EXHIBIT 10.1
TERMINATION AGREEMENT(1)
This Termination Agreement ("this Agreement"), dated as of this 7th day of
April 2004 (the "Termination Effective Date"), is by and between IMMUNOMEDICS,
INC., a Delaware corporation having its principal place of business at 000
Xxxxxxxx Xxxx, Xxxxxx Xxxxxx, Xxx Xxxxxx 00000 ("Immunomedics"), and AMGEN INC.,
a Delaware corporation having its principal place of business at Xxx Xxxxx
Xxxxxx Xxxxx, Xxxxxxxx Xxxx, Xxxxxxxxxx 00000 1789 ("Amgen").
WHEREAS, Immunomedics and Amgen are parties to a Development and License
Agreement, effective as of December 17, 2000, providing for development and
commercialization of Epratuzumab together with the Addendum to Development and
License Agreement of even date therewith and Amendment Number One thereto dated
as of Xxxxx 0, 0000 ("xxx X&X Agreement"), which agreement remains in effect as
of the Termination Effective Date;
WHEREAS, Amgen and Immunomedics wish to terminate the D&L Agreement in
accordance with the terms of this Termination Agreement and not the terms of the
D&L Agreement and to supersede all communications between the Parties relating
to the subject of termination;
WHEREAS, in conjunction with termination of the D&L Agreement, Amgen will
transfer to Immunomedics and Immunomedics will assume all obligations,
responsibility and control over regulatory and operational matters with respect
to certain clinical studies relating to Epratuzumab,
WHEREAS, in conjunction with termination of the D&L Agreement,
Immunomedics and Amgen wish to confirm termination or transfer to Immunomedics
of all other instruments related to the D&L Agreement and to finally resolve all
outstanding issues as to each party's rights and obligations arising out of or
relating to the D&L Agreement, in each instance in accordance with this
Termination Agreement,
NOW THEREFORE, in consideration of the foregoing, and the representations
and agreements set forth herein, Immunomedics and Amgen agree as follows:
1. CERTAIN CAPITALIZED TERMS. As used in this Termination Agreement, the
following terms shall have the respective meanings set forth below.
Additional capitalized terms used but not defined herein, if any, shall
have the respective meanings for such terms set forth in the D&L
Agreement.
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(1) LEGEND: IN THIS DOCUMENT, [*] CONNOTES MATERIAL THAT HAS BEEN
OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT OF
THE SAME. SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION ON A CONFIDENTIAL BASIS.
(a) "Affiliate" means any corporation or other entity which is directly
or indirectly controlling, controlled by, or under common control
with a party. For the purpose of this Termination Agreement,
"control" shall mean the direct or indirect ownership of fifty
percent (50%) or more of the outstanding shares or other voting
rights to elect directors of the subject entity, or if not meeting
the preceding, any entity owned or controlled by or owning or
controlling such entity at the maximum control or ownership right
permitted in the country where such entity exists.
(b) Amgen Confidential Information," means, other than Transferred
Confidential Information, any and all data, information, results,
conclusions and the like of any kind whatsoever (and all tangible
and intangible embodiments thereof of any kind whatsoever) which is
owned or controlled by Amgen prior to, or after, the Termination
Effective Date.
(c) "Amgen Inventory" has the meaning set forth in Section 4(a) hereof.
(d) "Amgen Know-How" [*] For the avoidance of doubt, it is intended that
Amgen Know-How shall exclude Immunomedics Know-How and Joint
Know-How.
(e) "Amgen Losses" has the meaning set forth in Section 16(b) hereof.
(f) "Amgen Materials" has the meaning set forth in Section 4(a) hereof.
(g) "Amgen Premises" means Amgen's premises in Thousand Oaks,
California.
(h) [*]
(i) [*]
(j) [*]
(k) "Assumed Clinical Studies" has the meaning set forth in Section
13(a) hereof.
(l) "Clinical Studies Assignment Agreements" has the meaning set forth
in Section 13(b) hereof.
(m) "Clinical Studies Contracts" has the meaning set forth in Section
13(b) hereof.
(n) "Clinical Trial Services Agreements" has the meaning set forth in
Section 13(e) hereof.
(o) "D&L Agreement" has the meaning set forth in the Recitals.
(p) "Deliverables" has the meaning set forth in Section 5 hereof.
(q) "Delivery" has the maining set forth in 4(b) hereof.
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(r) [*]
(s) "Genetic Material" shall mean (a) a nucleotide sequence, including
DNA, RNA and complementary and reverse complementary nucleotide
sequences thereto, whether coding or noncoding and whether intact or
a fragment, as well as vectors containing said nucleotide sequence,
(b) all other materials derived from or containing such nucleotide
sequence, including without limitation derivatives thereof, progeny
thereof, modifications thereof or improvements thereto (including,
but not limited to, additions, deletions and substitutions thereof),
and (c) gene therapy and delivery systems containing any such
nucleotide sequence and/or materials.
(t) [*]
(u) "Immunomedics Confidential Information" means any and all data,
information, results, conclusions and the like of any kind
whatsoever (and all tangible and intangible embodiments thereof of
any kind whatsoever) which are owned or controlled by Immunomedics
prior to, or after, the Termination Effective Date and (ii)
Transferred Confidential Information.
(v) "Immunomedics Know-How" [*]
(w) "Immunomedics Losses" has the meaning set forth in Section 16(a)
hereof.
(x) "Joint Confidential Information" means any and all data,
information, results, conclusions and the like of any kind
whatsoever (and all tangible and intangible embodiments thereof of
any kind whatsoever) relating to [*].
(y) [*]
(z) "Materials" means any and all proprietary materials including, but
not limited to, [*]
(aa) "Material Transfer Agreements" has the meaning set forth in Section
12 hereof.
(bb) "Other Transaction Document" has the meaning set forth in Section 2
hereof.
(cc) "Non-Assumed Clinical Studies Contracts" has the meaning set forth
in Section 13(d) hereof.
(dd) "Person" means any natural person, corporation, business trust,
association, partnership, limited liability company, joint venture,
governmental entity or any other entity.
(ee) "Product(s)" shall mean the following products which are owned or
controlled by Immunomedics or Amgen: (a) Epratuzumab and (b) any 2nd
Generation Product for which Amgen [*].
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(ff) [*]
(gg) [*]
(hh) [*]
(ii) "Termination Effective Date" has the meaning set forth in the
Recitals.
(jj) "Transferred Confidential Information" means any and all data,
information, results, conclusions and the like of any kind
whatsoever (and all tangible and intangible embodiments thereof of
any kind whatsoever) which are to be transferred to Immunomedics in
accordance with Sections 3, 4, 5, 6, 7, 11 and 12 of this Agreement,
all of which shall be deemed to be Immunomedics Confidential
Information.
2. TERMINATION OF AGREEMENTS, RIGHTS AND OBLIGATIONS.
(a) The parties hereby agree, acknowledge and confirm that, effective as
of the Termination Effective Date, the D&L Agreement and all
agreements or instruments between Immunomedics and Amgen (or by
Immunomedics or Amgen for the benefit of the other) listed on
Exhibit A hereto (collectively, the "Other Transaction Documents"),
are terminated in their entirety and of no force or effect,
including all licenses (except for the Amgen Retained License),
sublicenses, rights and obligations thereunder (including any rights
and obligations which according to their terms or otherwise were
intended to survive termination or expiration of the relevant
agreement).
(b) Without limitation of the foregoing, and for the avoidance of doubt
(i) Amgen acknowledges and agrees, on behalf of itself and its
Affiliates that, as of the Termination Effective Date, except
as expressly set forth herein, any and all rights of Amgen
with respect to Licensed Patent Rights, Licensed Trademark
Rights and Licensed Know-How revert to Immunomedics, and
neither Amgen nor any of its Affiliates has or shall have any
rights or claims of any nature whatsoever (A) to, in, arising
out of, or with respect to, Licensed Patent Rights, Licensed
Trademark Rights and Licensed Know How, or the development,
commercialization, sale, use, sublicense, assignment or other
transfer of Products, or (B) under or arising out of the D&L
Agreement or any Other Transaction Document, and
(ii) Immunomedics acknowledges and agrees, on behalf of itself and
its Affiliates that, as of the Termination Effective Date,
except as expressly set forth herein, any and all obligations
of Amgen or any of its Affiliates with respect to (A) the D&L
Agreement and all Other Transaction Documents or (B) the
Licensed Patent Rights, Licensed Trademark Rights, Licensed
Know-How and Products, are terminated and of no force
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or effect. Without limiting the generality of the foregoing,
Immunomedics acknowledges and agrees that Amgen has no further
monetary obligation pursuant to Sections 10.0, 11.0, 12.0,
16.4 or 18.3.2 of the D&L Agreement.
(c) Notwithstanding any other provision of this Agreement, Immunomedics
agrees that Amgen will retain and have the continuing right to
exploit the Amgen Retained License.
3. IMMUNOMEDICS KNOW-HOW LICENSE. [*] Amgen hereby grants to Immunomedics
an irrevocable, royalty-free, exclusive license, with the right to
sublicense, under Amgen's interest in [*] (but only to the
extent such grant is consistent with other contractual obligations
Amgen may have at the Effective Date of Termination) to make, have
made, use, sell, lease, offer to sell or lease, import, export or
otherwise exploit, or transfer physical possession of or title in,
Epratuzumab and 2nd Generation Products.
4. INVENTORY.
(a) Promptly after the Termination Effective Date, Immunomedics will
make, and Amgen will cooperate with Immunomedics' reasonable
requests in making, appropriate arrangements for the shipment from
Amgen to Immunomedics at Immunomedics' principal place of business
identified in the first paragraph hereof or such other location or
locations as may be determined by Immunomedics, Amgen's inventory of
Epratuzumab and antibody cell line samples as listed in Exhibit B
(collectively, "Amgen Inventory"). For the avoidance of doubt, Amgen
has no obligation to deliver to Immunomedics [*] (the "Amgen
Materials"). Subject to the Amgen Retained License, Amgen shall
destroy any such Amgen Materials within sixty (60) days after the
Termination Effective Date and shall, upon written request, so
certify to Immunomedics in writing.
(b) Subject to Immunomedics making appropriate shipping arrangements as
provided in the first sentence of Section 4(a), Amgen will effect
the delivery of Amgen Inventory (to the extent not previously
delivered to Immunomedics as indicated on Exhibit B hereto) to
Immunomedics' designated shipping company at the Amgen Premises (the
"Delivery") within ten (10) business days after the Termination
Effective Date. Upon Delivery, all Amgen Inventory shall be free and
clear of all liens, claims or encumbrances of any kind or nature
arising from any action of Amgen. Risk of loss for all Amgen
Inventory shall rest with Immunomedics after the Termination
Effective Date, except to the extent that loss arises as a result of
the [*] of Amgen in the storage and handling thereof.
(c) All Amgen Inventory is being transferred to Immunomedics on an "as
is" and "with all faults" basis and Amgen assumes no responsibility
therefor. Immunomedics agrees to accept the Amgen Inventory "as is"
and "with all faults"; provided, however, Amgen hereby represents
that to the best of its knowledge the Materials which are biological
materials are free from infectious or adventitious agents.
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(d) [*]
(e) Immunomedics hereby agrees to defend and indemnify and hold harmless
Amgen from and against any and all claims, liability or damage
arising from or relating to the use, storage, handling, distribution
or other exploitation of Amgen Inventory after delivery thereof to
Immunomedics pursuant to this Agreement.
5. DELIVERABLES. As promptly as practicable after the Termination
Effective Date, and in any event not later than the dates set forth in
Exhibit C, Amgen will deliver or cause to be delivered to Immunomedics,
at its principal place of business identified in the first paragraph
hereof or such other location or locations as may be designated by
Immunomedics to Amgen, all of the documents, clinical data and other
materials listed on Exhibit C hereto (collectively, "Deliverables") on
an "as is" and "with all faults" basis, to the extent not previously
delivered. [*] Amgen agrees to execute any and all additional
instruments of assignment or other documentation, and take any other
actions as reasonably necessary to vest in Immunomedics valid title to
all Deliverables, free and clear of all liens, claims or encumbrances
of any kind or nature arising from any action of Amgen, at
Immunomedics' sole cost and expense. Risk of loss for any Deliverable
shall rest with Immunomedics after the Termination Effective Date.
Notwithstanding the above, Amgen may retain, for archival purposes or
other purposes allowed hereunder, a copy of any and all individual
items of the Deliverables.
6. ADDITIONAL AMGEN INVENTORY AND DELIVERABLES. With respect to the Amgen
Inventory and Deliverables being provided to Immunomedics under
Sections 4 and 5 above, should Amgen, in the normal course of business,
and without any express obligation to investigate, discover any
additional Epratuzumab or murine LL2 monoclonal antibody or information
that would fall within one of the categories of Deliverables set forth
in Exhibit C, Amgen will provide such antibodies or information in a
reasonable manner to Immunomedics.
7. REGULATORY FILINGS.
Amgen hereby assigns to Immunomedics Amgen's entire right, title and
interest in and to all regulatory filings, regulatory approvals, and other
similar governmental authorizations, permits or approvals on an "as is"
and "with all faults" basis, in each case to the extent directly relating
to Epratuzumab, including without limitation, those listed on Exhibit D
hereto. Amgen represents, warrants and covenants that the items, property
and rights being assigned pursuant to this Section 7 are free and clear of
all liens, claims or encumbrances of any kind or nature arising from any
action of Amgen. Amgen agrees to execute, and to file or record with or
provide proper notice to, or (if appropriate) enable Immunomedics to file
or record with or provide proper notice to, the appropriate governmental
offices, and any additional instruments of assignment or other
documentation, as may be reasonably requested by Immunomedics to assure
Immunomedics of the benefit of the assignments provided for in this
Section 7, at Immunomedics' sole cost and expense.
8. [*]
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9. NO OTHER WARRANTIES.
EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES SET FORTH HEREIN,
NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND. EXCEPT
AS EXPRESSLY SET FORTH HEREIN, ALL ITEMS DELIVERED OR ASSIGNED BY AMGEN
HEREUNDER, INCLUDING WITHOUT LIMITATION THE AMGEN INVENTORY, DELIVERABLES,
AND REGULATORY FILINGS, APPROVALS, AUTHORIZATIONS OR PERMITS, ASSUMED
CLINICAL STUDIES, CLINICAL STUDIES CONTRACTS AND OTHER CONTRACTS, ARE
PROVIDED "AS IS", "WITH ALL FAULTS", AND WITH NO WARRANTY OF ANY KIND,
AMGEN EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING ANY IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE AND
NON-INFRINGEMENT.
10. PATENT PROSECUTION.
(a) Immunomedics shall have sole responsibility with respect to, and
bear all expenses arising in connection with, the prosecution,
maintenance and enforcement of Collaboration Patent Rights after the
Termination Effective Date.
(b) Promptly after the Termination Effective Date, Amgen will, or will
cause its agents to, transfer to Immunomedics or its designated
agent all files pertaining to prosecution or maintenance of patent
applications and patents directed to Collaboration Patent Rights,
Amgen will execute all documents reasonably necessary to transfer to
Immunomedics the right to control all such patent prosecution.
11. CONSIDERATION.
(a) On the Termination Effective Date, Immunomedics shall execute and
deliver to Amgen the warrant attached hereto as Exhibit E.
(b) Within thirty (30) days after FDA approval of sale in the United
States of Epratuzumab for the treatment of non Hodgkin's lymphoma,
Immunomedics or any successor thereof will pay to Amgen six hundred
thousand U.S. dollars ($600,000).
12. MATERIAL TRANSFER AGREEMENTS.
The parties acknowledge that, pursuant to a separate letter agreement,
Amgen will assign to Immunomedics effective as of the Termination
Effective Date certain of its rights, and Immunomedics will assume all of
Amgen's obligations relating to such assigned rights, under the material
transfer agreements listed on Exhibit F hereto (the "Material Transfer
Agreements"), subject, in the case of each Material Transfer Agreement, to
any required consent to such assignment of such Material Transfer
Agreement. In particular, Amgen will assign its rights relating to data
and results resulting from the conduct of the research
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program, intellectual property, publications and enforcement of such
rights. [*] Amgen and Immunomedics shall cooperate in good faith to obtain
any necessary consent to such assignment (and upon any such necessary
consent being obtained, such assignment shall be deemed to have been
effected hereby), provided that neither Immunomedics nor Amgen shall be
required to pay any consideration to obtain such consent. To the extent
any other obligations under the Material Transfer Agreements remain with
Amgen, Immunomedics hereby grants to Amgen rights under the Licensed
Patents Rights and Licensed Know How to the extent necessary for Amgen to
satisfy its obligations under such Material Transfer Agreements.
13. ASSUMED CLINICAL STUDIES.
(a) Immunomedics, promptly after the Termination Effective Date, will
assume all obligations, responsibility and control over regulatory
and operational matters with respect to the clinical studies
identified and described in Exhibit G (the "Assumed Clinical
Studies"). Immunomedics shall provide Amgen with a copy of any data
and results arising from the conduct and completion of the Assumed
Clinical Studies relating to the safety of the Product, including
but not limited to adverse events. Amgen will provide financial
reimbursement up to a total aggregate amount not to exceed [*] for
costs associated with such Assumed Clinical Studies, payable after
receipt by Amgen of a detailed invoice.
(b) The parties acknowledge that, pursuant to separate letter agreements
(the "Clinical Studies Assignment Agreements"), Amgen will assign to
Immunomedics, subject to the receipt of any required consent to such
assignment, all of Amgen's rights, and Immunomedics will assume all
of Amgen's obligations, under the agreements listed on Exhibit G
hereto as of the dates set forth therein, all of which are
agreements for clinical sites related to the Assumed Clinical
Studies (the "Clinical Studies Contracts").
(c) [*]
(d) With respect to those clinical sites not assumed by Immunomedics
pursuant to subparts (a) and (b) above, as listed in Exhibit H (the
"Non-Assumed Clinical Studies Contracts"), the parties acknowledge
that, pursuant to a separate letter agreement, Amgen will assign to
Immunomedics effective as of the Termination Effective Date, and
subject to the receipt of any required consent to such assignment,
its rights relating to data and results resulting from the conduct
of the clinical study, access to and inspection of all such data and
results, publications, confidentiality and enforcement of such
rights, [*] Immunomedics will assume all of Amgen's obligations
relating to such rights. Immunomedics hereby grants to Amgen the
rights, [*] necessary for Amgen to satisfy its obligations under
such Non-Assumed Clinical Studies Contracts. Amgen shall provide to
Immunomedics copies of all the contracts listed in Exhibit H within
ten (10) business days of the Termination Effective Date.
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(e) In connection with the conduct of the clinical studies under the
Clinical Studies Contracts and the Non-Assumed Clinical Studies
Contracts, Amgen entered into agreements with certain third party
vendors set forth in Exhibit I (the "Clinical Trial Services
Agreements") to perform certain clinical trial services. The parties
acknowledge that, pursuant to a separate letter agreement, Amgen
will assign to Immunomedics effective as of the Termination
Effective Date its rights relating to data and results resulting
from the performance of the services under the Clinical Trial
Services Agreements, confidentiality and enforcement of such rights,
and Immunomedics will assume all of Amgen's obligations relating to
such rights. [*]
(f) Amgen shall continue to be responsible for the costs of all clinical
studies not assumed by Immunomedics hereunder.
14. RELEASES; COVENANTS NOT TO XXX, NO ASSIGNMENT OF CLAIMS.
(a) Releases.
(i) Amgen, on behalf of itself and its officers, directors, employees,
agents and Affiliates and each of their respective successors and
assigns, hereby irrevocably and unconditionally releases and forever
discharges Immunomedics, and its officers, directors, employees,
agents and Affiliates and each of their respective successors and
assigns, from all claims, liabilities, indemnifications,
obligations, causes of action and demands of any nature whatsoever,
whether known or unknown, on account of or arising from the D&L
Agreement or any Other Transaction Documents, the Licensed Patent
Rights, Licensed Trademark Rights, Licensed Know How, or the
development, commercialization, sale, use, sublicense, assignment or
other transfer of Products or any breach of any of the foregoing,
including any remedies which Amgen might otherwise now or hereafter
have thereunder, both in equity and at law, except as set forth in
Section 16 of this Termination Agreement, but excluding all claims,
liabilities, indemnifications, obligations, causes of action and
demands that arise from and after the Termination Effective Date
under this Termination Agreement or any agreement or instrument
entered into on or after the Termination Effective Date between
Immunomedics and Amgen (or by Immunomedics or Amgen for the benefit
of the other) pursuant to or as contemplated by this Termination
Agreement.
(ii) Immunomedics, on behalf of itself and its officers, directors,
employees, agents and Affiliates and each of their respective
successors and assigns, hereby irrevocably and unconditionally
releases and forever discharges Amgen, and its officers, directors,
employees, agents and Affiliates and each of their respective
successors and assigns, from all claims, liabilities,
indemnifications, obligations, causes of action and demands of any
nature whatsoever, whether known or unknown, on account of or
arising from the D&L Agreement or any Other Transaction Documents,
the Licensed
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Patent Rights, Licensed Trademark Rights, Licensed Know How, or the
development, commercialization, sale, use, sublicense, assignment or
other transfer of Products or any breach of any of the foregoing,
including any remedies which Immunomedics might otherwise now or
hereafter have thereunder, both in equity and at law, except as set
forth in Section 16 of this Termination Agreement, but excluding all
claims, liabilities, indemnifications, obligations, causes of action
and demands that arise from and after the Termination Effective Date
under this Termination Agreement or any agreement or instrument
entered into on or after the Termination Effective Date between
Immunomedics and Amgen (or by Immunomedics or Amgen for the benefit
of the other) pursuant to or as contemplated by this Termination
Agreement.
(iii) In connection with the foregoing releases set forth in this Section
14(a), except as expressly set forth therein, each of Immunomedics
and Amgen hereby waives the benefits of Section 1542 of the
California Civil Code which provides:
"A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES
NOT KNOW OR SUSPECT TO EXIST IN HIS FAVOR AT THE TIME OF EXECUTING
THE RELEASE WHICH, IF KNOWN BY HIM, MUST HAVE MATERIALLY AFFECTED
HIS SETTLEMENT WITH THE DEBTOR."
Notwithstanding the provisions of Section 1542, this Termination
Agreement releases claims to the extent provided in Section 14(a)(i)
and (ii) above, whether known, unknown, foreseen, unforeseen, patent
or latent which each party has as of the date hereof against the
other, and this release shall act as a release of future claims that
may arise from acts arising prior to the Termination Effective Date,
whether such claims are currently known, unknown, foreseen,
unforeseen, patent or latent. Each of Immunomedics and Amgen
understands and acknowledges the significance and consequence of
such specific waiver of Section 1542 and hereby assumes full
responsibility for such waiver.
(b) Covenants Not to Xxx. The parties, on behalf of themselves and their
respective officers, directors, employees, agents and Affiliates and
each of their respective successors and assigns, hereby irrevocably
and unconditionally waive and give up any right to, and covenant and
agree not to and not to permit any other party acting on their
behalf to, commence any action, or bring any charge or complaint,
against each other or any of the other persons released under
Section 14(a) above, with, respect to the claims, liabilities,
obligations, causes of action or demands so released under Section
14(a) above, or to seek or be entitled to any equitable or monetary
relief in any action or in connection with any charge or complaint
that may be commenced or brought on their behalf with respect
thereto.
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(c) No Assignment of Claims. Each party hereby represents and warrants
to the other that neither it nor any of its Affiliates has assigned
to any other Person any claims, causes of action or demands released
pursuant to Section 14(a) above.
(d) No Admission. Each party acknowledges that this Termination
Agreement effects the settlement of existing and potential claims,
and nothing herein is intended to constitute or should be construed
as an admission of liability to any party or to any Person.
15. CONFIDENTIALITY.
(a) Immunomedics Confidential Information. Subject to the further
provisions of this Section 15, Amgen will keep confidential and will
not publish or otherwise disclose or use for any purpose any
Immunomedics Confidential Information except
(i) as separately agreed to in writing by Immunomedics after the
Termination Effective Date;
(ii) to the extent that such Immunomedics Confidential Information
(a) was generally available to the public or otherwise part of
the public domain at the time of its disclosure to Amgen, or
(b) became generally available to the public or otherwise part
of the public domain after its disclosure or development, as
the case may be, other than through any act or omission of
Amgen in breach of this Section 15, or
(iii) to the extent that (a) such Immunomedics Confidential
Information is required to be disclosed in prosecuting or
defending litigation (including any litigation relating to the
enforcement of this Termination Agreement) or complying with
any court order or governmental regulation or (b) Amgen
determines in good faith, after consultation with outside
legal counsel, that such Immunomedics Confidential Information
is otherwise required by law (including any rule, regulation,
policy or practice of any regulatory agency or authority or
any stock market or exchange on which any securities of Amgen
are listed and traded) to be disclosed.
(b) Permitted Disclosure. Notwithstanding the above, Amgen retains the
following rights:
(i) the right to use, publish or otherwise disclose Joint
Confidential Information (for the avoidance of doubt,
including in connection with the filing, prosecution or
enforcement of any patent applications/patents), only to the
extent Amgen uses or develops such Joint Confidential
Information in conjunction with practice under the Amgen
Retained License and, with respect to Joint Confidential
Information relating to Epratuzumab, subject to subpart (d)
below other than with respect to the permitted disclosures
under subpart (b)(ii) below;
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(ii) the right to publish Transferred Confidential Information in
connection with the publication of the following Amgen
manuscripts, subject to the right of Immunomedics to review
and comment on any such manuscript insofar as the same relates
to Epratuzumab by Amgen providing Immunomedics with a copy of
such manuscript in proposed final form at least thirty (30)
days prior to its submission; [*]
(c) Amgen Confidential Information. Immunomedics will keep confidential
and will not publish or otherwise disclose or use for any purpose
any Amgen Confidential Information, except
(i) as separately agreed to in writing by Amgen after the
Termination Effective Date;
(ii) to the extent that such Amgen Confidential Information (a) was
generally available to the public or otherwise part of the
public domain at the time of its disclosure to Immunomedics,
or (b) became generally available to the public or otherwise
part of the public domain after its disclosure or development,
as the case may be, other than through any act or omission of
Immunomedics in breach of this Section 15, or
(iii) to the extent that (a) such Amgen Confidential Information is
required to be disclosed in prosecuting or defending
litigation (including any litigation relating to the
enforcement of this Termination Agreement) or complying with
any court order or governmental regulation or (b) Immunomedics
determines in good faith, after consultation with outside
legal counsel, that such Amgen Confidential Information is
otherwise required by law (including any rule, regulation,
policy or practice of any regulatory agency or authority or
any stock market or exchange on which any securities of
Immunomedics are listed and traded) to be disclosed.
(d) Publication by Amgen. Other than with respect to the permitted
disclosures under subpart (b) above, Amgen shall hold confidential
and not publish, without the express written consent of
Immunomedics, any data, results, information (including, but not
limited to chemical, pharmacological, toxicological, research,
pre-clinical or clinical data) or analytical data or methods
regarding Epratuzumab not otherwise generally available to the
public or being part of the public domain at the time of disclosure.
16. INDEMNIFICATION.
(a) Indemnification By Amgen. Amgen shall indemnify Immunomedics
against, and hold Immunomedics harmless from, and at Immunomedics
option, defend Immunomedics against, any and all liabilities,
losses, damages, costs and expenses to Immunomedics (collectively,
"Immunomedics Losses") arising out of or relating to (i) any third
party claims of any kind or nature in connection with the research
or development of Epratuzumab, or actions or omissions relating
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thereto, in each case wherein any injury or claimed injury (personal
or otherwise) underlying such claim occurred or is alleged to have
occurred prior to the Termination Effective Date and was occasioned
or caused by, on behalf of, under authority of, or pursuant to
contracts with, Amgen, any of its Affiliates or their respective
licensees or sublicensees; or (ii) any representation or warranty of
Amgen contained in this Termination Agreement being untrue in any
material respect, except to the extent in either (i) or (ii) above
that such Immunomedics Losses are attributable to the willful
misconduct or negligence of Immunomedics or its Affiliates or their
respective licensees or sublicensees. For purposes hereof, any
manufacturing or other activities or obligations performed or
provided by Immunomedics shall not be considered to have been
performed or provided on behalf of, or under authority of, Amgen,
its Affiliates or sublicensees.
(b) Indemnification By Immunomedics. Immunomedics shall indemnify Amgen
against, and hold Amgen harmless from, and at Amgen's option, defend
Amgen against, any and all liabilities, losses, damages, costs and
expenses to Amgen (collectively, "Amgen Losses") arising out of or
relating to (i) any third party claims of any kind or nature (a) in
connection with the research, development, manufacturing, marketing
or sale of Epratuzumab, or actions or omissions relating thereto,
wherein any injury or claimed injury (personal or otherwise)
underlying such claim occurred or is alleged to have occurred prior
to the Effective Date of the D&L Agreement, or (b) in connection
with the research, development or manufacturing of Epratuzumab
(other than by, on behalf of or under authority of Amgen, its
Affiliates, or sublicensees), wherein any injury or claimed injury
(personal or otherwise) underlying such claim occurred or is alleged
to have occurred during the term of the D&L Agreement, or (c) in
connection with the research, development, manufacturing, marketing,
sale or other exploitation of Epratuzumab for the period from and
after the Termination Effective Date regardless of whether such
Amgen Losses are attributable to items assigned or transferred from
Amgen to Immunomedics; or (ii) any representation or warranty of
Immunomedics in this Termination Agreement being untrue in any
material respect; except to the extent in either (i) or (ii) above
that such Amgen Losses are attributable to the willful misconduct or
negligence of Amgen or its Affiliates or their respective licensees
or sublicensees.
(c) Notice of Indemnification Claim. Each party will notify the other
party in writing within five (5) business days of becoming aware of
a claim for which indemnification may be sought hereunder. Failure
to provide such notice shall not result in a waiver of the
indemnification rights set out in paragraphs 16(a) and (b) above in
the absence of a showing of actual prejudice to the party owing the
duty of indemnification from such failure to receive notice at an
earlier time than actually received. The party seeking
indemnification and its employees and agents shall cooperate
reasonably with, and allow access to, the other party and its legal
representatives in the investigation and defense of any action,
claim or liability covered by this indemnification section.
13
17. ENTIRE AGREEMENT. This Termination Agreement (including the Exhibits
attached hereto which are incorporated by reference herein) constitutes
the entire agreement between the parties with respect to the subject
matter hereof (and thereof) and supersedes all previous agreements or
understandings between the parties. This Termination Agreement shall
bind and inure to the benefit of, and be enforceable by, the parties
and, with respect to Sections 14 and 28, the other persons referred to
therein, and the respective successors, assigns, heirs, executors and
administrators of the parties and such other persons, respectively.
This Termination Agreement may only be changed or modified by written
agreement of the parties.
18. GOVERNING LAW AND JURISDICTION. This Termination Agreement will be
governed by and interpreted in accordance with the laws of the State of
California, without reference to its conflicts of law principles, The
parties hereby submit to the exclusive jurisdiction of the California
courts, both state and federal, in all matters concerning this Termination
Agreement.
19. COUNTERPARTS. This Termination Agreement may be executed in counterparts
(and by facsimile signatures), each of which shall be deemed an original
but which together shall constitute one and the same instrument.
20. VALIDITY AND BINDING NATURE OF AGREEMENT. Each party hereby represents and
warrants to the other that this Termination Agreement has been duly
authorized, executed and delivered by, and is the valid and binding
obligation of, such party, enforceable against such party in accordance
with its terms,
21. NO OTHER REPRESENTATIONS. Each party acknowledges having read this
Termination Agreement and fully understands its provisions, and
acknowledges and agrees that no representation or promise not contained
herein has been made to induce such party to enter into this Termination
Agreement.
22. LEGAL ADVICE. Each party has had the opportunity to receive and has
received independent legal advice from attorneys of their choice with
respect to the advisability of making the settlement and release provided
herein and of executing this Termination Agreement.
23. PUBLIC ANNOUNCEMENTS. Neither party will make any public announcement
regarding this Termination Agreement without the prior approval of the
other party, Notwithstanding the above, promptly after the execution
and delivery of this Agreement, the parties shall issue a press release
in the form attached hereto and incorporated herein as Exhibit J. In
addition, in no event will either party use the name of the other party
in any press release or other public announcement without the prior
approval of the named party; provided, however, that no such approval
of the other party shall be necessary if the press release or other
public announcement is substantially similar to releases or
announcements previously approved by such party (provided, however,
that the term "substantially similar" shall not be deemed to permit
additional information to be included in any such release or
announcement if such information has not been previously approved by
the other party) provided that this Section 23 shall not impair a
14
party's right to provide truthful testimony or other information, or to
otherwise make public statements or disclosures, to the extent a party,
after consultation with outside legal counsel, determines in good faith
that it is required by law to do so. The parties acknowledge that Amgen
and/or Immunomedics may be obligated to file a copy of this Agreement
with the U.S. Securities and Exchange Commission, and each such party
shall be entitled to make such filing, provided however, that it
requests confidential treatment of the more sensitive terms hereof to
the extent such confidential treatment is reasonably available to the
filing party under the circumstances then prevailing. In the event of
any such filing, the filing party will provide the non-filing party
with an advance copy of this Agreement marked to show provisions for
which the filing party intends to seek confidential treatment, and the
filing party shall include the non-filing party's comments thereon,
which comments shall be provided within [*] of receipt of the advance
copy by the non-filing party. Each party agrees not to publicly
disparage or defame, or make any material misrepresentation regarding
the other party or any officer, director or employee of the other party.
24. NOTICE. Any notice, demand or communication under this Termination
Agreement shall be in writing and served by personal delivery, registered
or certified mail, or by overnight delivery by a nationally recognized
overnight delivery service, to the address of the party receiving notice
as set forth in the first paragraph of this Termination Agreement, or at
any domestic address that a party may provide to any other party in
writing from time to time.
25. SEVERABILITY. Whenever possible, each provision of this Termination
Agreement shall be interpreted in such manner as to be effective and
valid under applicable law, but if any provision of this Termination
Agreement shall become prohibited or invalid under applicable law, such
provision shall be ineffective only to the extent of such prohibition
or invalidity without invalidating the remainder of such provision or
the remaining provisions of this Termination Agreement, which shall
remain in full force and effect.
26. WAIVER. No waiver of any provision of this Termination Agreement or of
any provision of any agreement or instrument entered into in accordance
herewith or as contemplated hereby shall be valid unless made in
writing and executed by a duly authorized officer of the waiving party.
Failure of either party to insist upon strict observance of or
compliance with any of the terms of this Termination Agreement in one
or more instances shall not be deemed to be a waiver of its rights to
insist upon such observance of or compliance with such terms or the
other terms hereof with respect to subsequent failures in the future,
27. FURTHER ASSURANCES. Each of the parties hereto hereby agrees to take or
cause to be taken such further actions, to execute, deliver and file or
cause to be executed, delivered and filed such further documents, and will
obtain such consents, as may be necessary or as may be reasonably
requested in order to fully effectuate the purposes, terms and conditions
of this Agreement.
15
IN WITNESS WHEREOF, Immunomedics, Inc. and Amgen Inc. have caused this
Termination Agreement to be duly executed by their authorized representatives
as of the date first written above.
IMMUNOMEDICS, INC.
By: /s/ Xxxxxxx X. Xxxxxxxx
-----------------------------------------------------
Name: Xxxxxxx X. Xxxxxxxx
-------------------------------------------------
Title: President & CEO
-------------------------------------------------
AMGEN INC.
By: /s/ Xxxxx X. Xxxxxxxxxx
---------------------------------------------------
Name: Xxxxx X. Xxxxxxxxxx
Title: Executive Vice President,
Research and Development
16
EXHIBIT A
Other Transaction Documents
[*]
A-1
EXHIBIT B
Amgen Inventory
MASTER CELL BANK VIALS
EPRATUZUMAB PRECLINICAL INVENTORY:
EPRATUZUMAB FROM [*]
EPRATUZUMAB FROM [*]
EPRATUZUMAB FROM [*]
EPRATUZUMAB FROM [*]
[*]
EPRATUZUMAB MANUFACTURING INVENTORY:
-----------------------------------------------------------------
LOT DESC. EXP DATE NO. VIALS
-----------------------------------------------------------------
Nude Vials [*] [*] [*] [*]
-----------------------------------------------------------------
[*] [*] [*] [*]
-----------------------------------------------------------------
----------------------------------------------------------------------------------------------------------
PACKAGED PACKAGING LOT LOT DESC. EXP DATE NO. VIALS VIALS/BX NO. BOX
----------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------
-----------------------------------------------------------------
LOT DESC. EXP DATE KG
-----------------------------------------------------------------
Bulk Lots [*] [*] [*] [*]
-----------------------------------------------------------------
B-1
EXHIBIT C
Deliverables
A. Deliverables to be transferred within [*] of the Termination Effective
Date:
1. [*]
2. [*]
3. [*]
4. [*]
5. [*]
a. [*]
b. [*]
c. [*]
6. [*]
7. [*]
8. [*]
9. [*]
B. Deliverables to be transferred [*] of the Termination Effective Date:
1. [*]
2. [*]
3. [*]
4. [*]
5. [*]
C. Deliverables to be transferred within [*] of the Termination Effective
Date:
1. [*]
2. [*]
C-1
3. [*]
4. [*]
C-2
EXHIBIT C-1
[*]
C-1-1
[*]
================================================================================
Sending company name:
--------------------------------------------------------------------------------
[*]
--------------------------------------------------------------------------------
[*]
[*] [ ] Other, specify __________________________
--------------------------------------------------------------------------------
[*]
[*] [ ] Other, specify
--------------------------------------------------------------------------------
[*]
[*] [ ] Other, specify
--------------------------------------------------------------------------------
Signature of person responsible [*]
Name ___________________________________ Title ___________________________
Signature _______________________________________ Date ______________________
================================================================================
================================================================================
Receiving company name:
--------------------------------------------------------------------------------
[*] completed and accepted
[ ] Yes [ ] Pending, explain ______________________________________
--------------------------------------------------------------------------------
Signature of person responsible for this transfer
Name _______________________________ Title _____________________________
Signature ______________________________ Date ______________________
================================================================================
C-1-2
EXHIBIT C-2
[*]
OBJECTIVE:
[*]
C-2-1
[*]
================================================================================
[*]
--------------------------------------------------------------------------------
[*]
--------------------------------------------------------------------------------
[*]
==========================================================
--------------------------------------------------------------------------------
[*]
Name Title
================================================================================
Signature Date
================================================================================
================================================================================
Receiving company name:
=======================
--------------------------------------------------------------------------------
Document total number of content files received:
================================================
===========================================================
--------------------------------------------------------------------------------
[*] completed and accepted
[ ] Yes [ ] Pending, explain
=========================================================================
---------------------------------------------------------------------------
Signature of person responsible for this transfer
=================================================
Name Title
================================================================================
Signature Date
================================================================================
================================================================================
C-2-2
EXHIBIT C-3
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REPORT OTHER ID STUDY TITLE RESEARCHERS STATUS CITED INCLUDED IN 2003 IND
NO. IN IB ANNUAL REPORT? (AR)
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C-3-1
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REPORT OTHER ID STUDY TITLE RESEARCHERS STATUS CITED INCLUDED IN 2003 IND
NO. IN IB ANNUAL REPORT? (AR)
================================================================================================================================
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C-3-2
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REPORT OTHER ID STUDY TITLE RESEARCHERS STATUS CITED INCLUDED IN 2003 IND
NO. IN IB ANNUAL REPORT? (AR)
================================================================================================================================
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C-3-3
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REPORT OTHER ID STUDY TITLE RESEARCHERS STATUS CITED INCLUDED IN 2003 IND
NO. IN IB ANNUAL REPORT? (AR)
================================================================================================================================
[*] [*] [*] [*] [*] [*]
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C-3-4
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REPORT OTHER ID STUDY TITLE RESEARCHERS STATUS CITED INCLUDED IN 2003 IND
NO. IN IB ANNUAL REPORT? (AR)
================================================================================================================================
[*] [*] [*] [*] [*] [*]
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[*] [*] [*] [*] [*] [*]
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[*]
[*]
[*]
[*]
C-3-5
EXHIBIT D
Regulatory Filings
[*]
D-1
EXHIBIT E
COMMON STOCK PURCHASE WARRANT
THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT
AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE
"ACT"), OR ANY APPLICABLE STATE SECURITIES LAW. SUCH SECURITIES MAY NOT BE SOLD
OR TRANSFERRED IN THE ABSENCE OF SUCH REGISTRATION OR AN EXEMPTION UNDER THE ACT
AND ANY APPLICABLE STATE SECURITIES LAW.
NUMBER OF SHARES: 100,000 WARRANT NO. _____
(SUBJECT TO ADJUSTMENT) APRIL 7, 2004
IMMUNOMEDICS, INC.
COMMON STOCK PURCHASE WARRANT
Void after the date set forth in Section 3 herein
This Common Stock Purchase Warrant (the "Warrant") entitles Amgen Inc.,
(together with its permitted transferees, the "Holder"), for value received, to
purchase from IMMUNOMEDICS, INC., a Delaware corporation (the "Company"), up to
100,000 fully paid and nonassessable shares of the Company's common stock, par
value $0.01 per share ("Common Stock"), subject to adjustment and vesting as set
forth herein (the "Warrant Shares"). This Warrant shall be exercisable, if at
all, at a price equal to $16.00 per share, subject to adjustment as set forth
herein (the "Exercise Price"). This Warrant also is subject to the following
terms and conditions:
1. EXERCISE OF WARRANT. Subject to the terms and conditions hereof, this
Warrant may be exercised at the option of the Holder in whole or in part at any
time from and after the date hereof and before the date of expiration set forth
in Section 3 below. Exercise shall be by presentation and surrender to the
Company at its principal office of this Warrant and the subscription form
annexed hereto as Exhibit I, executed by the Holder, together with payment to
the Company in accordance with Section 2 hereof in an amount equal to the
product of the Exercise Price multiplied by the number of Warrant Shares being
purchased upon such exercise. If this Warrant is exercised in part only, the
Company shall, promptly after presentation of this Warrant upon such exercise,
execute and deliver a new Warrant, dated as of the date hereof, evidencing the
right of the Holder to purchase the balance of the Warrant Shares purchasable
hereunder upon the same terms and conditions herein set forth. Upon and as of
receipt by the Company of such properly completed and duly executed subscription
form accompanied by
1
payment as herein provided, the Holder shall be deemed to be
the holder of record of the Warrant Shares issuable upon such exercise,
notwithstanding that the stock transfer books of the Company shall then be
closed or that certificates representing such Warrant Shares shall not then
actually be delivered to the Holder. Certificates for the Warrant Shares so
purchased, together with any other securities or property to which the Holder is
entitled upon such exercise, shall be delivered to the Holder by the Company's
transfer agent at the Company's expense promptly after this Warrant has been
exercised (and in any event within 30 days). Each stock certificate so delivered
shall be in such denominations of Warrant Shares as may be requested by the
Holder and shall be registered as set forth in the applicable subscription form.
2. PAYMENT OF EXERCISE PRICE. The Exercise Price for the Warrant Shares
being purchased may be paid in cash or by check payable to the Company or wire
transfer of immediately available funds.
3. EXPIRATION DATE. This Warrant shall expire on April 6, 2009 (or in the
event that April 6, 2009 is not a business day, the next succeeding business
day).
4. ADJUSTMENT OF EXERCISE PRICE AND NUMBER OF WARRANT SHARES. The number
and kind of securities purchasable upon the exercise of this Warrant and the
Exercise Price shall be subject to adjustment from time to time upon the
happening of certain events as follows:
4.1 SUBDIVISION OR COMBINATION OF STOCK. If at any time or from time
to time after the date hereof the Company shall subdivide its outstanding shares
of Common Stock, the Exercise Price in effect immediately prior to such
subdivision shall be reduced proportionately and the number of shares of Common
Stock (calculated to the nearest whole share) shall be increased
proportionately, and conversely, in the event the outstanding shares of Common
Stock shall be combined into a smaller number of shares, the Exercise Price in
effect immediately prior to such combination shall be increased proportionately
and the number of shares of Common Stock (calculated to the nearest whole share)
shall be decreased proportionately.
4.2 ADJUSTMENT FOR STOCK DIVIDENDS. If at any time the Company shall
declare a dividend payable in Common Stock or securities convertible into shares
of Common Stock or make any other distribution upon any class or series of stock
of the Company payable in shares of Common Stock or securities convertible into
shares of Common Stock, the Exercise Price and the number of shares to be
obtained upon exercise of this Warrant shall be adjusted proportionately to
reflect the issuance of any shares of Common Stock or convertible securities, as
the case may be, issuable in payment of such dividend or distribution.
4.3 REORGANIZATION, RECLASSIFICATION, CONSOLIDATION, MERGER OR SALE.
In the event of any reorganization of the capital stock of the Company, a
consolidation or merger of the Company with another corporation (other than a
merger in which the Company is the surviving corporation and the stockholders of
the Company prior to such merger own at least a majority of the outstanding
capital stock of the surviving corporation after such merger), the sale of all
or substantially all of the Company's assets or any transaction involving the
transfer of a majority of the voting power over the capital stock of the Company
effected in a manner such
2
that holders of Common Stock shall be entitled to receive stock, securities, or
other assets or property, then, as a condition of such reorganization,
reclassification, consolidation, merger, sale or transaction, lawful and
adequate provision shall be made whereby the Holder shall have the right to
purchase and receive (in lieu of the shares of the Common Stock immediately
theretofore purchasable and receivable upon the exercise of the rights
represented hereby) such shares of Common Stock, securities or other assets or
property as may be issued or payable with respect to or in exchange for a number
of outstanding shares of such Common Stock equal to the number of shares of such
stock immediately theretofore purchasable and receivable upon the exercise of
the rights represented hereby. In any such reorganization, consolidation,
merger, sale or transaction, including successive events of such nature,
appropriate provision shall be made with respect to the rights and interests of
the Holder such that the provisions hereof (including, without limitation,
provisions for adjustments of the Exercise Price and of the number of shares
purchasable and receivable upon the exercise of this Warrant) thereafter shall
be applicable, as nearly practicable, in relation to any shares of stock,
securities or assets thereafter deliverable upon the exercise hereof and,
promptly following any such reclassification, consolidation, merger, sale or
lease, the successor corporation (if other than the Company) resulting from such
reclassification, consolidation or merger or the corporation purchasing or
leasing such assets shall assume by a supplemental warrant agreement, executed
and mailed or delivered to the Holder at the last address thereof appearing on
the books of Company, the obligation to deliver to the Holder such shares of
stock, securities or assets as, in accordance with the foregoing provisions, the
Holder may be entitled to purchase.
4.4 ADJUSTMENT OF NUMBER OF WARRANT SHARES. Upon each adjustment in
the Exercise Price pursuant to any provisions of this Section 4, the number of
Warrant Shares purchasable hereunder at that Exercise Price shall be adjusted,
to the nearest whole share, to the product obtained by multiplying such number
of shares purchasable immediately prior to such adjustment in the Exercise Price
by a fraction, the numerator of which shall be the Exercise Price immediately
prior to such adjustment and the denominator of which shall be the Exercise
Price immediately thereafter.
4.5 MINIMAL ADJUSTMENTS. No adjustment in the Exercise Price and/or
the number of shares of Common Stock subject to this Warrant shall be made if
such adjustment would result in a change in the number of shares represented by
this Warrant of less than one (1) share (the "Adjustment Threshold Amount"). Any
adjustment not made because the Adjustment Threshold Amount is not satisfied
shall be carried forward and made, together with any subsequent adjustments, at
such time as (a) the aggregate amount of all such adjustments is equal to at
least the Adjustment Threshold Amount or (b) the Warrant is exercised.
4.6 CERTIFICATE AS TO ADJUSTMENTS. Upon the occurrence of each
adjustment or readjustment of the Exercise Price pursuant to this Section 4, the
Warrant shall, without any action on the part of the Holder, be adjusted in
accordance with this Section 4, and the Company shall promptly compute such
adjustment or readjustment in accordance with the terms hereof and prepare and
furnish to the Holder a certificate signed by the Company's chief financial
officer setting forth such adjustment or readjustment, showing in detail the
facts upon which such adjustment or readjustment is based.
3
4.7 WAIVER OF ADJUSTMENTS. Any adjustment of the Exercise Price
otherwise required to be made hereunder may be waived with the written consent
of the Holder and the Company.
5. NOTICES OF RECORD DATE. In the case of any dividend or distribution,
the adjustment(s) provided for in Section 4 shall become effective immediately
after the date of the issuance or distribution of the shares of Common Stock
and, in the case of any subdivision or combination, the adjustment(s) provided
for in Section 4 shall become effective immediately after the effective date of
such action.
6. FRACTIONAL SHARES. No fractional shares shall be issued upon exercise
of this Warrant. The Company shall, in lieu of issuing any fractional share, pay
the Holder entitled to such fraction a sum in cash equal to such fraction
multiplied by (i) if the Common Stock is not at the time of such determination
publicly traded, the fair market value as determined in good faith by the Board
of Directors of the Company or (ii) if the Common Stock is at the time of such
determination publicly traded, the market price of the Common Stock (the market
price determined, for any date, as the average of the closing prices of the
Common Stock on the Nasdaq National Market (or such other principal securities
exchange or automated quotation system upon which the Common Stock may then be
listed for public trading) for the five immediately preceding trading days on
such exchange).
7. LOST, STOLEN OR DESTROYED WARRANT. Upon receipt by the Company of
evidence reasonably satisfactory to it of loss, theft, destruction or mutilation
of this Warrant and, in the case of loss, theft or destruction, of reasonably
satisfactory indemnification, or, in the case of mutilation, upon surrender of
this Warrant, the Company, at its expense, will execute and deliver, or instruct
the transfer agent, if any, to execute and deliver, a new Warrant of like tenor
and date, and any such lost, stolen or destroyed Warrant thereupon shall become
void.
8. ISSUE TAX. The issuance of certificates for shares of Common
Stock upon the exercise of this Warrant shall be made without
charge to the Holder for any issue tax or other tax in respect
thereof; provided, however, that the Company shall not be
required to pay any tax that may be payable in respect of any
transfer involved in the issuance and delivery of any
certificate in a name other than that of the then current
Holder of the Warrant being exercised.
9. SHARES TO BE FULLY PAID; RESERVATION OF SHARES. The Company covenants
and agrees that all Warrant Shares which may be issued upon the exercise of this
Warrant will, upon issuance, be validly issued, fully paid and nonassessable and
free from all preemptive or any similar rights and free of any liens or
encumbrances arising through the Company, other than restrictions of transfer
under any state and federal securities laws, as applicable. The Company further
covenants and agrees that during the period within which this Warrant may be
exercised the Company will at all times have authorized and reserved, for the
purpose of issue or transfer upon exercise of this Warrant, a sufficient number
of authorized but unissued shares of Common Stock, when and as required to
provide for the exercise of the rights represented by this Warrant. The Company
will take all such action as may be necessary to assure that such shares of
4
Common Stock may be issued as provided herein without violation of any
applicable law or regulation, or of any requirements of any domestic securities
exchange or automated quotation system upon which the Common Stock is listed.
10. NO IMPAIRMENT. The Company will not, by amendment of its Certificate
of Incorporation or bylaws, or through reorganization, consolidation, merger,
dissolution, issue or sale of securities, sale of assets or any other voluntary
action, avoid or seek to avoid the observance or performance of any of the terms
of this Warrant, but will at all times in good faith assist in the carrying out
of all such terms and in the taking of all such action as may be necessary or
appropriate in order to protect the rights of the Holder of this Warrant against
impairment. Without limiting the generality of the foregoing, the Company (a)
will not increase the par value of any shares of stock issuable upon the
exercise of this Warrant above the amount payable therefor upon such exercise,
and (b) will take all such action as may be necessary or appropriate in order
that the Company may validly and legally issue fully paid and non-assessable
shares of Common Stock upon exercise of this Warrant.
11. NOTICES.
All notices and other communications required or permitted hereunder
shall be effective upon receipt and shall be in writing and may be delivered in
person, by facsimile, overnight delivery service or U.S. mail, in which event it
may be mailed by first-class, certified or registered, postage prepaid,
addressed:
if to the Holder, at
Amgen Inc.
Xxx Xxxxx Xxxxxx Xxxxx
Xxxxxxxx Xxxx, XX 00000-0000
Attention: Corporate Secretary
Fax: (000) 000-0000
or
if to the Company, at
Immunomedics, Inc.
000 Xxxxxxxx Xxxx
Xxxxxx Xxxxxx, Xxx Xxxxxx 00000
Attention:
Fax:
5
with a copy to
Xxxxxx Xxxxxx White & XxXxxxxxx LLP
0000 Xx Xxxxx Xxxxxxx Xxxxx
Xxx Xxxxx, Xxxxxxxxxx 92122Attention: Xxxxxxx X. Xxxxxxx,
Esq.
Fax: (000) 000-0000
or in any case at such other address as the Holder or the Company shall have
furnished to the other in writing.
12. RESTRICTIONS ON TRANSFER OF WARRANT SHARES; TRANSFERABILITY; REGISTER.
12.1 The Holder shall not sell Warrant Shares, either under a
registration statement or otherwise, until the date that is 31 days after the
date of exercise of the Warrant.
12.2 Prior to the time the Holder first exercises this Warrant, this
Warrant and all rights hereunder are transferable (to the extent permitted under
the Act), in whole, upon surrender of this Warrant with a properly executed
assignment (in the form of Exhibit II hereto) at the principal office of the
Company (or, if another office or agency has been designated by the Company for
such purpose, then at such other office or agency). The Warrant Shares may be
offered, resold, pledged or otherwise transferred from the Holder to a
transferee either (i) pursuant to an effective registration statement as
contemplated under Section 13, or (ii) in a transaction meeting the requirements
of Rule 144 under the Act ("Rule 144") or otherwise in accordance with the Act
and the applicable securities laws of any state of the United States or any
other applicable jurisdiction.
12.3 The Company will maintain a register containing the name and
address of the Holder of this Warrant. The Holder may change its address as
shown on the warrant register by written notice to the Company requesting such
change.
13. REGISTRATION RIGHTS.
13.1 HOLDER INCIDENTAL REGISTRATION. Subject to Section 13.5, if the
Company files a registration statement under the Act (other than a registration
statement on Form S-4 or S-8 or any successor or similar forms) registering an
underwritten offering of Common Stock for cash consideration on any form that
also would permit the registration of the Warrant Shares and any shares of
common stock that may be issued or distributed with respect to, or in exchange
for, the Warrant Shares (the "Registrable Securities") and such filing is to be
on its behalf and/or on behalf of selling holders of the Company's securities,
the Company shall each such time promptly give the Holder written notice of its
intent to make such filing, setting forth the date on which the Company proposes
to file such registration statement, and advising the Holder of its right to
have Registrable Securities included in such registration. The Company will
select the managing underwriter and all other underwriters in any underwritten
offering pursuant to this Section 13.1. Upon the written request of the Holder
received by the Company no later than ten (10) days after the date of the
Company's notice, the Company shall use commercially
6
reasonable efforts to cause to be registered under the Act all of the
Registrable Securities that the Holder has so requested to be registered;
provided that if, at any time after giving written notice of its intention to
register any securities and prior to the effective date of the registration
statement filed in connection with such registration, the Company shall
determine for any reason not to proceed with the proposed registration of the
securities to be sold by it, the Company may, at its election, give written
notice of such determination to the Holder and, thereupon, shall be relieved of
its obligation to register any Registrable Securities in connection with such
registration (but not from its obligation to pay the registration expenses
pursuant to Section 13.4 in connection therewith). If, in the written opinion of
the managing underwriter, the total amount of such securities to be so
registered, including such Registrable Securities, will exceed the maximum
amount of the Company's securities that can be marketed either (a) at a price
reasonably related to the then current market value of such securities, or (b)
without otherwise materially and adversely affecting the entire offering, then
the Company shall include in such registration first (1st), all the securities
the Company proposes to sell for its own account or is required to register on
behalf of any third party exercising demand registration rights and without
having the adverse effect referred to above, and second (2nd), all Registrable
Securities requested to be included in such registration by the Holder pursuant
to this Section 13.1 and all shares of Common Stock requested to be included by
third parties exercising the rights similar to those granted in this Section
13.1, up to the number which the Company has been advised can be sold in such
offering without having either of the adverse effects referred to above. The
number of such Registrable Securities requested to be included in such
registration by the Holder pursuant to this Section 13.1 shall be limited to
such extent and shall be allocated pro rata among the Holder and third parties
exercising rights similar to those granted in this Section 13.1 on the basis of
the relative number of Registrable Securities the Holder has requested to be
included in such registration and the number of shares of Common Stock requested
to be included in such registration by such third parties.
13.2 OBLIGATIONS OF THE COMPANY. Whenever the Company has filed a
registration statement pursuant to Section 13.1 that registers Registrable
Securities under the Act, the Company will:
(a) furnish the Holder with a reasonable numbers of copies of the
Registration Statement and any Prospectus included therein (including each
preliminary Prospectus and any amendments or supplements thereto (including all
exhibits and documents incorporated by reference) in conformity with the
requirements of the Act);
(b) use commercially reasonable efforts to register or qualify the
Registrable Securities covered by such Registration Statement under such other
securities or Blue Sky laws of such jurisdictions within the United States as
the Holder shall request for the distribution of the Registrable Securities
covered by the Registration Statement; provided, however, that the Company shall
not be required in connection therewith or as a condition thereto to qualify to
do business in or to file a general consent to service of process in any
jurisdiction wherein it would not but for the requirements of this paragraph (b)
be obligated to do so;
(c) promptly notify the Holder (1) when such Registration Statement,
amendment, supplement or post-effective amendment has been filed, and, with
respect to such Registration Statement or any post-effective amendment, when the
same has become effective,
7
(2) of any comments by the SEC or by any Blue Sky or securities commissioner or
regulator of any state with respect thereto, (3) of the issuance by the SEC of
any stop order suspending the effectiveness of such Registration Statement or
the initiation or threatening of any proceedings for that purpose, or (4) of the
receipt by the Company of any notification with respect to the suspension of the
qualification of the Registrable Securities for sale in any jurisdiction or the
initiation or threatening of any proceeding for such purpose;
(d) provide the Holder and not more than one outside counsel for the
Holder the opportunity to participate in the preparation of such Registration
Statement, each Prospectus included therein or filed with the SEC, and each
amendment or supplement thereto, and (a) promptly incorporate in a Prospectus
supplement or post-effective amendment such information as the Holder or the
Holder's counsel reasonably determine is necessary and appropriate to be
included therein, (b) make all required filings of such Prospectus supplement or
such post-effective amendment as soon as practicable after the Company has
received notification of the matters to be incorporated in such Prospectus
supplement or post-effective amendment, and (c) supplement or make amendments to
such Registration Statement;
(e) cooperate with the Holder to facilitate the timely preparation
and delivery of certificates representing Registrable Securities to be sold, and
enable such Registrable Securities to be in such denominations and registered in
such names as Holder may request at least five Business Days prior to any sale
of the Registrable Securities;
(f) otherwise comply with all applicable rules and regulations of
the SEC, and make available to its security holders, as soon as reasonably
practicable, but not later than eighteen months after the effective date of the
Registration Statement, an earnings statement covering the period of at least
twelve months beginning with the first full month after the effective date of
such Registration Statement, which earnings statement shall satisfy the
provisions of Section 11(a) of the Securities Act; and
(g) use commercially reasonable efforts to list the Registrable
Securities covered by such Registration Statement with any securities exchange
on which the Common Stock of the Company is then listed.
13.4 FURNISH INFORMATION. It shall be a condition precedent to the
obligations of the Company to take any action pursuant to this Warrant that the
Holder shall furnish to the Company such information regarding itself, the
Registrable Securities held by it, and the intended method of disposition of
such securities as the Company shall reasonably request in writing and as shall
be required in connection with the action to be taken by the Company.
13.5 EXPENSES OF REGISTRATION. All expenses other than underwriting
discounts and commissions incurred in connection with registrations, filings or
qualifications of Registrable Securities pursuant to Section 13.1, including
without limitation all registration, filing and qualification fees, word
processing, duplicating, printers' and accounting fees (including the expenses
of any special audits or "cold comfort" letters required by or incident to such
performance and compliance), fees of the NASD or listing fees, messenger and
delivery expenses, all fees and expenses of complying with state securities or
Blue Sky laws, and fees and
8
disbursements of counsel for the Company and one outside legal counsel for the
Holder, hired to review and oversee any offering [*], shall be borne by the
Company. The Holder shall bear and pay the underwriting commissions and
discounts applicable to the Registrable Securities offered for its account in
connection with any regulations, filings and qualifications made pursuant to
this Warrant.
13.6 UNDERWRITING REQUIREMENTS. In connection with any underwritten
offering, the Company shall not be required under Section 13.1 to include
Registrable Securities in such underwritten offering unless the Holder accepts
the terms of the underwriting of such offering that have been reasonably agreed
upon between the Company and the underwriters selected by the Company in
accordance with the terms of this Warrant.
13.7 INDEMNIFICATION. For the purpose of this Section 13.7:
(a) the term "Selling Stockholder" shall include the Holder and any
"affiliate" (as such term is defined in Rule 144) of the Holder, and their
respective permitted transferees and assigns;
(b) the term "untrue statement" shall, with respect to any
Registration Statement, include any untrue statement or alleged untrue statement
of a material fact contained in the related Registration Statement, or any
omission or alleged omission to state in the related Registration Statement a
material fact required to be stated therein or necessary to make the statements
therein, not misleading, and, with respect to any Prospectus, include any untrue
statement or alleged untrue statement of a material fact contained in the
related Prospectus, or any omission or alleged omission to state in the related
Prospectus a material fact required to be stated therein or necessary to make
the statements therein, in the light of the circumstances under which they were
made, not misleading.
(i) The Company agrees to indemnify and hold harmless the Selling
Stockholder (and each person, if any, who controls the Selling
Stockholder within the meaning of Section 15 of the Securities Act,
each officer of the Selling Stockholder and each director of the
Selling Stockholder) from and against any losses, claims, damages or
liabilities to which the Selling Stockholder (or any such officer,
director or controlling person) may become subject (under the
Securities Act or otherwise) insofar as such losses, claims, damages
or liabilities (or actions or proceedings in respect thereof) arise
out of, or are based upon (i) any untrue statement or (ii) any
failure by the Company to fulfill any undertaking included in the
related Registration Statement, and the Company will reimburse the
Selling Stockholder promptly as incurred for any legal or other
expenses reasonably incurred in investigating, defending or
preparing to defend any such action, proceeding or claim, provided,
however, that the Company shall not be liable in any such case to
the extent that such loss, claim, damage or liability (A) arises out
of, or is based upon, an untrue statement made in conformity with
written information furnished to the Company by the Selling
Stockholder specifically for use in preparation of the Registration
Statement or Prospectus (which has not been subsequently corrected
or supplemented), (B) results directly from the failure of the
Selling Stockholder to comply in all material respects with
9
its covenants and agreements contained in Section 13 hereof
respecting sale of the Warrant Shares, or (C) arises out of any
statement or omission in any Prospectus that is corrected in any
subsequent Prospectus that was delivered to the Selling Stockholder
prior to the pertinent sale or sales by the Selling Stockholder.
(ii) The Selling Stockholder agrees to indemnify and hold harmless
the Company (and each person, if any, who controls the Company
within the meaning of Section 15 of the Securities Act, each officer
of the Company and each director of the Company) from and against
any losses, claims, damages or liabilities to which the Company (or
any such officer, director or controlling person) may become subject
(under the Securities Act or otherwise), insofar as such losses,
claims, damages or liabilities (or actions or proceedings in respect
thereof) arise out of, or are based upon, any untrue statement if
such untrue statement was made in conformity with written
information furnished by the Selling Stockholder specifically for
use in preparation of the Registration Statement or Prospectus, and
the Selling Stockholder will reimburse the Company promptly as
incurred for any legal or other expenses reasonably incurred in
investigating, defending or preparing to defend any such action,
proceeding or claim, provided, however, that the Selling Stockholder
need not indemnify any of the aforementioned indemnitees for such
losses, claims, damages or liabilities arising from any statement or
omission in any Prospectus that is corrected in any subsequent
Prospectus if the subsequent Prospectus was furnished to the person
or entity asserting the loss, claim, damage or liability prior to
the pertinent transaction or transactions; provided, further, that
the Selling Stockholder's obligation to indemnify the Company shall
be limited to the net amount received by the Selling Stockholder
from the sale of the Warrant Shares to which the loss related.
(iii) Promptly after receipt by any indemnified person of a notice
of a claim or the beginning of any action in respect of which
indemnity is to be sought against an indemnifying person pursuant to
this Section 13.7, such indemnified person shall notify the
indemnifying person in writing of such claim or of the commencement
of such action, but the omission to so notify the indemnifying party
will not relieve it from any liability which it may have to any
indemnified party under this Section 13.7 (except to the extent that
such omission materially and adversely affects the indemnifying
party's ability to defend such action) or from any liability
otherwise than under this Section 13.7. Subject to the provisions
hereinafter stated, in case any such action shall be brought against
an indemnified person, the indemnifying person shall be entitled to
participate therein, and, to the extent that it shall elect by
written notice delivered to the indemnified party promptly after
receiving the aforesaid notice from such indemnified party, shall be
entitled to assume the defense thereof, with counsel reasonably
satisfactory to such indemnified person. After notice from the
indemnifying person to such indemnified person of its election to
assume the defense thereof, such indemnifying person shall not be
liable to such indemnified person for any legal expenses
subsequently incurred by such indemnified person in connection with
the defense thereof, provided, however, that if there exists or
shall exist a conflict of interest that would make it inappropriate,
in the opinion of
10
counsel to the indemnified person, for the same counsel to represent
both the indemnified person and such indemnifying person or any
"affiliate" or "associate" (as those terms are defined in Rule 405
promulgated under the Securities Act) thereof, the indemnified
person shall be entitled to retain its own counsel at the expense of
such indemnifying person; provided, however, that no indemnifying
person shall be responsible for the fees and expenses of more than
one separate counsel (together with appropriate local counsel) for
all indemnified parties. In no event shall any indemnifying person
be liable in respect of any amounts paid in settlement of any action
unless the indemnifying person shall have approved the terms of such
settlement; provided that such consent shall not be unreasonably
withheld. No indemnifying person shall, without the prior written
consent of the indemnified person, effect any settlement of any
pending or threatened proceeding in respect of which any indemnified
person is or could have been a party and indemnification could have
been sought hereunder by such indemnified person, unless such
settlement includes an unconditional release of such indemnified
person from all liability on claims that are the subject matter of
such proceeding.
(iv) If the indemnification provided for in this Section 13.7 is
unavailable to or insufficient to hold harmless an indemnified party
under subsection (i) or (ii) above in respect of any losses, claims,
damages or liabilities (or actions or proceedings in respect
thereof) referred to therein, then each indemnifying party shall
contribute to the amount paid or payable by such indemnified party
as a result of such losses, claims, damages or liabilities (or
actions in respect thereof) in such proportion as is appropriate to
reflect the relative fault of the Company on the one hand and the
Selling Stockholder on the other in connection with the statements
or omissions or other matters which resulted in such losses, claims,
damages or liabilities (or actions in respect thereof), as well as
any other relevant equitable considerations. The relative fault
shall be determined by reference to, among other things, in the case
of an untrue statement, whether the untrue statement relates to
information supplied by the Company on the one hand or the Selling
Stockholder on the other and the parties' relative intent,
knowledge, access to information and opportunity to correct or
prevent such untrue statement. The Company and the Selling
Stockholder agree that it would not be just and equitable if
contribution pursuant to this subsection (iv) were determined by pro
rata allocation (even if Selling Stockholder were treated as one
entity for such purpose) or by any other method of allocation which
does not take into account the equitable considerations referred to
above in this subsection (iv). The amount paid or payable by an
indemnified party as a result of the losses, claims, damages or
liabilities (or actions in respect thereof) referred to above in
this subsection (iv) shall be deemed to include any reasonable legal
or other expenses reasonably incurred by such indemnified party in
connection with investigating or defending any such action or claim.
Notwithstanding the provisions of this subsection (iv), Selling
Stockholder shall not be required to contribute any amount in excess
of the amount by which the net amount received by Selling
Stockholder from the sale of the Warrant Shares to which such loss
relates exceeds the amount of any damages which Selling Stockholder
has otherwise been required to pay by reason
11
of such untrue statement. No person guilty of fraudulent
misrepresentation (within the meaning of Section 11(f) of the
Securities Act) shall be entitled to contribution from any person
who was not guilty of such fraudulent misrepresentation. Selling
Stockholder's obligations in this subsection to contribute are
several in proportion to their sales of Warrant Shares to which such
loss relates and not joint.
(v) The parties to this Warrant hereby acknowledge that they are
sophisticated business persons who were represented by counsel
during the negotiations regarding the provisions hereof including,
without limitation, the provisions of this Section 13.7, and are
fully informed regarding said provisions. They further acknowledge
that the provisions of this Section 13.7 fairly allocate the risks
in light of the ability of the parties to investigate the Company
and its business in order to assure that adequate disclosure is made
in the Registration Statement as required by the Securities Act and
the Securities Exchange Act of 1934, as amended (the "Exchange
Act"). The parties are advised that federal or state public policy
as interpreted by the courts in certain jurisdictions may be
contrary to certain of the provisions of this Section 13.7, and the
parties hereto hereby expressly waive and relinquish any right or
ability to assert such public policy as a defense to a claim under
this Section 13.7 and further agree not to attempt to assert any
such defense.
13.8 INFORMATION AVAILABLE. So long as a Registration Statement is
effective covering the resale of Warrant Shares owned by the Holder, the Company
will furnish to the Holder, upon its request:
(a) as soon as practicable after it is available, one copy of (i)
its Annual Report to Stockholders (which Annual Report shall contain financial
statements audited in accordance with generally accepted accounting principles
by a national firm of certified public accountants), (ii) its Annual Report on
Form 10-K and amendments, if any, and (iii) its Quarterly Reports on Form 10-Q
and amendments, if any (the foregoing, in each case, excluding exhibits, unless
specifically requested by the Holder); and
(b) promptly upon the request of the Holder, an adequate number of
copies of the Prospectuses to supply to any other party requiring such
Prospectuses.
13.9 COMPANY REPORTS FILED UNDER THE EXCHANGE ACT. With a view to
making available to the Holder the benefits of Rule 144 and other rules or
regulations of the SEC that may permit the Holder to sell the Warrant Shares
without registration, for the first two years after the Holder first exercises
this Warrant, the Company covenants and agrees to (a) comply with all of the
reporting requirements of the Exchange Act applicable to it and shall comply
with all other public information reporting requirements of the SEC that are
conditions to the availability of Rule 144 for the sale of the Warrant Shares
and (b) furnish to the Holder, upon request, a written statement by the Company
that it has complied with the reporting requirements of Rule 144, the Act and
the Securities Exchange Act of 1934, and such other information as may be
reasonably requested in order to avail the Holder of any rule or regulation of
the SEC that permits the selling of any such Warrant Shares without
registration.
12
14. AMENDMENT. This Warrant is irrevocable and non-cancelable. The terms
of this Warrant may be amended, modified or waived only with the written consent
of the Company and the Holder.
15. GOVERNING LAW. This Warrant shall be governed by and construed in
accordance with the laws of the State of Delaware, as such laws are applied to
contracts entered into and wholly to be performed within the State of Delaware.
13
IN WITNESS WHEREOF, the Company has executed this Warrant as of
__________ __, 2004.
IMMUNOMEDICS, INC.
By:___________________________________
Name:
Title:
AGREED AND ACCEPTED BY:
AMGEN INC.
By:____________________________________
Name: Xxxxx X. Xxxxxxxxxx
Title: Executive Vice President,
Research and Development
14
EXHIBIT I
SUBSCRIPTION
Date:___________________________________
________________________________________
________________________________________
________________________________________
The undersigned, the Holder of the attached Warrant, irrevocably elects to
exercise the purchase right represented by such Warrant to purchase
_________________ shares of common stock, par value $0.01 per share, of the
Company. Simultaneously with the delivery of this subscription form, the
undersigned has made provision for the payment of $________ to the Company (via
[wire transfer] [enclosed check]) representing the Exercise Price. The
certificate(s) for such shares shall be issued in the name of the Holder or as
otherwise indicated below:
______________________________________
Holder's Signature
______________________________________
Name for Registration
______________________________________
Mailing Address
______________________________________
______________________________________
I-1
EXHIBIT II
ASSIGNMENT FORM
FOR VALUE RECEIVED, ________________________________________ hereby sells,
assigns and transfers all of the rights of the undersigned under the attached
Warrant (No. ____) with respect to the number of shares of common stock, par
value $0.01 per share, of Immunomedics, Inc. covered thereby set forth below,
unto:
Name of Assignee Address No. of Shares
---------------- ------- -------------
Dated:_____________________ Signature:________________________________
Signature Guaranteed:
By: _______________________
The signature should be guaranteed by an eligible guarantor institution (banks,
stockbrokers, savings and loan associations and credit unions with membership in
an approved signature guarantee medallion program) pursuant to Rule 17Ad-15
under the Securities Exchange Act of 1934.
I-2
EXHIBIT F
Material Transfer Agreements
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EXHIBIT G
Clinical Studies Contracts
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EXHIBIT H
Non-Assumed Clinical Studies Contracts
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H-2
EXHIBIT I
Clinical Trial Services Agreements
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I-1
EXHIBIT J
AMGEN(R)
Xxx Xxxxx Xxxxxx Xxxxx
Xxxxxxxx Xxxx, XX 00000-0000
Telephone (000) 000-0000
Fax (000) 000-0000
xxx.Xxxxx.xxx
News Release
________________________________________________________________________________
IMMUNOMEDICS REGAINS NORTH AMERICAN
DEVELOPMENT RIGHTS FROM AMGEN FOR
EPRATUZUMAB
Xxxxxx Plains, NJ and Thousand Oaks, Calif. (April 8, 2004) - Immunomedics,
Inc. (NASDAQ: IMMU) and Amgen Inc. (NASDAQ: AMGN) today announced that Amgen
has returned to Immunomedics all rights for epratuzumab, the humanized CD22
monoclonal antibody therapeutic licensed to Amgen by Immunomedics in December
2000, including rights to second generation molecules and conjugates.
As part of the transaction, Immunomedics has agreed to issue to Amgen a 5-year
warrant to purchase 100,000 shares of the Company's common stock with a strike
price equal to $16.00 per share. Amgen will receive a final payment of $600,000
from Immunomedics if epratuzumab is approved for commercialization in the United
States for non-Hodgkin's lymphoma therapy. There are no other financial
obligations between the parties as a result of the agreement.
Xxxxx Xxxxxxxxxx, M.D., Ph.D., executive vice president of Research and
Development at Amgen stated, "Our relationship with Immunomedics has been
positive. Phase 2 data demonstrate that epratuzumab is active against NHL.
Epratuzumab was also shown to be safe and well-tolerated when administered as a
single agent or in combination with rituximab (Rituxan). Our transfer of
preclinical and clinical data to Immunomedics will aid their efforts to develop
epratuzumab, in which endeavors we wish them well."
Immunomedics' president and chief executive officer, Xxxxxxx X. Xxxxxxxx,
commented, "Amgen has been an excellent partner, and we are pleased with their
decision to transfer the epratuzumab program to us. By regaining North American
and Australian rights to our product, we can now discuss worldwide licensing of
this product with other interested companies. Since epratuzumab is currently
being tested in patients with
J-1
autoimmune disease, we anticipate that it also may have utility in this group of
indications."
To date, epratuzumab has been studied, either alone or in combination with
rituximab, in over 300 patients with indolent or aggressive non-Hodgkin's
lymphomas, which are newly diagnosed in more than 50,000 patients annually in
the United States, and where there are over 350,000 patients being followed with
this disease.
About Immunomedics
Immunomedics is a biopharmaceutical company focused on the development,
manufacture and commercialization of diagnostic imaging and therapeutic products
for the detection and treatment of cancer and other serious diseases. Integral
to these products are highly specific monoclonal antibodies and antibody
fragments designed to deliver radioisotopes and chemotherapeutic agents to
tumors and other sites of disease. Immunomedics has nine therapeutic product
candidates in clinical development and has two marketed diagnostic imaging
products. The most advanced therapeutic product candidates are LymphoCide(R)
(epratuzumab), for which certain Phase II clinical trials for the treatment of
non-Hodgkin's lymphoma have already been completed, and CEA-Cide(R)
(labetuzumab), which is in Phase I/II clinical trials for the treatment of
certain solid tumors.
This release, in addition to historical information, contains forward-looking
statements made pursuant to the Private Securities Litigation Reform Act of
1995. Such statements, including statements regarding clinical trials, involve
significant risks and uncertainties and actual results could differ materially
from those expressed or implied herein. Factors that could cause such
differences include, but are not limited to, risks associated with new product
development (including clinical trials outcome and regulatory
requirements/actions), competitive risks to marketed products and availability
of financing and other sources of capital, as well as the risks discussed in the
Company's Annual Report on Form 10-K for the year June 30, 2003.
ABOUT AMGEN
Amgen is a global biotechnology company that discovers, develops, manufactures
and markets important human therapeutics based on advances in cellular and
molecular biology.
This news release contains forward-looking statements that involve significant
risks and uncertainties, including those discussed below and others that can be
found in Amgen's Form 10-K for the year ended December 31, 2003, and in Amgen's
periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information
as of the date of this news release and does not undertake any
J-2
obligation to update any forward-looking statements contained in this document
as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ
materially from those we project. Amgen's results may be affected by its ability
to successfully market both new and existing products domestically and
internationally, sales growth of recently launched products, difficulties or
delays in manufacturing its products, and regulatory developments (domestic or
foreign) involving current and future products and manufacturing facilities. In
addition, sales of Amgen's products are affected by reimbursement policies
imposed by third party payors, including governments, private insurance plans
and managed care providers, and may be affected by domestic and international
trends toward managed care and healthcare cost containment as well as possible
U.S. legislation affecting pharmaceutical pricing and reimbursement. Government
regulations and reimbursement policies may affect the development, usage and
pricing of Amgen's products. Furthermore, Amgen's research, testing, pricing,
marketing and other operations are subject to extensive regulation by domestic
and foreign government regulatory authorities. Amgen or others could identify
side effects or manufacturing problems with its products after they are on the
market. In addition, Amgen competes with other companies with respect to some of
its marketed products as well as for the discovery and development of new
products. Discovery or identification of new product candidates cannot be
guaranteed and movement from concept to product is uncertain; consequently,
there can be no guarantee that any particular product candidate will be
successful and become a commercial product. In addition, while Amgen routinely
obtain patents for its products and technology, the protection offered by its
patents and patent applications may be challenged, invalidated or circumvented
by its competitors. Further, some raw materials, medical devices and component
parts for Amgen's products are supplied by sole third party suppliers.
# # #
CONTACT:
Immunomedics, Xxxxxx Plains
Investor Relations, 973/605-8200
Amgen, Thousand Oaks
Xxxxxxxxx Xxxxxxxx, 805/447-4587 (media)
Xxxx Xxxxxxxx, 805/447-1060 (investors)
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EDITOR'S NOTE: An electronic version of this news release may be accessed via
our Web site at XXX.XXXXX.XXX. Visit the Corporate Center and click on Amgen
News. Journalists and media representatives may sign up to receive all news
releases electronically at time of announcement by filling out a short form in
the Amgen News section of the Web site.
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