Exhibit 10.24
RESEARCH AND LICENSE AGREEMENT
between
BIOCHEM PHARMA, INC.
and
SCRIPTGEN PHARMACEUTICALS, INC.
December 12, 1997
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY
[***]. THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED
WITH THE SECURITIES AND EXCHANGE COMMISSION.
RESEARCH AND LICENSE AGREEMENT
This RESEARCH AND LICENSE AGREEMENT (the "Agreement") is made this 12th day
of December 1997 (the "Effective Date"), by and between Scriptgen
Pharmaceuticals, Inc. (SP), a company organized and existing under the laws of
the State of Delaware, and having its principal place of business at 000 Xxxxxx
Xxxxxx, Xxxxxxx, Xxxxxxxxxxxxx, and BioChem Pharma, Inc. (BIOCHEM), a company
organized and existing under the laws of Canada, and having its principal place
of business at 000 Xxxxxx-Xxxxxxxx Xxxx., Xxxxx, Xxxxxx. For the purpose of
this agreement SP and BIOCHEM shall also include the Affiliates of each.
R E C I T A L S
WHEREAS, SP has made substantial investment in high-throughput screening
technology for (i) the Hepatitis B Research Program ("HBV") [***] and (ii)
the Dimerescent Receptor Research Program;
WHEREAS, BIOCHEM possesses drug development, manufacturing and
commercialization expertise related to development and marketing of
pharmaceuticals;
WHEREAS, SP desires to provide certain drug candidates to BIOCHEM for the
purpose of further development and eventual commercial exploitation of Products
embodying the Technology;
WHEREAS, BIOCHEM desires to acquire the drug candidates and develop
Compounds provided by SP for commercial exploitation; and
WHEREAS, both BIOCHEM and SP desire to enter into a license agreement which
balances the relative contributions of each to the discovery, development and
commercialization of the Products and rewards each according to their relative
contributions;
NOW, THEREFORE, in consideration of the financial terms set forth herein,
as well as other good and valuable consideration, the receipt and sufficiency of
which is hereby acknowledged, the parties hereto, intending to be legally bound,
hereby covenant, and agree as follows:
ARTICLE I
DEFINITIONS
As used in this Agreement, the following terms, whether used in the
singular or plural, shall have the respective meanings set forth below:
1.1 "AFFILIATE" shall mean any Person which, directly or indirectly, owns,
is owned by, or is under common ownership with a party to this Agreement or any
Person actually controlled by, controlling, or under control of a party to this
Agreement. For the purposes of this definition, "ownership" or "control" shall
mean a Person owns or controls the lesser of (i) fifty percent (50%) and (ii)
the maximum ownership interest permitted by law, of the equity conferring votes
or rights, and/or otherwise has the ability to direct the business affairs of
another Person.
1.2 "ANNUAL RESEARCH PLAN" shall mean the written plans describing the
research in the Field to be carried out during each year, of the Hepatitis B
Research Program and the Dimerescent Receptor Research Program pursuant to this
Agreement. Each Annual Research Plan will be set forth in a written document and
contain the mutually agreed criteria for determining a Drug Candidate.
1.3 "CALENDAR QUARTER" shall mean the respective periods of three (3)
consecutive calendar months ending on March 31, June 30, September 30 and
December 31.
1.4 "CALENDAR YEAR" shall mean each successive period of twelve (12)
months commencing on January 1 and ending on December 31.
1.5 "CLINICAL DEVELOPMENT PROGRAM" shall mean the drug development program
activities of BIOCHEM for the Drug Candidates to be described in SCHEDULE 1.5 as
amended from time to time including yearly updates.
1.6 "COMMERCIAL SALE" shall mean the transfer of title to a Product to an
independent third party in a country after the Product has received all
necessary approval for sale in such country by the appropriate Regulatory
Agency.
1.7 "CONFIDENTIAL INFORMATION" shall mean any proprietary and secret
ideas, technical information, trade secrets, know-how, commercial information,
techniques, data or other information, whether in written or verbal form, or any
other information marked as "Confidential," which relate to the Compound, the
Product, the manufacturing of the Product or Compound, or the Patent Rights, and
which are in the possession of or owned by either Party. The term "Confidential
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Information" does not include information which is or was: (i) in the public
domain or becomes public domain other than through a breach of this Agreement on
the part of the receiving Party; or (ii) received by the receiving Party from a
third party that is not under a confidential obligation to the disclosing Party;
or (iii) known to the receiving Party, as shown by its written records, prior to
execution of this Agreement; or (iv) developed by the receiving Party without
access to the Confidential Information; or (v) generally made available to the
public by the disclosing Party without restrictions or disclosure
1.8 "COMPOUNDS" shall mean any compounds which SP has identified in the
Hepatitis B Research Program and the Dimerescent Receptor Research Program [***]
1.9 "DIMERESCENT COMPOUNDS" shall mean compounds for the following
receptors: [***] and any other [***] subsequently identified.
1.10 "DIMERESCENT RECEPTOR RESEARCH PROGRAM" shall mean the research
program including acceptance criteria for a Drug Candidate described in
attached SCHEDULE 1.10 which shall be prepared and delivered within [***] of
the Effective Date and amended from time to time.
1.11 "DOLLARS" and the symbol "$" shall mean lawful money of the United
States of America.
1.12 "DRUG CANDIDATE" shall mean any and all Compounds, discovered by SP in
the course of conducting the Hepatitis B Research Program or the Dimerescent
Receptor Research Program including all formulations, mixtures or compositions
thereof discovered by SP in the Hepatitis B Research Program or the Dimerescent
Receptor Research Program that meets the criteria specified for acceptance in
SCHEDULES 1.10 AND 1.19.
1.13 "EFFECTIVE DATE" shall be the date set forth in the first paragraph of
this Agreement.
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1.14 "FDA" shall mean the United States Food and Drug Administration or any
replacement or successor entity thereto.
1.15 "FIELD" shall mean any application in human health care.
1.16 "FIRST COMMERCIAL SALE" shall mean the date of the first Commercial
Sale in a given country.
1.17 "GAAP" shall mean generally acceptable accounting principles for the
United States.
1.18 "GROSS PROFIT" shall mean Net Sales minus manufacturing cost all as
determined in accordance with GAAP.
1.19 "HEPATITIS B RESEARCH PROGRAM" shall mean the research program
including the acceptance criteria for an antiviral Drug Candidate described
in attached SCHEDULE 1.19 which shall be prepared and delivered within [***]
of the Effective Date and may be amended from time to time.
1.20 "IND" shall mean Investigational New Drug application as that term is
used in the FDA.
1.21 "NDA" shall mean New Drug Application as that term is used in the FDA.
1.22 "NET SALES" shall mean the amount of money (other than Sub-License
Receipts) received by BIOCHEM for BIOCHEM's Commercial Sale of a Product after
deducting:
(i) the normal or customary trade and/or quantity discounts and
allowances to customers;
(ii) refunds, rebates and allowances for returned, damaged goods or
outdated Product;
(iii) excise and sales taxes, customs duties, tariffs and other
governmental charges;
(iv) costs of transportation (including without limitation packing and
insurance) paid;
(v) retroactive price reductions applicable to sale of Product that
are actually allowed or granted;
(vi) royalties paid on a Drug Candidate to a third party.
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Notwithstanding the foregoing, if a Product is sold in conjunction with or
includes Royalty Bearing Components, Net Sales for purposes of determining
royalties payable under this Agreement shall be calculated as the product
obtained by using whichever of the following formulas is applicable:
[***]
[***]
1.23 "OTHER COMPENSATION" shall mean any and all compensation other than
Net Sales (no matter how classified) received by BIOCHEM from a third-party
sub-licensee of Compounds or Products.
1.24 "PARTY" shall mean SP or BIOCHEM and when used in the plural, shall
mean SP and BIOCHEM.
1.25 "PERSON" shall mean and include any individual, corporation,
partnership, joint venture, trust, unincorporated organization, university,
college or government or any agency or political subdivision thereof.
1.26 "PRODUCT" shall mean any therapeutic agent which is comprised, at
least in part, of a Drug Candidate.
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1.27 "PROFIT" shall mean Net Sales minus ( manufacturing cost plus
distribution and sales cost plus marketing cost plus any reasonable expenses
incurred under SECTION 12.12) all as determined in accordance with GAAP.
1.28 "R & D RECEIPTS" shall mean all value received, regardless of how
characterized, by a Party from a third party for the performance of research and
development on a Drug Candidate.
1.29 "R & D PROFIT" shall mean R & D Receipts minus (cost of supplies,
equipment, and salary directly attributable to the research and development
covered by the R & D Receipts).
1.30 "REGULATORY AGENCY" shall mean the FDA and any corresponding agencies
in other countries where Product is to be sold or used.
1.31 "RESEARCH INVENTIONS" shall have the meaning as set forth in SECTION
8.4.
1.32 "RESEARCH PROGRAMS" shall mean both the Hepatitis B Research Program
and the Dimerescent Receptor Research Program.
1.33 "ROYALTY BEARING COMPONENTS" shall mean all components, devices or
products which are sold in conjunction with or are included as part of a Product
and for which either (i) BIOCHEM must license and pay a royalty to an unrelated
third party or (ii) BIOCHEM owns a patent covering the component, device or
product in the appropriate territory where such component, product or device is
sold.
1.34 "SP PATENT RIGHTS" shall mean any and all patents and patent
applications licensed to or owned by SP during the term of this Agreement
which relate to the Compounds, Product or know-how of the Compounds and
Product and which are listed on SCHEDULE 1.34 as amended from time to time,
and any and all patents and patent applications which claim priority from any
such patent or application including without limitation all divisional,
reissue, re-examination, continuation, and continuations-in-part, extension
and renewal application and patent thereof and any and all other counterpart
application in any countries and patent and inventor certificates, utility
model and the like issuing therefrom; provided, however, SP Patent Rights
shall not include any rights to SP's proprietary Any Target Ligand Affinity
Screen ("ATLAS") and the proprietary Screen for Compounds with Affinity for
Nucleic Acid ("SCAN") technology.
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1.35 "SP TECHNOLOGY" shall include the SP Patent Rights, know-how,
Confidential Information, and any other technology, data, compounds, processes,
formulae, materials, devices, systems, notes, records, preparations, usage
information, procedures, regulatory information, manufacturing information and
other information all of which are related to the Compound, the Product or to
the Patent Rights; provided, however, SP Technology shall not include any rights
to SP's ATLAS and SCAN technology.
1.36 "SUB-LICENSE RECEIPTS" shall mean all value received by BIOCHEM,
including license or distribution fees, milestones fees or Other Compensation
regardless of how characterized. Any non-monetary consideration shall be
afforded at fair market value as of the date of receipt of such consideration as
calculated by the Parties acting reasonably and in good faith.
1.37 "TERRITORY" shall mean all of the countries in the world, including
their respective territories and possessions.
1.38 "TRANSFER DATE" shall mean the date on which SP sends notice to
BIOCHEM that it has transferred a Drug Candidate for clinical development. If
BIOCHEM disputes SP's claim of the Transfer Date, all such disagreement shall be
settled according to Section 13.1.
1.39 "VALID PATENT CLAIM" shall mean a claim of an issued and unexpired
patent included within the SP Patent Rights or pending patent applications
claiming an invention, which has not been revoked or held unenforceable or
invalid by a decision of a court or other governmental agency of competent
jurisdiction, unappealable or unappealed within the time allowed for appeal, and
which has not been disclaimed, denied or admitted to be invalid or unenforceable
through reissue, disclaimer or otherwise.
ARTICLE II
LICENSE
2.1 LICENSE TO COMPOUNDS AND PRODUCTS. Subject to the terms and
conditions of this Agreement, effective as of the Effective Date, SP hereby
grants to BIOCHEM an exclusive, non-royalty bearing license in the Territory
under SP Technology (to the extent such SP Technology covers composition of
matter, methods of use, manufacturing and formulation of Compounds or Product
thereof) to seek governmental approvals, discover, develop, make, use, offer
to sell, sell, import and export and have developed, made, used, offered for
sale, sold, imported and exported
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any of the Compounds and Products. Such license rights will remain in effect
until (i) the expiration of the last applicable patent in such country where
there is a Valid Patent Claim covering a Product in such county; or (ii) the
tenth (10th) anniversary after the First Commercial Sale of the Product in
such country.
2.2 LIMITED RIGHTS. Subject to the terms and conditions of this
Agreement, effective as of the Effective Date, and to the limited extent
necessary for BIOCHEM to seek governmental approvals, develop, have made, make,
use, offer to sell, sell, import and export and have developed, made, used,
offered for sale, sold, imported and exported Compounds and Products, SP agrees
not to xxx BIOCHEM for infringement under any of SP's patents; provided,
however, nothing in this SECTION 2.2 shall be interpreted to allow BIOCHEM to
screen for Compounds or Products using ATLAS and SCAN.
ARTICLE III
CONSIDERATION
3.1 EQUITY. BIOCHEM shall purchase such number of shares of Series D
Convertible Preferred Stock of SP which are convertible into [***] of SP's
outstanding shares of common stock on a fully diluted basis immediately
following the purchase for a payment of U.S. $20,000,000 (TWENTY MILLION
DOLLARS) as per that certain Stock Purchase Agreement of even Date hereof which
is attached as SCHEDULE 3.1.
3.2 CONTINUING PAYMENTS. BIOCHEM and SP shall share Profit with [***]
going to BIOCHEM and [***] going to SP; provided, however, after the second
anniversary of the First Commercial Sale on a country-by-country basis, the
share of Profit payable to SP shall never be less than [***] of Gross Profit.
3.3 SUB-LICENSING. All Sub-License Receipts shall be split as follows:
(a) if at the time of sub-license BIOCHEM has completed, at its
expense, clinical development of the Product covered by the
sub-license through completion of the Phase III clinical trials
to be used for the NDA for such Product, the split shall be
[***] to BIOCHEM and [***] to SP without any deductions.
(b) If a Product is sub-licensed to a third party before the
completion of the Phase III trials related to such Product, the
split shall be [***] to BIOCHEM and [***] to SP; provided,
however, that the royalty portion of said Sub-License
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Receipts payable to SP shall not exceed [***] [***] of the Net
Sales of the Product. Prior to BIOCHEM making any royalty or
milestone payments to SP under this SECTION 3.3(B), BIOCHEM
shall first be entitled to reimbursement in full for the
clinical development costs it has expended.
(c) Notwithstanding Section 3.3(b), if BIOCHEM sub-licenses its
rights under this Agreement to a related party or Affiliate of
BIOCHEM, any payments to BIOCHEM and any profit of such related
party or Affiliate shall be split [***] to BIOCHEM [***] to SP.
3.4 REDUCTION IN PROFIT SHARE. If the last of the SP Patent Rights expire
before the [***] anniversary of the First Commercial Sale of the Product, SP's
share of the Profit and Sub-Licensee Receipts after such expiration shall be
reduced by [***].
3.5 OPTION FEE. If BIOCHEM exercises its option under Section 5.2 it
shall pay SP:
[***]
[***]
Provided, however, the option fees under this section shall increase as
specified in Paragraph 5.2(ii).
3.6 R & D PROFITS. R & D Profits on a Drug Candidate which has not been
returned to SP by BIOCHEM shall be split in the same proportion as any Profits
or Sub-Licensee Receipts would be split on such Drug Candidate. If BIOCHEM
returns a Drug Candidate to SP, BIOCHEM shall not be entitled to any of the R &
D Profits which accumulate after the date of such return.
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ARTICLE IV
SUB-LICENSING
4.1 TERMS. If BIOCHEM sub-licenses its rights under this Agreement to a
third party it shall provide SP written notification of such sub-license and
provide SP a copy of such sub-license agreement within [***] of execution of
such agreement by BIOCHEM.
ARTICLE V
CLINICAL DEVELOPMENT AND MANUFACTURING
5.1 CLINICAL DEVELOPMENT. BIOCHEM shall use its best efforts based on
reasonable commercial judgment to carry out the Clinical Development Program.
Illustrative of this, after acceptance of a Drug Candidate, BIOCHEM will have
[***] BIOCHEM shall be responsible for all costs of the Clinical Development
Program.
5.2 DIMERESCENT COMPOUNDS OPTION. BIOCHEM shall have [***] to exercise
the options to Dimerescent Compound under the following schedule.
[***]
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[***]
5.3 RETURN OF DRUG CANDIDATE. If a Drug Candidate, which has been
accepted by BIOCHEM is voluntarily returned to SP by BIOCHEM prior to any
default by BIOCHEM, SP shall be free to further develop such returned Drug
Candidate; provided, however, if SP further develops such returned Drug
Candidate, then SP shall pay to BIOCHEM a royalty according to the following
schedule:
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[***]
ARTICLE VI
ACCOUNTING AND RECORDS
6.1 ACCOUNTING. At the close of each calendar quarter, the Net Sales,
Profit, Gross Profit, R & D Receipts, R &D Profit and Sub-License Receipts shall
be computed by BIOCHEM, and the share of Profits, R & D Profits and Sub-License
Receipts or payments earned thereon shall be paid to SP within [***] after the
close of said quarter.
6.2 REPORTS. With each payment, BIOCHEM shall furnish to SP a written
accounting report for the closed quarter stating the Net Sales, Profit, Gross
Profit and Sub-License Receipts, the payments due and the payments made.
With each such report delivered, BIOCHEM shall pay to SP all amounts, if any,
due under this Agreement. If no payments are due, BIOCHEM shall so report.
6.3 PAYMENTS. All payments required in this Agreement shall be paid to SP
in United States dollars at the address specified in SECTION 11.1 of this
Agreement or to such other place as SP may reasonably designate consistent with
applicable laws and regulations.
6.4 RECORDS. For a period of [***] from the date covered by any report
provided under SECTION 6.2, BIOCHEM agrees to maintain written records with
respect to its operations for such period pursuant to this Agreement in
sufficient detail to enable SP or its designated accountants to compute the
amount of Gross Profit, Profit, R & D Profit, Sub-License Receipts and other
payments payable to SP, and further agrees to permit said records to be
audited from time to time, on reasonable notice during normal business hours
to the extent necessary to verify the amount of royalties or payments due
hereunder. Any such audit shall be conducted by an independent auditor
selected by SP and approved by BIOCHEM. Any such auditor shall execute a
confidentiality agreement satisfactory to BIOCHEM. Any report by such
auditor shall only state that the amounts of royalties or payments were
accurate or state the specific amount overpaid or underpaid. A copy of such
report shall be provided to both BIOCHEM and SP. SP shall pay the costs of
said
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examination unless an underpayment of greater than [***] in royalties due is
present, in which case BIOCHEM shall reimburse SP for the reasonable expenses
of the examination.
6.5 PROFIT CALCULATIONS. Profit, Gross Profit, Net Sales, R & D Profit or
Sub-License Receipts subject to payments in any country outside the United
States shall be calculated on Profits, Gross Profits, R & D Profits or Sub
License Receipts fees paid in such country as expressed in United States dollars
in accordance with BIOCHEM's standard accounting procedure used for BIOCHEM's
reporting of income to its stockholders and for other external reporting, which
procedure shall comply with GAAP.
6.6 FOREIGN CURRENCY. BIOCHEM and its Sub-Licensees shall use their best
efforts to convert the Profit, Gross Profits, R & D Profits or Sub-License
Receipts due SP on sales in any country to United States dollars; provided,
however, that if conversion to and transfer of United States dollars cannot be
made in any country for any reason, at the election of SP, all such payments (i)
may be made in the currency of the country in which such sales are made and
deposited in SP's name in a bank designated by SP in any such country; or (ii)
the obligation of BIOCHEM or its Sub-Licensees to make such payment shall be
suspended until such conversion and transfer of all funds by BIOCHEM or its
Sub-Licensees becomes possible.
6.7 INCOME TAXES. All income taxes assessed or imposed against or
required to be withheld from payments due SP shall be deducted from amounts
payable hereunder and shall be paid to appropriate fiscal or tax authorities
on behalf of SP. Tax receipts received by BIOCHEM evidencing payment of such
taxes shall be forwarded to SP.
6.8 LATE PAYMENT. Any payments due hereunder which are not paid when
due shall bear an interest at a rate of lesser of the prime as specified by
[***] and the maximum rate allowed under the law from the due date until paid
in full. Payment of such interest shall be in addition to any other rights
and remedies to which SP may be entitled for failure of BIOCHEM to make
timely payments.
ARTICLE VII
TERM AND TERMINATION
7.1 TERM OF THIS AGREEMENT. Unless sooner terminated as otherwise
provided herein, this Agreement shall terminate on the later of [***]
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[***] and BIOCHEM shall have a fully paid-up license to make, have made, use,
rent, sell, lease, market, and otherwise commercially exploit the Compounds and
Product in such country.
7.2 TERMINATION BY SP. SP may terminate this Agreement if BIOCHEM
fails to perform any of its material obligations under this Agreement and
fails to remedy said breach within [***] after being given written notice of
the specific failure or default and termination by SP.
7.3 TERMINATION BY BIOCHEM. BIOCHEM may terminate this Agreement if SP
fails to perform any of its material obligations under this Agreement and
fails to remedy said breach within [***] after being given written notice of
the specific failure or default and termination by BIOCHEM.
7.4 RIGHTS AFTER TERMINATION DUE TO BREACH BY SP. In the event this
Agreement is terminated under SECTION 7.3, then BIOCHEM shall have a fully
paid-up license under SP Technology (to the extent such SP Technology covers
composition of matter, methods of use, manufacturing and formulation of
Compounds or Product thereof) to make, use and sell the Compounds and Products.
7.5 RIGHTS AFTER TERMINATION DUE TO BREACH BY BIOCHEM. In the event that
this Agreement is terminated under SECTION 7.2, then BIOCHEM shall sign and turn
over to SP and SP shall solely own all developments, Compounds, Products,
information, preclinical and clinical trial results and data, government filings
and other items created by BIOCHEM during the carrying out of the Clinical
Development Plan.
7.6 RIGHTS AFTER TERMINATION. In the event this Agreement is terminated
under SECTIONS 7.2 or 7.3:
(a) BIOCHEM shall have [***] to complete the manufacture and
[***] to complete sale or license of any Products in
stock or in the course of manufacture at the time of
termination, all subject, however, to payments of Profits,
Gross Profits, R & D Profits or Sub-License Receipts and
accounting as provided herein, even if such Profits, Gross
Profits, R & D Profits or Sub-License Receipts obligations
arise from transactions subsequent to the effective date of
termination;
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(b) BIOCHEM's obligation to make payments and its obligation to
keep records and to allow a final audit will survive any
termination; and
(c) Except as expressly provided herein, no Party hereunder
shall be discharged or relieved from any liability or
obligation existing prior to such termination.
7.7 MUTUAL TERMINATION. The Parties can mutually agree to terminate this
Agreement at any time.
ARTICLE VIII
PROPRIETARY RIGHTS AND TECHNOLOGY ASSISTANCE
8.1 RIGHT TO XXX. Each Party shall promptly inform the other of any
suspected infringement of any SP Patent Rights or misuse, misappropriation,
theft or breach of confidence of other proprietary rights in the SP
Technology, Compounds or Products by a third party. With respect to such
activities as are suspected and if such activities are a violation of
BIOCHEM's rights, BIOCHEM may, but shall not have the obligation, to bring
suit against a third party for infringement, misuse, misappropriation, theft
or breach of confidence of the proprietary rights against such third party.
If BIOCHEM does not bring suit within [***] of notice under this section,
then SP shall have the right to bring suit. If SP brings suit all recovery
shall belong to SP. BIOCHEM, if required by law, shall join SP as a party to
the suit at BIOCHEM's expense. In the event that BIOCHEM prosecutes any such
lawsuit, then BIOCHEM shall be entitled to deduct its costs and expenses from
any damages it is awarded. Any remaining damage awarded shall be treated as
Profit and subject to payment under SECTION 3.2. Before any action is taken
that will affect the validity of any rights or before such lawsuit is settled
or compromised, the Parties shall consult and cooperate with one another to
insure that the rights granted by this Agreement are not materially affected
by any such acts, settlement or compromise. SP shall have final approval of
all settlements, such approval shall not be unreasonably withheld.
8.2 DILIGENT PROSECUTION OF EXISTING APPLICATIONS. SP shall diligently
file, prosecute and maintain all existing and future patents and patent
applications within the Patent Rights including all pending and new patent
applications and respond to oppositions filed by third parties against the
grant of letters patent for such applications; provided however, BIOCHEM
shall reimburse SP for [***] of any expenses including filing, prosecution and
maintenance or restoration under SECTION 8.10 of patents under the SP Patent
Rights after the Effective Date.
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8.3 FURNISHING OF TECHNOLOGY. SP shall provide BIOCHEM with all the
information and documents in its possession, and which are reasonably necessary
to develop and commercially exploit the Compounds and Products and all
information in its possession which is required by the Regulatory Agency. If
any new information related to the Compounds and Products is developed by, or
comes into the possession SP and SP is not prevented from disclosing such
information by an agreement with a third party, then SP shall provide such
information in a timely manner.
8.4 IMPROVEMENTS. If any new uses for or derivatives of any Compounds or
Products developed by SP under the Research Programs hereunder are developed or
discovered by SP or BIOCHEM during the term of this Agreement (the "Research
Inventions"), ownership of such uses or derivative Compounds shall be governed
by United States Patent laws and such new uses or derivative Compounds and any
patent derived therefrom shall be included within the scope of this Agreement.
8.5 LICENSE OF RESEARCH INVENTIONS. Each Party shall promptly disclose to
the other Party the making, conception or reduction to practice of Research
Inventions. When a Research Invention has been made which may reasonably be
considered to be patentable, a patent application shall be filed as soon as
reasonably possible in accordance with SECTION 8.2. Such Research Inventions
shall be deemed to be SP Patent Rights in accordance with SECTION 1.34 herein.
With respect to Research Inventions which are not patentable, such research
information shall be deemed to be SP Technology, and shall be licensed in
accordance with the terms and conditions contained in ARTICLE III herein.
8.6 RESEARCH TERM. Except as otherwise provided herein, the term of the
Research Programs shall commence on the Effective Date and continue for a period
of [***]. The Research Program can be extended by the mutual agreement
of the Parties.
8.7 PROVIDE COPIES. SP shall provide to BIOCHEM copies of all patent
applications pertaining to the Research Programs prior to filing for the purpose
of obtaining substantive comment of BIOCHEM patent counsel and consult with
BIOCHEM regarding countries in which such patent applications should be filed
and shall file patent applications in those countries where BIOCHEM requests
that SP file.
8.8 PROSECUTION. SP shall provide to BIOCHEM copies of all documents
relating to prosecution of all patent applications in a timely manner for the
purpose of obtaining substantive comment of BIOCHEM patent counsel.
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8.9 ABANDONMENT. SP shall notify BIOCHEM in a timely manner of any
decision to abandon a pending patent application or to stop maintaining an
issued patent at which point, BIOCHEM shall have the option, at its expense, of
continuing to prosecute any pending patent application or of keeping the issued
patent in force.
8.10 PATENT TERM RESTORATION. The Parties hereto shall cooperate with each
other in obtaining patent term restoration or supplemental protection
certificates or their equivalents in any country in the Territory where
applicable to Patent Rights. In the event that elections with respect to
obtaining such patent term restoration are to be made, each of BIOCHEM and SP
shall have the right to make the election and non-selecting Party agrees to
abide by such election.
ARTICLE IX
RESEARCH PROGRAM
9.1 RESEARCH OBLIGATIONS. SP shall use its best efforts based on its
reasonable business judgment to diligently conduct the Research Programs. If SP
elects not to pursue research under the Hepatitis B Research Program and/or the
Dimerescent Receptor Research Program, SP shall have no continuing right to
pursue any research and development work on any Compounds or Products for any
purpose either in the Field or outside the Field under any such Research
Program(s) so discontinued; provided, however, it shall not be considered an
abandonment of any Research Program if SP terminates research on a target after
the Transfer Date or by mutual agreement of the Parties.
9.2 TERMINATION RIGHTS. Upon termination of any of the Research Programs
in accordance with this ARTICLE IX, SP shall immediately transfer to BIOCHEM
and/or its Affiliates, all documents, records and SP Technology in its
possession which directly relate to Compounds or Products, the development of
which is so abandoned by SP and BIOCHEM shall have the right to continue to
develop and commercialize such Compounds or Products for HBV or Dimerescent
Receptor Research Program for which an option was exercised, whichever is
abandoned by SP. In such occurrence, BIOCHEM shall be responsible, at its cost
and expense, for the filing, prosecution and maintenance of all patent rights
associated with such abandonment.
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9.3 LICENSE. SP hereby grants to BIOCHEM a limited, irrevocable,
exclusive, non-royalty bearing license in the Territory under the SP Technology
(to the extent such SP Technology covers composition of matter, methods of use,
manufacturing and formulation of Compounds or Product thereof) to the abandoned
Compounds or Products to seek governmental approvals, discover, develop, make,
use offer to sell, sell, import and export and have developed, made, used,
offered for sale, sold, imported and exported any of the abandoned Compounds or
Products arising from the Research Program(s).
9.4 WITHOUT PREJUDICE. Any termination of the Research Program(s) shall
be without prejudice to the rights of either Party against the other then
accruing or otherwise accrued under this Agreement.
9.5 NO SHARE. SP will not receive any share of the Profit, Gross Profit
or Sub-License Receipts from the Commercial Sale of abandoned Compounds or
Product.
ARTICLE X
FORCE MAJEURE
10.1 FORCE MAJEURE. Except as otherwise provided in this Agreement
(except the obligation to make payments when properly due), any delay or
failure to perform under this Agreement arising from causes beyond the
reasonable control of the Party concerned shall not be deemed to be a default
and shall not put an end to this Agreement, so that the same shall continue
in suspense or part performance until such cause shall have ceased. For the
above purpose the following causes shall be deemed to be beyond the
reasonable control of the Parties, unless conclusive evidence to the contrary
is provided by the Party alleging control, namely: strikes, lockouts, civil
commotion, riot, invasion, war, sabotage, embargo, fire, explosion, storm,
flood, earthquake; or voluntary or mandatory compliance with any direction,
request or order of any Person having or appearing to have governmental
authority, or purpose of national defense or national heath emergency. The
Party affected by an event reasonably beyond its control shall notify the
other Party within [***] and specify the event. Such Party shall take its
best efforts based on its reasonable business judgement to eliminate the
cause of such event. If a condition constituting force majeure as defined
herein exists for more than [***] the Parties shall meet to negotiate a
mutually satisfactory solution to the problem, if practicable.
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ARTICLE XI
NOTICES
11.1 NOTICES. All notices, requests, demands and other communications
under this Agreement or in connection therewith to be effective shall be in
writing in English and unless otherwise expressly provided herein shall be
deemed to have been duly given or made (i) on the date delivered in person; (ii)
on the date transmitted by facsimile if confirmation is sent by Federal Express
within one (1) day; (iii) on the date received if sent by Federal Express or
other nationally recognized overnight carrier service with service charges
prepaid; in each case (except for personal delivery) such notices, requests,
demands or other communications shall be sent to a Party at its address or
facsimile number as follows, or as otherwise designated by the Party by notice
in accordance herewith:
(i) If to SP, to:
Scriptgen Pharmaceuticals, Inc.
000 Xxxxxx Xxxxxx
Xxxxxxx, XX
Attention: President
Facsimile No.: (000) 000-0000
with copies to:
Fulbright & Xxxxxxxx
0000 XxXxxxxx Xxxxxx, Xxxxx 0000
Xxxxxxx, XX 00000-0000
Attention: Xxxxxx X Xxxx
Facsimile No.: (000) 000-0000
(ii) If to BIOCHEM, to:
BioChem Pharma Inc.
Xxxxxx-Xxxxxxxx Xxxxxxxxx
Xxxxx, Xxxxxx, Xxxxxx
Attention: President
Facsimile No.: (000) 000-0000
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with copies to:
BioChem Pharma Inc.
Xxxxxx-Xxxxxxxx Xxxxxxxxx
Xxxxx, Xxxxxx, Xxxxxx
Attention: Xxxxxxxx Xxxxxxxxxx
Senior Legal Counsel, Legal Affairs
Facsimile No.: (000) 000-0000
ARTICLE XII
WARRANTIES, REPRESENTATION AND INDEMNITY
12.1 RIGHT TO GRANT. SP represents and warrants that it has the legal
right to grant the license set forth in this Agreement.
12.2 AUTHORIZATION. Each Party represents and warrants to the other Party
that it is duly organized and has the authority to operate where it does
business and its execution, delivery, and performance of this Agreement and the
consideration set forth in this Agreement have been duly authorized by all
necessary corporate action and that this Agreement is not in conflict with any
other agreements to which it is party.
12.3 PATENT WARRANTY. To the best knowledge of the officers of SP (i) none
of the Drug Candidates for HBV infringe patents of third parties on the Transfer
Date unless written notice is otherwise provided to BIOCHEM by SP prior to the
Transfer Date and (ii) none of the Dimerescent Compounds infringe patents of
third parties on the date of execution of the option unless written notice is
otherwise provided to BIOCHEM prior to execution of the options.
12.4 COMPLIANCE WITH APPROPRIATE LAW. Each Party warrants that it shall
comply with any applicable national or local laws and regulations related to the
subject matter of this Agreement and that a Party shall indemnify and hold
harmless the other Party from actions related to a Party's violation of such
laws and regulations to the extent permitted by law.
12.5 RESPONSIBILITY FOR COMPLIANCE. Each Party shall be responsible for
compliance with laws applicable to any sale, manufacture or other use involving
the Technology or Product.
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12.6 WARRANTY DISCLAIMER.
EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY
MAKES ANY WARRANTY WITH RESPECT TO ANY TECHNOLOGY, GOODS SERVICES, RIGHTS OR
OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS WARRANTIES OR
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT WITH
RESPECT TO ANY AND ALL OF THE FOREGOING.
12.7 LIMITED LIABILITY.
NOTWITHSTANDING ANYTHING ELSE IN THIS AGREEMENT OR OTHERWISE, NEITHER
BIOCHEM NOR SP WILL BE LIABLE WITH RESPECT TO ANY SUBJECT MATTER OF THIS
AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR
EQUITABLE THEORY FOR (i) ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE
DAMAGES OR LOST PROFITS OR (ii) COST OF PROCUREMENT OF SUBSTITUTE GOODS,
TECHNOLOGY OR SERVICES.
12.8 WARRANTY INDEMNITY. Each Party agrees to indemnify and hold the other
Party and its directors, officers, trustees, employees, agents and
representatives, harmless from any liabilities, costs and expenses (including
attorney's fees and expenses), obligations or causes of action arising out of or
related to any breach of the representations and warranties made by such Party
herein.
12.9 GENERAL INDEMNITY. BIOCHEM agrees to protect, defend, indemnify
and hold SP and its directors, officers, trustees, employees, agents and
representatives harmless from and against, and to pay any and all losses,
liabilities, claims, demands, causes of action, lawsuits, or other
proceedings (whether in contract, tort, strict liability or otherwise),
fines, assessments, damages or any other amounts of whatever nature which SP,
its directors, officers, trustees, employees, agents and representatives may
sustain or incur, including all attorney's fees and court costs, as a
consequence of any third party's (including, but not limited to, BIOCHEM's
officers, directors, employees, agents, consultants, representatives or
servants) claims and demands arising from the use, testing, operation,
marketing, sale or manufacture of the Compound or Products, or Products by
BIOCHEM or its sub-licensees to the extent such liability is not due to SP'S
actions or failure to take actions or to SP's performance of the Research
Programs.
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12.10 INDEMNITY PROCEDURE. SP will promptly notify BIOCHEM in writing of
notice of any claims or the commencement of any action, if a claim in respect
thereof is to be made against BIOCHEM under SECTION 12.9. SP's failure to
notify BIOCHEM will not relieve BIOCHEM from any liability to SP except to the
extent such liability results from the delay. After receiving notice of said
action, BIOCHEM provide the defense thereof by promptly notifying SP in writing.
After SP has received notice of BIOCHEM's assumption the defense of said action,
BIOCHEM will not be liable to SP under SECTION 12.9 for any legal or other
expenses subsequently incurred by SP in connection with the defense thereof.
12.11 SETTLEMENT. Neither SP nor BIOCHEM shall settle any action covered
by SECTION 12.10 without first obtaining the consent of the other Party, which
consent will not be unreasonably withheld.
12.12 INFRINGEMENT EXPENSE.Unless SP is in breach of its warranty under
SECTION 12.3, BIOCHEM shall be responsible for any expenses or damages resulting
from any patent infringement suit brought by a third party as a result of
BIOCHEM's development, manufacture, use or sale of Compounds or Products. If
BIOCHEM requests SP to provide reasonable assistance in any such infringement
suit, SP shall take reasonable efforts to provide such assistance and BIOCHEM
shall reimburse SP for any expenses incurred by SP in providing such assistance.
12.13 SURVIVAL. BIOCHEM's indemnity obligations under this Agreement
shall survive the termination of this Agreement, regardless of the reasons for
which this Agreement is terminated.
ARTICLE XIII
DISPUTE RESOLUTION
13.1 DISPUTE RESOLUTION. If a dispute arises out of or relates to this
Agreement or its breach (the "Matter"), the Parties agree to resolve the Matter
as follows:
(a) A Party shall submit written notice of the Matter to the other
Party and request negotiation;
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(b) The Parties shall attempt in good faith to resolve any Matter
arising out of or relating to this Agreement promptly by
negotiation between representatives which the Parties may
appoint; and
(c) If the Matter has not been resolved within [***] of a
Party's request for negotiation, either Party may request that
the Matter be submitted to a sole mediator selected by the
Parties for a mandatory [***] mediation;
(d) If the Matter has not been resolved by such mediation, either
Party may submit the Matter for binding arbitration in accordance
with the Commercial Rules of the American Arbitration Association
("AAA"). The panel shall be selected from the AAA's large
complex case panel, provided, however, if this panel is of
insufficient size to pick the arbitrator(s), then the regular
commercial panel shall be used to pick any additional
arbitrator(s). The award shall be made within [***] of
selection of an arbitrator(s).
The mediation and arbitration shall be held in New York, New York. The
Parties, their representatives, the mediator and the arbitrator shall hold the
existence, content and results of any negotiation, mediation or arbitration in
confidence unless disclosure is required by law or regulation, and in such case
the Parties shall take reasonable precautions to only disclose what is required
by law or governmental regulation.
Any award of the Arbitration shall be binding on the Parties and shall be
enforceable in any court having jurisdiction over the Party from whom
enforcement is requested.
ARTICLE XIV
MISCELLANEOUS
14.1 SEVERABILITY. In case any one or more of the provisions contained in
this Agreement shall, for any reason, be held to be invalid, illegal, or
unenforceable in any respect, such invalidity, illegality or unenforceability
shall not affect any other provision of this Agreement and this Agreement shall
be construed as if such invalid, illegal or unenforceable provisions had never
been contained herein.
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14.2 ENTIRE AGREEMENT. This Agreement and attached Schedules sets forth
the entire agreement and understanding between the Parties as to the subject
matter of the Agreement, and merges and supersedes all prior discussions,
proposals, offers and agreements, if any, with respect to the subject matter
of this Agreement. However, the Confidentiality obligations contained in the
Non-Disclosure Agreement between the Parties dated November 13, 1997 shall
survive the termination of this Agreement for all confidential information
(as defined in the Non-Disclosure Agreement disclosed by either Party prior
to the Effective Date of this Agreement). There are no covenants, promises,
agreements, warranties, representations, conditions or understandings, either
oral or written, between the Parties other than as are set forth herein and
therein.
14.3 LIMITATION OF AUTHORITY. Neither BIOCHEM nor SP shall have any
authority arising out of this Agreement to create any implied or express
liability or obligation in the name or on behalf of the other Party, and neither
Party shall enter into any contract with any person or entity that purports to
bind the other Party.
14.4 CHOICE OF LAW. The validity and interpretation of this Agreement
shall be governed by the substantive law of the State of New York. Any national
law, United Nations treaty or convention, or law arising from any international
treaty is hereby waived in favor of the application of New York law. The
Parties hereby specifically exclude the application of The Convention for the
International Sale of Goods.
14.5 RECORDING. Each Party shall have the right, at any time, to record,
register, or otherwise notify this Agreement in appropriate governmental or
regulatory offices anywhere in the Territory, and SP or BIOCHEM, as the case may
be, shall provide reasonable assistance to the other in effecting such
recording, registering or notifying.
14.6 NO WAIVER. The failure of any Party to enforce or demand performance
of any term of this Agreement shall not be deemed a wavier of any said term or
right. A waiver may only be executed in writing and signed by the Party
granting such waiver.
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14.7 ASSIGNMENT. Except as otherwise specifically provided for herein,
neither this Agreement nor any or all of the rights and obligations of a Party
hereunder shall be assigned, delegated, sold, transferred, or otherwise disposed
of, by operation of law or otherwise, to any third party other than an Affiliate
of each Party, without the prior written consent of the other Party, any
attempted assignment, delegation, sale, transfer, or other disposition, by
operation of law or otherwise, of this Agreement or of any rights or obligations
hereunder contrary to this SECTION 14.7 shall be void and without force or
effect; provided, however, BIOCHEM or SP may, without such consent, assign the
Agreement and its rights and obligations hereunder to an Affiliate or in
connection with the transfer or sale of all or substantially all of its assets
related to the division or the subject business, or in the event of its merger
or consolidation or change in control or similar transaction. Nothing in this
SECTION 14.7 shall be construed to restrict (i) BIOCHEM's right to Sub-License;
or (ii) BIOCHEM's right to engage third Persons or Affiliates. Each Party shall
be responsible for the compliance by its Affiliates with the terms and
conditions of this Agreement.
14.8 AMALGAMATION. SP acknowledges that BioChem has advised it that it
proposes to carry out a reorganization, including an amalgamation, pursuant
to which, among other things, a corporation named BioChem Holdings Inc. (the
"Successor") will own all of the assets and be liable for all liabilities of
BioChem (the "Amalgamation"). SP hereby agrees that, upon consummation of
the Amalgamation, the Successor shall have all the rights and obligations of
BioChem as if Successor had executed this Agreement on the date hereof in
lieu of BioChem and that neither BioChem nor Successor shall be required to
send any notice of any kind regarding the Amalgamation nor seek the consent
of SP to such Amalgamation.
14.9 BINDING AGREEMENT. This Agreement is binding upon and shall inure to
the benefit of each Party's Affiliates, legal representatives, administrators,
successors, sub-licensees, and permitted assigns, of BIOCHEM or SP.
14.10 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original but all of which
together shall constitute one and the same instrument.
14.11 EXPORT CONTROLS. This Agreement is made subject to any restrictions
concerning the export of Products or Compounds from the United States which may
be imposed upon or related to either Party to this Agreement from time to time
by the Government of the United States. BIOCHEM will not export, directly or
indirectly, any Compounds or any Products utilizing such Compounds to any
countries for which the United States Government or any agency thereof at the
time of export requires an export license or other governmental approval,
without first
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obtaining the written consent to do so from the Department of Commerce or other
agency of the United States Government when required by the applicable statute
or regulation.
14.12 HEADINGS. The headings contained in this Agreement are for
convenience of reference only and shall not be considered in construing this
Agreement.
14.13 NO PUBLICITY. A Party may not use the name of the other Party in
any publicity or advertising and, except as provided in this SECTION 14.12 may
not issue a press release or otherwise publicize or disclose any information
related to this Agreement or the terms or conditions hereof, without the prior
written consent of the other Party. The Parties shall agree on a form of
initial press release that may be used by either Party to describe this
Agreement. Nothing in the foregoing, however, shall prohibit a Party from
making such disclosures to the extent deemed necessary under applicable federal,
state or provincial securities laws or any rule or regulation of any nationally
recognized securities exchange; in such event, however, the disclosing Party
shall use good faith efforts to consult with the other Party prior to such
disclosure and, where applicable, shall request confidential treatment to the
extent available.
14.14 PUBLICATION. During the term of the Research Programs, each
Party recognizes the mutual interest in obtaining valid patent protection and
in protecting business interests and trade secret information. Consequently,
either Party, its employees or consultants wishing to make a publication
covering information arising from the Research Programs and in the Field
shall deliver to the other Party a copy of the proposed written publication
or an outline of an oral disclosure at least [***] prior to submission for
publication or presentation (the "Review Period"). If either Party
reasonably determines that the proposed disclosure would reveal an invention
or Confidential Information, then such Party shall notify the other of such
determination and its basis prior to the expiration of the Review Period.
With respect to disclosure of an invention, both Parties agree not to submit
the written publication or presentation of the oral public disclosure, or
otherwise disclose the results of the Research Programs in any manner that
would compromise SP's ability to obtain valid Patent Rights covering such
invention. Neither Party shall disclose results of the Research Programs
until one of the following events occurs: (i) BIOCHEM and SP agrees that no
patentable invention or protectable trade secret exists; (ii) BIOCHEM or SP
files a patent application claiming the relevant invention; or (iii) BIOCHEM
and SP jointly agree upon revisions that prevent disclosure of any invention.
The foregoing notwithstanding, in the event that either of BIOCHEM or SP
(hereinafter referred to
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as a "Notifying Party) notifies the other that a proposed publication of
results of the Research Programs contains information which is of substantial
commercial importance to the Notifying Party, the proposed publication shall be
delayed by the publishing Party (including any other form of public disclosure
of such information) for a period not to exceed [***] from the filing date of
the first patent application covering the information contained in the proposed
publication. In the event that the Notifying Party notifies the other of
evidence that an independent third Person is preparing to publish, or otherwise
publicly disclose, essentially the same information as that contained in the
proposed publication which has been delayed, the Notifying Party will seriously
consider a request by the publishing Party to allow such delayed publication
to occur on an expedited bases, provided that absent written approval from
the notifying Party no such expedited publication shall occur. Nothing in
this SECTION 14.13 shall allow one Party to disclose the other Party's
Confidential Information.
14.15 MEETINGS. The Parties agree that they shall meet approximately
[***] alternating between [***] or other mutually agreed location. [***]
The first such meeting shall take place in [***]
14.16 RESPONSIBILITY FOR EXPENSES. Each Party is responsible for its own
expenses related to the execution of this Agreement.
14.17 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and
deliver such further instruments and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
14.18 AMENDMENTS. No amendment or modification to this Agreement is
effective unless in writing and signed by the Parties.
14.19 INFORMED REVIEW. Each Party acknowledges that it and its counsel
have received and reviewed this Agreement and that normal rules of construction,
to the effect that ambiguities are to be resolved against the drafting Party,
shall not apply to this Agreement or to any amendments, modifications, exhibits
or attachments to this Agreement.
14.20 EFFECTIVENESS. Notwithstanding any terms in this Agreement, this
Agreement shall not be effective until the Stock Purchase Agreement referenced
in SECTION 3.1 is consummated.
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IN WITNESS WHEREOF, the Parties hereto have executed and delivered this
Agreement in multiple originals by their duly authorized officers and
representatives on the respective dates shown below but effective as of the
Effective Date.
SCRIPTGEN PHARMACEUTICALS, INC. BIOCHEM PHARMA, INC.
By: /s/ Xxxx X. Xxxxxx By: /s/ Xxxxxx Xxxx
-------------------------------- -------------------------------
Xxxx X. Xxxxxx Xxxxxx Xxxx
President and Chief Executive Vice President of Corporate
Officer Development
Date: Date:
By: /s/ Xxxxxxxx Xxxxxxx
-------------------------------
Xxxxxxxx Xxxxxxx
Executive Vice President
Date:
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[***]
[***]
