Collaborative Research and License Agreement - IDEC Pharmaceuticals Corp. and SmithKline Beecham plc
AMENDED AND RESTATED COLLABORATIVE RESEARCH
AND LICENSE AGREEMENT
BETWEEN
IDEC PHARMACEUTICALS CORPORATION
AND
SMITHKLINE BEECHAM P.L.C.
<PAGE> 2
AMENDED AND RESTATED COLLABORATIVE RESEARCH
AND LICENSE AGREEMENT
IDEC PHARMACEUTICALS CORPORATION---SMITHKLINE BEECHAM P.L.C.
TABLE OF CONTENTS
Page
1. DEFINITIONS...................................................................4
2. LICENSE GRANT.................................................................7
3. SUPPLY OF COMPOUND AND RELATED KNOW-HOW AND STUDIES...........................7
4. DEVELOPMENT AND COMMERCIALIZATION RIGHTS......................................9
5. ROYALTIES....................................................................10
6. TERM, TERMINATION AND RIGHTS ON TERMINATION..................................11
7. EXCHANGE OF INFORMATION AND CONFIDENTIALITY..................................12
8. PATENT PROSECUTION...........................................................12
9. PATENT LITIGATION............................................................13
10. STATEMENTS AND REMITTANCES; AUDIT............................................15
11. WARRANTIES, REPRESENTATIONS, INSURANCE AND INDEMNIFICATIONS..................15
12. FORCE MAJEURE................................................................17
13. GOVERNING LAW................................................................18
14. ARBITRATION..................................................................18
15. SEPARABILITY.................................................................18
16. ENTIRE AGREEMENT.............................................................18
17. NOTICES......................................................................18
18. RECORDATION..................................................................19
19. ASSIGNMENT...................................................................19
20. EXECUTION IN COUNTERPARTS....................................................19
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AMENDED AND RESTATED COLLABORATIVE
RESEARCH AND LICENSE AGREEMENT
THIS AMENDED AND RESTATED COLLABORATIVE RESEARCH AND LICENSE AGREEMENT
(hereinafter the "AGREEMENT"), made as of the 29th day of February, 2000,
between SmithKline Beecham p.l.c., a company organized under English law and
having its registered office at New Horizons Court, Brentford, Middlesex TW8
9EP, England (hereinafter "SB") and IDEC Pharmaceuticals Corporation, a company
organized under the laws of the State of Delaware and having its principal
executive offices at 3020 Callan Road, San Diego, California 92121 (hereinafter
"IDEC").
WITNESSETH THAT:
WHEREAS, SB AND IDEC entered into a Collaborative Research and License
AGREEMENT dated October 12, 1992 as amended by: (i) an extension of Negotiation
Period executed January 15, 1993 by SB; (ii) an Amendment Agreement dated
January 20, 1993; (iii) an Amendment Agreement to the January 20, 1993 Amendment
Agreement dated January 27, 1993; (iv) an Amendment Agreement to the January 20,
1993 Amendment Agreement dated June 14, 1993; (v) a letter dated August 9, 1993;
(vi) an Amendment Agreement dated May 26, 1994; and (vii) an Amendment Agreement
dated February 1, 2000 (the "February 2000 Amendment")(collectively, the
"Original Agreement");
WHEREAS, pursuant to the Original Agreement, IDEC granted SB worldwide
licenses under certain patents, patent applications and know-how relating to
products directed against the CD4+ cell function and the use of such products
for the palliation, treatment and/or prophylaxis of disease states which are
caused or exacerbated by cells expressing the CD4+ determinant;
WHEREAS, pursuant to the February 2000 Amendment, the parties have
terminated (i) their collaboration for the development and commercialization of
products and (ii) all licenses granted to SB under the Original Agreement with
full reversion to IDEC of all IDEC's interest and rights in patent rights and
know-how subject to such licenses;
WHEREAS, also pursuant to the February 2000 Amendment, SB granted to
IDEC worldwide licenses under any and all patents, patent applications and
know-how owned or controlled by SB covering the making, use, importation, offer
or sale of COMPOUND (as defined in the Original Agreement) other than patents,
patent applications and know-how related to SB proprietary manufacturing or
formulation information, and SB further agreed to provide certain limited
technical assistance to IDEC in connection therewith;
WHEREAS, SB and IDEC desire to restate their respective rights and
obligations as currently set forth in the Original Agreement, as amended, and to
replace the Original Agreement with this AGREEMENT;
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NOW, THEREFORE, in consideration of the covenants and obligations
expressed herein, and intending to be legally bound, and otherwise to be bound
by proper and reasonable conduct, the parties agree as follows:
1. DEFINITIONS
1.1 "AFFILIATES" shall mean any corporation, firm, partnership or other
entity, whether de jure or de facto, which directly or indirectly owns, is owned
by or is under common ownership with a party to this AGREEMENT to the extent of
at least fifty percent (50%) of the equity (or such lesser percentage which is
the maximum allowed to be owned by a foreign corporation in a particular
jurisdiction) having the power to vote on or direct the affairs of the entity
and any person, firm, partnership, corporation or other entity actually
controlled by, controlling or under common control with a party to this
AGREEMENT.
1.2 "AT IDEC's EXPENSE" shall mean that IDEC shall pay all reasonable
FTE COSTS, materials, supplies and out-of-pocket expenses incurred by SB, its
agents, contractors and consultants, in executing SB's obligations to IDEC under
this AGREEMENT, including all costs and expenses incurred by SB for stability
testing and regulatory activities commenced by SB under Section 3 after February
2, 2000.
1.3 "CLENOLIXIMAB" shall mean the form of COMPOUND developed by SB and
IDEC pursuant to the Original Agreement.
1.4 "COMMERCIAL SALE" shall mean the first sale of COMPOUND to a THIRD
PARTY purchaser in an IDEC COUNTRY after receipt of all regulatory approvals
necessary to sell COMPOUND. Such approval in Europe shall include any requisite
pricing and reimbursement approvals in conjunction with the Marketing
Authorization Application for COMPOUND in at least one (1) MAJOR EUROPEAN
COUNTRY.
1.5 "COMPOUND" shall mean any composition of matter, the intellectual
property rights to which are owned in whole or in part by IDEC or licensed to
IDEC under Section 2, which is directed against the CD4+ determinant, such as,
but not limited to, the human/Old World monkey chimeric antibodies known as
CE9.1 and G4PE50 (CLENOLIXIMAB), which selectively binds to and/or regulates the
functions of CD4+ cells and/or the immune system.
1.6 "DEVELOPMENT" shall mean preclinical and clinical research on a
COMPOUND conducted primarily with the intent, and for the purpose, of generating
data for submission to a regulatory authority in any of the GEOGRAPHIES in
support of an application for governmental approval required for commercializing
COMPOUND for any indication.
1.7 "EFFECTIVE DATE" shall mean the date as of which this AGREEMENT is
effective and shall be the date of this AGREEMENT first written above.
1.8 "EUROPE" shall mean all countries that are Member States of the
European Union as of the EFFECTIVE DATE.
1.9 "FDA" shall mean the United States Food and Drug Administration.
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1.10 "FTE COSTS" shall apply to either (i) an SB employee who is a
full-time equivalent professional employee of SB, other than a clerical,
administrative assistant, or secretarial employee or (ii) an SB employee who
does not fit within the scope of Section 1.10(i). SB employees within the scope
of Section 1.10(i) shall be chargeable to IDEC at an hourly rate based on an FTE
rate of *_________________ * per annum. SB employees within the scope of Section
1.10(ii) shall be chargeable to IDEC at an hourly rate based on an FTE rate of
*___________________* per annum.
1.11 "GEOGRAPHY(IES)" shall mean, depending on context, the U.S.A.,
EUROPE, and/or the R.O.W.
1.12 "IND" shall mean an Investigational New Drug Application filed with
the FDA.
1.13 "IDEC" shall mean IDEC Pharmaceuticals Corporation, its AFFILIATES,
successors and permitted assigns.
1.14 "IDEC COUNTRY(IES)" shall mean those countries of the world for
which SB has no rights to develop and commercialize COMPOUND pursuant to
Sections 4.3 and 4.4 of this AGREEMENT.
1.15 "IDEC NET SALES" shall mean the gross receipts from sales of
COMPOUND in the IDEC COUNTRY(IES) by IDEC, its AFFILIATES and its licensees to
THIRD PARTIES, less deductions for: (i) transportation charges, including
insurance; (ii) sales and excise taxes and duties paid or allowed by a selling
party and any other governmental charges imposed upon the production,
importation, use or sale of such COMPOUND; (iii) normal and customary trade,
quantity and cash discounts allowed and actually taken; and (iv) allowances or
credits to customers on account of rejection or return of COMPOUND, subject to
the royalty provisions under this AGREEMENT. Sales between or among IDEC and its
AFFILIATES and its or their sublicensees shall be excluded from the computation
of IDEC NET SALES except where such AFFILIATES or sublicensees are end users,
but IDEC NET SALES shall include the subsequent final sales to THIRD PARTIES by
such AFFILIATES or sublicensees.
1.16 "MAJOR EUROPEAN COUNTRY(IES)" shall mean the United Kingdom,
France, Germany, Italy or Spain.
1.17 "NDA" shall mean a New Drug Application in accordance with the
requirements of the FDA.
1.18 "OPT IN" shall mean SB's exclusive, nontransferable (other than as
provided in Section 19) option to negotiate, for a period of *_____________*
right with IDEC to co-develop and co-commercialize COMPOUND with IDEC in the
*_________________,* as provided in Sections 4.2 and 4.3.
1.19 "R.O.W." shall mean all the countries of the world except for the
U.S.A. and EUROPE.
1.20 "SB" shall mean SmithKline Beecham p.l.c., its AFFILIATES,
successors and permitted assigns.
*_______* Indicates that material has been omitted and confidential treatment
has been requested therefor. All such omitted material has been filed
separately with the Secretary of Commission in the Company's Application
Requesting Confidential Treatment pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.
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1.21 "SB KNOW-HOW" shall mean all information and know-how which relates
to COMPOUND and shall include, without limitation, all chemical,
pharmacological, toxicological, clinical, and assay information, and any other
information relating to COMPOUND and useful or required for the DEVELOPMENT and
commercialization of COMPOUND for any indication, which is known by SB as of the
EFFECTIVE DATE, to the extent that SB is free to disclose such as provided by
this AGREEMENT. "SB KNOW-HOW" shall not include *_______*
1.22 "SB PATENTS" shall mean all patents and patent applications which
are owned by SB, or which SB otherwise has the right to grant licenses as of the
EFFECTIVE DATE, which generically or specifically claim COMPOUND, a process for
manufacturing COMPOUND, an intermediate used in such process, a method to
formulate or deliver COMPOUND or a use of COMPOUND. Included within the
definition of SB PATENTS are any continuations, continuations-in-part,
divisions, patents of addition, reissues, renewals or extensions thereof. The
current list of patent applications and patents encompassed within SB PATENTS,
if any, is set forth in APPENDIX A attached hereto and incorporated herein.
1.23 "STUDY *_________*" shall mean the clinical study whose protocol is
described in Exhibit I to this AGREEMENT, attached hereto and incorporated
herein.
1.24 "THIRD PARTY(IES)" shall mean any party other than SB, IDEC or
their respective AFFILIATES.
1.25 "THIRD PARTY KNOW-HOW" shall mean all information and know-how
which relates to COMPOUND and shall include, without limitation, all chemical,
pharmacological, toxicological, clinical, assay, control and manufacturing data
and any other information and shall include, without limitation, all chemical,
pharmacological, clinical, assay, control and manufacturing data and any other
information and reagents relating to COMPOUND and useful or required for the
DEVELOPMENT and commercialization of COMPOUND for any indication owned by a
THIRD PARTY which is controlled by SB or which SB otherwise has the right to
disclose or grant licenses as of the EFFECTIVE DATE.
1.26 "THIRD PARTY PATENTS" shall mean all patents and patent
applications which are owned by a THIRD PARTY but controlled by SB or which SB
otherwise has the right to grant licenses as of the EFFECTIVE DATE, which
generically or specifically claim COMPOUND. Included within the definition of
THIRD PARTY PATENTS are any continuations, continuations-in-part, divisions,
patents of addition, reissues, renewals or extensions thereof. The current list
of patent applications and patents encompassed within THIRD PARTY PATENTS (if
any) is set forth in APPENDIX A attached hereto and incorporated herein.
1.27 "U.S.A." shall mean the United States of America, and its
territories and possessions.
*_______* Indicates that material has been omitted and confidential treatment
has been requested therefor. All such omitted material has been filed
separately with the Secretary of Commission in the Company's Application
Requesting Confidential Treatment pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.
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2. LICENSE GRANT
2.1 SB hereby grants to IDEC an exclusive license, with the right to
grant sublicenses under SB PATENTS and SB KNOW-HOW to make, have made, use,
import, offer for sale, and sell COMPOUND in any country or territory of the
world; provided that such license shall not extend to the
*_____________________________________,* except as otherwise provided in this
AGREEMENT and subject to SB's obligations to *______________________* as
provided in this AGREEMENT. It is agreed and understood that SB retains its
interests and rights in such SB PATENTS and SB KNOW-HOW for all other purposes,
including, without limitation, the right to grant similar licenses under such SB
PATENTS and SB KNOW-HOW to THIRD PARTIES, but only to the extent that such SB
PATENTS and SB KNOW-HOW cover the making, use, import, offer of sale, or sale of
anything other than COMPOUND in any country of the world.
2.2 SB hereby grants to IDEC an exclusive license, with the right to
grant sublicenses under THIRD PARTY PATENTS and THIRD PARTY KNOW-HOW to make,
have made, use, import, offer for sale, and sell COMPOUND in any country or
territory in the world; provided that such license shall not extend to the use
of *__________________________,* except as otherwise provided in this AGREEMENT.
It is agreed and understood that SB retains its interests and rights in such
THIRD PARTY PATENTS and THIRD PARTY KNOW-HOW for all other purposes, including,
without limitation, the right to grant similar licenses under such THIRD PARTY
PATENTS and THIRD PARTY KNOW-HOW to THIRD PARTIES, but only to the extent that
such THIRD PARTY PATENTS and THIRD PARTY KNOW-HOW cover the making, use, import,
offer of sale, or sale of anything other than COMPOUND in any country of the
world. SB shall not take any action to terminate any licenses under THIRD PARTY
PATENTS and THIRD PARTY KNOW-HOW without IDEC's prior written consent.
2.3 Upon IDEC's request and for no additional consideration to SB, SB
shall grant IDEC a sublicense for the making, importing, use and/or sale of
COMPOUND in any country or territory in the world under SB's non-exclusive
license rights to make, have made, use, import, offer for sale or sell COMPOUND
as provided *_____________________________* In addition, within five (5) days
after *_______________________*
3. SUPPLY OF COMPOUND AND RELATED KNOW-HOW AND STUDIES
3.1 If not already done, SB will:
(a) transfer those components of SB's current IND related to the
manufacture of CLENOLIXIMAB as soon as practicable after the EFFECTIVE DATE to a
Drug Master File ("DMF"), AT IDEC's EXPENSE;
(b) provide IDEC with the right to cross-reference the DMF;
provided, however, IDEC may not access such DMF;
(c) make available to IDEC, upon request and within a reasonable
time period, a list of pre-clinical and clinical reports not related to COMPOUND
manufacture, but including any pre-clinical and clinical comparability reports,
that have been or will be submitted to SB's IND for CLENOLIXIMAB. Within thirty
(30) days after receipt of such list, IDEC will
*_______* Indicates that material has been omitted and confidential treatment
has been requested therefor. All such omitted material has been filed
separately with the Secretary of Commission in the Company's Application
Requesting Confidential Treatment pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.
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identify to SB, in writing, those reports which they require from SB to submit
to IDEC's IND for COMPOUND. AT IDEC's EXPENSE, SB will provide IDEC a copy of
the indicated reports. Such reports will be provided to IDEC in electronic form
to the extent available; otherwise they will be provided to IDEC in written
form. In the event that SB closes its IND for CLENOLIXIMAB, SB will give IDEC
prior notification thereof.
3.2 At IDEC's request, SB will provide IDEC with a copy of any existing
clinical databases related to COMPOUND that IDEC reasonably requires to support
its NDA for COMPOUND, AT IDEC's EXPENSE. Such databases will be provided to IDEC
in electronic form to the extent available, otherwise they will be provided to
IDEC in written form. Such delivery will take place as soon as practicable.
3.3 The following shall be applicable to SB's obligation to supply
CLENOLIXIMAB and reagents to IDEC or its designate under this AGREEMENT:
(a) If not already done, before *__________,* SB will initiate
stability testing on existing batches of CLENOLIXIMAB to obtain approximately
*________* vials of CLENOLIXIMAB *____________________* At such time as when the
testing has been completed and *__________________________,* SB shall ship the
vials to IDEC or its designate, and the vials shall become the property of IDEC
as soon as such supplies are in the charge of IDEC's designated carrier. IDEC
shall bear all of SB's costs related to the storage and stability testing of
such supplies *________________*
(b) For each product lot shipped to IDEC, SB will provide IDEC with
the following:
(i) Batch Documentation for each product lot;
(ii) Certificates of Analysis for each product lot;
(iii) Certificate of Compliance for each product lot; and
(iv) Stability reports for each product lot.
Each Certificate of Compliance will read: "SB certifies that the
referenced product lot was produced in compliance to applicable cGMPs with
respect to its materials, processes, procedures and analyses. The method of
manufacture and quality assurance/quality control of the drug substance and drug
product are consistent with that described in the filed DMF. SB certifies that
the reference product lot is not adulterated within the meaning of the Federal
Food, Drug, and Cosmetic Act. SB further certifies that the referenced product
lot is safe, potent and pure from a manufacturing perspective."
(c) SB warrants and represents that all such supplies of
CLENOLIXIMAB meet specifications as set forth in Section 3.3(b), and have been
kept under GMP and will continue to be kept under GMP by SB until such supplies
are in the charge of IDEC's designated carrier. IDEC shall select the carrier
for shipping of all such supplies and IDEC shall bear all costs associated with
the shipping of such supplies to IDEC. SB warrants and represents that stability
work will be conducted on such existing supplies of CLENOLIXIMAB in accordance
with FDA regulations.
*_______* Indicates that material has been omitted and confidential treatment
has been requested therefor. All such omitted material has been filed
separately with the Secretary of Commission in the Company's Application
Requesting Confidential Treatment pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.
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(d) At the same time that SB is shipping the supplies outlined in
Section 3.3(a), SB shall ship, at IDEC'S EXPENSE, the reagents/standards and
test procedures necessary to enable IDEC to carry out further stability testing
on such supplies and to perform the identity test after labeling.
(e) SB's DMF will cover manufacture of bulk drug substance as well
as unlabeled product lots shipped to IDEC.
3.4 IDEC acknowledges that, due to the period of time which has elapsed
since SB conducted clinical trials with COMPOUND and last manufactured COMPOUND,
the knowledge of SB with respect to preclinical and clinical information,
clinical trial databases/programming information, and manufacturing process
information, and all other information or data related to COMPOUND is not
current and, in some cases, key personnel have either left SB or moved to
different roles within SB and may not be available. IDEC further acknowledges
that all COMPOUND, information and assistance provided to IDEC under this
AGREEMENT *_______________________________________* Subject to the foregoing, SB
will attempt to provide a reasonable response to IDEC's reasonable inquires
related to the information transferred to IDEC pursuant to this AGREEMENT within
a reasonable time frame, and shall attempt to respond to FDA directly for
chemistry, manufacturing and controls ("CMC") questions, if any, asked by the
FDA, AT IDEC's EXPENSE, but only to the extent that SB has the available
resources and expertise to do so. SB shall be under no obligation to provide
substantive resources or maintain appropriate expertise for this effort or to
assist IDEC in the development of COMPOUND in any way. Notwithstanding the
foregoing, SB shall perform its obligations under this Section 3 with the same
effort that it would apply to its own compound with similar regulatory
requirements and market potential.
3.5 SB will have no obligation to provide IDEC with *________________*
3.6 *____________________________*
3.7 SB disclaims any and all implied warranties that COMPOUND provided
to IDEC under this AGREEMENT has been tested or will meet applicable
specifications except as otherwise expressly stated in this AGREEMENT. SB
disclaims any and all implied warranties that the information SB provided to
IDEC under this AGREEMENT is necessary or appropriate for FDA or other
regulatory or governmental agency review of COMPOUND except as otherwise
expressly stated in this AGREEMENT. Finally, with respect to COMPOUND,
information, and assistance provided to IDEC under this AGREEMENT, SB disclaims
any warranties or representations, either express or implied, whether in fact or
in law, including without limitation implied warranties of merchantability or
fitness for a particular purpose or noninfringement, except as otherwise
expressly stated in this AGREEMENT.
3.8 In consideration of execution of this AGREEMENT and the payment by
SB to IDEC of the amount of *_______________________* by March 3, 2000, SB's
obligations under Paragraph 13.01 of the Original Agreement shall be deemed
fulfilled.
4. DEVELOPMENT AND COMMERCIALIZATION RIGHTS
4.1 Subject to Section 4.2, IDEC will have full scientific and
management authority and control in connection with the DEVELOPMENT of COMPOUND
under IDEC's IND;
*_______* Indicates that material has been omitted and confidential treatment
has been requested therefor. All such omitted material has been filed
separately with the Secretary of Commission in the Company's Application
Requesting Confidential Treatment pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.
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provided that it is understood that IDEC's initial efforts at such continued
DEVELOPMENT shall be directed *___________________________* IDEC shall also have
full responsibility for the attainment and maintenance of regulatory approvals
and price registrations for COMPOUND in all GEOGRAPHIES in the world.
Notwithstanding the foregoing, the parties acknowledge that IDEC shall
have no obligation to continue DEVELOPMENT of COMPOUND. Subject to this Section
and Section 4.2, IDEC shall have the sole authority and control over DEVELOPMENT
and commercialization of COMPOUND in whatever form, including without
limitation, preclinical and clinical research, submissions of applications to
regulatory authorities in pursuit of approvals in a country for making,
importing, distributing and selling a product and the development and
implementation of marketing plans for COMPOUND.
4.2 At such time as *___________________________* SB shall have the OPT
IN and shall notify IDEC of its intent to exercise the OPT IN in writing no
later than thirty (30) days following SB's receipt of the headline data.
4.3 In the event that SB exercises the OPT IN, SB will have the
exclusive right to negotiate (for a period of *________________* following
SB's notice to IDEC of its exercise of the OPT IN) a mutually acceptable
agreement with IDEC related to such co-development/co-commercialization of
COMPOUND (a "Co-Development/Co-Commercialization Agreement") in the elected
GEOGRAPHIES. The Co-Development/Co-Commercialization Agreement may provide that
for each GEOGRAPHY, *_____________________* Notwithstanding the foregoing, SB
will have no obligation to exercise the OPT IN *_______________*
4.4 In the event that SB exercises the OPT IN for *_________________,*
but SB and IDEC are unable to reach mutually acceptable terms during the
*___________* period for the elected GEOGRAPHY(IES), *)________________*
4.5 *_____________________*
5. ROYALTIES
5.1 In consideration of the license grant to IDEC under Section 2, IDEC
shall pay SB the following royalties:
(a) if commercial supply of COMPOUND utilizes SB's proprietary cell
line expressing COMPOUND, then in consideration for such use of the cell line
together with SB's provision of the information, supplies and assistance to IDEC
under Section 3 of this AGREEMENT, IDEC shall pay SB the following royalties:
(i) *____________* of annual IDEC NET SALES up to and including
*___________________*
(ii) *___________* of annual IDEC NET SALES greater than
*_____________________*
*_______* Indicates that material has been omitted and confidential treatment
has been requested therefor. All such omitted material has been filed
separately with the Secretary of Commission in the Company's Application
Requesting Confidential Treatment pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.
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(b) if commercial supply of COMPOUND does not utilize SB's
proprietary cell line expressing COMPOUND, then IDEC shall pay SB
*_______________* of annual IDEC NET SALES.
5.2 IDEC's royalty obligations for COMPOUND under Section 5.1 shall
commence in each IDEC COUNTRY upon the COMMERCIAL SALE of COMPOUND in such
country and shall expire: (a) in the U.S.A., *__________________ * (b) in
EUROPE, upon the expiration of *__________________* and (c) in the R.O.W., upon
the expiration of *_______________ * Expiration of IDEC's royalty obligations
and payment obligations related to COMPOUND under this provision shall not
preclude IDEC from continuing to market COMPOUND and to use SB PATENTS, SB
KNOW-HOW, THIRD PARTY PATENTS, THIRD PARTY KNOW-HOW and other sublicensed rights
in the relevant GEOGRAPHY without further royalty payments or any other payments
to SB.
6. TERM, TERMINATION AND RIGHTS ON TERMINATION
6.1 Unless otherwise terminated, this AGREEMENT shall expire
*___________________* Expiration of this AGREEMENT under this provision shall
not preclude IDEC from continuing to market any COMPOUND and to use SB PATENTS,
SB KNOW-HOW, THIRD PARTY PATENTS and THIRD PARTY KNOW-HOW and other sublicensed
rights anywhere in the world without further royalty payments.
6.2 If SB materially fails or neglects to perform its respective
obligations set forth in this AGREEMENT and if such default is not corrected
within sixty (60) days after receiving written notice from IDEC with respect to
such default, IDEC shall have the right to terminate SB's rights under Sections
4 and 5 by giving written notice to SB. If IDEC materially fails or neglects to
perform its respective obligations set forth in this AGREEMENT and if such
default is not corrected within sixty (60) days after receiving written notice
from SB with respect to such default, SB shall have the right to terminate
IDEC's rights under Sections 2 and 3 by giving written notice to IDEC.
6.3 Either party may terminate this AGREEMENT if, at any time, the other
party shall file in any court or agency pursuant to any statute or regulation of
any state or country, a petition in bankruptcy or insolvency or for
reorganization or for an arrangement or for the appointment of a receiver or
trustee of the party or of its assets, or if the other party proposes a written
AGREEMENT of composition or extension of its debts, or if the other party shall
be served with an involuntary petition against it, filed in any insolvency
proceeding, and such petition shall not be dismissed within sixty (60) days
after the filing thereof, or if the other party shall propose or be a party to
any dissolution or liquidation, or if the other party shall make an assignment
for the benefit of creditors. Notwithstanding the bankruptcy of SB, IDEC shall
be entitled to retain the licenses granted herein, and subject to performance by
IDEC of its preexisting obligations under this AGREEMENT.
6.4 Termination of this AGREEMENT shall terminate all outstanding
obligations and rights between the parties arising from this AGREEMENT, except
those described in Sections 2, 5, 7, 8, 9, 10, 11, 13, 14, 15, 16, 17, 18 and 19
and any existing rights of one party against the other party for a breach by
that party.
*_______* Indicates that material has been omitted and confidential treatment
has been requested therefor. All such omitted material has been filed
separately with the Secretary of Commission in the Company's Application
Requesting Confidential Treatment pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.
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6.5 All rights to terminate, and rights upon termination, provided for
either party in this AGREEMENT are in addition to other remedies in law or
equity which may be available to either party.
7. EXCHANGE OF INFORMATION AND CONFIDENTIALITY
7.1 During the term of this AGREEMENT, SB shall promptly disclose to
IDEC and/or supply IDEC with SB KNOW-HOW and THIRD PARTY KNOW-HOW which SB owns
or controls as of the EFFECTIVE DATE; provided SB shall not be under any
obligation to disclose any SB proprietary manufacturing or formulation
information for the making, use or sale of COMPOUND except as otherwise provided
in this AGREEMENT.
7.2 Neither party, during the term of this AGREEMENT and for a period of
five (5) years after the date of termination of this AGREEMENT, shall disclose
or reveal to THIRD PARTIES any confidential information received from the other
party or otherwise developed by either party in the performance of activities in
furtherance of this AGREEMENT or the Original Agreement which relates
substantially to a COMPOUND. This confidentiality obligation shall not apply to
such information which is or becomes a matter of public knowledge, or came or
comes into the possession of the receiving party independently of this
AGREEMENT, or is disclosed to the receiving party by a THIRD PARTY having the
right to do so, or is subsequently and independently developed by employees of
the receiving party or AFFILIATES thereof who had no knowledge of the
confidential information disclosed. The parties shall take reasonable measures
to ensure that no unauthorized use or disclosure is made by others to whom
access to such information is granted. Notwithstanding the foregoing, IDEC shall
be entitled to use, reveal and disclose with and to THIRD PARTIES any
confidential information received from SB which relates to a COMPOUND whether
received pursuant to the AGREEMENT or the Original Agreement without first
obtaining the written consent of SB.
7.3 No public announcement or other disclosure to THIRD PARTIES
concerning the existence of or terms of this AGREEMENT shall be made, either
directly or indirectly, by either party to this AGREEMENT, except as may be
legally required or as may be required for recording purposes, without first
obtaining the written approval of the other party and AGREEMENT upon the nature
and text of such announcement or disclosure; provided that such approval shall
not be unreasonably withheld. The party desiring to make any such public
announcement or other disclosure shall use reasonable efforts to inform the
other party of the proposed announcement or disclosure in reasonably sufficient
time prior to public release, and shall use reasonable efforts to provide the
other party with a written copy thereof, in order to allow such other party to
comment upon such announcement or disclosure.
7.4 Nothing in this AGREEMENT shall be construed as preventing or in any
way inhibiting IDEC or SB from complying with statutory and regulatory
requirements governing the manufacture, use and sale or other distribution of
COMPOUND in any country in the world in any manner it reasonably deems
appropriate, including, for example, by disclosing to regulatory authorities
confidential or other information received from the other or THIRD PARTIES.
8. PATENT PROSECUTION
8.1 SB shall disclose to IDEC the complete texts of all SB PATENTS and
THIRD PARTY PATENTS (if any) filed by SB prior to the EFFECTIVE DATE which
relate to
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COMPOUND as well as all information received concerning the institution or
possible institution of any interference, opposition, re-examination, reissue,
revocation, nullification or any official proceeding involving such patents
anywhere in the world.
8.2 SB shall prepare, file, prosecute, maintain, extend and defend
patent applications and issued patents included in the licenses granted pursuant
to Section 2 so as to protect the commercial interests of the parties in
COMPOUND in the U.S., Europe and such other countries where patent applications
and issued patents exist as of the EFFECTIVE DATE. SB shall not abandon any such
patent applications in any country without IDEC's written consent. SB shall
promptly advise IDEC of the grant, lapse, revocation, surrender, invalidation,
or abandonment of any patents subject to Section 2 anywhere in the world.
Notwithstanding the foregoing, IDEC shall have the right to assume
responsibility for the preparation, filing, prosecution, maintenance and defense
of any a patent or patent application or any part thereof in any country for
which SB has the right to prosecute and maintain; provided that the claims of
such patents covers COMPOUND. IDEC acknowledges that all right, title and
interest in and to the SB PATENTS in and to the SB PATENTS are and shall remain
in SB, subject to the express license rights granted to IDEC under Section 2 of
this AGREEMENT.
9. PATENT LITIGATION
9.1 In the event of the institution of any suit by a THIRD PARTY against
IDEC, SB and/or its sublicensees for patent infringement involving an SB PATENT
or THIRD PARTY PATENT subject to Section 2 anywhere in the world, the party sued
shall promptly notify the other party in writing. IDEC shall have the right but
not the obligation to defend such suit at its own expense. IDEC and SB shall
assist one another and cooperate in any such litigation at the other's request
without expense to the requesting party.
9.2 In the event that IDEC or SB becomes aware of actual or threatened
infringement of an SB PATENT or THIRD PARTY PATENT subject to Section 2 anywhere
in the world, that party shall promptly notify the other party in writing. IDEC
shall have the first right but not the obligation to bring, at its own expense,
an infringement action or file any other appropriate action or claim directly
related to infringement of a patent or patent application subject to Section 2
wherein such infringement relates to COMPOUND, against any THIRD PARTY and to
use SB's name in connection therewith. If IDEC does not commence a particular
infringement action within ninety (90) days after it received such written
notice, SB, after notifying IDEC in writing, shall be entitled to bring such
infringement action or any other appropriate action or claim at its own expense.
The party conducting such action shall have full control over its conduct. In
any event, IDEC and SB shall assist one another and cooperate in any such
litigation at the other's request without expense to the requesting party.
9.3 IDEC and SB shall recover their respective actual out-of-pocket
expenses, or equitable proportions thereof, associated with any litigation or
settlement thereof from any recovery made by any party. Any excess amount shall
be shared between SB and IDEC, with each party receiving an amount proportional
to the amount spent by such party on such litigation or settlement thereof
relative to the total amount spent by both parties on such litigation or
settlement thereof.
9.4 The parties shall keep one another informed of the status of and of
their respective activities regarding any litigation or settlement thereof
concerning COMPOUND.
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<PAGE> 14
9.5 SB shall authorize IDEC to act as SB's agent for the purpose of
making any application for any extensions of the term of SB PATENTS or THIRD
PARTY PATENTS of which SB is entitled to act as such an agent in any country in
the world in which such extensions are or become available, and shall provide
reasonable assistance therefor to IDEC, AT IDEC'S EXPENSE.
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<PAGE> 15
10. STATEMENTS AND REMITTANCES; AUDIT
10.1 IDEC shall pay all invoices received from SB within thirty (30)
days of receipt of such invoices.
10.2 IDEC shall keep and require its AFFILIATES and sublicensees to keep
complete and accurate records of IDEC NET SALES. SB shall have the right, at
SB's expense, through a certified public accountant or like person reasonably
acceptable to IDEC, to examine such records during regular business hours during
the term of this AGREEMENT and for six (6) months after the later of its
termination or the last COMMERCIAL SALE of COMPOUND; provided, however, that
such examination shall not take place more often than once a year and shall not
cover such records for more than the preceding two (2) years; and provided
further that such accountant shall report to SB only as to the accuracy of the
IDEC NET SALES calculations, royalty statements and payments by IDEC to SB under
this AGREEMENT.
10.3 Within sixty (60) days after the close of each calendar quarter
commencing with the first calendar quarter in which the COMMERCIAL SALE of a
COMPOUND occurs, IDEC shall deliver to SB a true accounting of IDEC NET SALES of
COMPOUND during such quarter and shall at the same time pay all royalties due to
SB under Section 5.1. Such accounting shall show IDEC NET SALES on a
country-by-country and COMPOUND-by-COMPOUND basis. Any tax paid or required to
be withheld by IDEC on account of royalties payable to SB under this AGREEMENT
shall be deducted from the amount of royalties otherwise due. IDEC shall secure
and send to SB written proof of any such taxes withheld and paid by IDEC or its
sublicensees for the benefit of SB in a form sufficient to satisfy the United
States Internal Revenue Service.
10.4 All royalties due under this AGREEMENT shall be payable in U.S.
dollars. If governmental regulations in a country prevent remittances from IDEC
to SB in U.S. dollars with respect to IDEC NET SALES made in that country, SB
shall receive such royalty payment for IDEC NET SALES in that country in local
currency.
10.5 Monetary conversions from the currency of a foreign country, in
which COMPOUND is sold, into United States currency shall be made at the average
daily rates of exchange for the year from January 1 to the end of such calendar
quarter, from such country's currency into U.S. Dollars as reported in the Wall
Street Journal or other source agreeable to both parties, and shall be converted
at such average year-to-date rate at the end of such quarter.
11. WARRANTIES, REPRESENTATIONS, INSURANCE AND INDEMNIFICATIONS
11.1 As of the EFFECTIVE DATE, SB warrants that, to the best of its
belief and knowledge, it owns the entire right and title to the extent of its
ownership interests in SB PATENTS and SB KNOW-HOW, or has the right to grant the
licenses outlined in Section 2.
11.2 SB represents and warrants to IDEC that it has disclosed to IDEC:
(a) any information that SB obtained or develops in any country of
the world regarding the utility or safety of COMPOUND (including CLENOLIXIMAB)
and any
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<PAGE> 16
confirmed information of serious or unexpected reactions or side effects related
to the utilization or medical administration of COMPOUND. "Serious" as used in
this Section refers to experience which results in death, permanent or
substantial disability, in-patient hospitalization, prolongation of existing
in-patient hospitalization; or is a congenital anomaly, cancer, the result of an
overdose or life threatening. "Unexpected" as used in this Section refers to (i)
conditions or developments encountered during preclinical or clinical studies
which could be material to the successful continuance of development of
COMPOUND; (ii) conditions or developments not encountered during clinical
studies of COMPOUND, and (iii) conditions or developments occurring with greater
frequency, severity, or specificity than shown by information previously
submitted to governmental agencies or encountered during clinical studies of
COMPOUND.
(b) any information it has received regarding any threatened or
pending action by any regulatory agency in any country of the world which may
affect the safety or efficacy claims of COMPOUND or the continued marketing of
COMPOUND.
11.3 Prior to or upon the first administration of COMPOUND to a human by
or on behalf of IDEC, and for a period of five (5) years after the expiration of
this AGREEMENT or its earlier termination, IDEC shall obtain and/or maintain,
respectively, at its sole cost and expense, product liability insurance in
amounts, respectively, which are reasonable and customary in the U.S.
pharmaceutical industry for companies of comparable size and activities.
*___________________________* Such product liability insurance shall insure
against all liability, including liability for personal injury, physical injury
and property damage. IDEC shall provide written proof of the existence of such
insurance to SB.
11.4 IDEC shall indemnify and hold harmless SB, its officers, directors,
shareholders, employees, successors and assigns from any loss, damage, or
liability (including reasonable attorneys' fees) resulting from any claim,
complaint, suit, proceeding or cause of action against any of them alleging
physical or other injury, including death, brought by or on behalf of a THIRD
PARTY due to physical injury or death arising out of the administration,
utilization and/or ingestion of COMPOUND manufactured, sold or otherwise
provided to the THIRD PARTY by IDEC (or its permitted sublicensee), except to
the extent such damages, claims, costs, losses, liabilities or expenses are
directly and proximately caused by SB's negligent or wrongful actions and
provided:
(a) IDEC shall not be obligated under this Section 11.5 if it is
shown by evidence acceptable in a court of law having jurisdiction over the
subject matter and meeting the appropriate degree of proof for such action, that
the injury was the result of the negligence or willful misconduct of any
employee or agent of SB;
(b) IDEC shall have no obligation under this Section 11.5 unless SB
(i) gives IDEC prompt written notice of any claim or lawsuit or other action for
which it seeks to be indemnified under this AGREEMENT; (ii) IDEC is granted full
authority and control over the defense, including settlement, against such claim
or lawsuit or other action; and (iii) SB cooperates fully with IDEC and its
agents in defense of the claims or lawsuit or other action; and
(c) The parties shall have an equal right to participate in the
defense of any such claim, complaint, suit, proceeding or cause of action
referred to in this Section utilizing attorneys of its choice; provided,
however, that IDEC shall have full authority and control to handle any such
claim, complaint, suit, proceeding or cause of action, including any settlement
*_______* Indicates that material has been omitted and confidential treatment
has been requested therefor. All such omitted material has been filed
separately with the Secretary of Commission in the Company's Application
Requesting Confidential Treatment pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.
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or other disposition thereof, for which either SB or IDEC seek indemnification
under this Section.
11.5 IDEC shall defend, indemnify and hold harmless SB and its officers,
directors, shareholders, employees, successors and assigns from and against any
and all damages, claims, costs, losses, liabilities or expenses (including
reasonable attorneys' fees) arising out of, or resulting from or in connection
with IDEC's activities under this AGREEMENT or the Original Agreement except
such damages, claims, costs, losses, liabilities or expenses which are directly
and proximately caused by SB's negligent or wrongful actions. SB shall have the
right to participate in the defense of any such claim, complaint, suit,
proceeding or cause of action referred to in this Section utilizing attorneys of
its choice; provided, however, that IDEC shall have full authority and control
to handle any such claim, complaint, suit, proceeding or cause of action,
including any settlement or other disposition thereof, for which SB seeks
indemnification under this Section.
11.6 SB shall defend, indemnify and hold harmless IDEC and its officers,
directors, shareholders, employees, successors and assigns from and against any
and all damages, claims, costs, losses liabilities or expenses (including
reasonable attorneys' fees) arising out of, or resulting from or in connection
with SB's activities under this AGREEMENT or the Original Agreement, except such
damages, claims, costs, losses, liabilities or expenses which are directly and
proximately caused by IDEC's negligent or wrongful actions. IDEC shall have the
right to participate in the defense of any such claim, complaint, suit,
proceeding or cause of action referred to in this Section utilizing attorneys of
its choice; provided, however, that SB shall have full authority and control to
handle any such claim, complaint, suit, proceeding or cause of action, including
any settlement or other disposition thereof, for which IDEC seeks
indemnification under this Section.
12. FORCE MAJEURE
12.1 If the performance of any part of this AGREEMENT by either party,
or of any obligation under this AGREEMENT, is prevented, restricted, interfered
with or delayed by reason of any cause beyond the reasonable control of the
party liable to perform, unless conclusive evidence to the contrary is provided,
the party so affected shall, upon giving written notice to the other party, be
excused from such performance to the extent of such prevention, restriction,
interference or delay; provided that the affected party shall use its reasonable
best efforts to avoid or remove such causes of non-performance and shall
continue performance with the utmost dispatch whenever such causes are removed.
When such circumstances arise, the parties shall discuss what, if any,
modification of the terms of this AGREEMENT may be required in order to arrive
at an equitable solution.
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13. GOVERNING LAW
13.1 This AGREEMENT shall be deemed to have been made in the state of
California and its form, execution, validity, construction and effect shall be
determined in accordance with the laws of the state of California, U.S.A.
14. ARBITRATION
14.1 Any dispute, controversy or claim (except as to any issue relating
to intellectual property owned in whole or in part by SB) arising out of or
relating to this AGREEMENT, or the, breach, termination, or invalidity thereof,
shall be settled by arbitration in accordance with the Commercial Arbitration
Rules of the American Arbitration Association, except as modified by this
Section 14. The number of arbitrators shall be three (3). The arbitration
decision shall be binding and not be appealable to any court in any
jurisdiction. The prevailing party may enter such decision in any court having
competent jurisdiction. The arbitration proceeding shall be conducted in the
English language in San Diego, California, unless the parties agree in writing
to conduct the arbitration in another location.
15. SEPARABILITY
15.1 In the event any portion of this AGREEMENT shall be held illegal,
void or ineffective, the remaining portions hereof shall remain in full force
and effect.
15.2 If any of the terms or provisions of this AGREEMENT are in conflict
with any applicable statute or rule of law, then such terms or provisions shall
be deemed inoperative to the extent that they may conflict therewith and shall
be deemed to be modified to conform with such statute or rule of law.
15.3 In the event that the terms and conditions of this AGREEMENT are
materially altered as a result of Sections 15.1 or 15.2, the parties will
renegotiate the terms and conditions of this AGREEMENT to resolve any
inequities.
16. ENTIRE AGREEMENT
16.1 This AGREEMENT, entered into as of the EFFECTIVE DATE, constitutes
the entire AGREEMENT between the parties relating to the subject matter hereof
and supersedes all previous writings and understandings. No terms or provisions
of this AGREEMENT shall be varied or modified by any prior or subsequent
statement, conduct or act of either of the parties, except that the parties may
amend this AGREEMENT by written instruments specifically referring to and
executed in the same manner as this AGREEMENT.
17. NOTICES
17.1 Any notice required or permitted under this AGREEMENT shall be sent
by certified mail or overnight courier service, postage pre-paid to the
following addresses of the parties:
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<PAGE> 19
IDEC PHARMACEUTICALS CORPORATION
3020 Callan Road
San Diego, California 92121 U.S.A.
Attention: Corporate Secretary
SMITHKLINE BEECHAM p.l.c.
New Horizons Court
Brentford, Middlesex TW8 9EP, England
Attention: Senior Vice President, Worldwide Business Development
Copy to:
SMITHKLINE BEECHAM CORPORATION
Corporate Legal Department
One Franklin Plaza
200 North 16th Street
FP 2225
Philadelphia, PA 19102
Attention: General Counsel - U.S.
17.2 Any notice required or permitted to be given concerning this
AGREEMENT be effective upon receipt by the party to whom it is addressed.
18. RECORDATION
18.1 IDEC shall have the right, at any time during the term of this
AGREEMENT, to record, register, or otherwise notify this AGREEMENT in any patent
office or other appropriate facility anywhere in the world, and SB shall provide
reasonable assistance to IDEC in effecting such recording.
19. ASSIGNMENT
19.1 This AGREEMENT and the licenses herein granted shall be binding
upon and inure to the benefit of the successors in interest of the respective
parties. Neither this AGREEMENT nor any interest hereunder shall be assignable
by either party without the written consent of the other; provided, however,
that either party may assign this AGREEMENT or any patent owned by it to any
AFFILIATE or to any corporation with which it may merge or consolidate, or to
which it may transfer all or substantially all of its assets to which this
AGREEMENT relates, without obtaining the consent of the other party.
20. EXECUTION IN COUNTERPARTS
20.1 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.
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<PAGE> 20
IN WITNESS WHEREOF, the parties, through their authorized officers, have
executed this AGREEMENT as of the date first written above.
SMITHKLINE BEECHAM P.L.C.
By:_________________________________
Name:_______________________________
Title:______________________________
IDEC PHARMACEUTICALS CORPORATION
By:_________________________________
Name:_______________________________
Title:______________________________
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AMENDED AND RESTATED COLLABORATIVE RESEARCH
AND LICENSE AGREEMENT
IDEC PHARMACEUTICALS CORPORATION--SMITHKLINE BEECHAM P.L.C.
APPENDIX A
*
*
*_______* Indicates that material has been omitted and confidential treatment
has been requested therefor. All such omitted material has been filed
separately with the Secretary of Commission in the Company's Application
Requesting Confidential Treatment pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.
21
<PAGE> 22
AMENDED AND RESTATED COLLABORATIVE RESEARCH
AND LICENSE AGREEMENT
IDEC PHARMACEUTICALS CORPORATION--SMITHKLINE BEECHAM P.L.C.
EXHIBIT I
*
*
*_______* Indicates that material has been omitted and confidential treatment
has been requested therefor. All such omitted material has been filed
separately with the Secretary of Commission in the Company's Application
Requesting Confidential Treatment pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.
22
<PAGE> 23
AMENDED AND RESTATED COLLABORATIVE RESEARCH
AND LICENSE AGREEMENT
IDEC PHARMACEUTICALS CORPORATION--SMITHKLINE BEECHAM P.L.C.
EXHIBIT II
*
*
*_______* Indicates that material has been omitted and confidential treatment
has been requested therefor. All such omitted material has been filed
separately with the Secretary of Commission in the Company's Application
Requesting Confidential Treatment pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.
23