (“**Wyeth**”),acting through its Wyeth Pharmaceuticals Division, and Advanced Life SciencesHoldings, Inc., a corporation organized and existing under the laws of theState 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 hereinindividually as a “**Party**” andcollectively as the “**Parties**”.

 

WHEREAS, Wyethis engaged in the research, development and commercialization of pharmaceuticaland health care products;

 

WHEREAS, ADLScontrols proprietary rights related to cethromycin, an antibiotic from theketolide class;

 

WHEREAS, Wyethand ADLS desire to collaborate to develop, manufacture and commercializeproducts for the Territory (as defined below) based on cethromycin, asdescribed herein;

 

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

 

**1.****                                      DEFINITIONS.**

 

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

 

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

 

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

 

**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 AffiliatesControls as of the Effective Date or that comes into the Control of ADLS or anyof its Affiliates during the Term (other than through the grant of a license byWyeth) and (ii) is necessary or useful in the discovery, synthesis,research, use, Development, Manufacture or Commercialization of any Compound orany Product.

 

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

 

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

 

**1.6.         ADLS Patent Rights. **“**ADLSPatent Rights**” shall mean any Patent Right, other than any JointPatent Right, that (i) ADLS or any of its Affiliates Controls as of theEffective Date or that comes into the Control of ADLS or any of its Affiliatesduring the Term (other than through the grant of a license by Wyeth) and (ii) isnecessary 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 theEffective Date include without limitation those set forth on Exhibit 1.6attached hereto.

 

**1.7.         ADLS Product Data orFilings. **“**ADLS Product Data or Filings**” shall havethe 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 meanany agreement between ADLS and any Third Party under which ADLS obtains rightsin or to any Licensed Right.  Those ADLSThird Party Agreement(s) in existence as of the Effective Date are listedon Exhibit 1.10.

 

**1.11.       Affiliate(s). **“**Affiliate(s)**”****shall mean, with respect to any Person or entity, any otherPerson or entity that controls, is controlled by or is under common controlwith such Person or entity.  A Person orentity shall be regarded as in control of another entity if it owns or controlsmore than fifty percent (50%) of the equity securities of the subject entityentitled to vote in the election of directors (or, in the case of an entitythat is not a corporation, for the election of the corresponding managingauthority), provided, however, that the term “Affiliate” shall not includesubsidiaries or other entities in which a Party or its Affiliates owns amajority of the ordinary voting power necessary to elect a majority of theboard of directors or other managing authority, but is restricted from electingsuch majority by contract or otherwise, until such time as such restrictionsare 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) consecutivecalendar 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 successiveperiod 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 respectto a Party, (i) a merger, reorganization or consolidation of such Partywith a Third Party which results in the voting securities of such Partyoutstanding immediately prior thereto ceasing to represent at least fiftypercent (50%) of the combined voting power of the surviving entity immediatelyafter such merger, reorganization or consolidation, (ii) a Third Partybecoming the beneficial owner of fifty percent (50%) or more of the combinedvoting power of the outstanding securities of such Party or (iii) the saleor other transfer of all or substantially all of such Party’s business orassets 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 asactive ingredients both (a) any Compound and (b) one or more otherpharmaceutically 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 5.2hereof.

 

**1.21.       Commercialization. **“**Commercialization**”****or****“**Commercialize**” shall mean to use, haveused, offer for sale, have offered for sale, sell, have sold, import, haveimported and otherwise commercialize a product, including activities directedto obtaining pricing and reimbursement approvals for, marketing, promoting ordistributing a product. Commercialization shall not include any activities related toManufacturing or Development.

 

**1.22.       Commercially Reasonable Efforts. **“**Commercially Reasonable Efforts**” shallmean, with respect to the efforts to be expended by a Party with respect to anyobjective, those reasonable, diligent, good faith efforts to accomplish suchobjective as such Party would normally use to accomplish a similar objectiveunder similar circumstances.  Withrespect to any objective relating to the Development, Manufacture orCommercialization of a Product by Wyeth, generally or with respect to anyparticular country in the Territory, “Commercially Reasonable Efforts” shallmean those efforts and resources normally used by Wyeth, in the Territory or insuch country, as the case may be, with respect to a product owned or controlledby Wyeth, or to which Wyeth has similar rights, which product is of similarmarket potential in the Territory or in such country, as the case may be, andis at a similar stage in its development or life as is such Product, taking intoaccount issues of safety, efficacy, product 

 

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profile, thelikelihood of obtaining regulatory approvals, including satisfactoryreimbursement or pricing approvals for such product in the Territory or suchcountry, as the case may be, and the timing of such approvals, the current andprojected competitiveness of the marketplace for such product in the Territoryor in such country, as the case may be, the proprietary position andanticipated exclusivity of such product in the Territory or in such country, asthe case may be, the existing or projected sales and profitability of such productin the Territory or such country, as the case may be, and other relevantcommercial factors.  To the extent thatthe performance of a Party’s obligations hereunder is adversely affected by theother Party’s failure to perform its obligations hereunder, the impact of thefailing Party’s failure shall be taken into account in determining whether theother Party has used its Commercially Reasonable Efforts to perform any suchaffected obligations.

 

**1.23.       Commercial Payment. **“**Commercial Payment**” shall have the meaningset forth in Section 5.2.3.

 

**1.24.       Competing Product. **“**Competing Product**” shall mean, with respectto any Product, any product that contains an active ingredient that issubstantially the same as a Compound (or any analog or other pharmaceuticallyacceptable 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 activeingredient shall not be considered to be separate, distinct and different froma Compound solely on the basis of its method of production, method of deliveryor dosage level.

 

**1.25.       Compound. **“**Compound**”****means the compound set forth on Exhibit 1.25attached hereto, also known as cethromycin, or any prodrug or other pharmaceuticallyacceptable 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 shallmean all Know-How or other information, including, without limitation,proprietary information and materials (whether or not patentable) regardingsuch Party’s technology, products, business or objectives that is communicatedin any way or form by the Disclosing Party to the Receiving Party, either priorto or after the Effective Date of this Agreement, and whether or not suchKnow-How or other information is identified as confidential at the time ofdisclosure.  Subject to Section 7.3below, the terms and conditions of this Agreement shall be consideredConfidential 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 anyintellectual property right (including, without limitation, any Know-How, PatentRight or right regarding access or reference to Product Data or Filings orother data or information), possession of the ability (whether by sole or jointownership, license or otherwise, other than pursuant to this Agreement) togrant, without violating the terms of any Control Limitation Agreement, alicense, access or other right in, to or under such intellectual propertyright.

 

**1.29.       Control Limitation Agreement. **“**Control Limitation Agreement**”****shall mean any agreement or arrangementwhich limits the ownership rights of a Person with respect to, or limits theability of a Person to grant a license, sublicense or other right in, to orunder, any intellectual property right.

 

**1.30.       Current Product. **“**Current Product**”****shall mean the Product the formulation of which is describedin 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 setforth in Section 6.2.1(b) hereof.

 

**1.33.       Develop. **“**Develop**”shall mean shall mean to discover, research or develop a product, including theuse of any licensed right for the purpose of conducting any such discovery,research or development.  When used as anoun, “Development” shall mean any and all activities involved inDeveloping.  Develop and Developmentshall include, without limitation, conducting non-clinical and clinicalresearch and development activities such as toxicology, pharmacology and otherdiscovery efforts, test method development and stability testing, processdevelopment, formulation development, delivery system development, qualityassurance and quality control development, statistical analysis, clinicalstudies (including pre- and post-approval studies), regulatory affairs,pharmacovigilance and all activities directed to obtaining any RegulatoryApproval.

 

**1.34.       Development Program. **“**Development Program**”****shall mean the Development of Productspursuant 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 12.14.2hereof.

 

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

 

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**1.38.       Executive Officers. **“**Executive Officers**” shall mean anappropriate senior level executive designated by Wyeth (or an executive ofWyeth or an Affiliate of Wyeth designated by such senior level executive) andthe President of ADLS (or an officer of ADLS or an Affiliate of ADLS designatedby such President).

 

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

 

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

 

**1.41.       First Commercial Sale. **“**First Commercial Sale**” shall mean, withrespect to any Product and any country of the Territory and any indication, thefirst sale of such Product under this Agreement by Wyeth, its Affiliates or itsSublicensees to a Third Party in such country, after such Product has beengranted Regulatory Marketing Approval and Regulatory Pricing Approval for suchindication by the competent Regulatory Authorities in such country.  When used without reference to a specifiedindication, First Commercial Sale shall mean the First Commercial Sale for anyindication.

 

**1.42.       First Party. **“**First Party**” shall have the meaning set forthin 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.**  “**GenericProduct**” shall mean any product containing Compound as as an activeingredient.

 

**1.45.       Global Development Plan. **“**Global Development Plan**” shall have themeaning as set forth in Section 4.2.

 

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

 

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

 

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

 

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

 

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

 

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

 

**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 otherknow-how, whether or not patentable.

 

**1.54.       Label. **“**Label**”shall mean product labeling in accordance with all applicable RegulatoryApprovals.

 

**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 setforth in Section 5.2.1(a).

 

**1.57.       Leading Party. **“**Leading Party**” shall have the meaning setforth 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 ofADLS or any of its Affiliates in the ADLS Patent Rights, the ADLS Know-How andthe Joint Technology.

 

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

 

**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 testingand 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 1.64hereof.

 

**1.64.       Net Sales**.  “**Net Sales**”shall mean the gross amount actually received for any sale of any Product byWyeth, 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, ineach case to the extent specifically related to the Product and taken by theSelling Person or otherwise paid for or accrued by the Selling Person (“**Permitted Deductions**”):

 

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

 

(ii)        taxes on sales (such asexcise, sales or use taxes or value added taxes) to the extent imposed upon andpaid directly with respect to the sales price (and excluding national, sales orlocal taxes based on income);

 

(iii)       freight, insurance, packingcosts and other transportation charges to the extent included in the invoiceprice to the buyer;

 

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

 

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

 

(vi)       documented custom dutiesactually paid by the Selling Person.

 

Such PermittedDeductions shall be determined in accordance with GAAP.

 

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

 

If a Productis sold as part of a Combination Product (in each case, a “**Combination Sale**”), the Net Sales amountfor the Product sold in such a Combination Sale shall be that portion of thegross amount actually received for such Combination Sale (less all PermittedDeductions) determined as follows:

 

Except asprovided below, the Net Sales amount for a Combination Product shall equal thegross amount actually received for the Combination Sale, reduced by thePermitted Deductions (the “**Net CombinationSale Amount**”), multiplied by the fraction **A/(A+B)**, where:

 

**A**is the Wholesale Acquisition Cost, in the countrywhere such Combination Sale occurs, of the Product contained in the CombinationProduct, if sold as a separate Product in such country by the Selling Person,and **B** is the aggregate 

 

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WholesaleAcquisition Cost(s), in such country, of such other products or activeingredients/components, as the case may be, included in the Combination Productif sold separately in such country by the Selling Person.

 

In the event that the Selling Person sells the Product included in aCombination Product as a separate Product in a country, but does not separatelysell all of the other products or active ingredients/components, as the casemay be, included in such Combination Product in such country, the calculationof Net Sales resulting from such Combination Sale shall be determined bymultiplying the Net Combination Sale Amount by the fraction **A/C** where:

 

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

 

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

 

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

 

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

 

Where thecalculation of Net Sales resulting from a Combination Sale in a country cannotbe determined by any of the foregoing methods, the calculation of Net Sales forsuch Combination Sale shall be that portion of the Net Combination Sale Amountreasonably determined in good faith by Wyeth in consultation with ADLS asproperly reflecting the value of the Product included in the CombinationProduct.

 

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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) packagedtogether with another Product or (ii) in a Combination Product formalone), the Net Sales for such Product shall be based on the ratio of theWholesale Acquisition Cost for such Product to the sum of the WholesaleAcquisition Costs for each product in such bundle.  By way of example, if the WholesaleAcquisition Cost for such Product when sold separately is $10, and the sum ofthe Wholesale Acquisition Costs for each product in such bundle when soldseparately if $40, then the Net Sales attributable to the Product when sold aspart of the bundle would be twenty-five percent (25%) of the Net Sales of thebundle of products sold by the Selling Person.

 

Notwithstandingthe foregoing, Net Sales shall not include any consideration received by Wyeth,its Affiliates or its Sublicensees in respect of the sale, use or otherdisposition of a Product in a country as part of a clinical trial prior to thereceipt of all Regulatory Marketing Approvals required to commence commercialsales of such Product in such country.

 

Productsprovided by Wyeth, its Affiliates or Sublicensees free of charge, as samples,for administration to patients enrolled in clinical trials or distributed througha not-for-profit foundation or other compassionate use program at no charge toeligible patients, shall not be included in Net Sales, provided that Wyeth, itsAffiliates 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 themeaning 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, allprovisional 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 futureextension or restoration mechanisms, including, without limitation,supplementary protection certificates or the equivalent thereof, (d) inventor’scertificates, (e) any other form of government-issued right substantiallysimilar to any of the foregoing; and (f) all United States and foreigncounterparts of any of the foregoing.

 

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

 

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

 

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

 

**1.70.       Product. **“**Product**”****shall mean any pharmaceutical productcontaining a Compound, including, but not limited to, any formulation of anyCompound (including, but not limited to, oral formulations, oral suspensionformulations and intravenous formulations) and any Product Improvement.  “Product” includes, without limitation, anyCombination Product but does not include any separately formulatedpharmaceutical product not containing a Compound, even if such product is soldtogether with a Product.

 

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

 

**1.72.       Product Improvement. **“**Product Improvement**” shall mean anyalternative or improved dosage form of a Compound (e.g., a different dosagestrength or a novel formulation technology) that ADLS may develop or licensefor a Compound.

 

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

 

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

 

**1.75.       Recall. **“**Recall**”****shall mean, with respect to anypharmaceutical product, a “recall,” “product withdrawal,” “stock recovery,”“seizure” or any similar term as utilized by any Regulatory Authority undersuch Regulatory Authority’s procedures regarding the recall of pharmaceuticalproducts, as the same may be amended from time to time, and shall include anyrelated post-sale warning or mailing of information regarding such product,including any warnings or mailings described in the Regulatory Authority’sproduct 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.**   “**RegulatoryApproval**”****means anytechnical, medical, scientific or other license, registration, authorization orapproval 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 anypharmaceutical product or proposed pharmaceutical product.

 

**1.78.       Regulatory Authority.  **“**Regulatory Authority**” shall mean, withrespect to any national, supra-national, regional, state or local regulatoryjurisdiction, any agency, department, bureau, commission, council or othergovernmental entity involved in the granting of a Regulatory Approval for suchjurisdiction.

 

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

 

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

 

**1.81.       Regulatory Pricing Approval. **“**Regulatory Pricing Approval**”****shall mean, with respect to any Product inany regulatory jurisdiction, and for any indication, the achievement of allapplicable pricing and reimbursement approvals with respect to such Product insuch jurisdiction and for such indication.

 

**1.82.       Right of First Offer. **“**Right of First Offer**” shall have themeaning specified in Section 12.15.

 

**1.83.       Right of Reference. **“**Right of Reference**” shall mean a “Right ofReference,” as that term is defined in 21 C.F.R. § 314.3(b) and anycomparable 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 acountry-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 ina country for any indication until the latest of (i) the end of anyregulatory data exclusivity period

 

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

 

**1.87.       Second Party. **“**Second Party**” shall have the meaning setforth 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 3.1.1hereof.

 

**1.90.       Stock Purchase Agreement. **“**Stock Purchase Agreement**” shall mean theStock Purchase Agreement dated as of the Effective Date by and between Wyethand 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 meaningset 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, Vietnamand, if Wyeth accepts an Offer pursuant to Section 12.15, [***].

 

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

 

**1.96.       Third Party. **“**Third Party**” shall mean any Person otherthan 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, tradedress, design, logo, slogan, house mark or name used in connection with themarketing of a product, including, without limitation, any registration orapplication for registration of any of the foregoing.

 

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**1.99.       Transition Date. **“**Transition Date**”****shallhave the meaning set forth in Section 5.3.2 hereof.

 

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

 

**1.101.     Wholesale Acquisition Cost. **“**Wholesale Acquisition Cost**” for any product shall mean thelist price for wholesalers, distributors and other direct accounts before anyrebates, discounts, allowances or other price concessions that might be offeredby the supplier of the product.

 

**1.102.     Wyeth Indemnified Party. **“**Wyeth Indemnified Party**”****shallhave 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**”****shallmean any Know-How (other than the Joint Know-How) Controlled by Wyeth or any ofits Affiliates during the Term (other than through the grant of a license byADLS) pertaining to the composition of, or any method of making or using, orany Patent Right (other than a Joint Patent Right) Controlled by Wyeth or anyof its Affiliates during the Term (other than through the grant of a license byADLS) that covers or claims, any alternative or improved dosage form of aCompound (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 hasreceived, directly or indirectly, from Wyeth, a sublicense of any rightlicensed to Wyeth by ADLS hereunder.

 

**2.****                                   ****LICENSES AND RELATED GRANTS OF RIGHTS.**

 

**2.1.        LicensesGranted to Wyeth.**

 

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

 

**(a)          **A non-exclusivelicense to Develop and have Developed, in all countries throughout the world,Compounds and Products for Commercialization in the Territory, and toManufacture and have Manufactured, in all countries throughout the world, anysuch Compound or Product for use in such Development.

 

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**(b)          **An exclusivelicense (exclusive even as to ADLS and its Affiliates except as necessary tofulfill their obligations under this Agreement) to Commercialize Compounds andProducts in the Territory and, subject to the obligation to purchase Productfrom 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 suchCommercialization.

 

**2.1.2.      Sublicenses.**  Wyeth may grant and authorize sublicenseswithin the scope of the rights conveyed to Wyeth pursuant to Section 2.1.1.  Wyeth shall give ADLS prompt written noticeof each such sublicense, identifying the applicable Sublicensee, Productssublicensed, territory and scope of rights granted.  Wyeth shall be responsible to ensure thateach Sublicensee complies with all applicable terms and conditions of thisAgreement.

 

**2.1.3.      Trademark License. **Subject to the terms andconditions of this Agreement, ADLS, effective as of the Effective Date, herebygrants to Wyeth an exclusive, royalty-free license to use any Product Trademark(s) solelyin connection with Commercialization of Products in the Territory.  With respect to any Trademark Controlled by aLicensee and used by such Licensee in connection with the Commercialization ofProducts in the United States or Europe, other than any corporate name orcorporate logo of such Licensee or any Trademark used by such Licensee toidentify products other than Products (each, a “**Licensee Trademark**”), ADLS shall use Commercially ReasonableEfforts to obtain from such Licensee a written agreement confirming ADLS’ rightto include such Trademark in the Product Trademarks licensed to Wyeth asprovided in this Section 2.1.3.

 

**2.1.4.      Direct Licenses to Affiliates.**  Wyeth may at any time request and authorizeADLS to grant licenses directly to Affiliates of Wyeth by giving written noticedesignating to whom a direct license is to be granted.  Upon receipt of any such notice, ADLS shallenter into and sign a separate agreement with such designated Affiliate ofWyeth conveying such direct license for so long as such Affiliate remains anAffiliate of Wyeth.  All such directlicense agreements shall be consistent with the terms and conditions of thisAgreement, except for such modifications as may be required by the laws andregulations in the country in which the direct license will be exercised.  In countries where validity of the directlicense agreement requires prior government approval or registration, suchdirect license agreement shall not become binding between the parties theretountil such approval or registration is granted, which approval or registrationshall be obtained by Wyeth.  Allout-of-pocket costs incurred in granting a direct license, including ADLS’reasonable attorneys’ fees, 

 

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under this Section 2.1.4shall be borne by Wyeth.  Wyeth shallcause any such Affiliate to make all payments required to be made to ADLS andto satisfy all other obligations of such Affiliate to ADLS under any suchagreement and shall remain directly liable to ADLS for any breaches of any suchagreement by its Affiliate.  In the eventthat any such direct license results in the imposition on ADLS of any taxes in excessof those that would be imposed if Wyeth had granted a sublicense to suchAffiliate, Wyeth shall be obligated to pay to ADLS such amounts as may benecessary to “gross up” payments to ADLS to account for such additionaltaxes.  Any progress reports and royaltystatements to be provided under this Agreement shall be consolidated by Wyethto one single report and statement for all Affiliates of Wyeth.

 

**2.2.         Rights ofReference**.  ADLS andWyeth shall have Rights of Reference as set forth in Section 4.4.

 

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

 

**2.4.         LicensesGranted to ADLS.**

 

**2.4.1.      License for Compounds and Products.** Subject to the terms and conditions of thisAgreement, Wyeth, effective as of the Effective Date, hereby grants to ADLSunder any Wyeth Product Improvement, with the right to grant sublicenses as andto the extent provided in Section 2.4.2, the following royalty-freelicenses:

 

**(a)        **A non-exclusivelicense to Develop and have Developed, in all countries throughout the world,Products for future Commercialization outside the Territory, and to Manufactureand have Manufactured, in all countries throughout the world, any such Productfor use in such Development.

 

**(b)        **A non-exclusive license toCommercialize Products outside the Territory and to Manufacture and haveManufactured, in all countries throughout the world, Products solely for use orsale 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, ADLSmay sublicense any right licensed to ADLS by Wyeth in Section 2.4.1 to anyADLS Licensee.  ADLS shall give Wyethprompt written notice of each such sublicense, identifying the applicable ADLSLicensee, Products sublicensed, territory and scope of rights granted.  ADLS shall ensure that each such ADLSLicensee complies with all applicable terms and conditions of this Agreement.

 

**2.5.         JointTechnology.**  The Partiesmay exploit Joint Technology as provided in Section 6.1.

 

**2.6.         365(n) of U.S. Bankruptcy Code**.   All rights and licenses now or hereaftergranted by ADLS to Wyeth under or pursuant to any Section of thisAgreement, including, without limitation, Sections 2.1, 2.2, 2.3 and 2.4hereof, 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 itsAffiliates a right to access and to obtain possession of and to benefit fromand, in the case of any biological material or other tangible item of whichthere is a fixed or limited quantity, to obtain a pro rata portion of, each ofthe following to the extent related to any Compound or Product, or otherwiserelated to any right or license granted under or pursuant to this Agreement: (i) copiesof pre-clinical and clinical research data and results, (ii) all of thefollowing (to the extent that any of the following are so related): cell lines,antibodies, assays, reagents and other biological materials, (iii) productsamples and inventory, (iv) ADLS Technology, (v) laboratory notes andnotebooks, (vi) data and results related to clinical trials, (vii) ProductData or Filings, and (viii) Rights of Reference in respect of regulatoryfilings and approvals, all of which constitute “embodiments” of intellectualproperty pursuant to Section 365(n) of the Bankruptcy Code, and (xi)all other embodiments of such intellectual property, whether any of theforegoing are in ADLS’ possession or control or in the possession and controlof any Third Party but which ADLS has the right to access or benefit from andto make available to Wyeth.  ADLS shallnot interfere with the exercise by Wyeth or its Affiliates of rights andlicenses to intellectual property licensed hereunder and embodiments thereof inaccordance with this Agreement and agrees to use Commercially ReasonableEfforts to assist Wyeth and its Affiliates to obtain such intellectual propertyand embodiments thereof in the possession or control of Third Parties asreasonably necessary or desirable for Wyeth or its Affiliates to exercise suchrights and licenses in accordance with this Agreement.  The Parties hereto acknowledge and agree thatthe payments provided for under Section 5.2, and all other payments byWyeth to ADLS hereunder, other than royalty payments pursuant to Section 5.3,do not constitute royalties within the meaning of Section 365(n) ofthe Bankruptcy Code or relate to licenses of intellectual property hereunder.

 

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**2.7.         No Implied Rights.**  Except as expressly provided in thisAgreement, neither Party shall be deemed by estoppel or implication to havegranted the other Party any license or other right with respect to anyintellectual property of such Party.

 

**3.****                                   ****DECISION MAKING AND DISPUTE RESOLUTION.**

 

**3.1.        SteeringCommittee.**

 

**3.1.1.      Formation of the Steering Committee. **ADLS and Wyeth shallestablish a “**Steering Committee**”to facilitate communications regarding the Development of Products by theParties and to oversee, direct and coordinate the activities of the Partiesunder this Agreement in regard to the Development Program.  The Steering Committee shall also serve as aforum to facilitate communications between the Parties regarding Developmentactivities and Development of Products worldwide.  The Steering Committee shall be comprised ofup to four (4) representatives from each Party as appointed by suchParty.  The Steering Committee may changeits size from time to time by mutual consent of its members.  A Party may replace one or more of itsrepresentatives from time to time upon written notice to the other Party.  Each Party, respectively, shall designate itsinitial members of the Steering Committee within thirty (30) days after theEffective Date.  The Steering Committeeshall exist until the completion of the ADLS Study, the [***] Study and anyother studies included under the Global Development Plan, unless the Partiesotherwise agree in writing.  Followingtermination of the Steering Committee, each Party shall continue to have anapproval right with respect to matters specified to be decided by the SteeringCommittee under this Agreement.  In suchevent, if the Parties are unable to reach agreement on a matter specified inthis Agreement to have been decided by the Steering Committee, the matter shallbe resolved in accordance with Section 3.3.3 below.

 

**3.1.2.      Chairperson; Secretary of the SteeringCommittee.**  Thechairperson and secretary of the Steering Committee shall rotate on an annualbasis between the Parties.  Thechairperson and secretary shall not be from the same Party at the same time.  The first chairperson shall be designated byWyeth.  The chairperson shall beresponsible for scheduling meetings of the Steering Committee, preparingagendas for meetings and sending to all Steering Committee members notices ofall regular meetings and agendas for such meetings at least five (5) businessdays before such meetings.  Thechairperson shall solicit input from both Parties regarding matters to beincluded on the agenda, and any matter either Party desires to have included onthe agenda shall be included for discussion. Nothing herein shall be construed to prohibit the Steering Committeefrom discussing or acting on matters not included on the applicableagenda.  

 

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

 

**3.1.3.      Meetings.** It is currently contemplated that the SteeringCommittee shall meet at least once each Calendar Quarter until it has beenterminated in accordance with Section 3.1.1 at dates and times mutuallyagreed by the Steering Committee, unless otherwise mutually agreed by theParties.  The initial meeting of theSteering Committee shall be held within ninety (90) days after the EffectiveDate.  Either Party may call a specialmeeting of the Steering Committee on fifteen (15) days written notice to theother Party’s members of the Steering Committee (or upon such shorter notice asexigent circumstances may require).  Suchwritten notice shall include an agenda for the special meeting.  In-person meetings, including, withoutlimitation, special meetings, of the Steering Committee shall alternate betweenthe offices of the Parties, unless otherwise agreed upon by the members of theSteering Committee.  Meetings of theSteering Committee may be held telephonically or by video conference; providedhowever, that at least one (1) meeting per year shall be heldin-person.  Meetings of the SteeringCommittee shall be effective only if at least one (1) representativeof each Party is in attendance or participating in the meeting.  Members of the Steering Committee shall havethe right to participate in and vote at meetings held by telephone or videoconference.  In addition, the SteeringCommittee may act on any matter or issue without a meeting if it is documentedin a written consent signed by each member of the Steering Committee.

 

**3.2.         OtherCommittees.**  The SteeringCommittee may establish additional committees to oversee specific projects oractivities or to perform certain other functions under this Agreement, and suchcommittees shall always include equal representation from each Party.

 

**3.3.        DecisionMaking.**

 

**3.3.1.      Decisions by Consensus.**  All decisions of the Steering Committee andall other committees established under this Agreement shall be made byunanimous agreement of both Parties’ representatives.  If the Steering Committee cannot or does notreach 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 3.3.3below.

 

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

 

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decision on a matter, thelower committee shall refer the matter to the Steering Committee forresolution. A matter shall be considered referred to the Steering Committee asof the date that the lower committee or either Party provides each SteeringCommittee member a written description of the disputed matter.  The Party referring such disputed matter tothe Steering Committee shall use reasonable efforts to include in the writtendescription the positions taken by each Party’s members of the lower committeeas to such matter, all other material information relevant to such matter and acopy of the minutes (if any) of the applicable lower committee meeting(s) atwhich such matter was discussed.  Withinfifteen (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 anymatter within its purview by unanimous agreement, the matter may be referred byeither Party to the Executive Officers, who shall meet promptly (and in anyevent within ten (10) days after such matter is referred to theExecutive Officers) in an effort to resolve the matter.  If, after discussion, the Executive Officersare unable to reach consensus on the matter, any matter as to which one Partyhas final decision making authority (as described below in Section 3.4)may thereafter be resolved as determined by such Party and any other matter maythereafter be resolved in accordance with Section 11.2 below.

 

**3.4.         Allocation of Final Decision Making Authority.**  Final decision making authority shall beallocated to ADLS and Wyeth in regard to certain matters, to the extent suchmatters are within the purview of the Steering Committee, as described below.  Such final decision making authority may beexercised 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 theSteering Committee level or lower committee levels.  Each Party shall exercise its final decisionmaking authority described herein in a manner consistent with the terms andconditions of this Agreement.

 

**3.4.1.      ADLS.**  To the extent decisions regarding any of thefollowing fall within the purview of the Steering Committee, ADLS shall havefinal decision making authority as described in this Section 3.4 withrespect to the following matters:

 

**(a)          **Any decisioninvolving Development of any Compound or Product for use or sale outside theTerritory;

 

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

 

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**(c)          **Any decision relating toCommercialization of any Product outside the Territory;

 

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

 

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

 

**3.4.2.      Wyeth.**  Wyeth shall have final decision makingauthority as described in this Section 3.4 with respect to the followingmatters:

 

**(a)          **Any decisionregarding the Development of any Compound or Product for use or sale in theTerritory;

 

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

 

**(c)          **Any decision relating toCommercialization of any Product in the Territory;

 

**(d)          **Any decision regarding theManufacture by or on behalf of Wyeth or its Affiliate or Sublicensee of anyProduct for use or sale in the Territory or in any clinical study undertakenfor the purpose of obtaining any Regulatory Approval in the Territory (otherthan Manufacture by ADLS or its Affiliate or suppliers of ADLS or its Affiliateof 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 theLabel for a Product inside the Territory. Wyeth will reasonably consider, but shall have no obligation to acceptor 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 3.4.2above, (i) neither Party shall have the right to exercise its finaldecision making authority as described herein to obligate the other Party toexpend 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 mannerinconsistent with this Agreement, including the Global Development Plan, or toamend the provisions of this Agreement or the Global Development Plan, or toconvey licenses or rights to such Party beyond those rights and licensesexpressly set forth in this Agreement.

 

**3.5.         AllianceManagers**.  In additionto the foregoing governance provisions, each of the Parties shall appoint asingle individual to serve as that Party’s Alliance Manager.  The role of each Alliance Manager shall be tofacilitate the relationship between the Parties as established by thisAgreement.  The Alliance Managers shallattend meetings of the Steering Committee and support the chairperson of suchcommittee in the discharge of his or her responsibilities.  Unless otherwise determined by the SteeringCommittee, a Party’s Alliance Manager shall serve as secretary at each meetingof such committee for which the chairperson is a representative of the otherParty.  Alliance Managers shall benon-voting participants in such committee meetings.  A Party may replace its Alliance Manager fromtime to time upon written notice to the other Party.

 

**4.****                                   ****PRODUCT DEVELOPMENT, REGULATORY MATTERS, DATA SHARING AND CROSS REFERENCERIGHTS, MANUFACTURING, SUPPLY AND COMMERCIALIZATION.**

 

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

 

**4.2.         Global Development Plan. **From time to time, in orderto facilitate the Development of Products on a worldwide basis, a Party, actingthrough its representatives on the Steering Committee, may propose that certainDevelopment activities be performed in coordination between the Parties inaccordance with a written plan (the “**GlobalDevelopment Plan**”).  Ifapproved by the Steering Committee for inclusion in the Global DevelopmentPlan, such Development activities shall be incorporated in appropriate detailinto a written amendment of the Global Development Plan.  If not approved by the Steering Committee forinclusion in the Global Development Plan, such Development 

 

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activities may be performedby a Party to the extent in accordance with Section 4.1 above.  Except as expressly provided in this Agreementor agreed in writing by the Parties, each Party shall be solely responsible forthe expenses of performing its responsibilities under the Global DevelopmentPlan.

 

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

 

**4.2.2.     **During the Term, the GlobalDevelopment Plan may be updated from time to time as deemed necessary by theSteering Committee.

 

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

 

**4.3.         Initial Global Development Plan.**  The initial Global Development Plan, whichshall initially consist of the ADLS Study and the [***] Study, is attachedhereto as Exhibit 4.3.

 

**4.3.1.     **[***].

 

**4.3.2.     **[***].

 

**4.4.        DataSharing**.

 

**4.4.1.     **ADLS shall promptly discloseto and share with, or cause to be disclosed to and shared with, Wyeth, at nocost to Wyeth, each Product Data or Filing generated by or otherwise cominginto the ownership or Control of ADLS, any of its Affiliates or any ADLSLicensee in connection with the Development, Manufacture or Commercializationof Compounds or Products worldwide (the “**ADLSProduct Data or Filings**”). ADLS shall require each ADLS Licensee to allow ADLS to include in theADLS Product Data or Filings to be provided to Wyeth under this Section 4.4.1any Product Data or Filing generated by or otherwise coming into the ownershipor Control of such ADLS Licensee in connection with the Development,Manufacture or Commercialization 

 

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of Compounds orProducts.  Upon request, ADLS shallpromptly assign and transfer, or cause to be assigned and transferred, to Wyethany ADLS regulatory filing filed with any Regulatory Authority in theTerritory.

 

**4.4.2.**      Wyeth shall promptly disclose to and sharewith, 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 ownershipor Control of Wyeth, any its Affiliates or any Wyeth Sublicensee in connectionwith the Development, Manufacture or Commercialization of Compounds or Productspursuant to this Agreement.

 

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

 

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

 

**(a)          **ADLS hereby grants to Wyethand its Affiliates a Right of Reference, for regulatory filings in theTerritory (or for Manufacture, in countries outside the Territory, of Compoundsor Products for sale in the Territory, or for clinical trials related tosupporting or obtaining any Regulatory Approval in the Territory), to any ADLSProduct Data or Filing to be provided or disclosed by ADLS or its Affiliates orLicensees pursuant to Section 4.4.1, and ADLS shall, and shall require itsAffiliates and Licensees to, provide a signed statement to this effect, ifrequested by Wyeth.  Wyeth may sublicensethe Right of Reference set forth in this Section 4.4.4(a) to itsSublicensees in the Territory.

 

**(b)          **Wyeth hereby grants to ADLSand its Affiliates a Right of Reference, for regulatory filings outside theTerritory (or for Manufacture in the Territory of Compounds or Products forsale outside the Territory, or for clinical trials related to supporting orobtaining any Regulatory Approval outside the Territory) to any Product Data orFiling to be provided or disclosed by Wyeth or 

 

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

 

**4.4.5.     **Wyeth shall obtain from eachWyeth Sublicensee (i) an obligation by the Sublicensee to disclose to andshare 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 theownership or Control of such Sublicensee, and (ii) the right of ADLS, itsAffiliates and Licensees to disclose and to use such Product Data or Filings asset forth in Section 4.4.4(b).

 

**4.4.6.     **ADLS shall obtain from each ADLS Licensee (i) anobligation by such Licensee to disclose to and share with ADLS (for disclosureto and sharing with Wyeth as set forth in Section 4.4.1) any and allProduct Data or Filings generated by or otherwise coming into the ownership orControl of such Licensee, and (ii) the right of Wyeth, its Affiliates andSublicensees to disclose and to use such Product Data or Filings as set forthin Section 4.4.4(a).  Commencingupon the Effective Date, it shall be a condition to any Person becoming an ADLSLicensee that such Person agree in writing to the obligation and grant ofrights by such ADLS Licensee as set forth in this Section 4.4.6.

 

**4.5.        DevelopmentDiligence**.

 

**4.5.1.     **Wyeth shall use CommerciallyReasonable Efforts to Develop and obtain Regulatory Marketing Approval for theCurrent Product in each Major Market, provided that ADLS has successfullycompleted all Development activities to be performed by ADLS with respect tosuch Product pursuant to Section 4.5.2.  In addition, Wyeth shall use CommerciallyReasonable Efforts to perform its obligations under the Global Development Plan[***].  Wyeth shall have no diligenceobligation, express or implied, with respect to the Development of Productsexcept as provided in this Section 4.5.1.

 

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

 

**4.6.        RegulatoryApprovals**.

 

**4.6.1.     **Subject to ADLS’ obligationsunder Section 4.5.2, Wyeth shall file, in its own name and at its ownexpense, all applications for Regulatory 

 

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Approval in the Territoryfor 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 anyclinical study or other study or action necessary or desirable to obtain suchRegulatory Approval.  Wyeth shall havethe sole responsibility for communicating with any Regulatory Authority in theTerritory regarding any application for Regulatory Approval or any RegulatoryApproval once granted or any such other applications.

 

**4.6.2.**      Subject to its diligence obligations underSection 4.5.2, ADLS shall have the sole right, in its sole discretion, tofile and maintain, in its own name, all applications for Regulatory Approvaloutside the Territory for Products. Notwithstanding the foregoing, ADLS shall, or ADLS shall cause itsLicensee to, as applicable, use Commercially Reasonable Efforts to obtainRegulatory Marketing Approval for the Current Product, and ADLS shall, or ADLSshall cause its Licensee to, as applicable, use Commercially Reasonable Effortsto maintain such Regulatory Marketing Approval for the Current Product, as wellas any Regulatory Marketing Approval obtained from the FDA for any otherProduct.  If ADLS or its Licensee, asapplicable, elects not to continue to maintain any such Regulatory MarketingApproval, ADLS shall provide Wyeth with prompt written notice of the decisionnot to continue the maintenance of such Regulatory Marketing Approval insufficient time to allow Wyeth to continue the maintenance of such Regulatory MarketingApproval in a timely manner.  In suchevent, at Wyeth’s request in its sole discretion, ADLS shall, or ADLS shallcause its Licensee to, as applicable, execute such documents and perform suchacts, at no cost to Wyeth, as may be reasonably necessary (i) to assignand transfer to Wyeth all of the right, title and interest of ADLS or itsLicensee, as applicable, in and to such Regulatory Marketing Approval andrelated files and (ii) to permit Wyeth to continue the maintenance of suchRegulatory Marketing Approval.  If Wyethelects to obtain such assignment and/or continue the maintenance of suchRegulatory Marketing Approval, Wyeth may deduct from any payment to be made toADLS hereunder any expenses incurred by Wyeth in connection therewith, providedthat such deductions in aggregate shall not exceed the aggregate payments to bemade 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 meetingminutes pertaining to, all regulatory filings relating to this Section 4.6.2.

 

**4.7.         RegulatoryReporting**.  Wyeth shallbe responsible for filing, at its own expense, all reports required to be filedin order to maintain any Regulatory Approvals granted for Products in theTerritory.

 

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**4.8.        Pharmacovigilanceand Product Labeling**.

 

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

 

**4.8.2.      Pharmacovigilance**.   Wyethshall 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 safetyreports to the Regulatory Authorities as required; maintaining informationregarding 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 andsafety measures (e.g., clinical holds and restriction on distribution).

 

ADLS shall be solelyresponsible for all of the following outside the Territory or in connectionwith its clinical studies:  adverseexperience reports; literature review and associated reports; adverseexperience follow-up reports; preparation and submission of all safety reportsto the Regulatory Authorities as required; maintaining information regardingCompounds and Products for inclusion in the global safety database; allinteractions with relevant Regulatory Authorities and investigators; periodicsubmissions; risk management; safety monitoring, signal detection and safetymeasures (e.g., clinical holds and restriction on distribution).

 

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

 

·                  Fatal or life-threateningserious adverse events/adverse drug reactions judged by either the investigatoror sponsor to be reasonably related to the Compounds, Products or protocolshall be transmitted to the other Party within two (2) calendar days fromthe date received by the receiving Party.

 

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

 

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protocol shall betransmitted to the other Party within five (5) calendar days from the datereceived by the receiving Party.

 

Ifto Wyeth:

 

Facsimile:  610-989-5544

**or**

Overnight courier to:

GlobalSafety Surveillance Epidemiology & Labeling

WyethResearch

GSSELTriage Unit

Dock E

500 Arcola Road

Collegeville, PA  19426

 

Ifto ADLS:

 

Facsimile:  630-739-6754

**or**

Overnight courier to:

Advanced Life Sciences Holdings, Inc.

1440 Davey Road

Woodridge, IL 60517

**A**ttn:  Directorof Regulatory Affairs

 

**4.8.3.      ProductLabeling**.    Wyeth shall be solelyresponsible for the administrative aspects of preparing, updating andmaintaining product labeling in connection with Commercialization of Product(s) inthe 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 graphicalcontents of printed labels and labeling components, including but not limitedto healthcare professional leaflets or inserts, patient leaflets or inserts andcartons.

 

ADLS shall be solelyresponsible for the administrative aspects of preparing, updating andmaintaining product labeling in connection with Commercialization of Product(s) outsideof the Territory (and related Manufacturing of such Products).  Such labeling may include but is not limited totext 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 jointlydevelop the Developmental Core Data Sheet and Core Data Sheet for the Productsin order to achieve global labeling consistency.

 

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**4.8.4.      Pharmacovigilance Agreement**.  The Parties agree to meet promptly after theEffective Date to establish (if such agreement is mutually agreed to benecessary) a detailed pharmacovigilance agreement containing reasonable andcustomary terms that are mutually acceptable, outlining the responsibilities ofeach Party in connection with the collection and reporting of adverseexperiences and Product labeling which will supersede this Section 4.8.

 

**4.9.        Manufactureand Supply of Products.**

 

**4.9.1.      SupplyAgreement.**  Within [***]after the Effective Date, the Parties shall negotiate, draft, execute anddeliver, and the Parties shall thereafter perform their respective obligationsunder, a supply agreementpursuant to which ADLS shall supply or have supplied Wyeth’s clinical andcommercial requirements for Products in bulk (tablet or other) form andcontaining the key terms set forth in Exhibit 4.9.1 attachedhereto, as well as other reasonable and customary terms for an agreement ofsuch type (the “**Supply Agreement**”).

 

**4.9.2.      Final Labeling and Packaging of Products.**  Wyeth shall be responsible for the finallabeling and packaging of Products supplied to Wyeth under the Supply Agreementfor sale in the Territory.

 

**4.10.       Commercialization.**  Subject to the terms and conditions of thisAgreement, Wyeth shall have the sole authority and the exclusive right in theTerritory, at its expense, to Commercialize Products itself or through one ormore Affiliates or Third Parties selected by Wyeth and shall have soleauthority and responsibility in all matters relating to the Commercializationof Products in the Territory, including but not limited to:  booking sales of all Products in theTerritory, making decisions with respect to the pricing of each Product in eachcountry in the Territory and making all decisions regarding marketing of andpost-approval clinical studies for any Product in the Territory, provided,however, that prior to commencing any such post-approval clinical study, Wyethshall consult with ADLS in regard to the development of such study.  Wyeth shall use Commercially ReasonableEfforts to Commercialize the Current Product in each Major Market where Wyethhas obtained Regulatory Marketing Approval for such Product, provided that ADLShas successfully completed all Development activities to be performed by ADLSwith respect to such Product pursuant to Section 4.5.2.  Except for the foregoing, Wyeth shall have noother diligence obligations, express or implied, with respect to theCommercialization of Products.  ADLSshall have the sole authority and the exclusive right outside the Territory, atits expense, to Commercialize Products itself or through one or more Affiliatesor Third Parties selected by ADLS and shall have sole authority and responsibilityin all matters relating to the Commercialization of Products outside theTerritory, including but not limited to booking sales of all Products outsidethe Territory, making decisions with respect to the pricing of each 

 

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

 

**4.11.       Product Recalls.** Wyeth shall be solely responsible for allcontact with Regulatory Authorities relating to any Recall of any Product inthe Territory and ADLS shall be solely responsible for all contact withRegulatory Authorities related to any Recall of any Product outside of theTerritory.  The responsible Party shallbe solely responsible for implementing, directing and administering any Recallof any such Product required or recommended by any Regulatory Authority orcourt of competent jurisdiction, or determined by the responsible Party, in itssole discretion, to be necessary or advisable. Wyeth shall be responsible for the cost of any Recall of any Product inthe Territory and ADLS shall be responsible for the cost of any Recall of anyProduct outside of the Territory, except as otherwise provided in the SupplyAgreement.

 

**5.****                                   ****CONSIDERATION.**

 

**5.1.         EquityInvestment.**  Upon theEffective Date, Wyeth and ADLS shall each execute, deliver and consummate thepurchase by Wyeth and sale by ADLS of shares of ADLS’ common stock pursuant tothe terms and conditions of the Stock Purchase Agreement, and thereafter Wyethand ADLS shall perform their respective obligations thereunder.

 

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

 

**5.2.1.     Timingof Payment.**

 

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

 

**(b)          **Each Commercial Paymentpayable as provided below shall be payable with the royalty due for the fourthCalendar Quarter of the Calendar Year for which the Commercial Payment isearned.

 

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**(c)          **Each Launch Payment andCommercial Payment shall be payable one time only even if multiple Productsachieve such event.

 

**5.2.2.     Launch Payments.**

 
| **Launch Event** | ** ** | **Launch  Payment** | ** ** |
|------------------|------------|---------------------|------------|
| [***]            |       | $                   | [***]      |   |
| [***]            |       | $                   | [***]      |   |
| [***]            |       | $                   | [***]      |   |

 

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

 
| **Commercial Event** | ** ** | **Commercial  Payment** | ** ** |
|----------------------|------------|-------------------------|------------|
| [***]                |       | $                       | [***]      |   |
| [***]                |       | $                       | [***]      |   |
| [***]                |       | $                       | [***]      |   |

 

**5.3.        Royalties**.

 

**5.3.1.      Product Royalties**.  In consideration for the licenses granted toWyeth under Section 2.1 hereof, Wyeth shall pay to ADLS royalties duringthe Royalty Term for the applicable Product in the applicable country as setforth in Section 5.3.2 below, subject to the adjustments provided inSections 5.3.4 and 5.4.2 below.

 

**5.3.2.      Royalty Rates. **Except as provided inSections 5.3.4 and 5.4.2 below, Wyeth shall pay to ADLS royalties on aProduct-by-Product and country-by-country basis in the amount of the applicableroyalty rate set forth in the table below (the “**Royalty Rate**”) of the aggregate Net Sales 

 

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obtained by Wyeth, itsAffiliates or its Sublicensees from the sale of each Product in the Territoryduring the Royalty Term for such Product:

 
| ** ** | ** ** | **Royalty Rate  (% of Net Sales)** | ** ** |
|------------|------------|------------------------------------|------------|
| [***]      |       | [***]                              |       |
| [***]      |       | [***]                              |       |

 

“**Transition Date**” shall mean [***] or, if later, the last dateupon which there exists a Valid Claim, covering the use or sale of theapplicable Product in the applicable country, under the ADLS Patent Rightslicensed 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 whichADLS is obligated to pay royalties under the Abbott Agreement, provided thatADLS shall have delivered written evidence of such later date to Wyeth at leastthirty (30) days prior to [***].

 

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

 

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

 

**5.3.4.      Royalty Adjustments for Additional ThirdParty Licenses.**  In the eventWyeth determines, after good faith consultation with ADLS, that it is necessaryto obtain a license under any intellectual property right from any Third Partyin order to research, Develop, Manufacture or Commercialize any Compound orProducts pursuant to rights granted to Wyeth under this Agreement (an “**Additional Third Party License**”), Wyethshall be solely responsible for negotiating and obtaining any such AdditionalThird Party License, but shall not be obligated to do so.  Wyeth shall use Commercially ReasonableEfforts to consult with ADLS 

 

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regarding whether Wyethshould obtain such rights as part of an agreement through which ADLS or itslicensee obtains similar rights, provided, however, that Wyeth shall have noobligation to do so.  Wyeth may deduct fromthe royalties payable under Section 5.3.2 on the Net Sales of any Product[***], provided that such deduction shall not reduce the royalties payableunder Section 5.3.2 to less than [***] of the amount that would otherwisebe payable to ADLS.  [***].  Except for any permitted deduction describedin this Section 5.3.4, Wyeth shall be solely responsible for all costs ofany such Additional Third Party Licenses.

 

**5.3.5.      Other Third Party Agreements**.  ADLS shall be solely responsible for allpayment obligations related to the ADLS Technology under its licenses and otheragreements with Third Parties that are in effect as of the Effective Date,including, without limitation, those obligations arising under the ADLS ThirdParty Agreements.  If after the EffectiveDate ADLS enters into any license or other agreement with a Third Partyrelating to any Compound or Product, ADLS shall use Commercially ReasonableEfforts to obtain in such license or other agreement the right to sublicensethe rights granted under such license or other agreement to Wyeth under thisAgreement.  ADLS shall use CommerciallyReasonable efforts to consult with Wyeth prior to entering into any suchlicense or agreement and to allow Wyeth to obtain such rights either throughADLS or directly from such Third Party. Any payment made to such a Third Party or any additional payment made toADLS in order to obtain such rights shall be treated as a payment made for anAdditional Third Party License pursuant to Section 5.3.4.

 

**5.3.6.     **[***]

 

**5.4.        Reportsand Payments**.

 

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

 

**5.4.2.      Royalty Statements and Payments**.  Within [***] after the end of each CalendarQuarter [***], Wyeth shall deliver to ADLS a report setting forth for suchCalendar Quarter the following information, on a country-by-country basis: (a) theNet Sales of each Product in each country, (b) the basis for anyadjustments to the royalty payable for the sale of each Product, (c) theroyalty due hereunder for the sale of each Product and the resulting totalroyalty due for the sale of all Products during such Calendar Quarter, in eachcase prior to the application of the provisions of this Section 5.4.2, (d) thetransfer price (determined as provided in 

 

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Exhibit 4.9.1 attachedhereto) paid by Wyeth to ADLS for the supply of Products under the SupplyAgreement during such Calendar Quarter and any Wyeth Manufacturing Costincurred during such Calendar Quarter, (e) [***] and (f) thewithholding taxes, if any, required by law to be deducted in respect of theroyalties payable to ADLS after giving effect to the provisions of this Section 5.4.2.  The total royalty due for the sale ofProducts during any Calendar Quarter shall be reduced by [***].  No report shall be required with respect toany Calendar Quarter in which both (x) there are no Net Sales of Productsin the Territory and (y) there is no transfer price paid or payable byWyeth to ADLS for the supply of Products under the Supply Agreement or WyethManufacturing 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 thetime the royalty report for such Calendar Quarter is delivered.

 

**5.4.3.      Taxes and Withholding**.  All payments under this Agreement shall bemade in full without any deduction or withholding for or on account of any taxunless such deduction or withholding is required by applicable laws orregulations.  If Wyeth is so required todeduct or withhold, Wyeth will (a) promptly notify ADLS of suchrequirement, (b) pay to the relevant authorities the full amount requiredto be deducted or withheld promptly upon the earlier of determining that suchdeduction or withholding is required or receiving notice that such amount hasbeen assessed against ADLS, (c) promptly forward to ADLS an officialreceipt (or certified copy) or other documentation reasonably acceptable toADLS evidencing such payment to such authorities and (d) cooperatereasonably, as ADLS may request (at ADLS’ expense), in efforts of ADLS toobtain a refund or otherwise recover such withheld taxes.

 

**5.4.4.      Currency**.  All amounts payable and all calculations madehereunder shall be paid and made in United States dollars.  As applicable, Net Sales and any royaltydeductions shall be converted into United States dollars in accordance withWyeth’s customary and usual currency conversion procedures, consistentlyapplied.

 

**5.4.5.      Method of Payment**.  All payments by one Party to the other Partyunder this Agreement shall be made by wire transfer in immediately availablefunds to such account as the receiving Party shall designate before suchpayment is due (which account the receiving Party may from time to time changeupon written notice to the paying Party).

 

**5.4.6.      Additional Provisions Relating toRoyalties**.  Each Partyacknowledges and agrees that nothing in this Agreement (including, withoutlimitation, any exhibits or attachments hereto) shall be construed 

 

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as representing an estimateor projection of either (a) the number of Products that will or may besuccessfully Developed or Commercialized by either Party or (b) theanticipated sales or the actual value of any Product, and that the figures setforth in Section 5.2.3 or elsewhere in this Agreement or the exhibitshereto or that have otherwise been discussed by the Parties are merely intendedto define Wyeth’s payment obligations to ADLS in the event such salesperformance is achieved.  NEITHER PARTYMAKES ANY REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED, THAT WYETHWILL BE ABLE TO SUCCESSFULLY DEVELOP OR COMMERCIALIZE ANY PRODUCT OR, IFCOMMERCIALIZED, THAT WYETH WILL ACHIEVE ANY PARTICULAR SALES LEVEL OF SUCHPRODUCT(S).

 

**5.5.        Maintenanceof Records; Audits**.

 

**5.5.1.      RecordKeeping**.  Wyeth shall keep complete andaccurate books and accounts of record in connection with the sale of Products,in sufficient detail to permit accurate determination of all figures and other informationnecessary for verification of royalties and other amounts to be paidhereunder.  Wyeth shall maintain suchbooks and records for a period of at least three (3) years****after the end of the Calendar Year inwhich they were generated.

 

**5.5.2.      Audits**.  Upon thirty (30) days prior written noticefrom ADLS, Wyeth shall permit an independent certified public accounting firmof nationally recognized standing selected by ADLS and reasonably acceptable toWyeth to examine, at ADLS’ sole expense, the relevant books and records ofWyeth and Wyeth’s Affiliates as may be reasonably necessary to verify theaccuracy of the reports submitted by Wyeth in accordance with Section 5.4and the payment of royalties and Commercial Payments hereunder based on NetSales.  An examination by ADLS under thisSection 5.5.2 shall occur not more than once in any Calendar Year andshall be limited to the pertinent books and records for any Calendar Yearending not more than three (3) years before the date of the request.  The accounting firm shall be provided accessto 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 beconducted during Wyeth’s and Wyeth’s Affiliate’s normal business hours.  Wyeth may require the accounting firm to signa standard non-disclosure agreement before providing the accounting firm accessto Wyeth’s and Wyeth’s Affiliate’s facilities or books and records.  Upon completion of the audit, the accountingfirm shall provide both Wyeth and ADLS a written report disclosing whether thereports submitted by Wyeth are correct or incorrect, whether the royalties andother amounts paid hereunder are correct or incorrect and, in each case, theamount of any discrepancies and specific details concerning each suchdiscrepancy (if any).

 

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**5.5.3.      Underpayments/Overpayments**.  If such accounting firm correctly concludesthat additional royalties or Commercial Payment(s) were due to ADLS, Wyethshall pay to ADLS such additional royalties or Commercial Payment(s) (togetherwith applicable interest at [***]) within thirty (30) days of the date Wyethreceives such accountant’s written report so concluding.  In the case of such an underpayment, if suchaudit determines that the amount due is at least [***] more than the amountactually paid for the applicable period audited, Wyeth also shall reimburseADLS for the out-of-pocket expenses incurred in conducting the audit.  If such accounting firm concludes that Wyethoverpaid royalties or Commercial Payment(s) to ADLS, ADLS, within thirty(30) days of the date it receives such accountant’s report so concluding, willrefund such overpayments to Wyeth.

 

**5.5.4.      Confidentiality**.  All financial information of Wyeth which issubject to review under this Section 5.5 shall be deemed to be Wyeth’sConfidential Information subject to the provisions of Section 7 hereof,and ADLS shall not disclose such Confidential Information to any Third Party oruse such Confidential Information for any purpose other than verifying paymentsto be made by Wyeth to ADLS hereunder, provided, however*,* that such Confidential Information maybe 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 2.1hereof, any invention or Know-How made jointly by employees of both Parties (a “**Joint Invention**” or “**Joint Know-How**”) and any Patent Rightclaiming any such Joint Invention or Joint Know-How (a “**Joint Patent Right**”) shall be jointly ownedby the Parties.  All inventions andKnow-How made solely by one or more employees of a Party shall be solely ownedby such Party.  All determinations of inventorshipunder this Agreement shall be made in accordance with the patent law of theUnited States.  ADLS shall promptlydisclose to Wyeth any invention or any newly acquired or licensed Patent Rightor 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 JointTechnology under this Agreement.

 

During the Term and aftertermination of this Agreement, either Party may exploit and grant licensesunder such Party’s interest in any Joint Technology without accounting to orobtaining consent from the other Party, subject to the rights and obligationsof the Parties with respect to Joint Technology under this Agreement,including the licenses of ADLS’ interest under the Joint Technologygranted by ADLS to Wyeth under Section 2.1.1.

 

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**6.2.        PatentRights**.

 

**6.2.1.     Filing,Prosecution and Maintenance of Patent Rights.**

 

**(a)           ADLSPatent Rights**.  ADLS, atits expense, shall have the sole right but not the obligation to prepare, file,prosecute and maintain, throughout the world, all ADLS Patent Rights other thanTerritory Patent Rights using counsel of its choice.  ADLS shall have the first right but not theobligation to file or continue prosecution or maintenance of any applicationfor an ADLS Patent Right in the Territory (a “**TerritoryPatent Right**”) using patent counsel selected by ADLS and reasonablyacceptable to Wyeth.  Before filing anyTerritory Patent Right, ADLS shall give Wyeth a reasonable opportunity toreview and comment upon the text of the application.  ADLS shall consult with Wyeth with respect toany such application, shall not unreasonably refuse to address any of Wyeth’scomments with respect to such application and shall supply Wyeth with a copy ofeach such application as filed, together with notice of its filing date andserial number.  ADLS shall also keepWyeth advised of the status of prosecution of all such patent applicationsincluded within the ADLS Patent Rights and shall reasonably consider timelycomments of Wyeth with respect thereto, and provide Wyeth with a reasonableopportunity to comment on all material correspondence received from and allmaterial submissions to be made to any government patent office or authoritywith respect to any such patent application or patent.  In addition, if ADLS elects not to file inany country in the Territory a patent application on ADLS Know-How that, iffiled, would be a Territory Patent Right, or to cease the prosecution ormaintenance of any Territory Patent Right in the Territory, ADLS shall provideWyeth with prompt written notice upon the decision to not file or continue theprosecution of such patent application or maintenance of such patent insufficient time to allow Wyeth to file, continue prosecution of suchapplication or maintain such patent in a timely manner.  In such event, ADLS shall permit Wyeth, atWyeth’s sole discretion, to file or continue prosecution or maintenance of suchTerritory Patent Right in the applicable country on ADLS’ behalf and at Wyeth’sown expense.  If Wyeth elects to makesuch filing and/or continue such prosecution or maintenance, Wyeth may deductfrom any payment to be made to ADLS hereunder any expenses incurred by Wyeth inconnection therewith.

 

**(b)           Joint Patent Rights**.  In the event the Parties make any JointInvention, the Parties shall promptly meet to discuss and 

 

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determine, based on theadvice of patent counsel selected jointly by the Parties, whether to seekpatent protection thereon.  If theParties jointly decide to seek patent protection on a Joint Invention, theParties 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 theextent determined jointly by the Parties, using patent counsel selected byjointly the Parties.  The ProsecutingParty shall give the other Party a reasonable opportunity to review the text ofany application with respect to such Joint Patent Right before filing, shallconsult with such other Party with respect thereto, shall not unreasonablyrefuse to address any timely comments of such other Party with respect to suchapplication and shall supply such other Party with a copy of the application asfiled, together with notice of its filing date and serial number.  The Prosecuting Party shall keep the otherParty advised of the status of the actual and prospective patent filings (including,without limitation, the grant of any Joint Patent Rights), and shall providesuch other Party with advance copies of any material official correspondencerelated to the filing, prosecution and maintenance of such patent filings.  Subject to the opt-out provisions below, theParty other than the Prosecuting Party shall reimburse the Prosecuting Partyfor [***] of the out-of-pocket costs incurred by the Prosecuting Party inpreparing, filing, prosecuting and maintaining such Joint Patent Rights, whichreimbursement will be made pursuant to invoices submitted by the ProsecutingParty to the other Party no more often than once per Calendar Quarter.  If either Party (the “**Declining Party**”) at any time declines toshare in the costs of filing, prosecuting and maintaining any such Joint PatentRight, on a country-by-country basis, the Declining Party shall provide theother Party (the “**Continuing Party**”)with thirty (30) days prior written notice to such effect, in which event theDeclining Party shall (i) have no responsibility for any expenses incurredin connection with such Joint Patent Right in the applicable country after theend of such thirty (30) day period and (ii) if the Continuing Party electsto continue prosecution or maintenance, the Declining Party, upon theContinuing Party’s request, shall execute such documents and perform such acts,at the Continuing Party’s expense, as may be reasonably necessary (x) toassign to the Continuing Party all of the Declining Party’s right, title andinterest in and to such Joint Patent Right and (y) to permit theContinuing Party to file, prosecute and/or maintain such Joint PatentRight.  Any such Joint Patent Right shallcease to be a 

 

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Joint Patent Right and shallbecome a Patent Right of the Continuing Party.

 

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

 

**6.2.2.     Enforcementof Patent Rights.**

 

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

 

**(b)           Patent Rightsin the Territory.**  In all caseswhere such infringement occurs in the Territory or represents infringement ofany Territory Patent Right or Joint Patent Right in the Territory, except incases where any existing ADLS Third Party Agreement grants the first or soleright to prosecute such infringement to a Third Party, Wyeth shall have thefirst right, but not the obligation, to take action to obtain a discontinuanceof infringement or bring suit against a Third Party infringer of such PatentRights 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 joinADLS as a party plaintiff.  Wyeth shallbear all the expenses of any suit brought by it claiming infringement of anysuch Patent Rights.  ADLS will cooperatewith Wyeth in any such suit and shall have the right to consult with Wyeth andto participate in and be represented by independent counsel in such litigationat its own expense.  Wyeth shall incur noliability to ADLS as a consequence of such litigation or any unfavorabledecision resulting therefrom, including any decision holding any of such PatentRights invalid or unenforceable.  If,after the expiration of the foregoing [***] period (or, if earlier, the dateupon which Wyeth provides written notice that it does not plan to seek adiscontinuance or bring suit), Wyeth has not obtained a discontinuance ofinfringement of such Patent Rights or filed suit against any such Third Partyinfringer of such Patent Rights, then ADLS shall have the right, but not theobligation, to bring suit against such Third Party infringer of such 

 

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PatentRights and to join Wyeth as a party plaintiff, provided that ADLS shall bearall the expenses of such suit.  Wyethwill cooperate with ADLS in any such suit for infringement of such PatentRights brought by ADLS against a Third Party, and shall have the right toconsult with ADLS and to participate in and be represented by independentcounsel in such litigation at its own expense. ADLS shall incur no liability to Wyeth as a consequence of such litigationor any unfavorable decision resulting therefrom, including any decision holdingany of such Patent Rights invalid or unenforceable.  Neither Party shall have the right to settleany patent infringement litigation under this Section 6.2.2(b)  in amanner that diminishes the rights or interests of the other Party without theprior written consent of such other Party, such consent not to be unreasonablywithheld, conditioned or delayed.  Anyrecoveries obtained by either Party as a result of any proceeding against aThird Party infringer (where the infringement relates to the Manufacture,importation, use, offer for sale or sale of any Product) shall be allocated asfollows:

 

**(i)****                                   **Such recoveryshall first be used to reimburse each Party for all out-of-pocket costs inconnection with such litigation paid by that Party;

 

**(ii)****                               **[***];

 

**(iii)        **[***].

 

**(c)           Joint Patent Rights Outside theTerritory**.  Withrespect to any notice of a Third Party infringer of the Joint Patent Rightsoutside the Territory, the Parties shall meet as soon as reasonably practicableto discuss such infringement and determine an appropriate course of action,including an initial allocation of the fees and expenses of such course ofaction.  The Parties jointly shallappoint one of the Parties (the “**LeadingParty**”) to bring an action against such Third Party infringer orotherwise address such alleged infringement within [***] from the date ofnotice and to control such litigation or other means of addressing suchinfringement.  The other Party shallcooperate with the Leading Party in any such suit brought by the Leading Partyand shall have the right to consult with the Leading Party and participate inand be represented by independent counsel in such litigation at its ownexpense. The Leading Party shall not have the right to settle any patentinfringement litigation under this Section 6.2.2(c) in a manner thatdiminishes the rights or interests of the other Party without the prior writtenconsent of such other Party, such 

 

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

 

**6.2.3.     Infringementand Third Party Licenses.**

 

**(a)           Notice ofPotential Infringement of Third Party Rights**.  If the making, having made, importing,exporting, using, distributing, marketing, promoting, offering for sale orselling of any Product is alleged by a Third Party to infringe a Third Party’spatent or other intellectual property rights, the Party becoming aware of suchallegation 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 otherintellectual property rights, it may be desirable to obtain a license from suchThird Party with respect thereto, such Party shall promptly notify the otherParty of such determination.

 

**(b)           Option toNegotiate**.  In theevent that a Party determines that it may be desirable to obtain a licenseunder one or more patents or patent applications or other intellectual propertyrights Controlled by a Third Party (collectively, “**Third Party IP Rights**”), which Third Party IP Rights (i) relateto any Compound or any Product and (ii) if valid and issued, may, in theabsence of a license from such Third Party, be infringed by the Development,Manufacture, use or Commercialization of any Compound or Product by or onbehalf of Wyeth or any of its Affiliates or Sublicensees in the Territory oroutside of the Territory pursuant to the exercise of rights granted by ADLS toWyeth hereunder, such Party shall have the right, but not the obligation, tonegotiate and enter into an agreement with such Third Party, whereby such Partyis granted a license under such Third Party IP Rights permitting such Party topractice such Third Party IP Rights in connection with the Development,Manufacture, use or Commercialization of any Compounds or Products and theperformance of any of its obligations or the exercise of any of its rightsunder this Agreement; provided, however, that if such Party proceeds innegotiating and entering into such license agreement with such Third Party,then (a) if such Party is Wyeth, and the license agreement with such ThirdParty includes the grant of rights outside of the Territory, Wyeth shall useCommercially Reasonable Efforts to obtain the right under such licenseagreement to sublicense such Third Party IP Rights outside of the Territory toADLS, and (b) if such Party is ADLS, and the license agreement with suchThird Party includes the grant of rights in the Territory, ADLS shall useCommercially 

 

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ReasonableEfforts to obtain the right under such license agreement to sublicense suchThird Party IP Rights in the Territory to Wyeth.  The provisions of this Section 6.2.3(b) aresubject to the provisions of Sections 5.3.4 and 5.3.5.

 

**(c)           ThirdParty Infringement Suit**.  If aThird Party sues Wyeth or any of Wyeth’s Affiliates or Sublicensees (the “**Sued Party**”) alleging that the Sued Party’spractice of any right granted by ADLS to Wyeth hereunder through theDevelopment, Manufacture, use or Commercialization of any Compound or Productpursuant to this Agreement infringes or will infringe such Third Party’sintellectual property, then, upon the Sued Party’s request and in connectionwith the Sued Party’s defense of any such Third Party infringement suit, ADLSshall provide reasonable assistance to the Sued Party for such defense at theSued Party’s expense.  The Sued Partyshall be solely responsible for expenses incurred in defending against any suchsuit 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 writtennotice to the other of any certification of which it becomes aware filedpursuant to any statutory or regulatory requirement in any country in theTerritory similar to 21 U.S.C. § 355(b)(2)(A) or § 355(j)(2)(A)(vii) (orany amendment or successor statute thereto) claiming that any ADLS Patent Rightor Joint Patent Right covering any Compound or Product is invalid or thatinfringement will not arise from the Development, Manufacture, use orCommercialization in the Territory of such Compound or Product by a ThirdParty.  Upon the giving or receipt ofsuch notice, Wyeth shall have the first right, but not the obligation, to bringan infringement action against such Third Party.  In such a case, Wyeth shall notify ADLS atleast ten (10) days prior to the date set forth by statute or regulationof its intent to exercise, or not exercise, this right.  Any infringement action against a Third Partyarising 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 reasonablycooperate with each other in obtaining patent term restoration in any countryin the Territory under any statute or regulation equivalent or similar to 35U.S.C. § 156, where applicable to the ADLS Patent Rights and Joint PatentRights.  If any election with respect toseeking such patent term restoration is to be made in any country in theTerritory during the Term with respect to such country, Wyeth shall make suchelection (including, without limitation, by filing supplementary protectioncertificates and any other extensions that are now or in the future becomeavailable) and ADLS shall abide by such election and cooperate, as 

 

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reasonablyrequested by the Wyeth, in connection with the foregoing (including, withoutlimitation, by providing appropriate information and executing appropriatedocuments).

 

**6.3.         Recording**.  If Wyeth deems it necessary or desirable toregister or record this Agreement or evidence of this Agreement with any patentoffice or other appropriate government authorities in one or more jurisdictionsin the Territory, ADLS shall reasonably cooperate to execute and deliver toWyeth any documents accurately reflecting or evidencing this Agreement that arenecessary or desirable, in Wyeth’s reasonable judgment, to complete suchregistration or recordation.  Wyeth shallreimburse 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, selectand own all product-related Trademarks and related copyrights to be used inconnection with the Commercialization of any Product hereunder in theTerritory, except to the extent that Wyeth in its discretion may determine toexercise the right granted to Wyeth by ADLS under the Trademark licenseprovided for in Section 2.1.3.  ADLSshall neither use nor seek to register, anywhere in the world, any Trademarkwhich is confusingly similar to any Trademark used by or on behalf of Wyeth orits Affiliates or Sublicensees in connection with any Product commercializedhereunder (other than any Trademark rights to which were obtained by Wyeth fromADLS under Section 2.1.3; provided, however, that nothing in this Section 6.4shall be construed to prevent ADLS from enforcing its own Trademark rights.

 

**7.****                                   ****CONFIDENTIALITY.**

 

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

 

**(a)          **was alreadyknown by the Receiving Party (other than under an obligation ofconfidentiality) at the time of disclosure by the Disclosing Party and such ReceivingParty has documentary evidence to that effect;

 

**(b)          **was generally available tothe public or otherwise part of the public domain at the time of its disclosureto the Receiving Party;

 

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**(c)          **becamegenerally available to the public or otherwise part of the public domain afterits disclosure to the Receiving Party, and other than through any act oromission of the Receiving Party in breach of this confidentiality obligation;

 

**(d)          **wasdisclosed to the Receiving Party, other than under an obligation ofconfidentiality, by a Third Party who had no obligation to the Disclosing Partynot to disclose such information to others; or

 

**(e)          **wasindependently discovered or developed by or on behalf of the Receiving Partywithout the use of or reference to the Confidential Information belonging tothe Disclosing Party and the Receiving Party has documentary evidence to thateffect.

 

**7.2.         AuthorizedDisclosure and Use.**

 

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

 

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

 

**(b)          **prosecute ordefend litigation;

 

**(c)          **exerciserights hereunder provided such disclosure is covered by terms ofconfidentiality similar to those set forth herein;

 

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

 

**(e)          **facilitatediscussions with potential financial investors in connection with an investmentin or acquisition of the Receiving Party, subject to appropriateconfidentiality agreements; or

 

**(f)           **comply withapplicable governmental laws, regulations and orders.

 

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In the eventthat the Receiving Party shall reasonably deem it necessary to disclose,pursuant to Section 7.2.1(b) or 7.2.1(f), Confidential Informationbelonging to the Disclosing Party, the Receiving Party shall to the extentpossible give reasonable advance notice of such disclosure to the DisclosingParty and take reasonable measures to ensure confidential treatment of suchinformation.

 

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

 

**7.3.         SEC or Similar Filings**.  Either Party may disclose the terms of thisAgreement and events related to the Development or Commercialization ofProducts (including the achievement of Launch Events and Commercial Events andthe payment and amount of corresponding payments, as well as the equitypurchase described in Section 5.1) to the extent reasonably required tocomply with applicable laws, rules and regulations, including, withoutlimitation, the rules and regulations promulgated by the United StatesSecurities and Exchange Commission, comparable foreign regulatory organizationsand self-regulatory organizations (such as securities exchanges).  Subject to the foregoing, before disclosingthis 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 thisAgreement to be redacted in making any such disclosure.  If a Party discloses this Agreement or any ofthe terms hereof in accordance with this Section 7.3, such disclosingParty agrees, at its own expense, to seek confidential treatment of portions ofthis Agreement, or such terms, as may be reasonably and timely requested by theother Party.

 

**7.4.         PublicAnnouncements; Publications**.

 

**7.4.1.      Coordination**.  The Parties agree on the importance ofcoordinating their public announcements respecting this Agreement and thesubject matter thereof (other than academic, scientific or medical publicationsthat are subject to the publication provision set forth below).  Subject to Section 7.3, ADLS and Wyethshall, from time to time, and at the request of the other Party, discuss andagree on the general information content relating to this Agreement which maybe publicly disclosed (including, without limitation, by means of any printedpublication or oral presentation).

 

**7.4.2.      Announcements**.  Except as may be expressly permitted underSections 7.3, 7.4.3 and 7.4.4, or as may be appropriate for either Party tomake in connection with its Development or Commercialization activities ascontemplated hereunder, subject to Sections 7.1 and 7.2 hereof, neither 

 

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Party willmake any public announcement regarding this Agreement or the Development,Manufacturing or Commercialization of any Product without the prior writtenapproval of the other Party.

 

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

 

**7.4.4.      Publications**.  During the Term, each Party will submit tothe other Party for reasonable prior review and approval all proposed academic,scientific and medical publications and public presentations relating to theDevelopment, Manufacture or Commercialization of any Product, or any proposeddisclosure under Section 7.2.1(a) (but excluding marketing, sales andpromotional materials and presentations used for Commercialization), for reviewin connection with preservation of Patent Rights or to determine whether any ofsuch other Party’s Confidential Information should be modified or deleted.  Without limiting the foregoing, if suchproposed publication or presentation contains information or data that shouldreasonably be reviewed for the preservation of Patent Rights, written copies ofsuch proposed publication or presentation shall be submitted to thenon-publishing Party no later than sixty (60) days before submission forpublication or presentation and the non-publishing Party shall provide itscomments 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 anadditional ninety (90) days in the event the non-publishing Party candemonstrate reasonable need for such extension, including, but not limited to,the preparation and filing of patent applications.  By mutual agreement, this period may befurther extended.  Wyeth and ADLS willeach comply with standard academic practice regarding authorship of scientificpublications and recognition of the contribution of other parties in anypublications relating to the Development, Manufacture or Commercialization ofany Product.

 

**7.5.         Terminationof Prior Non-Disclosure Agreement**.  This Agreement supersedes the Non-DisclosureAgreement between the Parties dated July 18, 2007 (the “**Non-Disclosure Agreement**”), including anyamendments thereto, provided, however, that the foregoing shall not limit anyremedies available to either Party with respect to any breach of theNon-Disclosure Agreement which occurred prior to the Effective Date.  All Information (as defined in theNon-Disclosure Agreement) exchanged between the Parties under the Non-DisclosureAgreement shall be deemed to be Confidential Information under this Agreementand 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)          **itis a corporation duly organized and validly existing under the laws of thestate of its incorporation;

 

**(b)          **theexecution, delivery and performance of this Agreement by such Party has beenduly authorized by all requisite corporate action and does not require anystockholder action or approval;

 

**(c)          **it has thepower and authority to execute and deliver this Agreement and to perform itsobligations hereunder;

 

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

 

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

 

**(f)           **it shall atall times comply in all material respects with all laws and regulationsapplicable to its activities under this Agreement.

 

**8.2.         AdditionalRepresentations, Warranties and Covenants of ADLS**.  In addition to the representations,warranties and covenants made by ADLS elsewhere in this Agreement, ADLS herebyrepresents, warrants and covenants to Wyeth that:

 

**(a)          **except asdisclosed in Exhibit 8.2(a), as of the Effective Date, the ADLSPatent Rights and the ADLS Know-How are 

 

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existing and,to its knowledge, are not invalid or unenforceable, in whole or in part;

 

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

 

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

 

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

 

**(e)          **except asset forth in Exhibit 8.2(e) attached hereto, no ADLS PatentRight and no portion of the ADLS Know-How existing as of the Effective Date andrelating to any Compound or Product is subject to any funding agreement withthe United States government or any of its agencies;

 

**(f)           **to itsknowledge, as of the Effective Date, neither the Development, Manufacture, useor Commercialization of any Compound or Product infringes or would infringe anyexisting issued patent owned or possessed by any Third Party;

 

**(g)          **to itsknowledge, as of the Effective Date, there are no Third Party pending patentapplications which are not included in the ADLS Patent Rights and, if issued,would cover the Development, Manufacture, use or Commercialization of anyCompound or Product;

 

**(h)          **to itsknowledge, as of the Effective Date, there are no claims, judgments orsettlements against or owed by ADLS or any of its Affiliates, or pending orthreatened claims or litigation, in each case relating to the ADLS PatentRights listed in Exhibit 1.6 attached hereto or the ADLS Know-How;

 

**(i)           **during theTerm, ADLS will use diligent efforts not to diminish the rights under the ADLSPatent Rights or the ADLS Know-How granted to Wyeth hereunder, including,without limitation, by not committing or permitting any actions or 

 

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omissionswhich would cause ADLS to breach any ADLS Third Party Agreement; ADLS willprovide Wyeth promptly with written notice of any such breach or any allegationof any such breach; and as of the Effective Date, ADLS is in compliance in allrespects with each ADLS Third Party Agreement;

 

**(j)**            the ADLS Third PartyAgreements are in full force and effect; to ADLS’ knowledge, as of theEffective Date, no other party to such agreements is in breach or defaultthereunder; and ADLS has not waived or allowed to lapse or terminate any of itsrights relating to any Compound or Product under the ADLS Third PartyAgreements;

 

**(k)**           ADLS has provided atrue and complete copy of each ADLS Third Party Agreement to Wyeth, includingany amendment(s) thereto;

 

**(l)**            ADLS will not duringthe Term amend such ADLS Third Party Agreements in a manner that wouldadversely affect the rights, obligations or economic interests of Wyeth underthis Agreement without Wyeth’s prior written consent;

 

**(m)**          ADLS shall furnish Wyethwith copies of all notices received by ADLS relating to any alleged breach ordefault by ADLS under ADLS Third Party Agreements within five (5) businessdays after ADLS’ receipt thereof.  In theevent ADLS does not resolve any such alleged breach, it shall notify Wyethwithin a sufficient period of time before the expiration of the cure period forsuch breach under such ADLS Third Party Agreement such that Wyeth, in its solediscretion, is able to cure or otherwise resolve such alleged breach.  If Wyeth makes any payments to a Third Partyin 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 orother payments payable to ADLS pursuant to this Agreement;

 

**(n)**           ADLS shall promptlyfurnish Wyeth with copies of all (i) amendments of the ADLS Third PartyAgreements and (ii) correspondence (or in the case of oral discussions, asummary of such discussions) with or from and reports received from or providedto licensors under the ADLS Third Party Agreements to the extent material toWyeth or its rights granted under this Agreement;

 

**(o)**           except as disclosed in Exhibit 8.2(o) attachedhereto, as of the Effective Date, ADLS is not a party to or otherwise subjectto

 

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

 

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

 

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

 

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

 

**(s)**           [***]; and

 

**(t)**            [***].

 

**8.3.         Representationby Legal Counsel**. Each Party hereto represents that it has been represented by legalcounsel in connection with this Agreement and acknowledges that it hasparticipated in the drafting hereof.  Ininterpreting and applying the terms and provisions of this Agreement, theParties agree that no presumption shall exist or be implied against the Partywhich drafted such terms and provisions.

 

**8.4.         No Inconsistent Agreements**.  Neither Party has in effect and after the EffectiveDate neither Party shall enter into any oral or written agreement orarrangement that would be inconsistent with its obligations under thisAgreement.

 

**8.5.         Disclaimer**.  EXCEPT AS OTHERWISE EXPRESSLY SET FORTHHEREIN, THE PARTIES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANYKIND, EITHER EXPRESS OR IMPLIED, AND PARTICULARLY THAT PRODUCTS WILL BESUCCESSFULLY

 

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DEVELOPEDHEREUNDER, AND IF PRODUCTS ARE DEVELOPED, WITH RESPECT TO SUCH PRODUCTS, THE PARTIESDISCLAIM ALL IMPLIED WARRANTIES OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY ANDFITNESS FOR A PARTICULAR PURPOSE.

 

**9.****                                    TERMAND 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 theRoyalty 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, inits entirety or, at the terminating Party’s option, on a Product-by-Product andcountry-by-country basis, at any time during the Term by giving written noticeto the other Party in the event that the other Party commits a material breachof its obligations under this Agreement and such breach remains uncured for[***] (or [***] in the case of the breach of a payment obligation, other thanany payment obligation that the payor is disputing in good faith), measuredfrom 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 thestated period and the breaching Party uses active and continuous, diligent,good faith efforts to cure such breach, the stated period will be extended byan additional [***].  Notwithstanding theforegoing, a Party shall not have the right to terminate this Agreement in partpursuant to this Section 9.2 with respect to an individual Product orcountry unless the other Party’s material breach giving rise to suchtermination right specifically relates to such Product or country, asapplicable.

 

**9.3.         Terminationby Wyeth At Will or For Safety.**

 

**9.3.1.      TerminationAt Will.** Wyethshall have the right, exercisable upon [***] prior written notice to ADLS, toterminate this Agreement either (a) in its entirety or (b) on aProduct-by-Product basis. Notwithstanding the foregoing, in no event shall such termination atwill by Wyeth relieve it of its obligation to fully satisfy its paymentobligations 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 thisAgreement, at any time, either in its entirety or on a Product-by-Product andcountry-by-country basis, by giving [***] prior written notice to ADLS in theevent of any safety issue that would reasonably be expected to have a materialadverse effect on Wyeth’s ability to Develop, Manufacture or Commercialize anyCompound or 

 

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Product, asdetermined in Wyeth’s reasonable judgment and according to Wyeth’s standardinternal procedures for evaluating such safety issues.

 

**9.4.****         Terminationon Insolvency of ADLS.** ADLS shall bedeemed a “**Debtor**” under thisAgreement if, at any time during the Term (i) a case is commenced by oragainst ADLS under the Bankruptcy Code, (ii) ADLS files for or is subjectto the institution of bankruptcy, reorganization, liquidation or receivershipproceedings (other than a case under the Bankruptcy Code), (iii) ADLSassigns all or a substantial portion of its assets for the benefit ofcreditors, (iv) a receiver or custodian is appointed for ADLS’ business or(v) a substantial portion of ADLS’ business is subject to attachment orsimilar process; provided, however, that in the case of any involuntary caseunder the Bankruptcy Code, ADLS shall not be deemed a Debtor if the case isdismissed 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) ofthe Bankruptcy Code, licenses of rights to “intellectual property” as definedin Section 101 of the Bankruptcy Code, and Wyeth shall have such rights asare provided under the Bankruptcy Code in the event of the bankruptcy of ADLS.

 

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

 

**(a)****                                 **asWyeth may elect in a written request, immediately upon such request:

 

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

 

**(ii)          **provide toWyeth all such intellectual property (including all embodiments thereof) heldby ADLS and/or such successors and assigns or otherwise available to them; and

 

**(b)****                                 **notinterfere with Wyeth’s rights under this Agreement, or any agreementsupplemental hereto, to such intellectual property (including suchembodiments), including any right to obtain such intellectual property (or suchembodiments) from another entity, to the extent provided in Section 365(n) ofthe Bankruptcy Code.

 

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

 

**9.4.3.      AdditionalRights.**  All rights, powers and remedies of Wyethprovided herein are in addition to and not in substitution for any and allother 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 caseunder the Bankruptcy Code.  The Partiesagree that they intend the following rights to extend to the maximum extentpermitted by law, and to be enforceable under Bankruptcy Code Section 365(n):

 

**(a)          **theright of access to any intellectual property (including all embodimentsthereof) of ADLS, or any Third Party with whom ADLS contracts to perform anobligation of ADLS under this Agreement, and, in the case of the Third Party,which is necessary for the Development, Manufacture, Commercialization or useof Products; and

 

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

 

**9.5.         Effectsof Termination.**

 

**9.5.1.      Effect of Termination by Wyeth for Cause.**  If Wyeth terminates this Agreement withrespect 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 licensesconveyed by ADLS to Wyeth with respect to the applicable terminated Product inthe applicable terminated country shall become irrevocable and perpetual, Wyeth’srights 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 remainin effect and Wyeth shall have no further obligations to ADLS under thisAgreement with respect to such Product in such country other than (i) anobligation to pay royalties with respect to Net Sales of such Product in suchcountry in an amount equal to [***] of the amount that would otherwise havebeen payable under this Agreement, such amount to be paid in accordance withand subject to the other terms of this Agreement governing the payment ofroyalties, and (ii) those obligations that expressly survive terminationin accordance with Section 9.6 hereof;

 

**(b)          **Suchtermination shall not be construed to limit ADLS’ right to receive paymentsthat accrued before the effective date of such termination;

 

**(c)          **Wyeth shallhave the right to offset, against any payment owing to ADLS as provided forunder Section 9.5.1(a), any damages found or agreed by the Parties to beowed by ADLS to Wyeth;

 

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

 

**(e)          **Nothing inthis 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 onInsolvency of ADLS.** If Wyeth terminates this Agreement pursuant to Section 9.4(Termination on Insolvency of ADLS):

 

**(a)          **All licensesgranted to Wyeth shall become irrevocable and perpetual, Wyeth’s rights underSections 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 shallhave no further obligations to ADLS under this Agreement other than (i) thoseobligations that expressly survive termination in accordance with Section 9.6hereof and (ii) an obligation to pay royalties with respect to Net Salesof Products in an amount equal to [***] of the amount that would otherwise havebeen payable under this Agreement, such amount to be paid in accordance withand subject to the other terms of this Agreement governing the payment ofroyalties;

 

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**(b)          **Suchtermination shall not be construed to limit ADLS’ right to receive paymentsthat accrued before the effective date of such termination;

 

**(c)          **Wyeth shallhave the right to offset, against any payment owing to ADLS as provided for underSection 9.5.2(a), any damages found or agreed by the Parties to be owed byADLS to Wyeth;

 

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

 

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

 

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

 

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

 

**(i)           **Alllicenses granted by ADLS to Wyeth shall automatically terminate; and

 

**(ii)          **Suchtermination shall not be construed to limit ADLS’ right to receive paymentsthat accrued before the effective date of such termination.

 

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

 

**(i)           **Alllicenses granted by ADLS to Wyeth under Section 2.1 with respect to suchProduct(s) in such countr(y/ies) shall terminate, provided that thelicenses to

 

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Wyeth withrespect to all remaining Products and in all other countries in the Territoryshall remain in effect; and

 

**(ii)          **Suchtermination shall not be construed to limit ADLS’ right to receive paymentsthat accrued before the effective date of such termination.

 

**(c)          **Nothing inthis Section 9.5.3 shall limit any other remedy ADLS may have for Wyeth’sbreach of this Agreement.

 

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

 

**9.6.         Survival of Certain Obligations.** Expiration or termination of this Agreementshall not relieve the Parties of any obligation accrued prior to suchexpiration or termination.  The followingprovisions shall survive expiration or termination of this Agreement:  Section 1 (Definitions) (to the extentdefinitions 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 suchexpiration 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) and12.15 (Right of First Offer)).

 

**10.****                               LIABILITY,INDEMNIFICATION AND INSURANCE.**

 

**10.1.       Liability. **Except with respectto liability arising from a breach of Section 6 or 7, from anywillful misconduct or intentionally wrongful act, or to the extent such Partymay be required to indemnify the other Party under this Section 10, neitherParty nor its respective Affiliates shall be liable to the other for special,punitive or consequential damages, whether based on contract or tort, orarising 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 harmlessADLS and its Affiliates, Licensees and each of their respective employees,officers, directors and agents (each, an “**ADLSIndemnified Party**”) from and against any and all liability, loss,damage, expense (including reasonable attorneys’ fees and expenses) and cost(collectively, a “**Liability**”) thatthe ADLS Indemnified Party may be required to pay to one or more Third Partiesto the extent resulting from or arising out of (i) any claims of anynature, including product liability claims, arising out of the Development,Manufacture or Commercialization of Compounds or Products by, on behalf of orunder the authority of Wyeth (other than by ADLS, its Affiliates or Licenseesor any of their respective employees, officers, directors and agents), or (ii) anybreach by Wyeth of any representation, warranty or covenant set forth in thisAgreement, except, in each case, to the extent caused by the negligence orwillful misconduct of ADLS or any ADLS Indemnified Party or any breach by ADLSof any representation, warranty or covenant set forth herein.

 

**10.3.       Indemnification by ADLS**.  ADLS will indemnify, defend and hold harmlessWyeth and its Affiliates, Sublicensees and distributors and each of its andtheir respective employees, officers, directors and agents (each, a “**Wyeth Indemnified Party**”) from and againstany and all Liabilities that the Wyeth Indemnified Party may be required to payto one or more Third Parties to the extent resulting from or arising out of (i) anyclaims of any nature, including product liability claims, arising out of theDevelopment, Manufacture or Commercialization of any Compound or Product by, onbehalf of or under the authority of ADLS (other than by Wyeth, its Affiliatesor Sublicensees or any of their respective employees, officers, directors andagents), or (ii) any breach by ADLS of any representation, warranty orcovenant set forth in this Agreement, except, in each case, to the extentcaused by the negligence or willful misconduct of Wyeth or any WyethIndemnified Party or any breach by Wyeth of any representation, warranty orcovenant set forth herein.

 

**10.4.       Procedure**.  Each Party will notify the other promptly inthe event it becomes aware of a claim for which indemnification may be soughthereunder.  In furtherance and not inlimitation of the preceding sentence, in case any proceeding (including anygovernmental investigation) shall be instituted involving any Wyeth IndemnifiedParty or ADLS Indemnified Party in respect of which indemnity may be soughtpursuant to this Section 10, ADLS (if such proceeding is initiated againstan ADLS Indemnified Party) or Wyeth (if such proceeding is initiated against aWyeth Indemnified Party) (such Party referred to as the “**Indemnified Party**”) shall promptly notifythe other Party (the “**Indemnifying Party**”)in writing within fifteen (15) days after the Indemnified Party first becomesaware of such proceeding and the Indemnifying Party and Indemnified Party shallthen promptly meet to discuss how to respond to any claims that are the subjectmatter of such proceeding.  TheIndemnifying Party shall have the right to assume the defense of any ThirdParty claim subject to indemnification obligations hereunder.  The Indemnifying Party, upon assuming

 

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the defense ofthe claim, shall retain counsel reasonably satisfactory to the IndemnifiedParty to conduct the defense of the claim and shall pay the fees and expensesof such counsel related to such proceeding. The Indemnified Party agrees to cooperate fully with the IndemnifyingParty in the defense of any such claim, action or proceeding, or any litigationresulting from any such claim.  In anysuch proceeding, the Indemnified Party shall have the right to retain its owncounsel, but the fees and expenses of such counsel shall be at the expense ofthe Indemnified Party unless (a) the Indemnifying Party and theIndemnified Party shall have mutually agreed to the retention of such counselor (b) the named parties to any such proceeding (including any impleadedparties) include both the Indemnifying Party and the Indemnified Party andrepresentation of both Parties by the same counsel would be inappropriate dueto actual or potential differing interests between them.  All such fees and expenses shall bereimbursed as they are incurred.  TheIndemnifying Party shall not be liable for any settlement of any proceedingeffected without its written consent, but if settled with such consent, theIndemnifying Party agrees to indemnify the Indemnified Party from and againstany loss or liability by reason of such settlement.  The Indemnifying Party shall not, without thewritten consent of the Indemnified Party, effect any settlement of any pendingor threatened proceeding in respect of which the Indemnified Party is, orarising out of the same set of facts could have been, a party and indemnitycould have been sought hereunder by the Indemnified Party, unless such settlementincludes an unconditional release of the Indemnified Party from all liabilityon claims that are the subject matter of such proceeding.

 

**10.5.       Insurance**.  ADLS shall obtain and maintain, during theTerm, commercial general liability insurance, including products liabilityinsurance, with reputable and financially secure insurance carriers to coverits indemnification obligations under Section 10.3, with limits of notless than [***] per occurrence and in the aggregate.  Insurance shall be procured with carriershaving an A.M. Best Rating of A-VII or better.

 

**11.****                               DISPUTERESOLUTION**

 

**11.1.       General**.  Any controversy, claim or dispute arising outof or relating to this Agreement shall be settled, if possible, through goodfaith negotiations between the Parties. However, subject to Section 3.3 with respect to decisions of theSteering Committee and other committees established under this Agreement, ifthe Parties are unable to settle such dispute after good faith negotiations,the matter shall be referred to the Executive Officers (having authority tobind the Parties with respect to such dispute, subject to obtaining anynecessary corporate or management approvals) to be resolved by negotiation ingood faith as soon as is practicable but in no event later than thirty (30)days after referral.  The resolution, ifany, of a referred matter shall be reduced to writing signed by such ExecutiveOfficers 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 tosettle the dispute after good faith negotiation in the manner set forth above,either Party may seek resolution of the dispute through any remedies availableat law or in equity from any court of competent jurisdiction as provided in Section 12.9below.

 

**12.****                               MISCELLANEOUS.**

 

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

 

**12.2.       Further Actions**.  Each Party agrees to execute, acknowledge anddeliver such further instruments, and to do all such other acts, as may benecessary or appropriate in order to carry out the purposes and intent of theAgreement.

 

**12.3.       Force Majeure**.  Neither Party shall be liable to the otherfor delay or failure in the performance of the obligations on its partcontained in this Agreement if and to the extent that such failure or delay isdue to circumstances beyond its control which it could not have avoided by theexercise of reasonable diligence.  SuchParty shall notify the other Party promptly should such circumstances arise,giving an indication of the likely extent and duration thereof, and shall useall Commercially Reasonable Efforts to resume performance of its obligations assoon as practicable, provided, however, that neither Party shall be required tosettle any labor dispute or disturbance.

 

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**12.4.    Correspondenceand Notices**.

 

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

 

**12.4.2.    Extraordinary Notices**.  Any notice or notification required orpermitted 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 deemedgiven upon receipt if delivered personally or by facsimile transmission(receipt verified), five (5) days after deposited in the mail ifmailed by registered or certified mail (return receipt requested) postageprepaid, or on the next business day if sent by overnight delivery using anationally recognized express courier service and specifying next business daydelivery (receipt verified), to the Parties at the following addresses orfacsimile numbers (or at such other address or facsimile number for a Party asshall be specified by like notice, provided, however*,* that notices of a change of address shall be effectiveonly upon receipt thereof):

 

Allcorrespondence to Wyeth shall be addressed as follows:

 

Wyeth

500 Arcola Road

Collegeville, Pennsylvania 19426

Attn:  Senior Vice President, Corporate BusinessDevelopment

Fax:  (484) 865-6476

 

with a copyto:

 

Wyeth

5 GiraldaFarms

Madison, NewJersey 07940

Attn:  Executive Vice President and General Counsel

Fax:  (973) 660-7156

 

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Allcorrespondence to ADLS shall be addressed as follows:

 

Advanced LifeSciences Holdings, Inc.1440 Davey RoadWoodridge, IL  60517

Attn:  Chief Legal Counsel

Fax:  (630) 739-6754

 

with a copy to:

 

Winston &Strawn LLP35 West Wacker DriveChicago, IL  60601

Attn:  R. Cabell Morris, Jr.

Fax:  (312) 558-5700

 

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

 

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

 

**12.7.       Severability**.  If any clause or portion thereof in thisAgreement is for any reason held to be invalid, illegal or unenforceable, thesame shall not affect any other portion of this Agreement, as it is the intentof the Parties that this Agreement shall be construed in such fashion as tomaintain its existence, validity and enforceability to the greatest extentpossible.  In any such event, thisAgreement shall be construed as if such clause of portion thereof had neverbeen contained in this Agreement, and there shall be deemed substitutedtherefor such provision as will most nearly carry out the intent of the Partiesas expressed in this Agreement to the fullest extent permitted by applicablelaw.

 

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

 

**12.9.       Governing Law; Venue**.  This Agreement shall be governed by andinterpreted 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 actionbased upon a controversy, claim or dispute arising out of or relating to thisAgreement 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 venueof such courts.

 

**12.10.          EntireAgreement of the Parties**.  This Agreement constitutes and contains thecomplete, final and exclusive understanding and agreement of the Partiesrespecting the subject matter hereof and cancels and supersedes any and allprior negotiations, correspondence, understandings and agreements, whether oralor written, among the Parties respecting the subject matter hereof.

 

**12.11.          IndependentContractors**. Both Parties are independent contractors under this Agreement.  Nothing herein contained shall be deemed tocreate an employment, agency, joint venture or partnership relationship betweenthe Parties or any of their agents or employees, or any other legal arrangementthat would impose liability upon one Party for the act or failure to act of theother Party.  Neither Party shall haveany express or implied power to enter into any contracts or commitments or toincur any liabilities in the name of, or on behalf of, the other Party, or tobind the other Party in any respect whatsoever.

 

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

 

**12.13.          Interpretation**.  Except where the context requires otherwise, (a) theuse of any gender herein shall be deemed to encompass references to either orboth 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) theword “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 otherdocument herein shall be construed as referring to such agreement, instrumentor other document as from time to time amended, supplemented or otherwisemodified (subject to any restrictions on such amendments, supplements ormodifications set forth herein), (e) any reference herein to any Personshall be construed to include the Person’s successors and assigns, (f) thewords “herein”, “hereof” and “hereunder”, and words of similar import, shall beconstrued to refer to this Agreement in its entirety and not to any particularprovision hereof, (g) all references herein to Sections or Exhibits shallbe construed to refer to Sections or Exhibits of this Agreement, and referencesto this Agreement include all Exhibits hereto, (h) the word “notice” shallmean notice in writing (whether or not specifically stated) and shall includenotices, consents, approvals and other written communications contemplatedunder this Agreement, (i) provisions that require that a Party, theParties or any committee hereunder “agree,” “consent” or “approve” or the likeshall require that such agreement, consent or approval be specific and in writing,whether by written agreement, letter, approved minutes or otherwise (butexcluding e-mail and instant messaging),

 

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and (j) referencesto any specific law, rule or regulation, or article, section or otherdivision thereof, shall be deemed to include the then-current amendmentsthereto or any replacement or successor law, rule or regulation thereof.

 

**12.14.          Changeof Control of ADLS.**

 

**12.14.1.           Changeof 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 agreementwith respect to a Change of Control of ADLS.

 

**12.14.2.           DispositionUpon Divestiture.** If, in connection with any Change of Control of ADLS, any governmentalagency requires ADLS (including, but not limited to, pursuant to a consentdecree) to divest its interest in any Product or this Agreement (the “**Divested Asset(s)**”), Wyeth shall have theright to purchase ADLS’ interest in the Divested Asset(s) for fairconsideration.  ADLS shall propose inwriting a purchase price for the Divested Asset(s) within [***] afterreceiving notice of such divestiture requirement.  Wyeth shall have [***] after receipt of suchwritten proposal to accept or reject the proposed price for the DivestedAsset(s).  If Wyeth rejects the proposedprice, ADLS shall be free to offer the Divested Asset(s) for sale to aThird Party for [***].  If no sale to aThird Party is consummated within such [***] period, the provisions of this Section 12.14.2requiring ADLS to first offer the Divested Assets to Wyeth shall again apply.

 

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

 

**12.14.4.           Rightsif Acquiror Has Competing Product.** Furthermore, in the event that a Change ofControl of ADLS results in ADLS or any Affiliate of ADLS having, immediatelyfollowing the

 

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

 

**12.14.5.           NoRelief from Obligation. **Nothingin this Section 12.14 shall relieve ADLS of any of its obligations underthis Agreement.

 

**12.15.             Rightof 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 toWyeth before any such rights to Develop and Commercialize Products in [***] areoffered or granted by or on behalf of ADLS to any Third Party.  The Offer shall disclose the proposed termsand conditions of the arrangement and any other material facts relating to theOffer.  Wyeth shall have [***] afterreceipt 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 agreementcontaining the terms of such Development and Commercialization in [***].  Except for any terms and conditions expresslyset forth in the Offer, such agreement between the Parties for [***] shall besubstantially on the terms and conditions of this Agreement.  If Wyeth rejects the Offer, ADLS shall befree to make similar offers to Third Parties for a period of [***] on terms andconditions, on the whole, no less favorable to ADLS than those offered toWyeth.  If, after such [***] period, ADLShas not entered into a written agreement with a Third Party granting to suchThird Party rights to Develop and Commercialize Products in [***], ADLS shallnot offer or grant to a Third Party any rights to Develop or CommercializeProducts in [***] without again complying with the provisions of this Section 12.15.

 

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**INWITNESS WHEREOF**, duly authorized representatives ofthe Parties have duly executed this Agreement to be effective as of theEffective 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 |
|                                    |                                                             |                            |  |  |  |  |

 

***Signature Page to Development andCommercialization Agreement***

 

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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 LicenseAgreement, dated April 27, 2005, by and between Abbott Laboratories andAdvanced Life Sciences Holdings, Inc.

 

3.             Second Amendment to LicenseAgreement, dated August 2, 2005 by and between Abbott Laboratories andAdvanced Life Sciences Holdings, Inc.

 

4.             Third Amendment to LicenseAgreement, dated August 10, 2005, by and between Abbott Laboratories andAdvanced Life Sciences Holdings, Inc.

 

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

 

6.             Fifth Amendment to LicenseAgreement expected to be executed on or around September 30, 2008 by andbetween 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**

 

 

**ChemicalName**

 

[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.

 

**MolecularFormula**

 

C42H59N3O10

 

**MolecularWeight**

 

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.                                       RollingForecasts.  [***].

 

2.                                       Inventory;Launch.  ADLS shall at all timesmaintain an inventory of each Product (in bulk tablet form) equal to [***] ofthe estimate provided to ADLS under Section 1 above for the next[***].  ADLS shall at all times maintainan inventory of the API for each Product, and/or such Product in bulk tabletform, sufficient to support supply of [***] of the estimate for such Productprovided to ADLS under Section 1 above for the next [***].  Such inventory shall be maintained by ADLS atno charge to Wyeth.  The Supply Agreementshall also contain appropriate provisions with respect to launch quantities ofProducts.

 

3.                                       ShelfLife.  Each shipment of Productsshall have, as of the date of receipt by Wyeth, at least [***] of remainingshelf life.

 

4.                                       ThirdParty Manufacturers.  At all timesduring the Term and as provided in Section 9 below, ADLS shall satisfy itssupply obligations to Wyeth hereunder through binding written agreements withqualified Third Parties engaged to perform services or supply facilities orgoods in connection with the Manufacture of Products, provided that ADLS shallnot enter into any such agreement unless prior thereto ADLS shall have givenWyeth a written summary identifying the proposed manufacturer and the principalterms of such proposed agreement and Wyeth shall not have reasonably objectedthereto in writing within ten (10) days after receipt of suchsummary.  Upon reasonable request, ADLSshall permit and arrange for Wyeth to conduct due diligence inspections of anyproposed Third Party manufacturers.

 

5.                                       Changes.  Except as otherwise permitted under thechange control procedures to be specified in the Supply Agreement, ADLS shallnot modify or change the process, specifications, materials, suppliers,facilities or analytical testing methods used in connection with theManufacture of Products, regardless of whether such modification or changerequires the approval of any Regulatory Authority, without the prior writtenconsent of Wyeth, which consent shall not be unreasonably withheld.  ADLS shall provide Wyeth with a writtensummary of all proposed modifications or changes and must receive the writtenapproval of Wyeth prior to the implementation thereof, which approval shall notbe unreasonably withheld.  The detailedprovisions reflecting this Section 5 shall be set forth in a qualityagreement on reasonable and customary terms, and complying with applicableregulatory requirements, to be negotiated and entered into by the Parties inconnection with the Supply Agreement (the “**QualityAgreement**”).

 

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6.                                       Failureto Supply.  ADLS shall give Wyethprompt written notice if ADLS becomes aware that it will not be able to satisfyWyeth’s requirements for Products in any material way.  In such event, or in the event that, withoutsuch prior notice, ADLS actually fails to materially satisfy Wyeth’srequirements for Products, Wyeth and ADLS shall promptly work together, in goodfaith, to devise and implement measures to cure such failure to supply or toidentify an appropriate alternative source of Products.  In addition, in the event of an uncuredfailure to supply, if Wyeth determines to utilize an alternative source ofProducts, at Wyeth’s request, ADLS shall promptly transfer to Wyeth or itsdesignee, at no cost to Wyeth, all Know-How and other technical informationnecessary or useful to permit Wyeth to make or have made Products, providedthat, pending the full transfer of supply to an alternative source, ADLS shalluse best efforts to continue to supply Wyeth’s requirements for Products untilsuch time as Wyeth determines, in its sole reasonable discretion, that suchalternative supplier is fully able to supply all such requirements.  Until such time, available quantities ofProducts shall be allocated pro-rata among Wyeth’s requirements hereunder forthe Territory and ADLS’ requirements for outside the Territory based upon theirrelative sales of the applicable Products for the immediately preceding [***]period, or if such shortages occur during or prior to the first [***] period ofsales for a Product, then such pro-rata allocation shall be based upon theParties’ then current relative annualized projected requirements for suchProduct.

 

7.                                       TransferPrice.  The transfer price forcommercial supplies of the Current Product purchased by Wyeth during theRoyalty Term shall be [***].  Thetransfer price for commercial supplies of other Products purchased by Wyethduring the Royalty Term shall be as mutually agreed by the Parties, but shallin no event exceed [***].

 

8.                                       Inspectionand Other Rights.  Wyeth shall havereasonable 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 toProducts and (b) rights to information, consultation and participationwith respect to regulatory inspections of ADLS and its Third Partymanufacturers relating to Products.

 

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

 

10.                                 Qualificationof Back-Up Manufacturers.  Wyethshall have the right to qualify potential back-up manufacturers (for both APIand Products) for use in the event that Wyeth elects to Manufacture or haveManufactured any Product due to a failure by ADLS to supply or have suppliedsuch Product to Wyeth.

 

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11.                                 StabilityStudies.  ADLS, at its expense, shallperform stability studies with respect to each Product in accordance with ICHGuidelines and meeting the requirements of Regulatory Authorities in theTerritory, 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 setforth in further detail in the Supply Agreement or the Quality Agreement).  The detailed provisions reflecting this Section 11shall be set forth in the Quality Agreement.

 

12.                                 Term.  The Supply Agreement shall remain in effectwith respect to each Product supplied thereunder during the Royalty Term forsuch 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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