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EXHIBIT 10.14
VAXCEL / MEDEVA OPTION AGREEMENT
THIS OPTION AGREEMENT (the "Agreement") is made and executed on October 13th,
1995 (the "Effective Date") by and between VAXCEL, INC., having a principal
place of business at 000 Xxxxxxxxxx Xxxxxxx, Xxxxxxxxxx Xxxx/Xxxxxxx, Xxxxxxxx,
Xxxxxxx 00000 ("Vaxcel") and MEDEVA EUROPE LIMITED, having a principal place of
business at Xxxxx Xxxxx, Xxxxxx Xxxx, Xxxxxxxx Xxxx, Xxxxxxxxxxx, Xxxxxx XX00
0XX ("Medeva").
RECITALS
WHEREAS, CytRx Corporation ("CytRx") owns certain patents and patent
applications related to a copolymer known as CRL-1005 and its use as a vaccine
adjuvant as listed in Part I of Appendix 1 to this Agreement;
WHEREAS, CytRx granted to Vaxcel an exclusive, worldwide license in and to such
rights in accordance with the terms of a License Agreement amended and restated
on August 10, 1995, ("License Agreement") to develop and commercially exploit
such patents and patent applications for use as a vaccine adjuvant in humans;
WHEREAS, the License Agreement is in force and the terms thereof permit and
authorize Vaxcel freely to grant sublicenses of the rights granted to it under
such License Agreement for the purposes contemplated by this Agreement;
WHEREAS, Vaxcel owns certain technology and other rights related to CRL-1005
and its use as a vaccine adjuvant as listed in Part II of Appendix 1 to this
Agreement;
WHEREAS, Medeva possesses the know-how and capability for manufacturing,
marketing, and distributing an influenza virus vaccine according to certain
product approvals and establishment licenses issued by the United States Food
and Drug Administration, the Medicines Control Agency of the United Kingdom,
and certain other regulatory agencies in other countries; and
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WHEREAS, both parties wish to evaluate Vaxcel's Optivaxa System for its ability
to enhance the immune response of Medeva's influenza virus vaccine in
preclinical and Phase I human clinical trials, and if such trials are
successful, negotiate and conclude definitive licensing and supply agreements
covering further development, manufacturing, distribution, and marketing of
Vaxcel's Optivax System with Medeva's influenza virus vaccine.
NOW THEREFORE, in consideration of their mutual promises and intending to be
legally bound, Vaxcel and Medeva hereby agree to the following terms and
conditions:
ARTICLE 1
DEFINITIONS
For the purposes of this Agreement, the following terms shall have the
respective meanings set forth below:
1.1 "Affiliate" shall mean, when used with reference to a specified
entity, any person or entity directly or indirectly controlling, controlled by,
or under common control with the specified entity. For purposes of this
Agreement, the direct or indirect ownership of over 50% of the outstanding
voting shares of an entity, or the right to receive over 50% of the profits or
earnings of an entity, or the right to direct the affairs of a person or
entity, shall be deemed to constitute control.
1.2 "Antigen" shall mean Fluvirina, a purified-surface-antigen influenza
virus vaccine, manufactured, distributed, and marketed by Medeva or its
Affiliates.
1.3 "Confidential Information" is defined in Section 8.3 below.
1.4 "Copolymer" shall mean the polyoxyethylene/polyoxypropylene copolymer
designated by Vaxcel as CRL-1005, as more specifically described in Appendix 2,
and any other copolymers added to the Program in accordance with Section 2.2
(iii).
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1.5 "Development Cost Estimate" shall mean the estimated costs of the
Program to be incurred by Medeva and Vaxcel in performing the Work Plan under
this Agreement, as shown on Appendix 3 hereto.
1.6 "Development Option" is defined in Section 5.1 below.
1.7 "FDA" shall mean the United States Food and Drug Administration or any
successor agency thereto.
1.8 "Field" shall mean use of the Copolymer and/or Optivax System in an
injectable subunit, split, whole cell or otherwise inactivated influenza virus
vaccine in humans. The term "Field" excludes any other uses of the Copolymer
and/or Optivax System, and specifically excludes: (a) use for injectable
delivery of antigens other than influenza virus; (b) use for oral, mucosal, or
other noninjectable routes of delivery of any antigens, including influenza
virus; and (c) use for delivery of next generation influenza virus vaccines
based on recombinant DNA in a protein expression system or synthetic
peptides/proteins.
1.9 "Improvements" is defined in Section 10.4 below.
1.10 "MCA" shall mean the Medicines Control Agency of the United Kingdom or
any successor agency thereto.
1.11 "Optivaxa System" shall mean the Copolymer in a medium which, when
combined with an antigen in a vaccine formulation, will enhance the immune
response that is specific for that antigen.
1.12 "Product" shall mean the vaccine in which the Antigen is the antigen
incorporated or combined with the Optivax System under this Agreement to
produce the enhanced immune response referred to in Section 1.11 above.
1.13 "Program" shall mean the collaboration between Vaxcel and Medeva for
evaluation of the Product through Phase I human clinical trials in accordance
with the Work Plan.
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1.14 "Program Completion Date" shall mean the date when Phase I clinical
trials have been completed or when the Agreement is terminated pursuant to
Article 9, if earlier. The Phase I clinical trials shall be deemed complete
ninety (90) days after the last patient in the trials is vaccinated with the
Product.
1.15 "Program Information" shall mean any Technical Information developed
by either party in the course of carrying out the Program. Program Information
shall include any methods for Product development, formulation or manufacture
developed for, under or as a result of the Program and information arising
directly therefrom.
1.16 "Program Period" shall mean the time during which the Program is
conducted, which shall be from the Effective Date to the Program Completion
Date.
1.17 "Rights" shall mean the patents, patent applications, technology and
other rights listed in Appendix 1 to this Agreement.
1.18 "Technical Information" shall mean technology and information,
know-how, trade secrets, and data relating to the Antigen, Copolymer, Optivax
System, or Product, including improvements and modifications to any thereof,
necessary or useful to the Program, which a party hereto has the lawful and
contractual right to disclose to the other party. Technical Information shall
include, without limitation, processes and analytical methodologies used in
development, testing, analysis and manufacture, and medical, clinical,
toxicological and other scientific data. Notwithstanding the foregoing,
Technical Information shall not include patents or trademarks.
1.19 "Work Plan" shall mean the development plan and related timetable
necessary to conduct the Program, the current version of which is attached
hereto as Appendix 3 and which may be amended from time to time by the mutual
written agreement of the parties.
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ARTICLE 2
MEDEVA'S PARTICIPATION
2.1 Subject to the terms and conditions herein, Vaxcel hereby grants
Medeva the right under the Rights to evaluate the Product according to the Work
Plan during the Program Period.
2.2 (i) Nothing in this Agreement shall be construed to constitute a grant
to Medeva of any rights other than those expressly granted herein.
Specifically, Medeva shall not have the right to use the Optivax System or the
Copolymer: (a) with antigens other than the Antigen; (b) to immunize
individuals for the purpose of producing antibodies which will subsequently be
purified and concentrated to make a high titer, human immune globulin for
commercial sale; and (c) in any testing or analysis that would reverse engineer
or otherwise reveal the chemical or structural composition of the Copolymer or
the Optivax System, excepted as provided for in Section 2.3. In addition,
Vaxcel shall supply all of Medeva's requirements of the Copolymer during the
Program. Nothing in this Agreement shall be construed to constitute a grant to
Medeva of the right to manufacture the Copolymer either directly or through a
third party.
(ii) Nothing in this Agreement shall be construed to constitute a
grant to Vaxcel of any rights other than those expressly granted herein.
Specifically, Vaxcel shall not have any rights over or in respect of or
connected to the Antigen, its manufacture, use or sale.
(iii) Notwithstanding that the Copolymer referred to in Appendix 2 is
considered by the parties to be the most appropriate for use in the Program, if
Vaxcel acquires or holds rights in any other copolymer which, in Vaxcel's sole
judgment, may be useful to the Program and Medeva wishes to evaluate such
copolymer, then Vaxcel shall make such copolymer available to Medeva for the
purposes of this Agreement and such copolymer shall be deemed to be included
within the definition of "Copolymer" in Section 1.4 above.
2.3 Vaxcel shall prepare responses or conduct tests on the Copolymer
and/or Optivax System as required by regulatory authorities; provided, however,
that if regulatory authorities require Medeva to carry out its own testing
and/or analysis of the Copolymer or Optivax System, Medeva shall notify Vaxcel
of such requirement and Vaxcel shall permit and enable Medeva to do what may be
necessary to satisfy the requirements of such regulatory authorities.
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ARTICLE 3
PRODUCT DEVELOPMENT WORK PLAN
3.1 Upon execution of this Agreement, Vaxcel and Medeva shall commence the
Program pursuant to the Work Plan. Each party agrees to use its reasonable
efforts to diligently perform the Work Plan.
3.2 The parties agree that the Work Plan and the Development Cost Estimate
on Appendix 3 are reasonable estimates of the effort and costs required to
evaluate the Product.
3.3 Neither party shall deviate from the Work Plan in any material way nor
incur costs for which they are not responsible in excess of the Development
Cost Estimate, without the prior written consent of the other party.
3.4 If either party believes it necessary (and so notifies the other
party) to materially revise either the Work Plan or the Development Cost
Estimate, so that Appendix 3 may remain good faith estimates of the development
effort to be done by both parties and the costs related thereto, the parties
will enter into good faith discussions concerning the appropriate revisions to
such Appendix and will make such revisions to which both parties agree.
3.5 Each party shall appoint a representative by notice in writing to the
other party upon signature of this Agreement. Such representatives shall act as
the contact point for each party for the transmission of information, documents
and materials between the parties. Such representatives shall participate in
periodic conference calls or meetings to review the progress of the Work Plan,
adherence to the Development Cost Estimate and status of the Program. These
updates should be held on an "as needed" basis in the spirit of collaboration,
but at least every sixty (60) days. Each party's representative may appoint
additional individuals to deal with specific matters relating to the Program
and each party may change its representative by not less than seven (7) days
prior written notice to the other party.
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3.6 Subject to the terms of this Agreement and in particular to Articles 8
and 10 below, the parties shall share with each other all Program Information
generated under the Work Plan.
3.7 Each party shall use its reasonable efforts to ensure that the Work Plan
is performed in accordance with appropriate regulations issued by the FDA or
MCA, and cGLP.
ARTICLE 4
DEVELOPMENT COSTS AND PAYMENTS
4.1 Upon signing this Agreement, Medeva will pay Vaxcel ninety thousand
United States dollars (US$90,000).
4.2 If an IND or CTX for the Product has not been submitted to any one (1)
regulatory agency within one (1) year from the Effective Date, Medeva will pay
Vaxcel two hundred fifty thousand United States dollars (US$250,000), unless
the delay in filing the IND or CTX is caused by Vaxcel, in which case the
period for filing shall be extended to take account of such delay.
4.3 Medeva will pay Vaxcel one hundred sixty thousand United States dollars
(US$160,000) when an IND or CTX for the Product is submitted to any one (1)
regulatory agency. If Medeva paid the penalty for delay under Section 4.2 above
and the IND or CTX is submitted within three (3) months of the payment made
under Section 4.2, no additional moneys will be due to Vaxcel by Medeva for
this IND or CTX submission. If Medeva paid the penalty for delay under Section
4.2 above and the IND or CTX is submitted in a time period greater than three
(3) months of the payment made under Section 4.2 above, then Medeva will pay
Vaxcel the full one hundred sixty thousand United States dollar (US$160,000)
payment.
4.4 Medeva will pay Vaxcel two hundred fifty thousand United States dollars
(US$250,000) when the Phase I human clinical trials as referred to in the Work
Plan have been successfully completed. From a performance standpoint,
successful completion of Phase I trials is defined as the Product generating an
antibody response substantially greater than the Antigen alone as measured by
geometric mean titers and also having a safety profile sufficient to allow
continuation to Phase II human clinical trials. From a timing standpoint, Phase
I trials shall be considered complete ninety (90) days after the last patient
in the trials is vaccinated with the Product. This payment by Medeva to Vaxcel
is due regardless of whether Medeva exercises the Development Option (as
defined in Section 5.1).
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4.5 Medeva will reimburse Vaxcel for all expenses incurred by Vaxcel with
Medeva's prior written consent in performing the Work Plan. Vaxcel will provide
Medeva with cost estimates, quotes, invoices, or other documents which verify
Vaxcel's out-of-pocket expenses.
4.6 Medeva will be responsible for all of its direct and indirect costs
and expenses in performing the Work Plan.
ARTICLE 5
OPTION FOR DEVELOPMENT
5.1 Vaxcel hereby grants Medeva the option to secure a license to further
develop, manufacture, use, distribute and sell the Product in the Field upon
the completion of the Program (the "Development Option") subject to the terms
of Article 6. Medeva will, in its sole judgment, determine whether to exercise
the Development Option.
5.2 To exercise the Development Option, Medeva must give Vaxcel written
notice of exercise within forty-five (45) days after the Program Completion
Date.
ARTICLE 6
LICENSE AND SUPPLY AGREEMENT
6.1 If Medeva exercises the Development Option, the parties will enter
into good faith negotiations for definitive license and supply agreements
covering further development, regulatory approval, manufacture, use,
distribution and sale of the Product. From the date of Medeva's exercise of the
Development Option, the parties shall have ninety (90) days to conclude
definitive licensing and supply agreements. If at the end of such ninety (90)
day period (or such longer as the parties may agree) the definitive license and
supply agreements have not been concluded, neither party shall be obligated to
continue to negotiate the terms of nor enter into such definitive license and
supply agreement. Such agreements shall be co-exclusive (within the meaning of
Article 7), worldwide agreements.
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6.2 The following are the financial terms which will be included in
license and supply agreements entered into by the parties:
6.2.1 If the parties successfully negotiate and complete definitive
license and supply agreements, Medeva shall pay Vaxcel three hundred
thousand U.S. dollars (US$300,000), which must accompany the signed
agreements.
6.2.2 Medeva will be responsible for all further development
activities and costs associated with the Product, including, but not
limited to, human clinical testing, laboratory testing, pursuing
regulatory approval, final Product manufacturing, distribution, and
marketing.
6.2.3 Vaxcel will provide reasonable technical support to Medeva
during further development of the Product as requested by Medeva. For
any such work performed by Vaxcel, Medeva will pay Vaxcel for any and
all reasonable and agreed expenses associated with this effort.
6.2.4 Medeva will pay Vaxcel two hundred fifty thousand U.S. dollars
(US$250,000) when Phase II human trials have been successfully
completed. From a performance standpoint, successful completion of
Phase II trials is defined as the Product having the necessary safety
and efficacy profile to proceed to Phase III human trials. From a
timing standpoint, Phase II trials shall be considered complete ninety
(90) days after the last patient in the trials is vaccinated with the
Product.
If the Phase II trials have not been initiated within six (6) months
from the date that the license agreement is signed by both parties,
Medeva will pay Vaxcel thirty thousand U.S. dollars (US$30,000) per
month, unless delays in starting the Phase II trials are caused by
Vaxcel or regulatory authorities, in which case the period for filing
shall be extended to take account of such delay. These monthly
payments will continue until the Phase II trials are actually
initiated. Initiation of Phase II trials is defined as the date the
first patient is recruited in the trials.
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Under this Section 6.2.4, Phase II trials are defined as the challenge
studies in volunteers or some similar human trials as mutually determined
by the parties.
6.2.5 Medeva will pay Vaxcel three hundred thousand U.S. dollars
(US$300,000) when Phase III human trials have been successfully
completed. From a performance standpoint, successful completion of Phase
III trials is defined as the Product having the necessary safety and
efficacy profile to submit a Product License Application / New Drug
Application. From a timing standpoint, Phase III trials shall be
considered complete ninety (90) days after the last patient in the trials
is vaccinated with the Product.
If the Phase III trials have not been initiated within six (6) months
from the completion of the Phase II trials, Medeva will pay Vaxcel fifty
thousand U.S. dollars (US$50,000) per month, unless delays in starting
the Phase III trials are caused by Vaxcel, regulatory authorities, or
significant changes in the Phase III protocols not caused by Medeva, in
which case the period for filing shall be extended to take account of
such delay. These monthly payments will continue until the Phase III
trials are actually initiated. Initiation of Phase III trials is defined
as the date the first patient is recruited in the trials.
Under this Section 6.2.5, completion of Phase II trials is defined as
ninety (90) days after the last patient in the trials is vaccinated with
the Product. Phase III trials are defined as the pivotal protection
studies in the elderly or some similar human trials as mutually
determined by the parties.
6.2.6 Medeva shall pay Vaxcel three hundred thousand U.S. dollars
(US$300,000) when a Product License Application / New Drug Application is
submitted to the FDA and three hundred thousand U.S. dollars (US$300,000)
when a Product License Application / New Drug Application is submitted to
the MCA.
6.2.7 Medeva will pay to Vaxcel one million five hundred thousand U.S.
dollars (US$1,500,000) upon regulatory approval for commercialization of
the Product in the United States.
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6.2.8 Medeva will pay to Vaxcel one million one hundred fifty thousand
U.S. dollars (US$1,150,000) upon regulatory approval for
commercialization of the Product in the United Kingdom.
6.2.9 Medeva will pay to Vaxcel one hundred thousand U.S dollars
(US$100,000), per country, for regulatory approvals for
commercialization of the Product in countries other than the United
States and the United Kingdom. The limit on these regulatory approval
payments will be one million two hundred thousand U.S. dollars
(US$1,200,000) in total.
6.2.10 Vaxcel will cause Copolymer to be manufactured and supplied to
Medeva according to agreed specifications which are consistent with
appropriate regulatory approvals and under GMP conditions and Medeva
will be responsible for all final manufacturing of the Product
including formulating, bulk manufacturing, sterile filling, regulatory
approval, packaging and any other activities necessary for sale and
distribution. Vaxcel shall provide reasonable comfort to Medeva in
respect of the security and continuity of supply of the Copolymer.
6.2.11 In the event of CytRx being unable or unwilling to supply the
Copolymer to meet the requirements of the license and supply
agreements, Vaxcel shall procure that CytRx shall transfer to Vaxcel
or another party selected by CytRx the appropriate information and
knowledge to enable Vaxcel to have manufactured the Copolymer itself
to meet such requirements.
6.2.12 The costs for Vaxcel to supply Medeva with Copolymer CRL-1005
under the license and supply agreement will not exceed $20.00 per gram
in 1995 US dollars. In the event that a different Copolymer is used
pursuant to Section 2.2 (iii) above, this $20.00 per gram supply price
may need to be revised to reflect a higher cost of manufacturing.
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6.2.13 Medeva will pay Vaxcel a royalty rate of between 6% and 10% of
net sales, depending on the efficacy profile and production benefits
of the Product. The general guidelines that will determine these
royalty rates are: (i) the royalty rate to Vaxcel shall be 6% if the
Optivax System moderately improves the efficacy of the Antigen; (ii)
the royalty rate to Vaxcel shall be 8% if the Optivax System
significantly improves the efficacy of the Antigen; (iii) the royalty
rate to Vaxcel shall be 8% if the Optivax System moderately improves
the efficacy of the Antigen and reduces the amount of influenza virus
per recommended human dose; (iv) the royalty rate to Vaxcel shall be
10% if the Optivax System significantly improves the efficacy of the
Antigen and reduces the amount of influenza virus per recommended
human dose.
6.3 The license and supply agreement shall contain such other terms as the
parties consider appropriate and agree. The license and supply agreement shall
not become binding unless and until a document containing terms acceptable to
both parties is approved and executed by both of them.
ARTICLE 7
CO-EXCLUSIVITY
7.1 Save for as indicated in Section 7.2, Vaxcel shall not grant and shall
procure that CytRx shall not grant to any other person any rights over or in
respect of the Copolymer (or any other copolymer owned by or available to CytRx
or Vaxcel) and/or the Optivax System to any third party for use in the Field.
7.2 Vaxcel may grant to one other company ("Co-Developer") a license to
use the Copolymer and/or Optivax System in the Field ("Co-Exclusive License").
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7.3 If a license is granted to a Co-Developer pursuant to Section 7.2,
Vaxcel shall ensure that such license contains a royalty rate and supply price
which, in overall terms, are no more favorable to the Co-Developer than the
terms of any license and supply agreement entered into pursuant to Article 6
are to Medeva, unless such more favorable position, with respect to royalty
rate, is reasonably justified by the efficacy profile/production benefits of
the Co-Developer's product according to Section 6.2.13 or, with respect to
supply price, is reasonably justified by volume purchasing obligations. For the
purposes of verifying the observance of the provisions in this Section, Medeva
shall be entitled to have such license assessed by an independent expert who is
a partner of a "Big 6" accounting firm that does not serve as the auditor of
Medeva, Vaxcel or the Co-Developer and experienced in the matter at issue
nominated by Medeva and acceptable to Vaxcel , such acceptance not to be
unreasonably withheld, who shall report purely on whether in his/her view the
such terms are more favorable to such Co-Developer. If such independent expert
finds that such terms are more favorable to such Co-Developer, he/she shall
notify Vaxcel and Medeva of the amendments to be made to the terms of Article 6
and/or the license and supply agreements with Medeva to rectify the position
and such amendments shall be deemed to have taken effect from the effective
date of the license and supply agreements with Medeva or the effective date of
the license to the Co-Developer, whichever is later. The decision of such
independent expert shall be binding upon the parties and he/she shall act as an
expert and not as an arbitrator. The cost of such independent expert shall be
borne by Medeva if such expert considers such terms not to be more favorable to
the Co-Developer and by Vaxcel if he/she considers them to be more favorable.
Reciprocally, Medeva will allow Vaxcel to submit any license and supply
agreement entered into pursuant to Article 6 to a similar verification
procedure for the benefit of the Co-Developer.
For purposes of clarification, the analysis of the Co-Developer's or
Medeva's license by such independent expert shall not include upfront payments,
performance milestone payments, or other terms that do not constitute a royalty
rate or supply price.
7.4 Vaxcel hereby covenants and has procured a written covenant from CytRx
per Appendix 4 that: (i) no rights have been or will be granted directly or
indirectly by either of them to more than one other third party in relation to
the use of the Copolymer (or any other copolymer owned by or available to CytRx
or Vaxcel) and/or Optivax System in the Field for so long as this Agreement is
in being and during the term of any license and supply
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agreement entered into pursuant to Article 6; (ii) the provisions of Section
14.5 are true, accurate, and not misleading; (iii) if for any reason the
License Agreement is terminated in a manner that adversely affects Vaxcel's
ability to perform this Agreement or the license and supply agreement, then all
rights and licenses granted to Medeva hereunder and under any license and
supply agreement entered into pursuant to Article 6 to the extent consistent
with Section 6.2 of the Agreement and any other terms consented to in writing
by CytRx will be granted to Medeva directly by CytRx on the same terms and
conditions as are set out in this Agreement and any such license and supply
agreement.
ARTICLE 8
CONFIDENTIALITY
8.1 Each party (the "Receiving Party") receiving Confidential Information
(defined below) from the other party (the "Disclosing Party") agrees:
8.1.1 not to directly or indirectly disclose, communicate, or in any
way divulge to any person/organization outside of its organization,
any Confidential Information (as defined below) without the written
consent of the Disclosing Party.
8.1.2 to disclose Confidential Information received under this
Agreement only to persons within its organization, (or with prior
written consent of the other party to approved sub-contractors) who
have a need to know such Confidential Information and who are bound by
a written agreement to protect the confidentiality of such
Confidential Information.
8.1.3 to use and to procure that those persons and sub-contractors
referred to in 8.1.2 above use such Confidential Information only as
necessary to perform this Agreement including the Work Plan and for no
other purpose.
For the purposes of this Section 8.1, a party's organization shall include its
Affiliates.
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8.2 The above obligations shall not apply with respect to any Confidential
Information to the extent it can be demonstrated by the Receiving Party by
clear and convincing evidence that such Confidential Information:
8.2.1 was known to the Receiving Party prior to the date of
disclosure;
8.2.2 was lawfully disclosed to the Receiving Party by an independent,
unaffiliated third party, rightfully in possession of the Confidential
Information and with no confidentiality obligations to the Disclosing
Party;
8.2.3 becomes published or generally known to the public through no
fault or omission of the Receiving Party; or
8.2.4 is required to be disclosed to comply with applicable laws or
government regulations, provided that prior written notice of such
disclosure is given to the Disclosing Party to allow the Disclosing
Party to take actions to avoid and/or minimize the degree of such
disclosure.
8.3 "Confidential Information" shall mean: (i) in the case of Medeva or
its Affiliates, Technical Information concerning the Antigen (or the use or
manufacture thereof) owned by or licensed to Medeva; (ii) in the case of Vaxcel
or its Affiliates, Technical Information concerning the Copolymer or Optivax
System (or the use or manufacture thereof) owned by or sublicensed to Vaxcel;
and (iii) as to each party, Program Information owned by such party
(independently or jointly) in accordance with the provisions of Article 10
below and all information, whether or not in writing, of a private, secret, or
confidential nature concerning such party's business, business relationships,
financial affairs, or technology, including analyses, compilations, forecasts,
studies, or other documents. By way of illustration, but not limitation,
Confidential Information may include unpublished patent applications,
formulations, know-how, manufacturing processes, inventions, products,
processes, methods, techniques, formulas, compositions, compounds, research or
clinical data, development plans, customers and supplier lists.
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8.4 Nothing herein shall in any way reduce the rights of any party under
applicable laws concerning the protection of trade secrets and other
proprietary information.
8.5 The provisions of this Article 8 shall continue for ten (10) years
following the termination or expiry of this Agreement or, if later, the
termination or expiry of any license and supply agreement.
8.6 In so far as either party wishes to make an announcement regarding the
work to be carried out pursuant to this Agreement and/or the results thereof,
it shall notify the other in writing of the information which it wishes to
disclose and shall not disclose the same if such information amounts to
Confidential Information without the prior written consent of the other party.
Such consent shall not be unreasonably withheld. In its considerations
regarding the question of whether to give consent, the parties acknowledge that
they each have a requirement to keep their shareholders and investors informed
and will negotiate to minimize any inconsistency or discrepancy between the
information which is made available. Not withstanding the above, each party and
CytRx shall have the right to make such disclosures as are required by law.
8.7 Notwithstanding anything herein to the contrary, either party may
disclose (by presentation, publication, or otherwise) the existence of this
Agreement, and the methodology and results of the Phase I human clinical trials
of the Product. Each party shall give the other copies of any proposed
publication or presentation at least thirty (30) days before submission of any
proposed presentation or publication. At the reviewing parties request,
inaccuracies will be corrected and Confidential Information (other than
methodology and results of the Phase I human clinical trials of the Product) of
the reviewing party will be deleted.
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ARTICLE 9
TERMINATION
9.1 This Agreement shall begin on the Effective Date and, unless
terminated under this Article 9, shall remain in effect until:
(i) such time as the Development Option pursuant to Article 5 has not
been exercised and is no longer capable of being exercised; or, if
such option is exercised;
(ii) until the definitive license and supply agreements referred to in
Article 6 have been entered into or, if earlier, are no longer capable
of being entered into; or
(iii) the second anniversary of the Effective Date if earlier than
(i) and (ii) above.
9.2 Notwithstanding any other provisions of this Agreement, Medeva may
cease performing the Work Plan and terminate this Agreement:
9.2.1 at any time, if the preclinical or Phase I human clinical
results of the Product are in Medeva's opinion unfavorable; or
9.2.2 upon thirty (30) days notice to Vaxcel if Vaxcel does not
proceed diligently with the Program, and Vaxcel has not corrected its
performance within thirty (30) days after Medeva's notification of the
specific problems with Vaxcel's performance.
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9.3 Vaxcel may terminate Medeva's rights hereunder:
9.3.1 upon thirty (30) days notice to Medeva if Medeva does not
proceed diligently with the Program, and Medeva has not corrected its
performance within thirty (30) days after Vaxcel's notification of the
specific problems with Medeva's performance; or
9.3.2 if Medeva has failed to pay Vaxcel any amount payable to Vaxcel
hereunder, and such failure is continuing for thirty (30) days after
Vaxcel notifies Medeva of such nonpayment.
9.4 If this Agreement is terminated under this Article 9, all unused
Antigen, Copolymer and Optivax System shall be returned to their rightful owner
or destroyed, at the sole option of the rightful owner, within ten (10) days of
termination. In addition, any inventories of Product, including clinical
supplies, shall be destroyed. All disposals of materials shall be performed in
compliance with applicable law.
9.5 For the avoidance of doubt from the date of termination pursuant to
this Article 9, no further payments shall be due from Medeva to Vaxcel pursuant
to Article 4, but any payments due at the date of such termination shall remain
due and payable.
ARTICLE 10
OWNERSHIP
10.1 Improvements and Program Information to the extent that they do not
relate either: (i) exclusively to the Antigen or other constituents of the
Product (save for the Copolymer and the Optivax System), on one hand, or (ii)
exclusively to the Copolymer or Optivax System, on the other hand, shall be
jointly owned by the parties ("Jointly Owned Improvements and Program
Information"). In all other cases, Improvements and Program Information shall
be: (i) the exclusive property of Medeva if and to the extent it relates to the
Antigen itself or any other constituent of the Product other than the Copolymer
and/or Optivax System; and (ii) the exclusive property of Vaxcel if and to the
extent it relates to the Copolymer and/or Optivax System itself.
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19
10.2 If Jointly Owned Improvements and Program Information arise which are
jointly owned pursuant to Section 10.1 above, the parties will enter into good
faith negotiations to determine an appropriate course of action. Failing
agreement over such course of action, neither party shall be entitled to use or
authorize others to use such Jointly Owned Improvements and Program
Information.
10.3 Nothing in this Agreement shall be construed to constitute a grant by
Medeva of any rights related to the Antigen, nor a grant by Vaxcel of any of
its rights related to the Copolymer and/or Optivax System other than to perform
this Agreement including the Work Plan.
10.4 For the purposes of this Article 10, "Improvements" shall mean any
and/or new or useful processes, manufacturing methods, formulations or
compositions first conceived, discovered or developed in the course of carrying
out the Program.
10.5 If this Agreement terminates for any reason other than pursuant to
Section 9.2.2, Vaxcel will own all Jointly Owned Improvements and Program
Information referred to in Section 10.1 and Medeva will transfer to Vaxcel all
such Jointly Owned Improvements and Program Information in its possession, and
Vaxcel will be free to use or share such Jointly Owned Improvements and Program
Information with others for licensing or other purposes, at which time Article
8, Confidentiality, shall cease to apply to Vaxcel in relation to such Jointly
Owned Improvements and Program Information.
10.6 If this Agreement terminates pursuant to Section 9.2.2, Medeva will
own all Jointly Owned Improvements and Program Information referred to in
Section 10.1 and Vaxcel will transfer to Medeva all such Jointly Owned
Improvements and Program Information in its possession, and Medeva will be free
to use or share such Jointly Owned Improvements and Program Information with
others for licensing or other purposes, at which time Article 8,
Confidentiality, will cease to apply to Medeva in relation to such Jointly
Owned Improvements and Program Information.
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20
10.7 For the avoidance of doubt, the provisions of Sections 10.5 and 10.6
above shall not apply to Improvements and Program Information owned exclusively
by Medeva or Vaxcel pursuant to Section 10.1 above, which at all times shall
remain the property of Medeva or Vaxcel as appropriate, nor Technical
Information which is not Program Information, which shall remain at all times
the property of the party making such Technical Information available for use
in the Program.
ARTICLE 11
INDEMNITY
11.1 Medeva will indemnify Vaxcel and its Affiliates (if any), and the
employees, officers, directors, and agents of Vaxcel and its Affiliates (if
any), ("VAXCEL") from any and all liability, loss, damages, costs, or expenses
(including reasonable attorneys' fees) relating to legal liability to third
parties for death or personal injury which VAXCEL may incur, suffer, or be
required to pay resulting from or arising from this Agreement (including Phase
I human clinical trial), unless such liability is due solely to VAXCEL's or
CytRx's negligence or willful misconduct.
11.2 Vaxcel shall indemnify Medeva and its Affiliates and the employees,
officers, directors, and agents of Medeva and its Affiliates ('MEDEVA") from
any and all liability, loss, damages, costs, or expenses (including reasonable
attorneys' fees) relating to legal liability to third parties for death or
personal injury which MEDEVA may incur, suffer, or be required to pay resulting
from or arising from this Agreement, to the extent the same are due solely to
the negligence or willful misconduct of Vaxcel or CytRx or any of their agents
or employees.
ARTICLE 12
MISCELLANEOUS
12.1 All payments to Vaxcel under this Agreement shall be made in legal
currency of the United States. The initial ninety thousand dollar ($90,000)
payment to Vaxcel will be made by check upon Medeva's signing this Agreement.
All subsequent payments made by Medeva under this Agreement shall be made by
wire transfer and shall be delivered to Vaxcel at the account designated in
writing by Vaxcel from time to time.
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21
12.2 This Agreement shall be deemed to have been entered into and shall be
construed and enforced in accordance with the laws of England.
12.3 This Agreement, together with the Appendices hereto, sets forth and
constitutes the entire agreement between the parties with respect to the
subject matters and supersedes any and all prior agreements, understandings,
promises, and representations made by either party to the other concerning the
subject matter hereof and the terms applicable hereto. This Agreement may not
be released, discharged, amended, or modified in any manner except by an
instrument in writing signed by duly authorized representatives of Vaxcel and
Medeva.
12.4 In making and performing this Agreement, the parties act and shall act
at all times as independent entities and nothing contained in this Agreement
shall be construed or implied to create an agency, partnership, or employer and
employee relationship between Vaxcel and Medeva. Except as specifically
provided herein, at no time shall either party make commitments or incur any
charges or expenses for or in the name of the other party.
12.5 Any term or provision of this Agreement which is invalid or
unenforceable in any jurisdiction shall, as to such jurisdiction, be
ineffective to the extent of such invalidity or unenforceability without
rendering invalid or unenforceable the remaining terms and provisions of this
Agreement.
12.6 Any notice or other communication required or permitted to be made or
given to either party hereto pursuant to this Agreement shall be in writing,
shall be delivered by hand delivery, courier, registered or certified air mail
(return receipt requested) or faxed, and shall be addressed as follows or to
another address of which one party has given the other party notice with the
provisions of this clause:
If to Vaxcel: If to Medeva:
Vaxcel, Inc. Medeva PLC
000 Xxxxxxxxxx Xxxxxxx Xxxxx House, Regent Park
Technology Park/Atlanta Kingston Road
Norcross, Georgia 30092 Xxxxxxxxxxx Xxxxxx XX00 0XX
Attention: Mr. Xxxx Xxxxxx Attention: Xx. Xxxxx Xxxxxx
Fax No. (000) 000-0000 Fax No. 000 0 000 000000
Page 21
22
All notices given in accordance with this Section 12.6 shall be deemed to be
effective at the time of delivery or transmission to the addressee in the case
of hand delivery or fax, or seven (7) business days after being sent by
registered or certified air mail (return receipt requested) to the addressee.
12.7 Each party shall provide the other party with the opportunity
to approve any press release or similar public announcement concerning this
Agreement as soon as practical, but in no event later than forty-eight (48)
hours before the announcement is made. Any announcement or press release to be
made on or immediately after signing this Agreement shall be in an agreed form.
12.8 Neither this Agreement nor a party's rights and obligations hereunder
shall be assignable by either party without the prior written consent of the
other party, except that such consent is not required in connection with the
assignment of either party's rights or obligations hereunder to an Affiliate
thereof for so long as they remain an Affiliate or to any successor to
substantially all of the party's business. Subject to the foregoing, this
Agreement, and each and every provision hereof, shall be binding upon and shall
inure to the benefit of the parties, their respective successors,
successors-in-title, heirs and assigns, and each and every
successor-in-interest to any party, whether such successor acquires such
interest by way of gift, purchase, foreclosure, or by any other method, shall
hold such interest subject to all the terms and provisions of this Agreement.
Medeva shall be entitled to delegate its rights and the performance of its
obligations under this Agreement to Affiliates without the consent of Vaxcel.
12.9 The provisions of the following Articles and Sections of this
Agreement shall remain in force notwithstanding its termination for any reason;
Article 1, Article 8, Article 10, Article 11, Sections 12.2, 12.3,
12.6, 14.6 and Article 15.
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ARTICLE 13
FORCE MAJEURE
The parties shall not be responsible for failure to perform any of the
obligations imposed by this Agreement, provided such failure shall be
occasioned by fire, flood, explosion, lightening, windstorm, earthquake,
subsidence, destruction in whole or part of machinery or equipment or
discontinuity in the supply of power, government interferences, civil
commotion, riot, war, strikes, or any similar causes beyond the reasonable
control of the parties.
ARTICLE 14
WARRANTIES
14.1 Each party hereto represents and warrants that the statements in the
Recitals and the information in Appendix 1 relating to it (and in the case of
Vaxcel, to CytRx and the CytRx patents and other Rights) are true and accurate
at the date of this Agreement.
14.2 Vaxcel represents and warrants that: (i) it has the full right and
authority to enter into and comply with the terms of this Agreement, (ii) it
has not granted to any third party any rights which are inconsistent with the
rights granted to Medeva pursuant to this Agreement or which alter or purport
to alter the relationship between Vaxcel and Medeva contemplated by this
Agreement.
14.3 (i) Vaxcel represents that, to its knowledge and belief, utilizing for
the purposes of this Agreement (including the Program and Work Plan)
the Rights, the Copolymer, Optivax System and Technical
Information, relating thereto, Medeva and its Affiliates will not
infringe any intellectual property rights of any third party other
than Medeva or its Affiliates. Medeva's and its Affiliates' sole
remedy with respect to allegations or proof of infringement of
third-party intellectual property rights by the Rights, Copolymer,
Optivax System or Technical Information relating thereto or their use
by Medeva or its Affiliates, to the exclusion of all other remedies
therefore, will be for Medeva and its Affiliates to invoke the
provisions of this Section 14.3.
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(ii) Vaxcel, at its own expense and subject to the terms and
conditions hereof, will defend claims brought against Medeva
(and/or its Affiliates) in the United States and the United
Kingdom by third parties (other than Affiliates of Medeva)
that use of the Rights, Copolymer, Optivax System or Technical
Information related thereto in accordance with this Agreement
constitutes infringement of an intellectual property right
under the laws of the United States or the United Kingdom.
Vaxcel shall have no obligation to defend Medeva or any of its
Affiliates against, or to pay any judgment resulting from, any
claim that use of the Rights, Copolymer, Optivax System, or
the Technical Information in combination with anything else
infringes any other person's intellectual property rights,
unless such use of the Rights, Copolymer, Optivax System, or
the Technical Information is shown to be infringing when not
in combination or conjunction with anything else, in which
case, Vaxcel shall defend Medeva and its Affiliates in
accordance with this Section 14.3 (ii).
(iii) To be entitled to defense by Vaxcel against a
third-party infringement claim:
(a) Medeva shall advise Vaxcel of the existence of
the claim promptly upon learning of the assertion of
the claim (whether or not litigation or other
proceeding has been filed or served);
(b) Medeva shall permit Vaxcel to have the sole right
to control the defense and/or settlement of all such
claims, in litigation or otherwise; provided,
however, that if Medeva is named as a party in a
lawsuit and Vaxcel is unable to demonstrate to
Medeva's reasonable satisfaction that it will be able
to satisfy any award reasonably likely to be made
against Medeva in such a lawsuit and provide Medeva
with an indemnity or other security acceptable to
Medeva in respect thereof, then Medeva may undertake
its own defense, at its own cost, and Vaxcel shall
not have any obligations under Section 14.3 (viii).
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25
(iv) Medeva shall be entitled to be kept fully informed of all steps
taken in the course of the defense and/or settlement of all such
claims in litigation or otherwise and Vaxcel shall not enter into any
binding settlement of the same without Medeva's prior consent, unless
such settlement grants a full release to Medeva.
(v)Vaxcel shall consider reasonable comments and considerations
suggested by Medeva in connection with the defense of any
indemnification claim.
(vi) If a third-party infringement claim, of which Vaxcel was notified
in accordance with this Section 14.3 is sustained in a judgment,
includes an injunction prohibiting Medeva from continued use of the
Rights, Copolymer, Optivax System, or Technical Information related
thereto, then Vaxcel shall, in its sole election and at its expense:
(a) procure for Medeva the right to continue to use such
materials pursuant to this Agreement; or
(b) replace or modify such materials to make them
noninfringing; or
(c) direct Medeva to cease use of such materials or of the
specific functions of such materials that resulted in the
judgment.
(vii) (a) If Vaxcel elects to direct Medeva in accordance with the
provisions of sub-paragraph 14.3 (vi) (c) above, no further
payments shall be due to Vaxcel hereunder.
(b) In the event that Vaxcel elects to take the option
referred to in sub-paragraph 14.3 (vi) (b) above, it shall
compensate Medeva in full for any additional work and expenses
involved in repeating or carrying out fresh clinical trials
or other development work which Medeva will carry out with
noninfringing materials.
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26
(c) In the event that any injunction as referred to above is
granted, then Medeva shall not be obligated to make any
payments under the terms of this Agreement until and unless
(i) Vaxcel shall have procured the rights for Medeva referred
to in sub-paragraphs 14 (vi) (a) or (b) above, or, (ii)
notwithstanding such injunction, Medeva is entitled to and/or
does continue to use such materials in accordance with
direction by Vaxcel provided under sub-paragraph 14.3 (vi) (c)
without breach of the third party rights to which such
injunction relates or the injunction itself.
(viii) Vaxcel will pay or otherwise satisfy any monetary award made
against Medeva as part of a third-party infringement claim of which
Vaxcel was notified in accordance with this Section 14.3.
14.4 Each party warrants to the best of its knowledge and belief that all
Technical Information provided by it hereunder will be accurate and complete.
14.5 Vaxcel hereby warrants that: (i) CytRx is the owner of record of,
and owns all right, title, and interest in and to the patent and patent
applications described in Part I of Appendix 1 to the Agreement (the
"Patents"); (ii) CytRx has granted Vaxcel an exclusive, worldwide license to
rights under the Patents sufficient to allow Vaxcel to grant to Medeva the
rights specified in Section 2.1 and the license and supply agreement described
in Article 6 of the Agreement ("License and Supply Agreement"); (iii) although
CytRx does not currently manufacture commercial quantities of the Copolymer, it
is not aware of any reason why the Copolymer could not be manufactured in
commercial quantities nor why CytRx itself or through a third party contract
manufacturer would not be in a position to meet forecasts and orders for
Copolymer in amounts and time periods which are reasonable in the context of
other pharmaceutical products of this nature; (iv) neither the grant by CytRx
of the exclusive license rights to Vaxcel nor the arrangements for supply of
Copolymer to Vaxcel as currently agreed or as will be agreed by CytRx to
satisfy the requirements of the License and Supply Agreement do or will violate
or conflict with any rights to the Patents granted by CytRx to any other
person; and (v) the contents of the first four recitals on the first page of
the Agreement and Appendices 1 and 2 are true and accurate.
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27
14.6 (i) In the event of a material breach of warranty by Vaxcel hereunder,
Medeva shall be entitled to terminate this Agreement and recover from Vaxcel
all amounts paid to Vaxcel pursuant to this Agreement and be released from any
obligations to pay amounts due but not yet paid as its sole and exclusive
remedy.
(ii) In the event of a material breach of warranty by Medeva
hereunder, Vaxcel shall be entitled to terminate this Agreement and claim
damages for breach from Medeva without limiting and in addition to any other
rights which Vaxcel may have arising from such breach of warranty.
14.7 Except as set forth in this Agreement, each party hereby disclaims any
and all representations and warranties with respect to the subject matter of
this Agreement, and any products or services provided hereunder, express or
implied, including, without limitation warranties of title, noninfringement,
merchantibility and fitness for a particular purpose or use (whether or not
such party knows, has reason to know or has been advised of such purpose or
use).
ARTICLE 15
Neither party will be liable to the other for any consequential, punitive, or
exemplary damages of any kind.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date
first set forth above.
VAXCEL, INC. MEDEVA Europe Limited
By /s/ Xxxx X. Xxxxxx By /s/
-------------------------- ------------------------
Title President & CEO Title Director
----------------------- ---------------------
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APPENDIX 1
PART I
CYTRX PATENTS
U.S. FILING U.S. SERIAL CURRENT
TITLE DATE NUMBER STATUS
----- ---- ------ ------
Nonionic Block Copolymers August 9, 1994 08/292,814 Pending
Summary
This patent application is directed to copolymers with a high molecular weight
and includes the Copolymer designated in this Agreement as CRL-1005. The
application contains claims for: (i) composition of matter; (2) use of these
copolymers as adjuvants/delivery systems with a wide variety of antigens; and
(3) the manufacturing process. When mixed with an antigen, the copolymers can
either be used alone in an aqueous solution or combined with other ingredients
(e.g., emulsions) in a final vaccine formulation.
This patent application was filed in the United States in August 1994 and was
filed under the Patent Cooperation Treaty (PTC) in August 1995. All countries
were designated.
PART II
OTHER RIGHTS AND TECHNOLOGY
During the term of this Agreement, Vaxcel will make available to Medeva a copy
of all necessary information on the Copolymer and Optivax System (including,
but not limited to, the toxicology study on the Copolymer alone, stability
data, know-how for formulating with the Antigen) needed by the parties to
perform the Work Plan. Vaxcel and CytRx will prepare and CytRx will submit a
Drug Master File on the Copolymer to the FDA and/or MCA and allow Medeva to
access this information for confidential regulatory purposes.
29
APPENDIX 2
DESCRIPTION OF CRL-1005
CRL-1005 is a synthetic, linear, nonionic, triblock copolymer consisting of
polyoxypropylene (POP) and polyoxyethylene (XXX). The material is synthesized
so that one central hydrophobic block of POP is positioned between two smaller
hydrophilic blocks of XXX within each molecule. Thus, each molecule has an
amphipathic structure. CRL-1005 has an average molecular weight of
approximately 12,000 daltons. The POP block comprises about 95% of each
molecule of CRL-1005 and the two XXX blocks represent about 5%.
30
APPENDIX 3
WORK PLAN
PRELIMINARY SCHEDULE OF THE WORK PLAN AND DEVELOPMENT COSTS OF A MEDEVA
AND VAXCEL COLLABORATION ON AN ADJUVANTED INFLUENZA VIRUS VACCINE
-----------------------------------------------------------------------------------------------------------------------------------
MEDEVA/VAXCEL WHEN
TASK MANPOWER LOCATION DURATION STARTED
-----------------------------------------------------------------------------------------------------------------------------------
Formulation of Product 2 Ph.D.s & 2 Speke, UK & 12 Months As Soon As
Analytical Work-up Technicians Atlanta, Ga. Deal Signed
SRO
Potency Split Between
Other Tests Medeva & Vaxcel
Stability
-----------------------------------------------------------------------------------------------------------------------------------
Toxicology Studies (2) Contracted Out Where Most 6 Months As Soon As
2 Species Acute Cost Effective Product Defined
Rabbit Tolerance
Anaphylaxis (??)
-----------------------------------------------------------------------------------------------------------------------------------
Animal Efficacy Studies 7 MSR Speke, UK 3 Months As Soon As
Ferret Protection Studies Product Defined
-----------------------------------------------------------------------------------------------------------------------------------
CTX/IND Preparation 2+1 MSR MSR Leatherhead 6 Months As Soon As
UK To Approval Product Defined
-----------------------------------------------------------------------------------------------------------------------------------
Phase I Human Study MSR/CRO UK 6 Months On CTX or IND
Proof of Principle Approval
In Elderly (less than 75)
Volunteers
-----------------------------------------------------------------------------------------------------------------------------------
-----------------------------------------------------------------------------------------------------------------------------------
ESTIMATED ESTIMATED CUMULATIVE
TASK OUTPUT COST (POUND STERLING) COST (US$) TIME (1)
-----------------------------------------------------------------------------------------------------------------------------------
Formulation of Product Part of 250,000 $400,000 12 Months
Analytical Work-up CTX/IND
SRO
Potency
Other Tests
Stability
-----------------------------------------------------------------------------------------------------------------------------------
Toxicology Studies (2) Part of 100,000 $160,000 18 Months
2 Species Acute CTX/IND
Rabbit Tolerance
Anaphylaxis (??)
-----------------------------------------------------------------------------------------------------------------------------------
Animal Efficacy Studies Part of 50,000 $ 80,000 18 Months
Ferret Protection Studies CTX/IND
-----------------------------------------------------------------------------------------------------------------------------------
CTX/IND Preparation Allows Human 40,000 $ 64,000 18 Months
Studies
-----------------------------------------------------------------------------------------------------------------------------------
Phase I Human Study Part of NDA/PLA 150,000 $240,000 24 Months
Proof of Principle Strategy for
In Elderly (less than 75) Timely Submission
Volunteers
-----------------------------------------------------------------------------------------------------------------------------------
-----------------------------------------------------------------------------------------------------------------------------------
TASK COMMENTS
-----------------------------------------------------------------------------------------------------------------------------------
Formulation of Product
Analytical Work-up
SRO
Potency
Other Tests
Stability
-----------------------------------------------------------------------------------------------------------------------------------
Toxicology Studies (2)
2 Species Acute
Rabbit Tolerance
Anaphylaxis (??)
-----------------------------------------------------------------------------------------------------------------------------------
Animal Efficacy Studies
Ferret Protection Studies
-----------------------------------------------------------------------------------------------------------------------------------
CTX/IND Preparation
-----------------------------------------------------------------------------------------------------------------------------------
Phase I Human Study Probably 50 Volunteers
Proof of Principle Receive Fluvirin & 50 Adflu;
In Elderly (less than 75) HAI & NT Used To Define An
Volunteers Improvement
-----------------------------------------------------------------------------------------------------------------------------------
(1) Total Duration of Project; Some Studies Can Run Concurrently
(2) Exact Details Depend on How Much Tox There Is For The Copolymer (e.g. Do
We Need To Do Genotoxicity On Product/ Xxxx?)
Note: A US Dollar / UK Pound Conversion Rate of 1.60 Was Used
31
[CytRx Corporation Letterhead]
APPENDIX 4 Xxxx Xxxxxxx
President
Chief Executive Officer
Medeva Europe Limited
Xxxxx Xxxxx, Xxxxxx Xxxx
Xxxxxxxx Xxxx
Xxxxxxxxxxx Xxxxxx XX00 0XX
Attention: Xx. Xxxxx Xxxxxx, Head of Licensing
Dear Xx. Xxxxxx:
In connection with Medeva's execution of the Vaxcel/Medeva Agreement dated
as of the date hereof, CytRx Corporation hereby represents and warrants that:
(i) CytRx is the owner of record of, and owns all right, title, and
interest in and to the patent and patent applications described in Part
I of Appendix 1 to the Agreement (the "Patents");
(ii) CytRx has granted Vaxcel an exclusive, worldwide license to
rights under the Patents sufficient to allow Vaxcel to grant to
Medeva the rights specified in Section 2.1 and the license and
supply agreement described in Article 6 of the Agreement ("License and
Supply Agreement");
(iii) although CytRx does not currently manufacture commercial
quantities of the Copolymer, it is not aware of any reason why the
Copolymer could not be manufactured in commercial quantities nor why
CytRx itself or through a third party contract manufacturer would not
be in a position to meet forecasts and orders for Copolymer in amounts
and time periods which are reasonable in the context of other
pharmaceutical products of this nature;
32
(iv) neither the grant by CytRx of the exclusive license rights to
Vaxcel nor the arrangements for supply of Copolymer to Vaxcel as
currently agreed or as will be agreed by CytRx to satisfy the
requirements of the License and Supply Agreement do or will
violate or conflict with any rights to the Patents granted by CytRx
to any other person; and
(v) the contents of the first three recitals on the first page of the
Agreement and Part I of Appendix 1 and Appendix 2 are true and accurate.
CytRx covenants and agrees that:
(i) CytRx has not and will not directly or indirectly grant any
rights to any person other than Vaxcel in relation to the use of the
Patents, Copolymer (or any other copolymer owned by or available
to CytRx) and/or the Optivax System in the Field for so long as the
Agreement is in being and during the term of any License and Supply
Agreement entered into pursuant to Article 6 of the Agreement;
(ii) if for any reason the License Agreement granted by CytRx to
Vaxcel is terminated in a manner that adversely affects Vaxcel's
ability to perform the Agreement or the license and supply
agreement, then all rights and licenses granted to Medeva under the
Agreement and under any License and Supply Agreement entered into
pursuant to Article 6 to the extent consistent with Section 6.2 of the
Agreement and any other terms consented to in writing by CytRx will be
granted to Medeva directly by CytRx on the same terms and conditions
as are set out in the Agreement and any such License and Supply
agreements; and
(iii) prior to the entering into of the License and Supply
Agreement, CytRx will enter into binding arrangements with Vaxcel to
manufacture and supply to Vaxcel Copolymer which will enable Vaxcel to
perform such License and Supply Agreement in accordance with its the
terms set forth in Section 6.2.10 and other such terms as Vaxcel,
CytRx, and Medeva shall agree. In the event of CytRx being unwilling
or unable to do so, CytRx will transfer to Vaxcel or another party
selected by CytRx the appropriate information and knowledge to
enable Vaxcel to have manufactured the Copolymer itself to meet the
requirements of such License and Supply Agreements in accordance with
the provisions of 6.2.11 or, in the event of Vaxcel's default, to
transfer the same to Medeva to enable Medeva to manufacture or have
manufactured the Copolymer itself.
33
This letter shall be governed by the laws of England and may not be amended
or assigned without the prior written consent of CytRx. CytRx shall not be
liable in money damages for any breach of the representations and warranties
or covenants in this letter, except to the extent of Vaxcel's liability for
such breach under Section 14.6(i) less any amount paid by Vaxcel.
Capitalized terms used without definition herein shall have the meanings
ascribed to those terms in the Agreement.
Signed by: /s/ XXXX XXXXXXX
----------------------------
Duly authorized for and on behalf of
CytRx Corporation
