**Exhibit10.16**

 

**PUBLIC HEALTH SERVICE**

**FIRST AMENDMENT TOEXCLUSIVE LICENSE AGREEMENT (L-068-02/0)**

 

AMENDMENTL-068-02/1

 

This**Amendment** of the Exclusive PatentLicense L-068-02/0 (“**Agreement**”),L-068-02/1 (“**Amendment**”), is madebetween the National Institutes of Health (“**NIH**”),the Centers for Disease Control and Prevention (“**CDC**”), or the Food and Drug Administration (“**FDA**”), hereinafter singly or collectivelyreferred to as (“**PHS**”), agenciesof the United States Public Health Service within the Department of Health andHuman Services (“**DHHS**”) throughthe Office of Technology Transfer, **NIH**,having an address at 6011 Executive Boulevard, Suite 325, Rockville, Maryland20852-3804, U.S.A., Procept, Inc., having offices at the addressindicated on the Signature Page, hereinafter referred to as “**Licensee**”.

 

Whereas, **PHS** desires the **Agreement** to be amended a first time inorder to resolve issues concerning the following:

(a) Paragraphs 1.02 and 4.01; (b) Appendix C; (b) Appendix G; (d)Appendix H of said **Agreement**; and

 

Whereas, **PHS** and **Licensee** are willing to amend the terms ofthe **Agreement** a first time toaccommodate these issues.

 

Now Therefore, **PHS** and **Licensee**, intending to be bound, herebyagree that the following changes will be made to the **Agreement**:

 

1.                                       AmendedParagraph 1.02 will now read:

 

**PHS**, by executinginterinstitutional agreements with **PSU** (L-067-02/0), and **UC** (L-086-02/0), has obtainedthe exclusive license, including the right to sublicense, the **Licensed****Patent Rights** listed inAppendix A.  Once executed, the termsand conditions of this**Agreement** shall supersede, and therebyterminate the terms and conditions of the previous license agreement betweenPacific Pharmaceuticals, Inc., (now Procept, Inc.) and **PSU**, made effective onFebruary 6, 1998, provided that, the sublicense agreement, including itsassociated amendment, by and between AOI Pharmaceuticals, Inc. (“**Sublicensee”**)and **Licensee**made effective on October 13, 2000, and attached as Appendices G and H (suchsublicense agreement, and its associated amendment, the “**Sublicensee Agreement**”), andthe **Amendment** to this **Agreement**(L-068-02/1) shall continue toremain in full force and effect;

 

2.                                       AmendedParagraph 4.01 will now read:

 

Upon written approval by **PHS, Licensee** and**Sublicensee**may enter into sublicensing agreements under the **Licensed Patent Rights.**  Notwithstanding anything else stated herein,**PHS**acknowledgesthat this **Agreement**does not terminate, alter or supersede the **Sublicensee Agreement**thatexisted and continues to exist between**Licensee** and **Sublicensee,**and listed inAppendices G and H respectively,******pursuant to Section 1.02 of this **Agreement.   PHS**herebyapproves the**Sublicensee Agreement**in the event oftermination of this **Agreement**under Article 13, as long as **Sublicensee**and****all subtier sublicensees****conformto, and are in compliance with, the terms and conditions set forth in this **Agreement** within ninety (90) days of thedate **Sublicensee** receives noticeof such termination;

 

3.                                       Amended AppendixC will now read:

 

**Licensee**agrees to pay **PHS** sublicensing royalties as follows:

 

•                  The greater ofTwenty-Two and One-Half Percent (22.5%) of the royalties received by **Licensee**or any of its **Affiliates** from **Net Sales**by any sublicensee, including **Sublicensee**, of **Licensed Products** or **LicensedProcesses**or One and Four Fifths Percent (1.8%) of **Net Sales**by any sublicensee(s), including any subtierlicensing.

 

4.             Amendments toAppendix G are as follows:

 

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(1) The sentence:**“**WHEREAS,Procept is party to a License Agreement with The Penn State Research Foundation(“Penn”) dated February 6, 1998, (the “Penn License Agreement”), a copy ofwhich is attached hereto as Exhibit A, under which Procept is granted anexclusive worldwide license to certain Patent Rights (as defined therein) andKnow-how (as defined therein) which are co-owned by Penn, the NationalInstitutes of Health, Case Western Reserve University and the University ofChicago; is hereby modified in the following way:

 

•                  All references to Procept, Inc.,  (formerly Pacific Pharmaceuticals, Inc.)being party to a License Agreement with****The Penn State ResearchFoundation no longer apply.  The termsand conditions of such a LicenseAgreement are hereby replaced by the terms and conditions of this **Agreement;**

•                  “PatentRights” as referred to in Appendix G will now be defined as**“Licensed Patent Rights”**as defined in Paragraph 2.07 of the**Agreement;**

•                  Any use of the term “know-how”, and anyreference or terms regarding “Know-how” is hereby deleted and no longer apply;

•                  All references to Case Western ReserveUniversity are hereby deleted and no longer apply.

 

(2)The term “fields of use” in paragraph 2.1 shall now be defined as the **LicensedFields of Use** stated inAppendix B of said **Agreement**;

 

(3)Paragraph 5.1 shall now be amended to reference Appendix E of the **Agreement** as Benchmarks and Performance.

 

5.             Amendment to Item1. of Appendix H shall now read:

 

AOIPshall now be bound by the terms of Article 4 of the **RevisedLicense Agreement;**

 

6.                                       Appendix J, theComprehensive Release Agreement, once executed, shall remain binding and ineffect to all parties;

 

7.                                       All terms andconditions of the **Agreement** notherein amended remain binding and in effect;

 

8.                                       The**Agreement** and this **Amendment** constitute the entireunderstanding between **PHS** and **Licensee** and supersede all prior agreementsand understandings with respect to the aforementioned amendments; and

 

9.                                       This **Amendment**is effective when signed by all parties.

 

**SIGNATURES BEGIN ON NEXT PAGE**

 

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**AMENDMENT TO PHS LICENSE AGREEMENT L-068-02/0**

 

**PHS AMENDMENT TOPATENT LICENSE AGREEMENT–*EXCLUSIVE***

 
| **SIGNATURE PAGE**                                                                                                                                   |
|------------------------------------------------------------------------------------------------------------------------------------------------------|
|                                                                                                                                                 |   |
| For **PHS**:                                                                                                                                         |   |
|                                                                                                                                                 |   |
| /s/ Jack  Spiegel                                                                                                                                    |   | 5/13/2002 |   |
| Jack  Spiegel, Ph.D.                                                                                                                                 | Date |
| Director,  Division of Technology Development and Transfer                                                                                           |   |
| Office of Technology  Transfer                                                                                                                       |   |
| National  Institutes of Health                                                                                                                       |   |
|                                                                                                                                                 |   |
| Mailing  Address for Notices:                                                                                                                        |   |
|                                                                                                                                                 |   |
| Office of Technology Transfer

National Institutes of Health

6011 Executive Boulevard, Suite 325

Rockville,  Maryland  20852-3804  U.S.A |   |
|                                                                                                                                                      |  |  |  |

 

 

For **Licensee**(Upon, informationand belief, the undersigned expressly certify or affirm that the contents ofany statements of **Licensee**made or referred to in thisdocument are truthful and accurate.):

 

 
| PROCEPT, INC.                                 |
|-----------------------------------------------|
| 369 Lexington Avenue                          |
| 10th Floor                                    |
| New York, NY 10017                            |
|                                          |
|                                          |
| By: Salvatore A. Bucci                        |
|                                          |
| Name:                                         | /s/ Salvatore A.  Bucci |   |
|                                          |
| Title: President  and Chief Executive Officer |
|                                          |
| Date:                                         | 5/17/02 |   |
|                                               |  |  |  |

 

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**ACKNOWLEDGEMENT AND ACCEPTANCE**

 

AOI Pharmaceuticals, Inc.(“AOIP”), by its signature below, acknowledges and agrees to the following:

1.             AOIPshall be bound by the terms to this **Amendment**(L-068-02/1) to the **Revised LicensingAgreement**(L-068-02/0).

2.             AOIPshall be bound by the terms of Article 4 of the **Revised License Agreement**as amended by this **Amendment** (L-068-02/1).

3.             The**Amendment** (L-068-02/1) to the **Revised License Agreement**(L-068-02/0)serves as an Amendment to its Sublicensing Agreement with Procept, Inc.

 

For **Subli****censee**(Upon, information and belief, theundersigned expressly certify or affirm that the contents of any statements of **Sublicensee**made or referred to in thisdocument are truthful and accurate.):

 

 
| AOI  PHARMACEUTICALS, INC.       |
|----------------------------------|
| An Access Oncology Company       |
| 750 Lexington Avenue             |
|  26th  Floor                |
| New York, NY 10022               |
|                             |
|                             |
| By:   Craig Henderson, M.D. |
|                             |
|                             |
| Name:                            |  /s/ I. Craig Henderson |   |
|                             |
| Title: Chief  Executive Officer  |
|                             |
| Date:                            | 5/21/02 |   |
|                                  |  |  |  |

 

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