UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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
Commission file number: 0-15006
T CELL SCIENCES, INC.
(Exact name of registrant as specified in charter)
Delaware No. 13-3191702
(State of Incorporation) (I.R.S. Employer Identification No.)
119 Fourth Avenue, Needham, Massachusetts 02194-2725
(Address of principal executive offices) (Zip code)
(617) 433-0771
(Registrant's telephone number, including area code)
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 .
--- ---
Outstanding as of
Class November 12, 1997
----- -----------------
Common Stock, par value $.001 24,967,656
T CELL SCIENCES, INC.
Table of Contents
September 30, 1997
Page
----
Part I -- Financial Information
- -------------------------------
Condensed Consolidated Balance Sheet at September 30, 1997 and December 31, 1996.....................3
Condensed Consolidated Statement of Operations for the Quarters Ended
September 30, 1997 and 1996.................................................................4
Condensed Consolidated Statement of Operations for the Nine Months Ended
September 30, 1997 and 1996.................................................................5
Condensed Consolidated Statement of Cash Flows for the Nine Months Ended
September 30, 1997 and 1996.................................................................6
Notes to Condensed Consolidated Financial Statements.................................................7
Management's Discussion and Analysis of Financial Condition and Results of
Operations.........................................................................................9
Part II -- Other Information
- ----------------------------
Item 1. Legal Proceedings..........................................................................13
Item 5. Other Information..........................................................................13
Item 6. Exhibits and Reports on Form 8-K
A. Exhibits...............................................................................14
B. Reports on Form 8-K....................................................................14
Signatures..........................................................................................15
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
--------------------
T CELL SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEET
September 30, 1997 and December 31, 1996
September 30, December 31,
1997 1996
================================================================================
ASSETS
Current Assets:
Cash and Cash Equivalents $ 8,538,000 $ 12,591,800
Accounts Receivable 19,400 19,500
Inventories 5,200 24,000
Current Portion Note Receivable -- 400,600
Prepaid Expenses and Other 474,700 241,500
- --------------------------------------------------------------------------------
Total Current Assets 9,037,300 13,277,400
- --------------------------------------------------------------------------------
Property and Equipment, Net 403,900 511,600
Restricted Cash 585,000 685,000
Long-Term Note Receivable -- 1,402,100
Other Noncurrent Assets 1,477,300 1,347,600
- --------------------------------------------------------------------------------
Total Assets $ 11,503,500 $ 17,223,700
================================================================================
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts Payable $ 309,600 $ 326,000
Accrued Expenses 1,958,600 1,278,500
Deferred Revenue -- --
- --------------------------------------------------------------------------------
Total Current Liabilities 2,268,200 1,604,500
- --------------------------------------------------------------------------------
Other Liabilities 1,500,000 --
- --------------------------------------------------------------------------------
Stockholders' Equity:
Common Stock, $.001 Par Value 25,000 25,000
Additional Paid-in Capital 76,521,200 72,791,800
Less: Common Treasury Shares at Cost (35,800) (68,900)
Accumulated Deficit (68,775,100) (57,128,700)
- --------------------------------------------------------------------------------
Total Stockholders' Equity 7,735,300 15,619,200
- --------------------------------------------------------------------------------
Total Liabilities and
Stockholders' Equity $ 11,503,500 $ 17,223,700
================================================================================
See accompanying notes to condensed consolidated financial statements
3
T CELL SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
For the Quarters Ended September 30, 1997 and 1996
September 30, September 30,
1997 1996
================================================================================
OPERATING REVENUE:
Product Development and Licensing Agreements $ 48,500 $ 1,200
Product Sales 34,900 9,100
- --------------------------------------------------------------------------------
Total Operating Revenue 83,400 10,300
- --------------------------------------------------------------------------------
OPERATING EXPENSE:
Cost of Product Sales 16,800 6,100
Research and Development 1,269,700 1,520,800
General and Administrative 839,600 821,600
Marketing and Sales 15,400 108,700
- --------------------------------------------------------------------------------
Total Operating Expenses 2,141,500 2,457,200
- --------------------------------------------------------------------------------
Operating Loss (2,058,100) (2,446,900)
Non-Operating Income (Expense), Net (5,972,100) 171,800
- --------------------------------------------------------------------------------
Net Loss $ (8,030,200) $ (2,275,100)
================================================================================
Net Loss Per Common Share $ (0.32) $ (0.10)
================================================================================
Weighted Average Common Shares Outstanding 24,955,656 21,921,938
================================================================================
See accompanying notes to condensed consolidated financial statements
4
T CELL SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
For the Nine Months Ended September 30, 1997 and 1996
September 30, September 30,
1997 1996
================================================================================
OPERATING REVENUE:
Product Development and Licensing Agreements $ 803,900 $ 271,800
Product Sales 36,200 515,500
- --------------------------------------------------------------------------------
Total Operating Revenue 840,100 787,300
- --------------------------------------------------------------------------------
OPERATING EXPENSE:
Cost of Product Sales 17,200 357,200
Research and Development 4,088,600 4,448,900
General and Administrative 2,638,300 4,757,600
Marketing and Sales 86,300 391,700
- --------------------------------------------------------------------------------
Total Operating Expenses 6,830,400 9,955,400
- --------------------------------------------------------------------------------
Operating Loss (5,990,300) (9,168,100)
Non-Operating Income (Expense), Net (5,656,300) 733,500
- --------------------------------------------------------------------------------
Net Loss $(11,646,600) $(8,434,600)
================================================================================
Net Loss Per Common Share $ (0.47) $ (0.41)
================================================================================
Weighted Average Common Shares Outstanding 24,950,827 20,594,701
================================================================================
See accompanying notes to condensed consolidated financial statements
5
T CELL SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
For the Nine Months Ended September 30, 1997 and 1996
September 30, September 30,
1997 1996
================================================================================
Cash Flows from Operating Activities:
Net Loss $(11,646,600) $(8,434,600)
Adjustments to Reconcile Net Loss
to Net Cash
Used by Operating Activities:
Depreciation and Amortization 272,300 373,000
Gain on Sale of Research Products and
Operations of T Cell Diagnostics, Inc. -- (283,000)
Write-off of Capitalized Patent Costs 51,100 1,751,600
Settlement of Litigation with Former Landlord 6,109,200 --
Compensation Associated with Stock Options -- 170,300
Net Change in Current Assets and
Current Liabilities (409,600) (1,379,700)
- --------------------------------------------------------------------------------
Net Cash Used by Operating Activities (5,623,600) (7,802,400)
- --------------------------------------------------------------------------------
Cash Flows from Investing Activities:
Acquisition of Property and Equipment (70,300) (26,900)
Other Noncurrent Assets (175,100) (321,800)
Sale of Investment in Common Stock
of Endogen, Inc. 1,802,700 --
- --------------------------------------------------------------------------------
Net Cash Provided (Used) by Investing Activities 1,557,300 (348,700)
- --------------------------------------------------------------------------------
Cash Flows from Financing Activities:
Proceeds from Sale of Stock 12,500 11,600
Proceeds from Exercise of Stock Options -- 158,700
Proceeds from Issuance of Common Stock -- 10,068,600
- --------------------------------------------------------------------------------
Net Cash Provided by Financing Activities 12,500 10,238,900
- --------------------------------------------------------------------------------
Increase (Decrease) in Cash and Cash Equivalents (4,053,800) 2,087,800
Cash and Cash Equivalents at Beginning of Period 12,591,800 12,275,200
- --------------------------------------------------------------------------------
Cash and Cash Equivalents at End of Period $ 8,538,000 $14,363,000
================================================================================
See accompanying notes to condensed consolidated financial statements
6
T CELL SCIENCES, INC.
Notes to Condensed Consolidated Financial Statements
September 30, 1997
(1) Nature of Business
------------------
T Cell Sciences, Inc. (the "Company"), is a biopharmaceutical company
engaged in the discovery and development of innovative drugs targeting diseases
of the immune, inflammatory and vascular systems. The Company develops and
commercializes products on a proprietary basis and in collaboration with
established pharmaceutical partners, including Novartis Pharma AG, Astra AB and
Yamanouchi Pharmaceutical Co., Ltd. In March 1996, the Company sold
substantially all of the assets of its wholly-owned subsidiary, T Cell
Diagnostics, Inc. ("TCD"), while retaining all the rights to the TRAx(R)
diagnostic franchise.
The condensed consolidated financial statements include the accounts of
T Cell Sciences, Inc. and its wholly owned subsidiary, T Cell Diagnostics, Inc.
All intercompany transactions have been eliminated.
(2) Interim Financial Statements
----------------------------
The accompanying condensed consolidated financial statements for the
three and nine months ended September 30, 1997 and 1996 include the consolidated
accounts of the Company, and have been prepared in accordance with generally
accepted accounting principles and with the instructions to Form 10-Q and
article 10 of Regulation S-X. In the opinion of management, the information
contained herein reflects all adjustments, consisting solely of normal recurring
adjustments, that are necessary to present fairly the financial positions at
September 30, 1997 and December 31, 1996, the results of operations for the
three and nine months ended September 30, 1997 and 1996, and the cash flows for
the nine months ended September 30, 1997 and 1996. The results of operations for
the three and nine months ended September 30, 1997 are not necessarily
indicative of results for any future interim period or for the full year.
Certain information and footnote disclosures normally included in
financial statements prepared in accordance with generally accepted accounting
principles have been omitted, although the Company believes that the disclosures
included are adequate to make the information presented not misleading. The
condensed consolidated financial statements and the notes included herein should
be read in conjunction with footnotes contained in the Company's Annual Report
on Form 10-K for the year ended December 31, 1996.
(3) Litigation
----------
In December 1994, the Company filed a lawsuit in the Superior Court of
Massachusetts against the landlord of its former Cambridge, Massachusetts
headquarters, to recover the damages incurred by the Company resulting from the
evacuation of the building, due to air quality problems which caused skin and
respiratory irritation to a significant number of employees. The landlord
defendant filed counterclaims, alleging the Company breached its lease
obligations. The court ordered a limited trial between the Company and the
landlord on certain factual issues which began on November 20, 1996. Closing
arguments for the limited trial were heard on January 13, 1997. In a separate
lawsuit, the landlord's mortgagee filed claims against the Company for payment
of the same rent alleged to be owed. A motion for summary judgment filed by the
bank was denied by the court. In August 1997, the Superior Court of
Massachusetts entered findings of fact and conclusions of law on a limited trial
of the Company's lawsuit
7
against the landlord. In its findings on the limited trial, the Court concluded
that the Company had not proved at the limited trial that any fireproofing
fibers contaminated the Company's space, the Company's space was not
uninhabitable because of contamination from fireproofing fibers and the Company
was not justified in terminating its lease on the grounds that its office and
laboratories were uninhabitable. In November 1997, the Company reached a
settlement of the litigation with its former landlord and the landlord's
mortgagee. The Company agreed to pay $859,200 in cash on November 17, 1997 and
issue a total of 1,500,000 shares of its common stock. In addition, the Company
will also sign two notes for $750,000 each, due and payable on November 16, 1998
and November 15, 1999, respectively. The total settlement, valued at $6,109,200,
is comprised of the cash and notes totaling $2,359,200 and common stock valued
at $3,750,000 as of October 31, 1997 and has been recorded as non-operating
expense as of September 30, 1997. The common stock to be issued is subject to
restrictions on transfer per the settlement agreement. The settlement agreement
also provides for certain "piggyback" registration rights and demand
registration of the shares of common stock to become effective no later than
September 30, 1998. Upon such registration, however, the settlement agreement
limits the number of shares that may be sold over a given period of time. As
part of the settlement agreement, the Company will pledge as collateral $750,000
cash as security for the note due November 16, 1998. In addition, the note for
$750,000 due on November 15, 1999 will be secured by 132,500 of the shares of
common stock issued. The 132,500 shares may be returned to the Company or
retained under certain terms of the agreement.
(4) Disposition of Assets
---------------------
On March 5, 1996 the Company sold to Endogen, Inc. the research products
and operations of TCD for a purchase price of approximately $2,880,000, while
retaining the TRAx diagnostic product franchise. The consideration for this sale
was paid in the form of a convertible subordinated note receivable (the
"Convertible Note") in the principal amount of $2,003,000 and a combination of
cash and a short-term note used to repay approximately $980,000 of obligations
under the Company's operating lease. On February 10, 1997, the Company converted
the remaining outstanding principal balance of the Convertible Note into shares
of Endogen common stock which it subsequently sold. Net proceeds from the sale
were $1,829,000 and included an immaterial gain.
(5) Statement of Financial Accounting Standards No. 128, "Earnings per Share"
-------------------------------------------------------------------------
In February 1997, the Financial Accounting Standards Board issued Statement
of Financial Accounting Standards ("SFAS") No. 128, "Earnings per Share." SFAS
128 is effective for interim and annual periods ending after December 15, 1997.
The adoption of SFAS 128 is not expected to have a material impact in the
Company's net loss per share computation.
8
Safe Harbor Statement under the Private Securities Litigation Reform Act of
1995: Statements contained in the following, Item 2. Management's Discussion and
Analysis of Financial Condition and Results of Operations, that are not
historical facts may be forward-looking statements that are subject to a variety
of risks and uncertainties. There are a number of important factors that could
cause the actual results to differ materially from those expressed in any
forward-looking statements made by the Company. These factors include, but are
not limited to: (i) the Company's and its development and marketing partners'
ability to successfully complete product research and development, including
pre-clinical and clinical studies, and commercialization; (ii) the Company's
ability to obtain substantial additional funding; (iii) the Company's ability to
obtain required governmental approvals; (iv) the Company's ability to attract
manufacturing, sales, distribution and marketing partners and other strategic
alliances; and (v) the Company's ability to develop and commercialize its
products before its competitors.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
-------------------------------------------------------------------
AND RESULTS OF OPERATIONS
-------------------------
Overview
The Company's lead therapeutic program is focused on developing compounds
that inhibit complement activation which is part of the body's immune defense
system. In October 1997, the Company presented positive preliminary results from
the efficacy portion of its Phase I/II clinical trial of its lead therapeutic
compound, TP10. The trial was aimed at evaluating the ability of TP10 to reduce
reperfusion injury and improve lung function in patients with end-stage
pulmonary disease who were undergoing lung transplant surgery. The trial will
conclude in the fourth quarter of 1997 when the last patient completes a
six-month safety evaluation period. The Company initiated a Phase IIa clinical
trial to evaluate the use of TP10 in patients with adult respiratory syndrome in
January 1996. Completion of the Phase IIa trial is expected in the fourth
quarter of 1997. The Company also announced, in October 1997, that it had
entered into an option agreement with Novartis Pharma AG relating to the
development of TP10 for use in xenotransplantation (animal organs into humans)
and allotransplantation (human to humans). The option agreement provides for
annual option fees and supplies of TP10 for clinical trials in return for
granting a two-year option to license TP10 with exclusive worldwide marketing
rights (except Japan) in xenotransplantation and allotransplantation. In
February 1997, the Company was awarded a second $100,000 Phase I Small Business
Innovation Research ("SBIR") grant from the National Institute of Health ("NIH")
and in September the Company was awarded a $678,000 Phase II SBIR grant from the
NIH. Funding from the Phase I grant will contribute to the Company's program for
the development of a vaccine for the management of atherosclerosis. The Phase II
grant provides funding over a two-year period which will support research and
development of a novel transgenic rat model of atherosclerosis. In June 1997,
the Company received a milestone payment from its partner, Astra AB ("Astra"),
following approval received by Astra to initiate clinical trials for one of the
products derived from the TCAR technology platform for the treatment of multiple
sclerosis. In November 1997, the Company announced that it had reached a
settlement of its outstanding litigation with its former landlord. The
settlement, valued at $6,109,200, has been recorded as non-operating expense as
of September 30, 1997.
Results of Operations
Quarter Ended September 30, 1997 Compared to Quarter Ended September 30,
1996 -- The Company reported a consolidated net loss of $8,030,200 or $.32 per
share for the quarter ended September 30, 1997 compared with a net loss of
$2,275,100 or $.10 per share for the quarter ended September 30, 1996. Included
in the loss for the quarter ended September 30, 1997 is a charge to earnings of
$6,109,200 for a settlement that was reached in November 1997, of the Company's
outstanding litigation with its former landlord and the landlord's mortgagee.
Under the terms of the settlement, the Company has agreed to pay $859,200 in
cash on November 17,1997 and issue a total of 1,500,000 shares of its common
stock valued at $3,750,000 as of October 31, 1997. In addition, the Company will
also sign two notes for $750,000 each, due and payable on November 16, 1998 and
November 15, 1999, respectively. The total
9
settlement, valued at $6,109,200, is comprised of the cash and notes totaling
$2,359,200 and common stock valued at $3,750,000 as of October 31, 1997.
Excluding the settlement charge, the loss for the quarter is $1,921,000 or $.08
per share, a decrease of $354,100 or 15.6% compared to the same period last
year. The decrease for the quarter is primarily due to lower clinical trial
costs compared to the same period last year combined with a decrease in payroll
and benefits costs.
Research and development expenses were $1,269,700 for the quarter ended
September 30, 1997 compared to $1,520,800 for the same period last year. The
decrease is primarily due to a reduction in costs associated with the Phase I/II
and Phase IIa clinical trials for the quarter compared to the same period last
year. The clinical trials were initiated in July 1996 and January 1996,
respectively. Patient accrual was completed in the Phase I/II clinical trial in
May 1997. The trial will conclude in the fourth quarter following the six month
safety portion of the trial. The Phase IIa clinical trial is expected to
conclude in the fourth quarter.
General and administrative expenses increased to $839,600 for the quarter
ended September 30, 1997 from $821,600 for the comparable period last year. The
increase is primarily attributable to increased legal fees relating to the
Company's collaborative option agreement with Novartis Pharma AG and settlement
of the litigation, partially offset by a decrease in administrative payroll and
benefits costs.
Marketing and sales expenses decreased $93,300 to $15,400 for the quarter
ended September 30, 1997 compared to $108,700 for the quarter ended September
30, 1996. The decrease in marketing and sales expenses is primarily due to the
Company's reduced direct sales efforts for the TRAx(R) product line while it
focuses on establishing a partnership for the TRAx technology combined with a
decrease in sales and marketing payroll and benefit costs.
Non-operating expense of $5,972,100 for the quarter ended September 30,
1997 includes the $6,109,200 charge to earnings for the settlement of the
Company's litigation with its former landlord and the landlord's mortgagee.
Excluding the settlement charge, non-operating income reflects a 20.2% decrease
in interest income for the quarter, compared with the same period last year. The
decrease in interest income is primarily the result of lower cash balances
during the quarter ended September 30, 1997 compared with the quarter ended
September 30, 1996 partially offset by higher interest rates.
Nine months Ended September 30, 1997 Compared to Nine months Ended
September 30, 1996 -- The Company reported a consolidated net loss of
$11,646,600 or $.47 per share for the nine months ended September 30, 1997
compared with a net loss of $8,434,600 or $.41 per share for the nine months
ended September 30, 1996. Included in the loss for the nine months ended
September 30, 1997 is the charge to earnings of $6,109,200 for the settlement of
the Company's outstanding litigation with its former landlord and the landlord's
mortgagee. The nine months ended September 30, 1996 included two months of
operations of TCD prior to the sale of its research products and operations in
March 1996 and a gain recognized from the sale. The net loss for the first nine
months of 1997 increased $3,212,000 or 38.1% compared to the same period last
year due to the charge to earnings for the settlement of the litigation,
partially offset by a $1,751,600 write-off of certain capitalized patent costs
and a $425,300 charge to earnings resulting from a severance agreement with the
Company's former President and Chief Executive Officer included in the nine
months ended September 30, 1996. Excluding the settlement charge in 1997 and the
write-off of certain capitalized patent costs and charge to earnings resulting
from a severance agreement in 1996, the net loss for the nine months ended
September 30, 1997 decreased $720,300 or 11.5% to $5,537,400 or $.22 per share
compared to $6,257,700 or $.30 per share. The decrease compared to last year is
primarily due to expenses incurred during the two months of operations of TCD in
1996 prior to the sale combined with a decrease in payroll and benefits costs in
1997 partially offset by increased clinical trial costs and legal costs for the
nine months of 1997 compared to 1996.
For the nine months ended September 30, 1997, product development and
licensing agreements revenue increased $532,100 to $803,900 compared to $271,800
for the nine months ended September 30,
10
1996. The increase is primarily attributable to milestone payments received from
Astra in accordance with the amended agreement of December 1996. In addition,
the Company recognized approximately $153,900 of revenue relating to its SBIR
grants from the NIH. Included in product development and licensing agreements
revenue in 1996 is research and development funding from Astra relating to the
Company's earlier agreement and a $100,000 non-refundable execution fee
associated with a license agreement with CytoTherapeutics, Inc. Product sales
decreased $479,300 for the first nine months of 1997 compared to the same period
last year, primarily due to the sale of the research products and operations of
TCD in March 1996.
Research and development expenses were $4,088,600 for the nine months ended
September 30, 1997 compared to $4,448,900 for the same period last year. The
decrease is primarily attributed to the sale of the research products and
operations of TCD in March 1996 partially offset by increased costs associated
with two clinical trials initiated in 1996.
General and administrative expenses decreased $2,119,300 to $2,638,300 for
the nine months ended September 30, 1997 from $4,757,600 for the comparable
period last year. The decrease is primarily due to the $425,300 charge in June
1996 resulting from a severance agreement with its former President and Chief
Executive Officer combined with the $1,751,600 write-off of certain capitalized
patent costs in June 1996.
Marketing and sales expenses decreased 78.0% to $86,300 for the nine months
ended September 30, 1997 compared to $391,700 for the nine months ended
September 30, 1996. The decrease in marketing and sales expenses is primarily
due to the sale of the research products and operations of TCD in March 1996
combined with the Company's reduced direct sales efforts for the TRAx product
line while it focuses on establishing a partnership for the TRAx technology.
For the nine months ended September 30, 1997, non-operating expense is
$5,656,300 compared to non-operating income of $733,500 for the nine months
ended September 30, 1996. Included in non-operating expense for the nine months
ended September 30, 1997 is a $6,109,200 charge from the settlement of the
Company's litigation with its former landlord and the landlord's mortgagee. The
nine months ended September 30, 1996 included a $283,000 gain recognized from
the sale of the research products and operations of TCD in March 1996. Interest
income increased 11.1% for the nine months ended September 30, 1997 compared
with the same period last year. The increase in interest income is primarily the
result of higher cash balances during the nine months ended September 30, 1997
compared with the nine months ended September 30, 1996.
Liquidity and Capital Resources
The Company's cash and cash equivalents at September 30, 1997 was
$8,538,000 compared to $12,591,800 at December 31, 1996. Cash used in operations
was $5,623,600 for the nine months ended September 30, 1997 which was partially
offset by $1,829,000 received from the conversion and subsequent sale of the
convertible subordinated note receivable from Endogen, Inc. The Company received
the convertible subordinated note receivable in connection with the sale of the
research products and operations of TCD in March 1996. On February 10, 1997 the
Company converted the remaining outstanding principal balance of $1,802,700 into
shares of common stock of Endogen and subsequently sold the shares.
As discussed in the Company's annual report, filed on Form 10-K, for the
year ended December 31, 1996, the Company filed a lawsuit in the Superior Court
of Massachusetts, in December 1994, against the landlord of its former
Cambridge, Massachusetts headquarters, to recover the damages incurred by the
Company resulting from the evacuation of the building due to air quality
problems which caused skin and respiratory irritation to a significant number of
employees. The landlord defendant filed counterclaims, alleging the Company
has breached its lease obligations. In a separate lawsuit, the
11
landlord's mortgagee filed claims against the Company for payment of the
same rent alleged to be owed. In August 1997, the Superior Court of
Massachusetts entered findings of fact and conclusions of law on a limited trial
of the Company's lawsuit against the landlord. In its findings on the limited
trial, the Court concluded that the Company had not proved at the limited trial
that any fireproofing fibers contaminated the Company's space, the Company's
space was not uninhabitable because of contamination from fireproofing fibers
and the Company was not justified in terminating its lease on the grounds that
its office and laboratories were uninhabitable. In November 1997, the Company
reached a settlement of the litigation with its former landlord and the
landlord's mortgagee. The Company agreed to pay $859,200 in cash on November
17,1997 and issue a total of 1,500,000 shares of its common stock. In addition,
the Company will also sign two notes for $750,000 each, due and payable on
November 16, 1998 and November 15, 1999, respectively. The total settlement,
valued at $6,109,200, is comprised of the cash and notes totaling $2,359,200 and
common stock valued at $3,750,000 as of October 31, 1997 and has been recorded
as non-operating expense as of September 30, 1997. The common stock to be issued
is subject to restrictions on transfer per the settlement agreement. The
settlement agreement also provides for certain "piggyback" registration rights
and demand registration of the shares of common stock to become effective no
later than September 30, 1998. Upon such registration, however, the settlement
agreement limits the number of shares that may be sold over a given period of
time. As part of the settlement agreement, the Company will pledge as collateral
$750,000 cash as security for the note due November 16, 1998. In addition, the
note for $750,000 due on November 15, 1999 will be secured by 132,500 of the
shares of common stock issued. The 132,500 shares may be returned to the Company
or retained under certain terms of the agreement.
The Company believes its current cash and cash equivalents, combined
with anticipated net cash provided by operations will be sufficient to meet
working capital requirements into 1998. These requirements will depend on
several factors including, but not limited to, the progress and costs associated
with research and development programs; preclinical and clinical studies; time
and costs associated with obtaining regulatory approval; and timing and scope of
collaborative arrangements; long term facility costs. The Company will consider
alternative sources of funding and capital when available and appropriate.
In February 1997, the Financial Accounting Standards Board issued
Statement of Financial Accounting Standards ("SFAS") No. 128, "Earnings per
Share." SFAS 128 is effective for interim and annual periods ending after
December 15, 1997. The adoption of SFAS 128 is not expected to have a material
impact in the Company's net loss per share computation.
12
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
-----------------
In August 1997, the Superior Court of Massachusetts entered findings of
fact and conclusions of law on a limited trial of the Company's lawsuit against
the landlord of its former Cambridge, Massachusetts headquarters. The Company
was seeking to recover damages it incurred as a result of the evacuation of the
building due to air quality problems caused by contamination by fireproofing
fibers. The landlord defendant filed a counterclaim alleging the Company
breached its lease obligations. In its findings on the limited trial, the Court
concluded that the Company had not proved at the limited trial that any
fireproofing fibers contaminated the Company's space, the Company's space was
not uninhabitable because of contamination from fireproofing fibers and the
Company was not justified in terminating its lease on the grounds that its
office and laboratories were uninhabitable.
In November 1997, the Company reached a settlement of its outstanding
litigation with the landlord of its former Cambridge, Massachusetts headquarters
and the landlord's mortgagee. The Company agreed to pay a total of $2,359,200 in
cash with $859,200 payable on November 17, 1997 and additional payments of
$750,000 each on November 16, 1998 and November 15, 1999. In addition, the
Company will issue a total of 1,500,000 shares of its common stock to its former
landlord and the parties will exchange mutual releases (see "Management's
Discussion and Analysis of Financial Condition and Results of Operations -
Liquidity and Capital Resources").
ITEM 5. OTHER INFORMATION
-----------------
In August 1997, the Company announced the election of William J. Ryan to
its Board of Directors. Mr. Ryan currently provides business, legal and
financing advice to a number of companies, principally in the fields of
healthcare and biotechnology. He serves on the Board of Directors and is
Executive Vice President for strategic planning and new business development for
Arquest, Inc., a privately held manufacturing company. Mr. Ryan's election
increased the number of board members to nine.
The Company announced the retirement of James D. Grant as Chairman and a
member of its Board of Directors on September 3, 1997. Mr. Grant had been
Chairman of the Board since November 1986 and had also served as Chief Executive
Officer of the Company from November 1986 to February 1992 and from May 1996 to
August 1996. The Company concurrently announced the retirement of John P. Munson
from the Board, a member since 1992.
The Company received a Phase II Small Business Innovation Research grant to
support research and development of a novel transgenic rat model of
atherosclerosis. The Company plans to use the model as part of its efforts to
develop a vaccine approach to preventing atherosclerosis. The grant provides
$678,000 to the Company over a two-year period. The Company announced the award
in September 1997.
Two separate announcements were made in October 1997 relating to the
Company's lead therapeutic compound, TP10. The Company presented positive
preliminary results from the efficacy portion of its Phase I/II clinical trial
using TP10. The trial was aimed at evaluating the ability of TP10 to reduce
reperfusion injury and improve lung function in patients with end-stage
pulmonary disease who were undergoing lung transplant surgery. Patient accrual
began in August 1996 and was completed in May 1997. The results showed that 24
hours after surgery significantly fewer of the patients receiving TP10 require
ventilation as compared to those receiving placebo. Moreover, a subgroup of
patients who received TP10 and also underwent cardiopulmonary bypass as part of
the transplantation procedure showed significantly decreased intubation time and
time on ventilation. Reduction in the time that a patient requires intubation
and mechanical ventilation typically translates to better clinical outcome and
13
also implies an economic benefit from reduced time in the ICU. Concurrent with
the preliminary efficacy results from its clinical trial, the Company announced
that it had entered into an option agreement with Novartis Pharma AG, Basel,
Switzerland, relating to the development of TP10 for use in xenotransplantation
(animal organs into humans) and allotransplantation (human to human). In
exchange for granting Novartis a two-year option to license TP10 with exclusive
worldwide marketing rights (except Japan), in the fields of xenotransplantation
and allotransplantation, the Company will receive annual option fees and
supplies of TP10 for clinical trials, the combination of which are valued at up
to $5 million. Should Novartis exercise its option to license TP10 and continue
development, it will provide an equity investment, licensing fees and milestone
payments based upon attainment of certain development and regulatory goals. The
combined option agreement and license is valued at up to $25 million. The
Company may also receive funding for research as well as royalty payments on
eventual product sales.
In October 1997, the Company announced a collaborative agreement with
Repligen, Inc. designed to utilize the Company's proprietary screening and
functional assay technology to identify small molecule immunoregulatory
therapeutic compounds using Repligen's combinatorial chemistry library.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
--------------------------------
A. Exhibits
10.16 Option Agreement by and between the Company and Novartis Pharma AG
dated as of October 31, 1997
B. Reports on Form 8-K
The Company reported on Form 8-K, dated August 26, 1997, the findings of
the Superior court of Massachusetts in litigation relating to the Company's
former headquarters in Cambridge, Massachusetts.
14
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
T CELL SCIENCES, INC.
By: /s/ Norman W. Gorin
------------------------
Norman W. Gorin
Vice President, Finance
and Chief Financial Officer
15
OPTION AGREEMENT
by and between
T CELL SCIENCES, INC.
and
NOVARTIS PHARMA AG
Dated as of October 13, 1997
TABLE OF CONTENTS
-----------------
ARTICLE I DEFINITIONS................................................................2
ARTICLE II GRANT OF OPTION............................................................7
2.1 Option.............................................................7
2.2 Sub-licensing......................................................7
2.3 Rights in Japan....................................................8
2.4 Exercising the Option..............................................9
2.5 Delivery of Schedules to the Stock Purchase Agreement.............11
ARTICLE III OPTION PAYMENT............................................................11
ARTICLE IV EXTENSION OF OPTION PERIOD................................................12
4.1 Extension of the Option Period....................................12
4.2 Consideration for Extension of the Option Period..................12
ARTICLE V SUPPLY OF TP-10 DURING OPTION PERIOD......................................13
ARTICLE VI TRANSFER OF KNOW-HOW......................................................13
ARTICLE VII INDEMNIFICATION AND HOLD HARMLESS.........................................14
7.1 Novartis Indemnity................................................14
7.2 TCS Indemnity.....................................................15
7.3 Indemnity Procedure...............................................15
7.4 Insurance ........................................................16
ARTICLE VIII CONFIDENTIALITY...........................................................16
8.1 Confidentiality Obligations.......................................16
8.2 Prior Confidentality Agreements..................................17
8.2 Public Announcement...............................................18
ARTICLE IX CLEARANCE OF PUBLICATIONS.................................................18
ARTICLE X OWNERSHIP OF PATENT RIGHTS AND KNOW-HOW...................................19
ARTICLE XI NOTICES...................................................................19
ARTICLE XII TERM OF THIS AGREEMENT....................................................21
ARTICLE XIII TERMINATION OF THIS AGREEMENT.............................................21
13.1 Termination by NOVARTIS.........................................21
13.2 Termination for Breach..........................................21
13.3 Termination for Insolvency......................................21
13.4 Effect of Termination or Expiry of Option.......................22
ARTICLE XIV SURVIVABILITY.............................................................22
ARTICLE XV RIGHT TO EXTEND TO AFFILIATES.............................................23
ARTICLE XVI ASSIGNMENT................................................................23
ARTICLE XVII MUTUAL REPRESENTATIONS AND WARRANTIES.....................................23
17.1 Representations and Warranties..................................23
17.2 Representation and Warranties of TCS............................24
17.3 Warranties of Novartis..........................................25
17.4 Exclusion of Warranties.........................................25
17.5 Exclusion of Consequential Loss.................................26
ARTICLE XVIII ARBITRATION AND CONSTRUCTION..............................................26
18.1 Law.............................................................26
18.2 Dispute Resolution..............................................26
18.3 Arbitration.....................................................27
ARTICLE XIX FORCE MAJEURE.............................................................27
ARTICLE XX MISCELLANEOUS.............................................................28
20.1 Severability....................................................28
20.2 No Exclusion of Legal Rights....................................28
20.3 Survival........................................................28
20.4 Entire Agreement................................................29
20.5 No License......................................................29
20.6 Adverse Event Reporting.........................................29
20.7 Waiver..........................................................30
20.8 Relationship to the Parties.....................................30
20.9 Language........................................................30
20.10 Titles..........................................................31
APPENDICES
----------
APPENDIX A LICENSE AGREEMENT........................................................A-1
APPENDIX B LICENSED PROTEIN.........................................................A-2
APPENDIX C TCS PATENT...............................................................A-3
APPENDIX D SAMPLE INVOICE...........................................................A-4
APPENDIX E LIST OF CONTRACTING AGREEMENTS...........................................A-5
APPENDIX F JAPAN PATENTS............................................................A-6
APPENDIX G STOCK PURCHASE AGREEMENT.................................................A-7
3
OPTION AGREEMENT
THIS AGREEMENT, made and entered into as of October 13, 1997 (the
"Effective Date") by and between T CELL SCIENCES, INC., a corporation organized
and existing under the laws of the State of Delaware, U.S.A., having its
principal offices at 119 Fourth Avenue, Needham, MA 02194, U.S.A. (hereinafter
referred to as "TCS") and NOVARTIS PHARMA AG, a corporation organized and
existing under the laws of Switzerland, having its principal offices at
Lichstrasse 35, CH-4002 Basel, Switzerland (hereinafter referred to as
"Novartis").
WHEREAS TCS owns or controls and/or has the right to grant licenses to
certain patent rights and know-how relating to a protein known as soluble
complement receptor type 1 ("sCR1") and derivatives thereof, methods of their
production, including recombinant methods employing genes coding for their
expression, and human therapeutic uses thereof, including uses of such genes in
gene therapy or genetically modified organs and tissues; and
WHEREAS Novartis wishes to evaluate its interest in undertaking,
independently and at its own cost, expense and risk, further developmental
studies of such protein, derivatives or genes with the objective of developing
products for use in the Field (as hereinafter defined), including both
allotransplantation (i.e., same species), and more particularly,
xenotransplantation (i.e., cross-species); and
WHEREAS Novartis wishes to obtain from TCS and TCS wishes to grant to
Novartis an exclusive option to enter into an exclusive worldwide license
relating to such protein, derivatives and genes and their use in the Field.
WITNESSETH
----------
NOW, THEREFORE in consideration of the covenants and obligations
hereinafter contained and intending to be legally bound the Parties (as
hereinafter defined) do hereby agree as follows:
4
ARTICLE I
---------
DEFINITIONS
-----------
Unless specifically provided otherwise, the terms in this Agreement
with initial letters capitalized, whether used in the singular or plural, shall
have the meaning set forth below or the meaning as designated in places
throughout the Agreement.
1.1 "Affiliate" of any Party shall mean any corporation or other business entity
controlling, controlled by or under common control with such Party. "Control"
(including "controlling", "controlled by" and "under common control with") of
any Party, corporation or other business entity shall mean the direct or
indirect beneficial ownership of more than fifty percent (50%) of the voting
stock of, or more than a fifty percent (50%) interest in the income of such
corporation or other business entity or such other direct or indirect interest
or relationship as in fact constitutes actual control.
1.2 "Effective Date" shall mean the date first set forth above.
1.3 "Field" shall mean transplantation, including both allotransplantation and
xenotransplantation, in humans. The Field shall not extend to genetically
modified cells expressing Licensed Protein for the purpose of treating diseases
not associated with the maintenance and/or sustenance of an organ or tissue
transplanted for the purpose of supplementing or replacing non functional or
dysfunctional organ and/or tissue.
1.4 "Japan Agreement" shall mean the Product Development and Joint License
Agreement, dated as of January 23, 1990, by and among TCS, SB (as hereinafter
defined) and YPC (as hereinafter defined).
1.5 "Japan Patents" shall mean the patents listed in Appendix F hereto.
1.6 "Japan Technology" shall mean any and all information which relates to
TP10-HD and the injectable non-colloidal dose form of TP10-HD sold for
therapeutic use in humans including without limitation biological,
pharmacological, preclinical, clinical, chemical, biochemical, toxicological,
manufacturing and formulation information, data and developments, whether or not
capable of precise separate description but which alone or when accumulated is
or may be useful in the study, testing, development, production, formulation or
use of TP10-HD or the injectable non-colloidal dose form of TP10-HD sold for
therapeutic use in humans which is known to and/or possessed by TCS during the
life of the
5
Japan Agreement, subject to any obligation of TCS to maintain information of
third parties confidential excluding information of third parties obtained under
other agreements.
1.7 "Joint Patents" shall mean any patents and patent applications which are or
become controlled jointly by Novartis or an Affiliate and TCS or an Affiliate as
of the Effective Date or during the term of this Agreement or the License
Agreement and relating to Licensed Materials or Licensed Products, their
manufacture or use. Joint Patents shall include all divisionals, continuations,
continuations-in-part, reissues, extensions, re-examinations or registrations
thereof and any supplementary or complementary protection certificates and the
like.
1.8 "Know-How" shall mean all information and data, technical information, trade
secrets, specifications, instructions, processes, formulae, expertise and
information relating to the Licensed Materials or Licensed Products or any
improvement including, without limitation: (i) biological, chemical,
pharmacological, biochemical, toxicological, pharmaceutical, physical and
analytical, safety, quality control, manufacturing, preclinical and clinical
data, instructions, processes, formulae, expertise and information, including
Monitoring Technology, relevant to the manufacture, use or sale of and/or which
may be useful in studying, testing, the development, production, formulation or
use of the Licensed Materials or intermediates for the synthesis thereof, or the
Licensed Products; and (ii) copies of any IND or NDA or other health
registration documents and amendments or supplements thereto filed with the FDA
or other governmental, regulatory or health authorities in the Territory and all
correspondence to and from such agency relevant to the Licensed Materials or
Licensed Products which is known to and/or possessed and/or acquired by TCS, its
Affiliates or its licensees ("TCS Know-How") or Novartis, its Affiliates or its
sub-licensees ("Novartis Know-How").
1.9 "License Agreement" shall mean the License Agreement attached hereto as
Appendix A.
1.10 "Licensed Gene" shall mean a gene, whether natural or man-made, coding for
the expression of a Licensed Protein (as hereinafter defined).
1.11 "Licensed Gene Therapy Product" shall mean any product other than a
Licensed Organ or Tissue (as hereinafter defined), for use in gene therapy in
humans and comprising a Licensed Gene, the manufacture, use or sale of which
would, but for a license, constitute infringement of a Valid Claim (as
hereinafter defined) of TCS Patents or Joint Patents (as hereinafter defined) or
which incorporates or embodies TCS Know-How (as hereinafter defined).
6
1.12 "Licensed Materials" shall mean Licensed Proteins, Licensed Genes and
Licensed Organs or Tissues.
1.13 "Licensed Organ or Tissue" shall mean an organ or tissue, including an
animal organ or tissue, which has been genetically modified to insert a Licensed
Gene.
1.14 "Licensed Organ or Tissue Product" shall mean a product which is or
comprises a Licensed Organ or Tissue, for use in the Field, the manufacture, use
or sale of which would, but for a license, constitute infringement of a Valid
Claim of TCS Patents or Joint Patents or which incorporates or embodies TCS
Know-How.
1.15 "Licensed Products" shall mean Licensed Protein Products, Licensed Gene
Therapy Products and Licensed Organs and Tissue Products.
1.16 "Licensed Protein" shall mean sCR1 (having the amino acid sequence
identified in Appendix B hereto) and alleles thereof and analogs, fragments or
derivatives thereof, whether glycosylated, non-glycosylated or of altered
glycosylation (other than derivatives having a carbohydrate moiety which is a
ligand for a cell adhesion molecule, such as sialyl Lewis x. Licensed Protein
shall include the substance referred to by TCS as "TP-10" also known as
"TP10-HD".
1.17 "Licensed Protein Product" shall mean any product, in finished
pharmaceutical form, comprising a Licensed Protein, the manufacture, use or sale
of which would, but for a license, constitute infringement of a Valid Claim of
TCS Patents or Joint Patents, or which incorporates or embodies TCS Know-How.
1.18 "Monitoring Technology" shall mean all technology relating to the detection
or monitoring of levels of the Licensed Materials or Licensed Products, or
metabolites thereof, in bodily fluids (such as blood), including, without
limitation, antibodies (such as monoclonal or polyclonal antibodies),
hybridomas, haptens, tracer compounds, immunogens, methods, assays (such as
ELISAs, RIAs, FPIAs and other solid phase immunoassays) and kits, and all
proprietary data, instructions, processes, formulae, expertise and information
relating thereto.
1.19 "Novartis Patents" shall mean any patents and patent applications which are
or become owned or controlled by Novartis or an Affiliate thereof as of the
Effective Date or during the term of this Agreement or the License Agreement,
and relating to the Licensed Materials or Licensed Products, their manufacture
or use. Novartis Patents shall include all divisionals, continuations,
continuations-in-part, reissues, extensions, re-examinations or registrations
thereof and any supplementary or complementary protection
7
certificates and the like. Novartis Patents shall also include Novartis' or an
Affiliate's share of any Joint Patent or patent rights jointly owned by Novartis
or such Affiliate thereof in the event that Novartis or such Affiliate has not
acquired the right to license all joint owners' shares under such patent rights.
1.20 "Option Period" shall mean a period of two (2) years from the Effective
Date hereof and any extension thereof as set forth in Article 4.
1.21 "Option Year" shall mean a twelve (12) month period commencing on the
Effective Date and each twelve (12) month period thereafter during the term of
this Agreement.
1.22 "Party" shall mean either TCS or Novartis as the context requires and
"Parties" shall mean, collectively, TCS and Novartis.
1.23 "Proprietary Information" shall mean and include, without limitation,
information and data of one Party provided to the other in connection with this
Agreement, including TCS Know-How, TCS Patents, Novartis Know-How, Novartis
Patents, Joint Patents and all other scientific, clinical, regulatory,
marketing, financial, and commercial information or data, whether communicated
in writing or orally or by other means.
1.24 "Smithkline Agreement" shall mean the Product Development and License
Option Agreement, dated as of October 21, 1994, between TCS and SB pursuant to
which SB had rights under certain TCS patents in geographic areas other than
Japan.
1.25 "Stock Purchase Agreement" shall mean the Stock Purchase Agreement attached
hereto as Appendix G.
1.26 "TCS Patents" shall mean all patent and patent applications owned or
controlled (with the right to grant sub-licenses) by TCS or an Affiliate
thereof, as of the Effective Date or during the term of this Agreement or the
License Agreement, and relating to the Licensed Materials or Licensed Products,
their manufacture, or their use in the Field. TCS Patents existing as of the
Effective Date are set forth in Appendix C and TCS Patents obtained or acquired
by, or licensed to TCS or an Affiliate thereof during the term of this Agreement
or the License Agreement shall be promptly added to said Appendix. TCS Patents
shall include all divisionals, continuations, continuations-in-part,
re-examinations, reissues, extensions, registrations and supplementary or
complementary certificates and the like. TCS Patents shall also include TCS', or
an Affiliate's, share of any Joint Patent or patent rights jointly owned by TCS
or such Affiliate
8
thereof in the event that TCS or such Affiliate has not acquired the right to
license all joint owners' shares under such patent rights.
1.27 "Territory" shall mean the world.
1.28 "Valid Claim" shall mean a claim from any issued patent which has not been
revoked or held invalid or unenforceable by a decision of a court or other
government agency of competent jurisdiction, which decision is unappealable or
unappealed within the time allowed for appeal.
ARTICLE II
----------
GRANT OF OPTION
---------------
2.1 Option
Subject to the terms of this Agreement, TCS hereby grants to Novartis
and Novartis hereby accepts the exclusive option to enter into an exclusive,
royalty-bearing license, under and to the TCS Patents and TCS Know-How, to (a)
develop, have developed, import, make or have made for use, and to use, in the
Territory, the Licensed Materials, other than TP10-HD in an injectable
non-colloidal dose form in Japan, in the Field, (b) develop, have developed,
import, use, make or have made, offer for sale, sell and otherwise distribute in
the Territory, Licensed Protein in, or in connection with, Monitoring Technology
in the Field and (c) develop, have developed, import, make, have made for use,
sale, distribution and offer for sale and to use, sell, distribute and offer to
sell in the Territory, the Licensed Products, other than the injectable
non-colloidal dose form of TP10-HD in Japan, in the Field (hereinafter referred
to as "License"); provided, that, the limitations in the License on rights in
Japan are subject to the terms of Section 2.3 hereof and Section 2.3 of the
License Agreement. Said exclusive option shall be exercisable in accordance with
Section 2.4 hereof.
2.2 Sub-licensing
The License shall include the right to sub-license provided that (i)
Novartis warrants that any sub-licensee agrees to be bound by the applicable
terms of this Agreement; and (ii) Novartis guarantees the performance of any
sub-licensee and TCS shall be entitled to treat as a breach of this Agreement by
Novartis any failure of performance or lack of performance by any sub-licensee
as the case may be, for all purposes and subject to Article 13 hereof. Such
sub-license shall not include the right to sub-license.
9
2.3 Rights in Japan
(a) Under the terms of the Japan Agreement, TCS granted to Smithkline
Beecham, p.l.c. ("SB") and Yamanouchi Pharmaceutical Co., Ltd. ("YPC") the
co-exclusive right (including the right to sub-license) to practice under the
Japan Patents and Japan Technology to make, have made, use and sell the
injectable non-colloidal dose form of TP10-HD sold for therapeutic use in humans
in Japan. In the Letter Agreement, dated April 7, 1994, between TCS and SB,
terminating the Smithkline Agreement, (i) TCS and SB acknowledged the continuing
existence of the Japan Agreement and the need to modify the Japan Agreement in
light of the termination of the Smithkline Agreement, and (ii) TCS assumed SB's
obligations to YPC under the Japan Agreement.
The Parties acknowledge and agree that, Novartis wishes to obtain from TCS, and
TCS wishes to grant to Novartis, an exclusive option to the rights more
specifically discussed in Section 2.3(c) below. Towards this end, TCS shall make
diligent efforts, during the Option Period to terminate all rights held by SB
under the Japan Agreement and to gain for TCS clear title to the rights now held
by SB under the Japan Agreement (the "SB Rights"), in such a way as to retain,
along with YPC, a co-exclusive right to make, have made, use and sell the
injectable non-colloidal dose form of TP10-HD in Japan. All costs and expenses,
including but not limited to, payments made to SB and/or YPC, associated with
these efforts shall be borne by TCS.
(b) In the event that TCS is not able to gain clear title to the SB
Rights by the end of the first Option Year; provided, that, TCS is not at that
time in negotiations which the Parties agree have a reasonable chance of success
within the next three (3) months, Novartis shall have the right, beginning at
the start of the second Option Year, to enter into negotiations directly with SB
and, if necessary, YPC to have the SB Rights revert to TCS. All payments made by
Novartis to SB, YPC and TCS in connection with these efforts to gain clear title
for TCS to the SB rights, or any of their respective Affiliates or sub-licensees
in connection with these negotiations, shall be deducted, at the time the
License Agreement and the Stock Purchase Agreement are entered into and the
license granted and stock issued, from (i) the down payment to be made by
Novartis to TCS pursuant to Section 3.1 of the License Agreement and (ii) if
such payments exceed the amount of such down payment, the payment to be made by
Novartis to TCS pursuant to Section 1.3 of the Stock Purchase Agreement.
(c) Upon TCS' obtaining clear title to the SB Rights, the License, as
defined in Section 2.1 hereof automatically shall be expanded to include a
co-exclusive with YPC, royalty-bearing license, in Japan, under and to the TCS
Patents and TCS Know-How, to (i) develop, have developed, import, make or have
made for use, and to use TP10-HD in an injectable non-colloidal dose form in the
Field and (ii) develop,
10
have developed, import, make, have made for use, sale, distribution and offer
for sale and to use, sell, distribute and offer to sell the injectable
non-colloidal dose form of TP10-HD in the Field. The Parties agree that, in the
event that TCS assumes all of the rights and obligations of SB under the Japan
Agreement unless otherwise agreed to by the Parties in writing, TCS shall extend
to Novartis, and Novartis shall accept from TCS, pursuant to the License
Agreement, all rights required by Novartis to possess the license described
above in this paragraph and only those obligations of the Japan Agreement (i)
reasonably acceptable to Novartis and (ii) related to the license granted to
Novartis under the License Agreement in connection with the injectable
non-colloidal dose form of TP10-HD in the Field in Japan. For example,
notwithstanding the terms of the Japan Agreement or any renegotiated version of,
or amendment to, the Japan Agreement, Novartis shall have no rights or
obligations in connection with making, using or selling a Licensed Product or
Licensed Protein in, or in connection with, Monitoring Technology outside the
Field.
2.4 Exercising the Option
(a) Updating Representations and Warranties of the Stock Purchase
Agreement. During the Option Period, Novartis shall have the right from time to
time to notify TCS in writing that it is contemplating exercising the option,
and requests TCS to provide it, within five (5) business days, with then current
Schedules provided for in Section 2 of the Stock Purchase Agreement, containing
such information concerning developments or occurrences since the Effective Date
of this Agreement as is necessary to cause the representations and warranties
contained in Section 2 of the Stock Purchase Agreement to be true and correct.
Such notification by Novartis and receipt of the Schedules as provided for in
this paragraph shall not obligate Novartis to exercise its option at that time.
(b) Exercising the Option. At such time as Novartis decides to exercise
the option, Novartis shall notify TCS in writing, and the Parties shall agree
upon a time and place for the execution of the License Agreement and the Stock
Purchase Agreement and the closing of the sale and purchase of the Shares (as
defined in the Stock Purchase Agreement) (the "Closing"). Unless otherwise
agreed to by the Parties, the date of the Closing (the "Closing Date") shall be
no later than ten (10) business days after the date on which Novartis notifies
TCS of its intention to exercise the option.
(c) The Closing.
11
(i) Deliveries by TCS. At the Closing, TCS shall deliver to
Novartis the following:
(A) An opinion of Goodwin, Procter & Hoar, counsel for TCS, in
a form reasonably acceptable to Novartis, addressed to Novartis and dated the
Closing Date, mirroring the representations and warranties of TCS set forth in
Sections 2.1, 2.2(a),(c) and (d), 2.3 (a) and (b)(ii)(iii), 2.4, 2.5 (with
respect to governmental agencies and bodies only), 2.7 (last sentence only) of
the Stock Purchase Agreement;
(B) An executed License Agreement and an executed Stock
Purchase Agreement, subject to the same Schedules of exceptions last provided to
Novartis pursuant to Section 2.4(a) of this Agreement; and
(C) The stock certificate, registered in the name of Novartis,
representing the Shares.
(ii) Deliveries of Novartis. Subject to TCS making the deliveries
set forth in Section 2.4(c)(i) of this Agreement, at the Closing, Novartis shall
deliver to TCS the following:
(A) An executed License Agreement and an executed Stock
Purchase Agreement, subject to the same Schedules of exceptions last provided to
Novartis pursuant to Section 2.4(a) of this Agreement; and
(B) The payments required pursuant to Section 3.1 of the
License Agreement and Section 1.3 of the Stock Purchase Agreement.
2.5 Delivery of Schedules to the Stock Purchase Agreement.
Attached as Appendix G hereto is a true and correct set of Schedules provided
for in Section 2 of the Stock Purchase Agreement. This set of Schedules is the
set which would be attached to the Stock Purchase Agreement if it were executed
as of the Effective Date hereof.
12
ARTICLE III
-----------
OPTION PAYMENT
--------------
In consideration for the option granted in Section 2.1, Novartis shall
pay to TCS xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx per Option Year during the
Option Period. The first payment shall be due upon receipt by Novartis of an
invoice in the form of Appendix D hereto ("Invoice"), but in no case earlier
than the Effective Date, and payable to TCS within thirty (30) days after
receipt by Novartis of such Invoice, but in no case earlier than thirty (30)
days following the Effective Date. The second payment ("Second Option Payment")
shall be due upon receipt by Novartis of the related Invoice, but in no case
earlier than on the first day following the end of the first Option Year, and
shall be payable to TCS within thirty (30) days after receipt by Novartis of
such Invoice, but in no case earlier than the end of the first Option Year. All
payments under this Agreement shall be made in United States dollars and shall
be paid by wire transfer to a bank account designated by TCS within thirty (30)
days after receipt by Novartis of the related Invoices, but in no case earlier
than the date due, and the costs of such remittance shall be borne by Novartis.
Interest shall accrue on late payments compounded monthly at the prime lending
rate for United States dollars as published from time to time in the Wall Street
Journal plus two percent (2%) from the date payment fell due until the actual
date that payment is received by TCS.
ARTICLE IV
----------
EXTENSION OF OPTION PERIOD
--------------------------
4.1 Extension of the Option Period
Novartis, at its sole discretion, may elect to extend the Option Period
for a further term of up to one (1) year in increments ranging from one quarter
to one year in duration (i.e., to a total of three (3) years from the Effective
Date) by providing written notice thereof to TCS not less than ninety (90) days
prior to expiration of the Option Period or any such extension increment, as
appropriate.
4.2 Consideration for Extension of the Option Period
In consideration for said extension(s), Novartis shall pay to TCS
xxxxxxxxxxxx United States dollars xxxxxxxxxxxxxx for a one (1) year extension,
or, in the event Novartis elects to extend the Option Period for less than one
(1) full year, a pro rata amount(s) based on xxxxxxxxxxxxx per year. Such
payment shall be due upon receipt by Novartis of the related Invoice, but in no
case earlier than the first
13
day following the end of the expiration of the initial two (2) year Option
Period or any such extension increment, as appropriate, and shall be payable to
TCS within thirty (30) days after receipt by Novartis of such Invoice, but in no
case earlier than thirty (30) days following the expiration of the initial two
(2) year Option Period or any such extension increment, as appropriate.
ARTICLE V
---------
SUPPLY OF TP-10 DURING OPTION PERIOD
------------------------------------
5.1 TCS shall provide to Novartis, within thirty (30) days after the Effective
Date, xxxxxxxxxxxxxxxxx clinical grade TP-10 manufactured in accordance with
U.S. GMPs, at no cost to Novartis.
5.2 Novartis agrees during the course of 1998, to supply TCS, at no cost to TCS,
with such quantities of clinical grade TP-10 manufactured in accordance with
U.S. GMPs as TCS reasonably requires for clinical trials or other research and
development purposes outside the Field, up to a maximum of xxxxxxxxxxxxxxxxxxxx.
5.3 In order to facilitate production of such TP-10, TCS hereby assigns to
Novartis, and Novartis hereby assumes from TCS, the agreements with third party
contractors for the manufacture and quality control release of TP-10 listed on
Appendix E hereto ("Contracting Agreements"). Novartis agrees that it shall not
make any changes to the terms and conditions of any Contracting Agreement
without TCS' prior written consent, which consent shall not be unreasonably
withheld, until the earlier of (i) the end of the Option Period and (ii)
Novartis' fulfillment of its obligation relating to supplying TP-10 to TCS
pursuant to this Article 5.
ARTICLE VI
----------
TRANSFER OF KNOW-HOW
--------------------
6.1 Subject to the provisions of Section 8, TCS shall, to the extent it is free
to share such information, promptly within three (3) months after the Effective
Date disclose to Novartis all TCS Know-How relevant to the Field then in its
possession that has not been disclosed prior to the Effective Date. From time to
time, during the term of this Agreement, each Party, to the extent such Party is
free to share such information, shall make available to the other Party Know-How
which the other Party reasonably requires to facilitate, in the case of
Novartis, its research, development and commercialization of the Licensed
Products and/or Licensed Protein in, or in connection with, Monitoring
Technology, in the Field, in the case of TCS, its research, development and
commercialization of Licensed Protein outside the Field. TCS shall have an
option to obtain from Novartis a license under and to the Novartis Patents and
Novartis
14
Know-How on reasonable terms for such purposes. Each Party shall provide its
Know-How to the other Party in the form that it exists. It is expressly
understood that, for the purposes of this Article 6 only, Know-How shall exclude
all full reports of clinical and non-clinical studies other than those relating
to the Licensed Protein, registration files and the like including
correspondence with regulatory authorities, and summaries of clinical and
non-clinical studies other than those relating to Licensed Protein shall replace
full reports.
6.2 During the term of this Agreement, TCS shall not grant to any third party
any right or license in or to sCR1sLex in the Field.
ARTICLE VII
-----------
INDEMNIFICATION AND HOLD HARMLESS
---------------------------------
7.1 Novartis Indemnity
Subject to the provisions of Section 7.3, Novartis shall defend and
indemnify and hold harmless TCS and its Affiliates and their respective
directors, officers, agents and employees from and against any and all losses,
liabilities, claims, damages, penalties, fines, costs and expenses (including
reasonable legal fees and other litigation costs, regardless of outcome) arising
out of any and all governmental or private actions (or their insurers under
rights of subrogation or otherwise) that are related in any way (i) to
Novartis', its Affiliates' and/or sub-licensees' development, importation, sale,
manufacture, storage or use of the Licensed Materials or Licensed Products; (ii)
to any claim of failure by Novartis, its Affiliates and/or sub-licensees to
comply with governmental requirements relating to the Licensed Materials and/or
Licensed Products including, but not limited to, the reporting of adverse events
and safety information or (iii) to Novartis', its Affiliates' and/or
sub-licensees' negligence or any acts or omissions by Novartis in connection
with the Licensed Materials or Licensed Products or in violation of its
obligations under this Agreement.
7.2 TCS Indemnity
Subject to the provisions of Section 7.3, TCS shall defend and
indemnify and hold harmless Novartis, its Affiliates and sub-licensees and their
respective directors, officers, agents and employees from and against any and
all losses, liabilities, claims, damages, penalties, fines, costs and expenses
(including reasonable legal fees and other litigation costs, regardless of
outcome) arising out of any and all governmental or private actions (or their
insurers under rights of subrogation or otherwise) that are related in any way
(i) to the development, manufacture, packaging, storage, use, marketing,
promotion,
15
distribution, importation and sale of the Licensed Materials and/or Licensed
Products by TCS, any Affiliate of TCS or any licensee of TCS other than
Novartis; (ii) to any claim of failure by TCS, any Affiliate of TCS or any
licensee of TCS other than Novartis to comply with governmental requirements
relating to the Licensed Materials and/or Licensed Products including, but not
limited to, the reporting of adverse events and safety information; and (iii) to
TCS', its Affiliate's or its licensee's negligence or any acts or omissions by
TCS, its Affiliate or any sub-licensee of TCS other than Novartis in connection
with the Licensed Materials or Licensed Products or in violation of its
obligations under this Agreement.
7.3 Indemnity Procedure
The Party to be indemnified (the "Indemnitee") shall notify the
indemnifying party (the "Indemnitor") in writing promptly, but no later than
fifteen (15) days after becoming aware, of any claims, suits, actions or
proceedings made or instituted against it or which may be made or instituted
against it in respect of which indemnification may be sought hereunder. The
Indemnitee shall cooperate with the Indemnitor in the defense of any claim. The
Indemnitor shall have the right to select defense counsel and direct the defense
or settlement of any such claim or suit. The Indemnitee shall have the right to
select and obtain representation by separate legal counsel, at its own expense.
16
7.4 Insurance
(a) TCS hereby warrants that it maintains a policy or program of
insurance at levels no less than one million United States dollars ($1,000,000)
for each occurrence and in the aggregate, to support the indemnification
obligations assumed under this Article 7.
(b) Novartis hereby warrants that it maintains a policy or program of
insurance or self-insurance at levels sufficient to support the indemnification
obligations assumed under this Article 7.
ARTICLE VIII
------------
CONFIDENTIALITY
---------------
8.1 Confidentiality Obligations
Each Party shall receive and keep all Proprietary Information in
complete confidence in the same manner and with the same protection as such
Party maintains for its own proprietary information and hereby covenants not to
use such Proprietary Information or any part of it except for the purposes of
this Agreement or disclose or make such Proprietary Information or any part of
it available to third parties except:
(a) to its employees, Affiliates and responsible sub-contractors or
agents (including attorneys) who require such Proprietary Information for the
express purposes of this Agreement and who are bound in writing to the receiving
Party in a manner consistent with the confidentiality provisions of this
Agreement; provided, that, TCS shall not have the right to share Novartis
Proprietary Information in the Field with any of TCS' sub-licensees without the
prior written consent of Novartis;
(b) for disclosure to governmental health or regulatory agencies for
the purpose of obtaining and maintaining any necessary regulatory approvals for
the Licensed Materials or Licensed Products in the Territory (and then, to the
fullest extent possible, only under conditions of confidentiality);
(c) to the extent that the disclosing Party may agree in writing;
(d) to the extent that such can be clearly demonstrated by prior
written documents in its possession to be known to the receiving Party or an
Affiliate of the receiving Party from a source other than the disclosing Party
or an Affiliate of the disclosing Party who is not in breach or default of any
17
confidentiality obligation to the disclosing Party or an Affiliate of the
disclosing Party at the time of receipt from the disclosing Party hereunder;
(e) to the extent that such is a matter of public knowledge at the time
of disclosure hereunder or becomes a matter of public knowledge other than by
breach of this Agreement by the receiving Party, its employees or anyone that
received Proprietary Information from the receiving Party;
(f) to the extent that it is required by law or bona fide legal process
to be disclosed (and then, to the fullest extent possible, only under conditions
of confidentiality).
Each Party specifically agrees that, except as shall be necessary for
governmental notification purposes or to comply with applicable laws and
regulations, it will not provide a copy of this Agreement, the License
Agreement, the Stock Purchase Agreement or any other related agreement to any
third party except its employees, Affiliates and responsible sub-contractors or
agents (including attorneys) who require such copy for the express purposes of
this Agreement and who are bound in writing to the Party providing the copy in a
manner consistent with the confidentiality provisions of this Agreement without
the prior written consent of the other Party hereto.
8.2 Prior Confidentiality Agreements
Proprietary Information disclosed by either Party to the other Party
prior to the Effective Date of this Agreement under any previous agreements
between TCS and Sandoz Pharma Ltd shall be treated as Proprietary Information
under this Article 8 notwithstanding the expiration of the prior Confidentiality
Agreements. All Proprietary Information disclosed by either Party to the other
Party after the Effective Date of this Agreement shall be governed by this
Article 8.
8.3 Public Announcement
Except as shall be necessary for governmental notification purposes or
to comply with applicable laws and regulations, and except as otherwise agreed
to by the Parties in writing, the Parties agree to keep the existence of this
Agreement, the transactions contemplated hereby, and any proposed termination
hereof strictly confidential. The Parties shall agree upon the text of an
initial public announcement relating to the transactions contemplated by this
Agreement as soon as possible after the Effective Date. Prior to making any
subsequent public announcements regarding this Agreement or the transactions
contemplated herein, each Party agrees to provide the other Party with a
reasonable opportunity to review and comment upon such proposed announcement.
Written agreement between the Parties shall be required prior to
18
release of any such subsequent public announcement and such agreement shall not
be unreasonably withheld.
ARTICLE IX
----------
CLEARANCE OF PUBLICATIONS
-------------------------
If either Party wishes to make any written or oral public disclosure
(e.g., speeches or publications in scientific journals or other publications)
relating to the Licensed Materials or Licensed Products in the Field, whether or
not such disclosure involves the disclosure of Proprietary Information of the
other Party, the Party seeking to make such public disclosure (the "Disclosing
Party") shall provide the other Party with details of the proposed written or
oral public disclosure and/or an advance copy of any proposed publication thirty
(30) days prior to the earlier of (i) the intended date of release or (ii) the
submission of written text or abstract of a speech for oral presentation or of
written material for publication. The other Party shall have thirty (30) days to
make any comments or recommend any changes it reasonably believes are necessary
to preserve intellectual property rights or Proprietary Information and the
incorporation of such changes shall not be unreasonably refused by the
Disclosing Party; and if such other Party informs the Disclosing Party within
thirty (30) days of receipt of an advance notice of an oral public disclosure or
copy of a proposed publication (i) that such public disclosure or publication,
in its reasonable judgment, is expected to have a materially adverse effect on
its intellectual property rights or Proprietary Information, or (ii) of some
other reasonable objection, the Disclosing Party shall use its best efforts to
delay or prevent public disclosure or such publication. Such delay shall be
sufficiently long as to permit the timely preparation and filing of patent
applications if the reason given by the other Party for delaying public
disclosure or publication is that it would disclose patentable inventions.
ARTICLE X
---------
OWNERSHIP OF PATENT RIGHTS AND KNOW-HOW
---------------------------------------
Know-How and any resulting inventions (whether patentable or not) which
are made, conceived, reduced to practice or generated solely by TCS' employees
or agents including TCS Patents shall belong exclusively to TCS. Know-How and
any resulting inventions (whether patentable or not) which are made, conceived,
reduced to practice or generated solely by Novartis' employees or agents
including Novartis Patents shall belong exclusively to Novartis. TCS and
Novartis shall each own a fifty percent (50%) undivided interest in any Know-How
and any resulting inventions (whether patentable or not) made, conceived,
reduced to practice or generated (i) jointly by employees, agents or other
persons acting on
19
behalf of both Parties including Joint Patents or (ii) either solely by TCS'
employees or agents or jointly by employees, agents or other persons acting on
behalf of both Parties while carrying out activities under the terms of Section
4.2 of the License Agreement. Subject to the terms of this Agreement, each joint
owner may make, use and sell jointly owned inventions, discoveries, Know-How
including Joint Patents without accounting to the other joint owner in
accordance with its undivided rights hereunder.
ARTICLE XI
----------
NOTICES
-------
11.1 Any notice or other communication required or permitted to be given or made
hereunder shall be in writing in the English language and shall be deemed to
have been duly given if sent by registered air mail (return receipt requested),
facsimile letter or delivered by hand to the Party to whom such notice or
communication is required or permitted to be given. Any such notice or other
communications, if mailed, shall be considered given or made when mailed, as
evidenced by the postmark at point of mailing. If sent by facsimile letter such
notice shall be deemed to have been given on the date that it is sent provided
that a confirmatory copy of the facsimile letter is mailed on the same day as
the facsimile letter is sent to the receiving Party. If delivered by hand, any
such notice or communication shall be considered given when delivered.
11.2 All notices to TCS or to any transferee or designee of TCS, pursuant to
this Agreement shall be addressed as follows:
T Cell Sciences, Inc.
119 Fourth Avenue
Needham, MA 02194
U.S.A.
Facsimile: xxxxx
Attention: xxxxx
11.3 All notices to Novartis shall be addressed as follows:
Novartis Pharma AG
Lichstrasse 35
Post Office Box
CH-4002 Basel
Switzerland
Facsimile: xxxxx
Attention: xxxxx
20
With copy to:
Novartis Pharma AG
Lichstrasse 35
Post Office Box
CH-4002 Basel
Switzerland
Facsimile: xxxxx
Attention: xxxxx
11.4 Either Party may change the address to which notice and other
communications to it are to be given by notice as provided herein.
ARTICLE XII
-----------
TERM OF THIS AGREEMENT
----------------------
Unless sooner terminated as provided herein, this Agreement shall
commence on the Effective Date hereof and shall continue in full force and
effect until the expiration of the Option Period.
ARTICLE XIII
------------
TERMINATION OF THIS AGREEMENT
-----------------------------
13.1 Termination by Novartis
Novartis may terminate this Agreement in its sole discretion effective
the end of the first Option Year by giving TCS ninety (90) days' prior written
notice.
13.2 Termination for Breach
In the event that either Party shall be in breach of any material obligation
hereunder, the non-breaching Party shall give written notice to the other Party
specifying the claimed particulars of such breach, and in the event such
material breach is not cured, or effective steps to cure such material breach
have not been initiated or are not thereafter diligently pursued, within sixty
(60) days following the date of such written notification, the non-breaching
Party shall have the right thereafter to terminate this Agreement by giving
thirty (30) days' prior written notice to the other Party to such effect.
21
13.3 Termination in Insolvency
Either Party shall have the right to terminate this Agreement effective
upon written notice to the other Party in the event the non-notifying Party
becomes insolvent, or makes an assignment for the benefit of creditors, or has a
receiver or trustee appointed for substantially all of its property or in the
event that voluntary or involuntary bankruptcy proceedings are instituted
against the non-notifying Party or on the non-notifying Party's behalf.
13.4 Effect of Termination or Expiry of Option
Upon termination of this Agreement for whatever reason or upon
Novartis' election not to exercise its option during the Option Period or
Novartis' failure to exercise its option during the Option Period (i) all rights
granted to Novartis under this Agreement shall terminate and (ii) except as
provided below, each Party shall return to the other Party all tangible
materials comprising Proprietary Information of the other Party except that each
Party may retain one (1) copy of such Proprietary Information of the other Party
in its legal department in order to ascertain its continuing obligations under
Article 8. Upon termination of this Agreement for any reason other than
termination by Novartis for TCS' breach pursuant to Section 13.2 or upon
Novartis' election not to exercise its option during the Option Period or
Novartis' failure to exercise its option during the Option Period, Novartis
shall, at TCS' request, grant to TCS or its designee a non-exclusive, royalty
free license with the right to sub-license under and to the Novartis Patents and
Novartis Know-How relating to the Licensed Protein or a Licensed Protein Product
which exist at the time of termination.
In the event of termination by Novartis pursuant to Section 13.1 or
13.2 during the first Option Year, Novartis will not be required to pay to TCS
the Second Option Payment pursuant to Article 3.
ARTICLE XIV
-----------
SURVIVABILITY
-------------
Termination or expiry of this Agreement in whole or in part shall not
relieve the Parties of any obligation accruing prior to the effective date of
termination or expiry or with respect to limiting disclosure and use of
Proprietary Information.
22
ARTICLE XV
----------
RIGHT TO EXTEND TO AFFILIATES
-----------------------------
Either Party shall have the right to extend all or part of the rights
granted in this Agreement to any of its Affiliates; provided, that such Party
shall not then be in default with respect to any of its obligations under this
Agreement. All the terms and provisions of this Agreement, except this right to
extend, shall apply to such Affiliate to which this option has been extended to
the same extent as they apply to either of Novartis or TCS, as the case may be.
ARTICLE XVI
-----------
ASSIGNMENT
----------
Unless consent in writing is first obtained from the other Party, such
consent not to be unreasonably withheld, this Agreement and the rights granted
herein shall not be assignable by either Party hereto, except to a successor to
all or substantially all of its pharmaceutical or biotechnology business. Any
attempted assignment without consent shall be void. Notwithstanding the
foregoing, the Parties agree that Novartis shall have the right to assign this
Agreement to an Affiliate without TCS' consent. Any permitted assigns shall
assume all obligations of its assignor under this Agreement; provided, that the
assignor shall remain primarily liable under this Agreement.
ARTICLE XVII
------------
MUTUAL REPRESENTATIONS AND WARRANTIES
-------------------------------------
17.1 Representations and Warranties
Each Party hereby represents and warrants for itself as follows:
(a) It is a corporation duly organized, validly existing and is in good
standing under the laws of the jurisdiction of its incorporation with the full
power to conduct its affairs as currently conducted and contemplated in this
Agreement.
(b) The execution, delivery and performance by it of this Agreement
have been duly authorized by all necessary corporate action and do not and will
not (i) require any consent or approval of
23
its stockholders; (ii) violate any provision of any law, rule, regulation,
order, writ, judgment, injunction, decree, determination or award presently in
effect having applicability to it or any provision of its charter or by-laws; or
(iii) result in a breach of, or constitute a default under, any material
agreement, mortgage, lease, license, permit or other instrument or obligation to
which it is a party or by which it or its properties may be bound or affected.
(c) No authorization, consent, approval, license, exemption of, or
filing or registration with, any court or governmental authority or regulatory
body is required for the due execution, delivery or performance by it of this
Agreement, except as provided herein.
(d) This Agreement is a legal, valid and binding obligation of such
party, enforceable against it in accordance with its terms and conditions.
(e) It is not under any obligation to any person, contractual or
otherwise, that is conflicting or inconsistent in any respect with the terms of
this Agreement or that would impede the diligent and complete fulfillment of its
obligations hereunder.
(f) Any clinical investigations carried out with respect to any
Licensed Material or Licensed Product shall be conducted in accordance with good
manufacturing practices and good clinical practices applicable in the
jurisdiction in which such investigation is conducted, including but not limited
to, EEC and FDA good manufacturing and good clinical practice.
17.2 Representation and Warranties of TCS.
(a) TCS warrants that it has no information as of the Effective Date of
this Agreement to indicate that Novartis would not be free to make or have made
for use or sale in the Field, or to use and sell in the Field, in the Territory,
in accordance with the rights granted under Section 2.1 of this Agreement,
Licensed Materials and Licensed Products, without infringing any third-party
patent or any patent right of any Affiliate or parent company of TCS.
(b) TCS represents that as of the Effective Date it owns or possesses
all right, title and interest in and to the TCS Patents and the TCS Know-How, in
the sense of being able to convey to Novartis an exclusive license thereunder in
the Field in the Territory, in accordance with the rights granted
24
under Section 2.1 of this Agreement, other than with respect to the injectable
non-colloidal dose form of TP10-HD in the Field in Japan.
(c) The representations and warranties of TCS set forth in the Stock
Purchase Agreement, when read together with the set of Schedules to the Stock
Purchase Agreement attached hereto as Appendix G, are true and correct as of the
Effective Date hereof.
17.3 Warranties of Novartis
Novartis hereby warrants that the clinical grade TP-10 supplied by
Novartis to TCS pursuant to Article 5 of this Agreement shall be manufactured in
accordance with United States good manufacturing practices.
17.4 Exclusion of Warranties
Except as otherwise specifically set forth in this Agreement, neither
Party makes any representation, extends any warranties of any kind, either
express or implied, and assumes any responsibilities whatever with respect, in
particular (i) to the validity or scope of the TCS Patents, the TCS Know-How or
the Novartis Know-How; or (ii) that exploitation of the TCS Patents and the TCS
Know-How or the manufacture or use of the Licensed Materials or the manufacture,
use, sale, distribution or marketing of the Licensed Products will not infringe
the patent or other intellectual property rights of third parties.
17.5 Exclusion of Consequential Loss
Notwithstanding any provisions to the contrary in this Agreement, in no
event (including fault, negligence or strict liability of either Party) shall
either Party be liable to the other for indirect, incidental, consequential,
special, punitive or exemplary damages, loss of profit or loss of use related to
any claim, cause of action, proceeding or judgment arising in connection with
this Agreement.
25
ARTICLE XVIII
-------------
ARBITRATION AND CONSTRUCTION
----------------------------
18.1 Law
This Agreement shall be governed by and interpreted in accordance with
the laws of the State of New York.
18.2 Dispute Resolution
Any controversy or claim arising out of or relating to this Agreement,
or the breach, termination or validity thereof which cannot be settled within
three (3) months of it having arisen shall be submitted to the respective
President or General Manager of each Party and if, within thirty (30) days or
such other period as may be agreed upon between the Parties following such
reference, the dispute remains unresolved, it shall be settled on application by
either Party by arbitration conducted in the English language, in New York City,
New York in accordance with the then-existing rules of the American Arbitration
Association, and judgment upon the award rendered by the arbitrators may be
entered in any court having jurisdiction thereof.
26
18.3 Arbitration
In any arbitration pursuant to this Article the award shall be rendered
by a majority of three (3) arbitrators, one (1) of whom shall be appointed by
each Party and the third of whom shall be appointed by mutual agreement of the
two (2) Party-appointed arbitrators. In the event of failure of a Party to
appoint an arbitrator within sixty (60) days after commencement of the
arbitration proceeding or in the event of failure of the two (2) Party-appointed
arbitrators to agree upon the appointment of the third arbitrator within sixty
(60) days after commencement of the arbitration proceeding, such arbitrator
shall be appointed by the American Arbitration Association in accordance with
the then-existing Rules. The arbitrators shall apply the governing law set forth
in Section 18.1, and shall be required to give their conclusions in writing,
with an explanation of the facts and law on which they were based. The Parties
agree that the service of any notice in the course of such arbitration at their
respective addresses as provided for in Article 11 shall be valid and
sufficient.
ARTICLE XIX
-----------
FORCE MAJEURE
-------------
Each of the Parties hereto shall be excused from the performance of its
obligations hereunder in any country or countries of the Territory in the event
such performance is prevented by force majeure, and such excuse shall continue
as long as the condition constituting such force majeure continues plus thirty
(30) days after the termination of such condition. For the purpose of this
Agreement, force majeure is defined as follows: causes beyond the reasonable
control of Novartis or TCS (as the case may be), including, without limitation,
acts of God, acts, regulations or laws of any government, war, civil commotion,
destruction of production facilities or materials by fire, earthquake or storm,
labor disturbances (whether or not any such labor disturbance is within the
power of the affected Party to settle), epidemic, and failure of suppliers,
public utilities or common carriers. In the event of force majeure lasting more
than six (6) months, the Parties agree to meet and discuss how this Agreement
can be justly and fairly implemented under the circumstances prevailing in such
country or countries and if the Parties are unable to agree upon how the
Agreement can be implemented then either Party may terminate the Agreement in
relation to such country or countries upon thirty (30) days' written notice.
27
ARTICLE XX
----------
MISCELLANEOUS
-------------
20.1 Severability
Should any part or provision of this Agreement be held unenforceable or
in violation of or in conflict with any applicable law or regulation of any
jurisdiction, the invalid or unenforceable provision shall be replaced with a
provision which accomplishes, to the extent possible, the original business
purpose and economic benefit of such part or provision in a valid and
enforceable manner, and the balance of this Agreement (including any such
replacement provision) shall continue in full force and effect and be binding
upon the Parties hereto. To implement the requirements of this Section 20.1,
Novartis and TCS agree to endeavor in good faith to agree upon the wording of
any replacement provision. If no agreement is reached within ninety (90) days
after written request by one Party for the replacement of any such provision,
the rewording and replacement thereof shall be subject to arbitration in
accordance with Article 18 and both Parties hereto shall be deemed to have
entered into and be bound by this Agreement as so amended by the arbitrators.
20.2 No Exclusion of Legal Rights
Nothing in this Agreement is intended to nor shall it have the effect
of excluding, modifying or restricting any right or remedy available under any
relevant law which, by virtue of any such law, cannot be excluded, modified or
restricted.
20.3 Survival
Articles 5, 7, 8, 9 (with respect to written or oral public disclosures
containing information generated during the term of this Agreement only), 13.4,
14, 17.4, 17.5 and 18 shall be in force during the term of this Agreement and
any extension hereof and shall survive termination or expiration (as the case
may be) of this Agreement and shall remain in full force and effect. The
provisions of this Agreement which do not survive termination or expiration
hereof (as the case may be) shall nonetheless be controlling on, and shall be
used in construing and interpreting the rights and obligations of the Parties
hereto with regard to any dispute, controversy or claim which may arise under,
out of, in connection with, or relating to this Agreement.
28
20.4 Entire Agreement
This Agreement constitutes the entire understanding between the Parties
with respect to the subject matter hereof and supersedes and replaces all
previous negotiations, understandings and representations whether written or
oral including, but not limited to, prior Confidentiality Agreements between TCS
and Sandoz Pharma Ltd and such Confidentiality Agreements shall be terminated
upon the Effective Date of this Agreement. The Parties' obligations of
confidentiality, non-disclosure and non-use under the Confidentiality Agreements
shall continue with respect to confidential information disclosed prior to their
termination, and shall be subject to the provisions of Article 8 hereof. This
Agreement shall not be modified, altered or amended except by a written document
signed on behalf of and delivered by both Parties hereto.
20.5 No License
Except as specifically set forth herein, neither Party is granted any
rights or license by implication or otherwise.
20.6 Adverse Event Reporting
TCS and Novartis shall cooperate with respect to the exchange of
adverse event and safety information associated with the Licensed Material and
Licensed Products. The cooperation between TCS and Novartis in the exchange of
such adverse event and safety information shall be coordinated on the side of
Novartis by its central Clinical Safety and Epidemiology organization. Details
of the cooperation in the handling of adverse event and safety information
related to the Licensed Material and Licensed Products shall be the subject of
an addendum agreed upon between the designated primary liaisons of the
respective Parties (in the case of TCS, the Vice President for Development, and,
in the case of Novartis, Head, Global Clinical Safety and Epidemiology). Said
addendum shall be agreed upon no less than thirty (30) days prior to the
commencement of the first clinical investigational study of the Licensed
Material or a Licensed Product in the Field.
29
20.7 Waiver
Any waiver on the part of either Party hereto of any right or interest
hereunder shall be effective only if made in writing and shall not (unless
expressly so stated) constitute or imply a waiver of any other right or
interest, or a subsequent waiver.
20.8 Relationship of the Parties
Novartis and TCS shall act solely as independent contractors and
nothing in this Agreement shall be construed to create a partnership or joint
venture or legal entity between TCS and Novartis, nor shall it give either TCS
or Novartis the power or authority to act for, bind or commit the other in any
way. Neither Party is authorized to make any statement, claims, representations
or warranties, or to act on behalf of the other, except as specifically
authorized in writing by the other Party. Accordingly, neither Party shall have
the right to use or refer to the name, tradenames, trademarks or logo of the
other or its Affiliates or agreements with the other without the prior written
consent of the other.
20.9 Language
This Agreement is entered into in the English language. In the event of
any dispute concerning the construction or meaning of this Agreement, reference
shall be made only to this Agreement as written in English and not to any
translation hereof into any other language, and this English language version
shall be controlling for all purposes.
20.10 Titles
The titles used herein are for illustration purposes only and shall not
be construed as part of this Agreement.
30
IN WITNESS HEREOF, the Parties have caused this Agreement to be
executed by their duly authorized representatives.
T CELL SCIENCES, INC. NOVARTIS PHARMA AG
By: ________________________ By: ________________________
Name: ______________________ Name: ______________________
Title: _____________________ Title: _____________________
By: ________________________
Name: ______________________
Title: _____________________
31
5
U.S. DOLLARS
9-MOS
DEC-31-1997
JAN-1-1997
SEP-30-1997
1
8,538,000
0
19,400
0
5,200
9,037,300
3,096,700
(2,692,800)
11,503,500
2,268,200
0
0
0
25,000
7,710,300
11,503,500
36,200
840,100
17,200
6,813,200
6,127,000
0
(470,700)
(11,646,600)
0
(11,646,600)
0
0
0
(11,646,600)
(0.47)
(0.47)