EXHIBIT 10.1
EXECUTION COPY
EXCLUSIVE LICENSE AGREEMENT
AMONG
GLAXO GROUP LIMITED,
THE WELLCOME FOUNDATION LIMITED,
GLAXO WELLCOME INC.,
EMORY UNIVERSITY
AND
TRIANGLE PHARMACEUTICALS, INC.
[***] Confidential Treatment Requested
EXCLUSIVE LICENSE AGREEMENT
THIS AGREEMENT is made and entered into as of this 6th day of May,
1999, by and among GLAXO GROUP LIMITED, a company organized and existing under
the laws of England and having its registered office at Glaxo ▇▇▇▇▇▇▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇ ONN, United Kingdom, THE WELLCOME
FOUNDATION LIMITED, a company organized and existing under the laws of
England and having its registered office at Glaxo Wellcome House, Berkeley
Avenue, Greenford, Middlesex, UB6 ONN, United Kingdom, together with GLAXO
WELLCOME INC., a corporation organized and existing under the laws of the
State of North Carolina and having its principal place of business at Five
▇▇▇▇▇ Drive, Research ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ (hereinafter
collectively referred to as "GW"), EMORY UNIVERSITY, a Georgia non-profit
corporation with offices at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇.▇., ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇
▇▇▇▇▇ (hereinafter referred to as "EMORY") and TRIANGLE PHARMACEUTICALS,
INC., a corporation organized and existing under the laws of the State of
Delaware and having its principal place of business located at ▇ ▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ (hereinafter
referred to as "TRIANGLE").
WITNESSETH:
WHEREAS, GW owns certain patents and patent applications covering the
use of the compound FTC (as hereinafter defined), certain technology
regarding the compound FTC, and a certain quantity of FTC Drug Substance (as
hereinafter defined);
WHEREAS, Emory is the owner of certain patents and patent applications
covering the compound FTC, and is the owner of certain technology regarding
the compound FTC;
WHEREAS, Triangle and Emory have entered into a License Agreement,
dated as of April 17, 1996, pursuant to which Emory has granted to Triangle
the exclusive rights under certain patents and patent applications which
contain claims covering the compound FTC and its use; and
WHEREAS, Emory and its licensee, Triangle, are developing FTC for use
in the Field (as hereinafter defined) and in certain territories;
NOW, THEREFORE, for and in consideration of the mutual covenants and
the premises herein contained, the parties, intending to be legally bound,
hereby agree as follows.
ARTICLE 1. DEFINITIONS
The following terms as used herein shall have the following meanings:
1.1 "AFFILIATE" shall mean any corporation or non-corporate business
entity which controls, is controlled by, or is under common control with, a
party to this Agreement. A corporation or non-corporate business entity shall
be regarded as in control of another corporation if it owns, or directly or
indirectly controls, at least [***] ([***]%) percent of the voting stock of
the other corporation, or (a) in the absence of the ownership of at least
[***] ([***]%) percent of the voting stock of a corporation or (b) in the
case of a non-corporate business entity or non-profit corporation, if it
possesses, directly or indirectly, the power to direct or cause the direction
of the management and policies of such corporation or non-corporate business
entity, as applicable. For the avoidance of doubt, it is agreed that Glaxo
Wellcome plc is an Affiliate of GW.
1.2 "AGREEMENT" or "LICENSE AGREEMENT" shall mean this Agreement,
including all APPENDICES attached to this Agreement.
1.3 "DOLLARS" shall mean United States dollars.
1.4 "EFFECTIVE DATE" shall mean the date first set forth above or such
later date, if any, that all the conditions set forth in Article 9 have been
satisfied or, if applicable, waived.
1.5 "EMORY/TRIANGLE LICENSE AGREEMENT" shall mean the License
Agreement between Emory and Triangle, dated as of April 17, 1996, pursuant to
which Emory has granted to Triangle exclusive rights under certain patents
and patent applications relating to FTC, as may, from time to time, be
amended by Emory and Triangle.
1.6 "FDA" shall mean the United States Food and Drug Administration or
any successor entity.
1.7 "FIELD" shall mean the prevention and treatment of disease in
humans arising from infection by the human immunodeficiency virus (HIV)
and/or hepatitis B virus (HBV).
1.8 "FIRST COMMERCIAL SALE" shall mean the date, after approval by the
relevant regulatory authority, on which Emory or an Affiliate, or a
Sublicensee (including, but not limited to Triangle or its Affiliates and
Sublicensees or any Triangle Marketing Collaborator), or assignee first
transfers title to a Licensed Product to a third party for monetary
consideration.
1.9 "FTC" shall mean the (-)-enantiomer of
cis-4-amino-5-fluoro-1-[2-(hydroxymethyl)-1, 3-oxathiolan-5-yl]
-2(1H)-pyrimidinone, also known as (2R,cis)
-4-amino-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]
-2(1H)-pyrimidinone.
1.10 "FTC DRUG SUBSTANCE" shall mean such quantity of FTC, not less
than [***] in GW's possession as of the date first set forth above.
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1.11 "GW" shall mean Glaxo Group Limited, The Wellcome Foundation
Limited and Glaxo Wellcome Inc.
1.12 "GW COMPOUNDS" shall mean all compounds with respect to which GW
owns or is exclusively licensed under a patent claim to:
(i) the compound per se, or
(ii) a pharmaceutical composition containing it, or
(iii) its use to treat infections caused by HBV or HIV,
other than in combination with another active ingredient.
For the avoidance of doubt, the parties agree that:
(a) any combination of compounds not including the Licensed Compound,
but including a compound that is manufactured for commercial sale, sold or
marketed by GW or its Affiliates, and
(b) a combination containing Licensed Compound and any compound
manufactured for commercial sale, sold or marketed by GW or its Affiliates,
which combination is covered by a claim in a patent or patent application
owned or controlled by GW is and shall remain a GW Compound until the
expiration of such patent claim.
1.13 "HSR ACT" shall mean the ▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇▇ Antitrust Improvements
Act of 1976, as amended, and all regulations and rules promulgated thereunder.
1.14 "INDEMNITEES" shall mean (a) in the case of the indemnity set
forth in Sections 11.1 and 11.2, GW, its Affiliates, and their respective
directors, officers and employees; (b) in the case of the indemnity set forth
in Section 11.3, Emory, its Affiliates, Sublicensees, and their respective
directors, officers and employees; and (c) in the case of the Indemnitees
referenced in Section 11.4, the parties identified in Sections 11.1, 11.2 and
11.3, as applicable.
1.15 "LICENSED COMPOUND" shall mean (a) the compound with the chemical
name of 4-amino-5-fluoro-1-[2-(hydroxymethyl)-1, 3-oxathiolan-5-yl]-2(1H)-
pyrimidinone and shall be construed to include each isomer or
polymorph thereof, either separately or as part of a mixture; or (b) any
salts, esters and N-alkylated derivatives of any of the foregoing, or (c) FTC.
1.16 "LICENSED PATENTS" shall mean the patents and patent applications
identified in APPENDIX A attached hereto and made a part hereof, together
with any and all substitutions, extensions, divisionals, continuations,
continuations-in-part, renewals, supplementary protection certificates or
foreign counterparts of such patents and patent applications which issue
thereon, anywhere in the world, including reexamined and reissued patents.
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1.17 "LICENSED PRODUCT(S)" shall mean any pharmaceutical product
suitable for use in humans containing one or more Licensed Compounds as
active ingredients, alone or in combination with other active ingredients.
1.18 "LICENSED TECHNOLOGY" shall mean (a) the data, information,
reports, and other know-how, whether patented or not, listed on APPENDIX B
attached hereto and made a part hereof and (b) those regulatory filings
relating to Licensed Compound referred to in Section 8.4 hereof.
1.19 "LICENSED TERRITORY" shall mean the world.
1.20 "MAJOR MARKET COUNTRY" shall mean any of the [***]
1.21 "MARKETING COLLABORATOR" shall mean any entity or party with whom
Triangle (or Emory or any Emory Sublicensee) has a marketing arrangement with
respect to the marketing, sale, promotion or detail of Licensed Products,
including but not limited to co-marketing or co-promotion arrangements.
1.22 "MINOR MARKET COUNTRY" shall mean any country of the Territory
which is not specifically included in the definition of Major Market Country.
1.23 "NET SALES" shall mean:
(a) in the case of Licensed Product(s) which contain as their sole
active ingredient a Licensed Compound the proceeds of the sales of such
Licensed Product(s) sold by Emory, its Affiliates and Sublicensees (including
but not limited to Triangle or Triangle's Affiliates, Sublicensees or any
Triangle Marketing Collaborator) to third parties for use in the Field less
all normal and customary trade and quantity discounts, allowances, rebates
(including those paid to third party payors) and credits granted to third
parties on a country by country basis in the Licensed Territory, returns,
retroactive price reductions in lieu of returns and free replacements
actually granted to such third parties and taxes applicable to the use or
sale of Licensed Product(s) which Emory, its Affiliates and Sublicensees
(including but not limited to Triangle, its Affiliates, Sublicensees or any
Triangle Marketing Collaborator) have to pay or absorb on such use or sale on
a country by country basis in the Licensed Territory; or
(b) in the case of Licensed Products which contain as their active
ingredients both a Licensed Compound and one or more other compounds (a
"COMBINATION PRODUCT") the proceeds of the sales of Combination Product(s)
sold by Emory its Affiliates and Sublicensees (including but not limited to
Triangle or Triangle's Affiliates, Sublicensees or any Triangle Marketing
Collaborator) to third parties for use in the Field less all normal and
customary trade and quantity discounts, allowances, rebates (including those
paid to third party payors) and credits granted to third parties on a country
by country basis in the Licensed Territory, returns, retroactive price
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reductions in lieu of returns and free replacements actually granted to such
third parties and taxes applicable to the use or sale of Combination
Product(s) which Emory, its Affiliates and Sublicensees (including but not
limited to Triangle, its Affiliates, Sublicensees or any Triangle Marketing
Collaborator) have to pay or absorb on such use or sale on a country by
country basis in the Licensed Territory multiplied by a fraction the
numerator of which shall be the price at which Licensed Product is sold alone
in the quantity included in the Combination Product in a given country and
the denominator of which is the price of the Combination Product in such
country. In the event that the numerator of the formula referred to in the
preceding sentence cannot be determined due to the fact that a value for the
Licensed Product sold alone is not available in such country, then the
numerator of the formula shall be the simple average of the prices (in effect
with respect to the period for which royalties are being calculated
hereunder) at which Licensed Products are sold alone in the quantity included
in the Combination Product in all other countries of the Licensed Territory.
In the event that no Licensed Products are sold alone in any country of the
Licensed Territory, the parties shall negotiate in good faith a formula with
respect to the calculation of Net Sales for Combination Products.
1.24 "REGISTRATION" shall mean, in relation to any Licensed Product,
such approvals by the regulatory authorities in a given country (including,
where applicable, pricing approvals) as may be legally required before such
Licensed Product may be commercialized in such country.
1.25 "SETTLEMENT AGREEMENT" shall mean that certain settlement
agreement, by and among Glaxo Wellcome plc, Glaxo Wellcome Inc., Emory,
Triangle and ▇▇. ▇▇▇▇▇ ▇. ▇▇▇▇▇, providing for the settlement, release and
dismissal of [***] and all related claims, and the claims of ▇▇. ▇▇▇▇▇ ▇.
▇▇▇▇▇.
1.26 "SUBLICENSEE" shall mean and refer to any party to whom Emory
licenses or sublicenses any of the rights granted by GW to Emory hereunder in
accordance with Section 2.2 hereof, including but not limited to Triangle.
Sublicensee shall also mean and refer to any party to whom Triangle licenses
or sublicenses any of the rights granted by GW to Emory hereunder, and
subsequently sublicensed to Triangle pursuant to the terms of the
Emory/Triangle License Agreement.
1.27 "VALID CLAIM" shall mean (a) an issued claim of any unexpired
patent included among the Licensed Patents, or (b) a pending claim of any
pending patent application included among the Licensed Patents, which has
not been held unenforceable, unpatentable or invalid by a decision of a court
or governmental body of competent jurisdiction, and which decision is
unappealable or unappealed within the time allowed for appeal, which has not
been rendered unenforceable through disclaimer or otherwise or which has not
been lost through an interference or opposition proceeding (and which
proceeding is unappealable or unappealed within the time allowed for appeal).
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ARTICLE 2. GRANT OF LICENSES
2.1A GRANT OF LICENSED PATENTS TO EMORY. Subject to Section 2.3
below, GW and its Affiliates hereby grant to Emory the exclusive right and
license to practice, with the right to sublicense, the Licensed Patents to
develop, make, have made, use, import, offer for sale and sell Licensed
Products in the Field within the Licensed Territory. For the avoidance of
doubt, it is hereby confirmed that no license, right or immunity from suit
under any GW patent or know-how is granted by this Agreement to Emory, its
Affiliates and its Sublicensees to develop, make, have made, import, use or
sell any Licensed Compound or Licensed Product in physical combination with any
GW Compound.
2.1B GRANT OF LICENSED TECHNOLOGY TO EMORY. Subject to Section 2.3
below, GW and its Affiliates hereby grant to Emory the exclusive right and
license to practice, with the right to sublicense, the Licensed Technology to
develop, make, have made, use, import, offer for sale and sell Licensed
Products in the Field within the Licensed Territory.
2.2 SUBLICENSE TO TRIANGLE; SUBLICENSING IN GENERAL. The parties
acknowledge that certain of the rights granted by GW to Emory hereunder are
being simultaneously sublicensed by Emory to Triangle pursuant to the terms
of an amendment to the Emory/Triangle License Agreement dated as of the date
hereof. GW hereby consents to the sublicense of the Licensed Patents by Emory
to Triangle. GW hereby also consents to the sublicense of the Licensed
Technology by Emory to Triangle. Emory hereby guarantees the performance of
each of its Sublicensees (including, but not limited to, Triangle, and its
Affiliates and Sublicensees). Emory and Triangle, as the case may be, may
enter into further sublicenses of the rights granted to it hereunder without
GW's consent. Triangle agrees that all royalty payments which are due under
the terms of this Agreement and which arise from the sale by Triangle and its
Affiliates, Sublicensees and Marketing Collaborators of Licensed Products
shall be paid directly to GW.
2.3 RIGHTS RESERVED TO GW. Notwithstanding Section 2.1A and 2.1B
above, there is reserved to GW the right (a) under the Licensed Patents to
make, have made, use and import Licensed Compounds and to use Licensed
Technology in support of or in connection with its own research and (b) to
promote, make, have made, use, import, offer for sale and sell any compound,
other than a Licensed Compound, for use in combination or association with a
Licensed Compound. This provision shall not be construed by implication,
estoppel or otherwise to confer any rights upon GW under any patents owned by
Emory or to sell any compound in physical combination with Licensed Compound.
GW shall not have the right to sublicense or otherwise transfer the rights
under Section 2.3(a) above, except to (i) to a successor to all or
substantially all of the business of GW to which this Agreement pertains, or
(ii) an Affiliate.
2.4 NO IMPLIED LICENSE. (a) The license and rights granted in this
Agreement shall not be construed by implication, estoppel or otherwise
(except as expressly granted herein) to confer any rights upon Emory or
Emory's Affiliates or Sublicensees under:
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(i) any patents or patent applications owned or controlled by
GW to make, have made, use, import, offer for sale or sell any
compound other than a Licensed Compound. It is acknowledged by the
parties that certain patent and patent applications owned or
controlled by GW may contain claims to manufacturing processes (but
not any Swiss-style second medical use claims) which may be useful
in the manufacture of Licensed Compounds or Licensed Products and
which are not covered by the Licensed Patents (the "Specifically
Excluded Claims") and that no rights are conferred upon Emory or
Emory's Affiliates or Sublicensees under the Specifically Excluded
Claims, or
(ii) any manufacturing or other technology not specifically
identified in this Agreement as being licensed to Emory, its
Affiliates and Sublicensees.
(b) To the best of GW's knowledge, GW and its Affiliates do not,
as of the date of this Agreement, own or control any manufacturing process
patent or patent application that:
(i) recites in a claim a nucleoside or an intermediate for
producing a nucleoside; and
(ii) is specifically applicable to the manufacture of Licensed
Compound,
except for PCT International Publication Numbers WO 95/29174 and WO 92/20669.
Notwithstanding the foregoing, no assurance is given by GW and its Affiliates
with respect to any patent or patent application which may contain claims to
manufacturing processes that are not specific to nucleosides.
2.5 COVENANT-NOT-TO-▇▇▇. (a) GW and its Affiliates shall not, during
the term of this Agreement, assert, induce, assist or direct any third party
to assert against Emory, its Affiliates or its Sublicensees any patent claim,
other than the Specifically Excluded Claims, granted on an application filed
as of the Effective Date of this Agreement or within six months thereafter
that is or might be infringed by reason of and which, but for this covenant,
would prevent the manufacture, use, import, offer for sale or sale by Emory
or its Affiliates or Sublicensees in the Territory and for use in the Field
of (i) a Licensed Compound, or (ii) Licensed Compound in physical combination
with any compound(s) other than a GW Compound, or (ii) a Licensed Compound
in physical combination with a GW Compound in a particular country if, and
only if, a third party would be free to manufacture, use, import, offer for
sale such physical combination in such country without rights from GW.
(b) GW represents and warrants to Emory and Triangle that neither GW
nor its Affiliates have delayed or will delay the filing of any patent
application for the purpose of excluding such patent application from the
scope or effect of this Section 2.5.
(c) It is hereby confirmed, for the avoidance of doubt, that Emory, its
Affiliates and its Sublicensees shall be entitled to promote Licensed
Compound for use in the Field in co-administration with any and all products,
including products owned, controlled, sold, distributed, marketed or promoted
by GW and its Affiliates. It is also hereby confirmed that no license, right
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or immunity from suit under any GW patent or know-how is granted by this
Agreement to Emory, its Affiliates and its Sublicensees to develop, make,
have made, import, use or sell any Licensed Compound or Licensed Product in
physical combination with any GW Compound.
(d) It is hereby confirmed, for the avoidance of doubt, that the
covenant-not-to-▇▇▇ contained in Section 2.5(a) hereof shall not apply to any
patent claim or patent application which GW acquires, whether by license,
assignment, acquisition of assets, acquisition of stock, merger, operation of
law or other transfer, from any party (other than an Affiliate (as of the
date of this Agreement) of GW) subsequent to the date of this Agreement,
regardless of the date of application or the date of grant of such patent
claim.
ARTICLE 3. FEES, ROYALTIES AND OTHER PAYMENTS
3.1 LICENSED PATENTS FEE. As consideration for granting to Emory the
license referred to in Section 2.1A hereunder to the Licensed Patents, and the
consent by GW to the sublicense by Emory of the Licensed Patents to Triangle,
Triangle shall pay to GW a non-creditable, non-refundable license fee of [***]
Dollars [***] (the "Licensed Patents Fee") payable as specified in the
succeeding sentence. [***] Dollars ($[***]) of such Licensed Patents Fee
shall be payable to Glaxo Wellcome Inc. by wire transfer within [***] ([***])
[***] of the Effective Date, and [***] Dollars ($[***]) of such Licensed
Patents Fee shall be payable to Glaxo Group Limited by wire transfer within
[***] ([***]) [***] of the Effective Date; PROVIDED, in each case, that wire
transfer instructions have been given to Triangle within [***] ([***]) [***]
after the Effective Date by each of Glaxo Wellcome Inc. and Glaxo Group
Limited.
3.2 EARNED ROYALTIES ON LICENSED TECHNOLOGY. As consideration for
granting to Emory the license referred to in Section 2.1B hereunder to the
Licensed Technology, and the consent by GW to the sublicense by Emory of the
Licensed Technology to Triangle, Emory shall pay, or cause to be paid to, GW
a royalty of [***] percent ([***]%) of the Net Sales of Licensed Products
sold in the Licensed Territory for use in the Field by Emory, its Affiliates
and Sublicensees (including but not limited to Triangle, its Affiliates,
Sublicensees or any Triangle Marketing Collaborators). The parties agree,
however, that the royalty obligation of [***] percent ([***]%) with respect
to Net Sales of Licensed Products sold by Triangle (and its Affiliates,
Sublicensees and Marketing Collaborators) shall be paid by Triangle directly
to GW, in lieu of being paid to Emory and in complete satisfaction thereof.
Royalties shall be paid in respect of Licensed Products sold in a given Major
Market Country for a period of [***] from the date of First Commercial Sale
of the first Licensed Product in such Major Market Country. Royalties shall
be paid in respect of Licensed Products sold in a given Minor Market Country
from the date of First Commercial Sale of the first Licensed Product in such
Minor Market Country and lasting until the expiry of the [***] ([***]) [***]
period from the First Commercial Sale of the first Licensed Product in the
first Major Market Country. All royalties on Net Sales of Licensed Products
sold in the United States of America whether by Emory, its Affiliates or
Sublicensees (including but not limited to Triangle or Triangle's Affiliates,
Sublicensees or any Triangle Marketing Collaborator) shall be payable to
Glaxo Wellcome Inc., while all royalties on Net Sales of Licensed Products
sold in all other countries of the Licensed Territory whether by
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Emory, its Affiliates or Sublicensees (including but not limited to Triangle
or Triangle's Affiliates, Sublicensees or any Triangle Marketing
Collaborator) shall be payable to Glaxo Group Limited.
3.3 ACCRUAL OF ROYALTIES. No royalty shall be payable on a Licensed
Product made, sold, or used for tests or development purposes or distributed
as samples. No royalties shall be payable on sales among Emory, its
Affiliates and Sublicensees (including, but not limited to, Triangle), but
royalties shall be payable on subsequent sales by Emory, its Affiliates or
Sublicensees (including, but not limited to, Triangle or Triangle's
Affiliates, Sublicensees or any Triangle Marketing Collaborator, so long as
Triangle pays royalties to GW with respect to all sales made by such Triangle
Marketing Collaborator) to a third party. No multiple royalty shall be
payable because the manufacture, use, importation, sale, or offer for sale of
a Licensed Product may be covered by more than one aspect of the Licensed
Technology.
3.4 WITHHOLDING TAX ASSISTANCE. In the event that Emory, its
Affiliates, Sublicensees or any Triangle Marketing Collaborator (including,
but not limited to, Triangle and its Affiliates, Sublicensees or any Triangle
Marketing Collaborator) are required to pay or withhold any amount from any
payment (whether a fee, a royalty payment or otherwise) due to Glaxo Group
Limited or Glaxo Wellcome Inc., as the case may be, under the terms of this
Agreement, then in such event Emory, its Affiliates or Sublicensees
(including, but not limited to, Triangle and its Affiliates, Sublicensees or
any Triangle Marketing Collaborator) shall give each of Glaxo Wellcome Inc.
or Glaxo Group Limited, as the case may be, such assistance as may be
reasonably necessary to enable or assist each of Glaxo Wellcome Inc. or Glaxo
Group Limited, as the case may be, to claim exemption therefrom or a
reduction thereof, and Emory, its Affiliates or Sublicenses (including, but
not limited to, Triangle and its Affiliates, Sublicensees or any Triangle
Marketing Collaborator) shall, upon request, provide documentation from time
to time to confirm the payment of such tax or withholding. GW agrees to
reimburse any party providing assistance to GW pursuant to this Section 3.4
for such party's reasonable and necessary out-of-pocket expenses incurred in
rendering such assistance.
ARTICLE 4. REPORTS AND ACCOUNTING
4.1 ROYALTY REPORTS AND RECORDS. (a) Commencing with the First
Commercial Sale of the initial Licensed Product, Emory shall furnish, or
cause to be furnished to GW, written reports, substantially in the format
attached as Appendix C hereto, covering each of Emory's or Triangle's fiscal
quarters showing:
(i) the gross sales of all Licensed Products sold by Emory, its
Affiliates and Sublicensees (including but not limited to Triangle or
Triangle's Affiliates, Sublicensees or any Triangle Marketing
Collaborator) in the Licensed Territory during the reporting period,
together with the calculations of Net Sales in accordance with
Section 1.23 hereof; and
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(ii) the royalties payable in Dollars, which shall have accrued
hereunder in respect to such sales;
(iii) the exchange rates used, if any, in determining the amount of
Dollars;
(iv) the discounts, allowances, rebates, credits, returns, free
replacements and taxes applicable to the use and sale of Licensed
Products that have been required to be withheld during the reporting
period; and
(v) a summary of all financial reports provided to Emory by
Emory's Affiliates and Sublicensees (including but not limited to
Triangle) to which Emory has granted a license or sublicense of any of
the rights licensed by GW to Emory under this Agreement covering Net
Sales of Licensed Products.
(b) With respect to sales of Licensed Products invoiced in Dollars, the
gross sales, Net Sales, and royalties payable shall be expressed in Dollars.
With respect to sales of Licensed Products invoiced in a currency other than
Dollars, the gross sales, Net Sales, and royalties payable shall be expressed
in the domestic currency of the party making the sale together with the
Dollar equivalent of the royalty payable, calculated using the simple average
of the exchange rates for such domestic currency published in THE WALL STREET
JOURNAL on the last day of each month during the reporting period. If any
Emory Affiliate or Sublicensee (including but not limited to Triangle) makes
any sales invoiced in a currency other than its domestic currency, the gross
sales and Net Sales shall be converted to its domestic currency in accordance
with the Affiliate's or Sublicensee's normal accounting practices. Emory or
its Affiliate or Sublicensee (including but not limited to Triangle) making
any royalty payment shall furnish to GW appropriate evidence of payment of
any tax or other amount deducted from any royalty payment.
(c) Reports shall be made on a quarterly basis. Quarterly reports shall
be due within sixty (60) days of the close of every Emory or Triangle fiscal
quarter. Emory and its Affiliates and Sublicensees (including but not limited
to Triangle, and its Affiliates and Sublicensees) shall for a period of [***]
keep accurate records in sufficient detail and in accordance with normal
accounting principles to enable royalties and other payments payable
hereunder to be determined. Emory shall be responsible for all royalties and
late payments that are due to GW that have not been paid by Emory's
Affiliates and Sublicensees (including but not limited to Triangle, and its
Affiliates and Sublicensees).
4.2 RIGHT TO AUDIT EMORY. GW shall have the right, upon prior notice
to Emory, not more than once in each Emory fiscal year nor more than once in
respect of each fiscal year, through an independent certified public
accountant selected by GW and acceptable to Emory, which acceptance shall not
be unreasonably refused or delayed, to have access during normal business
hours to those records of Emory and its Affiliates as may be reasonably
necessary to verify the accuracy of the royalty reports required to be
furnished by Emory pursuant to Section 4.1 of the Agreement. Such accountant
may report only the accuracy or inaccuracy of the royalty reports furnished
by Emory and, in the event they are determined to be inaccurate, the
corrections in the amounts which need to be made to such reports. The accountant
may not disclose to GW any
10
other confidential information that it learns as a result of such audit.
Emory shall include in any sublicenses granted pursuant to this Agreement a
provision requiring the Sublicensee to keep and maintain records of sales
made pursuant to such Sublicense and to grant access to such records by GW's
independent certified public accountant in the same manner and extent
prescribed in this Section 4.2. If such independent certified public
accountant's report shows any underpayment of royalties by Emory, its
Affiliates or Sublicensees, within [***] after Emory's receipt of such
report, Emory shall remit or shall cause its Sublicensees to remit to GW:
(a) the amount of such underpayment; and
(b) if such underpayment exceeds [***] ([***]%) percent of the total
royalties owed for the fiscal year then being reviewed, the reasonable and
necessary fees and expenses of such independent certified public accountant
performing the audit. Otherwise, GW's accountant's fees and expenses shall be
paid by GW. Any overpayment of royalties shall be fully creditable against
future royalties payable in any subsequent royalty periods and, if no future
royalties are due, shall be promptly refunded. Upon the expiration of [***]
following the end of any fiscal year, the calculation of royalties payable
with respect to such fiscal year shall be binding and conclusive on GW and
Emory, unless an audit is initiated before expiration of such [***].
4.3 RIGHT TO AUDIT TRIANGLE. GW shall have the right, upon prior notice
to Triangle, not more than once in each Triangle fiscal year nor more than
once in respect of each fiscal year, through an independent certified public
accountant selected by GW and acceptable to Triangle, which acceptance shall
not be unreasonably refused or delayed, to have access during normal business
hours to those records of Triangle and its Affiliates as may be reasonably
necessary to verify the accuracy of the royalty reports required to be
furnished by Triangle pursuant to Section 4.1 of the Agreement, or the
royalty reports required to be furnished by Triangle under the terms of the
license agreement between Emory and Triangle, as the case may be. Such
accountant may report only the accuracy or inaccuracy of the royalty reports
furnished by Triangle, and in the event they are determined to be inaccurate,
the corrections in the amounts which need to be made to such reports. The
accountant may not disclose to GW any other confidential information that it
learns as a result of such audit. Triangle shall include in any sublicenses
granted by it pursuant to this Agreement a provision requiring the
Sublicensee to keep and maintain records of sales made pursuant to such
sublicense and to grant access to such records by GW's independent certified
public accountant in the same manner and extent prescribed in this Section
4.3. If such independent certified public accountant's report shows any
underpayment of royalties by Triangle, its Affiliates of Sublicensees, within
[***] after Triangle's receipt of such report, Triangle shall remit or shall
cause its Sublicensees to remit to GW:
(a) the amount of such underpayment; and
(b) if such underpayment exceeds [***] ([***]%) percent of the total
royalties owed for the fiscal year then being reviewed, the reasonable and
necessary fees and expenses of such independent certified public accountant
performing the audit. Otherwise, GW's accountant's fees and expenses shall be
paid by GW. Any overpayment of royalties shall be fully creditable against
11
future royalties payable in any subsequent royalty periods. Upon the
expiration of [***] following the end of any fiscal year, the calculation of
royalties payable with respect to such fiscal year shall be binding and
conclusive on GW and Triangle, unless an audit is initiated before expiration
of such [***] .
4.4 CONFIDENTIALITY OF RECORDS. All information subject to review under
this Article 4 shall be confidential. Except where otherwise required by
applicable law, GW and its accountant shall retain all such information in
confidence.
ARTICLE 5. PAYMENTS
5.1 PAYMENTS AND DUE DATES. Except as otherwise provided herein,
royalties payable to GW during the period covered by each royalty report
required to be submitted under Article 4 of this Agreement shall be due and
payable to the relevant GW party as specified in Section 3.2 hereof on the
date such royalty report is due. Payments of royalties in whole or in part
may be made in advance of such due date. Any payments due under this
Agreement shall be made by wire transfer to an account of the relevant GW
party specified in Section 3.2 hereof designated by such GW party, as the
case may be, from time to time; PROVIDED, HOWEVER, that in the event that the
relevant GW party as specified in Section 3.2 hereof, fails to designate such
account, Emory (or Triangle, as the case may be) may remit payment to the
relevant GW party in accordance with Section 3.2 hereof, and at the address
applicable for the receipt of notices hereunder.
5.2 INTEREST. Royalties and other payments required to be paid by Emory
(or Triangle, as the case may be) pursuant to this Agreement shall, if
overdue, bear interest at the lessor of [***] or a per annum rate of [***]
percent ([***] %) until paid from the date that such royalty or payment was
due until the date that such payment is paid. The payment of such interest
shall not foreclose GW from exercising any other rights it may have because
any payment is overdue.
ARTICLE 6. PATENT PROSECUTION
6.1. GW OBLIGATIONS. GW shall be primarily responsible, at GW's
expense, for all patent prosecution activities pertaining to the Licensed
Patents. GW shall, at its discretion, obtain from the relevant patent
offices, prosecute and maintain any interference or opposition involving or
in respect of the Licensed Patents or pertaining to their validity,
enforceability, allowability or subsistence (all of the foregoing activities
being referred to as "GW PATENT PROSECUTION ACTIVITIES") and shall provide
Emory, at Emory's cost, with copies of such applications, substantive filings
and substantive correspondence pertaining to such GW Patent Prosecution
Activities (pre and post the date hereof), in a timely manner, as required to
keep Emory informed of the status of GW Patent Prosecution Activities. GW
shall give good faith consideration to any suggestions or requests made by
Emory with respect to the prosecution of Licensed Patents.
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6.2 EMORY'S ASSUMPTION RIGHTS. If GW decides to abandon or allow to
lapse any of the patent applications or patents within the Licensed Patents
or to discontinue any other GW Patent Prosecution Activities in respect
thereof in any country of the Licensed Territory, GW shall notify Emory of
its decision to do so at least sixty (60) days before the decision is
implemented or becomes effective; PROVIDED, HOWEVER, that in the event that
sixty (60) days notice is not possible, GW shall give Emory such advance
notice as is reasonably practicable. Such notice shall contain a statement of
GW's out-of pocket expenses incurred in respect of such GW Patent Prosecution
Activities commencing with the Effective Date and ending on the date of such
notice. Thereafter, GW shall allow Emory, at Emory's discretion, to assume GW
Patent Prosecution Activities in respect thereof, PROVIDED, HOWEVER, that
Emory agrees in writing to reimburse GW for [***] percent ([***]%) of the
expenses specified in such notice. GW shall be responsible for all expenses
incurred by GW in respect to such GW Patent Prosecution Activities, except to
the extent, if any, that Emory assumes any GW Patent Prosecution Activities
which GW elects to abandon, allows to lapse or not to pursue, in which event,
Emory shall be responsible for any expenses it incurs in connection therewith
from and after the date of assumption. With respect to any GW Patent
Prosecution Activities assumed by Emory pursuant to this Section 6.2, Emory
shall thereafter have the right to abandon, allow to lapse or discontinue
such GW Patent Prosecution Activities, at its discretion.
ARTICLE 7. INFRINGEMENT OF LICENSED PATENTS
7.1 THIRD PARTY INFRINGEMENT. If Emory or GW becomes aware of any
activity that it believes represents a substantial infringement of a Valid
Claim, the party obtaining such knowledge shall promptly advise the other of
all relevant facts and circumstances pertaining to the potential
infringement. GW shall have the initial right to enforce any rights within
the Licensed Patents against such infringement, at its own expense.
7.2 EMORY'S RIGHT TO PURSUE THIRD PARTY INFRINGERS. To the extent
that any activity notified under Section 7.1 may represent a substantial
infringement of a Valid Claim and if GW shall fail, within [***] after
receiving notice from Emory of a potential infringement of the Licensed
Patents or after providing Emory with notice of such infringement, either (a)
to terminate such infringement or (b) to institute an action to prevent
continuation thereof and, thereafter, to prosecute such action diligently, or
if GW notifies Emory prior to the expiration of such [***] that it does not
plan to terminate the infringement of the Licensed Patents or institute such
action, then Emory shall have the right to do so. In the event that GW
institutes such an action, Emory and Triangle agree to fully cooperate with
GW, including being joined, at GW's expense, as a party if such action is
necessary. If Emory institutes such an action, GW shall cooperate with Emory
in such effort, including being joined, at Emory's expense, as a party to
such action if necessary. Any damage award or settlement payments made to GW
in connection with any action filed by it relating to infringement of the
Licensed Patents, after first reimbursing GW for its expenses, shall be
equally divided by GW and Emory. In the event Emory institutes any action
relating to infringement in any country of the Licensed Patents, Emory may
deposit up to [***] ([***]%) of any royalties which are otherwise payable to
GW in respect of sales of Licensed Products in that country during the
pendency of any such infringement action in
13
an interest-bearing escrow account (bearing interest at rates comparable to
other Emory deposits of immediately available funds). Emory shall, upon the
final resolution or settlement of such infringement action, provide GW with
an accounting of the total royalty payments escrowed (and interest thereon)
and Emory's expenses incurred in such infringement action. Emory shall be
entitled to offset any expenses which Emory fails to recoup from any damage
award or settlement payments arising from such infringement action against
such escrowed royalties. Upon the conclusion of such litigation, any escrowed
payments (and interest thereon) in excess of Emory's unrecouped expenses
shall be immediately paid to GW. Any damage award or settlement payments made
to Emory in respect of a Licensed Patent in excess of Emory's expenses in
connection with any infringement action Emory initiates relating to the
Licensed Patents shall be equally divided by GW and Emory. It is expressly
understood that GW shall not be entitled to enforce or share in any recovery
solely with respect to any patent owned by Emory.
ARTICLE 8. TRANSFER OF TECHNOLOGY AND FTC DRUG SUBSTANCE
8.1 DELIVERY OBLIGATIONS. Within sixty (60) days after the Effective
Date, GW shall deliver to each of Emory at Emory's office and to Triangle at
Triangle's place of business a copy of the Licensed Technology. Within fifteen
(15) days after the Effective Date, GW shall deliver to Emory at Triangle's
place of business, all FTC Drug Substance and the existing batch records and
certificates of analysis relating to the FTC Drug Substance. Thereafter, GW
and Emory agree that Triangle shall have legal title to the FTC Drug
Substance.
8.2 WARRANTY DISCLAIMER. Emory acknowledges that it shall be
responsible for conducting (or for causing Triangle to conduct) any quality
assurance or quality control activities necessary in order for the FTC Drug
Substance to meet Good Clinical Practices and other regulatory requirements.
GW DOES NOT MAKE, AND SHALL NOT BE DEEMED TO HAVE MADE, ANY
REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO THE QUALITY, SAFETY OR
UTILITY OF THE FTC DRUG SUBSTANCE WHICH IS BEING TRANSFERRED BY GW "AS IS".
GW EXPRESSLY DISCLAIMS ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE AND ANY OTHER IMPLIED WARRANTIES WITH RESPECT TO THE
QUALITY, SAFETY, OR UTILITY OF THE FTC DRUG SUBSTANCE.
8.3 RESPONSIBILITY. Emory agrees that Emory or Triangle or other
Sublicensees (as the case may be) shall bear all responsibility (including
regulatory responsibility) and liability for the use of any of the FTC Drug
Substance. Emory agrees that it shall not use, and Emory shall cause Triangle
and any other Sublicensee not to use any of the FTC Drug Substance in any
clinical trial or otherwise in humans unless results of its quality assurance
testing indicate that the FTC Drug Substance meets the specifications set
forth in a IND (which has been filed with, and not withdrawn from, the FDA)
with respect to FTC or a Licensed Compound, as determined in accordance with
the analytical methodology set forth therein.
14
8.4 TRANSFER OF REGULATORY FILINGS. (a) Within ten (10) days of the
Effective Date, GW shall prepare and deliver to Triangle, one complete
photocopy of GW's US IND for FTC (US Ind #[***]). Thereafter, GW shall
promptly prepare and submit to FDA (with a copy to Triangle) a Letter of
Authorization to enable Triangle to incorporate by reference any information
contained in US IND #[***] with respect to the Licensed Compound. After the
Letter of Authorization has been processed by FDA, GW shall promptly submit
to FDA (with a copy to Triangle) a request to inactivate US IND #[***]; and
GW shall not thereafter make any request to reactivate such IND filing.
(b) Within ten (10) days of the Effective Date, GW shall prepare and
deliver to Triangle, one complete photocopy of GW's Canadian IND for FTC (HPB
file number [***]). Thereafter, GW shall promptly take such actions as are
necessary to inactivate (or to effectuate the Canadian regulatory equivalent
of inactivate) the Canadian IND, while still allowing Triangle the
opportunity to incorporate by reference any of the information contained in
the Canadian IND with respect to the Licensed Compound. GW shall not
thereafter make any request to reactivate the Canadian IND filing.
ARTICLE 9. CERTAIN COVENANTS AND ACKNOWLEDGEMENTS
9.1 CONDITIONS. This Agreement will not come into effect until the
conditions set forth in (a) and (b) below have been met:
(a) the HSR Act shall have been fully complied with by the parties
hereto, including the expiration or early termination of all applicable
waiting periods or compliance with any second request thereunder; and
(b) the Settlement Agreement shall have been executed and delivered by
all parties thereto.
ARTICLE 10. WARRANTIES AND REPRESENTATIONS
10.1 WARRANTIES OF GW. GW hereby represents and warrants to Emory that:
(a) APPENDIX A is a complete list of all patents and patent
applications within the Licensed Patents owned or controlled by GW and its
Affiliates as of the date hereof, except as may be otherwise specifically
excluded by the terms of this Agreement.
(b) To the best of GW's knowledge, APPENDIX B is a complete list of all
Licensed Technology developed, owned or acquired by GW and its Affiliates.
(c) Subject to the limitations contained in Section 10.4 hereof, each
of GW and its Affiliates have the right and authority to grant and convey the
rights granted and properties conveyed by each of GW and its Affiliates under
this Agreement.
15
(d) To the best of GW's knowledge, the FTC Drug Substance delivered to
Emory hereunder constitutes the entire quantity of FTC presently possessed by
GW in bulk or dosage form. GW shall not bear any responsibility for
reductions in the quantity of FTC Drug Substance which occur between the date
of this Agreement and the date of transfer due to force majeur events.
(e) To the best of GW's knowledge, the rights contained in the Licensed
Patents and the rights contained in Section 2.5 hereof together provide Emory
sufficient rights to be able to develop, make, have made, use, import, offer
for sale and sell Licensed Compound in the Field.
10.2 WARRANTIES OF EMORY. Emory hereby represents and warrants to GW
that the Board of Directors (or, if applicable, officials exercising similar
functions) of Emory (or, if different, of Emory's ultimate parent entity)
have, in accordance with Section 801.10(c)(3) of the Premerger Notification
Rules, determined that the fair market value of the exclusive rights to be
acquired by Emory from GW pursuant to this Agreement and the Settlement
Agreement, less the fair market value of that portion of those exclusive
rights which Emory will exclusively assign, license, or sublicense to
Triangle, does not exceed $[***].
10.3 WARRANTIES OF EACH PARTY. Each party hereto represents to the
others that it is free to enter into this Agreement and to carry out all of
the provisions hereof, including, in the case of GW, its grant to Emory of
the license described in Section 2.1A and 2.1B hereunder.
10.4 GENERAL WARRANTY DISCLAIMER. GW MAKES NO REPRESENTATION OR
WARRANTY OTHER THAN THOSE EXPRESSLY PROVIDED HEREUNDER AND GW HEREBY
EXPRESSLY DISCLAIMS ALL SUCH OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, OR THE FITNESS FOR A
PARTICULAR PURPOSE OF THE LICENSED COMPOUND, THE LICENSED PRODUCT, THE
LICENSED PATENTS OR THE LICENSED TECHNOLOGY.
WITHOUT LIMITING THE FOREGOING, GW MAKES NO REPRESENTATION OR WARRANTY
THAT THE LICENSED COMPOUND OR ANY LICENSED PRODUCT ARE, OR WILL BE SHOWN TO
BE, SAFE OR EFFECTIVE FOR ANY INDICATION.
10.5 EXCLUSION OF IP WARRANTIES. GW MAKES NO REPRESENTATION OR
WARRANTY OR ANY KIND WITH RESPECT TO THE VALIDITY OF THE LICENSED PATENTS,
LICENSED TECHNOLOGY OR LICENSED PRODUCTS. WITHOUT LIMITING THE FOREGOING, GW
MAKES NO REPRESENTATION OR WARRANTY THAT THE LICENSED COMPOUND, THE LICENSED
PRODUCT OR THE LICENSED PATENTS WILL BE FREE FROM THE INTELLECTUAL PROPERTY
CLAIMS OF THIRD PARTIES. GW WILL NOT BEAR ANY RESPONSIBILITY OR LIABILITY IF
A THIRD PARTY WERE TO ASSERT RIGHTS WHICH WOULD HAVE THE EFFECT OF PREVENTING
A LICENSED COMPOUND OR LICENSED PRODUCT FROM LAWFULLY REACHING THE MARKET IN
ANY COUNTRY OF THE TERRITORY.
16
10.6 NO LIABILITY FOR CONSEQUENTIAL DAMAGES AND LIMITATION OF LIABILITY.
GW shall not be liable to Emory, its Affiliates, or its Sublicensees
(including but not limited to Triangle, or its Affiliates, Sublicensees and
Marketing Collaborators), its or their customers, or any other third party
for compensatory, special, incidental, indirect, consequential or exemplary
damages resulting from the manufacture, testing, design, labeling, use, sale,
distribution or promotion of Licensed Products by or through Emory, its
Affiliates or Sublicensees (including but not limited to Triangle, or its
Affiliates, Sublicensees and Marketing Collaborators).
ARTICLE 11. INDEMNIFICATION
11.1 EMORY'S INDEMNIFICATION. Subject to compliance by the Indemnitees
with their obligations set forth in Section 11.4, Emory shall defend,
indemnify, and hold harmless the Indemnitees, from and against any and all
claims, demands, losses, liabilities, expenses, and damages including
investigative costs, court costs and reasonable attorneys' fees and expenses
(collectively, the "Liabilities") which Indemnitees may suffer, pay, or
incur as a result of or in connection with: (a) any and all personal injury
(including death) and property damage caused or contributed to, in whole or
in part, by the manufacture, testing, design, use, labeling, sale,
distribution, promotion of any Licensed Products by Emory or Emory's
Affiliates or Sublicensees (including but not limited to Triangle and its
Affiliates and Sublicensees), (b) any breach by Emory or its Affiliates or
Sublicensees of its representations, warranties and covenants contained in
this Agreement. Emory's obligations under this Article shall survive the
expiration or termination of this Agreement for any reason. Any provision of
this Article 11 to the contrary notwithstanding, with respect to any claim
for indemnification made by any Indemnitee under subsection (a) above
involving the co-administration of a Licensed Product and one or more
products marketed, sold, promoted or distributed by GW, Emory shall have no
obligations or liabilities to GW and its Affiliates under this Article 11
unless and until (and only to the extent) that there is a judicial
determination (unappealable or unappealed within the time allowed for appeal)
or agreement between the Indemnitee and Emory that the liabilities for
which indemnification is being sought were caused by, or contributed to, by
the manufacture, testing, design, use, labeling, sale, distribution or
promotion of any Licensed Products by Emory or its Affiliates or Sublicensees
(including, but not limited to Triangle, and its Affiliates or Sublicensees).
11.2 TRIANGLE'S INDEMNIFICATION. Subject to compliance by the
Indemnitees with their obligations set forth in Section 11.4, Triangle shall
indemnify and hold the Indemnitees harmless from and against any and all
Liabilities which Indemnitees may suffer, pay or incur as a result of or in
connection with: (a) any and all personal injury (including death) and
property damage caused or contributed to, in whole or in part, by the
manufacture, testing, design, use, labeling, sale, distribution, promotion
of any Licensed Products by Triangle or Triangle's Affiliates or
Sublicensees, (b) any breach by Triangle of its representations, warranties
and covenants contained in this Agreement. Triangle's obligations under this
Article shall survive expiration or termination of this Agreement for any
reason. Any provision of this Article 11 to the contrary notwithstanding,
with respect to any claim for indemnification made by any Indemnitee under
17
subsection (a) above involving the co-administration of a Licensed Product
and one or more products marketed, sold, promoted or distributed by GW,
Triangle shall have no obligations or liabilities to GW and its Affiliates
under this Article 11 unless and until (and only to the extent) that there is
a judicial determination (unappealable or unappealed within the time allowed
for appeal) or agreement between the Indemnitee and Triangle that the
liabilities for which indemnification is being sought were caused by, or
contributed to, by the manufacture, testing, design, use, labeling, sale,
distribution or promotion of any Licensed Products by Triangle or its
Affiliates or Sublicensees.
11.3 GW'S INDEMNIFICATION. Subject to compliance by the Indemnitees
with their obligations set forth in Section 11.4, GW shall indemnify and hold
the Indemnities harmless from and against any and all Liabilities which
Indemnitees may suffer, pay or incur as a result of or in connection with any
breach by GW of any of its representations, warranties and covenants set
forth in this Agreement GW's obligations under this Article shall survive
expiration or termination of this Agreement for any reason. Any provision
of this Article 11 to the contrary notwithstanding, with respect to any claim
for indemnification made by any Indemnitee under subsection (a) above
involving the co-administration of a Licensed Product and one or more
products marketed, sold, promoted or distributed by GW, GW shall have no
obligations or liabilities to Emory and its Affiliates under this Article 11
unless and until (and only to the extent) that there is a judicial
determination (unappealable or unappealed within the time allowed for appeal)
or agreement between the Indemnitee and GW that the liabilities for which
indemnification is being sought were caused by, or contributed to, by the
manufacture, testing, design, use, labeling, sale, distribution or promotion
of any products marketed, sold, promoted or distributed by GW.
11.4 INDEMNIFICATION PROCEDURES. Any Indemnitee which intends to claim
indemnification under this Article shall promptly notify the other party (the
"Indemnitor") in writing of any matter in respect of which the Indemnitee or
any of its employees intend to claim such indemnification. The Indemnitee
shall permit, and shall cause its employees to permit, the Indemnitor, at
its discretion, to settle any such matter and agrees to the complete control
of such defense or settlement by the Indemnitor; PROVIDED, HOWEVER, that such
settlement does not adversely affect the Indemnitee's rights hereunder or
impose any material obligations on the Indemnitee in addition to those set
forth herein in order for it to exercise such rights. No such matter shall be
settled without the prior written consent of the Indemnitor and the Indemnitor
shall not be responsible for any legal fees or other costs incurred other
than as provided herein. The Indemnitee and its employees shall cooperate
fully with the Indemnitor and its legal representatives in the investigation
and defense of any matter covered by the applicable indemnification. The
Indemnitee shall have the right, but not the obligation, to be represented by
counsel of its own selection and expense.
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ARTICLE 12. CONFIDENTIALITY
12.1 TREATMENT OF CONFIDENTIAL INFORMATION. Except as otherwise
provided hereunder, during the term of this Agreement and in the event Emory
shall terminate this Agreement in accordance with Section 13.3 for a period
of [***] ([***]) years thereafter and in event of any other termination for a
period of [***] ([***]) years thereafter:
(a) Emory and its Affiliates and Sublicensees shall retain in
confidence and use only for purposes of this Agreement, any written
information and data (including without limitation Licensed Technology)
supplied by or on behalf of GW under this Agreement; and
(b) GW shall retain in confidence and use only for purposes of this
Agreement any written information and data supplied by or on behalf of Emory
to GW under this Agreement.
For purposes of this Agreement, all such information and data which a
party is obligated to retain in confidence shall be called "INFORMATION."
12.2 RIGHT TO DISCLOSE. (a) To the extent that it is reasonably
necessary to fulfill its obligations or exercise its rights under this
Agreement, or any rights which survive termination or expiration hereof, a
party may disclose Information to its Affiliates, Sublicensees (actual or
prospective), consultants, outside contractors, actual or prospective
investors, and clinical investigators on condition that such entities or
persons agree:
(i) to keep the Information confidential for at least a period of
[***] ([***]) years from the date of disclosure and otherwise to the same
extent as such party is required to keep the Information confidential; and
(ii) to use the Information only for those purposes for which the
disclosing party is authorized to use the Information.
(b) Each party or its Affiliates or Sublicensees, as applicable, may
disclose Information to the government or other regulatory authorities to the
extent that such disclosure (i) is necessary or desirable for the prosecution
and enforcement of patents, or authorizations to conduct preclinical or
clinical trials of, or to commercially market, Licensed Products, provided
such party is then otherwise entitled to engage in such activities in
accordance with the provisions of this Agreement, or (ii) is legally required
including, without limitation, all applicable securities laws and regulations.
12.3 RELEASE FROM RESTRICTIONS. The obligation not to disclose or use
Information shall not apply to any part of such Information that:
(a) is or becomes patented (but the existence of a patent shall only
permit disclosure and not, unless otherwise provided hereunder, use),
published or otherwise part of the public domain, other than by unauthorized
acts of the party obligated not to disclose such Information (for
19
purposes of this Article 12 the "receiving party") or its Affiliates or
Sublicensees in contravention of this Agreement;
(b) is disclosed to the receiving party or its Affiliates or
Sublicensees by a third party provided that such Information was not
obtained by such third party directly or indirectly from the other party to
this Agreement under an obligation of confidentiality;
(c) prior to disclosure under this Agreement, was already in the
possession of the receiving party, its Affiliates or Sublicensees, provided
that such Information was not obtained directly or indirectly from the other
party to this Agreement under an obligation of confidentiality;
(d) results from research and development by the receiving party or its
Affiliates or Sublicensees, independent of disclosures from the other party
to this Agreement, provided that the persons developing such information have
not had exposure to the Information received from the other party to this
Agreement;
(e) is required by law to be disclosed by the receiving party, provided
that in the case of disclosure in connection with any litigation, the
receiving party uses reasonable efforts to notify the other party immediately
upon learning of such requirement in order to give the other party reasonable
opportunity to oppose such requirement; or
(f) The disclosing party agrees in writing may be disclosed.
ARTICLE 13. TERM AND TERMINATION
13.1 TERM. Unless sooner terminated as otherwise provided in this
Agreement, the term of this Agreement shall commence on the Effective Date
and shall continue in full force and effect until the expiration of Emory's
obligations to pay royalties hereunder.
13.2 TERMINATION BY DEFAULT. If either Emory or Triangle defaults in
the performance of, or fails to be in compliance with, any material
agreement, condition or covenant of this Agreement including without
limitation the obligation to make royalty payments hereunder with respect to
the Licensed Technology, GW may terminate this Agreement including all rights
granted with respect to the Licensed Technology granted pursuant to Section
2.1B hereunder, as well as all rights to the Licensed Patents granted
pursuant to Section 2.1A hereunder, if such default, noncompliance, breach or
nonpayment shall not have been remedied, or reasonable steps shall not have
been initiated to remedy the same, within (60) days after receipt by Emory or
Triangle, as the case may be, of a written notice thereof from GW. If GW
defaults in the performance of, or fails to be in compliance with, any
material agreement, condition or covenant of this Agreement, Emory may
terminate this Agreement if such default or noncompliance shall not have been
remedied, or reasonable steps shall not have been initiated to remedy the
same, within sixty (60) days after receipt by GW of a written notice thereof
from Emory. In the event of
20
a breach of this Agreement by any party hereto, the non-breaching parties
shall be entitled to all remedies provided by law or in equity in addition to
the remedies provided in this Agreement.
13.3 TERMINATION BY [***]. In the event [***] determines, in its sole
discretion, to cease development of the Licensed Products in a given country
or not to seek Registration of Licensed Products in a given country prior to
Registration of a Licensed Product in such country, [***] shall have the
right to terminate this Agreement in such country (without affecting this
Agreement in the remaining countries of the Territory), by giving GW [***]
prior written notice thereof.
13.4 OBLIGATIONS UPON TERMINATION. If this Agreement is terminated as a
result of Emory's or Triangle's breach pursuant to Section 13.2, or is
terminated in whole (but not in part) by [***] in accordance with Section
13.3, then Emory shall promptly cease using the Licensed Technology and the
Licensed Patents, and furthermore Emory and Triangle shall cease using the
FTC Drug Substance, and shall promptly return to GW or destroy, at GW's
option, all remaining quantities of the FTC Drug Substance. If GW elects to
have Triangle or Emory destroy the FTC Drug Substance, Triangle or Emory, as
the case may be, shall certify in writing that all quantities of FTC Drug
Substance have been destroyed within thirty (30) days of such election. If
this Agreement is terminated in part (but not in whole) by Emory in
accordance with Section 13.3, then Emory shall promptly cease using the
Licensed Technology and the Licensed Patents in respect of each such country
in which the license has been terminated by Emory.
13.5 EFFECT OF EXPIRATION OR TERMINATION. In the event of any
expiration or termination pursuant to this Article 13, neither party shall
have any remaining rights or obligations under this Agreement other than as
provided below:
(a) GW will have the right to receive all royalties and other payments
accrued prior to the effective date of termination, including interest
thereon as determined in accordance with Section 5.2 hereof;
(b) termination or expiration of this Agreement for any reason shall
have no effect on the parties' obligations under Articles 11 and 12;
(c) termination of this Agreement by Emory pursuant to Section 13.2
shall have no effect on Emory's rights under Sections 2.1A, 2.1B and 2.2,
subject to the fulfillment of its royalty and related obligations in
connection therewith as specified elsewhere in this Agreement;
(d) upon expiration of Emory's royalty obligations under this Agreement
in a given country, Emory, its Affiliates or Sublicensees (including
Triangle, its Affiliates and Sublicensees) shall have a perpetual, fully
paid-up license to use the Licensed Technology and Licensed Patents in such
country, and the covenant-not-to-▇▇▇ provided in Section 2.5 hereof shall
continue in perpetuity with respect to such country without further
consideration from Emory, its Affiliates and Sublicensees;
21
(e) termination of this Agreement by GW pursuant to Section 13.2 or by
Emory pursuant to Section 13.3, shall give rise to Emory's obligations under
Section 13.4; and
(f) except as otherwise specified herein, the parties' shall retain any
other remedies for breach of this Agreement they may otherwise have.
13.6 SEVERABILITY OF SUBLICENSEES. GW's right to terminate this
Agreement pursuant to Section 13.2 shall be severable with respect to each of
Emory's Sublicensees. Any remedy available to GW under Section 13.2 with
respect to any default or noncompliance by Triangle shall be limited to
termination of the rights granted to Emory hereunder only in that portion of
the Licensed Territory pursuant to which Triangle is Emory's Sublicensee
under the Emory/Triangle License Agreement; and any remedy available to GW
under Section 13.2 with respect to any default or noncompliance by any Emory
Sublicensee other than Triangle shall be limited to termination of the rights
granted to Emory hereunder only in that portion of the Licensed Territory in
which such Emory Sublicensee is sublicensed by Emory.
ARTICLE 14. ASSIGNMENT
14.1 ASSIGNMENT. None of the parties shall assign this Agreement or
any part thereof without the prior written consent of the other party, which
consent shall not be unreasonably withheld or delayed. Each party may,
however, without consent, assign or sell its rights under this Agreement (a)
to an Affiliate; (b) in connection with the sale or transfer of all or
substantially all of its assets of its business to which this Agreement
pertains; or (c) in the event of its merger or consolidation with another
company irrespective of the surviving company in such merger or
consolidation. Any permitted assignee shall assume all obligations of its
assignor under this Agreement. No assignment shall relieve the assigning
party of responsibility for the performance of any accrued obligation which
such party has under this Agreement.
ARTICLE 15. GENERAL PROVISIONS
15.1 LEGAL COMPLIANCE. Each party shall comply with all laws and
regulations relating to the performance of its obligation or the exercise of
its rights hereunder.
15.2 INDEPENDENT CONTRACTORS. It is understood and agreed that the
parties hereto are independent contractors and are engaged in the operation
of their own respective businesses, and neither party hereto is to be
considered the agent, partner, or joint venturer of the other party for any
purpose whatsoever, and neither party shall have any authority to enter into
any contracts or assume any obligations for the other party nor make any
warranties or representations on behalf of that other party. It is
understood and agreed that to the extent that any relationship other than an
independent contractors relationship may have existed, or was alleged to have
existed, prior to the Effective Date of this Agreement, between GW or its
Affiliates on the one hand, and one or more
22
of Emory or its Affiliates, and Triangle or its Affiliates on the other
hand, such relationship is hereby terminated and the parties are now solely
independent contractors.
15.3 PUBLICITY. On the date that this Agreement is executed, GW, Emory
and Triangle shall issue a joint press release the form of which shall be
agreed to by all parties hereto. Each of GW, Emory and Triangle shall be
permitted to issue additional press releases limited to the subject of the
economic or financial impact of this Agreement on each of GW, Emory or
Triangle, as the case may be, however, none of the specific financial terms
of this Agreement shall be disclosed. The other parties hereto shall have a
reasonable opportunity to review and comment on any such proposed press
release, which comments shall not be unreasonably refused. The specific terms
of this Agreement shall be confidential and neither party may publicly
disclose, except to legal, accounting and financial consultants and except as
otherwise provided herein, any such term without the prior written approval
of the other party, unless such disclosure is compelled by a court or
administrative agency or otherwise required by law. In the event that such
disclosure is compelled by a court or administrative agency or otherwise
required by law, the disclosing party shall make reasonable effort to provide
the other party with notice beforehand. Emory and its Affiliates and
Sublicensees (including Triangle) may disclose the terms of this Agreement to
a bona fide prospective sublicensee or Marketing Collaborator, subject to an
obligation of confidentiality of such sublicensee or Marketing Collaborator
that is no less restrictive than the confidentiality obligations contained
herein. GW and Emory hereby acknowledge that Triangle has notified each of
them that this Agreement constitutes a material agreement to Triangle and
must be filed by Triangle with the Securities and Exchange Commission
pursuant to Triangle's reporting obligations under the Securities and
Exchange Act of 1934, as amended. In any case where a party makes disclosure
of the terms hereunder to a court, it shall be disclosed under seal. In all
other respects, except as required by law, neither party shall use the name
of the other party in any publicity release without the prior written
permission of such other party, which shall not be unreasonably withheld.
The parties acknowledge that for the avoidance of doubt, each of GW and Emory
shall be free to disclose both the existence and the terms of this Agreement
to the [***] for the [***] in connection with [***] between Emory and GW.
15.4 HSR ACT COMPLIANCE. Promptly after the execution of this
Agreement, each of GW and Triangle shall file with the Federal Trade
Commission and the United States Department of Justice HSR Act Notification
and Report forms together with all information and documents necessary to
comply with the HSR Act notification and reporting requirements, and each of
them shall promptly furnish any and all additional information and
documentary material thereafter requested by either of such agencies, in
connection with the transactions contemplated by this Agreement. Each of GW
and Triangle shall also furnish to the other such information as the other
shall reasonably request to assist it in making such filings as it may be
legally required to make under the HSR Act. Each party shall use its best
efforts to obtain HSR Act clearance of the transactions contemplated by this
Agreement. All fees in connection with the HSR Act shall be borne by
Triangle, except that each party shall pay its own attorney's fees and
expenses.
23
15.5 GOVERNING LAW. This Agreement and all amendments, modifications,
alterations, or supplements hereto, and the rights of the parties hereunder,
shall be construed under and governed by the laws of the [***] exclusive of
its conflicts of laws principles.
15.6 ENTIRE AGREEMENT; AMENDMENTS. (a) This Agreement and the
Settlement Agreement constitute the entirety of the agreements and
understandings between GW on the one hand and any other party on the other
hand and anyone acting for, associated with or employed by any party
concerning the subject matter hereof and thereof, respectively and replace
and supersede any and all prior discussions, agreements or understandings.
With respect to the subject matter hereof and thereof, respectively, there
are no promises, representations or agreements, whether oral or written,
between the parties hereto or anyone acting for, associated with or employed
by any party hereto other than as set forth in this Agreement and the
Settlement Agreement. Each party hereto represents and warrants that, other
than as recited herein and therein, there has been no reliance, inducement,
representation or agreement causing, affecting or in connection with this
Agreement and the Settlement Agreement.
(b) This Agreement can be amended or modified only by a written
instrument referencing this Agreement and executed by all of the parties
hereto.
15.7 SEVERABILITY. All rights and restrictions contained herein may be
exercised and shall be applicable and binding only to the extent that they do
not violate any applicable laws and are intended to be limited to the extent
necessary so that they will not render this Agreement illegal, invalid or
unenforceable. If any provision or portion of any provision of this
Agreement, not essential to the commercial purpose of this Agreement, shall
be held to be illegal, invalid or unenforceable by a court of competent
jurisdiction, it is the intention of the parties that the remaining
provisions or portions thereof shall constitute their agreement with respect
to the subject matter hereof, and all such remaining provisions, or portions
thereof, shall remain in full force and effect. To the extent legally
permissible, any illegal, invalid or unenforceable provision of this
Agreement shall be replaced by a valid provision which shall implement the
commercial purpose of the illegal, invalid, or unenforceable provision. In
the event that any provision essential to the commercial purpose of this
Agreement is held to be illegal, invalid or unenforceable and cannot be
replaced by a valid provision which will implement the commercial purpose of
this Agreement, this Agreement and the rights granted herein, shall terminate.
15.8 COUNTERPARTS. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
15.9 NOTICES. All notices, statements, and reports required to be given
under this Agreement shall be in writing and shall be deemed to have been
given upon delivery in person or, when deposited (a) in the mail in the
country of residence of the party giving the notice, registered or certified
postage prepaid or (b) with a professional courier service (e.g. FedEx,
Airborne Express or UPS), and addressed as follows:
24
If to GW: Glaxo Group Limited
Glaxo ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇▇ ONN
United Kingdom
Attn: Company Secretary
Fax: [***]
With a required copy to:
The Wellcome Foundation Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford, Middlesex
UB6 ONN, United Kingdom
Attn: Company Secretary
Fax: [***]
And a required copy to:
Glaxo Wellcome Inc.
Five ▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇
Attn: General Counsel
Fax: [***]
If to Emory: Emory University
Office of the Executive Vice President
▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: ▇▇▇▇ ▇. ▇▇▇▇▇▇
Fax: [***]
With a required copy to:
Emory University
Office of the Vice President and General Counsel
▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: General Counsel
Fax: [***]
25
If to Triangle: Triangle Pharmaceuticals, Inc.
▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn: ▇▇▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇,
Vice President Business Development,
Secretary and General Counsel
Fax: [***]
Any party hereto may change the address to which notices to such party
are to be sent by giving notice to the other party at the address and in the
manner provided above. Any notice may be given, in addition to the manner
set forth above, by telex, facsimile or cable, provided that the party giving
such notice obtains acknowledgment by telex, facsimile or cable that such
notice has been received by the party to be notified. Notices made in this
manner shall be deemed to have been given when such acknowledgment has been
transmitted.
15.10 WAIVER. The failure of a party to enforce at any time for any
period any of the provisions hereof shall not be construed as a waiver of
such provisions or the rights of such party thereafter to enforce each such
provision.
26
IN WITNESS WHEREOF, GW, Emory and Triangle have caused this Agreement to
be signed by their duly authorized representatives, as of the day and year
indicated above.
GLAXO GROUP LIMITED
By: /s/ ▇ ▇ ▇▇▇▇▇▇▇▇
-------------------------------
Name: ▇ ▇ ▇▇▇▇▇▇▇▇
Title: Assistant Secretary
THE WELLCOME FOUNDATION LIMITED
By: /s/ ▇ ▇ ▇▇▇▇▇▇▇▇
-------------------------------
Name: ▇ ▇ ▇▇▇▇▇▇▇▇
Title: Assistant Secretary
GLAXO WELLCOME INC.
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, ▇▇.
--------------------------------
Name: ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, ▇▇.
Title: Senior Vice President, General Counsel
and Secretary
EMORY UNIVERSITY
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇
--------------------------------
Name: ▇▇▇▇ ▇. ▇▇▇▇▇▇
Title: Executive Vice President
TRIANGLE PHARMACEUTICALS, INC.
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇
--------------------------------
Name: ▇▇▇▇▇ ▇. ▇▇▇▇▇
Title: Chairman and Chief Executive Officer
26
APPENDIX A
LICENSED PATENTS
CASE NO. PB1226
------------------------------------------------------------------------------
COUNTRY APPLICATION NO. STATUS
------------------------------------------------------------------------------
Australia 1351292 Granted
------------------------------------------------------------------------------
Canada 2105487 Pending
------------------------------------------------------------------------------
Czechoslovakia PV1836.93 Granted
------------------------------------------------------------------------------
Europe 92905707.3 Pending/Allowed
------------------------------------------------------------------------------
Hong Kong 98103372.5 Pending
------------------------------------------------------------------------------
Hungary P9302496 Pending
------------------------------------------------------------------------------
Ireland 920702 Pending
------------------------------------------------------------------------------
Israel 101145 Granted
------------------------------------------------------------------------------
Japan 50556492 Pending
------------------------------------------------------------------------------
Republic of Korea 93702626 Pending
------------------------------------------------------------------------------
Malaysia ▇▇▇▇▇▇▇▇▇ Granted
------------------------------------------------------------------------------
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ Granted
------------------------------------------------------------------------------
Philippines 44010 Granted
------------------------------------------------------------------------------
Portugal 100199 Pending
------------------------------------------------------------------------------
Russia 93045710.14 Granted
------------------------------------------------------------------------------
Slovak Republic PV0951.93 Granted
------------------------------------------------------------------------------
Taiwan 81101695 Granted
------------------------------------------------------------------------------
Ukraine 94051479 Pending
------------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ Granted
------------------------------------------------------------------------------
[***] [***] [***]
------------------------------------------------------------------------------
South Africa 921660 Granted
------------------------------------------------------------------------------
-1-
CASE NO. PA1344
------------------------------------------------------------------------------
COUNTRY APPLICATION NO. STATUS
------------------------------------------------------------------------------
Europe 93910190.3 Pending/Allowed
------------------------------------------------------------------------------
Japan S1999693 Pending
------------------------------------------------------------------------------
[***] [***] [***]
------------------------------------------------------------------------------
[***] [***] [***]
------------------------------------------------------------------------------
CASE NO. PB1614
------------------------------------------------------------------------------
COUNTRY APPLICATION NO. STATUS
------------------------------------------------------------------------------
Brazil PI9607850.2 Pending
------------------------------------------------------------------------------
China 96193016.0 Pending
------------------------------------------------------------------------------
Europe 96911954.4 Pending
------------------------------------------------------------------------------
Hong Kong 98110455.0 Pending
------------------------------------------------------------------------------
Hungary P9801576 Pending
------------------------------------------------------------------------------
Japan 528932.96 Pending
------------------------------------------------------------------------------
Norway 97.4512 Pending
------------------------------------------------------------------------------
Pakistan 172.96 Granted
------------------------------------------------------------------------------
Poland P322503 Pending
------------------------------------------------------------------------------
[***] [***] [***]
------------------------------------------------------------------------------
-▇-
▇▇▇▇▇▇▇▇ ▇
LICENSED TECHNOLOGY
GW FTC DATA
1. PRECLINICAL DATA
The attached "Index to Item 8" lists the preclinical studies submitted in the
US IND (IND #[***]) on 28 January 1994. All studies listed in the "index to
Item 8" and Section 1.1 below were submitted in the Canadian regulatory
filing referenced as HPB file number [***] [***] on 16 March 1995 except for
the last study listed in Section 1.1 as noted.
1.1 TOXICOLOGY - COMPLETED STUDIES (FINAL REPORTS ISSUED)
In addition to the toxicology studies listed in the "Index to Item 8", the
following studies have been submitted to the US IND since the original IND
submission. These studies were submitted in the original Canadian IND on 16
March 1995 except for the last study, item d.
[***]
1.2 TOXICOLOGY - COMPLETED STUDIES (DATA TO BE ANALYZED AND/OR REPORTS TO BE
WRITTEN)
-3-
[***]
1.2 VIROLOGY
[***]
2. CLINICAL DATA
[***]
-4-
INDEX TO ITEMS 8 - US IND
PHARMACOLOGY AND TOXICOLOGY INFORMATION
PRECLINICAL TECHNICAL SUMMARIES:
Pharmacology
Toxicology
Pharmacokinetics
Microbiology (Virology)
Mechanism of Action Studies
Antiviral Preclinical Studies
PHARMACOLOGY STUDY REPORTS
[***]
-5-
[***]
TOXICOLOGY STUDY REPORTS
[***]
-6-
PHARMACOKINETICS (ADME) STUDY REPORTS
[***]
-7-
MICROBIOLOGY (VIROLOGY) STUDY REPORTS AND REFERENCES
[***]
-8-
MICROBIOLOGY (VIROLOGY) STUDY REPORTS AND REFERENCES
(CONTINUED)
[***]
-9-
-------------------------------------------------------------------------------
APPENDIX C
-------------------------------------------------------------------------------
CONSOLIDATED EMORY ROYALTY REPORT
-------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------------------------
[***]
[***]
---------------------------------------------------------------------------------------------------------------------------------
Payment to GGL
---------------------------------------------------------------------------------------------------------------------------------
[COUNTRY] [DATE] [LOCAL CURRENCY]
[COUNTRY] [DATE] [LOCAL CURRENCY]
Example of Countries which may be applicable:
CHINA (Sub-licensed) HONG KONG DOLLARS
CHINA HONG KONG DOLLARS
CZECH CZECH KOAUNA
DENMARK DANISH KRONA
ECUADOR U.S. DOLLARS
ESTONIA POUNDS STERLING
---------------------------------------------------------------------------------------------------------------------------------
Total 0.00 0.00 0.00 0.00
---------------------------------------------------------------------------------------------------------------------------------
Less: Withholding tax (if applicable)
------
------
Net Royalty to GGL 0.00
------
------
[***]
---------------------------------------------------------------------------------------------------------------------------------
[***] US DOLLARS N/A N/A
[***] US DOLLARS N/A N/A
---------------------------------------------------------------------------------------------------------------------------------
[***] 0.00 0.00 0.00 0.00
---------------------------------------------------------------------------------------------------------------------------------
Payment Date to GGL [Date]
-----------
Payment Date to GW Inc. [Date]
-----------
-----------------------------------------------------------------------------
THE INFORMATION CONTAINED IN THIS STATEMENT IS CONFIDENTIAL AND IS SUBJECT TO
THE RELEVANT PROVISIONS OF THE LICENSE AGREEMENT UNDER WHICH THIS ROYALTY
PAYMENT IS DUE.
-----------------------------------------------------------------------------
**An explanation of adjustments must be made separately
This report is framed on the assumption that Triangle is the exclusive world
wide licensee