Exhibit 10.61

Page: 1/29

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 240.24b-2.

LICENSE AGREEMENT

THIS LICENSE AGREEMENT is made and entered into as of the 12th day of
August 1998, by and among Mountain View Pharmaceuticals, Inc., Duke University,
and Bio-Technology General Corporation.

WHEREAS, DUKE has developed certain recombinant mammalian uricases prior to the
start of the GRANT, including PBC URICASE;

WHEREAS, DUKE and/or MVP have developed, pursuant to the GRANT, additional
recombinant mammalian uricases;

WHEREAS, DUKE and MVP have developed, pursuant to the GRANT, PEG conjugates of
PBC URICASE and other mammalian uricases;

WHEREAS, MVP has developed PEG conjugates of non-mammalian uricases;

WHEREAS, DUKE and MVP, in order to have the benefits of these developments made
available to the public, desire to license their rights therein exclusively, on
a worldwide basis, to BTG in the FIELD; and

WHEREAS, BTG desires to obtain such a license.

NOW THEREFORE, in consideration of the premises and the faithful performance of
the covenants herein contained, the PARTIES agree as follows:

ARTICLE 1 – INDEPENDENT CONTRACTORS

 

1.0

MVP’s and DUKE’S relationships to one another and to BTG under this AGREEMENT
are those of independent contractors and not as agents, joint venturers or
partners.

ARTICLE 2 – DEFINITIONS

 

2.0

As used throughout this AGREEMENT, the terms and phrases set forth herein in
capital letters shall be defined as set forth in this Article 2.

 

2.1

“AFFILIATES” of a person or an entity shall mean any individual, sole
proprietorship, firm, partnership, corporation, trust, joint venture or other
entity, whether de jure or de facto, which, directly or indirectly, controls, is
controlled by or is under common control with such person or entity. As used in
this definition, “control” means the possession, directly or indirectly, of the
power to direct or cause the direction of the policies and management of a
person or entity, whether by the ownership of stock, by contract or otherwise.

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2.2

“AGREEMENT” shall mean this License Agreement as amended from time to time.

 

2.3

“BIRD” shall mean the U.S.-Israel Binational Industrial Research and Development
Foundation.

 

2.4

“BTG” shall mean Bio-Technology General Corporation, a corporation organized
under the laws of Delaware, and having its principal offices at Iselin, New
Jersey 08830, and its AFFILIATES.

 

2.5

“DUKE” shall mean Duke University, a North Carolina not-for-profit corporation,
having its principal office at Durham, North Carolina 27710, and its AFFILIATES.

 

2.6

“DUKE TECHNOLOGY” shall mean technologies conceived, reduced to practice,
developed, or acquired, by or for DUKE, or licensed to DUKE, or developed
jointly with MVP, relating to mammalian urate oxidase (mammalian uricase),
including the know-how and other information described in detail in Exhibit A
attached hereto and made a part hereof, as of the EFFECTIVE DATE, and including
any improvement made by DUKE thereon during the TERM of this AGREEMENT, for use
in the FIELD; provided, however, that with respect to such improvements, DUKE
shall promptly disclose each such improvement to BTG and it shall be included in
the license only if, within six (6) months after disclosure, BTG elects to
incorporate the improvement into LICENSED PRODUCTS or the manufacturing process
thereof.

 

2.7

“EFFECTIVE DATE” shall mean the date first written above.

 

2.8

“FIELD” shall mean the treatment of humans.

 

2.9

“GRANT” shall mean the STTR grant from NIH (Grant No. DK48529) for a research
project titled, “Mammalian PEG-Uricase for Therapy of Intractable Gout” under
which LICENSORS received funding from September 30, 1996, through August 31,
1998.

 

2.10

“IMPUTED NET SALES” shall have the meaning ascribed to it in Section 2.17(a).

 

2.11

“INFORMATION” shall have the meaning ascribed to it in Section 11.1.

 

2.12

“LICENSED PRODUCTS” shall mean any products (including all dosage forms,
strengths, and package sizes) that utilize TECHNOLOGY in whole or in part.

 

2.13

“LICENSEE” shall mean BTG.

 

2.14

“LICENSOR” shall mean MVP, DUKE or both of them, depending on the context.

 

2.15

“MVP” shall mean Mountain View Pharmaceuticals, Inc., a corporation organized
under the laws of California, and having its principal place of business at
Menlo Park, California 94025, and its AFFILIATES.

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2.16

“MVP TECHNOLOGY” shall mean technologies conceived, reduced to practice,
developed, or acquired, by or for MVP, or licensed to MVP, or developed jointly
with DUKE, relating to mammalian urate oxidase (mammalian uricase) and
non-mammalian urate oxidase (non-mammalian uricase) and PEG conjugates of both
mammalian uricase and non-mammalian uricase, including the know-how and other
information described in detail in Exhibit B attached hereto and made a part
hereof, as of the EFFECTIVE DATE, including any improvements made by MVP thereon
during the TERM of this AGREEMENT, for use in the FIELD; provided, however, that
with respect to such improvements, MVP shall promptly disclose each such
improvement to BTG and it shall be included in the license only if, within six
(6) months after disclosure, BTG elects to incorporate the improvement into
LICENSED PRODUCTS or the manufacturing process thereof.

 

2.17

“NET SALES” shall mean LICENSEE’ s aggregate arm’s length gross charges to the
trade, physicians or patients charged for sales by LICENSEE of the LICENSED
PRODUCTS, less all normal and customary trade and quantity discounts and less
any sales and excise taxes and duties paid by LICENSEE.

 

  (a)

In the event that the LICENSED PRODUCTS are distributed by LICENSEE at no cost
to the recipient for revenue-producing activities, these shall be deemed to be
NET SALES (“IMPUTED NET SALES”) for purposes of computing royalty obligations,
except for LICENSED PRODUCTS distributed that are not reimbursable or which are
used for non-revenue-producing activities such as promotional samples and
supplies for clinical studies or field trials.

 

  (b)

IMPUTED NET SALES shall be valued at the mean price for such respective LICENSED
PRODUCTS sold by LICENSEE during the calendar quarter preceding the calendar
quarter during which such IMPUTED NET SALES occur.

 

  (c)

Transfer prices for LICENSED PRODUCTS between AFFILIATES shall not be considered
for the purpose of computing NET SALES or IMPUTED NET SALES.

 

2.18

“NIH” shall mean the U.S. National Institutes of Health.

 

2.19

“PATENT RIGHTS” shall mean rights to any claims directed to any aspect of the
TECHNOLOGY in all United States and foreign patent applications filed and any
patents now issued or hereinafter issuing from such patent applications,
substitutes, continuations, continuations-in-part, divisional applications,
reexaminations or reissues thereof, which contain at least one claim directed to
any aspect of the TECHNOLOGY, a current listing of which appears in Exhibit C
attached hereto and made a part hereof, as amended from time to time during the
TERM of this AGREEMENT.

 

2.20

“PARTY” or “PARTIES” shall mean LICENSEE on the one hand and DUKE and/or MVP on
the other hand, or all three, depending on the context.

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2.21

“PBC URICASE” shall mean […***…].

 

2.22

“PEG” shall mean poly(ethylene glycol) or poly(ethylene oxide).

 

2.23

“SALES AND REVENUE REPORTS” shall have the meaning ascribed to it in Section
6.9.

 

2.24

“STTR” shall mean the Small Business Technology Transfer Research program.

 

2.25

“SUBLICENSE REVENUES” shall mean all revenues or other consideration received by
LICENSEE from sublicensees, including, without limitation, sublicense issue
fees, other sublicense fees, royalties, and milestone payments.

 

2.26

“TECHNOLOGY” shall mean the DUKE TECHNOLOGY and the MVP TECHNOLOGY.

 

2.27

“TERM” shall have the meaning ascribed to it in Section 10.1.

 

2.28

“TERRITORY” shall mean each and every country of the world, including, with
respect to each country, its territories and possessions.

 

2.29

“TOP […***…] MARKETS” shall mean the […***…] countries with the greatest dollar
volume of sales of allopurinol during the twelve (12) months preceding any
particular date, based on monthly data compiled by IMS America.

 

2.30

“TOTAL REVENUES” shall mean the sum of NET SALES plus SUBLICENSE REVENUES.

 

2.31

“TOTAL SALES” shall mean the cumulative sum of NET SALES of LICENSED PRODUCTS by
LICENSEE plus net sales of LICENSED PRODUCTS by its sublicensees from the
EFFECTIVE DATE.

 

2.32

“USPTO” shall mean the United States Patent and Trademark Office.

ARTICLE 3 – SPONSORED RESEARCH

 

3.1

LICENSEE shall sponsor research relevant to the TECHNOLOGY at the facilities of
each of the LICENSORS.

 

3.2

LICENSEE agrees to provide not less than $[…***…] to DUKE and $[…***…] to MVP
(less any amounts received by MVP from BIRD) for sponsored research during the
first twenty-four (24) months following the EFFECTIVE DATE.

 

3.3

Payments for such sponsored research shall be made at least semiannually to each
of the LICENSORS at the annual rate of at least $[…***…] per year; provided,

 

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however, that with respect to MVP, these payments shall be reduced by the
amounts received by MVP from BIRD.

 

3.4

The funding for sponsored research at DUKE is to support research at DUKE by Dr.
[…***…], and it is understood that if for any reason, Dr. […***…] should no
longer be affiliated with DUKE during the period for which the funding is
provided, then DUKE will transfer the funding to another institution with which
Dr. […***…] may affiliate, upon his departure from DUKE.

ARTICLE 4 – LICENSE AND TRANSFER OF TECHNOLOGY

 

4.1

LICENSORS hereby grant to LICENSEE and LICENSEE hereby accepts from LICENSORS,
upon the terms and conditions herein specified, an exclusive, royalty-bearing
license in the TERRITORY, with the right to grant sublicenses, under the
TECHNOLOGY and PATENT RIGHTS, subject to U.S. Government rights in the
TECHNOLOGY, to make and have made, use and have used, and sell and have sold,
LICENSED PRODUCTS for use in the FIELD. In recognition of the general
applicability to other drugs of MVP’s technology for the production of PEG
conjugates of uricases, BTG expressly agrees that it shall not utilize such
technology in any manner except for the production of PEG conjugates of uricases
and only as provided in this AGREEMENT; provided, however, that MVP expressly
agrees that nothing contained in this AGREEMENT shall be read to preclude
LICENSEE from using technology for the production of PEG conjugates which is in
the public domain, or which is developed by LICENSEE independent of MVP’s
technology for the production of PEG conjugates, or which LICENSEE acquires or
licenses from a third party.

 

4.2

Within sixty (60) days after the execution of this AGREEMENT:

 

  (a)

DUKE agrees to provide LICENSEE with the materials and copies of the protocols
and representative results for the methods listed in Exhibit A.

 

  (b)

MVP agrees to provide LICENSEE with the materials and copies of the protocols
and representative results for the methods listed in Exhibit B.

 

  (c)

LICENSORS agree to provide LICENSEE with copies of any and all patents and
patent applications identified in Exhibit C.

 

4.3

MVP hereby grants to LICENSEE the exclusive, royalty-free, right and license in
the TERRITORY and in the FIELD to use such rights as MVP may possess in the
trademark, PURICASETM, the registration of which has been published in the
Official Gazette of the USPTO (Volume 1211, Number 2, page TM 100) and is
pending in the European Community (Application No. 716019).

 

  (a)

LICENSEE may use whichever trademark or trademarks it may elect, in its sole
discretion, in connection with the marketing of LICENSED

 

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PRODUCTS, and shall be under no obligation to use the trademark, PURICASE™.

 

  (b)

If LICENSEE elects not to use the trademark PURICASE™ or otherwise fails to use
such trademark by one (1) year after the first sale of any LICENSED PRODUCT, MVP
shall retain all rights to its use.

 

4.4

LICENSEE shall comply with all obligations imposed by the U.S. Government on
exclusive licenses of inventions made under a U.S. Government funding agreement
including, but not limited to, the requirement that any products which are sold
in the United States be substantially manufactured in the United States, if such
products are based on inventions conceived or first actually reduced to practice
under such funding agreements.

 

  (a)

LICENSORS recognize that the currently projected market for LICENSED PRODUCTS
does not justify a second manufacturing facility, and that LICENSEE currently
has a manufacturing facility in Israel, and, therefore, LICENSORS and LICENSEE
agree to cooperate and use their best efforts to promptly obtain a waiver of the
U.S. manufacturing requirement.

 

  (b)

DUKE represents that PBC URICASE was constructed at DUKE prior to its receipt of
the GRANT and that U.S. Government funds did not support its development; and
represents further that subject to review and determination by DUKE, other
uricases may also have been constructed at DUKE prior to its receipt of the
GRANT, developed without the support of U.S. Government funds, and that DUKE
shall promptly identify any such uricases for LICENSEE.

 

4.5

Any sublicenses granted by LICENSEE shall be on such financial terms as LICENSEE
may negotiate in its sole discretion but otherwise shall be subject to, and
shall incorporate therein, conditions at least as stringent as those imposed on
LICENSEE by the terms of this AGREEMENT.

 

  (a)

LICENSEE agrees to be responsible for any obligations assumed hereunder by its
sublicensees.

 

  (b)

LICENSEE further agrees that all sublicense agreements will provide that if
LICENSORS terminate this AGREEMENT pursuant to Section 10.3 or 10.6 prior to the
end of the TERM in one or more countries, or if LICENSEE terminates this
AGREEMENT pursuant to Section 10.2, all such sublicenses in those countries
shall be assigned directly to LICENSORS; provided, however, that LICENSORS first
agree, in writing, to assume all of LICENSEE’s obligations under such
sublicenses and to hold LICENSEE harmless with respect to any claims made by
such sublicensees as a result of such termination; provided, however, that
LICENSORS shall not be liable for any claims against LICENSEE arising out of
LICENSEE’s negligence or willful wrongdoing, or claims arising from LICENSEE’s
breach, prior to termination, of its obligations under a sublicense.

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  (c)

LICENSORS shall promptly be provided a copy of each sublicense agreement,
provided, however, that during the TERM of this AGREEMENT, LICENSORS shall
maintain such agreements in confidence and shall not contact any such
sublicensee without LICENSEE’ s prior written consent.

 

4.6

Upon expiration of the TERM of this AGREEMENT with respect to each country as
set forth in Article 10, the licenses granted in this Article 4 shall become
fully paid-up, irrevocable and non-exclusive in each such country.

ARTICLE 5 – LICENSE FEES AND MILESTONE PAYMENTS

 

5.1

The LICENSEE shall make separate payments to MVP and to DUKE according to the
following schedule:

 

     […***…] of U.S. Dollars Event Triggering Payments    To MVP    To DUKE   
Total

1)      Execution of this AGREEMENT

   […***…]    […***…]    […***…]

2)      Successful transfer of the technology for the production of PEG
conjugates of uricase

   […***…]    […***…]    […***…]

3)      First anniversary of execution of this AGREE-MENT

   […***…]    […***…]    […***…]

4)      Filing for an investigational new drug exemption

   […***…]    […***…]    […***…]

5)      Commencement of a Phase 2 clinical study

   […***…]    […***…]    […***…]

6)      Filing of an application to permit marketing in any one of the […***…]

   […***…]    […***…]    […***…]

7)      Marketing approval in any one of the […***…]

   […***…]    […***…]    […***…]

8)      Cumulative TOTAL REVENUES of $[…***…]

   […***…]    […***…]    […***…]

9)      Cumulative TOTAL REVENUES of $[…***…]

   […***…]    […***…]    […***…]

         Totals:

   […***…]    […***…]    […***…]

 

5.2

LICENSEE shall make the payments identified in Section 5.1 as follows:

 

  (a)

Payments 1) upon execution of this AGREEMENT.

 

  (b)

Payments 2) not later than thirty (30) days after successful transfer of the
technology for the production of PEG conjugates of uricase, as set forth in
Section 5.10.

 

  (c)

Payment 3) on the first anniversary of the EFFECTIVE DATE.

 

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  (d)

Payments 4) not later than thirty (30) days after the first filing of an
application for an investigational new drug exemption for LICENSED PRODUCTS.

 

  (e)

Payments 5) not later than thirty (30) days after enrolling the first patient in
a Phase 2 clinical study of LICENSED PRODUCTS.

 

  (f)

Payments 6) not later than thirty (30) days after filing an application to
permit marketing of LICENSED PRODUCTS in any one of the […***…].

 

  (g)

Payments 7) not later than thirty (30) days after obtaining approval to market
LICENSED PRODUCTS in any one of the […***…].

 

  (h)

Payments 8) not later than sixty (60) days after the end of the calendar quarter
in which cumulative TOTAL REVENUES from LICENSED PRODUCTS exceed the equivalent
of $[…***…].

 

  (i)

Payments 9) not later than sixty (60) days after the end of the calendar quarter
in which cumulative TOTAL REVENUES from LICENSED PRODUCTS exceed the equivalent
of $[…***…].

 

5.3

All of the payments in this Article 5 are in addition to the royalties specified
in Article 6.

 

5.4

All payments required by this AGREEMENT, if not paid when due, shall bear
interest at the rate of one and one-half percent (1 1⁄2%) per month or fraction
thereof, or the maximum interest rate allowed by applicable law, whichever is
less.

 

5.5

If this AGREEMENT is executed before LICENSEE has had the opportunity to review
and approve the version of the patent application (titled “PEG-URATE OXIDASE
CONJUGATES AND USE THEREOF”) that has been filed with the United States Patent
and Trademark Office, then:

 

  (a)

If upon such review subsequent to execution of this AGREEMENT, which LICENSEE
shall complete within sixty (60) days after receipt of such application,
LICENSEE determines in good faith that such application is inadequate (e.g., for
lack of support in the specification or in view of the prior art), LICENSEE may
elect, in its sole discretion, to terminate this AGREEMENT.

 

  (b)

If LICENSEE does so elect to terminate, MVP and DUKE shall each refund to
LICENSEE all payments made to them by LICENSEE as of the date of termination,
and MVP shall be solely responsible for the repayment to BIRD, should such
repayment be required, of any funds received by MVP from BIRD.

 

5.6

MVP shall commence the transfer to BTG of its proprietary technology for the
production of PEG conjugates of uricases once the following conditions have been
met:

 

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  (a)

MVP and DUKE have been notified, in writing, by BTG following the review of
their patent application as set forth in Section 5.5, either that such patent
application is acceptable or, if unacceptable, that BTG nonetheless elects not
to terminate the AGREEMENT, and that, therefore, the payments made by BTG to MVP
and DUKE as of the date of such written notice are irrevocable;

 

  (b)

BTG and MVP have selected a specific uricase and BTG has provided at least
[…***…] from a single batch to MVP for each […***…] of PEG conjugate to be
prepared by MVP as part of the technology transfer; and

 

  (c)

BTG has installed at its facility in Israel all of the necessary instruments,
accessories, columns and other materials for assessing the activity of uricase,
the purity of the PEG-uricase conjugates and the number of strands of PEG
attached per uricase subunit according to MVP’s protocols. […***…]

 

5.7

Such transfer shall commence as soon as practical after BTG has met all of the
conditions in Section 5.6.

 

5.8

The technology transfer shall include the following steps:

 

    

[…***…]

 

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[…***…]

 

5.9

BTG and MVP shall use their best efforts to complete successful transfer of such
technology as promptly as possible and each company shall therefore assign
appropriately skilled personnel to this task.

 

5.10

The technology transfer shall be complete once Sections 5.8(c) and 5.8(d) have
been completed and BTG shall notify LICENSORS in writing within thirty (30) days
of such completion.

 

5.11

Failure to successfully transfer the technology within one (1) year after the
transfer is initiated by MVP, unless such failure is caused by BTG’s failing to
comply with Section 5.9, shall have the following consequences:

 

  (a)

MVP and DUKE shall forfeit payments 2) in Section 5.1 and they shall not be made
pursuant to Section 5.2 or otherwise; and

 

  (b)

MVP and DUKE shall forfeit the royalties attributable to know-how pursuant to
Section 6.4 as further defined in Section 6.5.

 

5.12

If the U.S. Government declines to waive the U.S. manufacturing requirement, MVP
shall cooperate with LICENSEE to transfer such technology to a U.S. manufacturer
selected by LICENSEE; provided, however:

 

  (a)

that payments 2) in Section 5.1 shall have been made;

 

  (b)

that such manufacturer shall first agree to maintain such technology in
confidence on terms no less restrictive than those applicable to LICENSEE under
this AGREEMENT, and to use such technology only for the production of
PEG-uricase conjugates for LICENSEE;

 

  (c)

that such manufacturer does not manufacture PEG-uricase conjugates for itself or
any third party;

 

  (d)

that such manufacturer is not […***…], or […***…]; and

 

  (e)

that such manufacturer is a company for which, as of the effective date of the
agreement between LICENSEE and such company, none of the following three (3)
individuals: […***…], is an employee, director, consultant, or shareholder
possessing at least ten percent of the outstanding shares of common stock,
unless MVP’s prior written consent has been obtained, which consent shall not be
unreasonably withheld.

 

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ARTICLE 6 – ROYALTIES, RECORDS AND REPORTS

 

6.1

Within sixty (60) days after the end of each calendar quarter, LICENSEE shall
pay to LICENSORS, in equal shares, any running royalties due pursuant to this
Article 6 on NET SALES of LICENSED PRODUCTS made by LICENSEE during the
preceding calendar quarter.

 

6.2

The total rates of such running royalties, subject to adjustment pursuant to
Section 6.5, shall be:

 

  (a)

[…***…] percent ([…***…] %) of the NET SALES of LICENSED PRODUCTS made by
LICENSEE until the TOTAL SALES equal $[…***…];

 

  (b)

[…***…] percent ([…***…] %) of NET SALES of LICENSED PRODUCTS made by LICENSEE
once the TOTAL SALES exceed $[…***…] and until such TOTAL SALES equal $[…***…];
and

 

  (c)

[…***…] percent ([…***…] %) of NET SALES of LICENSED PRODUCTS made by LICENSEE
once the TOTAL SALES exceed $[…***…].

 

6.3

Concurrent with the payments provided for in Sections 6.1 and 6.2 and subject to
Sections 6.5 and 6.6, LICENSEE shall pay to LICENSORS, in United States Dollars,
royalty payments in the amount of […***…] percent ([…***…]%) of SUBLICENSE
REVENUES accrued by LICENSEE during the preceding calendar quarter.

 

6.4

Of the percentages specified in Sections 6.2 and 6.3, one half ( 1⁄2) shall be
considered a patent royalty, and one half ( 1⁄2) shall be considered a royalty
for use of know-how.

 

6.5

Subject to Article 8, the actual royalty rates payable in any country pursuant
to Sections 6.1, 6.2 and 6.3 shall be determined as follows:

 

  (a)

If there is no patent protection under PATENT RIGHTS in a country in the
TERRITORY and no protection under the U.S. Orphan Drug Act or any foreign
equivalent in such country, then the applicable royalty rates for such country
shall be […***…] percent ([…***…]%) of the royalty rates specified in Sections
6.2 and 6.3 if there has been a successful transfer of technology pursuant to
Section 5.10, and […***…] percent ([…***…]%) if there has not been a successful
transfer.

 

  (b)

If there is patent protection under PATENT RIGHTS in a country in the TERRITORY
or protection under the U.S. Orphan Drug Act or any foreign equivalent in such
country, then the applicable royalty rates for such country shall be the royalty
rates specified in Section 6.2 and 6.3 if there has been a successful transfer
of technology pursuant to Section 5.10, and […***…] percent ([…***…]%) of the
royalty rates specified in Sections 6.2 and 6.3 if there has not been a
successful transfer.

 

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6.6

For the purpose of calculating royalties due to LICENSORS, revenues in
currencies other than United States Dollars shall be converted to United States
Dollars using the exchange rates that were published in the Wall Street Journal
on the last business day of the calendar quarter during which LICENSEE accrued
such revenues.

 

6.7

LICENSEE shall keep full, true and accurate books of accounts and other records
containing all particulars that may be necessary to properly ascertain and
verify the royalties payable by LICENSEE hereunder.

 

6.8

Upon the request of LICENSORS, LICENSEE shall permit an independent Certified
Public Accountant selected by LICENSORS (except one to whom the LICENSEE has
some reasonable objection, such as that the accountant represents either of
LICENSORS with respect to its own matters) to have access, not more than once in
any calendar year, and during ordinary business hours, to such of LICENSEE’S
records as may be necessary to determine, in respect of any quarter ending not
more than three (3) years prior to the date of such request, the correctness of
any report and/or payment made under this AGREEMENT.

 

  (a)

If such examination results in a determination that LICENSEE has underpaid its
obligations to LICENSORS by more than three percent (3%), the cost of such
examination shall be borne by LICENSEE.

 

  (b)

If such examination results in a determination that LICENSEE has correctly paid
or overpaid its obligations to LICENSORS, the cost of such examination shall be
borne by LICENSORS.

 

  (c)

All adjustments resulting from such examinations shall be made by appropriate
payments within thirty (30) days after the results of the examination become
known to the PARTIES.

 

  (d)

Such accountant shall maintain all information learned during such inspection in
confidence and shall report to LICENSORS whether there has been an overpayment,
correct payment or underpayment of royalties and, if applicable, the amount of
such overpayment or underpayment.

 

6.9

For each quarterly payment, LICENSEE shall render to each of the LICENSORS
written accounts (“SALES AND REVENUE REPORTS”) of the NET SALES of LICENSED
PRODUCTS by LICENSEE and AFFILIATES, net sales by SUBLICENSEES, and the
SUBLICENSE REVENUES accrued by LICENSEE during the preceding quarter.

 

  (a)

LICENSEE warrants that such SALES AND REVENUE REPORTS will be prepared in
accordance with Generally Accepted Accounting Principles.

 

  (b)

SALES AND REVENUE REPORTS will be supplied to each of the LICENSORS not later
than sixty (60) days after the end of each calendar quarter in which the
LICENSEE accrues revenue from sales of LICENSED PRODUCTS or from sublicenses of
the LICENSED PRODUCTS.

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  (c)

LICENSORS agree to hold such SALES AND REVENUE REPORTS in confidence.

ARTICLE 7 – PERFORMANCE OBLIGATIONS

 

7.1

The LICENSEE shall use its best efforts to bring LICENSED PRODUCTS to market and
to diligently market LICENSED PRODUCTS during the TERM of this AGREEMENT.

 

7.2

LICENSEE and MVP shall commit such funds as each may receive from BIRD solely to
the development of LICENSED PRODUCTS.

 

7.3

LICENSEE shall repay all funds provided by BIRD to LICENSEE and MVP, up to
[…***…] percent ([…***…]%) of the grant, as required by BIRD.

 

7.4

Beginning in 1999 (for calendar year 1998), and continuing until the year
following the year of the first commercial sale of LICENSED PRODUCTS, the
LICENSEE shall submit annual progress reports to LICENSORS by February 28th of
each year, which reports shall discuss the progress and results, as well as
ongoing plans, with respect to the development of LICENSED PRODUCTS.

ARTICLE 8 – PATENTS AND INFRINGEMENT

 

8.1

Subsequent to the EFFECTIVE DATE, LICENSORS shall continue to have
responsibility, at their shared expense, for filing, prosecuting and maintaining
their jointly owned patent applications in the USPTO on TECHNOLOGY; DUKE shall
continue to have responsibility, at its own expense, for filing, prosecuting and
maintaining its solely owned patent applications in the USPTO on DUKE
TECHNOLOGY; and MVP shall continue to have responsibility, at its own expense,
for filing, prosecuting and maintaining its solely owned patent applications in
the USPTO on MVP TECHNOLOGY. LICENSORS shall keep LICENSEE advised as to the
prosecution of such applications by forwarding to LICENSEE copies of all
official correspondence relating thereto, and shall give LICENSEE an opportunity
to comment on all applications, responses to Office Actions, Declarations and
other papers before they are filed with the USPTO, and shall consult with
LICENSEE concerning the scope of allowed claims before paying any issue fee.

 

8.2

LICENSEE agrees to cooperate with the LICENSORS in the prosecution of the U.S.
patent applications to ensure that the applications reflect, to the best of
LICENSEE’s knowledge, all items of commercial and technical interest and
importance.

 

***Confidential Treatment Requested

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8.3

LICENSORS shall seek patent protection in Europe (including the United Kingdom),
Japan and such other countries as LICENSEE may designate, and LICENSEE shall
reimburse LICENSORS within thirty (30) days for their reasonable, out-of-pocket
costs associated with obtaining such protection; provided, however, that the
prosecution of such applications shall be at the direction of LICENSEE and
LICENSEE may elect to prosecute such applications itself or have them prosecuted
through LICENSEE’s agents.

 

  (a)

Regardless of whether LICENSORS or LICENSEE prosecute(s) such application, the
resultant patents shall be owned by LICENSORS.

 

  (b)

LICENSORS may elect to seek patent protection in countries not designated by
LICENSEE, in which case LICENSORS shall be responsible for all expenses
attendant thereto.

 

  (c)

In the event that LICENSEE elects to prosecute foreign patent applications
itself, LICENSORS will be kept informed, will have an opportunity to comment,
and shall have the right to approve such applications, which approval will not
be unreasonably withheld.

 

  (d)

If LICENSEE decides to abandon or not pursue any application, LICENSEE shall
notify LICENSORS in a timely manner so that LICENSORS can decide whether or not
to assume the prosecution.

 

8.4

Any inventions made, during the TERM of this AGREEMENT, with respect to the
manufacture, use or sale of LICENSED PRODUCTS shall be:

 

  (a)

the sole property of LICENSEE if made solely by LICENSEE;

 

  (b)

the joint property of LICENSEE and LICENSORS if made jointly by LICENSEE and
LICENSORS; and

 

  (c)

the sole property of LICENSORS if made solely by LICENSORS;

provided, however, that any such invention made solely by LICENSORS shall be
included within PATENT RIGHTS.

 

8.5

Upon learning of the infringement by a third party of PATENT RIGHTS, the PARTY
learning of such infringement shall promptly inform the other PARTIES, in
writing, of that fact and shall provide any evidence available pertaining to
such infringement.

 

  (a)

LICENSEE may elect, within sixty (60) days after notice and at its own expense,
to take whatever steps are necessary to stop the infringement and recover
damages.

 

  (i)

If LICENSEE elects to take such action, it will:

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  (A)

keep LICENSORS informed of the steps taken and the progress of any legal actions
taken;

 

  (B)

during the pendency of such actions, offset against royalties owed to LICENSORS
on NET SALES in the country or countries affected by the infringement, the costs
of any actions taken to stop such infringement up to a maximum of fifty percent
(50%) of the royalties owed or owing to LICENSORS;

 

  (C)

be entitled to enter into a settlement on such terms as it may elect;

 

  (D)

retain for its own account, after first deducting the costs of any actions taken
to stop such infringement, seventy-five percent (75%) of any amounts received in
settlement or awarded as damages with the remaining twenty-five percent (25%)
being paid in equal shares to LICENSORS; and

 

  (E)

if unsuccessful in halting such infringement, be entitled to reduce its
royalties owed to LICENSORS, with respect to the country or countries affected
by such infringement, by fifty percent (50%) during the remaining TERM of the
Agreement in each of those countries; provided that the infringer has achieved
ten percent (10%) or more of the market defined by LICENSED PRODUCTS and the
infringing product in those countries in which the infringement exists.

 

  (ii)

If LICENSEE does not elect to take such action within such period, it will
promptly inform LICENSORS, in which event LICENSORS may elect within thirty (30)
days:

 

  (A)

to take such action as is required to stop such infringement, and will then be
entitled to settle such actions on such terms as they may elect (provided,
however, that if they grant a license to the infringer, LICENSEE shall be
entitled to reduce its royalties owed to LICENSORS for the country or countries
affected by fifty percent (50%) and shall be entitled to the benefit of any
terms which are more favorable than those granted to LICENSEE under this
AGREEMENT), will keep LICENSEE informed of the steps taken and the progress of
any legal actions taken, and will be entitled to retain any amounts received in
settlement or awarded in damages; provided, however, that during the period and
for the country or countries in which LICENSEE does not enjoy exclusivity, or
with respect to which LICENSORS are not able to stop such infringement, LICENSEE
shall be entitled to reduce the applicable royalty rate by fifty percent (50%);
provided that the infringer has achieved ten percent (10%) or more of the market
defined by LICENSED PRODUCTS and the infringing product; or

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  (B)

not to take any action against such infringers, in which event LICENSEE shall be
entitled to elect either:

 

  (1)

to terminate this AGREEMENT pursuant to Section 8.8; or

 

  (2)

to reduce the applicable royalty rate by fifty percent (50%) for each country
affected by such infringement; provided that the infringer has achieved ten
percent (10%) or more of the market defined by LICENSED PRODUCTS and the
infringing product in the countries where such infringement exists.

 

8.6

LICENSORS shall give prompt notice to LICENSEE of any inquiry received with
respect to the availability of a license under PATENT RIGHTS or TECHNOLOGY and
also of any third party patent of which LICENSORS become aware that may present
an issue of infringement with respect to LICENSEE’s activities under this
AGREEMENT.

 

8.7

LICENSEE shall give LICENSORS prompt notice of each claim or allegation received
by it that the manufacture, use or sale of LICENSED PRODUCTS constitutes an
infringement of a third party patent or other intellectual property rights. If
such alleged infringement is due to the incorporation of DUKE TECHNOLOGY or MVP
TECHNOLOGY in the LICENSED PRODUCTS, then:

 

  (a)

LICENSEE shall have the primary right and responsibility, but not the
obligation, at its own expense to defend and control the defense of any such
claims against LICENSEE, using counsel of its choosing.

 

  (b)

During the pendency of any such action, no royalties shall be payable to
LICENSORS on account of NET SALES of LICENSED PRODUCTS in any countries affected
by such action.

 

  (c)

LICENSEE’s attorneys’ fees and any amounts agreed to be paid in settlement of
any such action or awarded against LICENSEE as damages, shall be deducted by
LICENSEE from any future royalties due to LICENSORS.

 

  (d)

If LICENSEE is required to pay a royalty to any third party as a result of
settlement of any such claim or allegation of infringement, it shall be entitled
to deduct such royalty from the royalties due to LICENSORS under this AGREEMENT.

 

  (e)

The settlement of any such action must be approved by LICENSORS, which approval
shall not be unreasonably withheld.

 

8.8

Independent of any action which LICENSEE or LICENSORS may elect to take pursuant
to Section 8.5 or 8.7 with respect to the prosecution, defense or compromise of
any such allegation or claim, LICENSEE may elect to terminate this AGREEMENT
solely with respect to the country or countries to which such claim or
allegation pertains. In such event, all rights to the use and sale of LICENSED
PRODUCTS and regulatory filings in that country or those countries

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shall revert to LICENSORS.

 

8.9

In any action brought under this Article 8, the PARTIES not bringing or
defending the action shall, in their sole discretion, be entitled to participate
through counsel of their own choosing in any such action; provided, however,
that such participation shall be limited to an advisory role and counsel for the
PARTY bringing or defending the action shall be lead counsel and the action
shall be directed by such PARTY.

 

8.10

Each PARTY agrees to cooperate with the other PARTIES in any reasonable manner
deemed by the PARTY defending or prosecuting an action under this Article 8, to
be necessary in defending or prosecuting such action.

ARTICLE 9 – REGULATORY, PUBLICATION,

OTHER USE, AND EXPORT

 

9.1

LICENSEE agrees to use its best efforts to have the LICENSED PRODUCTS cleared by
the responsible government agencies requiring such clearance for marketing in
those countries in which LICENSEE intends to sell LICENSED PRODUCTS or award
sublicenses.

 

  (a)

To accomplish such clearances at the earliest possible dates, LICENSEE agrees to
file, according to the standard practice in the industry, any and all necessary
data with the appropriate government agencies.

 

  (b)

Where permitted by law, LICENSEE shall include the names of both LICENSORS as
co-registrants on all regulatory filings.

 

9.2

LICENSEE further agrees that the right of publication of the TECHNOLOGY shall
reside in the inventor(s) and other personnel of LICENSORS and the LICENSORS
shall use their best efforts to provide a copy of such publication forty-five
(45) days in advance of publication for review by LICENSEE. If LICENSEE
determines that the publication by LICENSORS will disclose any trade secrets,
LICENSORS shall delay publication for an additional sixty (60) days after the
forty-five (45) day period to allow patent applications to be filed.

 

9.3

It is agreed that, notwithstanding any provisions herein, LICENSORS are free to
use the TECHNOLOGY and PATENT RIGHTS for their own non-commercial purposes,
whether educational, teaching, research or clinical purposes, without payment of
royalties or other fees.

 

9.4

LICENSEE and LICENSORS agree to comply with all United States laws and
regulations controlling the export of technical data, computer software,
laboratory prototypes and other commodities and technology.

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ARTICLE 10 – DURATION AND TERMINATION

 

10.1

This AGREEMENT shall become effective upon the EFFECTIVE DATE and shall remain
in full force and effect, on a country-by-country basis, for the longer of: ten
(10) years from the date of first sale of LICENSED PRODUCTS in each country, or
the date of expiration of the last-to-expire patent, of those patents included
in the PATENT RIGHTS, in each country; such period of time with respect to each
country being known as the TERM of this AGREEMENT; provided, however, that this
AGREEMENT may be terminated in one or more countries prior to the TERM in
accordance with Sections 8.8, 10.2, 10.3 or 10.6.

 

10.2

LICENSEE may, prior to expiration of the TERM, elect to terminate this AGREEMENT
with respect to any one or more countries in the TERRITORY, at any time,
effective after the first anniversary of the EFFECTIVE DATE, by giving LICENSORS
written notice at least six (6) months prior to each such termination. On the
effective date of each such termination, LICENSEE shall cease the manufacture,
use and sale of LICENSED PRODUCTS in the country or countries in which LICENSEE
has elected to terminate prior to expiration of the TERM.

 

10.3

As used in this Section 10.3, PARTY shall mean either (1) BTG or (2) MVP and
DUKE, jointly. Any PARTY may immediately terminate this AGREEMENT for fraud,
willful misconduct, or illegal conduct of the other PARTY upon written notice of
same to such PARTY. Except as provided above, if a PARTY fails to fulfill any of
its material obligations under this AGREEMENT, the non-breaching PARTY may
terminate this AGREEMENT, with respect to the country or countries affected,
upon written notice to the other PARTY, as provided below. Such notice must
contain a full description of the event or occurrence constituting a breach of
this AGREEMENT. A PARTY receiving notice that it has breached the AGREEMENT will
have the opportunity to cure that breach within thirty (30) days of the receipt
of notice. A PARTY’s ability to cure a breach will apply only to the first two
(2) material breaches properly noticed to that PARTY under the terms of this
AGREEMENT. Any subsequent material breach by that PARTY will entitle the other
PARTY to terminate this AGREEMENT immediately upon proper notice to such PARTY
without a cure period. In the event that a PARTY commits such a subsequent
breach, the non-breaching PARTY may, at its option and in addition to any other
remedies it may have in law or in equity, terminate this AGREEMENT for default
by sending to the breaching PARTY written notice of termination, effective
immediately upon receipt.

 

10.4

Upon the termination of this AGREEMENT in one or more countries prior to the end
of the TERM, LICENSEE shall notify LICENSORS of the quantity of LICENSED
PRODUCTS that LICENSEE then has in inventory with respect to the country or
countries for which the termination is effective and LICENSEE shall then have a
license in each such country to sell that amount of LICENSED PRODUCTS, but no
more, provided that the LICENSEE shall pay the royalty thereon at the rate and
at the time provided for herein.

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10.5

If this AGREEMENT is terminated pursuant to Section 8.8 or pursuant to this
Article 10 by either LICENSEE or LICENSORS prior to the end of the TERM in one
or more countries, then all intellectual property rights conveyed by LICENSORS
to LICENSEE under this AGREEMENT (including, without limitation: rights in the
mark, PURICASETM, approved and pending regulatory applications, Orphan Drug
Designations, Drug Master Files, sublicenses, preclinical data and clinical
data) shall revert to LICENSORS with respect to those countries.

 

10.6

If, during the TERM of this AGREEMENT, a PARTY shall become bankrupt or
insolvent, or if the business of a PARTY shall be placed in the hands of a
receiver or trustee, whether by the voluntary act of such PARTY or otherwise, or
if a PARTY shall cease to exist as an active concern, then if the PARTY
experiencing such event is:

 

  (a)

LICENSEE, then this AGREEMENT shall terminate immediately, and all rights to
LICENSED PRODUCTS and the TECHNOLOGY shall revert to the LICENSORS or their
respective successors or assignees;

 

  (b)

MVP or DUKE, then the rights granted to LICENSEE under this AGREEMENT by such
LICENSOR shall become paid-up, exclusive, and irrevocable, this AGREEMENT shall
terminate with respect to such LICENSOR, and LICENSEE shall make such payments
to the remaining LICENSOR that it would have received absent termination of the
AGREEMENT with respect to the other LICENSOR.

 

10.7

Expiration or termination of this AGREEMENT shall be without prejudice to or
limitation on any other remedies or any accrued obligations of any of the
PARTIES.

ARTICLE 11 – CONFIDENTIAL INFORMATION

 

11.1

Confidential information (“INFORMATION”) shall mean all information provided by
LICENSORS to LICENSEE or by LICENSEE to LICENSORS and identified as confidential
at the time of disclosure. Specifically excepted from this definition is all
information that is:

 

  (a)

already known by the receiving PARTY at the time of disclosure, as demonstrated
by clear and convincing evidence contemporaneous with or preceding the
disclosure;

 

  (b)

publicly disclosed through no improper act or omission of the receiving PARTY;

 

  (c)

rightfully received by the receiving PARTY from a third party without any
obligation of confidentiality; or

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  (d)

disclosed pursuant to any judicial or government requirement or order, provided
that the receiving PARTY takes reasonable steps to provide the disclosing PARTY
with sufficient prior notice in order to allow the disclosing PARTY to contest
such requirement or order; or

 

  (e)

independently developed by DUKE alone, without reference or access to the
disclosing PARTY’s INFORMATION.

 

11.2

In the event the receiving PARTY is required by law, regulation or court order
to disclose any of the disclosing PARTY’s INFORMATION, the receiving PARTY will
promptly notify the disclosing PARTY in writing prior to making any such
disclosure in order to facilitate the disclosing PARTY seeking a protective
order or other appropriate remedy from the proper authority. The receiving PARTY
agrees to cooperate with the disclosing PARTY in seeking such order or other
remedy. The receiving PARTY further agrees that if the disclosing PARTY is not
successful in precluding the requesting legal body from requiring the disclosure
of the INFORMATION, it will furnish only that portion of the INFORMATION that is
legally required and will exercise all reasonable efforts to obtain reliable
assurances that confidential treatment will be accorded the INFORMATION.

 

11.3

The receiving PARTY agrees to hold INFORMATION in trust and confidence for the
disclosing PARTY, using the same care and discretion that the receiving PARTY
uses with respect to its own proprietary information that it considers
confidential and, in any event, at least the care that is standard in the
industry for confidential, proprietary information of another. The receiving
PARTY will not use such information for any purpose except those expressly set
forth in this AGREEMENT and will not disclose such information to any third
party without the prior written authorization from the disclosing PARTY.

 

  (a)

Any INFORMATION that MVP discloses to BTG related to PEGylation of proteins or
to purification or analysis of PEG-protein conjugates may not be disclosed to
DUKE. Except as provided in the foregoing sentence, any other INFORMATION that
MVP discloses to BTG may be disclosed by BTG to DUKE.

 

  (b)

Obligations of this Section 11.3 shall remain in effect during the TERM of this
AGREEMENT and for a period of five (5) years after the expiration or termination
of the AGREEMENT in the last-to-expire or last-to-terminate country, whichever
occurs later.

 

  (c)

No provision contained in this AGREEMENT shall be read to preclude BTG from
providing PEGylated uricase to DUKE for research or clinical purposes, or from
informing DUKE of the number of strands and molecular weight of the PEG and
other descriptive characteristics of the PEGylated uricase provided to DUKE.

 

  (d)

Notwithstanding the foregoing, DUKE shall not be obligated to hold in confidence
another PARTY’s INFORMATION for longer than five (5) years after such
INFORMATION is disclosed to it.

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ARTICLE 12 – LAW TO GOVERN

 

12.1

The laws of the State of California will govern the construction, interpretation
and performance of this AGREEMENT, without giving effect to conflicts of law
rules thereof.

ARTICLE 13 – ASSIGNMENT

 

13.1

No PARTY may assign any of its rights or delegate any of its duties under this
AGREEMENT without the prior written consent of the other PARTIES except:

 

  (a)

In connection with the sale of a PARTY’s entire business operation; or

 

  (b)

In connection with the assignment of the rights or delegation of the duties of
any PARTY to any of its AFFILIATES.

 

13.2

Any unauthorized attempted assignment or delegation shall be null and void and
of no force or effect.

ARTICLE 14 – NOTICES

 

14.1

Any notice or other communication required or permitted under this AGREEMENT
will be in writing and will be deemed given as of the date it is: (a) delivered
by hand, or (b) mailed, postage prepaid, first class, certified mail, return
receipt requested, to the PARTY/PARTIES at the address listed below or
subsequently specified in writing, or (c) sent, postage prepaid, return receipt
requested, by courier service, to the PARTY/PARTIES at the address listed below
or subsequently specified in writing:

If to the LICENSORS:

Mountain View Pharmaceuticals, Inc.

3475-S Edison Way

Menlo Park, California 94025

Attn.: Merry R. Sherman, Ph.D.

AND:

Office of Science and Technology

North Building, Room 230

Research Drive

Duke University, Box 90083

Durham, North Carolina 27708

Attn.: License Administrator

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With a copy to:

Office of the University Counsel

Allen Building, Room 011

Duke University

Durham, North Carolina 27708

If to the LICENSEE:

Bio-Technology General Corporation

70 Wood Avenue South

Iselin, New Jersey 08830

Attn.: Sim Fass, Ph.D.

ARTICLE 15 – INDEMNITY, INSURANCE

AND REPRESENTATIONS

 

15.1

LICENSEE agrees to indemnify, hold harmless and defend LICENSORS, their
officers, employees, and agents, against any and all claims, suits, losses,
damages, costs, fees, and expenses, including reasonable attorneys’ fees,
asserted by third parties, both government and non-government, resulting from or
arising out of LICENSEE’s exercise of the rights granted under this AGREEMENT.
LICENSEE shall not be responsible for the intentional wrongdoing of LICENSORS.

 

15.2

LICENSORS agree to indemnify, hold harmless and defend LICENSEE, its officers,
employees, and agents, against any and all claims, suits, losses, damages,
costs, fees, and expenses, including reasonable attorneys’ fees, asserted by
third parties, both government and non-government, resulting from or arising out
of LICENSORS’s exercise of their rights and obligations under this AGREEMENT.
LICENSORS shall not be responsible for the intentional wrongdoing of LICENSEE.

 

15.3

The PARTIES shall maintain in force at their sole cost and expense general
liability insurance coverage in an amount reasonably sufficient to protect
against liability under this Article 15. LICENSEE also shall maintain in force
at its sole cost and

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expense product liability insurance coverage in an amount reasonably sufficient
to protect against liability under this Article 15. Each PARTY shall have the
right to request and to receive copies of the appropriate certificates of
insurance from the other PARTIES for the purpose of ascertaining the sufficiency
and currency of such coverage.

 

15.4

Except as provided in Section 15.8, nothing in this AGREEMENT shall be deemed to
be a representation or warranty by LICENSORS of the validity of any of the
patents or the accuracy, safety, efficacy, or usefulness, for any purpose, of
any TECHNOLOGY.

 

15.5

LICENSORS shall have no obligation, expressed or implied, to supervise, monitor,
review or otherwise assume responsibility for the production, manufacture,
testing, clinical trials, marketing or sale of any LICENSED PRODUCTS, and
LICENSORS shall have no liability whatsoever to LICENSEE, its officers,
employees or agents for or on account of any injury, loss, or damage, of any
kind or nature, sustained by, or any damage assessed or asserted against, or any
other liability incurred by or imposed upon LICENSEE, its officers, employees or
agents or any other person or entity, arising out of or in connection with or
resulting from LICENSEE’s:

 

  (a)

production, use, or sale of any LICENSED PRODUCTS;

 

  (b)

use of any TECHNOLOGY; or

 

  (c)

advertising or other promotional activities with respect to any of the
foregoing.

 

15.6

MVP hereby represents and warrants to BTG and DUKE that MVP has the right to
grant the licenses set forth herein under PATENT RIGHTS and MVP TECHNOLOGY,
including the license to the technical know-how summarized in Exhibit B, and to
the use of the trademark, PURICASETM.

 

15.7

DUKE hereby represents and warrants to BTG and MVP that DUKE has the right to
grant the licenses set forth herein under PATENT RIGHTS and DUKE TECHNOLOGY,
including the license to the technical know-how and materials summarized in
Exhibit A.

 

15.8

Each of the LICENSORS hereby separately represents and warrants to BTG that:

 

  (a)

it has no actual knowledge, as of the EFFECTIVE DATE, that the use of TECHNOLOGY
for the manufacture, use or sale of LICENSED PRODUCTS will infringe any patent
or other intellectual property right of any third party in any country in the
world, and that, if at any time during the TERM of this AGREEMENT, it becomes
aware of any such information, it will promptly disclose such to BTG;

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  (b)

it has no actual knowledge, as of the EFFECTIVE DATE, of any prior art that
would raise any issue concerning the validity of any patents issued or to issue
on any applications which are included in PATENT RIGHTS, and that, if at any
time during the TERM of this AGREEMENT, it becomes aware of any such
information, it will promptly disclose such to BTG;

 

  (c)

it is not aware of any other agreements, amendments or licenses that affect its
authority or ability to enter into this AGREEMENT;

 

  (d)

prior to the execution of this AGREEMENT, it has not assigned, encumbered,
pledged, mortgaged, used as collateral, granted a security interest or lien in
or otherwise engaged in any action that affects its ability to grant LICENSEE
the rights granted pursuant to the terms of this AGREEMENT; and

 

  (e)

during the TERM of this AGREEMENT, it will not engage in any action that could
reasonably be anticipated to adversely affect its ability to grant LICENSEE the
rights to manufacture, use and sell LICENSED PRODUCTS anywhere in the world
pursuant to the terms of this AGREEMENT.

ARTICLE 16 – USE OF A PARTY’S NAME

 

16.1

Except for the rights granted to LICENSEE herein with respect to the mark
PURICASETM, no PARTY to this AGREEMENT will, without the prior written consent
of another party:

 

  (a)

use in advertising, publicity or otherwise, the name of any employee or agent,
any trade-name, trademark, trade dress, service mark, symbol, or any
abbreviation, contraction or simulation thereof owned by another PARTY; or

 

  (b)

represent, either directly or indirectly, that any product or service of another
PARTY is a product or service of the representing PARTY or that it is made in
accordance with or utilizes the information or documents of another PARTY.

 

16.2

No PARTY will originate any publicity, news release or other public announcement
or comment, written or oral, related to this AGREEMENT without the prior written
consent of the other PARTIES, except as may be required by law. The PARTY making
any announcement, which it reasonably believes to be required by law, will first
give the other PARTIES an opportunity to review the form and content of any such
announcement and comment upon it before it is made.

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Notwithstanding the foregoing, LICENSORS acknowledge that BTG is a publicly
traded company, and hereby consent to BTG’s disclosure of this AGREEMENT and its
relationship with LICENSORS in its filings with the Securities and Exchange
Commission and its disclosures to its stockholders.

ARTICLE 17 – SEVERABILITY

 

17.1

Each clause of this AGREEMENT is distinct and severable. If any clause is deemed
illegal, void or unenforceable, it is the PARTIES’ intent that all other clauses
or portions of this AGREEMENT shall remain in effect to the maximum extent
possible.

ARTICLE 18 – WAIVER

 

18.1

The failure of any PARTY in any instance to insist upon the strict performance
of the terms of this AGREEMENT will not be construed to be a waiver or
relinquishment of any of the terms of this AGREEMENT, either at the time of the
PARTY’s failure to insist upon strict performance or at any subsequent time, and
such terms will continue in full force and effect.

ARTICLE 19 – TITLES

 

19.1

All titles and article headings contained in this AGREEMENT are inserted only as
a matter of convenience and reference. They do not define, limit, extend or
describe the scope of this AGREEMENT or the intent of any of its provisions.

ARTICLE 20 — ENTIRE UNDERSTANDING

 

20.1

This AGREEMENT represents the entire understanding between the LICENSEE and the
LICENSORS, and supersedes all other agreements, expressed or implied,

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between the LICENSEE and the LICENSORS, with the sole exception of the agreement
dated July 30, 1998 among BIRD, BTG and MVP.

IN WITNESS WHEREOF, the PARTIES have caused this AGREEMENT to be executed by
their duly authorized representatives as of the EFFECTIVE DATE.

 

MOUNTAIN VIEW PHARMACEUTICALS, INC. By:     /s/Merry R. Sherman, Ph.D.  
     Merry R. Sherman, Ph.D.        President

 

  DUKE UNIVERSITY   By:     /s/Robert L. Taber         Robert L. Taber, Ph.D.  
 

    Associate Vice-Chancellor and Director,

    Office of Science and Technology

 

  BIO-TECHNOLOGY GENERAL CORP.   By:       /s/Robert M. Shaw         Robert M.
Shaw         Vice President, General Counsel

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Exhibit A

Summary of Know-how, Information and Materials to be Provided by

DUKE to BTG as Part of DUKE TECHNOLOGY

[…***…]

 

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Exhibit B

Summary of Know-how, Information and Materials to be Provided by MVP

to BTG as Part of MVP TECHNOLOGY

[…***…]

 

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Exhibit C

Patents and Patent Applications included within PATENT RIGHTS

(To Be Amended from Time to Time during the TERM)

[…***…]

 

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Amendment

BTG, Duke and MVP agree as follows:

Article 1— Definitions

 

1.0

Unless specifically defined in this Amendment, the capitalized terms shall have
the meanings ascribed to them in the Agreement.

 

1.1

“Agreement” shall mean the License Agreement entered into by and among BTG, Duke
and MVP on August 12, 1998.

 

1.2

“Amendment” shall mean this amendment to the Agreement entered into by and among
BTG, Duke and MVP as of the Amendment Date.

 

1.3

“Amendment Date” shall mean November 12, 2001.

Article 2 — Amendments.

 

3.0

Effective as of the Amendment Date, the Agreement is amended to delete Section
9.1(b) in its entirety.

 

3.1

This amendment is conditioned upon the payment to MVP by BTG (by wire transfer)
of $[…***…], (consisting of $[…***…] allocated to Milestone No. 4 and $[…***…]
allocated to Milestone No. 5), as an advance payment in partial satisfaction of
the payments due under Milestone Nos. 4 and 5.

 

3.2

BTG shall provide to MVP complete copies of all written and electronic
communications related to PEG-uricase, such as regulatory filings and other
correspondence, to and from government regulatory agencies (including, without
limitation, the U.S. Food and Drug Administration), within five (5) business
days of BTG’s filing or receipt, respectively, of such communications.

Article 3 — Miscellaneous

 

3.1

This Amendment shall be effective as of the Amendment Date.

 

3.2

Except as expressly modified in this Amendment, the Agreement shall remain in
full force and effect according to its terms.

IN WITNESS WHEREOF, BTG, Duke and MVP have caused this Amendment to be executed
as of the Amendment Date by their duly authorized officers.

 

BIO-TECHNOLOGY GENERAL CORP.

By:

 

/s/ Norman W. Barton

Name:

 

Norman W. Barton

Title:

 

Chief Medical Officer

 

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DUKE UNIVERSITY

By:

 

  /s/ Robert L. Taber

Name:

 

    Robert L. Taber, Ph.D.

Title:

 

    Vice Chancellor, Science & Tech. Dev.

 

              MOUNTAIN VIEW PHARMACEUTICALS,  INC.

              By:     /s/ Mark Saifer

              Name:       Mark Saifer

              Title:         Vice President

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SECOND AMENDMENT TO LICENSE AGREEMENT

THIS SECOND AMENDMENT is made and entered effective as of the 30th day of
August, 2010, (hereinafter, the “SECOND AMENDMENT EFFECTIVE DATE”).

 

AMONG:    SAVIENT PHARMACEUTICALS, INC.   

a Delaware corporation, formerly known as Bio-Technology General Corporation
(hereinafter, “SAVIENT”)

  

AND

   MOUNTAIN VIEW PHARMACEUTICALS, INC.   

a California corporation, (hereinafter, “MVP”)

  

AND

   DUKE UNIVERSITY   

a North Carolina not-for-profit corporation, hereinafter, “DUKE”).

WHEREAS:

SAVIENT, MVP and DUKE are PARTIES to a License Agreement dated August 12, 1998,
as amended by the. Amendment effective as of November 21, 2001 (hereinafter, the
“AGREEMENT”) pursuant to which SAVIENT licensed from MVP and DUKE the exclusive
rights to develop, manufacture and sell certain LICENSED PRODUCTS, as defined in
the AGREEMENT,

NOW THEREFORE in consideration of the mutual promises, agreements and covenants
contained herein, the adequacy of such consideration having been agreed and
acknowledged by each PARTY, the PARTIES agree to further amend the AGREEMENT as
follows:

 

1.

Definitions. All capitalized terms utilized herein shall have the same meaning
ascribed to them and set forth in Article 2, DEFINITIONS of the AGREEMENT,
unless specifically stated otherwise herein or unless a defined term is
specifically modified hereby. For the avoidance of doubt, as used throughout the
AGREEMENT, the term “LICENSORS” is meant to designate one or both of MVP and
DUKE, as the context requires.

 

2.

Change of Name Acknowledgement. Section 2.4 of the AGREEMENT is hereby deleted
in its entirety and replaced as follows:

“SAVIENT” shall mean Savient Pharmaceuticals, Inc., formerly known as
Bio-Technology General Corporation (“BTG”), a corporation organized under the
laws of Delaware, and having its principal offices located at One Tower Center,
East Brunswick, New Jersey 08816, and its AFFILIATES. The PARTIES acknowledge
that Bio-Technology General Corporation formally changed its name to Savient
Pharmaceuticals, Inc. on June 24, 2003. All references to “BTG” in the AGREEMENT
are hereby deleted and replaced with “SAVIENT” and SAVIENT assumes all rights,

 

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assignments and responsibilities under this AGREEMENT previously due to, owned
by, assigned to or due or responsible from BTG.

 

3.

Activities of […***…] of LICENSED PRODUCTS. Section 5.12(d) of the AGREEMENT is
hereby deleted in its entirety and replaced as follows:

“(d) that such manufacturer is not […***…] (hereinafter, “[…***…]”), or […***…]
or any AFFILIATE, subsidiary or successor thereof; […***…]. Except with respect
to the matters specifically contemplated herein; the PARTIES agree that no PARTY
waives any claim that may have arisen prior to the date hereof under the terms
and conditions of the AGREEMENT; and”

 

4.

Completion of Technology transfer and Payment of Milestones. The PARTIES
acknowledge and agree that the technology transfer contemplated in Section 5.8
of the AGREEMENT has been successfully completed and that all milestone payments
identified in Section. 5.1(1) through and including Section 5.1(6) have been
made lay SAVIENT to each of the LICENSORS in accordance with the relevant terms
of Section 5.2 of the AGREEMENT as of the Effective Date of this SECOND
AMENDMENT.

 

5.

No Notice of Breach of Agreement. The PARTIES acknowledge and agree that the
AGREEMENT is in full force and effect and that no PARTY has provided notice to
any other PARTY of any breach of the AGREEMENT pursuant to Section 10.3 of the
AGREEMENT.

 

6.

Updated Patent Rights. The PARTIES acknowledge and agree that Exhibit C to the
AGREEMENT is hereby amended to reflect the PATENT RIGHTS contemplated under the
AGREEMENT as of the SECOND AMENDMENT EFFECTIVE DATE and as set forth in the
attached Exhibit C-1 and that the

 

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PATENT RIGHTS and Exhibit C-1 shall be subject to further updating by the
PARTIES during the TERM as provided in Section 2.19 of the AGREEMENT.

 

7. Representation of LICENSORS. The LICENSORS and LICENSEE represent and warrant
that Exhibit C-1 is complete and accurate in all material respects.

 

8. Section 8.4 is hereby deleted in its entirety and replaced as follows:

“8.4 Any inventions made, during the TERM of this AGREEMENT, with respect to the
manufacture, use or sale of LICENSED PRODUCTS shall be:

(a) the sole property of LICENSEE if made solely by LICENSEE;

(b) the joint property of LICENSEE and both LICENSORS if made jointly by
LICENSEE and both LICENSORS;

(c) the joint property of LICENSEE and a LICENSOR if made jointly by LICENSEE
and that LICENSOR and not by the other LICENSOR;

(d) the joint property of LICENSORS if made jointly by LICENSORS and not by
LICENSEE; and

(e) the sole property of a LICENSOR if made solely by that LICENSOR;

Provided, however, that any such invention that is DUKE TECHNOLOGY and/or MVP
TECHNOLOGY as defined in Sections 2.6 and 2.16, respectively, made solely by a
LICENSOR or jointly by the LICENSORS (i) shall be automatically included within
the TECHNOLOGY (ii) shall be promptly disclosed by the LICENSORS or relevant
LICENSOR to LICENSEE and (iii) any patents and patent applications in which at
least one claim is directed to any such invention so included in the TECHNOLOGY
shall be automatically included within the PATENT RIGHTS.

Provided, further, that in the event that a patent application on any invention
coveted by section 8.4 (a), (b), or (c) is directed to subject matter described
or disclosed in or claimed by any PATENT RIGHTS: (A) LICENSEE will advise the
applicable LICENSOR that such LICENSOR’S PATENT RIGHTS are implicated by the
prosecution of such LICENSEE patent application by forwarding to such LICENSOR a
copy of any application and all official correspondence relating thereto
received from any patent office and any proposed material response thereto
drafted by LICENSEE no later than […***…] ([…***…]) business days prior to the
anticipated filing date for such application or response (except in the event of
a provisional patent application filed on an emergency basis, LICENSEE shall
provide a commercially reasonable period dictated by the prevailing
circumstances), to allow LICENSOR a reasonable opportunity to provide
appropriate written comments on LICENSEE’S draft application, responses to
Office Actions,

 

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Declarations, and any other papers affecting the prosecution of the patent
application before such papers are filed with the USPTO or an equivalent non-US
patent authority, such comments provided by such LICENSOR shall be limited to
that portion of LICENSEE’S draft application, responses to Office Actions,
Declarations, and any other papers affecting the prosecution of the patent
application which relate, are directed to or implicate the subject matter
described or disclosed in or claimed by such LICENSOR’S PATENT RIGHTS; (B)
LICENSEE will reasonably incorporate or otherwise appropriately address any such
written comments received from such LICENSOR in such papers to be so filed; and
(C) LICENSEE will provide each such LICENSOR with a reasonable opportunity to
timely consult with LICENSEE concerning the scope of allowed claims before
paying any issue or equivalent non-US fee. In no event, however will LICENSEE’S
acceptance or non-acceptance of any comments from any LICENSOR provided in
accordance with this section, in whole or in part, be a basis for alleging a
breach of this Section 8.4.”

 

9.

Notices. Section 14.1 of the AGREEMENT is hereby deleted in its entirety and
replaced as follows:

 

14.1

Any notice or other communication required or permitted under this AGREEMENT
will be in writing and will be deemed given as of the date it is: (a) delivered
by hand, or (b) mailed, postage prepaid, first class, certified mail, return
receipt requested, to the PARTY/PARTIES at the address(es) listed below or
subsequently specified in writing, or (c) sent, postage prepaid, return receipt
requested, by courier service, to the PARTY/PARTIES at the address(es) listed
below or subsequently specified in writing;

 

If to the LICENSORS:

  

With a copy to:

Mountain View Pharmaceuticals, Inc.

  

Skadden, Arps, Slate, Meagher & Flom LLP

3475-S Edison Way

  

Four Times Square

Menlo Park, California 94025-1821

  

New York, New York 10036

Attn: Merry R. Sherman, Ph.D.

  

Attn: Matthew B. Zisk, Ph.D., Esq.

AND:

  

With a copy to:

Duke University School of Medicine

  

Duke University

Office of Corporate Research Collaborations

  

Office of University Counsel

2200 W. Main St., Suite 700

  

310 Blackwell Street, 4th Floor

Box 104025

  

Box 104124

Durham, North Carolina 27710

  

Durham, North Carolina 27710

Attn: Director

  

 

 

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If to the LICENSEE:

  

With a copy to:

Savient Pharmaceuticals, Inc.

  

Wilmer, Hale, Cutler, Pickering & Dorr

One Tower Center, 14th Floor

  

60 State Street

East Brunswick, NJ 08816

  

Boston, MA 02109

Attn: Philip K. Yachmetz, Esq.

  

Attn: Graham Robinson, Esq.

Senior Vice President & General Counsel

  

 

9.

No Modification. Except as expressly provided for herein, the AGREEMENT shall
remain in full force and effect without amendment. The AGREEMENT, as amended by
this SECOND AMENDMENT, contains the entire agreement among the PARTIES with
respect to the subject matter contemplated herein and from and after the SECOND
AMENDMENT EFFECTIVE DATE, the AGREEMENT shall mean the AGREEMENT as so further
amended by this SECOND AMENDMENT. The PARTIES agree that no further amendment or
modification to the AGREEMENT shall become binding unless such further amendment
or modification is reduced to writing and is contained in a written amendment
signed by all PARTIES hereto.

[The remainder or this page is intentionally blank.]

 

 

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IN WITNESS WHEREOF, the PARTIES have caused this SECOND AMENDMENT to be executed
by their respective duly authorized representatives as of the date first written
above.

 

SAVIENT PHARMACEUTICALS, INC.     DUKE UNIVERSITY By:   /s/ Philip K. Yachmetz  
  By:   /s/ H. Gilbert Smith  

Philip K. Yachmetz, Esq.

    Name:   H. Gilbert Smith, Ph. D  

Senior Vice President &

General Counsel

    Title:  

Managing Director, Corporate Research

  Collaborations & Licensing Officer

 

MOUNTAIN VIEW PHARMACEUTICALS, INC. By:   /s/ Merry R. Sherman  

Merry R. Sherman, Ph.D.

CEO and President

 

 

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Exhibit C-1

Patents and Patent Applications included within PATENT RIGHTS

(To Be Amended from Time to Time during, the TERM)

[…***…]

 

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LOGO [g101482stamp_216.jpg]

April 14, 2014

Merry R. Sherman, Ph.D.

CEO and President

Mountain View Pharmaceuticals, Inc.

3475 Edison Way, Suite S

Menlo Park, CA 94025-1821

H. Gilbert Smith, Ph.D.

Associate Dean & Managing Director

Corporate Research Collaborations

Duke University School of Medicine

2200 W. Main Street, Suite 910B

Durham, NC 27705

 

Re:

Third Amendment to License Agreement by and among Mountain View Pharmaceuticals,
Inc. (“MVP”), Duke University (“Duke”), and Savient Pharmaceuticals, Inc.
(formerly known as Bio-Technology General Corporation (“BTG)) dated August 12,
1998, as amended November 12, 2001 and August 30, 2010 (the “License”)

Dear Drs. Sherman and Smith:

The purpose of this letter agreement (this “Third Amendment”) is to amend the
License effective as of March 12, 2014 (the “Effective Date”). In connection
with the acquisition by Crealta Pharmaceuticals LLC (“Crealta”) of the business
operations of Savient Pharmaceuticals, Inc. (“Savient”), Savient assigned all of
its rights and obligations under the License to Crealta effective as of January
9, 2014 (the “Assignment Effective Date”). As a result, all references in the
License to either BTG or Savient are hereby understood to refer to Crealta,
provided that the foregoing shall not be interpreted as granting Crealta any
rights prior to the Assignment Effective Date, granting MVP or Duke any
additional rights under the License, requiring MVP or Duke to render performance
to Crealta of any obligations satisfied by MVP or Duke prior to the Assignment
Effective Date, or requiring Crealta to render performance to MVP or Duke of any
obligations satisfied by BTG or Savient prior to the Assignment Effective Date.
Crealta, MVP and Duke are the “Parties” hereto and each, individually, is a
“Party”.

In addition, the Parties confirm that the current notice information for each of
the Parties for the purposes of Section 14.1 of the License is as follows:

 

LOGO [g101482footnote.jpg]

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If to MVP:

Mountain View Pharmaceuticals, Inc.

3475 Edison Way, Suite S

Menlo Park, CA 94025-1821

Attention: Merry R. Sherman, Ph.D.

  

With a copy to:

Cooley LLP

3175 Hanover Street

Palo Alto, CA 94304-1130

Attention: Marya Postner, Ph.D., Esq.

If to Duke:

Duke University School of Medicine

Office of Research Collaborations

2200 W. Main Street, Suite 910B

Durham, NC 27705

Attention: Managing Director

  

With a copy to:

Duke University

Office of Counsel

310 Blackwell St., 4th floor

Box 104124

Durham, NC 27710

If to Crealta:

Crealta Pharmaceuticals LLC

500 W. Silver Spring Dr., Suite K-200

Glendale, WI 53217

Attention: Edward Donovan

  

With a copy to:

Lando & Anastasi

One Main Street

Cambridge, MA 02142

Attention: Diana M. Collazo

Further, attached to this Third Amendment is Exhibit C-2, which reflects the
Patent Rights contemplated under the License as of the Effective Date. This
Exhibit C-2 replaces Exhibit C of the License and Exhibit C-1 of the Second
Amendment, and it is subject to further updating by the Parties during the Term
as contemplated in Section 2.19 of the License.

The Parties also acknowledge and agree that: (i) all milestone payments
identified in Section 5.1(1) through and including Section 5.1(9) have been made
by Licensee to each of the Licensors; (ii) the License is in full force and
effect; and (iii) that no Party to the License has provided notice to any other
Party to the License of any breach of the License pursuant to Section 10.3 of
the License.

Finally, the Parties agree that: (i) in Article 2 of the Amendment of the
License dated November 12, 2001, the section numbers shall be corrected to read
2.0, 2.1, and 2.2, respectively; and (ii) in the Second Amendment of the License
dated August 30, 2010, Section 9 titled “No Modification” shall be corrected to
Section 10.

Except as previously provided for herein, the License shall remain in full force
and effect without amendment. The License, as amended by this Third Amendment,
contains the entire agreement among the Parties with respect to the subject
matter contemplated herein and from and after the Effective Date, the License
shall mean the License as so further amended by this Third Amendment. The
Parties agree that no further amendment or modification to the License shall
become binding unless such further

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amendment or modification is reduced to writing and is contained in a written
amendment signed by all Parties hereto.

All capitalized terms used in this Third Amendment that are not otherwise
defined herein shall have the meanings set forth in the License.

Please confirm MVP’s and Duke’s agreement with the foregoing by signing and
dating where indicated below and returning the countersigned Third Amendment to
me.

Sincerely,

 

/s/ Edward Donovan

Edward Donovan

General Counsel, Crealta Pharmaceuticals LLC

Acknowledged and Agreed:

MOUNTAIN VIEW PHARMACEUTICALS, INC.

By:

 

    /s/ Merry R. Sherman

Name:

 

Merry R. Sherman

Title:

 

CEO and President

Date:

 

April 14, 2014

DUKE UNIVERSITY

By:

 

    /s/ H. Gilbert Smith

Name:

 

H. Gilbert Smith, Ph.D.

Title:

 

Assoc. Dean and Managing Director

Corporate Research Collaborations

Date:

 

April 14, 2014

 

Cc: Marya Postner, Ph.D., Esq.
Cooley LLP
3175 Hanover Street
Palo Alto, CA 94304-1130

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Exhibit C-2

See attached.

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SCHEDULE A

Patents and Patent Applications included within PATENT RIGHTS

(To Be Amended from Time to Time during the TERM)

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EXECUTION COPY

FOURTH AMENDMENT

TO LICENSE AGREEMENT BY AND AMONG

MOUNTAIN VIEW PHARMACEUTICALS, INC., DUKE UNIVERSITY AND

CREALTA PHARMACEUTICALS LLC,

INCLUDING PATENT ASSIGNMENT

BACKGROUND

Mountain View Pharmaceuticals, Inc. (“MVP”), Duke University (“Duke”), and
Crealta Pharmaceuticals LLC (“Licensee”) are parties to that certain License
Agreement dated August 12, 1998, as previously amended on November 12, 2001,
August 30, 2010 and March 12, 2014 (the “Agreement”). The Parties now wish to
further amend the Agreement, in accordance with the terms and conditions set
forth in this Fourth Amendment to the Agreement (this “Amendment”).

AGREEMENT

NOW, THEREFORE, in consideration of the foregoing and the covenants and promises
contained herein, the Parties hereby agree to amend the Agreement as follows,
effective as of the last date signed by all of the Parties (the “Amendment
Effective Date”), subject to being binding on MVP and Licensee as set forth in
Section 9:

 

1.

Definitions.    Capitalized terms used herein and not otherwise defined shall
have the meaning ascribed in the Agreement.

 

  (a)

The following definitions are hereby added to Article 2 of the Agreement:

2.33 “Assigned Patent Rights” means the U.S. patents and patent applications set
forth in Exhibit A hereto, together with all substitutes, continuations,
divisional applications, reexaminations or reissues of the foregoing. For the
avoidance of doubt, the Assigned Patent Rights do not include any patents or
patent applications in any country or jurisdiction other than the United States.

2.34 “Ex-U.S. Net Sales” means […***…].

2.35 “United States” or “U.S.” means the United States and its 50 States and
territories.

2.36 “U.S. Net Sales” means […***…].

 

  (b)

The following sentence is hereby added to the end of the definition of Patent
Rights in Section 2.19 of the Agreement: Notwithstanding the foregoing, Patent
Rights shall not include MVP’s interest in the Assigned Patent Rights.

 

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2.

Consideration. Within […***…] days of the Amendment Effective Date, Licensee
shall pay to MVP the non-creditable, non-refundable amount of […***…] U.S.
Dollars ($[…***…]) in immediately available funds in consideration of the
assignment of MVP’s interest in the Assigned Patent Rights and the other
modifications to the Agreement set forth herein. Licensee shall make such
payment to MVP by wire transfer to the bank account specified in Exhibit B of
this Amendment. The modifications to Licensee’s rights and obligations under the
Agreement set forth in Sections 3 and 4 below and the assignment of MVP’s
interest in the Assigned Patent Rights are contingent upon, and shall not become
effective until, MVP’s receipt of such payment in full (the date of MVP’s
receipt of such payment, the “Modification Effective Date”). Upon the
Modification Effective Date, the transfer of MVP’s interest in the Assigned
Patent Rights shall be final and irrevocable, and MVP shall not have any of
MVP’s interest in the Assigned Patent Rights returned, reverted, or otherwise
assigned back to MVP, unless agreed to in writing by Licensee and MVP.

 

3.

Modifications with respect to Licensee’s U.S. Royalty Obligations to
MVP. Subject to Section 2 above, and without affecting any rights of Duke or any
obligations of Licensee to Duke:

 

  (a)

Commencing as of […***…] (the “Royalty Adjustment Date”), the license granted to
Licensee pursuant to Section 4.1 of the Agreement shall become royalty-free and
fully paid up solely with respect to MVP’s interest in the Technology, Assigned
Patent Rights, and the Patent Rights, in each case, solely with respect to the
U.S.. Accordingly, U.S. Net Sales made prior to the Royalty Adjustment Date
shall remain royalty-bearing under Article 6 of the Agreement, and U.S. Net
Sales made on or after the Royalty Adjustment Date shall be royalty-free, as
further set forth in subsection (b) below.

 

  (b)

Commencing upon the Royalty Adjustment Date, Licensee shall be relieved of its
obligations (i) under Section 6.1 of the Agreement to pay any royalty to MVP on
U.S. Net Sales, and (ii) under Section 6.3 of the Agreement to pay any royalty
to MVP on Sublicense Revenues solely to the extent arising from sublicenses
granted by Licensee to use, sell or offer to sell Licensed Products in the U.S.
(and to manufacture, have manufactured and/or import Licensed Products in
connection therewith) (such Sublicense Revenues, “U.S. Sublicense Revenues”). If
Licensee grants a sublicense that either (A) includes both the U.S. and
territories outside of the U.S., or (B) is made with respect to the U.S. and is
in connection with a sublicense of a territory outside of the U.S., then the
Parties shall reasonably establish an equitable allocation of the consideration
paid to Licensee with respect to such sublicense(s) as between U.S. Sublicense
Revenues and Sublicense Revenues allocable to such other territory(ies). For
clarity, following the Royalty Adjustment Date, Licensee’s payment obligation
under Sections 6.1, 6.2, and 6.3 solely with respect to U.S. Net Sales and U.S.
Sublicense Revenues shall be to pay Duke […***…] percent ([…***…]%) of U.S. Net
Sales and […***…] percent ([…***…]%) of U.S. Sublicense Revenues, and Licensee’s
payment obligation under Sections 6.1, 6.2, and 6.3 with respect to all other
Net Sales and all other Sublicense Revenues shall remained unchanged.

 

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  (c)

MVP’s rights under Section 4.5(c), Section 6.7, Section 6.8, and Section 6.9 of
the Agreement shall cease to apply with respect to any U.S. Net Sales or any
U.S. Sublicense Revenues accrued by Licensee on or following the Royalty
Adjustment Date. For clarity, Section 4.5(c), Section 6.7, Section 6.8 and
Section 6.9 of the Agreement shall continue to apply with respect to (i) any
sales of Licensed Products by Licensee in the U.S. prior to the Royalty
Adjustment Date, (ii) any U.S. Sublicense Revenues accrued by Licensee prior to
the Royalty Adjustment Date, and (iii) all Ex-U.S. Net Sales and all Sublicense
Revenues in the Territory other than U.S. Sublicense Revenues, whether accrued
prior to, on or after the Royalty Adjustment Date.

 

  (d)

MVP shall have no further right to enforce Section 7.1 or Section 9.1 of the
Agreement, in each case, solely with respect to Licensed Products in the
U.S. For clarity, if Licensee fails to fulfill any of its material obligations
under the Agreement with respect to any country or countries outside of the
U.S., then the Licensors retain their rights to terminate the Agreement with
respect to the country or countries affected in accordance with Section 10.3 of
the Agreement.

 

4.

Assignment of Interest in Assigned Patent Rights; Modifications with respect to
Patent-Related Rights and Obligations. Subject to Section 2 above, and, except
as expressly set forth in this Section 4, without affecting any rights of Duke
or any obligations of Licensee to Duke, effective as of the Modification
Effective Date:

 

  (a)

MVP hereby sells, assigns, transfers and conveys to Licensee, free and clear of
all liens and encumbrances (subject to subsection (b) below), all of MVP’s
right, title, and interest in and to the Assigned Patent Rights. Within […***…]
following the Modification Effective Date, MVP shall execute and deliver to
Licensee a patent assignment for the Assigned Patent Rights in the form attached
as Exhibit C hereto. MVP shall take all reasonable further actions, and provide
Licensee, Licensee’s successors, assigns or other legal representatives, all
such cooperation and assistance (including the execution and delivery of any and
all affidavits, declarations, oaths, exhibits, assignments, powers of attorney
or other documentation) reasonably requested by Licensee to more fully and
effectively effectuate the purposes of this assignment, including, without
limitation with respect to the following: (1) the prosecution of any
applications assigned herein; (2) the prosecution or defense of any
interference, opposition, reexamination, reissue, infringement or other
proceedings that may arise in connection with any of the Assigned Patent Rights,
including, but not limited to, testifying as to any facts relating to the
Assigned Patent Rights and to this assignment; and (3) in the implementation or
perfection of this assignment in the United States. […***…] For the avoidance of
doubt, the Parties acknowledge and agree that this Amendment shall have no
effect on Licensee’s receipt and enjoyment of the exclusive license to or

 

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under the Patent Rights and Technology (including MVP Technology) granted to
Licensee pursuant to Section 4.1 of the Agreement, which license shall remain in
full force and effect.

 

  (b)

Licensee acknowledges that: (i) all of the Assigned Patent Rights are jointly
owned by MVP and Duke (prior to the assignment set forth in subsection (a)
above); (ii) Duke’s ownership in the Assigned Patent Rights remains unchanged by
the assignment set forth in subsection (a) above; and (iii) the Assigned Patent
Rights are subject to retained government rights in connection with the funding
of the inventions claimed therein.

 

  (c)

Licensee hereby grants to MVP the exclusive, perpetual, irrevocable,
royalty-free, fully paid-up, world-wide, non-transferable license (except as
permitted by Sections 13.1 and 13.3) under Licensee’s interest in the Assigned
Patent Rights, subject to all encumbrances therein as of the Modification
Effective Date, sublicenseable through multiple tiers of sublicensees, for
[…***…]. THE FOREGOING ARE LICENSED TO MVP “AS IS” AND WITHOUT WARRANTY OF ANY
KIND. LICENSEE DISCLAIMS ALL EXPRESS AND IMPLIED WARRANTIES, INCLUDING THE
IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE,
AND NON-INFRINGEMENT.

 

  (d)

Section 8.1 of the Agreement shall hereby be labeled Section 8.1(a). The
following is added to the Agreement as Section 8.1(b): Notwithstanding the
foregoing, and solely with respect to the Assigned Patent Rights in the U.S.,
Duke and Licensee shall have responsibility, at their shared expense (or as they
may otherwise decide between them), for filing, prosecuting and maintaining
their jointly owned patent applications within the Assigned Patent Rights in the
USPTO. Licensee shall keep MVP advised as to the prosecution of such
applications by forwarding to MVP copies of all official correspondence relating
thereto, and shall give MVP an opportunity to comment on all applications,
responses to office actions, declarations and other papers before they are filed
with the USPTO, and shall consult with MVP concerning the scope of allowed
claims before paying any issue fee. MVP shall be responsible for any costs
incurred by MVP in connection with MVP’s receipt, review, comment, consultation,
or other activities it takes with respect to any of the documentation provided
Licensee pursuant to this Section 8.1(b).

 

  (e)

Solely with respect to the […***…], if Licensee elects to stop an infringement
of the […***…] and recover damages as set forth in Section 8.5(a) of the
Agreement, then the following shall apply in lieu of Section 8.5(a)(i)(D):
Licensee shall be entitled to retain for its own account, after first deducting
the costs of any actions taken to stop such infringement, […***…] percent
([…***…]%) of any amounts received in settlement or awarded as damages, with the
remaining […***…] percent ([…***…]%) being paid to Duke.

 

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  (f)

Solely with respect to an infringement of the Assigned Patent Rights, the
references in Section 8.5(a)(ii)(A) to “Licensors” shall be deemed to refer
solely to Duke and the references in Section 8.9 to “Parties” shall be deemed to
refer solely to Duke and Licensee.

 

  (g)

Solely with respect to inquiries regarding licenses in the U.S. or third party
patents in the U.S., the references in Section 8.6 to “Licensors” shall be
deemed to refer solely to Duke.

 

  (h)

Licensee shall not have the right under Section 8.7(c) or Section 8.7(d) to
offset any attorneys’ fees, settlement amounts and/or royalties due to a third
party in connection with a third party infringement action to the extent based
on the inclusion of the Assigned Patent Rights in the U.S. that are incurred
after the Royalty Adjustment Date against any royalties owed to MVP by Licensee
based on Ex-U.S. Net Sales or on Sublicense Revenues attributable to any
territory outside of the U.S.

 

  (i)

If the Licensee terminates the Agreement in the U.S. pursuant to Section 8.8
thereof, or if Licensee or Licensors terminate the Agreement in the U.S.
pursuant to Article 10 thereof, then MVP’s rights in the Assigned Patent Rights
conveyed to Licensee pursuant to Section 4(a) of this Amendment shall not revert
to MVP and instead shall remain with Licensee; however, Licensee shall remain
subject to the prohibition of the manufacture, use and sale of Licensed Products
in the country or countries in which Licensee has elected to terminate as set
forth in Sections 8.8 and 10.2 of the Agreement.

 

  (j)

The Parties acknowledge that, as between Duke and Licensee, Licensee shall have,
subject to Licensee’s continued compliance with the terms of the Agreement (but
provided, however, that Duke provides the appropriate notice and opportunity to
cure in the event of any non-compliance), the sole and exclusive right to use
the Assigned Patent Rights in connection with […***…].

 

  (k)

Upon the Modification Effective Date, MVP shall deliver to Licensee, to the
extent not already in Licensee’s or its patent counsel’s possession:

  (i)

copies of the Assigned Patent Rights and, to the extent reasonably available to
MVP and reasonably requested by Licensee, other manifestations or embodiments of
the Assigned Patent Rights;

  (ii)

all internal and outside patent counsel files that comprise U.S. Patent and
Trademark Office (“USPTO”) notices, and correspondence from and to the USPTO
relating to the prosecution and maintenance of the Assigned Patent Rights; and

  (iii)

accurate and complete copies of all unpublished patent applications, if any,
included in the Assigned Patent Rights.

For clarity, MVP may retain copies of the foregoing consistent with its
obligations under Article 11 of the Agreement.

 

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  (l)

Solely with respect to inventory of the Licensed Products in the U.S., the
references in Section 10.4 of the Agreement to “Licensors” shall be deemed to
refer solely to Duke.

 

  (m)

(i) Upon learning of an actual or reasonably suspected infringement by a third
party of the Assigned Patent Rights exclusively licensed to MVP, the Party
learning of such infringement shall promptly inform the other Parties in writing
of that fact and shall provide any evidence available pertaining to such
infringement.

(ii) MVP may elect, within […***…] days after notice and at its own expense, to
take whatever steps are necessary to enforce against such third party the
Assigned Patent Rights exclusively licensed to MVP.

 

  1.

If MVP elects to take such action, it will: (a) keep Duke and Licensee informed
of the steps taken and the progress of any legal actions taken; and (b) be
entitled to enter into a settlement on such terms as it may elect, subject to
Duke and Licensee’s consent; and

 

  2.

If MVP does not elect to take such action within such period, it will promptly
inform Duke and Licensee, in which event Duke and Licensee may elect within
[…***…] days: (a) to take such action as is required to stop such infringement,
and will then be entitled to settle such actions on such terms as they may
elect, subject to MVP’s consent, will keep MVP informed of the steps taken and
the progress of any legal actions taken, and will be entitled to retain any
amounts received in settlement or awarded in damages; or (b) not to take any
action against such infringers.

 

  (n)

MVP shall give Duke and Licensee prompt notice of each claim or allegation
received by MVP that the manufacture, use or sale of products under MVP’s
exclusive license constitutes an infringement of a third party patent or other
intellectual property rights. If such alleged infringement is due to MVP’s or
its sublicensee’s manufacture, use, sale, offer for sale or U.S. importation of
one or more products that incorporate subject matter disclosed in the Assigned
Patent Rights, then:

 

  (i)

MVP shall have the primary right and responsibility, but not the obligation, at
its own expense to defend and control the defense of any claims against MVP,
using counsel of its choosing; and

 

  (ii)

The settlement of any such action must be approved by Duke and Licensee, which
approval shall not be unreasonably withheld.

 

  (o)

In any action brought under Section 4(m) or Section 4(n), the Parties not
bringing or defending the action shall, in their sole discretion, be entitled to
participate through counsel of their own choosing in any such action; provided
however, that such participation shall be limited to an advisory role and
counsel for the Party bringing or defending the action shall be lead counsel and
the action shall be directed by such Party. Each Party agrees to cooperate with
the other Parties in any reasonable

 

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manner deemed by the Party defending or prosecuting an action under Section
4(m), or defending an action under Section 4(n) of this Amendment, to be
necessary in defending or prosecuting such action.

 

5.

Representations and Warranties. MVP represents and warrants to Licensee that:

 

  (a)

MVP’s right, title and interest in and to the Assigned Patent Rights are free
and clear of any liens, security interests or other encumbrances, subject to
Section 4(b) of this Amendment;

 

  (b)

MVP has the full right and authority to execute this Amendment and to assign to
Licensee the rights assigned herein; and

 

  (c)

MVP has not executed, and will not execute, any agreement or other instrument:
(i) in conflict herewith; or (ii) that would permit MVP to make or have made,
use or have used, sell or have sold, or license or sublicense, any drug that
relates to (a) mammalian or non-mammalian uricases or (b) PEG conjugates of
mammalian or non-mammalian uricases, in each case that is indicated for any of
the treatments for which the drug marketed or sold as of the Modification
Effective Date under the brand or name Krystexxa is or was indicated.

 

6.

Indemnification. MVP agrees to indemnify, hold harmless and defend Licensee, its
officers, employees, and agents, against any and all claims, suits, losses,
damages, costs, fees, and expenses, including reasonable attorneys’ fees,
asserted by third parties, both government and non-government, resulting from or
arising out of the misrepresentation or breach of: (a) any representation,
warranty or covenant of MVP under Section 5 of this Amendment; or (b) any
covenant of MVP under any other Section of this Amendment.

 

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7.

Effect of MVP Corporate Liquidation and Assignment.

 

  (a)

The following is added at the end of Section 10.6(b) of the Agreement:

“provided, however, that this Section 10.6(b) shall not apply by reason of a
transaction by MVP that satisfies the conditions of Section 13.3.”

 

  (b)

The following is added at the beginning of Section 13.1 of the Agreement:

“Except as provided in Section 13.3,”.

 

  (c)

The following is added as a new Section 13.3 of the Agreement:

“At any time after the Amendment Effective Date, MVP may effect a corporate
liquidation and associated assignment of this Agreement without the consent of
the other Parties, provided, however, that following such liquidation event (1)
MVP’s rights and obligations under this Agreement have been assigned to an
entity formed by MVP or one or more of its stockholders, and (2) such entity is
also the assignee of all of or substantially all of MVP’s Patent Rights and the
MVP Technology, and all related obligations, in each case as then existing. Any
such entity must agree to be bound by all terms and conditions of this
Agreement.”

 

8.

Miscellaneous. Except as expressly set forth in this Amendment, all terms and
conditions of the Agreement remain in full force and effect. This Amendment sets
forth and constitutes the entire agreement and understanding between the Parties
with respect to the subject matter hereof and all prior agreements,
understanding, promises and representations, whether written or oral, with
respect thereto. Each Party confirms that it is not relying on any
representations or warranties of any other Party except as specifically set
forth herein. No amendment or modification of this Amendment will be binding
upon the Parties unless in writing and duly executed by an authorized
representative of each Party. In the event of a conflict or inconsistency
between the terms of this Amendment and the terms of the Agreement (or any other
amendment), the terms of this Amendment shall control with respect to such
conflict or inconsistency. Any term or condition of this Amendment may be waived
at any time by the Party that is entitled to the benefit thereof, but no such
waiver will be effective unless set forth in a written instrument duly executed
by or on behalf of the Party waiving such term or condition. The waiver by any
Party hereto of any right hereunder or of claims based on the failure to perform
or a breach by another Party will not be deemed a waiver of any other right
hereunder or of any other breach or failure by said other Party whether of a
similar nature or otherwise. Each Party acknowledges that it has been
represented by legal counsel with respect to the negotiation and preparation of
this Amendment and agrees that no provision hereof shall be strictly construed
against any Party, irrespective of which Party is deemed to have drafted such
provision. The captions of this Amendment are for convenience of reference only
and in no way define, describe, extend or limit the scope or intent of this
Amendment or the intent of any provision contained in this Amendment. This
Amendment may be executed in two or more counterparts, each of which will be
deemed an original, but all of which together will

 

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constitute one and the same instrument. In addition, this Amendment may be
executed by facsimile or PDF and such facsimile or PDF signature shall be deemed
to be an original.

 

9.

Execution by All Parties. This Amendment shall be binding upon MVP and Licensee
effective on the date last signed by both of them. If this Amendment has not
been also executed by Duke by midnight, Pacific Daylight Time, July 24, 2015,
then upon written notice from MVP or Licensee to the other Parties, this
Amendment shall be terminated and all terms and conditions hereof shall be
deemed null, void and of no further effect.

REMAINDER OF PAGE INTENTIONALLY BLANK;

SIGNATURE PAGE FOLLOWS.

 

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IN WITNESS WHEREOF, the Parties have duly executed this Amendment.

 

MOUNTAIN VIEW PHARMACEUTICALS, INC.     DUKE UNIVERSITY

By:

 

/s/Merry R. Sherman

   

By:

 

/s/ Rose Ritts

Name:

 

Merry R. Sherman

   

Name:

 

Rose Ritts

Title:

 

CEO and President

   

Title:

 

Executive Dir., OCU

Date:

 

July 15, 2015

   

Date:

 

July 16, 2016

 

CREALTA PHARMACEUTICALS LLC

By:

 

/s/Edward Fiorentino

Name:

 

Edward Fiorentino

Title:

 

Chairman & CEO

Date:

 

7/15/15

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Exhibit A

Patents and Patent Applications included within the Assigned Patent Rights

[…***…]

 

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[…***…]

 

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Exhibit B

Bank Wiring Instructions

[…***…]

 

***Confidential Treatment Requested

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Exhibit C

PATENT ASSIGNMENT

THIS PATENT ASSIGNMENT (“Assignment”) is made and entered into by and between
Mountain View Pharmaceuticals, Inc., a California corporation having its
principal offices at 3475 Edison Way, Suite S, Menlo Park, CA, USA 94025
(“Assignor”), and Crealta Pharmaceuticals LLC, a Delaware limited liability
company having its principal offices at 500 W. Silver Spring Dr., Suite K-200,
Glendale, WI, USA 53217 (“Assignee”).

WHEREAS, Assignor and Assignee are parties to a Fourth Amendment to License
Agreement By and Among Mountain View Pharmaceuticals, Inc., Duke University, and
Crealta Pharmaceuticals LLC, Including Patent Assignment, dated as of July __,
2015 (the “Amendment”); and

WHEREAS, pursuant to the Amendment, Assignor wishes to assign to Assignee, and
Assignee wishes to acquire from Assignor, the patents and patent applications
set forth on Schedule A attached hereto, including any substitutes,
continuations, divisions, reissues reexaminations or extensions thereof, and
including the subject matter of all claims thereof (collectively, the “Assigned
Patent Rights”).

NOW, THEREFORE, for good and valuable consideration, Assignor does hereby sell,
assign, transfer and set over to Assignee, subject to the terms of the
Amendment, Assignor’s right, title and interest in and to the Assigned Patent
Rights, for the United States, including, without limitation, all corresponding
rights that are or may be secured under the laws of the United States, now or
hereafter in effect, for Assignee’s use and enjoyment, and for the use and
enjoyment of Assignee’s successors, assigns or other legal representatives, as
fully and entirely as the same would have been held and enjoyed by Assignor if
this Assignment had not been made, including, without limitation, all claims for
damages by reason of infringement occurring on or after the Modification
Effective Date as defined in the Amendment or other unauthorized use of the
Assigned Patent Rights occurring on or after the Modification Effective Date,
with the right to sue for, and collect the same for Assignee’s use and enjoyment
and for the use and enjoyment of its successors, assigns or other legal
representatives.

Assignor hereby permits the Commissioner for Patents to record Assignee as an
assignee and owner of the Assigned Patent Rights.

REMAINDER OF PAGE INTENTIONALLY BLANK;

SIGNATURE PAGE FOLLOWS.

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MOUNTAIN VIEW PHARMACEUTICALS, INC.

By:

   

Name:

   

Title:

   

 

CREALTA PHARMACEUTICALS LLC

By:

   

Name:

   

Title: