**PUBLIC HEALTH SERVICE**

**PATENT LICENSE AGREEMENT -- *NONEXCLUSIVE***

COVER PAGE

For PHS internal use only:

> License Number:
>
> License Application Number:
>
> Serial Number(s) of Licensed Patent(s) or Patent Application(s):
>
> Licensee:
>
> Cooperative Research and Development Agreement (CRADA) Number (if a
> subject invention):
>
> 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 (Fields of Use and Territory), Appendix C
(Royalties), Appendix D ((Benchmarks and Performance), Appendix E
(Commercial Development Plan), Appendix F (Example Royalty Report), and
Appendix G (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**."

PHS PATENT LICENSE AGREEMENT\--*NONEXCLUSIVE*

**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 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. §3710(a), 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 commercialization licenses to facilitate the
        commercial development of products and processes for public use
        and benefit.

    5.  **Licensee** desires to acquire commercialization rights to
        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.  "**Benchmarks**" mean the performance milestones that are set
        forth in Appendix D.

    3.  "**Commercial Development Plan**" means the written
        commercialization plan attached as Appendix E.

    4.  "**First Commercial Sale**" means the initial transfer by or on
        behalf of **Licensee** of **Licensed Products** or the initial
        practice of a **Licensed Process** by or on behalf of
        **Licensee** in exchange for cash or some equivalent to which
        value can be assigned for the purpose of determining **Net
        Sales**.

    5.  "**Government**" means the Government of the United States of
        America.

    6.  "**Licensed Fields of Use**" means the fields of use identified
        in Appendix B.

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

        a.  Patent applications (including provisional patent
            applications and PCT patent applications) or patents listed
            in Appendix A, all divisions and continuations of these
            applications, all patents issuing from these applications,
            divisions, and continuations, and any reissues,
            reexaminations, and extensions of all these patents;

        b.  to the extent that the following contain one or more claims
            directed to the invention or inventions disclosed in 2.7(a):

            i.  continuations‑in‑part of 2.7(a);

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

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

            iv. priority patent application(s) of 2.7(a); and

            v.  any reissues, reexaminations, and extensions of all
                these patents;

        c.  to the extent that the following contain one or more claims
            directed to the invention or inventions disclosed in 2.7(a):
            all counterpart foreign and U.S. patent applications and
            patents to 2.7(a) and 2.7(b), including those listed in
            Appendix A; and

        d.  **Licensed Patent Rights** shall *not* include 2.7(b) or
            2.7(c) to the extent that they contain one or more claims
            directed to new matter which is not the subject matter
            disclosed in 2.7(a).

    8.  "**Licensed Processes**" means processes, 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.

    9.  "**Licensed Products**" means tangible materials, 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.

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

    11. "**Net Sales**" means the total gross receipts for sales of
        **Licensed Products** or practice of **Licensed Processes** by
        or on behalf of **Licensee**, and from leasing, renting, or
        otherwise making **Licensed Products** available to others
        without sale or other dispositions, whether invoiced or not,
        less returns and allowances, packing costs, insurance costs,
        freight out, taxes or excise duties imposed on the transaction
        (if separately invoiced), and wholesaler and cash discounts in
        amounts customary in the trade to the extent actually granted.
        No deductions shall be made for commissions paid to individuals,
        whether they are with independent sales agencies or regularly
        employed by **Licensee**, and on its payroll, or for the cost of
        collections.

    12. "**Practical Application**" means to manufacture in the case of
        a composition or product, to practice in the case of a process
        or method, or to operate in the case of a machine or system; and
        in each case, under these conditions as to establish that the
        invention is being utilized and that its benefits are to the
        extent permitted by law or **Government** regulations available
        to the public on reasonable terms.

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 have made, to use and have used, to sell
        and have sold, to offer to sell, and to import any **Licensed
        Products** in the **Licensed Fields of Use** and to practice and
        have practiced any **Licensed Processes** in the **Licensed
        Fields of Use**.

    2.  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 these patents are dominant or subordinate to the
        **Licensed Patent Rights**.

4.  SUBLICENSING

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

5.  STATUTORY AND PHS REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS

    1.  Prior to the **First Commercial Sale**, **Licensee** agrees to
        provide **PHS** with reasonable quantities of **Licensed
        Products** or materials made through the **Licensed Processes**
        for **PHS** research use.

    2.  **Licensee** agrees that products used or sold in the United
        States embodying **Licensed Products** or produced through use
        of **Licensed Processes** shall be manufactured substantially in
        the United States, unless a written waiver is obtained in
        advance from **PHS**.

6.  ROYALTIES AND REIMBURSEMENT

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

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

    3.  **Licensee** agrees to pay **PHS** earned royalties as set forth
        in Appendix C.

    4.  **Licensee** agrees to pay **PHS** benchmark royalties as set
        forth in Appendix C.

    5.  A patent or patent application licensed under this **Agreement**
        shall cease to fall within the **Licensed Patent Rights** for
        the purpose of computing earned royalty payments in any given
        country on the earliest of the dates that:

        a.  the application has been abandoned and not continued;

        b.  the patent expires or irrevocably lapses; or

        c.  the patent has been held to be invalid or unenforceable by
            an unappealed or unappealable decision of a court of
            competent jurisdiction or administrative agency.

    6.  No multiple royalties shall be payable because any **Licensed
        Products** or **Licensed Processes** are covered by more than
        one of the **Licensed Patent Rights**.

    7.  On sales of **Licensed Products** by **Licensee** made in other
        than an arms‑length transaction, the value of the **Net Sales**
        attributed under this Article 6 to this transaction shall be
        that which would have been received in an arms‑length
        transaction, based on sales of like quantity and quality
        products on or about the time of this transaction.

    8.  With regard to unreimbursed expenses associated with the
        preparation, filing, prosecution, and maintenance of all patent
        applications and patents included within the **Licensed Patent
        Rights** and incurred by **PHS** prior to the effective date of
        this **Agreement**, **Licensee** shall pay **PHS**, as an
        additional royalty, within sixty (60) days of **PHS'**
        submission of a statement and request for payment to
        **Licensee**, an amount equivalent to the unreimbursed patent
        expenses previously incurred by **PHS**.

    9.  With regard to unreimbursed expenses associated with the
        preparation, filing, prosecution, and maintenance of all patent
        applications and patents included within the **Licensed Patent
        Rights** and incurred by **PHS** on or after the effective date
        of this **Agreement**, **PHS**, at its sole option, may require
        **Licensee**:

        a.  to pay **PHS** on an annual basis, within sixty (60) days of
            **PHS**\' submission of a statement and request for payment,
            a royalty amount equivalent to these unreimbursed expenses
            incurred during the previous calendar year(s);

        b.  to pay these unreimbursed expenses directly to the law firm
            employed by **PHS** to handle these functions. However, in
            this event, **PHS** and not **Licensee** shall be the client
            of the law firm; or

        c.  under exceptional circumstances, **Licensee** may be given
            the right to assume responsibility for the preparation,
            filing, prosecution, or maintenance of any patent
            application or patent included with the **Licensed Patent
            Rights**. In that event, **Licensee** shall directly pay the
            attorneys or agents engaged to prepare, file, prosecute, or
            maintain these patent applications or patents and shall
            provide **PHS** with copies of each invoice associated with
            these services as well as documentation that these invoices
            have been paid.

    10. **PHS** agrees, upon written request, to provide **Licensee**
        with summaries of patent prosecution invoices for which **PHS**
        has requested payment from the **Licensee** under Paragraphs 6.8
        and 6.9. **Licensee** agrees that all information provided by
        **PHS** related to patent prosecution costs shall be treated as
        confidential commercial information and shall not be released to
        a third party except as required by law or a court of competent
        jurisdiction.

    11. **Licensee** may elect to surrender its rights in any country of
        the **Licensed Territory** under any of the **Licensed Patent
        Rights** upon sixty (60) days written notice to **PHS** and owe
        no payment obligation under Paragraph 6.9 for patent-related
        expenses incurred in that country after the effective date of
        the written notice.

7.  PATENT FILING, PROSECUTION, AND MAINTENANCE

    1.  **PHS** agrees to take responsibility for the preparation,
        filing, prosecution, and maintenance of any and all patent
        applications or patents included in the **Licensed Patent
        Rights**.

8.  RECORD KEEPING

    1.  **Licensee** agrees to keep accurate and correct records of
        **Licensed Products** made, used, sold, or imported and
        **Licensed Processes** practiced under this **Agreement**
        appropriate to determine the amount of royalties due **PHS**.
        These records shall be retained for at least five (5) years
        following a given reporting period and shall be available during
        normal business hours for inspection, at the expense of **PHS**,
        by an accountant or other designated auditor selected by **PHS**
        for the sole purpose of verifying reports and royalty payments
        hereunder. The accountant or auditor shall only disclose to
        **PHS** information relating to the accuracy of reports and
        royalty payments made under this **Agreement**. If an inspection
        shows an underreporting or underpayment in excess of five
        percent (5%) for any twelve (12) month period, then **Licensee**
        shall reimburse **PHS** for the cost of the inspection at the
        time **Licensee** pays the unreported royalties, including any
        additional royalties as required by Paragraph 9.8. All royalty
        payments required under this Paragraph shall be due within
        sixty (60) days of the date **PHS** provides **Licensee** notice
        of the payment due.

    2.  **Licensee** agrees to have an audit of sales and royalties
        conducted by an independent auditor at least every two (2) years
        if annual sales of the **Licensed Products** or **Licensed
        Processes** are over two (2) million dollars. The audit shall
        address, at a minimum, the amount of gross sales by or on behalf
        of **Licensee** during the audit period, terms of the license as
        to percentage or fixed royalty to be remitted to the
        **Government**, the amount of royalties owed to the
        **Government** under this **Agreement**, and whether the
        royalties owed have been paid to the **Government** and is
        reflected in the records of the **Licensee**. The audit shall
        also indicate the **PHS** license number, product, and the time
        period being audited. A report certified by the auditor shall be
        submitted promptly by the auditor directly to **PHS** on
        completion. **Licensee** shall pay for the entire cost of the
        audit.

9.  REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS

    1.  Prior to signing this **Agreement**, **Licensee** has provided
        **PHS** with the **Commercial Development Plan** in Appendix E,
        under which **Licensee** intends to bring the subject matter of
        the **Licensed Patent Rights** to the point of **Practical
        Application**. This **Commercial Development Plan** is hereby
        incorporated by reference into this **Agreement**. Based on this
        plan, performance **Benchmarks** are determined as specified in
        Appendix D.

    2.  **Licensee** shall provide written annual reports on its product
        development progress or efforts to commercialize under the
        **Commercial Development Plan** for each of the **Licensed
        Fields of Use** within sixty (60) days after December 31 of each
        calendar year. These progress reports shall include, but not be
        limited to: progress on research and development, status of
        applications for regulatory approvals, manufacturing, marketing,
        importing, and sales during the preceding calendar year, as well
        as, plans for the present calendar year. **PHS** also encourages
        these reports to include information on any of **Licensee's**
        public service activities that relate to the **Licensed Patent
        Rights**. If reported progress differs from that projected in
        the **Commercial Development Plan** and **Benchmarks**,
        **Licensee** shall explain the reasons for such differences. In
        any annual report, **Licensee** may propose amendments to the
        **Commercial Development Plan**, acceptance of which by **PHS**
        may not be denied unreasonably. **Licensee** agrees to provide
        any additional information reasonably required by **PHS** to
        evaluate **Licensee's** performance under this **Agreement**.
        **Licensee** may amend the **Benchmarks** at any time upon
        written approval by **PHS**. **PHS** shall not unreasonably
        withhold approval of any request of **Licensee** to extend the
        time periods of this schedule if the request is supported by a
        reasonable showing by **Licensee** of diligence in its
        performance under the **Commercial Development Plan** and toward
        bringing the **Licensed Products** to the point of **Practical
        Application**.

    3.  **Licensee** shall report to **PHS** the dates for achieving
        **Benchmarks** specified in Appendix D and the **First
        Commercial Sale** in each country in the **Licensed Territory**
        within thirty (30) days of such occurrences.

    4.  **Licensee** shall submit to **PHS**, within sixty (60) days
        after each calendar half‑year ending June 30 and December 31, a
        royalty report, as described in the example in Appendix F,
        setting forth for the preceding half‑year period the amount of
        the **Licensed Products** sold or **Licensed Processes**
        practiced by or on behalf of **Licensee** in each country within
        the **Licensed Territory**, the **Net Sales**, and the amount of
        royalty accordingly due. With each royalty report, **Licensee**
        shall submit payment of earned royalties due. If no earned
        royalties are due to **PHS** for any reporting period, the
        written report shall so state. The royalty report shall be
        certified as correct by an authorized officer of **Licensee**
        and shall include a detailed listing of all deductions made
        under Paragraph 2.11 to determine **Net Sales** made under
        Article 6 to determine royalties due.

    5.  Royalties due under Article 6 shall be paid in U.S. dollars and
        payment options are listed in Appendix G. 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, and any loss of
        exchange, value, taxes, or other expenses incurred in the
        transfer or conversion to U.S. dollars shall be paid entirely by
        **Licensee**. The royalty report required by Paragraph 9.4 shall
        be mailed to **PHS** at its address for **Agreement** Notices
        indicated on the Signature Page.

    6.  **Licensee** shall be solely responsible for determining if any
        tax on royalty income is owed outside the United States and
        shall pay this tax and be responsible for all filings with
        appropriate agencies of foreign governments.

    7.  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.

    8.  All plans and reports required by this Article 9 and marked
        "confidential" by **Licensee** shall, to the extent permitted by
        law, be treated by **PHS** as commercial and financial
        information obtained from a person and as privileged and
        confidential, and any proposed disclosure of these records by
        the **PHS** under the Freedom of Information Act (FOIA), 5
        U.S.C. §552 shall be subject to the predisclosure notification
        requirements of 45 CFR §5.65(d).

10. PERFORMANCE

    1.  **Licensee** shall use its reasonable commercial efforts to
        bring the **Licensed Products** and **Licensed Processes** to
        **Practical Application**. "Reasonable commercial efforts" for
        the purposes of this provision shall include adherence to the
        **Commercial Development Plan** in Appendix E and performance of
        the **Benchmarks** in Appendix D.

    2.  Upon the **First Commercial Sale**, until the expiration or
        termination of this **Agreement**, **Licensee** shall use its
        reasonable commercial efforts to make **Licensed Products** and
        **Licensed Processes** reasonably accessible to the United
        States public.

    3.  **Licensee** agrees, after its **First Commercial Sale,** to
        make reasonable quantities of **Licensed Products** or materials
        produced through the use of **Licensed Processes** available on
        a compassionate use basis to patients, either through the
        patient\'s physician(s) or the medical center treating the
        patient.

    4.  **Licensee** agrees, after its **First Commercial Sale** and as
        part of its marketing and product promotion, to develop
        educational materials (e.g., brochures, website, etc.) directed
        to patients and physicians detailing the **Licensed Products**
        or medical aspects of the prophylactic and therapeutic uses of
        the **Licensed Products**.

    5.  **Licensee** agrees to supply, to the Mailing Address for
        **Agreement** Notices indicated on the Signature Page, the
        Office of Technology Transfer, **NIH** with inert samples of the
        **Licensed Products** or **Licensed Processes** or their
        packaging for educational and display purposes only.

11. INFRINGEMENT AND PATENT ENFORCEMENT

    1.  **PHS** and **Licensee** agree to notify each other promptly of
        each infringement or possible infringement of the **Licensed
        Patent Rights**, as well as, any facts which may affect the
        validity, scope, or enforceability of the **Licensed Patent
        Rights** of which either Party becomes aware.

    2.  In the event that a declaratory judgment action alleging
        invalidity of any of the **Licensed Patent Rights** shall be
        brought against **PHS**, **PHS** agrees to notify **Licensee**
        that an action alleging invalidity has been brought. **PHS**
        does not represent that it shall commence legal action to defend
        against a declaratory action alleging invalidity. **Licensee**
        shall take no action to compel the **Government** either to
        initiate or to join in any declaratory judgment action. Should
        the **Government** be made a party to any suit by motion or any
        other action of **Licensee**, **Licensee** shall reimburse the
        **Government** for any costs, expenses, or fees, which the
        **Government** incurs as a result of the motion or other action.
        Upon **Licensee\'s** payment of all costs incurred by the
        **Government** as a result of **Licensee\'s** joinder motion or
        other action, these actions by **Licensee** shall not be
        considered a default in the performance of any material
        obligation under this **Agreement**.

12. NEGATION OF WARRANTIES AND INDEMNIFICATION

    1.  **PHS** offers no warranties other than those 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 TANGIBLE MATERIALS RELATED THERETO.

    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 or on behalf of **Licensee**, its directors,
            employees, or third parties of any **Licensed Patent
            Rights**; or

        b.  the design, manufacture, distribution, or use of any
            **Licensed Products**, **Licensed Processes** or materials
            by **Licensee**, 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.

13. TERM, TERMINATION, AND MODIFICATION OF RIGHTS

    1.  This **Agreement** is effective when signed by all parties,
        unless the provisions of Paragraph 14.15 are not fulfilled, and
        shall extend to the expiration of the last to expire of the
        **Licensed Patent Rights** unless sooner terminated as provided
        in this Article 13.

    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 13.5, 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.  In the event that **Licensee** becomes insolvent, files a
        petition in bankruptcy, has such a petition filed against it,
        determines to file a petition in bankruptcy, or receives notice
        of a third party's intention to file an involuntary petition in
        bankruptcy, **Licensee** shall immediately notify **PHS** in
        writing. Furthermore, **PHS** shall have the right to terminate
        this **Agreement** immediately upon **Licensee's** receipt of
        written notice.

    4.  **Licensee** shall have a unilateral right to terminate this
        **Agreement** in any country or territory by giving **PHS**
        sixty (60) days written notice to that effect.

    5.  **PHS** shall specifically have the right to terminate or
        modify, at its option, this **Agreement**, if **PHS** determines
        that the **Licensee**:

        a.  is not executing the **Commercial Development Plan**
            submitted with its request for a license and the
            **Licensee** cannot otherwise demonstrate to **PHS'**
            satisfaction that the **Licensee** has taken, or can be
            expected to take within a reasonable time, effective steps
            to achieve **Practical Application** of the **Licensed
            Products** or **Licensed Processes**;

        b.  has not achieved the **Benchmarks** as may be modified under
            Paragraph 9.2;

        c.  has willfully made a false statement of, or willfully
            omitted, a material fact in the license application or in
            any report required by this **Agreement**;

        d.  has committed a material breach of a covenant or agreement
            contained in this **Agreement**;

        e.  is not keeping **Licensed Products** or **Licensed
            Processes** reasonably available to the public after
            commercial use commences;

        f.  cannot reasonably satisfy unmet health and safety needs; or

        g.  cannot reasonably justify a failure to comply with the
            domestic production requirement of Paragraph 5.2, unless
            waived.

    6.  In making the determination referenced in Paragraph 13.5,
        **PHS** shall take into account the normal course of such
        commercial development programs conducted with sound and
        reasonable business practices and judgment and the annual
        reports submitted by **Licensee** under Paragraph 9.2. Prior to
        invoking termination or modification of this **Agreement** under
        Paragraph 13.5, **PHS** shall give written notice to
        **Licensee** providing **Licensee** specific notice of, and a
        ninety (90) day opportunity to respond to, **PHS'** concerns as
        to the items referenced in 13.5(a)-13.5(g). If **Licensee**
        fails to alleviate **PHS'** concerns as to the items referenced
        in 13.5(a)-13.5(g) or fails to initiate corrective action to
        **PHS'** satisfaction, **PHS** may terminate this **Agreement**.

    7.  **PHS** reserves the right according to 35 U.S.C. §209(d)(3) to
        terminate or modify this **Agreement** if it is determined that
        the 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**.

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

    9.  Within ninety (90) days of expiration or termination of this
        **Agreement** under this Article 13, a final report shall be
        submitted by **Licensee**. Any royalty payments, including those
        incurred but not yet paid (such as the full minimum annual
        royalty), and those related to patent expense, due to **PHS**
        shall become immediately due and payable upon termination or
        expiration. Unless otherwise specifically provided for under
        this **Agreement**, upon termination or expiration of this
        **Agreement**, **Licensee** shall return all **Licensed
        Products** or other materials included within the **Licensed
        Patent Rights** to **PHS** or provide **PHS** with written
        certification of the destruction thereof.

14. GENERAL PROVISIONS

    1.  Neither party may waive or release any of its rights or
        interests in this **Agreement** except in writing. The failure
        of the **Government** to assert a right hereunder or to insist
        upon compliance with any term or condition of this **Agreement**
        shall not constitute a waiver of that right by the
        **Government** or excuse a similar subsequent failure to perform
        any of these terms or conditions by **Licensee**.

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

    3.  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, this determination shall not in any way affect the
        validity or enforceability of the remaining provisions of this
        **Agreement**.

    4.  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.

    5.  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.

    6.  All **Agreement** notices required or permitted by this
        **Agreement** shall be given by prepaid, first class, registered
        or certified mail or by an express/overnight delivery service
        provided by a commercial carrier, properly addressed to the
        other party at the address designated on the Signature Page, or
        to any other address as may be designated in writing by such
        other party. **Agreement** notices shall be considered timely if
        such notices are received on or before the established deadline
        date or sent on or before the deadline date as verifiable by
        U.S. Postal Service postmark or dated receipt from a commercial
        carrier. Parties should request a legibly dated U.S. Postal
        Service postmark or obtain a dated receipt from a commercial
        carrier or the U.S. Postal Service. Private metered postmarks
        shall not be acceptable as proof of timely mailing.

    7.  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.
        In the event that **PHS** approves a proposed assignment,
        **Licensee** shall pay **PHS**, as an additional royalty, one
        percent (1%) of the fair market value of any consideration
        received for any assignment of this **Agreement** within
        sixty (60) days of the assignment

    8.  **Licensee** agrees in its use of any **PHS**‑supplied materials
        to comply with all applicable statutes, regulations, and
        guidelines, including **PHS** and **HHS** regulations and
        guidelines. **Licensee** agrees not to use the materials 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 materials for
        research involving human subjects or clinical trials outside of
        the United States without notifying **PHS**, in writing, of the
        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 the research
        or trials.

    9.  **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 these 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.

    10. **Licensee** agrees to mark the **Licensed Products** or their
        packaging sold in the United States with all applicable U.S.
        patent numbers and similarly to indicate "Patent Pending"
        status. All **Licensed Products** manufactured in, shipped to,
        or sold in other countries shall be marked in a manner to
        preserve **PHS** patent rights in those countries.

    11. By entering into this **Agreement**, **PHS** does not directly
        or indirectly endorse any product or service provided, or to be
        provided, by **Licensee** whether directly or indirectly related
        to this **Agreement**. **Licensee** shall not state or imply
        that this **Agreement** is an endorsement by the **Government**,
        **PHS**, any other **Government** organizational unit, or any
        **Government** employee. Additionally, **Licensee** shall not
        use the names of **NIH**, **PHS**, **FDA** or **HHS** or the
        **Government** or their employees in any advertising,
        promotional, or sales literature without the prior written
        approval of **PHS**.

    12. 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 modifications or
        termination decisions provided for in Article 13. **Licensee**
        agrees first to appeal any 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.

    13. Nothing relating to the grant of a license, nor the grant
        itself, shall be construed to confer upon any person any
        immunity from or defenses under the antitrust laws or from a
        charge of patent misuse, and the acquisition and use of rights
        pursuant to 37 CFR Part 404 shall not be immunized from the
        operation of state or Federal law by reason of the source of the
        grant.

    14. Paragraphs 8.1, 9.6-9.8, 12.1‑12.5, 13.8, 13.9, 14.12 and 14.14
        of this **Agreement** shall survive termination of this
        **Agreement**.

    15. 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 PATENT LICENSE AGREEMENT -- *NONEXCLUSIVE*

SIGNATURE PAGE

For **PHS**:

\_\_\_\_\_\_\_\_\_**DRAFT**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

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.):

by:

\_\_\_\_\_\_\_\_\_**DRAFT**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

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) and/or imprisonment).

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

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

I.  
II. 
III. 
IV. 
V.  
VI. 

APPENDIX B -- Licensed Fields of Use and Territory

I.  **Licensed Fields of Use:**

    a.  

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VII. **Licensed Territory:**

     a.  

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

      a.  The first minimum 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

      b.  Subsequent minimum annual royalty payments are due and payable
          on January 1 of each calendar year and may be credited against
          any earned royalties due for sales made in that year.

IX. **Licensee** agrees to pay **PHS** earned royalties of \_\_\_
    percent (X%) on **Net Sales** by or on behalf of **Licensee**.

X.  **Licensee** agrees to pay **PHS** **Benchmark** royalties within
    sixty (60) days of achieving each **Benchmark**:

    a.  
    b.  
    c.  
    d.  
    e.  
    f.  

APPENDIX D -- Benchmarks and Performance

**Licensee** agrees to the following **Benchmarks** for its performance
under this **Agreement** and, within thirty (30) days of achieving a
**Benchmark**, shall notify **PHS** that the **Benchmark** has been
achieved.

I.  

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XI. 
XII. 
XIII. 
XIV. 
XV. 
XVI. 

APPENDIX E -- Commercial Development Plan

APPENDIX F -- Example Royalty Report

**Required royalty report information includes:**

• OTT license reference number (L-XXX-200X/0)

• Reporting period

• Catalog number and units sold of each Licensed Product (domestic and
foreign)

• Gross Sales per catalog number per country

• Total Gross Sales

• Itemized deductions from Gross Sales

• Total Net Sales

• Earned Royalty Rate and associated calculations

• Gross Earned Royalty

• Adjustments for Minimum Annual Royalty (MAR) and other creditable
payments made

• Net Earned Royalty due

**Example**

  ---------------- -------------- ------------- ------------- -------------
  **Catalog        **Product      **Country**   **Units       **Gross Sales
  Number**         Name**                       Sold**        (US\$)**

  1                A              US            250           62,500

  1                A              UK            32            16,500

  1                A              France        25            15,625

  2                B              US            0             0

  3                C              US            57            57,125

  4                D              US            12            1,500
  ---------------- -------------- ------------- ------------- -------------

Total Gross Sales 153,250

Less Deductions:

Freight 3,000

Returns 7,000

Total Net Sales 143,250

Royalty Rate 8%

Royalty Due 11,460

Less Creditable Payments 10,000

**Net Royalty Due 1,460**

Appendix G -- 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}***