<PAGE>
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
X QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
- ---- OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 1997
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the transition period from ________ to _______.
Commission File Number: 000-21589
TRIANGLE PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
DELAWARE 56-1930728
(State or other jurisdiction (I.R.S. Employer
of incorporation or organization) Identification No.)
4 University Place
4611 University Drive
Durham, North Carolina 27707
(Address of principal executive offices) (zip code)
Registrant's telephone number, including area code: (919) 493-5980
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days. Yes X No
--- ---
As of October 31, 1997, there were 19,995,338 shares of Triangle
Pharmaceuticals, Inc. Common Stock outstanding.
<PAGE>
TRIANGLE PHARMACEUTICALS, INC.
TABLE OF CONTENTS
Part I. Financial Information Page No.
--------
Item 1. Financial Statements (unaudited)
Condensed Consolidated Balance Sheets -
December 31, 1996 and September 30, 1997................... 3 - 4
Condensed Consolidated Statements of Operations -
Three and Nine Months Ended September 30, 1996 and 1997,
and Period From Inception (July 12, 1995) Through
September 30, 1997......................................... 5
Condensed Consolidated Statements of Cash Flows -
Nine Months Ended September 30, 1996 and 1997 and
Period From Inception (July 12, 1995) Through
September 30, 1997......................................... 6
Condensed Consolidated Statements of Stockholders' Equity -
Period From Inception (July 12, 1995) Through
December 31, 1995, 1996 and Nine Months Ended
September 30, 1997......................................... 7
Notes to Condensed Consolidated Financial Statements......... 8 - 10
Item 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations................... 11 - 26
Part II. Other Information
Item 2. Changes in Securities................................... 27
Item 6. Exhibits and Reports on Form 8-K........................ 28
Signatures........................................................ 29
2
<PAGE>
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
TRIANGLE PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED BALANCE SHEETS
DECEMBER 31, SEPTEMBER 30,
ASSETS 1996 1997
- ------ ------------- -------------
(unaudited)
Current assets:
Cash and cash equivalents........ $25,255,006 $45,288,572
Restricted deposits.............. 56,067 42,087
Investments...................... 17,226,221 21,047,462
Interest receivable.............. 272,716 319,248
Other receivables................ 455,910 1,110
Prepaid expenses................. 558,423 283,248
------------- -------------
Total current assets.......... 43,824,343 66,981,727
------------- -------------
Property, plant and equipment, net.. 832,049 1,689,761
Investments......................... 10,719,917 --
Restricted deposits................. 118,933 86,901
------------- -------------
Total assets.................. $55,495,242 $68,758,389
------------- -------------
------------- -------------
The accompanying notes are an integral part of these
condensed consolidated financial statements.
3
<PAGE>
TRIANGLE PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED BALANCE SHEETS
DECEMBER 31, SEPTEMBER 30,
LIABILITIES AND STOCKHOLDERS' EQUITY 1996 1997
- ------------------------------------ ------------ -------------
(unaudited)
Current liabilities:
Accounts payable............................ $ 1,584,348 $ 2,380,667
Accrued license fees........................ 150,000 --
Capital lease obligation-current............ 102,006 176,909
Other accrued expenses...................... 639,255 2,775,730
------------ ------------
Total current liabilities............... 2,475,609 5,333,306
Capital lease obligation-noncurrent........... 364,385 344,082
------------ ------------
Total liabilities....................... 2,839,994 5,677,388
------------ ------------
Commitments and contingencies (See notes 4
and 5)...................................... -- --
Stockholders' equity:
Common Stock, $0.001 par value; authorized
75,000,000 shares; issued and outstanding
17,567,890 and 19,995,338 shares........... 17,568 19,995
Warrants...................................... 151,873 216,471
Additional paid-in capital.................... 64,548,647 102,242,194
Accumulated deficit during development stage.. (11,884,166) (39,259,071)
Deferred compensation......................... (178,674) (138,588)
------------ ------------
Total stockholders' equity.............. 52,655,248 63,081,001
------------ ------------
Total liabilities and stockholders'
equity................................. $ 55,495,242 $ 68,758,389
------------ ------------
------------ ------------
The accompanying notes are an integral part of these
condensed consolidated financial statements.
4
<PAGE>
TRIANGLE PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
<TABLE>
PERIOD FROM
INCEPTION
(JULY 12, 1995)
THREE MONTHS ENDED SEPTEMBER 30, NINE MONTHS ENDED SEPTEMBER 30, THROUGH
-------------------------------- ------------------------------- SEPTEMBER 30,
1996 1997 1996 1997 1997
----------- ------------ ----------- ------------ --------------
<S> <C> <C> <C> <C> <C>
Operating expenses:
License fees......................... $ 494,397 $ -- $ 3,246,226 $ 500,000 $ 3,767,147
Development.......................... 1,270,731 6,568,629 2,613,322 13,262,108 18,228,840
Purchased research and
development........................ -- 11,261,150 -- 11,261,150 11,261,150
General and administrative........... 998,528 1,471,220 2,488,684 4,935,830 9,498,686
----------- ------------ ----------- ------------ ------------
2,763,656 19,300,999 8,348,232 29,959,088 42,755,823
----------- ------------ ----------- ------------ ------------
Interest income........................ 224,797 1,086,993 309,955 2,584,183 3,496,752
----------- ------------ ----------- ------------ ------------
Net loss............................... $(2,538,859) $(18,214,006) $(8,038,277) $(27,374,905) $(39,259,071)
----------- ------------ ----------- ------------ ------------
----------- ------------ ----------- ------------ ------------
Net loss per share..................... -- $ (0.91) -- $ (1.48)
------------ ------------
------------ ------------
Pro forma net loss per share........... $ (0.19) -- $ (0.58) --
----------- -----------
----------- -----------
Shares used in computing pro forma
net loss per share and net loss per
share................................ 13,045,548 19,988,451 13,863,850 18,554,524
----------- ------------ ----------- ------------
----------- ------------ ----------- ------------
</TABLE>
The accompanying notes are an integral part of these
condensed consolidated financial statements.
5
<PAGE>
TRIANGLE PHARMACEUTICALS, INC.
(A Development Stage Company)
Condensed Consolidated Statements of Cash Flows
(Unaudited)
<TABLE>
<CAPTION> PERIOD FROM
INCEPTION
NINE MONTHS ENDED SEPTEMBER 30, (JULY 12, 1995)
------------------------------- THROUGH
1996 1997 SEPTEMBER 30, 1997
-------------- ------------- ------------------
<S> <C> <C> <C>
Cash flows from operating activities:
Net loss............................................... $ (8,038,277) $ (27,374,905) $ (39,259,071)
Adjustments to reconcile net loss to net
cash used by operating activities:
Depreciation and amortization....................... 51,035 195,534 296,226
Purchased research and development.................. -- 11,261,150 11,261,150
Stock-based compensation: license fees.............. 636,000 -- 636,000
Stock-based compensation: development............... 332,135 33,647 380,216
Stock-based compensation: general and
administrative................................... 185,286 91,818 323,340
Change in assets and liabilities:.....
Receivables......................................... (523,049) 408,268 (320,358)
Prepaid expenses.................................... (686,348) 275,175 (283,248)
Accounts payable.................................... 229,868 796,319 2,380,667
Accrued license fees and other expenses............. 1,377,141 1,967,614 2,687,078
------------- -------------- -------------
Net cash used by operating activities.................. (6,436,209) (12,345,380) (21,898,000)
------------- -------------- -------------
Cash flows from investing activities:
(Purchase) sale of restricted deposits.............. (175,000) 46,012 (128,988)
Purchase of investments............................. (9,558,127) (17,564,880) (50,832,805)
Proceeds from sale and maturity of investments...... -- 24,463,556 29,785,343
Purchase of property, plant and equipment........... (745,454) (994,446) (1,810,723)
Acquisition of Avid Corp., net of cash acquired..... -- (3,052,921) (3,052,921)
------------- -------------- -------------
Net cash (used by) provided from investing activities.. (10,478,581) 2,897,321 (26,040,094)
------------- -------------- -------------
Cash flows from financing activities:
Sale of stock, net of related issuance costs........ 18,496,839 29,523,079 92,892,975
Sale of options..................................... -- 52,500 52,500
Sale of warrants.................................... 130 -- 130
Proceeds from stock options exercised............... 23,588 975 26,063
Equipment financing................................. -- -- 354,416
Principal payments on capital lease obligation...... -- (94,929) (99,418)
------------- -------------- -------------
Net cash provided from financing activities............ 18,520,557 29,481,625 93,226,666
------------- -------------- -------------
Net increase in cash and cash equivalents.............. 1,605,767 20,033,566 45,288,572
Cash and cash equivalents at beginning of period....... 3,081,586 25,255,006 --
------------- -------------- -------------
Cash and cash equivalents at end of period............. $ 4,687,353 $ 45,288,572 $ 45,288,572
------------- -------------- -------------
------------- -------------- -------------
Supplemental disclosure of noncash investing activities:
On August 28, 1997, the Company issued 400,000 shares of common stock in exchange for
all outstanding shares of Avid Corporation.
</TABLE>
The accompanying notes are an integral part of these
condensed consolidated financial statements.
6
<PAGE>
TRIANGLE PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
<TABLE>
<CAPTION>
CONVERTIBLE
PREFERRED STOCK COMMON STOCK ADDITIONAL
------------------ ------------------- PAID-IN ACCUMULATED DEFERRED
SHARES AMOUNT WARRANTS SHARES AMOUNT CAPITAL DEFICIT COMPENSATION TOTAL
---------- ------- -------- ---------- ------- ---------- ------------ ------------ -----------
<S> <C> <C> <C> <C> <C> <C> <C> <C> <C>
Initial sale of stock...... 933,334 $ 933 -- 1,175,000 $ 1,175 $ 709,642 -- -- $ 711,750
Additional sale of stock... 4,248,337 4,249 -- 1,495,000 1,495 3,137,355 -- -- 3,143,099
Stock-based compensation... -- -- -- -- -- 12,000 -- $ (11,750) 250
Net loss, July 12 through
December 31, 1995......... -- -- -- -- -- -- $ (967,583) -- (967,583)
--------------------------------------------------------------------------------------------------------
Balance, December 31, 1995. 5,181,671 5,182 -- 2,670,000 2,670 3,858,997 (967,583) (11,750) 2,887,516
Sale of stock.............. 3,756,234 3,756 -- 4,942,652 4,943 59,506,348 -- -- 59,515,047
Sale of warrants........... -- -- $ 130 -- -- -- -- -- 130
Stock-based compensation... -- -- 151,743 700,000 700 1,126,500 -- 141,181) 1,137,762
Stock options exercised.... -- -- -- 317,333 317 56,802 -- (25,743) 31,376
Conversion of Preferred to
Common Stock..............(8,937,905) (8,938) -- 8,937,905 8,938 -- -- -- --
Net loss................... -- -- -- -- -- -- (10,916,583) -- (10,916,583)
--------------------------------------------------------------------------------------------------------
Balance, December 31, 1996. -- -- 151,873 17,567,890 17,568 64,548,647 (11,884,166) (178,674) 52,655,248
(UNAUDITED)
Sale of stock.............. 2,014,448 2,014 29,521,065 -- -- 29,523,079
Acquisition of Avid........ -- -- -- 400,000 400 8,117,100 -- -- 8,117,500
Sale of options............ -- -- -- -- -- 52,500 -- -- 52,500
Stock-based compensation... -- -- 64,598 -- -- -- -- 35,891 100,489
Stock options exercised.... -- -- -- 13,000 13 2,882 -- 4,195 7,090
Net loss................... -- -- -- -- -- -- (27,374,905) -- (27,374,905)
--------------------------------------------------------------------------------------------------------
Balance, September 30,
1997....................... -- $ -- $216,471 19,995,338 $19,995 $102,242,194 $(39,259,071) $ (138,588) $63,081,001
--------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------
</TABLE>
The accompanying notes are an integral part of these
condensed consolidated financial statements.
7
<PAGE>
TRIANGLE PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
1. Basis of Presentation
The accompanying unaudited condensed financial statements of Triangle
Pharmaceuticals, Inc. and its subsidiary (the "Company" or "Triangle") have
been prepared in accordance with generally accepted accounting principles and
applicable Securities and Exchange Commission regulations for interim
financial information. These financial statements do not include all of the
information and footnotes required by generally accepted accounting
principles for complete financial statements. It is presumed that users of
this interim financial information have read or have access to the audited
financial statements for the preceding fiscal year contained in Triangle
Pharmaceuticals, Inc. Annual Report on Form 10-K. In the opinion of
management, all adjustments (consisting of normal recurring adjustments)
considered necessary for fair presentation have been included. Operating
results for the interim periods presented are not necessarily indicative of
the results that may be expected for the full year.
2. Principles of Consolidation
The condensed consolidated financial statements include the accounts of
Triangle Pharmaceuticals, Inc. and its wholly-owned subsidiary. All
significant intercompany accounts and transactions have been eliminated.
3. Net Loss Per Share
The weighted average shares outstanding used in the calculation of pro
forma net loss per share includes the effect of the conversion of all of the
Company's Preferred Stock as if such conversion occurred as of July 12, 1995.
Additionally, common stock or equivalent shares from stock options and awards
sold or issued at prices below the Initial Public Offering ("IPO") price per
share in the twelve months preceding the initial filing of the Company's
Registration Statement on Form S-1 on September 11, 1996, have been included
in the calculations as if outstanding from July 12, 1995 through June 30,
1996 pursuant to the requirements of the Securities and Exchange Commission.
The common stock equivalents have been excluded from the calculation
subsequent to June 30, 1996 because they have the effect of reducing net loss
per share.
For the three and nine month periods ended September 30, 1997, the
weighted average shares outstanding used in the calculation of net loss per
share do not include Common Stock equivalents because they have the effect of
reducing net loss per share. Fully diluted earnings per share were not
materially different from primary earnings per share.
4. Licensing Agreements
The Company's existing license agreements require future payments of up
to $43,250,000 contingent upon the achievement of certain development
milestones. Additionally, the Company will pay royalties based on a
percentage of net sales of each licensed product incorporating these drug
candidates. Most of the Company's license agreements require minimum royalty
payments after regulatory approval. Depending on the Company's success and
timing in obtaining regulatory approval, aggregate annual minimum royalties
could range from $2,000,000 (if only a single drug candidate is approved for
one indication) to $49,500,000 (if all drug candidates are approved for all
indications) under the Company's existing license agreements. In addition,
beginning in 1998 the Company is required to make an annual payment ranging
from $500,000 to $1,000,000 to maintain the exclusivity of it's license for
one of it's drug candidates beginning in 1998.
8
<PAGE>
TRIANGLE PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
5. Avid Acquisition
On August 28, 1997 ("the Closing Date"), the Company acquired Avid
Corporation ("Avid"), a private, antiviral pharmaceutical company. Pursuant
to the merger agreement, Triangle issued 400,000 shares of common stock for
all outstanding shares of Avid and agreed to issue up to 2,100,000 additional
shares of common stock contingent upon the attainment of certain development
milestones of Avid's compounds. The 400,000 shares issued had an aggregate
fair market value of approximately $8,117,500 and direct transaction costs
were approximately $1,100,000. The total purchase price of $9,217,500 has
been allocated to the assets purchased and liabilities assumed based on their
respective values. In connection with the acquisition, the Company incurred a
non-recurring charge of $11,261,150 for acquired in-process research and
development as it assumed operating and other liabilities of Avid totaling
$1,250,000 and certain development liabilities totaling approximately
$1,000,000. Each option under Avid's stock option plans and each warrant to
purchase Avid stock outstanding at the closing was converted into the right
upon exercise to receive that portion of the merger consideration that would
have been received had such option or warrant been exercised immediately
prior to the merger. The merger is being accounted for as a purchase and the
operating results of Avid have been included from the date of acquisition.
The issuance of any of the 2,100,000 contingent shares of the Company's
common stock will be recorded as additional purchase price and will be
allocated upon resolution of the underlying contingency. The amount recorded
will be the fair market value of the common stock issued at the time the
contingency is resolved.
Avid's principal assets consist of worldwide license rights to a protease
inhibitor (DMP-450) for the treatment of human immunodeficiency virus
infection, early preclinical stage compounds for the treatment of Hepatitis B
virus infection, proprietary assays to screen drug candidates for the
treatment of HBV and assay technology for the potential use in screening drug
candidates for the treatment of Hepatitis C virus infection.
The following unaudited pro forma consolidated results of operations have
been prepared as if the acquisition of Avid had occurred at the beginning of
1996 and 1997:
NINE MONTHS ENDED SEPTEMBER 30,
---------------------------------
1996 1997
--------------- ---------------
Revenues $ -- $ --
--------------- ---------------
--------------- ---------------
Net (loss) $ (21,066,205) $ (30,527,921)
--------------- ---------------
--------------- ---------------
Net (loss) per common share $ (1.48) $ (1.62)
--------------- ---------------
--------------- ---------------
The pro forma net loss and net loss per share amounts for each period
above include the acquired in-process research and development charge. The
pro forma consolidated results do not purport to be indicative of results
that would have occurred had the acquisition been in effect for the periods
presented, nor do they purport to be indicative of the results that will be
obtained in the future.
9
<PAGE>
TRIANGLE PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
6. Accounting Pronouncements
In February 1997, the Financial Accounting Standards Board issued
Statement of Financial Accounting Standards ("SFAS 128"), "Earnings per
Share." SFAS 128 changes the computation of net income per share from the
method currently prescribed by Accounting Principles Board Opinion No. 15.
The Company intends to adopt SFAS 128 for periods ending after December 15,
1997 and to restate previously reported historical information at that time.
Adoption of SFAS 128 is not expected to materially affect the Company's
financial statements.
Statement of Financial Accounting Standards No. 130, "Reporting
Comprehensive Income" ("SFAS 130"), was issued in June 1997. SFAS 130
establishes standards for reporting and display of comprehensive income and
its components in a full set of general-purpose financial statements. SFAS
130 is effective for financial statements for fiscal years beginning after
December 31, 1997. The Company believes that the adoption of SFAS 130 will
not have a material impact on the Company's financial position or results of
operations.
10
<PAGE>
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
This Quarterly Report on Form 10-Q may contain certain projections,
estimates and other forward-looking statements that involve a number of risks
and uncertainties, including those discussed below at "-Risks and
Uncertainties." While this outlook represents management's current judgment
on the future direction of the business, such risks and uncertainties could
cause actual results to differ materially from any future performance
suggested below. The Company undertakes no obligation to release publicly
the results of any revisions to the statements contained in this report to
reflect events or circumstances arising after the date hereof. Unless the
context otherwise requires, references in this Quarterly Report on Form 10-Q
to "Triangle" and the "Company" are to Triangle Pharmaceuticals, Inc. and its
wholly-owned subsidiary, Avid Corporation.
The following should be read in conjunction with the Company's condensed
consolidated financial statements.
OVERVIEW
Triangle is a pharmaceutical company engaged in the development of new
drug candidates primarily in the antiviral area. Since its inception on July
12, 1995, the Company's operating activities have related primarily to
recruiting personnel, negotiating license and option arrangements for its
drug candidates, raising capital and developing the Company's drug
candidates. The Company has not received any revenues from the sale of
products, and does not expect any of its drug candidates to be commercially
available for at least the next several years. As of September 30, 1997, the
Company's consolidated accumulated deficit was approximately $39.3 million.
The Company's drug development programs will require substantial capital
expenditures, including expenditures for preclinical testing, chemical
synthetic scale-up, clinical trials of drug candidates and payments to the
Company's licensors. The Company has been unprofitable since its inception
and expects to incur substantial and increasing losses for at least the next
several years, due primarily to the expansion of its drug development
programs. The Company expects that losses will fluctuate from period to
period and that such fluctuations may be substantial. See "--Risks and
Uncertainties--History of Operating Losses; Accumulated Deficit; Uncertainty
of Future Profitability."
The Company has only a limited operating history upon which an evaluation
of the Company and its prospects can be based. The risks, expenses and
difficulties encountered by companies at an early stage of development must
be considered when evaluating the Company's prospects. To address these
risks, the Company must, among other things, successfully develop and
commercialize its drug candidates, secure all necessary proprietary rights,
respond to competitive developments and continue to attract, retain and
motivate qualified persons. There can be no assurance that the Company will
be successful in addressing these risks. See "--Risks and
Uncertainties--Development Stage Company; Uncertainty of Product Development."
The operating expenses of the Company will depend on several factors,
including the level of development expenses. Development expenses will depend
on the progress and results of the Company's drug development efforts, which
the Company cannot predict. Management may in some cases be able to control
the timing of development expenses in part by accelerating or decelerating
preclinical testing and clinical trial activities. As a result of these
factors, the Company believes that period to period comparisons in the future
are not necessarily meaningful and should not be relied upon as an indication
of future performance. Due to all of the foregoing factors, it is possible
that the Company's operating results will be below the expectations of market
analysts and investors. In such event, the prevailing market price of the
Common Stock would likely be materially adversely affected. See "--Risks and
Uncertainties--Volatility of Stock Price."
11
<PAGE>
RESULTS OF OPERATIONS
AVID ACQUISITION
On August 28, 1997 ("the Closing Date"), the Company acquired Avid
Corporation ("Avid"), a private, antiviral pharmaceutical company. Pursuant
to the merger agreement, Triangle issued 400,000 shares of the Company's
common stock for all outstanding shares of Avid and agreed to issue up to
2,100,000 additional shares of common stock contingent upon the attainment of
certain development milestones of Avid's compounds. The 400,000 shares
issued had an aggregate fair market value of approximately $8,117,500 and
direct transaction costs were approximately $1,100,000. The total purchase
price of $9,217,500 has been allocated to the assets purchased and
liabilities assumed based on their respective values. In connection with the
acquisition, the Company incurred a non-recurring charge of $11,261,150 for
acquired in-process research and development as it assumed operating and
other liabilities of Avid totaling $1,250,000 and certain development
liabilities totaling approximately $1,000,000. Each option under Avid's
stock option plans and each warrant to purchase Avid stock outstanding at the
closing was converted into the right upon exercise to receive that portion of
the merger consideration that would have been received had such option or
warrant been exercised immediately prior to the merger. The merger is being
accounted for as a purchase and the operating results of Avid have been
included from the date of acquisition.
The issuance of any of the 2,100,000 contingent shares of the Company's
common stock will be recorded as additional purchase price and will be
allocated upon resolution of the underlying contingency. The amount recorded
will be the fair market value of the common stock issued at the time the
contingency is resolved.
Avid's principal assets consist of worldwide license rights to a protease
inhibitor (DMP-450) for the treatment of human immunodeficiency virus ("HIV")
infection, early preclinical stage compounds for the treatment of Hepatitis B
virus ("HBV") infection, proprietary assays to screen drug candidates for the
treatment of HBV and assay technology for the potential use in screening drug
candidates for the treatment of Hepatitis C virus infection.
THREE MONTHS ENDED SEPTEMBER 30, 1997 AND 1996
The Company had total interest income of $1,086,993 for the three months
ended September 30, 1997, compared to $224,797 for the same period in 1996.
The increase in interest income is due primarily to an increase in
investments associated with financing activities. See "--Liquidity and
Capital Resources."
There were no license fees for the three months ended September 30,
1997, compared to $494,397 for the same period in 1996. The decrease is due
to the absence of any new license agreements executed by the Company during
the three month period ended September 30, 1997. The amount in the prior
year relates to one of the Company's license agreements.
Purchased research and development totaled $11,261,150 for the three
months ended September 30, 1997 which relates to the Company's acquisition of
Avid on August 28, 1997. The amount represents a non-recurring charge for
in-process research and development technology.
Development expenses totaled $6,568,629 for the three months ended
September 30, 1997, compared to $1,270,731 for the same period in 1996. The
increase is due to the expansion of the Company's drug development
activities. Development expenses for the three month period ended September
30, 1997 consisted primarily of expenses for development work relating to
drug synthesis, clinical trials, compensation expenses, toxicology studies,
and preclinical testing of the Company's drug candidates. During the same
period the Company also recognized non-cash charges of $11,234 relating to
the amortization of deferred consulting expenses. Development expenses were
reduced by approximately $202,000 relating to the reimbursable development
expenses by the licensor under the agreement for one of the Company's drug
candidates. Development expenses for the three months ended September 30,
1996 consisted primarily of expenses related to the preclinical testing of
certain of the Company's drug candidates. During the
12
<PAGE>
same period the Company also recognized non-cash charges of $18,808 relating
to the amortization of deferred consulting expenses. The Company expects its
development expenses to continue to increase substantially in the future as
the Company continues to expand its drug development activities, including
preclinical testing and clinical trials. In addition, the Company's
acquisition of rights to additional drug candidates, like DMP-450, will
increase significantly the Company's development expenses.
General and administrative expenses totaled $1,471,220 for the three
months ended September 30, 1997, compared to $998,528 for the same period in
1996. General and administrative expenses for the three months ended
September 30, 1997, consisted primarily of compensation expenses, rent
expense and amounts paid for outside professional services and included
non-cash charges of $25,544 related to the amortization of deferred
compensation expenses. The increase in general and administrative expenses
compared to the three months ended September 30, 1996, is comprised primarily
of increases in compensation expense, rent expenses associated with office
and laboratory facilities due to the hiring of additional employees and
increases in professional fees due to the growth of the Company's operations.
The Company expects that its general and administrative expenses will
increase in future periods.
NINE MONTHS ENDED SEPTEMBER 30, 1997 AND 1996
The Company had total interest income of $2,584,183 in the nine months
ended September 30, 1997 compared to $309,955 for the same period in 1996.
The increase in interest income is due primarily to an increase in
investments associated with financing activities. See "-Liquidity and
Capital Resources."
License fees totaled $500,000 for the nine months ended September 30,
1997 and related to the execution of the license agreement with Mitsubishi
for the anti-HIV drug candidate, MKC-442. License fees totaled $3,246,226
during the same period in 1996. The decrease is due primarily to a decrease
in the number of license agreements executed during the nine month period
ended September 30, 1997 as compared to the same period in 1996. Future
license fees may also consist of milestone payments under licensing
arrangements, the amount of which could be substantial and the timing of
which will depend on a number of factors that the Company cannot predict.
These factors include, among others, the success of the Company's drug
development programs and the extent to which the Company acquires rights to
additional drug candidates.
Purchased research and development totaled $11,261,150 for the nine
months ended September 30, 1997, and relates to the Company's acquisition of
Avid on August 28, 1997. The amount represents a non-recurring charge for
in-process research and development.
Development expenses totaled $13,262,108 for the nine months ended
September 30, 1997, compared to $2,613,322 for the same period in 1996.
Development expenses consisted primarily of expenses for development work
relating to drug synthesis, clinical trials, toxicology studies and
compensation expenses. The Company also recognized non-cash charges of
$33,647 related to the amortization of deferred consulting expenses. The
increase in development expenses relates to the expansion of drug development
activities. Development expenses were reduced by approximately $1,168,000
relating to the reimbursable development expenses by the licensor under the
agreement for one of the Company's drug candidates. The Company expects its
development expenses to continue to increase substantially in the future as
the Company continues to expand its drug development activities, including
preclinical testing and clinical trials. In addition, the Company's
acquisition of rights to additional drug candidates, like DMP-450, will
increase significantly the Company's development expenses.
General and administrative expenses totaled $4,935,830 for the nine
months ended September 30, 1997 compared to $2,488,684 for the same period
in 1996. General and administrative expenses for the nine months ended
September 30, 1997 consisted primarily of compensation expenses, rent expense
and amounts paid for outside professional services and included non-cash
charges of $91,818 related to the amortization of deferred compensation
expenses. The increase in general and administrative expenses compared to
the nine months ended September 30, 1996, is comprised primarily of increases
in compensation expense, rent expenses associated with office and laboratory
facilities, the hiring of additional employees and increases in professional
fees. The increase is due primarily to the growth of
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the Company's operations. The Company expects that its general and
administrative expenses will increase in future periods.
LIQUIDITY AND CAPITAL RESOURCES
The Company has financed its operations since inception (July 12, 1995)
through September 30, 1997 primarily with the net proceeds received from
private placements of equity securities, which provided aggregate net
proceeds of approximately $51,700,000, and the Company's initial public
offering, which provided aggregate net proceeds to the Company totaling
$42,153,664 before deducting expenses of the offering of approximately
$1,100,000.
Through September 30, 1997, the Company received approximately
$2,000,000 as reimbursement of certain development expenses under an
agreement for one of its drug candidates.
As a result of the acquisition of Avid on August 28, 1997, the Company
assumed operating and other liabilities of Avid totaling approximately
$1,250,000 and certain development expenses totaling approximately
$1,000,000, previously incurred by Avid. The Company also expects
development expenses to increase as a result of its acquisition of the Avid
compounds.
At September 30, 1997, the Company's principal source of liquidity was
$45,288,572 in cash and cash equivalents and $21,047,462 in short term
investments which are "available for sale." At September 30, 1997, the
Company had utilized $529,679 of a secured equipment lease-line facility
for which the ability to borrow additional funds expired on August 9, 1997.
The Company expects that its capital requirements will increase
substantially in future periods as the Company's drug development programs
expand. The Company's future capital requirements will depend on many
factors, including the progress of the Company's drug development programs,
the magnitude of these programs, the scope and results of preclinical testing
and clinical trials, the cost, timing and outcome of regulatory reviews, the
costs under the license and/or option agreements relating to the Company's
drug candidates, administrative and legal expenses, the establishment of
capacity for sales and marketing functions, the establishment of
relationships with third parties for manufacturing and sales and marketing
functions, and other factors. Amounts payable by the Company in the future
under its existing license agreements are uncertain due to a number of
factors, including the progress of the Company's drug development programs,
the Company's ability to obtain approval to commercialize any drug candidate
and the commercial success of any approved drug. The Company's existing
license agreements require future payments of up to $43,250,000 contingent
upon the achievement of certain development milestones. Additionally, the
Company will pay royalties based on a percentage of net sales of each
licensed product incorporating these drug candidates. Most of the Company's
license agreements require minimum royalty payments after regulatory
approval. Depending on the Company's success and timing in obtaining
regulatory approval, aggregate annual minimum royalties could range from
$2,000,000 (if only a single drug candidate is approved for one indication)
to $49,500,000 (if all drug candidates are approved for all indications)
under the Company's existing license agreements. In addition, beginning in
1998 the Company is required to make an annual payment ranging from $500,000
to $1,000,000 to maintain the exclusivity of its license to one of it's drug
candidates.
The Company believes that its existing cash and investments will be
adequate to satisfy its anticipated capital requirements through June 1998.
The Company expects that it will be required to raise substantial additional
funds through equity or debt financings, collaborative arrangements with
corporate partners or from other sources. There can be no assurance that
additional funding will be available on favorable terms from any of these
sources or at all. See "--Risks and Uncertainties--Future Capital Needs;
Uncertainty of Additional Funding."
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RISKS AND UNCERTAINTIES
DEVELOPMENT STAGE COMPANY; UNCERTAINTY OF PRODUCT DEVELOPMENT
Triangle was incorporated in July 1995 and accordingly has only a limited
operating history upon which an evaluation of the Company's business and
prospects can be based. In addition, the Company's drug candidates are all
in the early developmental stage and require significant, time consuming and
costly development, testing and regulatory clearances. The Company does not
expect any of its drug candidates to be commercially available for at least
the next several years. The successful development of any new drug,
including any of the Company's drug candidates, is highly uncertain and is
subject to a number of significant risks. These risks include, among others,
the possibility that any or all of the Company's drug candidates will be
found to be ineffective, toxic or otherwise fail to receive necessary
regulatory clearances; that the drug candidates will be uneconomical to
manufacture, market or will not achieve broad market acceptance; that third
parties will hold proprietary rights that will preclude the Company from
marketing the drug candidates; or that third parties will market equivalent
or superior products. The failure of the Company's drug development programs
to result in commercially viable products would have a material adverse
effect on the Company.
HISTORY OF OPERATING LOSSES; ACCUMULATED DEFICIT; UNCERTAINTY OF FUTURE
PROFITABILITY
The Company has incurred losses since its inception. As of September 30,
1997, the Company's consolidated accumulated deficit was approximately $39.3
million. Losses have resulted principally from costs incurred in the
acquisition and development of the Company's drug candidates and general and
administrative costs. These costs have exceeded the Company's revenues,
which to date have been generated primarily from interest income. The Company
has not generated any revenue to date from the sale of drugs and does not
expect to do so for at least the next several years. The Company expects to
incur significant additional operating losses over the next several years and
expects losses to increase as the Company's drug development efforts expand.
The Company's ability to achieve profitability will depend upon its ability
to develop and obtain regulatory approval for its drug candidates and to
develop the capacity (or establish relationships with third parties) to
manufacture, market and sell any drug candidates it successfully develops.
There can be no assurance that the Company will ever generate significant
revenues or achieve profitable operations.
FUTURE CAPITAL NEEDS; UNCERTAINTY OF ADDITIONAL FUNDING
The Company's drug development programs currently require and will in the
future require substantial capital expenditures, including expenditures for
preclinical testing, chemical synthetic scale up, clinical trials of drug
candidates and payments to the Company's licensors. The Company's future
capital requirements will depend on many factors, including the progress of
the Company's drug development programs, the magnitude of these programs, the
scope and results of preclinical testing and clinical trials, the cost,
timing and outcome of regulatory reviews, the costs under the license and/or
option agreements relating to the Company's drug candidates, the costs of
seeking and maintaining patent protection for the Company's drug candidates,
administrative and legal expenses, the establishment of capacity for sales
and marketing functions, the establishment of relationships with third
parties for manufacturing and sales and marketing functions, and other
factors. The Company expects that its capital requirements will increase
significantly in the future.
The Company has incurred negative cash flow from operations since
inception and does not expect to generate positive cash flow to fund its
operations for at least the next several years. As a result, the Company
believes that substantial additional equity or debt financings will be
required to fund its operations. There can be no assurance that the Company
will be able to consummate any such financings at all or on favorable terms,
or that such financings will be adequate to meet the Company's capital
requirements. Any additional equity or convertible debt financings could
result in substantial dilution to the Company's stockholders. If adequate
funds are not available, the Company may be required to delay, reduce the
scope of or eliminate one or more of its drug development programs or attempt
to continue development by entering into arrangements with collaborative
partners or others that may require the Company to relinquish some or all of
its rights to certain technologies or
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drug candidates that the Company would not otherwise desire to relinquish. In
addition, from time to time, the Company considers the acquisition of
technologies and drug candidates that, if completed, could increase the
Company's capital requirements. The Company's inability to fund its capital
requirements would have a material adverse effect on the Company.
UNCERTAINTIES RELATED TO CLINICAL TRIALS
Before obtaining required regulatory approvals for the commercial sale of
any of its drug candidates under development, the Company must demonstrate
through preclinical testing and clinical trials that each product is safe and
effective for use in each target indication. The results from preclinical
testing and early clinical trials may not be predictive of results that will
be obtained in pivotal clinical trials, and there can be no assurance that
the Company's clinical trials will demonstrate sufficient safety and
effectiveness to obtain required regulatory approvals or will result in
marketable products. A number of companies in the pharmaceutical industry
have suffered significant setbacks in advanced clinical trials, even after
promising results in earlier trials. The administration of any drug candidate
developed by the Company may produce undesirable side effects in humans. The
occurrence of side effects could interrupt, delay or halt clinical trials of
such drug candidate and could ultimately prevent its approval by the United
States Food and Drug Administration ("FDA") or foreign regulatory authorities
for any and all targeted indications. The Company or the FDA may suspend or
terminate clinical trials at any time if it is believed that the trial
participants are being exposed to unacceptable health risks. There can be no
assurance that clinical trials will demonstrate that any drug candidate under
development by the Company is safe or effective.
The rate of completion of the Company's clinical trials will depend upon,
among other factors, obtaining adequate clinical supplies and the rate of
patient enrollment. Patient enrollment is a function of many factors,
including the size of the patient population, the nature of the protocol, the
proximity of patients to clinical sites and the eligibility criteria for the
study. Delays in planned patient enrollment can result in increased costs or
delays or both, which could have a material adverse effect on the Company.
There can be no assurance that if clinical trials are successfully completed,
the Company will be able to submit a New Drug Application ("NDA") in a timely
manner or that any such application will be approved by the FDA. Any failure
of the Company to complete successfully its clinical trials and obtain
approvals of corresponding NDAs would have a material adverse effect on the
Company.
UNCERTAINTY OF PATENTS; DEPENDENCE ON PATENTS, LICENSES AND PROPRIETARY
RIGHTS
The Company's success will depend in large part on the ability of the
Company and its licensors to obtain patent protection with respect to its
drug candidates, defend patents once obtained, maintain trade secrets and
operate without infringing upon the patents and proprietary rights of others
and to obtain appropriate licenses to patents or proprietary rights held by
third parties, both in the United States and in foreign countries. The
Company has no patents in its own name and has only one patent application of
its own pending, but has obtained licenses to patents, patent applications
and other proprietary rights from third parties with respect to each of the
Company's eight drug candidates.
The patent positions of pharmaceutical companies, including those of the
Company, are uncertain and involve complex legal and factual questions for
which important legal principles are unresolved. There can be no assurance
that the Company or its licensors have or will develop or obtain the rights
to products or processes that are patentable, that patents will issue from
any of the pending applications or that claims allowed will be sufficient to
protect the technology licensed to the Company. In addition, no assurance can
be given that any patents issued to or licensed by the Company will not be
challenged, invalidated, infringed or circumvented, or that the rights
granted thereunder will provide competitive advantages to the Company. The
Company's success will also depend in large part on the Company not breaching
the licenses pursuant to which the Company obtained its technology and drug
candidates.
A number of pharmaceutical companies, biotechnology companies,
universities and research institutions have filed patent applications or
received patents to technologies that cover or are similar to the technologies
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licensed by the Company. The Company is aware of certain patent applications
previously filed by and patents already issued to others that conflict with
patents or patent applications licensed to the Company either by claiming the
same methods or compounds or by claiming methods or compounds that could
dominate those licensed to the Company. In addition, there can be no
assurance that the Company is aware of all patents or patent applications
that may materially affect the Company's ability to make, use or sell any
drug candidates that are successfully developed. United States patent
applications are confidential while pending in the United States Patent and
Trademark Office ("PTO"), and patent applications filed in foreign countries
are often first published six months or more after filing. Any conflicts
resulting from third party patent applications and patents could
significantly reduce the coverage of the patents licensed to the Company and
limit the ability of the Company or its licensors to obtain meaningful patent
protection. If patents are issued to other companies that contain competitive
or conflicting claims, the Company may be required to obtain licenses to
these patents or to develop or obtain alternative technology. There can be no
assurance that the Company will be able to obtain any such license on
acceptable terms or at all. If such licenses are not obtained, the Company
could be delayed in or prevented from pursuing the development or
commercialization of its drug candidates, which would have a material adverse
effect on the Company.
The Company is aware of significant risks regarding the patent rights
licensed by the Company relating to three of the eight compounds comprising
the Company's existing drug candidate portfolio. The Company may not be able
to commercialize FTC, DAPD or CS-92 for HIV and/or HBV due to patent rights
held by third parties other than the Company's licensors. The Company is
aware of numerous patent applications and issued patents in the United States
and numerous foreign countries held by third parties other than the Company's
licensors that relate to these compounds and their use alone or with other
compounds to treat HIV and HBV. As a result, the positions of the Company and
its licensors with respect to the use of FTC, DAPD and CS-92 to treat HIV
and/or HBV are highly uncertain and involve numerous complex legal and
factual questions that are unknown or unresolved. If any of these questions
is resolved in a manner that is not favorable to the Company's licensors or
the Company, the Company would not have the right to commercialize FTC, DAPD
and/or CS-92 in the absence of a license from one or more third parties,
which may not be available on acceptable terms or at all. In addition, even
in the absence of an unfavorable resolution of any of these questions, the
Company may attempt to obtain licenses from one or more third parties in
order to reduce or eliminate the risks relating to some or all of these
matters. There can be no assurance that the Company will elect to obtain any
such licenses or that such licenses will be available on acceptable terms or
at all. The Company's inability to commercialize any of these compounds would
have a material adverse effect on the Company.
FTC
FTC belongs to the same general class of nucleosides as 3TC, which has
been approved in the United States by the FDA for use in combination with AZT
for the treatment of HIV and by similar regulatory agencies in Europe for use
in combination with other nucleoside analogues for the treatment of HIV. 3TC
is currently being sold by Glaxo Wellcome plc ("Glaxo") for the treatment of
HIV under a license agreement with BioChem Pharma Inc. ("BioChem Pharma").
The Company obtained its rights to purified forms of FTC under a license from
Emory University ("Emory"). In 1990 and 1991, Emory filed in the United
States and thereafter in numerous foreign countries patent applications with
claims to composition of matter and methods to treat HIV and HBV with FTC.
Yale University ("Yale") filed patent applications on FTC and its use to
treat HBV in 1991 in the United States, and subsequently licensed its rights
under those patent applications to Emory. The Company's license arrangement
with Emory includes all rights under the Yale patent applications.
HIV. Emory received a United States patent in 1993 covering a method to
treat HIV infection with FTC. BioChem Pharma filed a patent application in
the United States in 1989 and was issued a patent in 1991 covering a group of
nucleosides in the same general class as FTC, but which did not include FTC.
BioChem Pharma filed foreign patent applications in 1990 based upon its 1989
United States patent application, and in those foreign applications included
FTC among a large class of nucleosides. The foreign patent applications are
pending in a large number of countries, and have issued in a number of
countries with claims directed to FTC and its use to treat HIV. In addition,
BioChem Pharma filed a United States patent application in 1991 specifically
directed to a purified form of FTC that exhibits advantageous properties for
the treatment of HIV on which two patents have
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issued, one directed to the purified form of FTC and another directed to a
method for treating antiviral diseases with the purified form of FTC. The
PTO has recently declared an interference between the latter BioChem Pharma
patent and a patent application filed by Emory. There can be no assurance,
however, that Emory will prevail in the interference proceeding, or that the
interference proceeding will not delay the decision of the PTO regarding
Emory's patent application. BioChem Pharma has also filed patent
applications in a large number of foreign countries based upon its 1991
United States patent application, and patents have issued in certain
countries. BioChem Pharma may have additional patent applications pending in
the United States.
In the United States, the first to invent a subject matter is entitled to
patent protection on that invention. With respect to patent applications
filed prior to January 1, 1996, United States patent law provides that if a
party invented a technology outside the United States, then for purposes of
determining the first to invent the technology, that party is deemed to have
invented the technology on the earlier of the date it introduced the
invention in the United States or the date it filed its patent application.
In a registration statement filed with the United States Securities and
Exchange Commission, BioChem Pharma stated that since it conducts
substantially all of its research activities outside the United States, it is
at a disadvantage as to inventions made prior to January 1, 1996 with respect
to obtaining United States patents as compared to companies that maintain
research facilities in the United States. The Company does not know whether
Emory or BioChem Pharma was the first to invent the subject matter claimed in
their respective United States patent applications or patents, or whether
BioChem Pharma invented the technology disclosed in its patent applications
in the United States or introduced that technology in the United States
before the date of its patent applications. In foreign countries, the first
party to file a patent application on an invention, not the first to invent
the subject matter, is entitled to patent protection on that invention. While
the Company believes that Emory's patent applications that disclosed FTC as a
useful anti-HIV agent were filed in foreign countries before BioChem Pharma
filed its foreign patent applications on that subject matter, BioChem Pharma
has been issued patents in several foreign countries. Further, BioChem
Pharma has filed for patent protection on FTC and its uses in certain
countries in which Emory did not file for patent protection. There can be no
assurance that Emory will initiate or be successful in any foreign proceeding
attempting to revoke patents issued to BioChem Pharma or addressing the
relative rights of BioChem Pharma and Emory. BioChem Pharma has opposed
patent claims on FTC granted to Emory in Japan and Australia. Emory has
opposed patent claims on FTC granted to BioChem Pharma in Norway. There can
be no assurance that BioChem Pharma will not make additional challenges to
any Emory patents or patent applications, or that Emory will succeed in
defending any such challenges. There can be no assurance that the sale of FTC
by the Company for the treatment of HIV would not be held to infringe United
States and foreign patent rights of BioChem Pharma. Under the patent laws of
most countries, a product can be found to infringe a third party patent
either if the third party patent expressly covers the product or method of
treatment using the product, or in certain circumstances, if the third party
patent, while not expressly covering the product or method, covers subject
matter that is substantially equivalent in nature to the product or method.
If it is determined that the sale of FTC for the treatment of HIV infringes a
BioChem Pharma patent, the Company would not have the right to make, use or
sell FTC for the treatment of HIV in one or more countries in the absence of
a license from BioChem Pharma. There can be no assurance that the Company
could obtain a license from BioChem Pharma on acceptable terms or at all.
HBV. Burroughs Wellcome Co. ("Burroughs Wellcome") filed patent
applications in March and May 1991 in Great Britain on a method to treat HBV
with FTC. Burroughs Wellcome filed similar patent applications in other
countries, which the Company believes includes the United States. Glaxo
subsequently acquired Burroughs Wellcome's rights under those patent
applications. Those applications were filed in foreign countries prior to the
date Emory filed its patent application on the use of FTC to treat HBV, and
therefore, the foreign patent applications filed by Burroughs Wellcome have
priority over those filed by Emory. In July 1996, Emory instituted litigation
against Glaxo in the United States District Court to obtain ownership of the
patent applications filed by Burroughs Wellcome, alleging that Burroughs
Wellcome converted and misappropriated Emory's invention and property, and
that an Emory employee is the inventor or a co-inventor of the subject matter
covered by the Burroughs Wellcome patent applications. There can be no
assurance that Emory will succeed in its efforts to establish ownership
rights. If Emory fails to establish ownership rights, the Company could not
make, use or sell FTC for the treatment of HBV in countries in which patents
are issued to Glaxo without a license from Glaxo. If Emory establishes only
co-ownership rights (and not sole ownership) to these patents and patent
applications, laws in Europe, Korea and perhaps other countries could
prohibit Emory from licensing any co-owned patent rights
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without Glaxo's consent. If the Company is required to obtain a license from
Glaxo to sell FTC for the treatment of HBV, there can be no assurance that
the Company would be able to obtain such a license on acceptable terms or at
all.
BioChem Pharma filed a patent application in May 1991 in Great Britain
also directed to a method to treat HBV with FTC. BioChem Pharma filed similar
patent applications in other countries, and in January 1996 was issued a
patent in the United States. The PTO has recently declared an interference
between the BioChem Pharma patent and a patent application filed by Yale.
There can be no assurance, however, that Yale will prevail in the
interference proceeding, or that the interference proceeding will not delay
the decision of the PTO regarding Yale's patent application. In addition,
Emory has informed the Company that Emory intends to challenge BioChem
Pharma's issued United States patent. There can be no assurance that Emory
will pursue or succeed in any such proceeding. The Company cannot sell FTC
for the treatment of HBV in the United States unless the BioChem Pharma
patent is held invalid by a United States court or administrative body or
unless the Company obtains a license from Biochem Pharma. There can be no
assurance that the Company would be able to obtain such a license on
acceptable terms or at all. In July 1991, BioChem Pharma was issued a United
States patent on the use of 3TC to treat HBV and has corresponding
applications pending or issued in foreign countries. If it is determined that
the use of FTC to treat HBV is not substantially different from the use of
3TC to treat HBV, a court could hold that the use of FTC to treat HBV
infringes these BioChem Pharma 3TC patents.
In addition, BioChem Pharma has filed in the United States and foreign
countries several patent applications on manufacturing methods relating to a
class of nucleosides that includes FTC. If the Company uses a manufacturing
method that is covered by patents issuing on any of these applications, the
Company would not be able to manufacture FTC without a license from BioChem
Pharma. There can be no assurance that the Company would be able to obtain
such a license on acceptable terms or at all.
DAPD
The Company obtained its rights to DAPD under a license from Emory and
University of Georgia Research Foundation, Inc. ("UGARF"). The DAPD
portfolio licensed to the Company consists of two issued United States
patents and several United States and foreign patent applications that cover
a method for the synthesis of DAPD and its use to treat HIV and HBV. Emory
and UGARF filed patent applications claiming these inventions in the United
States in 1990, 1992 and 1993, respectively. BioChem Pharma filed a patent
application in the United States in 1988 on a group of nucleosides in the
same general class as DAPD and their use to treat HIV, and has filed
corresponding patent applications in foreign countries. The PTO issued a
patent to BioChem Pharma in 1993 covering a class of nucleosides that
includes DAPD and its use to treat HIV. Corresponding patents have been
issued to BioChem Pharma in many foreign countries. Emory has filed an
opposition to BioChem Pharma's granted patent application in the European
Patent Office based, in part, upon Emory's assertion that BioChem Pharma's
patent does not disclose how to make DAPD, and Emory has informed the Company
that Emory intends to challenge BioChem Pharma's patents and patent
applications in other countries. Patent claims granted to Emory on a portion
of the DAPD technology by the Australian Patent Office have been opposed by
BioChem Pharma. There can be no assurance that a court or administrative body
would invalidate BioChem Pharma's patent claims or that a sale of DAPD by the
Company would not infringe BioChem Pharma's patents. If Emory, UGARF and the
Company do not challenge, or are not successful in any challenge to, BioChem
Pharma's issued patents or pending patent applications (or patents that may
issue as a result of such applications), the Company will not be able to
manufacture, use or sell DAPD in the United States and any foreign countries
in which BioChem Pharma receives a patent without a license from BioChem
Pharma. There can be no assurance that the Company would be able to obtain a
license from BioChem Pharma on acceptable terms or at all.
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CS-92
The Company obtained its rights to CS-92 under a license from Emory and
UGARF. Emory and UGARF have obtained two United States patents that cover
CS-92 and its use to treat HIV, and have filed a European patent application
and a Japanese patent application with claims limited to the use of CS-92 as
a method for administering AZT, which includes the administration of CS-92 as
a precursor form of AZT, to treat HIV infection. Burroughs Wellcome filed an
application with the European Patent Office in September 1986 directed to a
broad group of nucleosides that includes CS-92, and their use to treat HIV
infection. Burroughs Wellcome subsequently filed similar applications in
other countries, and the Company believes Burroughs Wellcome filed a similar
patent application in the United States. Patents have been issued to
Burroughs Wellcome in certain countries based upon these patent applications.
Glaxo now has the rights to these patents and patent applications. There can
be no assurance that, if challenged, a court would uphold the Emory/UGARF
patents in light of the disclosures contained in the earlier filed Burroughs
Wellcome patent applications. In addition, CS-92 is metabolized to AZT in
cell lines IN VITRO, and based on that, the Company believes that it may
likewise be converted to AZT IN VIVO. A court could hold that United States
and foreign patents owned by Glaxo covering the use of AZT to treat HIV
infection would be infringed by the sale of CS-92 to treat HIV infection. If
the use of CS-92 is found to infringe the patents owned by Glaxo, then the
Company would not have the right to sell CS-92 in one or more countries
without a license from Glaxo. There can be no assurance that the Company
would be able to obtain a license from Glaxo on acceptable terms or at all.
Litigation, which could result in substantial cost to the Company, may
also be necessary to enforce any patents to which the Company has rights or
to determine the scope, validity and enforceability of other parties'
proprietary rights, which may affect the Company's drug candidates and
technology. United States patents carry a presumption of validity and
generally can be invalidated only through clear and convincing evidence. The
Company's licensors may also have to participate in interference proceedings
declared by the PTO to determine the priority of an invention, which could
result in substantial cost and/or delays to the Company. As indicated above,
one interference has already been declared by the PTO in connection with the
FTC technology. There can be no assurance that the Company's licensed
patents would be held valid by a court or administrative body or that an
alleged infringer would be found to be infringing. Further, with respect to
the drug candidates licensed or optioned by the Company from Emory, UGARF and
the Regents of the University of California ("Regents"), and The Dupont Merck
Pharmaceutical Company ("Dupont Merck"), Emory, UGARF, the Regents and Dupont
Merck are primarily responsible for any litigation, interference, opposition
or other action pertaining to patents or patent applications related to the
licensed technology and the Company is required to reimburse them for the
costs they incur in performing these activities. As a result, the Company
generally does not have the ability to institute or determine the conduct of
any such patent proceedings unless Emory, UGARF and/or the Regents and/or
Dupont Merck do not elect to institute or elect to abandon such proceedings.
In cases where Emory, UGARF and/or the Regents and/or Dupont Merck elect to
institute and prosecute patent proceedings, the Company's rights will be
dependent in part upon the manner in which Emory, UGARF and/or the Regents
and/or Dupont Merck conduct the proceedings. Emory, UGARF and/or the Regents
and/or Dupont Merck could, in any of these proceedings they elect to initiate
and maintain, elect not to vigorously pursue or defend or to settle such
proceedings on terms that are not favorable to the Company. An adverse
outcome in any patent litigation or interference proceeding could subject the
Company to significant liabilities to third parties, require disputed rights
to be licensed from third parties or require the Company to cease using such
technology, any of which could have a material adverse effect on the Company.
Moreover, the mere uncertainty resulting from the initiation and continuation
of any technology related litigation or interference proceeding could have a
material adverse effect on the Company pending resolution of the disputed
matters.
The Company also relies on unpatented trade secrets and know-how to
maintain its competitive position, which it seeks to protect, in part, by
confidentiality agreements with employees, consultants and others. There can
be no assurance that these agreements will not be breached or terminated,
that the Company will have adequate remedies for any breach, or that the
Company's trade secrets will not otherwise become known or be independently
discovered by competitors. The Company relies on certain technologies to
which it does not have exclusive rights or which may not be patentable or
proprietary and thus may be available to competitors. The Company has filed
an application for but has not obtained a trademark registration with respect
to its corporate name and its logo.
20
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Another company has filed an application to obtain a trademark registration
for the name "Triangle Coordinated Care," and the Company is aware that
several other companies use trade names that are similar to the Company's for
their businesses. If the Company is not able to obtain any licenses that may
be necessary for the Company to use its corporate name, it may be required to
change its corporate name. The Company's management personnel were previously
employed by other pharmaceutical companies. In many cases, these individuals
are conducting drug development activities for the Company in areas similar
to those in which they were involved prior to joining the Company. As a
result, the Company, as well as these individuals, could be subject to
allegations of violation of trade secrets and other similar claims.
EXTENSIVE GOVERNMENT REGULATION; NO ASSURANCE OF REGULATORY APPROVAL
Human pharmaceutical products are subject to rigorous preclinical testing
and clinical trials and other approval procedures mandated by the FDA and
foreign regulatory authorities. Various federal and foreign statutes and
regulations also govern or influence the manufacturing, safety, labeling,
storage, record keeping and marketing of pharmaceutical products. The process
of obtaining these approvals and the subsequent compliance with appropriate
United States and foreign statutes and regulations are time consuming and
require the expenditure of substantial resources. In addition, these
requirements and processes vary widely from country to country. The time
required for completing preclinical testing and clinical trials and obtaining
regulatory approvals is uncertain. The Company may decide to replace a drug
candidate in preclinical testing and/or clinical trials with a modified drug
candidate, thus extending the development period. In addition, the FDA or
similar foreign regulatory authorities may require additional clinical
trials, which could result in increased costs and significant development
delays. Delays or rejections may also be encountered based upon changes in
FDA policy during the period of product development and FDA review. Similar
delays or rejections may be encountered in other countries. The Company's
drug candidates may not qualify for accelerated development and/or approval
under FDA regulations and, even if some of the Company's drug candidates
qualify for accelerated development and/or approval, they may not be approved
for marketing sooner than would be historically expected or at all. There can
be no assurance that even after substantial time and expenditures, any of the
Company's drug candidates under development will receive marketing approval
in any country on a timely basis or at all. If the Company is unable to
demonstrate the safety and effectiveness of its drug candidates to the
satisfaction of the FDA or foreign regulatory authorities, the Company will
be unable to commercialize its drug candidates and would be materially and
adversely affected. Further, even if regulatory approval of a drug candidate
is obtained, the approval may entail limitations on the indicated uses for
which the drug candidate may be marketed. A marketed product, its
manufacturer and the manufacturer's facilities are subject to continual
review and periodic inspections, and subsequent discovery of previously
unknown problems with a product, manufacturer or facility may result in
restrictions on such product or manufacturer, including withdrawal of the
product from the market. The failure to comply with applicable regulatory
requirements can, among other things, result in fines, suspension of
regulatory approvals, refusal to approve pending applications, refusal to
permit exports from the United States, product recalls, seizure of products,
injunctions, operating restrictions and criminal prosecutions. Further, FDA
policy may change and additional government regulations may be established
that could prevent or delay regulatory approval of the Company's drug
candidates.
The effect of governmental regulation may be to delay the marketing of
new products for a considerable period of time or to prevent such marketing
altogether, to impose costly requirements on the Company's activities or to
provide a competitive advantage to other companies that compete with the
Company. Adverse clinical results by others could have a negative impact on
the regulatory process and timing with respect to the development and
approval of the Company's drug candidates. A delay in obtaining or failure to
obtain regulatory approvals could have a material adverse effect on the
Company. The extent and character of potentially adverse governmental
regulation that may arise from future legislation or administrative action
cannot be predicted.
The Company is also subject to various federal, state and local laws and
regulations relating to safe working conditions, laboratory and manufacturing
practices, the experimental use of animals and the use and disposal of
hazardous or potentially hazardous substances, including radioactive
compounds and infectious disease agents, used in connection with its
development work.
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<PAGE>
INTENSE COMPETITION; RISK OF TECHNOLOGICAL CHANGE
The Company is engaged in segments of the pharmaceutical industry that
are highly competitive and rapidly changing. If successfully developed and
approved, the drug candidates that the Company is currently developing will
compete with numerous existing therapies. In addition, a number of companies
are pursuing the development of novel pharmaceuticals that target the same
diseases the Company is targeting. The Company believes that a significant
number of drugs are currently under development and will become available in
the future for the treatment of HIV. The Company anticipates that it will
face intense and increasing competition in the future as new products enter
the market and advanced technologies become available. There can be no
assurance that existing products or new products developed by the Company's
competitors will not be more effective, or more effectively marketed and
sold, than any that may be developed by the Company. Competitive products may
render the Company's licensed technology and products obsolete or
noncompetitive prior to the Company's recovery of development or
commercialization expenses incurred with respect to any such products. The
development by others of a cure or new treatment methods for the indications
for which the Company is developing drug candidates could render the
Company's drug candidates noncompetitive, obsolete or uneconomical. Many of
the Company's competitors have significantly greater financial, technical and
human resources than the Company and may be better equipped to develop,
manufacture and market products. In addition, many of these companies have
extensive experience in preclinical testing and clinical trials, obtaining
FDA and other regulatory approvals and manufacturing and marketing
pharmaceutical products. Many of these competitors also have products that
have been approved or are in late stage development and operate large, well
funded research and development programs. Smaller companies may also prove to
be significant competitors, particularly through collaborative arrangements
with large pharmaceutical and biotechnology companies. Furthermore, academic
institutions, governmental agencies and other public and private research
organizations are becoming increasingly aware of the commercial value of
their inventions and are more actively seeking to commercialize the
technology they have developed.
If the Company's drug candidates are successfully developed and approved,
the Company will face competition based on the safety and effectiveness of
its products, the timing and scope of regulatory approvals, availability of
supply, marketing and sales capability, reimbursement coverage, price and
patent position. There can be no assurance that the Company's competitors
will not develop more effective or more affordable technology or products, or
achieve earlier patent protection, product development or product
commercialization than the Company. Accordingly, the Company's competitors
may succeed in commercializing products more rapidly or effectively than the
Company, which could have a material adverse effect on the Company.
RISKS RELATED TO LICENSE AND OPTION AGREEMENTS
The agreements pursuant to which the Company has in-licensed or obtained
an option to in-license its drug candidates permit the Company's licensors to
terminate the agreements under certain circumstances, such as the failure by
the Company to achieve certain development milestones or the occurrence of an
uncured material breach by the Company. The termination of any of these
agreements could have a material adverse effect on the Company. Upon
termination of the license agreements with Emory and UGARF, the Company is
required to grant to Emory and UGARF a non-exclusive, royalty free license to
all of the Company's interest in the licensed technology (including any
improvements to the technology developed by the Company). Upon termination of
the license agreement with Dupont Merck, the Company is required to transfer
all approved and pending NDA's relating to DMP-450 to Dupont Merck. In
addition, the license and option agreements with Emory, UGARF, the Regents
and Dupont Merck provide that Emory, UGARF, the Regents and DuPont Merck are
primarily responsible for any litigation, interference, opposition or other
action seeking to obtain patent protection for the technology licensed to the
Company, and except for litigation expenses incurred by DuPont Merck, the
Company is required to reimburse them for the costs they incur in performing
these activities. The Company believes that these costs as well as other
costs under the license and option agreements relating to the Company's drug
candidates will be substantial, and any inability or failure of the Company
to pay these costs with respect to any drug candidate could result in the
termination of the license or option agreement for such drug candidate.
22
<PAGE>
LACK OF MANUFACTURING CAPABILITIES
The Company does not have any manufacturing capacity and currently plans
to seek to establish relationships with third party manufacturers for the
manufacture of clinical trial material and the commercial production of any
products it may develop. There can be no assurance that the Company will be
able to establish relationships with third party manufacturers on
commercially acceptable terms or that third party manufacturers will be able
to manufacture products in commercial quantities under good manufacturing
practices mandated by the FDA on a cost effective basis. The Company's
dependence upon third parties for the manufacture of its products may
adversely affect the Company's profit margins and its ability to develop and
commercialize products on a timely and competitive basis. Further, there can
be no assurance that manufacturing or quality control problems will not arise
in connection with the manufacture of the Company's products or that third
party manufacturers will be able to maintain the necessary governmental
licenses and approvals to continue manufacturing the Company's products. Any
failure to establish relationships with third parties for its manufacturing
requirements on commercially acceptable terms would have a material adverse
effect on the Company.
LACK OF SALES AND MARKETING CAPABILITIES
The Company currently has only one marketing employee and no sales
personnel. The Company will have to develop a sales force or rely on
marketing partners or other arrangements with third parties for the
marketing, distribution and sale of any products it develops. The Company
currently intends to market in the United States most of the drug candidates
that it successfully develops primarily through a direct sales force and
outside the United States through a combination of a direct sales force and
arrangements with third parties. There can be no assurance that the Company
will be able to establish marketing, distribution or sales capabilities or
make arrangements with third parties to perform those activities on terms
satisfactory to the Company or that any internal capabilities or third party
arrangements will be cost effective.
In addition, any third parties with which the Company establishes
marketing, distribution or sales arrangements may have significant control
over important aspects of the commercialization of the Company's products,
including market identification, marketing methods, pricing, composition of
sales force and promotional activities. There can be no assurance that the
Company will be able to control the amount and timing of resources that any
third party may devote to the Company's products or prevent any third party
from pursuing alternative technologies or products that could result in the
development of products that compete with the Company's products and the
withdrawal of support for the Company's programs.
DEPENDENCE ON THIRD PARTIES FOR DEVELOPMENT, MANUFACTURING AND
IN-LICENSING
The Company intends to engage third party contract research organizations
("CROs") to perform certain functions in connection with the development of
the Company's drug candidates and third parties to perform many aspects of
the manufacture of drug substance. The Company intends to design clinical
trials, but have CROs conduct the clinical trials. The Company will rely on
the CROs to perform many important aspects of clinical trials. As a result,
these aspects of the Company's drug development programs will be outside the
direct control of the Company. In addition, there can be no assurance that
the CROs or third parties will perform all of their obligations under
arrangements with the Company. In the event that the CROs or third parties do
not perform clinical trials or manufacture drug substance in a satisfactory
manner or breach their obligations to the Company, the commercialization of
any drug candidate may be delayed or precluded, which would have a material
adverse effect on the Company. The Company does not intend to engage in drug
discovery. The Company's strategy for obtaining additional drug candidates is
to utilize the relationships of its management team and Scientific Advisory
Board to identify compounds for in-licensing from companies, universities,
research institutions and other organizations. There can be no assurance that
the Company will succeed in in-licensing additional drug candidates on
acceptable terms or at all.
23
<PAGE>
NO ASSURANCE OF MARKET ACCEPTANCE
The Company's success will depend in substantial part on the extent to
which any product it develops achieves market acceptance. The degree of
market acceptance will depend upon a number of factors, including the receipt
and scope of regulatory approvals, the establishment and demonstration in the
medical community of the safety and effectiveness of the Company's products
and their potential advantages over existing treatment methods, and
reimbursement policies of government and third party payors. There can be no
assurance that physicians, patients, payors or the medical community in
general will accept or utilize any product that the Company may develop.
RISKS RELATING TO COMBINATION THERAPY
The Company's success will also depend in large part on the extent to
which combination therapy for the treatment of HIV in the United States and
Europe and for the treatment of HBV in developing areas of the world,
particularly Asia, achieves market acceptance. Present combination treatment
regimens for the treatment of HIV are expensive (published reports indicate
the cost per patient per year can exceed $13,000), and may increase as new
combinations are developed. These costs have resulted in a limitation of
reimbursement available from third party payors for the treatment of HIV
infection, and the Company expects that reimbursement pressures will continue
in the future. If combination therapy is accepted as a method to treat HBV,
treatment regimens are also likely to be expensive. The Company expects that
even the cost of monotherapy for HBV will be considered expensive in
developing countries. Any failure of combination therapy to achieve
significant market acceptance for the treatment of HIV or potentially HBV
could have a material adverse effect on the Company.
DEPENDENCE ON KEY EMPLOYEES
The Company is highly dependent on its senior management and scientific
staff, including Dr. David Barry, the Company's Chairman and Chief Executive
Officer. Except for Dr. Barry, the Company has not entered into employment
agreements with any of its personnel. The loss of the services of any member
of its senior management or scientific staff may significantly delay or
prevent the achievement of product development and other business objectives.
Retaining and attracting qualified personnel, consultants and advisors is
critical to the Company's success. In order to pursue its drug development
programs and marketing plans, the Company will be required to hire additional
qualified scientific and management personnel. Competition for qualified
individuals is intense and the Company faces competition from numerous
pharmaceutical and biotechnology companies, universities and other research
institutions. There can be no assurance that the Company will be able to
attract and retain such individuals on acceptable terms or at all, and the
failure to do so would have a material adverse effect on the Company. In
addition, the Company relies on members of its Scientific Advisory Board to
assist the Company in formulating its drug development strategy. All of the
members of the Scientific Advisory Board are employed by other employers and
each such member may have commitments to, or consulting or advisory
contracts, with other entities that may limit his availability to the Company.
UNCERTAINTY OF HEALTH CARE REFORM MEASURES AND THIRD PARTY REIMBURSEMENT
The business and financial condition of pharmaceutical companies will
continue to be affected by the efforts of governments and third party payors
to contain or reduce the cost of health care through various means. A number
of legislative and regulatory proposals aimed at changing the health care
system have been proposed in recent years. In addition, an increasing
emphasis on managed care in the United States has and will continue to
increase the pressure on pharmaceutical pricing. While the Company cannot
predict whether legislative or regulatory proposals will be adopted or the
effect those proposals or managed care efforts may have on its business, the
announcement and/or adoption of such proposals or efforts could have a
material adverse effect on the Company. In the United States and elsewhere,
sales of prescription pharmaceuticals are dependent in part on the
availability of reimbursement to the consumer from third party payors, such
as government and private insurance plans that mandate predetermined
discounts from list prices. Third party payors are increasingly challenging
the prices charged for medical products and services. If the Company succeeds
in bringing one or more products to the market, there can be no assurance
that these products will be considered cost effective or that
24
<PAGE>
reimbursement to the consumer will be available or will be sufficient to
allow the Company to sell its products on a competitive basis.
LIMITED PRODUCT LIABILITY INSURANCE; INSURANCE RISKS
The Company's business will expose it to potential product liability
risks that are inherent in the testing, manufacturing and marketing of
pharmaceutical products. There can be no assurance that product liability
claims will not be asserted against the Company. The Company currently has
only limited product liability insurance relating to potential claims arising
from its clinical trials. The Company intends to expand its insurance
coverage if and when the Company begins marketing commercial products. There
can be no assurance, however, that the Company will be able to obtain any
additional product liability insurance on commercially acceptable terms or
that the Company will be able to maintain its existing insurance and/or any
additional insurance it may obtain in the future at a reasonable cost or in
sufficient amounts to protect the Company against potential losses. A
successful product liability claim or series of claims brought against the
Company could have a material adverse effect on the Company.
HAZARDOUS MATERIALS
The Company's drug development programs involve the controlled use of
hazardous materials, chemicals, viruses and various radioactive compounds.
Although the Company believes that its handling and disposing of such
materials comply with the standards prescribed by state and federal
regulations, the risk of accidental contamination or injury from these
materials cannot be completely eliminated. In the event of such an accident,
the Company could be held liable for any damages or fines that result and any
such liability could exceed the resources of the Company.
CONCENTRATION OF STOCK OWNERSHIP; CONTROL BY MANAGEMENT AND EXISTING
STOCKHOLDERS
As of October 31, 1997 the Company's directors, executive officers and
their respective affiliates beneficially owned approximately 45% of the
Company's outstanding Common Stock. As a result, these stockholders are able
to exercise significant influence over all matters requiring stockholder
approval, including the election of directors and approval of significant
corporate transactions. Such concentration of ownership may also have the
effect of delaying or preventing a change in control of the Company that may
be favored by other stockholders.
VOLATILITY OF STOCK PRICE
The market price of the Company's Common Stock is likely to be highly
volatile and could be subject to wide fluctuations in response to factors
such as announcements of the results of clinical trials, developments with
respect to patents or proprietary rights, announcements of technological
innovations, new products or new contracts by the Company or its competitors,
actual or anticipated variations in the Company's operating results due to a
number of factors including, among others, the level of development expenses,
changes in financial estimates by securities analysts, conditions and trends
in the pharmaceutical and other industries, adoption of new accounting
standards affecting the industry, general market conditions and other
factors. As a result, it is possible that the Company's operating results
will be below the expectations of market analysts and investors, which would
likely have a material adverse effect on the prevailing market price of the
Common Stock.
Sales of a substantial number of shares of Common Stock in the public
market could also adversely affect the market price of the Common Stock. In
addition, holders of approximately 11,740,000 shares of Common Stock
(including shares issuable upon the exercise of outstanding warrants) are
entitled to certain rights with respect to registration of such shares of
Common Stock for offer or sale to the public. Any such sales may have an
adverse effect on the Company's ability to raise needed capital through an
offering of its equity or convertible debt securities and may adversely
affect the prevailing market price of the Common Stock.
25
<PAGE>
Further, the stock market has experienced extreme price and volume
fluctuations that have particularly affected the market prices of equity
securities of many pharmaceutical and biotechnology companies and that often
have been unrelated or disproportionate to the operating performance of such
companies. These market fluctuations, as well as general economic, political
and market conditions such as recessions or international currency
fluctuations, may adversely affect the market price of the Common Stock. In
the past, following periods of volatility in the market price of the
securities of companies in the pharmaceutical and biotechnology industries,
securities class action litigation has often been instituted against those
companies. Such litigation, if instituted against the Company, could result
in substantial costs and a diversion of management attention and resources,
which would have a material adverse effect on the Company. The realization of
any of the risks described in these "Risks and Uncertainties" could have a
dramatic and adverse impact on the market price of the Common Stock.
ANTITAKEOVER EFFECTS OF CHARTER, BYLAWS AND DELAWARE LAW
The Company's Second Restated Certificate of Incorporation (the
"Certificate") authorizes the Company's Board of Directors (the "Board") to
issue shares of undesignated preferred stock without stockholder approval on
such terms as the Board may determine. The rights of the holders of Common
Stock will be subject to, and may be adversely affected by, the rights of the
holders of any such preferred stock that may be issued in the future.
Moreover, the issuance of preferred stock may make it more difficult for a
third party to acquire, or may discourage a third party from acquiring, a
majority of the voting stock of the Company. The Company's Restated Bylaws
(the "Bylaws") divide the Board into three classes of directors with each
class serving a three year term. These and other provisions of the
Certificate and the Bylaws, as well as certain provisions of Delaware law,
could delay or impede the removal of incumbent directors and could make more
difficult a merger, tender offer or proxy contest involving the Company, even
if such events could be beneficial to the interest of the stockholders. Such
provisions could limit the price that certain investors might be willing to
pay in the future for the Common Stock.
NO DIVIDENDS
The Company has never declared or paid any cash dividends on its capital
stock. The Company currently does not intend to pay any cash dividends in the
foreseeable future and intends to retain its earnings, if any, for the
operation of its business.
26
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TRIANGLE PHARMACEUTICALS, INC.
PART II - OTHER INFORMATION
ITEM 2. CHANGES IN SECURITIES
c. Issuance of Unregistered Securities
On August 28, 1997, Triangle acquired Avid Corporation, through a merger
(the "Merger") of Triangle's wholly-owned subsidiary, Project Z Corporation,
a Delaware corporation ("Merger Sub"), with and into Avid. The Merger was
consummated on the terms set forth in an Agreement and Plan of Reorganization
dated June 30, 1997, by and among Triangle, Merger Sub and Avid (the "Merger
Agreement"). As a result of the Merger, Avid is now a wholly-owned subsidiary
of Triangle.
In connection with the Merger, on August 28, 1997, the Company issued to
Avid's stockholders 400,000 shares of the Company's Common Stock and agreed
to issue up to an additional 2,100,000 shares of its Common Stock contingent
upon the attainment of certain development milestones with Avid's drug
candidates. The shares of the Company's Common Stock were issued to the Avid
stockholders in exchange for all outstanding capital stock of Avid. The
Company also assumed all outstanding options and warrants to acquire Avid
common stock. The assumed options and warrants are exercisable for the
portion of the shares of the Company's Common Stock that the option or
warrant holder would have received had the option or warrant been exercised
immediately prior to the Merger.
The shares issued by Triangle in connection with the Merger are
restricted and may not be transferred or sold, except pursuant to a
registration of the shares or an available exemption from registration. The
offer and sale of the shares was made pursuant to a claim of exemption under
Regulation D promulgated by the Securities and Exchange Commission or,
alternatively, under Section 4(2) of the Securities Act of 1933, as amended.
The Company did not use any general advertisement or solicitation in
connection with the offer or sale of the shares to the Avid stockholders.
The Avid stockholders represented and warranted, among other things, that
they were purchasing the shares for investment only and not with a view to
distribution. Less than 35 of the Avid stockholders were not "accredited
investors" (as defined in Regulation D), and each of these stockholders was
represented by a purchaser representative. Appropriate legends were affixed
to the certificates for the shares.
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ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
a. Exhibits
*10.1 License Agreement dated as of December 18, 1996 between
Avid Corporation and The Dupont Merck Pharmaceutical Company.
*10.2 First Amendment to License Agreement between Avid
Corporation and The Dupont Merck Pharmaceutical Company,
dated as of August 26, 1997.
11.1 Computation of Net Loss Per Share and Pro Forma Net Loss
Per Share
27.1 Financial Data Schedule
b. Reports on Form 8-K.
On September 11, 1997 the Company filed a Current Report on Form 8-K
dated September 11, 1997 describing the Company's acquisition of
Avid Corporation.
On November 12, 1997, the Company filed Amendment No. 1 to Current
Report on Form 8-K, amending its Current Report on form 8-K filed
September 11, 1997, to include financial statements of Avid
Corporation and pro forma financial statements of the combined
companies.
---------------
*Certain confidential portions of this Exhibit were omitted by means
of marking such portions with an asterisk (the "Mark"). This
Exhibit has been filed separately with the Secretary of the
Securities and Exchange Commission without the Mark pursuant to the
Company's Application Requesting Confidential Treatment pursuant to
Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
28
<PAGE>
TRIANGLE PHARMACEUTICALS, INC.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the Registrant has duly caused this Quarterly Report on Form 10-Q to be
signed on its behalf by the undersigned, hereunto duly authorized.
TRIANGLE PHARMACEUTICALS, INC.
Date: November 14, 1997 By: /s/ David W. Barry
----------------------------
David W. Barry
Chairman and Chief
Executive Officer
TRIANGLE PHARMACEUTICALS, INC.
Date: November 14, 1997 By: /s/ James A. Klein, Jr.
----------------------------
James A. Klein, Jr.
Chief Financial Officer
and Treasurer
29
<PAGE>
EXHIBIT INDEX
EXHIBIT DESCRIPTION
- ------- -----------
*10.1 License Agreement dated as of December 18, 1996 between
Avid Corporation and The Dupont Merck Pharmaceutical Company.
*10.2 First Amendment to License Agreement between Avid
Corporation and The Dupont Merck Pharmaceutical Company, dated
as of August 26, 1997.
11.1 Computation of Net Loss Per Share and Pro Forma Net Loss
Per Share
27.1 Financial Data Schedule
------------------------
* Certain confidential portions of this Exhibit were omitted by means
of marking such portions with an asterisk (the "Mark"). This
Exhibit has been filed separately with the Secretary of the
Securities and Exchange Commission without the Mark pursuant to the
Company's Application Requesting Confidential Treatment pursuant to
Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
30
<PAGE>
EXHIBIT 10.1
LICENSE AGREEMENT
BETWEEN
AVID CORPORATION (LICENSEE)
AND
THE DUPONT MERCK
PHARMACEUTICAL COMPANY (LICENSOR)
*** Certain confidential portions of this Exhibit were omitted by means
of blackout of the text (the "Mark"). This Exhibit has been filed separately
with the Secretary of the Commission without the Mark pursuant to the
Company's Application Requesting Confidential Treatment under Rule 24b-2
under the 1934 Act.
<PAGE>
TABLE OF CONTENTS
Page
----
I. DEFINITIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.01 "Affiliate" . . . . . . . . . . . . . . . . . . . . . . . 2
1.02 "Agency". . . . . . . . . . . . . . . . . . . . . . . . . 2
1.03 "Calendar Quarter". . . . . . . . . . . . . . . . . . . . 2
1.04 "Calendar Year" . . . . . . . . . . . . . . . . . . . . . 2
1.06 "Field" . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.07 "First Commercial Sale" . . . . . . . . . . . . . . . . . 2
1.08 "IND" . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.09 "Know-How". . . . . . . . . . . . . . . . . . . . . . . . 3
1.10 "Licensed Compound" . . . . . . . . . . . . . . . . . . . 3
1.11 "Licensed Product". . . . . . . . . . . . . . . . . . . . 3
1.12 "NDA" . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.13 "Net Sales" . . . . . . . . . . . . . . . . . . . . . . . 3
1.14 "Patent Rights" . . . . . . . . . . . . . . . . . . . . . 4
1.15 "Confidential Information". . . . . . . . . . . . . . . . 4
1.16 "Sublicensee" . . . . . . . . . . . . . . . . . . . . . . 4
1.17 "Territory" . . . . . . . . . . . . . . . . . . . . . . . 4
1.18 "Valid Patent Claim". . . . . . . . . . . . . . . . . . . 4
II. GRANT OF LICENSE . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.01 Grant By DuPont Merck . . . . . . . . . . . . . . . . . . 5
2.02 Reservation . . . . . . . . . . . . . . . . . . . . . . . 5
III. PAYMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3.01 Licensee's Up Front Payment . . . . . . . . . . . . . . . 5
3.02 Licensee's Milestones . . . . . . . . . . . . . . . . . . 5
3.03 Licensee's Royalties. . . . . . . . . . . . . . . . . . . 6
3.04 Licensee's Annual License Preservation Fee to Licensor. . 6
3.05 In The Event of Sublicense by Licensee. . . . . . . . . . 7
3.06 Payment and Exchange Rate . . . . . . . . . . . . . . . . 8
IV. RECORDS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4.01 Reports . . . . . . . . . . . . . . . . . . . . . . . . . 9
4.02 Books and Records . . . . . . . . . . . . . . . . . . . . 9
4.03 Sublicensees. . . . . . . . . . . . . . . . . . . . . . . 9
V. DEVELOPMENT OF LICENSED PRODUCT. . . . . . . . . . . . . . . . . . . 10
5.01 Product Development . . . . . . . . . . . . . . . . . . . 10
5.02 Development Schedule. . . . . . . . . . . . . . . . . . . 10
5.03 Data Transfer . . . . . . . . . . . . . . . . . . . . . . 10
5.04 Periodic Updates. . . . . . . . . . . . . . . . . . . . . 11
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VI. PATENT MAINTENANCE/PATENT INFRINGEMENT . . . . . . . . . . . . . . . 11
6.01 Patent Maintenance. . . . . . . . . . . . . . . . . . . . 11
6.02 Reimbursement By Licensee . . . . . . . . . . . . . . . . 11
6.03 Notice of Infringement. . . . . . . . . . . . . . . . . . 11
6.04 Licensor's Right to Bring Suit. . . . . . . . . . . . . . 12
6.05 Licensee's Right to Bring Suit. . . . . . . . . . . . . . 12
6.06 Litigation Expenses . . . . . . . . . . . . . . . . . . . 12
VII. NOTICES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
7.01 Notices . . . . . . . . . . . . . . . . . . . . . . . . . 13
7.02 Payments. . . . . . . . . . . . . . . . . . . . . . . . . 13
VIII. INDEMNIFICATION. . . . . . . . . . . . . . . . . . . . . . . . . . . 14
8.01 Indemnification by Licensee . . . . . . . . . . . . . . . 14
8.02 Procedure . . . . . . . . . . . . . . . . . . . . . . . . 15
8.03 Insurance . . . . . . . . . . . . . . . . . . . . . . . . 15
8.04 Warranty. . . . . . . . . . . . . . . . . . . . . . . . . 15
IX. TERM; TERMINATION. . . . . . . . . . . . . . . . . . . . . . . . . . 16
9.01 Term and Expiration . . . . . . . . . . . . . . . . . . . 16
9.02 Termination for Breach. . . . . . . . . . . . . . . . . . 16
9.03 Termination by Licensee . . . . . . . . . . . . . . . . . 16
9.04 Termination by Licensor . . . . . . . . . . . . . . . . . 17
9.05 On Termination or Expiration. . . . . . . . . . . . . . . 17
9.06 Survival of Certain Obligations . . . . . . . . . . . . . 17
9.07 Paid-up License . . . . . . . . . . . . . . . . . . . . . 18
X. CONFIDENTIALITY. . . . . . . . . . . . . . . . . . . . . . . . . . . 18
10.01 Nondisclosure Obligation. . . . . . . . . . . . . . . . . 18
10.02 Use of Confidential Information . . . . . . . . . . . . . 19
10.03 Publication . . . . . . . . . . . . . . . . . . . . . . . 19
XI. MISCELLANEOUS. . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
11.01 Modifications . . . . . . . . . . . . . . . . . . . . . . 20
11.02 Waiver. . . . . . . . . . . . . . . . . . . . . . . . . . 20
11.03 Assignment. . . . . . . . . . . . . . . . . . . . . . . . 20
11.04 Severability. . . . . . . . . . . . . . . . . . . . . . . 20
11.05 Headings. . . . . . . . . . . . . . . . . . . . . . . . . 20
11.06 Applicable Law/Jurisdiction . . . . . . . . . . . . . . . 20
11.07 Force Majeure . . . . . . . . . . . . . . . . . . . . . . 21
11.08 Entire Agreement. . . . . . . . . . . . . . . . . . . . . 21
11.09 Counterparts. . . . . . . . . . . . . . . . . . . . . . . 21
11.10 Use of Names. . . . . . . . . . . . . . . . . . . . . . . 21
11.11 Independent Contractors . . . . . . . . . . . . . . . . . 21
11.12 Representations and Warranties. . . . . . . . . . . . . . 22
11.13 Publicity . . . . . . . . . . . . . . . . . . . . . . . . 22
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LICENSE AGREEMENT
This License Agreement, effective as of the date of last signature, by a
party hereto (the "Effective Date"), is entered into by and between Avid
Corporation, a corporation organized and existing under the laws of the
Commonwealth of Pennsylvania, and its Affiliates (collectively, "Licensee")
and The DuPont Merck Pharmaceutical Company ("Licensor"), a general
partnership organized and existing under the laws of the State, of Delaware.
WHEREAS, Licensor and Licensee entered into that certain Exclusive Option
Agreement ("Option Agreement") dated March 7, 1996, whereby Licensor granted
Licensee an exclusive, worldwide option to enter into an exclusive, worldwide
license Agreement covering the development and commercialization of Licensed
Compound.
WHEREAS, Licensee has now exercised the option granted in the Option
Agreement and duly so notified DuPont Merck in a letter dated November 11,
1996; and
WHEREAS, Licensor desires to grant, and Licensee desires to receive, an
exclusive, worldwide license to make, have made, import, use and sell
Licensed Product, under the circumstances, set forth below;
NOW THEREFORE, intending to be legally bound, Licensor and Licensee
hereby covenant and agree as follows:
I. DEFINITIONS
The terms in this Agreement with initial letters capitalized, whether used
in the singular or plural, shall have the meaning designated below or, if
not designated below, the meaning as designated in places throughout this
Agreement.
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1.01 "Affiliate" means any corporation or other entity which controls, is
controlled by, or is under common control with a party to this
Agreement. A corporation or other entity shall be regarded as in
control of another corporation or entity if it owns or directly or
indirectly controls fifty percent (50%) or more of the voting stock or
other ownership interest of the other corporation or entity, or if it
possesses, directly or indirectly, the power to direct or cause the
direction of the management and policies of the corporation or other
entity or the power to elect or appoint fifty percent (50%) or more of
the members of the governing body of the corporation or other entity.
1.02 "Agency" means any governmental regulatory authority responsible for
granting health or pricing approvals, registrations, import permits,
and other approvals required before Licensed Product may be tested or
marketed in any country.
1.03 "Calendar Quarter" means the respective periods of three (3)
consecutive calendar months ending on March 31, June 30, September 30
and December 31.
1.04 "Calendar Year" means each successive period of twelve (12) months
commencing on January 1 and ending on December 31.
1.06 "Field" means prophylactic and/or therapeutic treatment of patients
suffering from human immunodeficiency virus ("HIV"), acquired
immunodeficiency disease ("AIDS") and/or AIDS-related diseases.
1.07 "First Commercial Sale" means, with respect to a Licensed Product, the
first sale for use or consumption by the public of such Licensed
Product in a country after all required approvals, including marketing
and pricing approvals, have been granted by the governing health
authority of such country.
1.08 "IND" means Investigational New Drug application, or the like, as
defined in the applicable laws and regulations of the governmental
drug regulatory agencies in each country in the Territory.
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1.09 "Know-How" means all information and materials, including but not
limited to, technology, experience, discoveries, improvements,
processes, formulae, data (including but not limited to all
preclinical, clinical, toxicological, and pharmacological data) and
inventions, know-how and trade secrets, patentable or otherwise, which
on the Effective Date of this Agreement are in Licensor's possession
or control, are not generally known and are necessary or useful for
Licensee in the research, development, manufacture, marketing, use or
sale of Licensed Product for the Field in the Territory. Know-How
shall not include any such data or information which is available to
Licensor under a license pursuant to which Licensor does not have the
light to grant sublicenses.
1.10 "Licensed Compound" means Licensor's protease inhibitor for treatment
of human immunodeficiency virus ("HIV"), which is known as DMP450, and
which has the chemical name, [4R-(4a,5a,6b,7b)]-hexahydro-5,6-
bis(hydroxy)-1,3-bis[(3-aminophenyl)methyl]-4,7 -bis(phenylmethyl)-
2H-1,3-diazepin-2-one, bis-methanesulfonic acid salt.
1.11 "Licensed Product" means a formulation for human pharmaceutical use in
unit dosage form comprising Licensed Compound the manufacture, import,
use or sale of which would infringe a Valid Patent Claim but for the
license provided under Article 11 hereinbelow.
1.12 "NDA" means either the accelerated or regular new drug application
filed in the U.S. or the corresponding application for authorization
for marketing of Licensed Product in any other country, as defined in
the applicable laws and regulations and filed with the Agency of a
given country in the Territory.
1.13 "Net Sales" means the aggregate gross invoice price of Licensed
Product sold by LICENSEE, its Affiliates and Sublicensees to an
independent third party after deducting (to the extent not already
deducted in the amount invoiced):
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(i) trade and quantity discounts;
(ii) returns and allowances; and
(iii) rebates, chargebacks and other amounts paid, credited or accrued.
1.14 "Patent Rights" means the patents and patent applications listed on
Exhibit A and any and all patents and patent applications owned by or
licensed to Licensor as of the Effective Date, which contain one or
more claims directed to Licensed Product for the Field, and any and
all divisions, continuations, continuations-in-part, reissues,
renewals, extensions or the like of any such patents and patent
applications and all foreign equivalents thereof. Patent Rights shall
not include any patents or patent rights available to Licensor under a
license pursuant to which Licensor does not have the light to grant
sublicenses. It is understood that Licensor shall not assert against
Licensee any other patent rights it may now possess or it acquires in
the future as they relate to the manufacture, importation, use or and
sale of Licensed Compound and Licensed Product.
1.15 "Confidential Information" means and includes, without limitation,
information and data of one party supplied to the other, know-how, and
all other scientific, clinical, regulatory, marketing, financial and
commercial information or data, whether communicated in writing or
orally or by other means, which is provided by one party to the other
party in connection with this Agreement.
1.16 "Sublicensee" means a business entity which is sublicensed by Licensee
under this Agreement.
1.17 "Territory" means the entire world.
1.18 "Valid Patent Claim" means a claim of an issued and unexpired patent
included within Patent Rights which, but for the license provided
under Article II hereof, would be infringed by Licensee's manufacture,
use, sale or import of Licensed Product, and which has not been
revoked or held unenforceable or invalid by a decision of a court
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or other governmental agency of competent jurisdiction, unappealable
or unappealed within the time allowed for appeal, or which has not
been disclaimed, denied or admitted to be invalid or unenforceable
through reissue or disclaimer or otherwise.
II. GRANT OF LICENSE
2.01 GRANT BY DUPONT MERCK Subject to the reservation of Section 2.02,
Licensor hereby grants Licensee an exclusive license, with right to
sublicense, for the Field under the Patent Rights and Know-How to
make, have made, import, use and sell Licensed Compound and Licensed
Product in the Territory.
2.02 RESERVATION DuPont Merck expressly reserves the right to make and use
Licensed Compound in its internal research programs.
III. PAYMENTS
3.01 LICENSEE'S UP FRONT PAYMENT - In consideration of the rights granted
Licensee in 2.01 hereinabove, Licensee shall pay Licensor an initial
license fee equal to one million seven hundred fifty thousand dollars
($1,750,000.00)(the "Initial License Fee"). Said Initial License Fee
shall be due on the Effective Date, and shall not be returnable in any
event, nor shall it be creditable against earned royalties.
3.02 LICENSEE'S MILESTONES - Licensee shall make the following payments to
Licensor on achievement of the following milestones:
***
***
***
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***
***
***
***
***
***
***
***
***
*** of all milestone payments shall be ***
but no single royalty payment shall be reduced by more than ***
Licensee shall notify Licensor in writing within thirty (30) days upon
the achievement of each milestone event and such milestone payment
shall be paid no later than *** following achievement of the
milestone event.
3.03 LICENSEE'S ROYALTIES - As further consideration for the rights and
licenses granted herein, Licensee shall pay Licensor a royalty equal
to *** of Licensee's and/or Licensee's Affiliates annual Net
Sales following First Commercial Sale of License Product, the
manufacture, importation, use or sale of which would, but for the
licenses granted hereunder, infringe a Valid Patent Claim.
3.04 LICENSEE'S ANNUAL LICENSE PRESERVATION FEE TO LICENSOR - In the event
that Licensee's total payments to Licensor in any calendar year
commencing with 1998, whether in the form of royalties, milestones, or
Additional Payment (as this term defined below), do not at least equal
the Annual License Preservation Fees set forth below, Licensee, as a
condition of maintaining the exclusivity of the licenses granted
hereunder, shall by the end of the calendar year in question pay the
difference between the Annual License
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Preservation Fee specified below and the total of royalties,
milestones and Additional Payments made to Licensor that year
(hereafter, the "Unpaid Difference");
Annual License Preservation Fee Calendar Year
------------------------------- -------------
*** ***
*** ***
*** ***
*** ***
The Unpaid Difference in any given calendar year shall be Paid by
Licensee to Licensor in cash, provided however, that up to ***
of the Unpaid Difference in each of ***
may, at Licensee's election, be paid to Licensor in the form of
Licensee's stock valued at the then prevailing fair market price for
such stock and having those rights and preferences as mutually agreed
upon by the parties. The fair market price will be determined as the
average price of Licensee's stock for the prior thirty (30) days if
Licensee stock is on a major exchange. If Licensee's stock is not
traded on a major exchange, the fair market price will be the price of
Licensee's stock as determined in its most recent private placement.
If royalties, milestones or Additional Payments in any given year
exceed the Annual License Preservation Fee, the excess shall be
carried over and applied against the ensuing year(s)' Annual License
Preservation Fee.
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3.05 IN THE EVENT OF SUBLICENSE BY LICENSEE - Licensee has the right to
sublicense the rights granted it hereunder to unrelated, unaffiliated
third parties, after obtaining the prior written consent of DuPont
Merck, such consent not to be unreasonably withheld. In the event
Licensee enters into such a sublicense agreement, then Licensee shall
pay Licensor *** of the cash equivalent of any license fee and
technology premium equity payment that Licensee receives from its
Sublicensee ("Additional Payment"). As used herein, technology premium
equity payment means A(B-C), where A is the number of shares of
Licensee's stock purchased by the Sublicensee, B is the share price
paid by the Sublicensee, and C is the share price paid by the most
recent non-pharmaceutical investor to purchase at least ***
*** of the same type of Licensee stock, or, if Licensee is
publicly traded, then C is the average trading price of Licensee's
stock for the ten business days immediately prior to the transaction.
Moreover, Licensee shall pay Licensor *** of all milestones
that licensee receives from its Sublicensee. This *** share
shall be applied against, but will not excuse Licensee from, the above
milestone obligations (i.e. Licensor shall receive the greater of its
*** share of Licensee's milestones or the milestones specified
above). Also, Licensee shall pay Licensor a royalty equal to the
greater of *** of the royalties that Licensee receives from
its Sublicensee(s) or *** of the Sublicensee(s)' Net Sales
following First Commercial Sale of Licensed Product, the manufacture,
importation, use or sale of which would, but for the licenses granted
hereunder, infringe a Valid Patent Claim.
3.06 PAYMENT AND EXCHANGE RATE - All payments to be made under this
Agreement shall be made in United States dollars and shall be paid by
bank wire transfer in immediately available funds as provided in
Section 7.02 hereinbelow or to such other bank account in the United
States designated in writing by DuPont Merck. In the case of sales
outside the United States, the rate of exchange to be used in
computing the amount of currency equivalent in United States dollars
due shall be the month-end exchange rate applicable for the month in
which the sales are recorded. Such month-end rate of
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exchange shall be the rate prevailing at the close of the last
business day of the month as identified by THE WALL STREET JOURNAL. If
royalties are paid outside the U.S., Licensee shall use all reasonable
efforts to help Licensor obtain the lowest tax rate possible under the
applicable international treaty with the U.S.
IV. RECORDS
4.01 REPORTS - During the term of the Agreement following the First
Commercial Sale of a Licensed Product, Licensee shall furnish to
Licensor a quarterly written report for the Calendar Quarter stating
the gross sales price and the Net Sales (including a listing of
deductions) of all Licensed Product(s) sold by Licensee, its
Affiliates and its Sublicensees in the Territory during the reporting
period and the royalties payable under this Agreement. Reports shall
be due on the *** following the close of each Calendar
Quarter. Royalties shown to have accrued by each royalty report shall
be due and payable on the date such royalty report is due.
4.02 BOOKS AND RECORDS - Licensee agrees to keep full and accurate books of
account, records, data and memoranda regarding the sales of the
Product in sufficient detail to enable the payments due to Licensor
hereunder to be determined. Licensee grants Licensor the right, at
its own expense, to examine said books and records insofar as they
concern the Product once in any calendar year for the purpose of
verifying the reports provided for in this Agreement. Licensee shall
retain such records for *** ***. If Licensor examines the records,
documents and materials in the possession or under the control of
Licensee, such examination shall be conducted during normal business
hours in such manner as to not unduly interfere with Licensee's
business. Licensor and its representatives shall not disclose to any
other person, firm, or corporation any information acquired as a
result of any such examination, provided, however. that nothing
contained herein shall be construed to prevent Licensor and/or its
duly authorized representatives from testifying in any court or
tribunal of competent
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jurisdiction with respect to the information obtained as a result of
such examination in any action instituted to enforce Licensor's rights
under the terms of this Agreement. If any audit by Licensor discloses
a discrepancy of more than *** in the amount paid to Licensor
and the amount actually owed to Licensor, Licensee shall reimburse
Licensor for the reasonable actual costs of such audit and shall
promptly pay the discrepancy to Licensor, plus interest thereon at
*** from the date such amount was originally due.
4.03 SUBLICENSEES. - Licensee shall include in each sublicense granted by
it pursuant to this Agreement a provision requiring the Sublicensee to
make reports to Licensee, to keep and maintain records of sales made
pursuant to such sublicense and to grant access to such records by
Licensor's independent accountant to the same extent required of
Licensee under this Agreement.
V. DEVELOPMENT OF LICENSED PRODUCT
5.01 PRODUCT DEVELOPMENT - Licensee shall be responsible, at its own cost
and expense, for the development and commercialization of Licensed
Product. Licensee shall use its *** to develop the Licensed
Product. As used herein the term ***
***
***
*** Licensee shall diligently perform or cause to be performed
all research and development necessary to obtain and maintain in full
force and effect Agency approval in ***
***
***
*** Licensee shall at the earliest possible time, consistent with
sound scientific and business principles, Cite applications for Agency
approval to sell Licensed Products in ***
***
***
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5.02 DEVELOPMENT SCHEDULE - Attached hereto as Exhibit B is an initial
Development Schedule outlining the Licensed Product development plan
for the United States market. The Development Schedule may be
modified periodically as mutually agreed to, in writing, by the
parties. Licensee's substantial compliance with the Development
Schedule, as it may be amended from time to time, shall be deemed to
satisfy the *** *** referred to in Section 5.01,
above.
5.03 DATA TRANSFER - To the extent not provided during the term of the
Option Agreement, Licensor shall provide Licensee with existing
pre-clinical and clinical data. Such data will include the
*** Licensor shall also provide reasonable
technical assistance to facilitate an orderly transfer of the project,
provided that such assistance shall not be at a level that is unduly
burdensome to Licensor. At the request of Licensee, Licensor may, in
its sole discretion, provide additional assistance at Licensee's
expense. Promptly after the Effective Date, Licensor shall notify the
FDA that Licensee has acquired exclusive rights to Licensed Product,
and so should have access to relevant data relating to Licensed
Product on file at the FDA.
5.04 PERIODIC UPDATES - Licensee will update Licensor in writing not less
frequently than *** on the development status of the Licensed
compound.
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Confidential Treatment and filed separately with the commission.
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VI. PATENT MAINTENANCE/PATENT INFRINGEMENT
6.01 PATENT MAINTENANCE, Licensor shall be responsible for prosecuting and
maintaining the Patent Rights. In meeting such responsibility,
Licensor will rely on its staff attorneys to the same extent it
usually does in prosecuting similar patents and patent applications
owned by Licensor.
6.02 REIMBURSEMENT BY LICENSEE, Licensee shall reimburse Licensor for all
costs incurred by Licensor in filing, prosecuting and maintaining the
Patent Rights during the term of this Agreement, except for those
costs relating to efforts of Licensor's staff attorneys. In the event
that Licensee determines that it does not make commercial sense to
pursue filing, prosecuting and maintaining the Patent Rights in a
particular country and no longer desires to reimburse Licensor for
associated costs in such country, then Licensee shall so notify
Licensor, and Licensor may, in Licensor's discretion, maintain or
abandon the Patent Rights in that particular country.
6.03 NOTICE OF INFRINGEMENT, Each party shall immediately give notice to
the other of any potential infringement or infringement by a third
party of any Patent Rights of which they become aware or of any
certification of which they become aware filed under the United States
"Drug Price Competition and Patent Term Restoration Act of 1984"
claiming that Patent Rights covering the Licensed Product are invalid
or unenforceable or that infringement will not arise from the
manufacture, use or sale of Licensed Product by a third party.
6.04 LICENSOR'S RIGHT TO BRING SUIT, Licensor will have the right to
settle with the infringer or to bring suit or other proceeding at its
expense against the infringer in its own name
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or in the name of Licensee where necessary, after consultation with
Licensee. Licensee shall be kept advised at all times of such suit or
proceedings brought by Licensor. Licensee may, in its discretion,
join Licensor as party to the suit or other proceeding, provided that
Licensor shall retain control of the prosecution of such suit or
proceedings in such event. Licensee agrees to cooperate with Licensor
in its efforts to protect Patent Rights, including joining as a party
where necessary. Licensor agrees to prosecute diligently any
litigation it initiates under this Section 6.04.
6.05 LICENSEE'S RIGHT TO BRING SUIT, If within ninety (90) days after
receiving notice under Section 6.03 hereinabove, Licensor does not
settle with the infringer or bring suit or other proceeding against
the infringer, Licensee may in its discretion, bring suit or other
proceeding at its expense against the infringer, provided however,
that Licensee shall first consult with Licensor as to whether such
act(s) by a third party reasonably constitute infringement and whether
it is commercially advisable to bring such suit or proceeding, as
reasonably determined by Licensor. Licensor shall be kept advised at
all times of such suit or proceedings brought by Licensee. Licensor
may, in its discretion, join Licensor as party to the suit or other
proceeding, provided that Licensee shall retain control of the
prosecution of such suit or proceedings in such event. Licensor
agrees to cooperate with Licensee in its efforts to protect Patent
Rights, including joining as a party where necessary. Licensee agrees
to prosecute diligently any litigation it initiates under this Section
6.05.
6.06 LITIGATION EXPENSES, Each party will bear its own expenses with
respect to any suit or other proceeding against an infringer. Any
recovery in connection with such suit or proceeding will first be
applied to reimburse Licensee and Licensor for their out-of-pocket
expenses, including attorney's fees. Any remaining recovery shall be
divided by the parties as follows: (i) if the damages awarded the
party controlling the suit include an amount based on ***
then Licensor shall retain *** *** and Licensee shall retain
*** of said amount after first subtracting
from the award those amounts not based on ***
(ii) if the damages awarded the party controlling the suit include an
amount based on *** *** then, Licensee shall retain
*** and Licensor *** of the award after first
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subtracting from the award those amounts not based on ***
*** (iii) if the damages awarded the party controlling the suit
includes an amount based *** ***
then the parties will each retain *** of such amount
and (iv) if the damages awarded the party controlling the suit
includes an amount not contemplated by (i)-(iii) above, then the
parties will each retain *** of such amount.
VII. NOTICES; PAYMENTS
7.01 NOTICES, Any notice required or permitted to be given hereunder
shall, except where specifically provided otherwise, be given in
writing to the person listed below by personal delivery, registered or
certified mail, return receipt requested, NEXT DAY AIR, telegram,
telex, or telecopier, and the date upon which such notice is so
personally delivered (or if notice is given by registered or certified
mail, the date that is three (3) business days from sending, or if by
NEXT DAY AIR, telegram, or telex or telecopier, the date of receipt at
the designated address) shall be deemed to be the date of such notice,
irrespective of the date appearing thereon:
The DuPont Merck Pharmaceutical Company Avid Corporation
DuPont Merck Plaza, Walnut Run 1667 Davis Street
974 Centre Road Camden, NJ 08029
Wilmington, DE 19805 Attn: Executive VP
Attn: Vice President, Business Development
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7.02 PAYMENTS, Payments made to Licensor under Article II shall be wire to
Licensor's account as follows:
Mellon Bank, N.A.
Independence Center
701 Market Street
Philadelphia, PA 19016
***
***
VIII. INDEMNIFICATION; INSURANCE; WARRANTIES
8.01 INDEMNIFICATION BY LICENSEE - Licensee shall at all times during the
term of this Agreement and thereafter, indemnify, defend and hold
Licensor, its officers, employees, parent companies and Affiliates,
from and against any and all claim, loss, damage, liability, injury,
cost or expense, including without limitation expenses of litigation
and reasonable attorneys' fees, in connection with any claims made or
suits brought by third parties against Licensor relating to this
Agreement including, without limitation, those arising out of the
death of or injury to any person or persons or out of any damage to
property and resulting from the production, manufacture, sale, use,
lease, consumption or advertisement of Licensed Product and those
arising from the negligence, willful misconduct, or material breach of
this Agreement by Licensee, its Affiliates, subcontractors or agents.
8.02 PROCEDURE. - Should Licensor or any of its officers, agents, parent
companies, affiliates, or employees (the "Indemnitee") intend to claim
indemnification under this Article VIII, such Indemnitee shall
promptly notify the Licensee (the "Indemnitor") in writing of any
loss, claim, damage, liability or action in respect of which the
Indemnitee intends to claim such indemnification, and the Indemnitor
shall be entitled to assume the defense thereof with counsel selected
by the Indemnitor and approved by the
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Indemnitee, such approval not to be unreasonably withheld, PROVIDED,
HOWEVER, that if representation of Indemnitee by such counsel first
selected by the Indemnitor would be inappropriate due to a conflict of
interest between such Indemnitee and any other party represented by
such counsel, then Indemnitor shall select other counsel for the
defense of Indemnitee, with the fees and expenses to be paid by the
Indemnitor, such other counsel to be approved by Indemnitee and such
approval not to be unreasonably withheld. The indemnity agreement in
this Article VIII shall not apply to amounts paid in settlement of any
loss, claim damage, liability or action if such settlement is effected
without the consent of the Indemnitor, which consent shall not be
withheld unreasonably. The failure to deliver notice to the
Indemnitor within a reasonable time after the commencement of any such
action, if prejudicial to its ability to defend such action, shall
relieve such Indemnitor of any liability to the Indemnitee under this
Article VIII, but the omission so to deliver notice to the Indemnitor
will not relieve it of any liability that it may have to any
Indemnitee otherwise than under this Article VIII. The Indemnities
under this Article VIII, its employees and agents, shall cooperate
fully with the Indemnitor and its legal representatives in the
investigation of any action, claim or liability covered by this
indemnification.
8.03 INSURANCE. - Licensee shall use best efforts to obtain liability
insurance promptly after the Effective Date and in no event later than
thirty (30) days after the Effective Date. Such liability insurance
shall protect Licensee and Licensor in regard to events covered by
Section 8.01, and the nature and extent of the insurance coverage
shall be commensurate with usual and customary industry practices.
Thereafter, for the term of this Agreement, upon the commencement of
production, sale, or transfer, whichever occurs first, of any Licensed
Product, Licensee shall obtain and carry in full force and effect
liability insurance which shall protect Licensee and Licensor in
regard to events covered by Section 8.01, the nature and extent of
which insurance coverage shall be commensurate with usual and
customary industry practices. Licensee shall name Licensor as an
additional insured and provide Licensor a certificate of insurance
evidencing coverage.
-16-
<PAGE>
8.04 WARRANTY. - Except as otherwise expressly set forth in this Agreement,
LICENSOR MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY
KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND
VALIDITY OF PATENT RIGHTS' CLAIMS, ISSUED OR PENDING.
IX. TERM; TERMINATION
9.01 TERM AND EXPIRATION. - This Agreement shall be effective as of the
Effective Date and unless terminated earlier pursuant to Section 9.02,
9.03 or 9.04 below, the terms of this Agreement shall continue in
effect on a ***
***
9.02 TERMINATION FOR BREACH - In the event of a material breach by either
Licensor or Licensee of any of the obligations contained in this
Agreement, the other party shall be entitled to terminate this
Agreement by notice in writing under Section 7.01 provided that such
notice shall specify the complained of breach or breaches. If the
said breach or breaches are capable of remedy, the party committing
such breach or breaches shall be entitled to a period of ***
from the delivery of such notice in which to remedy or to undertake to
remedy the same. In the case the defaulting party shall fail to
remedy the breach or to undertake to remedy the breach to the
satisfaction of the injured party, the injured party shall have the
right *** ***
Failure of a party to exercise its rights under this Section 9.02
shall not be construed as a waiver as to future breaches whether or
not they are similar.
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the commission.
-17-
<PAGE>
9.03 TERMINATION BY LICENSEE - Licensee may terminate this Agreement, with
respect to:
***
***
Licensee will disclose to Licensor its reasons for any such
termination.
9.04 TERMINATION BY LICENSOR - Licensor shall have the further right to
terminate this Agreement *** on written notice to License if:
***
***
***
***
9.05 ON TERMINATION - Licensee shall, upon termination of this Agreement:
(a) Immediately cease manufacture, use, importation and sale of
License Product;
(b) return to Licensor all copies of documents containing
Confidential Data and any materials received from Licensor under
confidentiality concerning compound, except that Licensee may
retain one (1) copy in its legal files to meet its obligations
hereunder that continue after termination under this Agreement;
(c) make no further use of any kind of any and all technology or
Confidential Data disclosed hereunder by Licensor with respect to
Licensed Product, except to the
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the commission.
-18-
<PAGE>
extent such information has become public knowledge other than
through fault of Licensee;
(d) transfer to Licensor all approved and pending NDAs for all
countries within the Territory.
9.06 SURVIVAL OF CERTAIN OBLIGATIONS - The obligations set forth in
Sections 8.01 and 8.02, and Article X, and any obligations otherwise
accrued hereunder as of the date of termination shall survive
termination of this Agreement.
9.07 PAID-UP LICENSE - For each country, upon expiration of Licensee's
obligation to pay royalties pursuant to Section 3.03, License shall
have a fully paid-up, nonexclusive license under any Know-How, to
make, have made, use and sell Licensed Product in that country.
X. CONFIDENTIALITY
10.01 NONDISCLOSURE OBLIGATION. - The parties hereto entered into a
Confidential Disclosure Agreement ("CDA") on December 18, 1995. The
parties hereby agree that this Article X shall supersede and take the
place of the CDA, and that all Confidential Information disclosed by
one party to another, whether in the past or in the future, shall be
governed by the terms and conditions of this Article X. Confidential
Information includes but is not limited to compounds, intermediates,
data, designs, methods and processes, know-how, marketing strategies,
product plans, plans for research, developmental or experimental work,
development tools, financial information, test and safety data, and
supplier lists and information relating to Licensed Product. The
parties hereto agree that all Confidential Information shall be
maintained in confidence by the recipient and shall not be disclosed
by the recipient to any other natural person, or any corporation,
firm, partnership or other business entity, or any government or any
agency or political subdivision thereof, without the prior written
consent of the other party, except to the extent that such
Confidential Information:
-19-
<PAGE>
(a) is known by recipient at the time of its receipt, and not through
a prior disclosure by the disclosing party, as documented by
business records;
(b) is properly in the public domain;
(c) is subsequently disclosed to the receiving party by a third party
who may lawfully do so and is not under an obligation of
confidentiality to the disclosing party;
(d) is developed by the receiving party independently of Proprietary
Information or other information received from the other party;
(e) is disclosed to governmental or other regulatory agencies in
order to obtain patents or to gain approval to conduct clinical
trials or to market Licensed Product, but such disclosure may be
only to the extent reasonably necessary to obtain patents or
authorizations;
(f) is necessary or useful to be disclosed to prospective investors,
Sublicensees, agents, consultants, Affiliates and/or other third
parties for the research and development, manufacturing,
marketing and or sale of Licensed Product (or for such parties to
determine their interest in performing such activities) in
accordance with this Agreement on the condition that such third
parties agree to be bound by the confidentiality obligations
contained in this Agreement, provided that the term of
confidentiality for such third parties shall be no less than ten
(10) years; or
(g) is required to be disclosed by law or court order, provided that
notice is promptly delivered to the other party in order to
provide an opportunity to challenge or limit the disclosure,
obligations.
-20-
<PAGE>
10.02 USE OF CONFIDENTIAL INFORMATION. Both parties agree that the
Confidential Information shall only be used in connection with the
parties' respective rights and obligations under this Agreement.
10.03 PUBLICATION. During the term of this Agreement, Licensee and Licensor
each acknowledge the other party's interest in publishing its results
to obtain recognition within the scientific community and to advance
the state of scientific knowledge. Each party also recognizes the
mutual interest in obtaining valid patent protection and in protecting
business interests and trade secret information, Consequently, each
party agrees not to disclose Confidential Information of the other
party in publications without the express written consent of the other
party. In addition, the contributions of the parties to the research
shall be expressly noted in such publications or other public
disclosures by acknowledgment or co-authorship, whichever is
appropriate.
XI. MISCELLANEOUS
11.01 MODIFICATIONS - The terms and conditions of this Agreement may not be
amended or modified, except in a writing signed by both parties.
11.02 WAIVER - No failure or delay of either party to exercise any rights or
remedies under this Agreement shall operate as a waiver thereof nor
shall any single, or partial exercise or any rights or remedies
preclude any further or other exercise of the same or any other rights
or remedies with respect to any circumstances to be construed as a
waiver thereof with respect to any other circumstances.
11.03 ASSIGNMENT - Licensee may not assign any of its rights or delegate any
of its duties pursuant to this Agreement without the prior written
consent of Licensor and any attempted assignment without such consent
shall be void.
-21-
<PAGE>
11.04 SEVERABILITY - In the event that any provision of this Agreement is
held invalid or unenforceable in any circumstance by a court of
competent jurisdiction, the remainder of this Agreement, and
application of such provision in any other circumstances, shall not be
affected thereby.
11.05 HEADINGS - The headings of articles and sections of this Agreement are
for convenience of reference only and shall not affect the meaning or
interpretation of this Agreement in any way.
11.06 APPLICABLE LAW/JURISDICTION - This Agreement shall be governed by and
construed in accordance with the laws of the *** without
regard to its conflicts of laws principles. Any litigation regarding
this Agreement or performance of obligations in connection therewith
shall be in the courts of the ***
***
11.07 FORCE MAJEURE - Neither party shall be responsible for any loss or
damage resulting from any delay in performing or failure to perform
any provisions of this Agreement, so long as any such failure or delay
arises from fires, floods, storms, earthquakes, civil commotion's,
strikes or other differences with workers or unions, or from any delay
or failure in delivery when the supplies of either party or the
facilities of production, manufacture, transportation or distribution
which otherwise would be available to either party are impaired by
mechanical breakdown or by causes beyond its control or by the order,
requisition, request, or recommendation of any governmental agency or
acting governmental authority, or either party's compliance therewith,
or by governmental regulation.
11.08 ENTIRE AGREEMENT - This Agreement constitutes the entire agreement
between Licensor and Licensee with respect to the subject matter
hereof, and supersedes all proposals,
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the commission.
-22-
<PAGE>
oral or written, purchase orders, confidentiality agreements, and all
other communications between the parties with respect to such subject
matter, subject to any moneys due under the purchase orders between
the parties as of the date hereof.
11.09 COUNTERPARTS - This Agreement may be executed in counterparts, and
when each party has signed and delivered at least one counterpart,
each counterpart shall be deemed an original, and, when taken together
with other signed counterparts, shall constitute one Agreement, which
shall be binding upon and effective as to both parties.
11.10 USE OF NAMES - This Agreement does not confer any right to use the
name, tradename, trademark or other designation of either party.
11.11 INDEPENDENT CONTRACTORS - At all times during the term of this
Agreement, each party shall act as an independent contractor and
neither the making of this Agreement nor the performance of any of the
provisions hereof shall be construed to make one party an agent,
employee or legal representative of another party for any purpose, nor
shall this Agreement be deemed to establish a joint venture or
partnership.
11.12 REPRESENTATIONS AND WARRANTIES - Each party represents and warrants to
the other that it has the full right and authority to enter into this
Agreement, and that it is not aware of any impediment which would
inhibit its ability to perform the terms and conditions imposed on it
by such Agreement.
11.13 PUBLICITY - Each party will provide the other with a copy of any draft
press release covering the subject matter of this Agreement at least
one business day before issuance and in the case of a press release
covering the initial announcement of this Agreement, at least three
(3) business days before issuance - unless in the opinion of counsel
such delay in the issuance of the press release would result in a
violation of the securities law or other applicable law. Each party
will give due regard to comments, if any, made by the other party in
response to a draft release. Neither party may use the
-23-
<PAGE>
name of the other party or the other party's divisions affiliates,
subsidiaries, or products to imply an endorsement, without the written
consent of such other party.
IN WITNESS WHEREOF, the parties intending to be bound have duly executed this
Agreement in duplicate by their appropriate authorized representative.
THE DUPONT MERCK AVID CORPORATION
PHARMACEUTICAL COMPANY
/s/ illegible /s/ illegible
- ----------------------------- -----------------------------
By By
President and CEO Executive Vice Pres
- ----------------------------- -----------------------------
Title Title
December 18, 1996 December 18, 1996
- ----------------------------- -----------------------------
Date Date
-24-
<PAGE>
SCHEDULE A
DOCKET NO.: DM-6566-E
TITLE: Substituted Cyclic Carbonyls and Derivatives Thereof Useful as
Retroviral Protease Inhibitors
- -------------------------------------------------------------------------------
COUNTRY APPLN NO. APPLN DATE STATUS PATENT NO. ISSUE DATE EXPIRY DATE
- -------------------------------------------------------------------------------
US 08/197,630 2/16/94 Allowed
- -------------------------------------------------------------------------------
1 of 6
<PAGE>
SCHEDULE A
DOCKET NO.: DM-6566-B
TITLE: Substituted Cyclic Carbonyls and Derivatives Thereof Useful as
Retroviral Protease Inhibitors
FOREIGN FAMILY FOR DM-6566-E
- -------------------------------------------------------------------------------
COUNTRY APPLN NO. APPLN DATE STATUS PATENT NO. ISSUE DATE EXPIRY DATE
- -------------------------------------------------------------------------------
ASTL 94/061808 10/13/92 Pending
- -------------------------------------------------------------------------------
ATRA unknown 10/13/92 Pending
- -------------------------------------------------------------------------------
BELG unknown 10/13/92 Pending
- -------------------------------------------------------------------------------
BRAZ PI9206623-2 10/13/92 Pending
- -------------------------------------------------------------------------------
CANA 2120925 10/13/92 Pending
- -------------------------------------------------------------------------------
CZEC PV00814-94 10/13/92 Pending
- -------------------------------------------------------------------------------
DENM unknown 10/13/92 Pending
- -------------------------------------------------------------------------------
EPC 92922262.8 10/13/92 Pending
- -------------------------------------------------------------------------------
FINL 94/001649 10/13/92 Pending
- -------------------------------------------------------------------------------
FRAN unknown 10/13/92 Pending
- -------------------------------------------------------------------------------
GBRI unknown 10/13/92 Pending
- -------------------------------------------------------------------------------
GERM unknown 10/13/92 Pending
- -------------------------------------------------------------------------------
GREC unknown 10/13/92 Pending
- -------------------------------------------------------------------------------
HUNG P94/01020 10/13/92 Pending
- -------------------------------------------------------------------------------
IREL unknown 10/13/92 Pending
- -------------------------------------------------------------------------------
ITAL unknown 10/13/92 Pending
- -------------------------------------------------------------------------------
JAPA 93/507244 04/11/94 Pending
- -------------------------------------------------------------------------------
KORS 94/701169 10/13/92 Pending
- -------------------------------------------------------------------------------
LUXE unknown 10/13/92 Pending
- -------------------------------------------------------------------------------
NETH unknown 10/13/92 Pending
- -------------------------------------------------------------------------------
NORW 94/001278 10/13/92 Pending
- -------------------------------------------------------------------------------
PCT US92/08749 10/13/92 (Pending)
- -------------------------------------------------------------------------------
RUSS 94/031126 10/13/92 Pending
- -------------------------------------------------------------------------------
SLVK PV00407-94 10/13/92 Pending
- -------------------------------------------------------------------------------
SPAI unknown 10/13/92 Pending
- -------------------------------------------------------------------------------
SWED unknown 10/13/92 Pending
- -------------------------------------------------------------------------------
SWIT unknown 10/13/92 Pending
- -------------------------------------------------------------------------------
2 of 6
<PAGE>
SCHEDULE A
DOCKET NO.: DM-6681
TITLE: Method of Treating Human Immunodeficiency Virus Infection Using a
Cyclic Protease Inhibitor in Combination with a Reverse Transcriptase
Inhibitor
- -------------------------------------------------------------------------------
COUNTRY APPLN NO. APPLN DATE STATUS PATENT NO. ISSUE DATE EXPIRY DATE
- -------------------------------------------------------------------------------
US 08/110,603 8/26/93 Allowed
- -------------------------------------------------------------------------------
3 of 6
<PAGE>
SCHEDULE A
DOCKET NO.: DM-6663
TITLE: Improved Pharmaceutical Formulations of Cyclic Urea Type Compounds
- -------------------------------------------------------------------------------
COUNTRY APPLN NO. APPLN DATE STATUS PATENT NO. ISSUE DATE EXPIRY DATE
- -------------------------------------------------------------------------------
US 08/208,243 3/9/94 Granted 5,559,110 9/24/96 3/9/2014
- -------------------------------------------------------------------------------
4 of 6
<PAGE>
SCHEDULE A
DOCKET NO.: DM-6751
TITLE: Method for Preparing N,N'-Disubstituted Cyclic Ureas
- -------------------------------------------------------------------------------
COUNTRY APPLN NO. APPLN DATE STATUS PATENT NO. ISSUE DATE EXPIRY DATE
- -------------------------------------------------------------------------------
US 08/469409 6/6/95 Granted 5,532,356 7/2/96 6/6/2015
- -------------------------------------------------------------------------------
5 of 6
<PAGE>
SCHEDULE A
DOCKET NO.: ***
TITLE: ***
FOREIGN FAMILY FOR ***
- -------------------------------------------------------------------------------
COUNTRY APPLN NO. APPLN DATE STATUS PATENT NO. ISSUE DATE EXPIRY DATE
- -------------------------------------------------------------------------------
***
- -------------------------------------------------------------------------------
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*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the commission.
6 of 6
<PAGE>
SCHEDULE B
DMP 450 DEVELOPMENT TIME LINE (1)
***
***
***
***
***
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the commission.
<PAGE>
EXHIBIT 10.2
AMENDMENT TO LICENSE AGREEMENT
This Amendment to License Agreement ("Amendment") is entered into as of
August 26, 1997, by and between Avid Corporation, a Pennsylvania corporation
("Licensee"), and The DuPont Merck Pharmaceutical Company, a Delaware general
partnership ("Licensor"), and amends certain terms of that certain License
Agreement dated December 18, 1996, between Licensee and Licensor (the
"Agreement"). Capitalized terms not defined herein shall have the meanings
given to them in the Agreement.
RECITALS
A. Licensee and Licensor have previously entered into the Agreement,
pursuant to which Licensor has licensed certain technology to Licensee.
B. Licensee and Licensor desire to amend certain terms of the Agreement
as set forth in this Amendment.
NOW, THEREFORE, for good and valuable consideration, Licensee and
Licensor hereby agree as follows:
1. AMENDMENTS. The Agreement is hereby amended as follows:
a. SECTION 1.10. In Section 1.10, the words "bismethanesulfonic
acid salt" in the fourth and fifth lines are hereby deleted, and the words
"and all salts thereof, and all esters of the vicinal dihydroxy group and all
salts thereof" are hereby inserted after the word "3-diazepin-2-one," in the
fourth line.
b. SECTION 3.05. In Section 3.05, the first two sentences are
hereby deleted, and the following sentences are hereby added to the beginning
of Section 3.05: "Licensee has the right to sublicense the rights granted it
pursuant to this Agreement to any unrelated, unaffiliated third party after
obtaining Licensor's prior written consent. Licensor agrees to consider any
request for consent to sublicense in good faith and shall not unreasonably
withhold or delay such consent. In the event Licensee sublicenses the rights
granted it hereunder to any unrelated, unaffiliated third party, then
Licensee shall pay Licensor *** of the cash equivalent of any
license fee and technology premium equity payment that Licensee receives it
from its Sublicensee ("Additional Payment").
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the commission.
<PAGE>
c. SECTION 6.01: In Section 6.01, insert the subsection
designation "(i)" after the section heading and before the first sentence and
add the following sentences as a new Section 6.01 (ii):
"(ii) Licensor shall reasonably cooperate with Licensee and shall
provide Licensee with copies of material filings and correspondence
pertaining to the prosecution and maintenance of the Patent Rights
("Patent Prosecution Activities") and give Licensee an opportunity to
comment thereon. Licensor shall consider requests made by Licensee to
pursue Patent Prosecution Activities, and shall make a good faith
determination of whether to pursue such Patent Prosecution Activities.
Licensor shall provide notice to Licensee of any decision by Licensor
to discontinue or to not pursue Patent Prosecution Activities in a
particular country promptly upon reaching such decision and, in the
case of a decision to discontinue Patent Prosecution Activities, no
less than *** before the discontinuance thereof. Upon
receipt of such notice, or in the event that Licensor fails to timely
pursue Patent Prosecution Activities, Licensee shall be free at its
own expense, to pursue, continue or discontinue any or all of the
Patent Prosecution Activities in that particular country. Upon the
request of Licensee, Licensor shall consider in good faith filing for
reissue patents with claims specifically directed to the Licensed
Compound and methods for its therapeutic use. Notwithstanding
anything to the contrary, failure by Licensor to perform any of its
obligations described in this Section 6.01 (ii) shall not be
considered a breach of this Agreement."
d. SECTION 11.03. Section 11.03 is hereby amended in its entirety
to read as follows:
"Both Licensor and Licensee may freely transfer or assign their rights and
obligations under this Agreement to any Affiliate without the prior consent
of the other party. Licensee may not assign its rights and obligations
under this Agreement to any unrelated, unaffiliated third party without the
prior written consent of Licensor and any attempted assignment without such
consent shall be void. Licensor agrees to consider any request for such an
assignment in good faith and shall not unreasonably withhold or delay its
consent thereto. As a condition to any transfer or assignment, the
transferee must agree to be bound by the obligations of the transferor.
Subject to the foregoing, this Agreement shall bind and inure to the
benefit of the parties and their respective successors and assigns."
e. SCHEDULE B. Schedule B is hereby amended in its entirety and
replaced with Schedule B in the form attached to this Amendment.
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the commission.
<PAGE>
2. ACKNOWLEDGEMENT. Licensor hereby acknowledges that, as of the date
hereof, Licensee has substantially complied with the Development Schedule and
has satisfied its *** under Section 5.01 of the Agreement.
3. GENERAL TERMS. The Agreement, as amended by this Amendment,
constitutes the entire agreement between Licensee and Licensor 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 *** 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.
IN WITNESS WHEREOF, Licensee and Licensor have each executed this
Amendment through an authorized officer as of the date written below.
AVID CORPORATION
By: /s/ illegible
---------------------------------------
Its: Executive Vice Pres & General Counsel
--------------------------------------
Date: August 26, 1997
-------------------------------------
THE DUPONT MERCK
PHARMACEUTICAL COMPANY
By: /s/ illegible
---------------------------------------
Its: President
--------------------------------------
Date: August 26, 1997
-------------------------------------
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the commission.
<PAGE>
SCHEDULE B
***
***
***
***
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the commission.
<PAGE>
EXHIBIT 11.1
TRIANGLE PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
COMPUTATION OF NET LOSS PER SHARE AND PRO FORMA NET LOSS PER SHARE
(UNAUDITED)
<TABLE>
THREE MONTHS NINE MONTHS THREE MONTHS NINE MONTHS
ENDED ENDED ENDED ENDED
SEPTEMBER 30, SEPTEMBER 30, SEPTEMBER 30, SEPTEMBER 30,
------------- ------------- ------------- -------------
1996 (1) 1996 (1) 1997 (2) 1997 (2)
------------- ------------- ------------- -------------
<S> <C> <C> <C> <C>
Historical weighted average
shares........................... 19,988,451 18,554,524
Pro forma historical weighted
average shares outstanding........ 4,107,643 4,925,945 -- --
Series A preferred stock,
convertible to Common Stock at
consummation of the initial
public offering.................. 5,231,671 5,231,671 -- --
Series B preferred stock,
convertible to Common Stock at
consummation of the initial
public offering.................. 3,706,234 3,706,234 -- --
Common stock equivalents for
preferred stock warrants
outstanding...................... -- -- -- --
Common stock equivalents for
options outstanding.............. -- -- -- --
----------- ----------- ------------ ------------
Shares used in computing pro
forma net loss per share......... 13,045,548 13,863,850 19,988,451 18,554,524
----------- ----------- ------------ ------------
----------- ----------- ------------ ------------
Net Loss.......................... $(2,538,859) $(8,038,277) $(18,214,006) $(27,374,905)
----------- ----------- ------------ ------------
----------- ----------- ------------ ------------
Pro forma net loss per share...... $ (0.19) $ (0.58) $ (0.91) $ (1.48)
----------- ----------- ------------ ------------
----------- ----------- ------------ ------------
</TABLE>
(1) Weighted average common stock outstanding during the period including
all common stock issued at prices below the public offering price
during the twelve month period preceding the offering as if it was
outstanding at inception (July 12, 1995). Issuance of convertible
preferred stock, preferred stock warrants and common stock options at
prices below the public offering price during the twelve month period
preceding the offering have been included as common stock equivalent
as if they had been issued as common stock as of July 12, 1995.
(2) The weighted average shares outstanding used in the calculation of net
loss per share do not include common stock equivalents because they
have the effect of reducing net loss per share.
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<LEGEND>
THE SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM FORM 10-Q FOR
THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 1997 AND IS QUALIFIED IN IT'S ENTIRETY
BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<S> <C>
<PERIOD-TYPE> 9-MOS
<FISCAL-YEAR-END> DEC-31-1997
<PERIOD-START> JAN-01-1997
<PERIOD-END> SEP-30-1997
<CASH> 45,288,572
<SECURITIES> 21,047,462
<RECEIVABLES> 320,358
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 66,981,727
<PP&E> 1,689,761
<DEPRECIATION> 0
<TOTAL-ASSETS> 68,758,389
<CURRENT-LIABILITIES> 5,333,306
<BONDS> 0
0
0
<COMMON> 19,995
<OTHER-SE> 63,061,006
<TOTAL-LIABILITY-AND-EQUITY> 68,758,389
<SALES> 0
<TOTAL-REVENUES> 0
<CGS> 0
<TOTAL-COSTS> 0
<OTHER-EXPENSES> 29,959,088
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (27,374,905)
<INCOME-TAX> 0
<INCOME-CONTINUING> (27,374,905)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (27,374,905)
<EPS-PRIMARY> 0
<EPS-DILUTED> 0
</TABLE>
