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EXHIBIT 10.1
THIRD AMENDMENT TO LICENSE AGREEMENT
This Amendment to License Agreement ("Amendment") is entered into as of
August 26, 2002, by and between BUKWANG PHARM. CO., LTD., with its principal
offices at 398-01, Daebang-Dong, Dongjak-Ku, Seoul 156-811, Korea ("Bukwang")
and TRIANGLE PHARMACEUTICALS, INC., with its principal offices located at 4
University Place, 4611 University Drive, Durham, North Carolina 27707
("Triangle") and amends certain terms of that certain License Agreement, dated
as of February 27, 1998, between Bukwang and Triangle, as amended April 1, 1999
and September 5, 2000 (the "Agreement"). Capitalized terms not defined herein
shall have the meanings given them in the Agreement.
RECITALS
A. Bukwang and Triangle have previously entered into the Agreement,
pursuant to which Bukwang has licensed certain patent rights and know-how to
Triangle relating to a compound known as L-FMAU (also known as clevudine).
B. Triangle has certain diligence obligations with respect to the
clinical development of a Licensed Product.
C. Bukwang and Triangle desire to amend and clarify certain terms of the
Agreement relating to milestone payments and diligence obligations and the
calculation of Net Sales.
NOW, THEREFORE, for good and valuable consideration, Triangle and Bukwang
hereby agree as follows:
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1. AMENDMENTS. The Agreement is hereby amended as follows:
(a) Section 1.23. Delete Section 1.22 and replace it with the
following:
"NDA" shall mean a New Drug Application or its equivalent filed
in the U.S., China, Japan, Taiwan or, in the case of Europe, with the
European Agency for the Evaluation of Medicinal Products."
(b) SECTION 1.24. Delete Section 1.24 and replace it with the
following:
"'Net Sales' of Licensed Products which contain as their active
ingredients one or more Compounds and other compounds (a 'Combination
Product') shall mean the portion of the gross sales price of such
Combination Product attributable to the Compounds contained therein,
billed by Triangle, its Affiliates or sublicensees to independent
customers, including any consideration received, directly or
indirectly, from such customers in respect of the sale, distribution
or transfer of Licensed Products, less all the allowances,
adjustments, reductions, discounts, taxes, duties, rebates and other
items referred to in Section 1.23. The "portion of the gross sales
price of such Combination Product attributable to the Compounds
contained therein" shall be determined on a country-by-country basis
and shall mean, in each country, the average gross sales price per
gram of a Compound in the most comparable stock keeping unit of a
Licensed Product having a Compound as the sole active ingredient in
that country multiplied by the total number of grams of Compound
contained in the Combination Product billed in that country during
such royalty period.
In the event that a Combination Product containing a Compound and
one other active ingredient is sold in a country before a Licensed
Product containing only one or more Compounds is sold in that country,
the portion of gross sales price of such Combination Product
attributable to Compounds until a Licensed Product containing only one
or more Compounds as active ingredients is sold in that country shall
be *** percent. In the event that a Combination Product containing a
Compound and two or more other compounds as active ingredients is sold
in a country before a Licensed Product containing only one or more
Compounds is sold in that country, the portion of gross sales price of
such Combination products attributable to Compounds until a Licensed
Product containing only one or more Compounds as active ingredients is
sold in that country shall be the percentage determined by ***.
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In the event that Triangle or its Affiliates or sublicensees
distribute any Licensed Products to a third party for non-monetary
consideration (e.g. barter or exchange), such distribution shall be
considered a sale for accounting and royalty purposes. Net Sales for
any such distributions shall be determined on a country-by-country
basis and shall be the average price of 'arm's length' sales by
Triangle or its Affiliates or sublicensees in such country in the
Territory during the royalty period in which such sale occurs or, if
no such 'arm's length' sales occurred in such country in the Territory
during such royalty period, during the last royalty period in which
such 'arm's length' sales occurred. If no 'arm's length' sales have
occurred in a particular country in the Territory, Net Sales for any
such distributions in such country in the Territory, shall be the
average price of 'arm's length' sales in all countries in the
Territory during such royalty period."
(c) SECTION 1.25. Delete Section 1.25 and replace it with the
following:
"'Phase II Completion Date' shall mean sixty (60) days after the
completion of statistical analyses of the final results of those Phase
II clinical trials which Triangle considers reasonably necessary for
purposes of inclusion in an NDA for approval of a Licensed Product for
HBV. As used in the preceding sentence, 'Phase II clinical trials'
shall mean those well-controlled clinical trials sponsored by Triangle
or Bukwang, the primary objective of which is to ascertain additional
data regarding the safety and tolerance of a Licensed Product and
preliminary data regarding such Licensed Product's antiviral effects
against HBV."
(d) SECTION 1.26. Delete Section 1.26 and replace it with the
following:
"'Phase III Completion Date' shall mean sixty (60) days after the
completion of statistical analyses of the final results of those
Phase III clinical trials which Triangle considers reasonably
necessary for purposes of inclusion in an NDA for approval of a
Licensed Product for HBV. As used in the preceding sentence,
'Phase III clinical trials' shall mean those well-controlled clinical
trials sponsored by Triangle or Bukwang, the primary objective of
which is to ascertain definitive safety data and efficacy data
regarding such Licensed Product's antiviral effects against HBV
sufficient to support an NDA.
(e) SECTION 3.2.
(i) Delete Section 3.2(a)(vi) and replace it with the following:
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"(vi) ***
(ii) Add the following after the Milestone and Milestone Payment
chart in Section 3.2(a):
"(1) If the Milestone Payment identified in item (iii) above has
not been paid by *** and Triangle has not given notice of
termination of this Agreement prior to such date, Triangle will
pay Bukwang *** , such amount to be credited against the
Milestone Payment due on ***.
(2) The balance *** of the Milestone Payment due on *** shall be
paid to Bukwang upon the first to occur of *** or *** .
(3) If the Milestone Payment identified in item (iv) above has
not been paid by *** and Triangle has not given notice of
termination of this Agreement prior to such date, Triangle will
pay Bukwang *** , such amount to be credited against the
Milestone Payment due on *** .
(4) The balance *** of the Milestone Payment due on ***shall be
paid to Bukwang upon the first to occur of *** or ***."
(f) SUBSECTIONS 6.2(a)(i) AND 6.2(a)(ii). Delete Subsections
6.2(a)(i) and 6.2(a)(ii) and replace them as follows:
"(i) files what it reasonably believes to be a complete NDA
for a Licensed Product for HBV within *** after the Effective
Date; provided, however, said *** period shall be subject to up
to *** extensions of *** each, at Triangle's election, by payment
to Bukwang of a sum of *** for each *** extensions, *** for each
*** extensions and *** for each *** extensions; and"
"(ii) "files an NDA for a Licensed Product containing the
Compound as its sole active ingredient no later than the same
time as Triangle files an NDA for a Combination Product; and"
(f) SUBSECTION 6.2(a)(iii). A new Subsection 6.2(a)(iii) shall be
inserted as follows:
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"(iii) commercially introduces, or causes its Affiliates or
sublicensees to commercially introduce, any Licensed Product
(including any Licensed Product containing the Compound as its
sole active ingredient) approved in any country in which an NDA
has been filed within *** of Registration of such Licensed
Product in such country."
(g) SECTION 7.3. Delete the word "and" at the end of Subsection
7.3(b). Delete the period at the end of Subsection 7.3(c) and insert ";
and" and add the following Subsection 7.3(d):
"(d) evaluating all preclinical and clinical data in order to
assess the optimal dose of Licensed Products containing the
Compound as its sole active ingredient or containing the Compound
as one active ingredient in Combination Product to be used in
Phase III clinical studies to support Registration of Licensed
Products."
2. GENERAL TERMS. The Agreement, as amended by this Amendment,
constitutes the entire agreement between Bukwang and Triangle or regarding the
subject matters contained therein and herein. In the event of any conflict
between the provisions of the Agreement and this Amendment, the provisions of
this Amendment shall govern and control. This Amendment shall be governed by,
and construed in accordance with, the laws of the State of Georgia without
regard to its conflicts of laws principles. This Amendment may be executed in
any number of counterparts, each of which shall be deemed an original and all of
which shall constitute one and the same instrument. If any provision of this
Amendment is for any reason held to be ineffective, unenforceable or illegal,
such condition shall not affect the validity or enforceability of any of the
remaining portions hereof; provided, further, that the parties shall negotiate
in good faith to replace any ineffective, unenforceable or illegal provision
with an effective replacement as soon as is practical.
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IN WITNESS WHEREOF, Bukwang and Triangle have each executed this Amendment
through an authorized officer as of the date written below.
BUKWANG PHARM. CO., LTD.
By: /s/ S.K. Lee
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Its: Executive Managing Director
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Date: August 27, 2002
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TRIANGLE PHARMACEUTICALS, INC.
By: /s/ R. Andrew Finkle
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Its: Executive Vice President
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Date: August 26, 2002
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*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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