**PUBLIC HEALTH SERVICE**

**NON‑EXCLUSIVE PATENT LICENSE AGREEMENT**

**FOR INTERNAL COMMERCIAL USE**

COVER PAGE

For PHS internal use only:

License Number:

> License Application Number:
>
> Serial Number(s) of Licensed Patent(s) or Patent Application(s):
>
> Licensee:
>
> Additional Remarks:
>
> Public Benefit(s):

This Patent License Agreement, hereinafter referred to as the
"**Agreement**", consists of this Cover Page, an attached **Agreement**,
a Signature Page, Appendix A (List of Patent(s) or Patent
Application(s)), Appendix B (Licensed Products, Processes, Territory,
Field of Use and Termination), Appendix C (Royalties), Appendix D
(Shipping Information) and Appendix E (Royalty Payment Options). The
Parties to this **Agreement** are:

> 1\) The National Institutes of Health ("**NIH**") or the Food and Drug
> Administration ("**FDA**"), hereinafter singly or collectively
> referred to as "**PHS**", agencies of the United States Public Health
> Service within the Department of Health and Human Services
> ("**HHS**"); and
>
> 2\) The person, corporation, or institution identified above and on
> the Signature Page, having offices at the address indicated on the
> Signature Page, hereinafter referred to as "**Licensee**."

**PUBLIC HEALTH SERVICE**

**NON-EXCLUSIVE PATENT LICENSE AGREEMENT**

**FOR INTERNAL COMMERCIAL USE**

This **Agreement** is entered into between the National Institutes of
Health ("**NIH**") or the Food and Drug Administration ("**FDA**"),
hereinafter singly or collectively referred to as "**PHS**", agencies of
the United States Public Health Service within the Department of Health
and Human Services ("**HHS**") through the Office of Technology
Transfer, **NIH**, 6011 Executive Boulevard, Suite 325, Rockville,
Maryland 20852‑3804 U.S.A.; and
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
("**Licensee**"), a corporation of
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_, having an
office at
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_.

**PHS** and **Licensee** agree as follows:

1.  BACKGROUND

    1.  In the course of conducting biomedical and behavioral research,
        **PHS** investigators made inventions that may have commercial
        applicability.

    2.  By assignment of rights from **PHS** employees and other
        inventors, **HHS**, on behalf of the **Government**, owns
        intellectual property rights claimed in any United States or
        foreign patent applications or patents corresponding to the
        assigned inventions. **HHS** also owns any tangible embodiments
        of these inventions actually reduced to practice by **PHS**.

    3.  The Secretary for Health of **HHS** has delegated to **PHS** the
        authority to enter into this **Agreement** for the licensing of
        rights to these inventions under 35 U.S.C. §§200-212, the
        Federal Technology Transfer Act of 1986, 15 U.S.C. §3710a, and
        the regulations governing the licensing of Government‑owned
        inventions, 37 CFR Part 404.

    4.  **PHS** desires to transfer these inventions to the private
        sector through commercial research licenses to facilitate the
        commercial development of products and processes for public use
        and benefit.

    5.  **Licensee** desires to acquire the rights to use certain of
        these inventions in order to develop processes, methods, or
        marketable products for public use and benefit.

2.  DEFINITIONS

    1.  "**Affiliate(s)**" means a corporation or other business entity,
        which directly or indirectly is controlled by or controls, or is
        under common control with **Licensee**. For this purpose, the
        term \"control\" shall mean ownership of more than fifty percent
        (50%) of the voting stock or other ownership interest of the
        corporation or other business entity, or the power to elect or
        appoint more than fifty percent (50%) of the members of the
        governing body of the corporation or other business entity.

    2.  "**Government**" means the government of the United States of
        America.

    3.  "**Licensed Patent Rights**" shall mean:

        a.  U.S. patent applications and patents listed in Appendix A,
            all divisions and continuations of these applications, all
            patents issuing from such applications, divisions, and
            continuations, and any reissues, reexaminations, and
            extensions of all such patents;

        b.  to the extent that the following contain one or more claims
            directed to the invention or inventions claimed in 2.3(a):

            i.  continuations‑in‑part of 2.3(a);

            ii. all divisions and continuations of these
                continuations‑in-part;

            iii. all patents issuing from these continuations‑in‑part,
                 divisions, and continuations; and

            iv. any reissues, reexaminations, and extensions of these
                patents;

        c.  to the extent that the following contain one or more claims
            directed to the invention or inventions claimed in 2.3(a):
            all counterpart foreign applications and patents to 2.3(a)
            and 2.3(b), including those listed in Appendix A; and

        d.  **Licensed Patent Rights** shall *not* include 2.3(b) or
            2.3(c) to the extent that they contain one or more claims
            directed to new matter which is not the subject matter of a
            claim in 2.3(a).

    4.  "**Licensed Products**" means tangible materials, identified in
        Appendix B, which, in the course of manufacture, use, sale, or
        importation would be within the scope of one or more claims of
        the **Licensed Patent Rights** that have not been held
        unpatentable, invalid or unenforceable by an unappealed or
        unappealable judgment of a court of competent jurisdiction.

    5.  "**Licensed Processes**" means processes, identified in Appendix
        B, which, in the course of being practiced, would be within the
        scope of one or more claims of the **Licensed Patent Rights**
        that have not been held unpatentable, invalid or unenforceable
        by an unappealed or unappealable judgment of a court of
        competent jurisdiction.

    6.  "**Licensed Territory**" means the geographical area identified
        in Appendix B.

    7.  "**Licensed Fields of Use**" means the field of use identified
        in Appendix B.

3.  GRANT OF RIGHTS

    1.  **PHS** hereby grants and **Licensee** accepts, subject to the
        terms and conditions of this **Agreement**, a nonexclusive
        license under the **Licensed Patent Rights** in the **Licensed
        Territory** to make and to use, but not to sell the **Licensed
        Products** and **Licensed Processes** in the **Licensed Fields
        of Use** only.

    2.  **Licensee** has no right to sublicense.

    3.  This **Agreement** confers no license or rights by implication,
        estoppel, or otherwise under any patent applications or patents
        of **PHS** other than the **Licensed Patent Rights** regardless
        of whether such patents are dominant or subordinate to the
        **Licensed Patent Rights**.

    4.  **PHS** acknowledges that information relating to the **Licensed
        Patent Rights** may be of assistance to **Licensee** in its
        commercialization efforts. Accordingly, **PHS** shall consider
        reasonable requests by **Licensee** for access to the inventors
        of the **Licensed Patent Rights**.

4.  ROYALTIES

    1.  **Licensee** agrees to pay **PHS** a non-creditable,
        nonrefundable license issue royalty as set forth in Appendix C.

    2.  **Licensee** agrees to pay **PHS** a nonrefundable annual
        royalty as set forth in Appendix C.

    3.  All royalties due under this **Agreement** shall be paid in U.S.
        dollars, net of all non‑U.S. taxes, and payment options are
        listed in Appendix E. For conversion of foreign currency to U.S.
        dollars, the conversion rate shall be the New York foreign
        exchange rate quoted in *The Wall Street Journal* on the day
        that the payment is due.

    4.  Additional royalties may be assessed by **PHS** on any payment
        that is more than ninety (90) days overdue at the rate of one
        percent (1%) per month. This one percent (1%) per month rate may
        be applied retroactively from the original due date until the
        date of receipt by **PHS** of the overdue payment and additional
        royalties. The payment of any additional royalties shall not
        prevent **PHS** from exercising any other rights it may have as
        a consequence of the lateness of any payment.

5.  PERFORMANCE

    1.  Upon receipt and verification of the royalties due under
        Paragraphs 4.1 and 4.2, **PHS** agrees, if **Licensed Products**
        are available to **PHS**, to provide **Licensee** with samples
        of the **Licensed Products** to the individual and address
        listed in Appendix D and, at reasonable cost to **Licensee**, to
        replace them in the event of their unintentional destruction.
        **Licensee** agrees to retain control over the **Licensed
        Products** and shall not distribute or release them to others
        without the prior written consent of **PHS**.

    2.  **Licensee** shall expend reasonable efforts and resources to
        carry out the research development plan submitted with
        **Licensee\'s** application for a license and shall begin
        research within six (6) months of the effective date of this
        **Agreement**.

    3.  **Licensee** agrees in its use of any **Licensed Products**
        provided by **PHS** to comply with all applicable statutes,
        regulations, and guidelines, including **PHS** and **HHS**
        regulations and guidelines. **Licensee** agrees not to use the
        **Licensed Products** for research involving human subjects or
        clinical trials in the United States without complying with 21
        CFR Part 50 and 45 CFR Part 46. **Licensee** agrees not to use
        the **Licensed Products** for research involving human subjects
        or clinical trials outside of the United States without
        notifying **PHS**, in writing, of this research or trials and
        complying with the applicable regulations of the appropriate
        national control authorities. Written notification to **PHS** of
        research involving human subjects or clinical trials outside of
        the United States shall be given no later than sixty (60) days
        prior to commencement of this research or trials.

    4.  **Licensee** shall provide written annual reports within
        sixty (60) days of the end of each calendar year detailing the
        current status of on-going research using **Licensed Products**.

    5.  All plans and reports required by this Article 5 shall be
        treated by **PHS** as commercial and financial information
        obtained from a person and as privileged and confidential and,
        to the extent permitted under the research development plan by
        law, not subject to disclosure under the Freedom of Information
        Act, 5 U.S.C. §552.

6.  NEGATION OF WARRANTIES AND INDEMNIFICATION

    1.  **PHS** offers no warranties other than those expressly
        specified in Article 1.

    2.  **PHS** does not warrant the validity of the **Licensed Patent
        Rights** and makes no representations whatsoever with regard to
        the scope of the **Licensed Patent Rights**, or that the
        **Licensed Patent Rights** may be exploited without infringing
        other patents or other intellectual property rights of third
        parties.

    3.  **PHS** MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, OF
        MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF ANY
        SUBJECT MATTER DEFINED BY THE CLAIMS OF THE **LICENSED PATENT
        RIGHTS** OR OF ANY **LICENSED PRODUCTS** PROVIDED TO
        **LICENSEE** UNDER PARAGRAPH 5.1.

    4.  **PHS** does not represent that it shall commence legal actions
        against third parties infringing the **Licensed Patent Rights**.

    5.  **Licensee** shall indemnify and hold **PHS**, its employees,
        students, fellows, agents, and consultants harmless from and
        against all liability, demands, damages, expenses, and losses,
        including but not limited to death, personal injury, illness, or
        property damage in connection with or arising out of:

        a.  the use by **Licensee**, its directors, employees, or third
            parties of any **Licensed Patent Rights**, or

        b.  the design, manufacture, distribution, or use of any
            **Licensed Products** or materials provided under Paragraph
            5.1, or other products or processes developed in connection
            with or arising out of the **Licensed Patent Rights**.

    6.  **Licensee** agrees to maintain a liability insurance program
        consistent with sound business practice.

7.  TERM, TERMINATION AND MODIFICATION OF RIGHTS

    1.  This **Agreement** is effective when signed by all parties,
        unless the provisions of Paragraph 8.8 are not fulfilled, and
        shall terminate at the time specified in Appendix B, unless
        previously terminated under the terms of this Article 7.

    2.  In the event that **Licensee** is in default in the performance
        of any material obligations under this **Agreement**, including
        but not limited to the obligations listed in Paragraph 7.3 and
        if the default has not been remedied within ninety (90) days
        after the date of notice in writing of the default, **PHS** may
        terminate this **Agreement** by written notice and pursue
        outstanding royalties owed through procedures provided by the
        Federal Debt Collection Act.

    3.  **PHS** shall specifically have the right to terminate this
        **Agreement** by written notice if **Licensee**:

        a.  has not demonstrated that it is executing the research plan
            submitted with its application for a license or that it has
            not taken or cannot be expected to take, within a reasonable
            time, effective steps to achieve the practical application
            of the **Licensed Patent Rights** as contemplated by this
            **Agreement**; or

        b.  has willfully made a false statement of or willfully omitted
            a material fact in its application for a license or in any
            report required by this **Agreement**.

    4.  **PHS** reserves the right according to 35 U.S.C. §209(d)(3) to
        terminate this **Agreement** if it is determined that this
        action is necessary to meet the requirements for public use
        specified by Federal regulations issued after the date of the
        license and these requirements are not reasonably satisfied by
        **Licensee**.

    5.  **Licensee** shall have a unilateral right to terminate this
        **Agreement** by giving **PHS** sixty (60) days written notice
        to that effect.

    6.  Within thirty (30) days of receipt of written notice of **PHS'**
        unilateral decision to terminate this **Agreement**,
        **Licensee** may, consistent with the provisions of 37 CFR
        §404.11, appeal the decision by written submission to the
        Director of **NIH** or designee. The decision of the **NIH**
        Director or designee shall be the final agency decision.
        **Licensee** may thereafter exercise any and all administrative
        or judicial remedies that may be available.

    7.  If either party desires a modification to this **Agreement**,
        the parties shall, upon reasonable notice of the proposed
        modification by the party desiring the change, confer in good
        faith to determine the desirability of the modification. No
        modification shall be effective until a written amendment is
        signed by the signatories to this **Agreement** or their
        designees.

    8.  Within thirty (30) days of the termination of this **Agreement**
        under this Article 7 or expiration under Paragraph 7.1,
        **Licensee** shall submit payment of any royalties due and shall
        return all **Licensed Products** or other materials included
        within the **Licensed Patent Rights** to **PHS** or provide
        **PHS** with certification of their destruction.

    9.  Paragraphs 4.3, 5.5, 6.1-6.5, 7.6, and 7.8 of this **Agreement**
        shall survive termination of this **Agreement**.

8.  GENERAL PROVISIONS

    1.  This **Agreement** constitutes the entire agreement between the
        parties relating to the subject matter of the **Licensed Patent
        Rights**, and all prior negotiations, representations,
        agreements, and understandings are merged into, extinguished by,
        and completely expressed by this **Agreement**.

    2.  The provisions of this **Agreement** are severable, and in the
        event that any provision of this **Agreement** shall be
        determined to be invalid or unenforceable under any controlling
        body of law, such determination shall not in any way affect the
        validity or enforceability of the remaining provisions of this
        **Agreement**.

    3.  The construction, validity, performance, and effect of this
        **Agreement** shall be governed by Federal law as applied by the
        Federal courts in the District of Columbia.

    4.  All **Agreement** notices required or permitted by this
        **Agreement** shall be given by prepaid, first class, registered
        or certified mail properly addressed to the other party at the
        address designated on the following Signature Page, or to
        another address as may be designated in writing by such other
        party, and shall be effective as of the date of the postmark of
        such notice.

    5.  This **Agreement** shall not be assigned or otherwise
        transferred (including any transfer by legal process or by
        operation of law, and any transfer in bankruptcy or insolvency,
        or in any other compulsory procedure or order of court) except
        to **Licensee's** **Affiliate(s)** without the prior written
        consent of **PHS**. The parties agree that the identity of the
        parties is material to the formation of this **Agreement** and
        that the obligations under this **Agreement** are nondelegable.

    6.  **Licensee** acknowledges that it is subject to and agrees to
        abide by the United States laws and regulations (including the
        Export Administration Act of 1979 and Arms Export Control Act)
        controlling the export of technical data, computer software,
        laboratory prototypes, biological materials and other
        commodities. The transfer of these items may require a license
        from the appropriate agency of the **Government** or written
        assurances by **Licensee** that it shall not export other items
        to certain foreign countries without prior approval of the
        agency. **PHS** neither represents that a license is or is not
        required or that, if required, it shall be issued.

    7.  The parties agree to attempt to settle amicably any controversy
        or claim arising under this **Agreement** or a breach of this
        **Agreement**, except for appeals of modification or termination
        decisions provided for in Article 7. **Licensee** agrees first
        to appeal any such unsettled claims or controversies to the
        designated **PHS** official or designee, whose decision shall be
        considered the final agency decision. Thereafter, **Licensee**
        may exercise any administrative or judicial remedies that may be
        available.

    8.  The terms and conditions of this **Agreement** shall, at
        **PHS'** sole option, be considered by **PHS** to be withdrawn
        from **Licensee's** consideration and the terms and conditions
        of this **Agreement**, and the **Agreement** itself to be null
        and void, unless this **Agreement** is executed by the
        **Licensee** and a fully executed original is received by
        **PHS** within sixty (60) days from the date of **PHS**
        signature found at the Signature Page.

**SIGNATURES BEGIN ON NEXT PAGE**

**PHS** **NON-EXCLUSIVE PATENT** **LICENSE AGREEMENT**

**FOR INTERNAL COMMERCIAL USE**

FOR **PHS**:

by: [\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline} **DRAFT**
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

Richard U. Rodriguez Date

Director, Division of Technology Development and Transfer

Office of Technology Transfer

National Institutes of Health

Mailing Address for **Agreement** notices:

Chief, Monitoring & Enforcement Branch

Office of Technology Transfer

National Institutes of Health

6011 Executive Boulevard, Suite 325

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

FOR **Licensee** (Upon information and belief, the undersigned expressly
certifies or affirms that the contents of any statements of **Licensee**
made or referred to in this document are truthful and accurate.):

# Licensee

by: [\_\_\_\_\_\_\_]{.underline} **DRAFT**
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

Signature of Authorized Official Date

Printed Name

Title

I.  Official and Mailing Address for **Agreement** notices:

> Name
>
> Title
>
> Mailing Address
>
> Email Address:
>
> Phone:
>
> Fax:

II. Official and Mailing Address for Financial notices (**Licensee's**
    contact person for royalty payments)

> Name
>
> Title
>
> Mailing Address:
>
> Email Address:
>
> Phone:
>
> Fax:

Any false or misleading statements made, presented, or submitted to the
**Government**, including any relevant omissions, under this
**Agreement** and during the course of negotiation of this **Agreement**
are subject to all applicable civil and criminal statutes including
Federal statutes 31 U.S.C. §§3801‑3812 (civil liability) and 18 U.S.C.
§1001 (criminal liability including fine(s) or imprisonment).

APPENDIX A -- Patent(s) or Patent Application(s)

**Patent(s) or Patent Application(s):**

I.  
II. 
III. 

APPENDIX B -- Licensed Products, Processes, Territory, Field of Use and
Termination

I.  **Licensed Products**:

    a.  

II. **Licensed Processes**:

    a.  

III. **Licensed Territory**:

     a.  

IV. **Licensed Fields of Use**:

    a.  

V.  Termination:

    a.  This **Agreement** shall terminate \_\_\_\_\_\_\_\_ (X) years
        from the effective date as defined in Paragraph 7.1.

APPENDIX C -- Royalties

**Royalties:**

I.  **Licensee** agrees to pay to **PHS** a noncreditable, nonrefundable
    license issue royalty in the amount of \_\_\_\_\_\_\_\_ dollars
    (\$X) within sixty (60) days from the effective date of this
    **Agreement**.

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IV. **Licensee** agrees to pay to **PHS** a nonrefundable annual royalty
    in the amount of \_\_\_\_\_\_\_\_ dollars (\$X) as follows:

    1.  The first annual royalty is due within sixty (60) days of the
        effective date of this **Agreement** and may be prorated
        according to the fraction of the calendar year remaining between
        the effective date of this **Agreement** and the next subsequent
        January 1; and

    2.  Subsequent annual royalty payments are due and payable on
        January 1 of each calendar year.

APPENDIX D -- SHIPPING INFORMATION

**[Licensee's Shipping Contact:]{.underline} information or questions
regarding shipping should be directed to Licensee's Shipping Contact
at:**

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

> Shipping Contact's Name Title

Phone: [()]{.underline} Fax: [()]{.underline} E-mail:

**[Shipping Address:]{.underline} Name & Address to which Materials
should be shipped (please be specific):**

Company Name & Department

Address:

Appendix E -- Royalty Payment Options

***[NIH/PHS License Agreements]{.underline}***

*[**\*In order to process payment via Electronic Funds Transfer sender
MUST supply the following information**:]{.underline}*

***Procedure for Transfer of Electronic Funds to NIH for Royalty
Payments***

Bank Name: Federal Reserve Bank

ABA# 021030004

TREAS NYC

BNF=/AC-75080031

OBI=Licensee Name and OTT Reference Number

Dollar Amount Wired=\$\$

NOTE: Only U.S. banks can wire directly to the Federal Reserve Bank.
Foreign banks cannot wire directly to the Federal Reserve Bank, but must
go through an intermediary U.S. bank. Foreign banks may send the wire
transfer to the U.S. bank of their choice, who, in turn forwards the
wire transfer to the Federal Reserve Bank.

***Checks drawn on a U.S. bank account should be sent directly to the
following address:***

National Institutes of Health (NIH)

P.O. Box 979071

St. Louis, MO 63197-9000

***Overnight or courier deliveries should be sent to the following
address:***

US Bank

Government Lockbox SL-MO-C2GL

1005 Convention Plaza

St. Louis, MO 63101

Phone: 314-418-4087

***Checks drawn on a foreign bank account should be sent directly to the
following address:***

National Institutes of Health (NIH)

Office of Technology Transfer

Royalties Administration Unit

6011 Executive Boulevard

Suite 325, MSC 7660

Rockville, Maryland 20852

Phone: 301-496-7057

***All checks should be made payable to "NIH Patent Licensing".***

***[The OTT Reference Number MUST appear on checks, reports and
correspondence]{.underline}***