EX-10.24



 



Exhibit 10.24



CONFIDENTIAL
MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.



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.




	 	 	 	 	 
	 	BlO-TECHNOLOGY GENERAL CORP.

 	 
	 	By:  	/s/ Norman Barton
 	 
	 	 	Name:  	Norman Barton 	 
	 	 	Title:  	Chief Medical Officer 	 
	 



	 	 	 	 	 
	 	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	 
	 



 









 








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.






	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 EFFECT1VE
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.






	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 US. 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.
	 
	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, 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 PRODUCTS, and shall be under
no obligation to use the trademark, PURICASETM.
	 
	 	(b)	 	If LICENSEE elects not to use the trademark PURICASETM 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.
	 
	 	(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 AGREEMENT
	 	[**]	 	[**]	 	[**]
	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.
	 
	 	(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:






	 	(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: [**]
	 
	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-unease conjugates for itself or
any third party;
	 
	 	(d)	 	that such manufacturer is not [xx], or [xx]; 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: [xx], 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.





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.






	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.
	 
	 	(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 finds 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.






	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:




	 	(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
	 
	 	(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 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.





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.
	 
	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
	 
	 	(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.





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



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 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;




 









 






	 	(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.






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, 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 Ph.D.
 	 
	 	 	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 	 




	 	 	 	 	 






 









 


Exhibit A



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

Part of DUKE TECHNOLOGY



[**]







 



Exhibit B



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

to BTG as Part of MVP TECHNOLOGY



[**]







 


Exhibit C



Patents and Patent Applications included within PATENT RIGHTS

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



[**]