Exhibit 10.37
* The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
This LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT is entered into as of
May 7, 2003 (the "Effective Date"), by and between PFIZER INC ("Pfizer"), a
Delaware corporation, having an office at 000 Xxxx 00xx Xxxxxx, Xxx Xxxx, Xxx
Xxxx 00000, and GUILFORD PHARMACEUTICALS INC., a Delaware corporation, having an
office at 0000 Xxxxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000, and GPI NAALADASE
HOLDINGS, INC., a Delaware corporation, having an office at 000 Xxxxxxxx Xxxxxx,
Xxxxxxxxxx, Xxxxxxxx 00000 (collectively, with Guilford Pharmaceuticals Inc.,
"Guilford").
WHEREAS, Pfizer desires to obtain an exclusive license under Guilford's right,
title and interest in the Patent Rights so that Pfizer can evaluate the Patent
Rights and manufacture, use, sell, offer for sale and import the Products; and
WHEREAS, Guilford is willing to grant a license on the terms and subject to the
conditions set forth in this Agreement;
Therefore, in consideration of the mutual covenants and promises set forth in
this Agreement, the parties agree as follows:
1. DEFINITIONS. The capitalized terms used in this Agreement and not defined
elsewhere in it shall have the meanings specified for such terms in
Section 1.
(a) "PATENT RIGHTS" shall mean (a) all the patents and patent
applications listed in Exhibit A, and patents issuing on them,
including any divisional, continuation, continuation-in-part,
renewal, extension, reexamination, reissue or foreign counterpart of
such patent applications; (b) Other Patent Rights; and (c) any
patent restoration or extension period granted by a Governmental
Authority, including but not limited to the compensation for patent
term lost during the clinical trial or regulatory approval process.
(b) "VALID CLAIM" shall mean a claim within the Patent Rights so long as
such claim shall neither have been disclaimed by the owner of the
patent, nor held invalid in a final decision rendered by a tribunal
of competent jurisdiction from which no appeal has been taken during
the applicable appeal period or for
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which no further appeal can be taken.
(c) "PRODUCT" means any compound that the manufacture, use, sale, offer
for sale or import of which would infringe any Valid Claim within
the Patent Rights in the absence of a license. For purposes of this
Agreement, in the event there is more than one compound as an active
pharmaceutical ingredient in a single drug formulation, such
combination of compounds shall be considered a single compound,
which shall be separate and distinct from each of the individual
compounds so combined.
(d) "AFFILIATE" shall mean with respect to a party to this Agreement,
any entity which controls, is controlled by, or is under common
control with such party. Control" means the ownership or ability to
direct the voting power of at least 50% of all voting securities of
an entity.
(e) "NET SALES" means the gross amount invoiced by Pfizer, its
Affiliates, or any sublicensee of Pfizer for sales to a third party
or parties of Products, less normal and customary trade discounts
actually allowed, credits or allowances for rejected or returned
Products previously sold, taxes the legal incidence of which is on
the purchaser and separately shown on Pfizer's, its Affiliate's, or
any sublicensee of Pfizer's, invoices and transportation, insurance
and postage charges, if prepaid by Pfizer, any of its Affiliates or
any sublicensee of Pfizer and billed on Pfizer's, its Affiliate's or
any sublicensee of Pfizer's invoices as a separate item, and
compulsory payments and rebates, accrued, paid or deducted pursuant
to governmental regulations or agreements (other than employment
agreements or agreements with Affiliates) with third parties
(provided such agreements with third parties are identified and made
available to Guilford for review and deductions relating to such
agreements are identified separately in any statements pursuant to
Section 4.6(b)).
(f) "GUILFORD COLLABORATIONS" means (a) (1) Guilford's research for the
evaluation of NAALADase inhibitor conjugated to chemotherapy and
radiotherapy for the treatment of prostate cancer; (2) Guilford's
research for the formulation and evaluation of I.V. NAALADase
inhibitors in acute conditions of glutamate toxicity, such as
traumatic brain insult, spinal cord injury, cardiac arrest and/or
global ischemia; and (3) Guilford's proposed clinical trial and
research with * for the evaluation of NAALADase inhibitors for
the treatment of drug addiction; and any agreements covering or
arising out of any of the above-described trials or research; and
(b) such other collaborations as Guilford may enter into following
notice to and approval by Pfizer of such collaborations. Unless
otherwise agreed to by Pfizer, Guilford shall not use * (or any
other Guilford compounds as to which Pfizer has previously notified
Guilford that it intends to pursue in development) in connection
with the Guilford Collaborations. Guilford and Pfizer shall
cooperate to ensure that compounds developed by Pfizer under
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this Agreement are not also developed by Guilford under the Guilford
Collaborations.
(g) "COLLABORATION MILESTONE" means, with respect to each Guilford
Collaboration, unless the parties otherwise agree, the completion of
a Phase II trial demonstrating safety and efficacy with a
presentation of data sufficient to enable Pfizer to decide whether
or not to advance into Phase III trials.
(h) "OTHER PATENT RIGHTS" means all patents and patent applications
relating to NAALADase and patents issuing on them, including any
divisional, continuation, continuation-in-part, renewal, extension,
reexamination, reissue or foreign counterpart of such patents and
patent applications, that arise pursuant to Guilford Collaborations
to the extent of Guilford's interest therein.
(i) "INFORMATION" means all information, including data; process
information; Product information, know-how; technical and
nontechnical materials; and Product samples and specifications,
which one party delivers or makes available to the other pursuant to
this Agreement.
(j) "GUILFORD CONFIDENTIAL INFORMATION" means all Information that
Guilford discloses to Pfizer and designates "Confidential" in
writing at the time of disclosure or within thirty (30) days
following disclosure, to the extent that such Information as of the
date of disclosure to Pfizer is not (i) known to Pfizer other than
by virtue of a prior confidential disclosure to Pfizer by Guilford;
or (ii) disclosed in published literature, or otherwise generally
known to the public through no fault or omission of Pfizer; or (iii)
obtained from a third party free from any obligation of
confidentiality to Guilford.
(k) "PFIZER CONFIDENTIAL INFORMATION" means all Information that Pfizer
discloses to Guilford and designates "Confidential" in writing at
the time of disclosure or within thirty (30) days following
disclosure to the extent that such information as of the date of
disclosure to Guilford is not (i) known to Guilford other than by
virtue of a prior confidential disclosure to Guilford by Pfizer; or
(ii) disclosed in published literature, or otherwise generally known
to the public through no fault or omission of Guilford; or (iii)
obtained from a third party free from any obligation of
confidentiality to Pfizer.
(l) "GUILFORD TECHNOLOGY" means (A) all proprietary Information and
intellectual property (other than Patent Rights) (i) developed,
discovered or invented by Guilford or on behalf of Guilford under an
agreement which grants Guilford the right to convey the information
or property, whether on, before or after the Effective Date,
relating to (a) the modulation of NAALADase or (b) the compounds
provided by Guilford to Pfizer under the Agreement; (ii) owned by
Guilford on the Effective Date or at any time during the term of
this Agreement which describes or relates to (a) the modulation of
NAALADase or
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(b) the compounds provided by Guilford to Pfizer; or (iii) owned by
Guilford on the Effective Date or at any time during the term of
this Agreement and necessary or useful to manufacture, use, sell,
offer for sale or import Products or compounds that modulate
NAALADase, or (B) any exclusivity rights (other than Patent Rights)
under Applicable Law that limit the ability of another Person to
manufacture, use, sell, offer for sale or import a product that
modulates NAALADase.
(m) "NAALADASE" means the enzyme known as
N-Acetylated-Alpha-Linked-Acid-Dipeptidase.
(n) "INITIAL PERIOD" means the period commencing on the Effective Date
and ending at the earlier of (i) 5:00 p.m., New York, New York time,
on March 31, 2004; (ii) ninety (90) days after the date on which
Pfizer, pursuant to its Candidate Alert Notice guidelines, formally
nominates a compound to proceed in human clinical trials of a
Product; or (iii) the date on which this Agreement terminates in
accordance with the provisions of Section 9.
(o) "APPLICABLE LAW" means, with respect to any Person, any domestic or
foreign, federal, state or local statute, treaty, law, ordinance,
rule, regulation, administrative interpretation, order, writ,
injunction, judicial decision, decree or other requirement of any
Governmental Authority applicable to such Person or any of such
Person's respective properties, assets, officers, directors,
employees, consultants or agents (in connection with such officers',
directors', employees', consultants' or agents' activities on behalf
of such Person).
(p) "PERSON" means an individual, a corporation, a general partnership,
a limited partnership, a limited liability company, a limited
liability partnership, an association, a trust or any other entity
or organization, including a Governmental Authority.
(q) "GOVERNMENTAL AUTHORITY" means any foreign, domestic, federal,
territorial, state or local governmental authority,
quasi-governmental authority, instrumentality, court, government or
self-regulatory organization (including any national or
international securities exchange and The NASDAQ Stock Market),
commission, tribunal or organization or any regulatory,
administrative or other agency, or any political or other
subdivision, department or branch of any of the foregoing.
(r) "FDA" means the Federal Food and Drug Administration of the United
States Department of Health and Human Services or any successor
agency thereof.
(s) "INITIAL TARGET COMPOUNDS" means Guilford's compounds known as *,
and to the extent contemplated by Exhibit B, such other Guilford
compounds
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relating to NAALADase inhibitors (including * and those in the*) as
Guilford and Pfizer may agree during the Initial Period.
(t) "SECURITIES LAWS" means the United States Securities Act of 1933, as
amended, the United States Securities Exchange Act of 1934, as
amended, and any other similar law or regulation of a Governmental
Authority, or any successor to any such laws or regulations,
together with any rules, regulations or listing standards or
agreements of any national or international securities exchange or
The NASDAQ Stock Market.
(u) "EXCLUSIVITY PERIOD" means, with respect to a Product in a
particular country, the period prior to the termination of the
Patent Rights in that country for any reason (including but not
limited to any patent restoration period granted by a Governmental
Authority to compensate for patent term lost during the clinical
trial or regulatory approval process), and with respect to that
country, any period in which Guilford or Pfizer has exclusivity
rights (other than Patent Rights) under Applicable Law that limit
the ability of all other Persons in the country to manufacture,
obtain regulatory approval, use, sell, offer for sale or import the
Product, including data exclusivity and/or exclusivity based on
approval of a new chemical entity or new use of a previously
approved drug (including but not limited to that afforded under the
Hatch Waxman Act), pediatric exclusivity, orphan drug exclusivity,
or the 180-day Abbreviated New Drug Application Exclusivity.
(v) "NDA" means a New Drug Application, "SNDA" means a Supplemental New
Drug Application, and "IND" means an Investigational New Drug
Application under 21 U.S.C. Section 355.
(w) "ADDITIONAL INDICATION" means an indicated use of a Product,
separate from a previously indicated use, for which the commercial
marketing or sale would require approval of an application under 21
U.S.C. Section 355 (or an equivalent provision of Applicable Law of
a foreign jurisdiction).
(x) "BACK UP COMPOUND" means a compound identified and nominated by
Pfizer as a "back up compound" to a specified lead compound in
accordance with Pfizer's ordinary business practices; provided,
however, that such a compound shall only qualify as a "Back Up
Compound" so long as and if (a) on or before the time Pfizer first
files a regulatory application with a regulatory authority in
respect of particular lead compound, Pfizer notifies Guilford in
writing of the identity of the lead compound and the respective
possible "back up compound or compounds," (b) no more than two (2)
compounds may be identified and qualify as possible Back Up
Compounds for a particular lead compound, (c) a Back Up Compound
must initially be and remain for the same indication as the lead
compound, (d) a compound shall only qualify as a Back Up Compound if
Pfizer is no longer pursuing regulatory approval or
6
conducting clinical trials with respect to the identified lead
compound and any other compound initially identified by Pfizer as a
possible Back Up Compound to that lead compound, and (e) a compound
shall no longer qualify as a Back Up Compound at such time as the
lead compound or another Back Up Compound as to the same lead
compound is approved for marketing and sale by the FDA or a
comparable foreign regulatory authority.
2. GRANT OF EXCLUSIVE COMMERCIAL LICENSE UNDER PATENT RIGHTS AND GUILFORD
TECHNOLOGY
In consideration of Pfizer paying Guilford (i) $5,000,000 on the Effective
Date, (ii) unless this Agreement has been earlier terminated, $10,000,000
on or before the last day of the Initial Period, and (iii) the royalties
contemplated by Section 4, Guilford hereby grants Pfizer the following
licenses, on the terms and conditions set forth in this Agreement:
2.1 GRANT OF RESEARCH LICENSE
Guilford hereby grants Pfizer a nonexclusive, irrevocable, worldwide,
royalty-free, perpetual license, including the right to grant sublicenses
to Affiliates, to use Patent Rights and Guilford Technology, but only for
internal research purposes in respect of human therapeutic purposes, and
not for the sale, manufacture for sale or import of products or processes.
2.2 EXCLUSIVE LICENSE UNDER THE PATENT RIGHTS
Subject to any limitations or restrictions set forth in this Agreement,
Guilford grants Pfizer a worldwide license, including the right to grant
sublicenses, to manufacture, use, sell, offer for sale and import Products
under the Patent Rights and Guilford Technology, such license to be
exclusive as to Patent Rights and nonexclusive as to Guilford Technology,
it being understood and agreed that the exclusive license as to Patent
Rights and the nonexclusive license as to Guilford Technology may not be
assigned or sublicensed separately. Guilford shall retain the right to
practice the inventions under the Patent Rights (i) for internal research
purposes, but not for the sale or manufacture for sale of products or
processes generally, and/or (ii) in connection with the pursuit of any of
the Guilford Collaborations at any time up to the date on which Guilford
may assign its rights in respect of any such Guilford Collaboration to
Pfizer pursuant to Section 2.4.1, and/or (iii) in connection with the
pursuit of any of the Guilford Collaborations to the extent that Pfizer no
longer has the right to acquire Guilford's rights in respect of such
Guilford Collaboration pursuant to Section 2.4.3, and thereafter to
manufacture, use, sell, offer for sale and import products resulting from
such Guilford Collaborations, either directly or indirectly through
another Person pursuant to a co-promotion, distribution or other
arrangement intended to further Guilford's commercialization of such
products in accordance with the
7
provisions of Section 2.4.3, and/or (iv) for diagnostic purposes. The
license granted under this Section 2.2 in each country shall commence on
the date of this Agreement and shall terminate in accordance with Section
9 of this Agreement.
2.3 TECHNICAL ASSISTANCE. Guilford shall provide to Pfizer or any permitted
sublicensee of Pfizer, at Pfizer's request and expense, during normal
business hours and upon reasonable advance notice and request, any
technical assistance reasonably necessary to enable Pfizer or such
sublicensee to manufacture, use, sell, offer for sale or import each
Product and to enjoy fully all the rights granted to Pfizer pursuant to
this Agreement; provided, however, that Guilford is reasonably capable of
providing that assistance and the terms upon which such assistance shall
be provided are mutually agreeable to Guilford and Pfizer.
2.4 GUILFORD COLLABORATIONS
During the Initial Period (and, with respect to each Guilford
Collaboration until such time as Pfizer no longer has the right to acquire
Guilford's rights under such Guilford Collaboration), subject to any
restrictions of Applicable Law and the terms and conditions of the
agreements constituting such Guilford Collaboration, Guilford shall permit
Pfizer, and shall use reasonable commercial efforts to cause its
collaborators in each Guilford Collaboration to permit Pfizer, to be kept
apprised of the work of such Guilford Collaboration and Guilford shall
keep Pfizer apprised of the work of such Guilford Collaborations at
quarterly Steering Committee meetings.
2.4.1 Pfizer may, in respect of each Guilford Collaboration, at any
time during the period commencing on the date of delivery to
Pfizer by Guilford of a report, in form and substance
satisfactory to Pfizer and containing all information relating
to the Guilford Collaborations in Guilford's possession and
material to Pfizer's decision under this Section 2.4.1,
summarizing the results of the respective Guilford
Collaboration through the Collaboration Milestone, and ending
on the sixtieth (60th) day thereafter, by advance, written
irrevocable notice, direct Guilford to make Guilford's rights
under any or all of the Guilford Collaborations available to
Pfizer subject to the terms and conditions of the agreements
constituting such Guilford Collaborations.
2.4.2 If Pfizer elects to direct Guilford to make its rights
available to Pfizer pursuant to Section 2.4.1, thereafter
Pfizer will have the right to control the assigned
collaboration (including the right to modify the scope of the
collaboration or terminate it, in either case in accordance
with the terms and conditions of the collaboration), in
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Pfizer's sole discretion, subject only to (i) Pfizer paying
Guilford * within thirty (30) days of receipt of an invoice or
invoices from Guilford; and (ii) Pfizer assuming the
obligations of Guilford in respect of the collaboration from
and after the date on which such rights are made available to
Pfizer in accordance with an agreement between Guilford and
Pfizer consistent with this Section 2.4. and on other terms
and conditions acceptable to Guilford and Pfizer. Payment of
such costs shall be subject to Pfizer's receipt of appropriate
documentation of such costs, and such costs shall include
Guilford's internal direct and indirect costs as well as costs
of the collaborator and any other third-party costs to the
extent borne, directly or indirectly, by Guilford.
2.4.3 If Pfizer does not direct Guilford to make Guilford's rights
under a particular Guilford Collaboration available to Pfizer,
as set forth in Section 2.4.1, Guilford in its sole discretion
may develop and commercialize the Products resulting from that
particular Guilford Collaboration for its own account at its
own cost. In such event Guilford may manufacture, use, sell,
offer for sale and import products resulting from such
Guilford Collaboration directly or, subject to Pfizer's
consent (which will not be unreasonably withheld), indirectly
through another Person pursuant to a co-promotion,
distribution or other arrangement intended to further
Guilford's commercialization of such products.
2.5 STEERING COMMITTEE.
2.5.1 Guilford and Pfizer agree to form a steering committee (the
"Steering Committee") that will meet at least on a quarterly
basis to (i) consult regarding Pfizer's evaluation of the
Initial Target Compounds and the screening of Pfizer and other
Guilford compounds for efficacy in the modulation of
NAALADase, (ii) review and evaluate the progress in respect of
Pfizer's research, development and commercialization of
Products, including the results of any clinical trials and the
status of any regulatory applications, (iii) discuss and seek
to resolve any Disputes (as hereinafter defined) in accordance
with the provisions of Section 11, and (iv) review and
evaluate the progress being made in connection with the
Guilford Collaborations.
2.5.2 Guilford and Pfizer each shall appoint, in its sole
discretion, three members, respectively, to the Steering
Committee. The party who appointed any particular member of
the Steering Committee shall at all times have the power and
authority to remove that member of the Steering Committee by
providing written notice of such removal
9
to the other party. Substitutes may be appointed at any time
by the party who appointed the member whose resignation or
removal caused a vacancy on the Steering Committee.
The initial members of the Steering Committee shall be:
Guilford:
*
Pfizer:
*
2.5.3 Steering Committee meetings will take place on a quarterly
basis on mutually agreeable dates, times and places. Such
meetings may be conducted by videoconference no more than
twice a year. Pfizer shall prepare and distribute an agenda at
least fifteen (15) days before each meeting of the Steering
Committee. Guilford may propose changes and additions to the
agenda. Pfizer shall cause one of its representatives on the
Steering Committee to prepare and send meeting minutes to
Guilford for review and comment within fifteen (15) days
following the applicable committee meeting. Final minutes
shall be completed by Guilford and Pfizer within thirty (30)
days of each meeting.
2.5.4 Pfizer shall have all decision authority regarding the
research and development and commercialization of Products.
Notwithstanding the foregoing, subject to its obligation to
maintain the confidentiality of the Pfizer Confidential
Information in accordance with the provisions of this
Agreement and any restrictions of Applicable Law, Guilford
shall have reasonable access to any data or reports prepared
in connection with Steering Committee meetings.
3. PFIZER DILIGENCE.
3.1 Pfizer shall use reasonable efforts to develop and exploit the
Products commercially employing similar effort to that applied to
similarly situated Pfizer products and programs that are being
actively pursued.
3.2 In furtherance of the provisions of Section 3.1, during the Initial
Period Guilford will transfer to Pfizer its NAALADase screening
assay. Upon successful incorporation of Guilford's screening assay
into Pfizer's high throughput screening format, Pfizer will begin to
screen Pfizer's compound library for NAALADase inhibitors in
accordance with Pfizer's
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standard procedures and criteria for screening and progression.
During the Initial Period, Pfizer will perform the compound
characterization studies on * set forth in Exhibit B, and take the
other actions contemplated by Exhibit B.
3.3 If Pfizer grants a sublicense pursuant to Section 2, Pfizer shall
give written notice to Guilford of such sublicense, shall cause the
sublicensee to confirm in writing to and for the benefit of Guilford
that it will comply with the covenants and agreements of Pfizer
hereunder and shall guarantee that any sublicensee fulfills all of
Pfizer's obligations under this Agreement; provided, however, that
Pfizer shall not be relieved of its obligations pursuant to this
Agreement by virtue of any such sublicense.
4. MILESTONE PAYMENTS, ROYALTIES, PAYMENTS OF ROYALTIES, ACCOUNTING FOR
ROYALTIES, RECORDS.
4.1 MILESTONES
Pfizer shall pay Guilford, in respect of each Product (regardless of
whether the active ingredient in the Product is an Initial Target
Compound, another compound of Guilford, or a compound of Pfizer or
another Person), within thirty (30) business days of the achievement
by such Product of each event set forth below (each a "Milestone"),
the payment listed opposite that Milestone (the "Milestone Amount").
------------------------------------------------------------------------------------
Milestone Milestone Amount
--------- ----------------
* *
------------------------------------------------------------------------------------
Guilford shall be entitled to payment of the Milestone Amounts in
respect of each Milestone set forth above only once for each Product
(including Back Up Compounds).
4.2 ADDITIONAL INDICATIONS.
If Pfizer pursues an Additional Indication for a Product as to which
another indicated use has been approved by the FDA (or a comparable
regulatory authority of a foreign jurisdiction) or in respect of
which such approval is
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being pursued, Pfizer shall pay Guilford the payment listed opposite
each Milestone (each an "Additional Indication Milestone Amount")
set forth below within thirty (30) business days of the achievement
of the respective Milestone. Pfizer shall pay each Additional
Indication Milestone Amount in respect of a Milestone for an
Additional Indication only once, regardless of how many additional
indications are pursued with respect to a Product or how many
different Products are the subject of attempts to seek approvals for
Additional Indications; provided, however, that the Additional
Indication Milestone Amounts set forth below need not be paid in
respect of the same Additional Indication.
-------------------------------------------------------------------------------------
Milestone Additional Indication
--------- Milestone Amount
----------------
* *
-------------------------------------------------------------------------------------
4.3 *
4.4 ROYALTIES. Pfizer shall pay Guilford a royalty based on the Net
Sales of each Product. Such royalty shall be paid with respect to
each country of the world from the date of the first commercial sale
by Pfizer or any sublicensee of Pfizer of such Product in each such
country until the termination of the Exclusivity Period covering
such Product in such country.
4.5 ROYALTY RATES.
4.5.1 Pfizer shall pay Guilford a royalty for the sale of each
Product as set forth in Section 4.6 based on the royalty rates
set forth in this Section 4.5; provided, however, that such
Royalty shall be subject to application of the credits set
forth in Section 4.3.
4.5.2 The royalty paid each calendar year by Pfizer to Guilford
shall be based on increments of Net Sales with respect to each
Product sold during the calendar year according to the
following schedule:
Annual Net Sales of each Product Per Product Royalty Rate
-------------------------------- -------------------------
* *
4.6 PAYMENT.
(a) Pfizer shall pay royalties on Net Sales within sixty (60) days
after the end of each calendar quarter in which such Net Sales
are made.
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(b) Such payments shall be accompanied by a statement showing the
Net Sales of each Product by Pfizer or any sublicensee of
Pfizer in each country, the applicable royalty rate for such
Product, and a calculation of the amount of royalty due,
including the application of any credits contemplated by
Section 4.3.
(c) All payments due to Guilford by Pfizer, whether in payment of
a Milestone Amount or a royalty, shall be computed and paid in
U.S. dollars by wire transfer in immediately available funds
to a U.S. bank account designated by Guilford, or by other
mutually acceptable means.
(d) For purposes of determining the amount of royalties due, the
amount of Net Sales in any respect of sales originally
denominated in a foreign currency shall be computed by
converting such foreign currency amount into U.S. dollars at
the prevailing commercial rate of exchange for purchasing
dollars with such foreign currency as published in the Wall
Street Journal for the close of the last business day of the
calendar quarter for which the relevant royalty payment is to
be made by Pfizer.
(e) In the event that any payment due hereunder is not paid when
due, such payment obligation shall bear interest from the date
on which the payment was due and payable at a rate of interest
per annum equal to*.
(f) *
4.7 TAXES If Applicable Laws require Pfizer to withhold any tax from any
payment to Guilford, Pfizer will do so and will pay such tax to the
proper taxing authority. If Pfizer does so, it will provide Guilford
with copies of official receipts for such taxes withheld and paid by
Pfizer to such taxing authority, and Pfizer will cooperate as
Guilford may reasonably request and at Guilford's expense, in any
filings or other actions by Guilford with respect to such taxes.
4.8 RECORDS.
4.8.1 Pfizer shall keep for three (3) years from the date of each
payment of royalties complete and accurate records of sales by
Pfizer of each Product in sufficient detail to allow the
accruing royalties to be determined accurately. Guilford shall
have the right for a period of three (3) years after receiving
any report or statement with respect to royalties due and
payable to appoint at its expense an
13
independent certified public accountant reasonably acceptable
to Pfizer to inspect the relevant records of Pfizer to verify
such report or statement. Pfizer shall make its records
available for inspection by such independent certified public
accountant during regular business hours at such place or
places where such records are customarily kept, upon
reasonable notice from Guilford, to verify the accuracy of the
reports and payments. Such inspection right shall not be
exercised more than once in any calendar year nor more than
once with respect to sales in any given period. Guilford
agrees to hold in strict confidence all information concerning
royalty payments and reports, and all information learned in
the course of any audit or inspection, except to the extent
necessary for Guilford to reveal such information in order to
enforce its rights under this Agreement or if disclosure is
required by law. The failure of Guilford to request
verification of any report or statement during said three-year
period shall be considered acceptance of the accuracy of such
report, and Pfizer shall have no obligation to maintain
records pertaining to such report or statement beyond said
three-year period. The results of each inspection, if any,
shall be binding on both parties unless Pfizer objects, by
delivery to Guilford of a written notice of objections, within
thirty (30) days of receipt of a report of the independent
certified public accountant retained by Guilford. In the event
Pfizer disagrees with the conclusions reached by the
independent certified public accountant retained by Guilford
within such thirty (30) day period in accordance with the
preceding sentence, the disagreement shall be considered a
Dispute within the meaning of Section 11 and shall be treated
accordingly.
4.8.2 The costs and expenses of the independent certified public
accountant retained by Guilford pursuant to Section 4.8.1 to
review the records of Pfizer shall be paid by Guilford;
provided, however, that if the results of any review of the
records of Pfizer pursuant to Section 4.8.1 shall reveal that
the Net Sales reported by Pfizer for any period covered by
such review shall have been understated by five percent (5%)
or more, Pfizer shall reimburse Guilford for all such costs
and expenses.
4.8.3 In the event that it is determined (by failure of Pfizer to
object to the report of the independent certified public
accountant retained by Guilford, by agreement of the parties
or upon any other resolution of a Dispute) that the royalties
paid by Pfizer to Guilford hereunder shall have been
understated as a result of underreporting of Net Sales for the
applicable period, any amount of royalties that were
understated shall be paid within thirty (30) days of the final
14
determination of the amount by which such royalties were
understated and the amount so understated shall bear interest
from the date on which the royalties otherwise would have been
due and payable had they not been understated at a rate of
interest per annum equal to*.
4.9 MISCELLANEOUS.
For purposes of further defining the Milestones in Sections 4.1 and
4.2, the following provisions apply:
(a) a clinical trial shall be deemed to have started at the time
the relevant Governmental Authority grants permission to begin
human clinical testing (as one example, in the United States,
the approval of the IND);
(b) Phase I clinical trials include a clinical trial anywhere in
the world;
(c) a Phase III clinical trial shall be deemed to have started at
the time that (i) in the United States the FDA grants
permission to begin a Phase III clinical trial or (ii) in any
other country the relevant Governmental Authority grants
permission to begin the final clinical trial needed to obtain
approval to make a commercial sale of the Product in such
country;
(d) NDA Filing or SNDA filing shall include the filing of an
application under 21 U.S.C. Section 355 (or an equivalent
provision of Applicable Law of a foreign jurisdiction); and
(e) NDA Approval or SNDA Approval shall include the approval of an
application under 21 U.S.C. Section 355 (or an equivalent
provision of Applicable Law of a foreign jurisdiction).
5. LEGAL ACTION.
5.1 If information comes to the attention of Pfizer to the effect that
any Patent Rights claiming a Product have been or are threatened to
be unlawfully infringed or a Person is engaged in unauthorized use
of Guilford Technology in connection with a Product, Pfizer shall
have the right at its expense to take such action as it may deem
necessary to prosecute or prevent such unlawful infringement or
unauthorized use, including the right to bring or defend any suit,
action or proceeding involving any such infringement or unauthorized
use. Pfizer shall notify Guilford promptly of the receipt of any
such information and of the commencement of any such suit, action or
proceeding and shall consult with Guilford concerning the
15
actions it intends to take; provided, that Pfizer may not take any
action that reasonably could be expected to prejudice Guilford's
rights in respect of such Patent Rights or Guilford Technology. If
Pfizer determines that it is necessary or desirable for Guilford to
join any such suit, action or proceeding, Guilford shall, at
Pfizer's expense, execute all papers and perform such other acts as
may be reasonably required to permit Pfizer to commence such action,
suit or proceeding in which case Pfizer shall hold Guilford free,
clear and harmless from any and all costs and expenses of
litigation, including attorneys fees.
If Pfizer brings a suit, it shall have the right first to reimburse
itself out of any sums recovered in such suit or in its settlement
for all costs and expenses, including attorneys' fees, related to
such suit or settlement, and * of any funds that shall remain from
said recovery shall be paid to Guilford and the balance of such
funds shall be retained by Pfizer. If Pfizer does not, within one
hundred twenty (120) days after giving notice to Guilford of the
above-described information, notify Guilford of Pfizer's intent to
bring suit against any infringer, Guilford shall have the right to
bring suit for such alleged infringement, but it shall not be
obligated to do so, and may join Pfizer as party plaintiff, if
appropriate, in which event Guilford shall hold Pfizer free, clear
and harmless from any and all costs and expenses of such litigation,
including attorney's fees, and any sums recovered in any such suit
or in its settlement shall belong to Guilford. However, * of any
such sums received by Guilford, after deduction of all costs and
expenses, including attorneys' fees, related to such suit or
settlement shall be paid to Pfizer. Each party shall always have the
right to be represented by counsel of its own selection and at its
own expense in any suit instituted by the other for infringement
under the terms of this Section.
5.2 DEFENSE OF INFRINGEMENT CLAIMS. Guilford will cooperate with Pfizer
at Pfizer's expense in the defense of any suit, action or proceeding
against Pfizer or any sublicensee of Pfizer alleging the
infringement of the intellectual property rights of a third party by
reason of the use of Patent Rights in the manufacture, use or sale
of the Product. Pfizer shall give Guilford prompt written notice of
the commencement of any such suit, action or proceeding or claim of
infringement and will furnish Guilford a copy of each communication
relating to the alleged infringement. Guilford shall give to Pfizer
all authority (including the right to exclusive control of the
defense of any such suit, action or proceeding and the exclusive
right after consultation with Guilford, to compromise, litigate,
settle or otherwise dispose of any such suit, action or proceeding),
at Pfizer's expense, including by providing information and
assistance necessary to defend or settle any such suit, action or
proceeding; provided, however, Pfizer shall
16
obtain Guilford's prior consent to such part of any settlement which
contemplates payment or other action by Guilford or has a material
adverse effect on Guilford's business. If the parties agree that
Guilford should institute or join any suit, action or proceeding
pursuant to this Section, Pfizer may, at Pfizer's expense, join
Guilford as a defendant if necessary or desirable, and Guilford
shall execute all documents and take all other actions, including
giving testimony, which may reasonably be required in connection
with the prosecution of such suit, action or proceeding.
5.3 NO CHALLENGE TO PATENT RIGHTS. Pfizer shall not challenge the
validity or enforceability of any of the Patent Rights by
litigation, opposition, re-examination, revocation, or invalidation
proceeding; or by requesting or participating in a declaration of an
interference against any Patent Rights; or by contesting or
disputing Guilford's entitlement to or ownership of the Patent
Rights.
5.4 THIRD PARTY LICENSES. If the manufacture, use or sale by Pfizer of a
Product in any country would, in the reasonable opinion of Pfizer,
infringe a patent owned by a third party and Pfizer has obtained or
will obtain a license under such patent, * of any payments made by
Pfizer to such third party under the license agreement with such
third party shall be deductible from royalty payments due from
Pfizer to Guilford pursuant to this Agreement; provided, however,
that in no event will royalty payments payable to Guilford hereunder
in respect of the relevant Product be reduced by an amount greater
than * of Net Sales for that Product in any quarterly period.
6. REPRESENTATIONS AND WARRANTIES Guilford represents and warrants to Pfizer
that it has all legal right, title and authority to grant the licenses
contemplated by Section 2 of this Agreement, and that, except for rights
of third parties (including Governmental Authorities) who have provided or
provide funding in respect of the Guilford Collaborations, or rights of
third parties in respect of such Guilford Collaborations to consent to the
actions contemplated by Section 2.4., such licenses do not conflict with
or violate the terms of any agreement between Guilford and any third
party.
7. TREATMENT OF CONFIDENTIAL INFORMATION.
7.1 CONFIDENTIALITY.
Subject to Pfizer's and Guilford's right and obligations pursuant to
this Agreement, Pfizer and Guilford each agree that during the term
of this Agreement and for five (5) years thereafter, it will keep
confidential all Guilford Confidential Information or Pfizer
Confidential Information, as the case may be, that is disclosed to
it pursuant to this Agreement. Neither Pfizer nor Guilford shall use
Confidential Information of the other party
17
except as expressly permitted under this Agreement.
Subject to Pfizer's and Guilford's rights and obligations pursuant
to this Agreement, Pfizer and Guilford each agree that any
disclosure of the other's Confidential Information to any officer,
employee or agent of the other party shall be made only if and to
the extent necessary to carry out its responsibilities under this
Agreement and shall be limited to the maximum extent possible
consistent with such responsibilities. Subject to Pfizer's and
Guilford's rights and obligations pursuant to this Agreement, Pfizer
and Guilford each agree not to disclose the other's Confidential
Information to any third parties under any circumstance without
written permission from the other party. Each party shall take such
action to preserve the confidentiality of each other's Confidential
Information as it would customarily take to preserve the
confidentiality of its own Confidential Information. Upon
termination of this Agreement, each party, upon the other's request,
(i) will return all the Confidential Information disclosed to it by
the other party pursuant to this Agreement, including all copies and
extracts of documents, within sixty (60) days of the request upon
the termination of this Agreement except for one (1) copy which may
be kept for the purpose of complying with continuing obligations
under this Agreement; or (ii) will destroy and certify such
destruction, if acceptable to the other party.
Except as required by Applicable Law and except for the Guilford
press release attached hereto as Exhibit C (and any subsequent
disclosure consistent with the information included in such press
release), neither party may disclose the terms of this Agreement
without the written consent of the other party. Notwithstanding the
foregoing or the provisions of Section 7.2, each party acknowledges
and agrees that the other party may be required to disclose the
existence of this Agreement or some or all of the information
included in this Agreement in order to comply with its obligations
under the Securities Laws or under the rules of a national or
international securities exchange or The NASDAQ Stock Market, and
hereby consents to such disclosure to the extent deemed advisable or
appropriate by counsel to the other party.
7.2 DISCLOSURE REQUIRED BY APPLICABLE LAW.
If either party is requested to disclose the Confidential
Information in connection with a legal or administrative proceeding
or is otherwise required by Applicable Law to disclose the
Confidential Information, such party will give the other party
prompt notice of such request. The disclosing party may seek an
appropriate protective order or other remedy or waive compliance
with the provisions of this Agreement. If such party seeks a
protective order or other remedy, the other party will cooperate. If
18
such party fails to obtain a protective order or waive compliance
with the relevant provisions of this Agreement, the other party will
disclose only that portion of Confidential Information which its
legal counsel determines it is required to disclose.
8. FILING, PROSECUTION AND MAINTENANCE BY GUILFORD.
8.1 With respect to Patent Rights, except as set forth in Section 8.1.2.
and Section 8.1.3., Guilford shall have the exclusive right and
obligation:
(a) to file applications for letters patent on patentable
inventions; provided, however, that Guilford shall consult
with Pfizer regarding countries in which such patent
applications should be filed and shall file patent
applications in those countries where Pfizer requests that
Guilford file such applications; and, further provided, that
Guilford, at its option and expense, may file in countries
where Pfizer does not request that Guilford file such
applications;
(b) to take all reasonable steps to prosecute all pending and new
patent applications;
(c) to respond to oppositions, nullity actions, re-examinations,
revocation actions and similar proceedings filed by third
parties against the grant of letters patent for such
applications;
(d) to maintain in force any letters patent included in Patent
Rights by duly filing all necessary papers and paying any fees
required by the patent laws of the particular country in which
such letters patent were granted; and
(e) to cooperate fully with, and take all necessary actions
requested by, Pfizer in connection with the preparation,
prosecution and maintenance of any letters patent included in
Patent Rights. Guilford shall notify Pfizer in a timely manner
of any decision to abandon a pending patent application or an
issued patent included in Patent Rights. Thereafter, Pfizer
shall have the option, at its expense, of continuing to
prosecute any such pending patent application or of keeping
the issued patent in force.
8.1.1 COPIES OF DOCUMENTS.
Guilford shall provide to Pfizer copies of all patent
applications that are part of Other Patent Rights prior to
filing, for the purpose of obtaining substantive comment of
Pfizer's patent counsel. Guilford shall also provide to Pfizer
other copies of all documents relating to prosecution of all
such patent applications in a timely manner and shall provide
every six (6) months a report detailing the status of all
patent applications that are a part of Other Patent Rights.
19
8.1.2 REIMBURSEMENT OF COSTS FOR FILING PROSECUTING AND
MAINTAINING PATENT RIGHTS.
Within thirty (30) days of receipt of invoices from Guilford,
Pfizer shall reimburse Guilford for all the costs of filing,
prosecuting, responding to opposition or other interested
parties proceedings and maintaining patent applications and
patents during the term of this Agreement. Such reimbursement
shall be in addition to other funding payments under this
Agreement and shall include such costs of all activities
described in Section 8.1 (a)-(e) above. However, Pfizer may,
upon sixty (60) days notice, request that Guilford discontinue
filing or prosecution of patent applications in any country
(other than the countries listed in Schedule 8.1.2) and
discontinue reimbursing Guilford for the costs of filing,
prosecuting, responding to opposition or maintaining such
patent application or patent in any such country (other than
the countries listed in Schedule 8.1.2). Guilford shall pay
all costs in those countries in which Pfizer requests that
Guilford not file, prosecute or maintain patent applications
and patents, but in which Guilford, at its option, elects to
do so in accordance with this Section 8.1.2; provided,
however, that in the event Guilford so elects to continue to
file, prosecute or maintain patent applications and patents in
those countries the licenses granted to Pfizer in respect of
such patent applications and patents under Section 2 shall no
longer extend to such patent applications and patents in those
countries.
8.1.3 PATENT AND OTHER EXCLUSIVITY EXTENSIONS.
Pfizer and Guilford will consult with each other from time to
time regarding all applications for exclusivity extensions
pursuant to Applicable Law, including but not limited to
extensions pursuant to 35 USC Section 156 and foreign
counterparts, with respect to the Products to the extent that
such extensions are available. Guilford agrees to sign such
further documents and take such further actions as may be
reasonably requested by Pfizer to support all actions
necessary to obtain any such extension in this regard, at
Pfizer's expense.
9. TERMINATION AND DISENGAGEMENT.
9.1 Each of the following events shall constitute events of termination
("Events of Termination") for purposes of this Agreement:
(a) with respect to each Product, the termination of the
Exclusivity Period with respect to that Product;
(b) Guilford or Pfizer shall fail in any material respect to
perform or
20
observe any term, covenant or understanding contained in this
Agreement or in any of the other documents or instruments
delivered pursuant to, or concurrently with, this Agreement,
which failure remains unremedied for thirty (30) days after
written notice to the failing party; or
(c) during the Initial Period, Pfizer shall fail to take the
actions contemplated by, or conduct the evaluation of the
Initial Target Compounds and the compounds included in
Pfizer's compound library in accordance with, Exhibit B.
9.2 Upon the occurrence of any Event of Termination under Section 9.1(b)
or 9.1(c), the party not responsible may, by notice to the other
party, terminate this Agreement.
9.3 Termination of this Agreement by either party, with or without
cause, will not terminate the Research License granted pursuant to
Section 2.1.
9.4 Termination of this Agreement for any reason shall be without
prejudice to:
(a) the rights and obligations of the parties set forth in
sections which provide for performance of either party
subsequent to termination;
(b) Guilford's right to receive payments in respect of all
Milestone Amounts and royalties accrued hereunder prior to the
termination date; or
(c) any other remedies which either party may otherwise have under
and in accordance with Applicable Law or this Agreement.
9.5 Prior to the end of the Initial Period, Pfizer at its sole
discretion may terminate this Agreement by written notice to
Guilford. In the event that Pfizer fails to make payment of a total
of $15,000,000 in accordance with Section 2 prior to the end of the
Initial Period, Guilford at its sole discretion may terminate this
Agreement by written notice to Pfizer.
9.6 At any time, Pfizer at its sole discretion may terminate this
Agreement with respect to any Product in any country or countries in
the world upon thirty (30) days prior notice to Guilford and
cessation of sale of the Product. Upon such termination by Pfizer,
all licenses other than the license granted under Section 2.1 of
this Agreement, shall terminate with respect to such country or
countries for any such Product.
9.7 In addition to the right to terminate this Agreement upon the
occurrence of
21
any Event of Termination, if at any time during the term of this
Agreement Pfizer, directly or indirectly, takes any action or
assists or supports another Person in taking any action challenging
any of the Patent Rights, including any action in connection with an
opposition, re-examination, revocation or invalidation proceeding,
or requests a declaration of an interference against or otherwise
attacks the validity or enforceability of any Patent Rights, or
contests or disputes Guilford's entitlement to or ownership of the
Patent Rights, Guilford shall have the right to terminate this
Agreement immediately.
9.8 (a) Upon termination of this Agreement (except for breach by
Guilford), Pfizer shall make available to and transfer or assign to
Guilford the following: the clinical human experience database, all
audited toxicology reports and all in vivo animal study data
including ADME in vivo data, any regulatory submissions and any
correspondence with the FDA or other regulatory authorities.*
(b)*
(c)*
22
9.9 Upon termination, this Agreement shall become void and of no further
force or effect, except for the following provisions, which shall
remain in full force and effect: provisions relating to payment or
reimbursement accruing before the termination of the Agreement,
Sections 4.7, 4.8, and 4.9, Article 5 to the extent relating to the
period or accruing before the termination of the Agreement, and
Articles 7, 9, 10, 11, 13 and 14. Any termination shall not affect
any right or claim hereunder that arises prior to such termination,
which claims and rights shall survive termination.
10. INDEMNIFICATION. Pfizer and Guilford will indemnify each other for
damages, settlements, costs, legal fees and other expenses incurred in
connection with a claim by a third party against either party based on any
action or omission of the indemnifying party's agents, employees, or
officers related to its obligations under this Agreement; provided,
however, that the foregoing shall not apply (i) if the claim is found to
be based upon the negligence, recklessness or wilful misconduct of the
party seeking indemnification; or (ii) if such party fails to give the
other party prompt notice of any claim it receives and such failure
materially prejudices the other party with respect to any claim or action
to which its obligation pursuant to this Section applies.
Each party will notify the other in the event it becomes aware of a claim
for which indemnification may be sought hereunder. In case any proceeding
shall be instituted involving any party in respect of which indemnity may
be sought pursuant to this Section 10, such party (the "Indemnified
Party") shall promptly notify the other party (the "Indemnifying Party")
in writing and the Indemnifying Party and Indemnified Party shall meet to
discuss how to respond to any claims that are the subject matter of such
proceeding. The Indemnifying Party, upon request of the Indemnified Party,
shall retain counsel reasonably satisfactory to the Indemnified Party to
represent the Indemnified Party and shall pay the fees and expenses of
such counsel related to such proceeding. In any such proceeding, the
Indemnified Party shall have the right to retain its own counsel, but the
fees and expenses of such counsel shall be at the expense of the
Indemnified Party unless (i) the Indemnifying Party and the Indemnified
Party shall have mutually agreed to the retention of such counsel or (ii)
the named parties to any such proceeding include both the Indemnifying
Party and the Indemnified Party and representation of both parties by the
same counsel would be inappropriate due to actual or potential differing
interests between them. All such fees and expenses shall be reimbursed as
they are incurred. The Indemnifying Party shall not be liable for any
settlement of any proceeding effected without its written consent, but if
settled with such consent or if there be
23
a final judgment for the plaintiff, the Indemnifying Party agrees to
indemnify the Indemnified Party from and against any loss or liability by
reason of such settlement or judgment. The Indemnifying Party shall not,
without the written consent of the Indemnified Party, effect any
settlement of any pending or threatened proceeding in respect of which the
Indemnified Party is, or arising out of the same set of facts could have
been, a party and indemnity could have been sought hereunder by the
Indemnified Party, unless such settlement includes an unconditional
release of the Indemnified Party from all liability on claims that are the
subject matter of such proceeding.
11. DISPUTE RESOLUTION.
If a dispute, controversy or difference (in each case, a "Dispute")
between the parties arises out of or is related to this Agreement, then
such Dispute first shall be referred to the Steering Committee to seek a
resolution of the Dispute. In such an event, the Steering Committee shall
hold at least one (1) meeting within thirty (30) days of the date on which
the Dispute is referred to the Steering Committee. In the event that the
Steering Committee is unable to resolve the Dispute within forty five (45)
days of the date on which the Dispute is referred to the Steering
Committee, each party shall designate a member of its senior management to
discuss the Dispute in an effort to settle it amicably during a period of
no less than thirty (30) days.
12. NOTICES AND REPORTS.
12.1 All notices shall be in writing mailed via certified mail, return
receipt requested, courier, or facsimile transmission addressed as
follows, or to such other address as may be designated from time to
time:
IF TO PFIZER: Pfizer Global R&D Headquarters
00 Xxxxxx Xxxxxx
Xxx Xxxxxx, XX 00000
Attn.: Executive Vice President, PGRD
with copy (which shall not constitute notice) to:
Assistant General Counsel
Invoices should be sent to the attention of Xxxx
Xxxxxxxxx, Strategic Alliances, PGRD Groton
Laboratories, at the following address:
Pfizer Global Research & Development
Xxxxxx Xxxxxxxxxxxx
Xxxxxxx Xxxxx Xxxx - XX 0000-00
Xxxxxx, XX 00000
24
IF TO GUILFORD: Guilford Pharmaceuticals Inc.
0000 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attn: Senior Vice President Corporate Development
with a copy (which shall not constitute notice) to:
Senior Vice President & General Counsel
and
GPI NAALADase Holdings, Inc.
000 Xxxxxxxx Xxxxxx
Xxxxxxxxxx, Xxxxxxxx 00000
Attn: Vice President & Secretary
Notices shall be deemed given as of the date sent.
12.2 On a quarterly basis during the term of this Agreement, to the
extent not made available to Guilford through the Steering
Committee, Pfizer will provide Guilford with written reports,
summarizing all material data and information arising out of the
actions contemplated by this Agreement and the research and
development conducted by Pfizer in respect of NAALADase inhibitors.
In the event that after receipt of any such report, Guilford shall
request additional data or information relating to the report,
Pfizer shall promptly provide such data or information to Guilford.
13. GOVERNING LAW. This Agreement shall be governed by and construed in
accordance with the laws of the State of New York.
14. MISCELLANEOUS.
14.1 BINDING EFFECT. This Agreement shall be binding upon and inure to
the benefit of the parties and their respective legal
representatives, successors and permitted assigns.
14.2 HEADINGS. Section headings are inserted for convenience of reference
only and do not form a part of this Agreement.
14.3 COUNTERPARTS. This Agreement may be executed simultaneously in two
or more counterparts, each of which shall be deemed an original.
14.4 AMENDMENT; WAIVER; ETC. This Agreement may be amended, modified,
superseded or cancelled, and any of the terms may be waived, only by
a written instrument executed by each party or, in the case of
waiver, by the party or parties waiving compliance. The delay or
failure of any party at any time or times to require performance of
any provisions shall in no
25
manner affect the rights at a later time to enforce the same. No
waiver by any party of any condition or of the breach of any term
contained in this Agreement, whether by conduct, or otherwise, in
any one or more instances, shall be deemed to be, or considered as,
a further or continuing waiver of any such condition or of the
breach of such term or any other term of this Agreement.
14.5 NO THIRD PARTY BENEFICIARIES. No third party including any employee
of any party to this Agreement, shall have or acquire any rights by
reason of this Agreement. Nothing contained in this Agreement shall
be deemed to constitute the parties partners with each other or any
third party.
14.6 ASSIGNMENT AND SUCCESSORS. This Agreement may not be assigned by
either party, except that each party may assign this Agreement and
the rights and interests of such party, in whole or in part, to any
of its Affiliates, any purchaser of all or substantially all of its
assets or to any successor corporation resulting from any merger or
consolidation of such party with or into such corporations.
14.7 FORCE MAJEURE. Neither Pfizer nor Guilford shall be liable for
failure of or delay in performing obligations set forth in this
Agreement, and neither shall be deemed in breach of its obligations,
if such failure or delay is due to an act of God, weather
conditions, strikes, lockouts, inability to procure labor,
materials, or fuels due to shortages, fires, riots, interference by
civil or military authorities, or acts of war, or other cause which
is beyond the reasonable control of Pfizer or Guilford.
14.8 SEVERABILITY. If any provision of this Agreement is or becomes
invalid or is ruled invalid by any court of competent jurisdiction
or is deemed unenforceable, it is the intention of the parties that
the remainder of the Agreement shall not be affected.
14.9. INTERPRETATION. The Section headings contained in this Agreement are
for convenience of reference only and shall not affect the meaning
or interpretation of this Agreement. As used in this Agreement, any
reference to the masculine, feminine or neuter gender shall include
all genders, the plural shall include the singular, and singular
shall include the plural. Unless the context otherwise requires, the
term "party" when used herein means a party hereto. References
herein to a party or other Person include their respective
successors and assigns. The words "include," "includes" and
"including" when used herein shall be deemed to be followed by the
phrase "without limitation" unless such phrase otherwise appears.
Unless the context otherwise requires, references herein to
Sections, Schedules and Exhibits shall be deemed references to
Sections of, and Schedules and Exhibits to, this Agreement. Unless
the
26
context otherwise requires, the words "hereof," "hereby" and
"herein" and words of similar meaning when used in this Agreement
refer to this Agreement in its entirety and not to any particular
Section or provision hereof. With regard to each and every term and
condition of this Agreement, the parties understand and agree that
the same have or has been mutually negotiated, prepared and drafted,
and that if at any time the parties desire or are required to
interpret or construe any such term or condition or any agreement or
instrument subject thereto, no consideration shall be given to the
issue of which party actually prepared, drafted or requested any
term or condition of this Agreement.
14.10 ENTIRE AGREEMENT. This Agreement embodies the entire agreement and
understanding between the parties hereto with respect to the subject
matter hereof and supersedes all prior agreements, commitments,
arrangements, negotiations or understandings, whether oral or
written, between the parties hereto and their respective Affiliates
with respect thereto. There are no agreements, covenants or
undertakings with respect to the subject matter of this Agreement
other than those expressly set forth or referred to herein and no
representations or warranties of any kind or nature whatsoever,
express or implied, are made or shall be deemed to be made herein by
the parties hereto, except those expressly made in this Agreement.
THE PARTIES HERETO ACKNOWLEDGE AND AGREE THAT NO REPRESENTATION,
WARRANTY, PROMISE, INDUCEMENT, UNDERSTANDING, COVENANT OR AGREEMENT
HAS BEEN MADE OR RELIED UPON BY ANY PARTY HERETO OTHER THAN THOSE
EXPRESSLY SET FORTH IN THE TRANSACTION DOCUMENTS. WITHOUT LIMITING
THE GENERALITY OF THE DISCLAIMER SET FORTH IN THE PRECEDING
SENTENCE, (I) NEITHER GUILFORD NOR ANY OF ITS AFFILIATES HAS MADE OR
SHALL BE DEEMED TO HAVE MADE ANY REPRESENTATIONS OR WARRANTIES, IN
ANY PRESENTATION OR WRITTEN INFORMATION RELATING TO THE BUSINESS OR
THE TECHNOLOGY GIVEN OR TO BE GIVEN IN CONNECTION WITH THE
CONTEMPLATED TRANSACTIONS, IN ANY FILING MADE OR TO BE MADE BY OR ON
BEHALF OF GUILFORD OR ANY OF ITS AFFILIATES WITH ANY GOVERNMENTAL
AUTHORITY, AND NO STATEMENT MADE IN ANY SUCH PRESENTATION OR WRITTEN
MATERIALS, MADE IN ANY SUCH FILING OR CONTAINED IN ANY SUCH OTHER
INFORMATION SHALL BE DEEMED A REPRESENTATION OR WARRANTY HEREUNDER
OR OTHERWISE, AND (II) GUILFORD EXPRESSLY DISCLAIMS ANY IMPLIED
WARRANTIES, INCLUDING WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE
AND WARRANTIES OF MERCHANTABILITY. PFIZER ACKNOWLEDGES THAT GUILFORD
27
HAS INFORMED IT THAT NO PERSON HAS BEEN AUTHORIZED BY GUILFORD OR
ANY OF ITS AFFILIATES TO MAKE ANY REPRESENTATION OR WARRANTY IN
RESPECT OF THE BUSINESS OR THE TECHNOLOGY OR IN CONNECTION WITH THE
CONTEMPLATED TRANSACTIONS, UNLESS IN WRITING AND CONTAINED IN THIS
AGREEMENT OR IN ANY OF THE TRANSACTION DOCUMENTS TO WHICH THEY ARE A
PARTY.
14.11 EXPENSES. Except as expressly set forth herein, each party hereto
shall bear all fees and expenses incurred by such party in
connection with, relating to or arising out of the execution,
delivery and performance of this Agreement and the consummation of
the transactions contemplated by this Agreement, including
attorneys', accountants' and other professional fees and expenses.
28
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by
their duly authorized representatives as of the date first set forth above.
PFIZER INC GUILFORD PHARMACEUTICALS INC.
By: /s/ Xxxxx X. Xxxx By: /s/ Xxxxx X. Xxxxx, M.D.
--------------------------- --------------------------------
Name: Xxxxx X. Xxxx Name: Xxxxx X. Xxxxx, M.D.
Title: Senior Vice President, Title: Chairman, President and Chief
Science and Technology Executive Officer
GPI NAALADASE HOLDINGS, INC.
By: /s/ Xxxxxx X. XxXxxxxx
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Name: Xxxxxx X. XxXxxxxx
Title: Vice President and Secretary
EXHIBIT A
PATENTS AND PATENT APPLICATIONS
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EXHIBIT B
DILIGENCE ACTIONS
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EXHIBIT C
FORM OF GUILFORD PRESS RELEASE
FOR IMMEDIATE RELEASE
GUILFORD PHARMACEUTICALS SIGNS LICENSE AGREEMENT WITH PFIZER
NOVEL NAALADASE INHIBITOR TECHNOLOGY TO BE DEVELOPED TO
TREAT NEURODEGENERATIVE DISEASES
BALTIMORE, MD, May 8, 2003, Guilford Pharmaceuticals Inc. (Nasdaq: GLFD)
announced today that it has entered into an exclusive license agreement with
Pfizer for a novel class of potential drugs called NAALADase inhibitors that
have been shown in preclinical testing to ameliorate certain central and
peripheral neurodegenerative diseases, such as diabetic peripheral neuropathy
and neuropathic pain.
Under the terms of the agreement, Pfizer will have exclusive right to develop
Guilford's NAALADase inhibitors worldwide and will conduct and pay for all costs
associated with research, development, manufacturing, and commercialization of
any products that may emerge from this agreement. Guilford retains the right to
continue to conduct and pay for the development of NAALADase inhibitors not
under development by Pfizer for prostate cancer, head and spinal cord injury,
and drug addiction. Pfizer has the exclusive right in the future to acquire, for
certain consideration, any products developed by Guilford for these indications.
In exchange, Pfizer has agreed to pay Guilford $15 million in cash, including $5
million at signing, and $10 million by March 31, 2004 (or earlier depending on
whether a lead compound has been selected for clinical development). If Pfizer
does not pay the additional $10 million on or before March 31, 2004, all rights
revert to Guilford at its election, along with data and other information
generated by Pfizer relating to Guilford's NAALADase inhibitors.
As part of the agreement, Guilford is eligible to receive royalties on future
product sales and milestone payments related to the successful development and
commercialization of a NAALADase inhibitor. The schedule of milestone payments
outlines a total of $42 million to be paid for each compound developed through
commercialization, as well as one additional set of milestone payments totaling
$20 million for an additional indication for the same compound.
"We are very pleased to license our NAALADase inhibitor program to Pfizer, the
world's leading pharmaceutical company. Pfizer has a major commitment to the
fields of central and peripheral nervous system disorders," commented Xxxxx X.
Xxxxx, M.D., Chairman, President and Chief Executive Officer of Guilford. "Our
agreement with Pfizer is consistent with Guilford's objective of finding the
highest-quality strategic partnerships for the programs we intend to license,
while continuing to advance select product development efforts in the US
independently."
Guilford has one marketed product, GLIADEL(R) Wafer, which recently received FDA
approval for an expanded indication for use in patients with newly diagnosed
high-grade malignant glioma as an adjunct to surgery and radiation, and a
pipeline which includes two product candidates, GPI 1485 and AQUAVAN(TM)
Injection, in Phase II clinical testing.
NAALADASE INHIBITOR PROGRAM BACKGROUND
NAALADase, or N-Acetylated-Alpha-Linked-Acidic-Dipeptidase, is a membrane-bound
enzyme found principally in the central and peripheral nervous systems.
NAALADase is believed to play a role in modulating the release of glutamate, one
of the most common chemical messengers between nerves. During conditions of
acute injury or chronic neurodegenerative disorders, there may be a large
increase in
glutamate release that incites a cascade of biochemical events, ultimately
leading to cell injury and death.
Guilford has created several unique classes of NAALADase inhibitors and
evaluated their potential therapeutic application in preclinical models of
various acute and chronic neurodegenerative disorders, including diabetic
peripheral neuropathy, neuropathic pain, Xxx Xxxxxx'x Disease (ALS), head and
spinal cord trauma, and stroke. NAALADase is the same protein as prostate
specific membrane antigen (PSMA), a protein found on the surface of prostate
cancer cells. Guilford has also shown that its compounds may have utility for
diagnostic or therapeutic purposes in prostate cancer.
In preclinical animal models of diabetic peripheral neuropathy and neuropathic
pain, Guilford scientists have shown that treatment with a NAALADase inhibitor
can normalize pain sensitivity, increase nerve conduction velocity and prevent
or slow peripheral nerve degeneration.
Diabetic peripheral neuropathy is a debilitating and progressive disorder
involving increased pain sensitivity, tingling, weakness and numbness in a
patient's extremities. It is believed to affect approximately one million people
in the United States.
Guilford has 37 issued US patents and 10 pending patent applications, and
corresponding foreign counterparts protecting its NAALADase inhibitor
technology.
ABOUT GUILFORD
Guilford Pharmaceuticals Inc. is a fully integrated pharmaceutical company that
discovers, develops and markets novel pharmaceutical products targeting the
hospital and neurological markets. Guilford's product pipeline includes a
marketed therapeutic for the most common form of brain cancer, GLIADEL(R) Wafer,
and products in
development for Xxxxxxxxx'x disease, post-prostatectomy erectile dysfunction,
peripheral nerve damage, and anesthesia and sedation.
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Contact: Guilford Pharmaceuticals Inc.
Xxxxxx Jurchison 410.631.5022
Internet addresses: xxx.xxxxxxxxxxxxx.xxx
This press release contains forward-looking statements that involve risks and
uncertainties, including those described in the section entitled "Risk Factors"
contained in the Company's Annual Report on Form 10-K filed with the SEC on
March 31, 2003, that could cause the Company's actual results and experience to
differ materially from anticipated results and expectations expressed in these
forward-looking statements. Among other things, there can be no assurance that
the Company will receive additional payments from Pfizer, or that Pfizer will
successfully develop the Company's NAALADase technology into an approved
pharmaceutical product.
SCHEDULE 4
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SCHEDULE 8.1.2
TIER I COUNTRIES
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