EXHIBIT 10.4
COLLABORATIVE RESEARCH AND OPTION AGREEMENT
This COLLABORATIVE RESEARCH AND OPTION AGREEMENT is entered into as of
December 22, 1997 by and between PFIZER INC., a Delaware corporation, having an
office at 000 Xxxx 00xx Xxxxxx, Xxx Xxxx, Xxx Xxxx 00000 and its Affiliates
("Pfizer"), and PEPTIDE THERAPEUTICS LIMITED ("Peptide"), a corporation having
an office at 321 Cambridge Science Park, Xxxxxx Xxxx, Xxxxxxxxx XX0 0XX,
Xxxxxxx.
WHEREAS, Peptide has developed a vaccine candidate for the prevention and/or
treatment of allergy; and
WHEREAS, Peptide has already granted an exclusive world-wide license for human
applications of the vaccine to SmithKline Xxxxxxx plc; and
WHEREAS, Peptide wishes to grant an exclusive world-wide license for
veterinary applications of the vaccine to Pfizer; and
WHEREAS, Pfizer has the capability to undertake research for the discovery and
evaluation of agents for prevention and/or treatment of allergy and also the
capability for clinical analysis, manufacturing and marketing with respect to
such agents;
NOW, THEREFORE, the parties agree as follows:
1. Definitions
Whenever used in this Agreement, the terms defined in this Section 1 shall have
the meanings specified.
1.1 "Allergy Vaccine" means the vaccine comprising a certain peptide
sequence from the target animal species from the fourth constant region
of IgE coupled to a carrier. Examples of peptide sequences include but
are not limited to;
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
1.2 "Affiliate" means any corporation or other legal entity owning, directly
or indirectly, fifty percent (50%) or more of the voting capital shares
or similar voting securities of Pfizer or Peptide; any corporation or
other legal entity fifty percent (50%) or more of the voting capital
shares or similar voting rights of which is owned, directly or
indirectly, by Pfizer or Peptide or any by a corporation or other legal
entity which owns, directly or indirectly, fifty percent (50%) or more
of the voting capital shares of similar voting rights of which is owned,
directly or indirectly, by a corporation or other legal entity which
owns, directly or indirectly, fifty percent (50%) or more of the voting
capital shares or similar voting securities of Pfizer or Peptide.
1.3 "Research Plan" means the written plan describing the research and
budgets for the research to be carried out by Pfizer pursuant to this
Agreement, as may be amended from time to time. The current Research
Plan is attached to and made a part of this Agreement as Exhibit A.
1.4 "Research Program" is the research program in the Area conducted by
Pfizer pursuant to the Research Plan in effect during the Contract
Period.
1.5 "Effective Date" is December 22, 1997.
1.6 "Contract Period" means the period beginning on the Effective Date and
ending on the date on which this Agreement terminates.
1.7 "Area" means veterinary applications of the Allergy Vaccine which shall,
for the avoidance of doubt, exclude any and all applications to humans
of the Peptide Technology.
1.8 "Technology" means and includes all materials, technology, technical
information, know-how, expertise and trade secrets within the Area.
1.9 "Peptide Patents" means (i) the patents and patent applications set out
in Exhibit B including all continuations, continuations-in-part,
divisions, and renewals, all letters patent granted thereon, and all
reissues, re-examinations and extensions thereof and (ii) any
corresponding patent applications in additional countries and (iii) any
patents and
patent applications owned or controlled solely by Peptide which Peptide
is free to offer to Pfizer and covering improvements and/or other
developments of the patents and patent applications mentioned in (i) and
(ii) hereinbefore
1.10 "Peptide Technology" means Technology that Peptide has the lawful right
to disclose or otherwise transfer use rights to Pfizer and that is or
was:
(a) developed by employees of or consultants to Peptide alone or
jointly with third parties prior to the Effective Date; or
(b) acquired by purchase, license, assignment or other means from
third parties by Peptide prior to the Effective Date.
(c) for the avoidance of doubt Peptide Technology shall include
"Peptide Patents set forth in parts (i) and (ii) of section 1.9".
1.11 "Joint Technology" means Technology that is or was:
(a) developed by employees of or consultants to Pfizer using Peptide
Technology during the Contract Period;
(b) developed by employees of or consultants to Peptide alone or
jointly with third parties in the Area during the Contract
Period, except for Technology so developed that Peptide is
prohibited to disclose or otherwise transfer use rights to Pfizer
by the terms of an agreement in existence at such time as the
subject matter thereof became a part of the Research Plan; or
(c) acquired by purchase, license, assignment or other means from
third parties by Peptide in the Area during the Contract Period,
except for Technology so acquired that Peptide is prohibited to
disclose or otherwise transfer use rights to Pfizer by the terms
of an agreement in existence at such time as the subject matter
thereof became a part of the Research Plan.
1.12 "Pfizer Technology" means Technology that Pfizer has the lawful right to
disclose or otherwise transfer use rights to Peptide and that is or was:
(a) developed by employees of or consultants to Pfizer alone or
jointly with third parties prior to the Effective Date or during
the Contract Period.
(b) acquired by purchase, license, assignment or to other means from
third parties by Pfizer prior to the Effective Date or during the
Contract Period.
1.13 "Peptide Confidential Information" means all information about any
element of the Peptide or Joint Technology which is disclosed by Peptide
to Pfizer and designated "Confidential" in writing by Peptide at the
time of disclosure to Pfizer 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 Peptide; 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
Peptide.
1.14 "Pfizer Confidential Information" means all information about any
element of Pfizer or Joint Technology which is disclosed by Pfizer to
Peptide and designated "Confidential" in writing by Pfizer at the time
of disclosure to Peptide to the extent that such information as of the
date of disclosure to Peptide is not (i) known to Peptide other than by
virtue of a prior confidential disclosure to Peptide by Pfizer; or (ii)
disclosed in published literature, or otherwise generally known to the
public through no fault or omission of Peptide; or (iii) obtained from a
third party free from any obligation of confidentiality to Pfizer.
1.15 "Joint Patent Rights" means all patentable inventions within Joint
Technology including all the valid claims of patent applications,
whether domestic or foreign, claiming such patentable inventions,
including all continuations, continuations-in-part, divisions, and
renewals, all letters patent granted thereon, and all reissues,
re-examinations and extensions thereof.
1.16 "Product" means the Allergy Vaccine or any product for the prevention
and/or treatment of allergy in animals, the manufacture, use, sale,
offer for sale or import of which would infringe a valid claim within
Peptide Patents or Joint Patent Rights in the absence of a license.
2. Research Program
2.1 Purpose. Pfizer shall conduct the Research Program throughout the
Contract Period. All Technology in the Area developed in the Research
Program will become part of the Joint Technology. The objective of the
Research Program is to develop prophylactic and/or therapeutic vaccines
against allergy for animals, based on the Allergy Vaccine.
2.2 Research Plan. The Research Plan is described in the attached Exhibit A.
The attached Research Plan, and any subsequent Research Plan, shall be
amended from time to time, as needed, and made part of this Agreement.
2.3 Exclusivity. Peptide agrees that during the Contract Period, and in the
Area, neither Peptide nor any of its Affiliates shall sponsor any other
research, or engage in any research sponsored by any third party without
Pfizer's consent.
2.4 Reports and Materials
2.4.1 Reports. During the Contract Period, Pfizer shall furnish to Peptide:
(a) brief summary written reports within ten (10) business days after
the end of each three-month period commencing on the Effective
Date, describing its progress under the Research Plan; and
(b) comprehensive written reports within forty-five (45) days after
the end of the twelve (12) month period commencing on the
Effective Date, describing in detail the work accomplished by it
under the Research Plan and discussing and evaluating the results
of such work.
2.4.2 Materials. Peptide shall, during the Contract Period, as a matter of
course as described in the Research Plan, or upon Pfizer's written or
oral request, furnish to Pfizer samples of Allergy Vaccine and other
reagents in reasonable quantities which are necessary for Pfizer to
carry out its responsibilities under the Research Plan.
2.5 Laboratory Facilities and Personnel. Pfizer shall provide suitable
laboratory facilities, equipment and personnel for the work to be done
by Pfizer in carrying out the Research Program. Peptide shall provide
technical assistance to Pfizer in carrying out the Research Plan as may
be requested and/or required by Pfizer during the Contract Period. Such
technical assistance may include visits by Peptide personnel to Pfizer
facilities. In the event Pfizer requests that Peptide personnel visit
Pfizer facilities, Pfizer shall reimburse Peptide for reasonable costs
associated with such visit, including lodging and travel expenses.
2.6 Diligent Efforts. Pfizer shall use reasonably diligent efforts to
achieve the objectives of the Research Program. Pfizer shall carry out
the Research Program using qualified personnel in accordance with
generally accepted professional standards for such work; however, it is
recognised by both parties that the work is developmental or
experimental in nature and there can be no guarantee of success or that
any particular result can be obtained in a timely fashion.
3. Funding the Research Program
3.1 Research Funding. Pfizer shall perform the research in accordance with
the Research Plan at no cost to Peptide, except as otherwise provided in
this Agreement.
4. Treatment of Confidential Information
4.1 Confidentiality
4.1.1 Pfizer and Peptide each recognise that the other's Confidential
Information constitutes highly valuable, confidential information.
Subject to, the obligations set forth in sections 4.2 and 4.3, Pfizer
and Peptide each agree that during the term of this Agreement and for
seven (7) years thereafter, it will keep confidential, and will cause
its Affiliates to keep confidential, all Peptide Confidential
Information or Pfizer Confidential Information, as the case may be,
that is disclosed to it, or to any of its Affiliates pursuant to this
Agreement. Neither Pfizer nor Peptide nor any of their respective
Affiliates shall use such Confidential Information except as
expressly permitted in this Agreement.
4.1.2 Pfizer and Peptide each agree that any disclosure of the other's
Confidential Information to any officer, employee or agent of the
other party or of any of its Affiliates 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. Pfizer and Peptide 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, and shall cause its
Affiliates to 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.
Each party, upon the other's request, will return all the Confidential
Information disclosed to 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.
4.1.3 Pfizer represents that all of its employees, and any consultants to
Pfizer, participating in the Research Program who shall have access to
Peptide Technology or Joint Technology and Peptide Confidential
Information are bound by agreement to maintain such information in
confidence.
4.2 Publication. Notwithstanding any matter set forth with particularity in
this Agreement to the contrary, results obtained in the course of the
Research Program may be submitted for publication following scientific
review by the Peptide and Pfizer management. After receipt of the
proposed publication by both Pfizer and Peptide management's written
approval or disapproval shall be provided by Pfizer and Peptide within
sixty (60) days or time otherwise sufficient to allow for filing for
patent protection on the contents of the publication. In the event of
disagreement concerning approval or disapproval, Pfizer shall have final
decision making authority.
4.3 Publicity. Except as required by law, or the rules of any stock
exchange, neither party may disclose the terms of this Agreement nor the
research described in it without the written consent of the other party,
which consent shall not be unreasonably withheld. However, Pfizer
acknowledges that Peptide wishes to announce the signing of this
Agreement without disclosing any commercial terms and shall provide a
draft press
release for Pfizer's approval prior to such announcement which shall not
be unreasonably withheld or delayed.
4.4 Disclosure of Inventions. Pfizer shall promptly inform Peptide about all
inventions in the Area that are conceived, made or developed in the
course of carrying out the Research Program by employees of, or
consultants to, Pfizer.
4.5 Restrictions on Transferring Materials. Pfizer and Peptide recognise
that the biological, synthetic chemical and biochemical materials which
are part of Pfizer Technology, Peptide Technology or Joint Technology,
represent valuable commercial assets. Therefore, throughout the Contract
Period and for seven (7) years thereafter, subject to the license rights
granted in Section 5.3, Peptide and Pfizer agree not to transfer such
materials of the other party or joint materials to any third party,
unless prior written consent for any such transfer is obtained from the
other party.
5. Intellectual Property Rights. The following provisions (section 6, 7 and
8) relate to rights in the intellectual property developed or used by
Pfizer during the course of carrying out the Research Program.
6. Ownership. All Peptide Confidential Information and Peptide Technology
shall be owned by Peptide. All Pfizer Confidential Information and
Pfizer Technology shall be owned by Pfizer. All Joint Technology shall
be owned jointly by Peptide and Pfizer. All Joint Patent Rights shall be
jointly owned.
7. Grant of Research Licenses. Peptide grants to Pfizer a nonexclusive,
irrevocable, world-wide, royalty-free license, including the right to
grant sub-licenses to Affiliates, to make and use Peptide Confidential
Information and Peptide Technology and Joint Technology and Joint Patent
Rights for all research purposes other than the sale or manufacture for
sale of products or processes.
8. Grant of License Option. As consideration for Pfizer's performance of
the Research Program and the payment by Pfizer to Peptide on the date
of signing this Agreement of the total sum of one hundred and fifty
thousand US dollars (US $150,000.00), during the term of this Agreement
and for a period of six (6) months thereafter, Pfizer shall have the
exclusive option to acquire an exclusive world-wide, royalty bearing,
license,
including the right to grant sub-licenses, to make, use, sell, offer for
sale and import Products under all Peptide's right, title and interest
in the Peptide Technology, Joint Technology and Joint Patent Rights in
every country in the world. If Pfizer wishes to take up the option then
the parties shall negotiate in good faith to reach agreement on the
terms of the license which shall include the terms set forth in Exhibit
C.
9. Term and Termination
9.1 Term. Unless sooner terminated or extended, this Agreement shall expire
two (2) years from the Effective Date.
9.2 Events of Termination. The following events shall constitute events of
termination ("Events of Termination"):
(a) any written representation or warranty by Peptide or Pfizer, or
any of its officers, made under or in connection with this
Agreement shall prove to have been incorrect in any material
respect when made, or
(b) Peptide or Pfizer shall fail in any material respect to perform
or 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, and
any such failure shall remain unremedied for ninety (90) days
after written notice to the failing party.
9.3 Termination
9.3.1 Upon the occurrence of any Event of Termination, the party not
responsible may, by notice to the other party, terminate this Agreement.
9.3.2 Pfizer may terminate this Agreement, with or without cause, upon ninety
(90) days notice to Peptide.
9.3.3 If Pfizer terminates this Agreement pursuant to Section 9.2(a) or
9.2(b), the license option set forth in Section 8 shall continue
according to its terms. If Peptide terminates
this Agreement pursuant to Section 9.2(a) or 9.2(b), that license shall,
only upon mutual agreement of the parties, continue according to its
terms.
9.3.4 Termination of this Agreement for any reason shall be without prejudice
to any other remedies which either party may otherwise have.
9.3.5 If Pfizer do not exercise the License Option as described in section 8
then Pfizer shall;
(i) grant to Peptide a royalty free perpetual license with a right
of sub-license for research purposes to use the Joint
Technology within the Area
(ii) grant to Peptide a royalty bearing perpetual license with a
right of sub-license for commercial purposes to use the Joint
Technology within the Area. The commercial terms for such a
license to be reasonable taking into account the relative
contribution of the Joint Technology and the Peptide
Technology
10. Representations and Warranties. Peptide and Pfizer each represent and
warrant as follows:
10.1 It is a corporation duly organised validly existing and is in good
standing and is qualified to do business and is in good standing as a
foreign corporation in each jurisdiction in which the conduct of its
business or the ownership of its properties requires such qualification
and has all requisite power and authority, corporate or otherwise, to
conduct its business as now being conducted, to own, lease and operate
its properties and to execute, deliver and perform this Agreement.
The execution, delivery and performance by it of this Agreement have
been duly authorised by all necessary corporate action and do not and
will not (a) require any consent or approval of its stockholders, (b)
violate any provision of any law, rule, regulations, order, writ,
judgement, injunctions, decree, determination award presently in effect
having applicability to it or any provision of its certificate of
incorporation or by-laws or (c) result in a breach of or constitute a
default under any material agreement, mortgage, lease, license, permit
or other instrument or obligation to which it is a party or by which it
or its properties may be bound or affected.
10.2 This Agreement is a legal, valid and binding obligation of it
enforceable against it in accordance with its terms and conditions,
except as such enforceability may be limited by applicable bankruptcy,
insolvency, moratorium, reorganisation or similar laws, from time to
time in effect, affecting creditor's rights generally.
10.3 It is not under any obligation to any person, or entity, contractual or
otherwise, that is conflicting or inconsistent in any respect with the
terms of this Agreement or that would impede the diligent and complete
fulfilment of its obligations.
10.4 It has good and marketable title to or valid leases or licenses for, all
of its properties, rights and assets necessary for the fulfilment of its
responsibilities under the Research Program, subject to no claim of any
third party other than the relevant lessors, licensors or lienors.
11. Covenants of Peptide and Pfizer other than Reporting Requirements.
Throughout the Contract Period, Peptide and Pfizer each shall:
11.1 maintain and preserve its corporate existence, rights, franchises and
privileges in the jurisdiction of its incorporation, and qualify and
remain qualified as a foreign corporation in good standing in each
jurisdiction in which such qualification is from time to time necessary
or desirable in view of their business and operations or the ownership
of their properties.
11.2 comply in all material respects with the requirements of all applicable
laws, rules, regulations and orders of any government authority to the
extent necessary to conduct the Research Program, except for those laws,
rules, regulations, and orders it may be contesting in good faith.
12. Indemnification. Pfizer will indemnify Peptide for damages,
settlements, costs, legal fees and other expenses incurred in connection
with a claim against Peptide based on any action or omission of Pfizer,
its agents or employees related to the obligations of Pfizer under this
Agreement, provided, however, that the foregoing shall not apply (i)
the claim is found to be based upon the negligence, recklessness or
willful misconduct of Peptide or (ii) if Peptide fails to give Pfizer
prompt notice of any claim it receives.
such failure materially prejudices Pfizer with respect to any
claim or action to which Pfizer's obligation pursuant to this
Section applies, Pfizer, in its sole discretion, shall choose
legal counsel, shall control the defense of such claim or
action and shall have the right to settle same on such terms
and conditions as it deems advisable.
13. Notices. All notices shall be in writing mailed via certified mail,
return receipt requested, courier, or facsimile transmission addressed
as follow, or to such other address as may be designated from time to
time:
If to Pfizer: To Pfizer at its address as set forth at the beginning
of this Agreement.
Attention: Vice President, Animal Health Discovery
Research with copy to: Legal Division, Xxxxxx, XX 00000.
If to Peptide: Peptide at its address as set forth at the beginning of
this Agreement.
Attention: Commercial Director.
Notices shall be deemed given as of the date received.
14. Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of England.
15. Miscellaneous
15.1 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.
15.2 Headings. Paragraph headings are inserted for convenience of reference
only and do not form a part of this Agreement.
15.3 Counterparts. This Agreement may be executed simultaneously in two or
more counterparts, each of which shall be deemed an original.
15.4 Amendment, Waiver. 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 required
performance of any provisions shall in no 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 reach of such term or any other term of this
Agreement.
15.5 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 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.
15.6 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.
15.7 Force Majeure. Neither Pfizer nor Peptide 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 natural disasters or any causes reasonably beyond the
control of Pfizer or Peptide.
15.8 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.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by
their duly authorised representatives.
PFIZER INC
By: /s/ illegible
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Title: President, Central Reasearch
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Vice President, Pfizer Inc.
PEPTIDE THERAPEUTICS LIMITED
By: /s/ XX Xxxxxxx
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Title: Commercial Director
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EXHIBIT A
Anti-IgE Vaccine
Development Plan for Decapeptide from Peptide Therapeutics
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
EXHIBIT B
The Patents
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
EXHIBIT C
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
