Certain portions of this Exhibit have been omitted pursuant to a request for
confidentiality. Such omitted portions, which are marked with brackets [ ]
and/or an asterisk *, have been separately filed with the Commission.
DEVELOPMENT AND LICENSE AGREEMENT
THIS DEVELOPMENT AND LICENSE AGREEMENT (the "Agreement") is made the 25th day
of January, 2000, by and between TITAN PHARMACEUTICALS, INC., a corporation
organized and existing under the laws of the State of Delaware and having its
principal place of business at 000 Xxxxxx Xxxxx Xxxxxxxxx, Xxxxx 000, Xxxxx
Xxx Xxxxxxxxx, Xxxxxxxxxx 00000, X.X.X. (hereinafter referred to as "Titan")
and SCHERING AG, a corporation organized and existing under the laws of
Germany and having its principal place of business at Xxxxxxxxxxxxxx 000,
Xxxxxx-Xxxxxxx, X-00000 Xxxxxx, Xxxxxxx (hereinafter referred to as
"Schering"). Titan and Schering are sometimes referred to herein individually
as a "Party" and collectively as the "Parties."
WHEREAS:
(A) Titan is developing through its research and development activities a
compound consisting of human retinal pigment epithelial cells on
microcarriers for use, inter alia, in the treatment of Xxxxxxxxx'x Disease
and Parkinsonian Movement Disorders and has the right to grant rights and
licenses and/or sublicenses under the Titan Patents (hereinafter defined) and
Titan Know-How (hereinafter defined);
(B) Schering has expressed to Titan its interest in obtaining from Titan
certain rights and licenses under the Titan Patents and Titan Know-How and in
cooperating with Titan in the development and commercialization of Product(s)
containing the Compound (hereinafter defined);
(C) Titan is willing to grant such rights and licenses and/or sublicenses
to Schering and to cooperate with Schering under the terms and conditions set
forth in this Agreement:
NOW, THEREFORE, in consideration of the foregoing recitals and the mutual
covenants and agreements contained herein, the Parties hereto, intending to
be legally bound, do hereby agree as follows:
1. DEFINITIONS
The following terms, when capitalized, shall have the following
meanings (such meanings to be equally applicable to both the singular
and plural forms of the terms defined) as used in this Agreement:
1.1 "Additional Indications" means the use of Product for any preventative,
diagnostic or therapeutic indication(s) other than the Initial
Indication.
1.2 "Affiliate" means any person, corporation, partnership, firm, joint
venture or other entity which, directly or indirectly, through one or
more intermediaries, controls, is controlled by, or is under common
control with, Titan or Schering, as the case may be. As used in this
definition, "control" means the possession of the power to direct or
cause the direction of the management and policies of an entity,
whether through the ownership of the outstanding voting securities or
by contract or otherwise.
1.3 "Agreement Year" shall mean a period of twelve months beginning on the
Effective Date and each anniversary thereof.
1.4 "Bankruptcy Event" shall have the meaning set forth in Section 11.2(d).
1.5 "Clinical Development" shall refer to all activities relating to
planning and execution of clinical studies in humans directed toward
obtaining Regulatory Approval of a Product, but does not include any
activities falling within the definition of CMC / Manufacturing.
Clinical Development includes clinical studies and related regulatory
affairs and outside counsel regulatory legal services.
1.6 "CMC / Manufacturing" shall mean the development of one or more
processes for the manufacture and packaging of the Compound and / or
the Product for Preclinical Development, Clinical Development and
Commercialization, and shall include, without limitation, formulation,
production, fill / finish, sourcing of components, raw materials and
packaging supplies, development of regulatory methods and controls,
including assays, quality control and quality assurance methodology and
stability protocols, and qualification of one or more Compound and
Product production facilities.
1.7 "Commercialization" and "Commercialize" shall refer to all activities
undertaken relating to the pre-marketing, marketing, distribution and
sale of the Product.
1.8 "Confidential Information" shall have the meaning set forth in Article
7.
1.9 "Compound" shall mean a composition consisting of neo-natal human
retinal pigment epithelial (RPE) cells on microcarriers (biocompatible
particulate support matrices for cells).
1.10 "Control" or "Controlled" shall refer to possession of the ability to
grant a license or sublicense of Patent Rights, Know-How, information
or other intangible rights as provided for herein without violating the
terms of any agreement or other arrangement with any Third Party.
1.11 "Development" or "Develop" shall refer to all activities relating to
Preclinical Development, Clinical Development and CMC / Manufacturing.
1.12 "Development Plan" and Budget" shall have the meaning set forth in
Section 3.2(b).
1.13 "Drug Approval Application" shall mean an application for Regulatory
Approval required to be approved before commercial sale or use of a
Product as a drug in a regulatory jurisdiction, including, for the
purposes of Regulatory Approval in the United States, a Biologic
License Application and all supplements filed pursuant to the
requirements of the FDA (including all documents, data and other
information concerning a Product which are necessary for or included in
FDA approval to market the Product) and, for the purposes of Regulatory
Approval in Europe, applications for Regulatory Approval to EMEA.
1.14 "Effective Date" shall mean the date set out at the start of this
Agreement.
2
1.15 "EMEA" shall mean the European Medicines Evaluation Agency, or any
successor agency.
1.16 "Europe" shall mean the countries which are members of the European
Union as such membership may change from time to time.
1.17 "FDA" shall mean the United States Food and Drug Administration or any
successor agency.
1.18 "Field" shall mean all uses of Product for the Initial Indication and
for any Additional Indications which Schering decides, at it
discretion, to develop and commercialize.
1.19 "First Commercial Sale" shall mean the date on which Schering or an
Affiliate or a sublicensee of Schering first sells commercially,
pursuant to a Regulatory Approval, a Product in any country of the
Territory.
1.20 "GCPs" shall mean clinical practices in conformity with the current
Good Clinical Practices as established by the International Conference
on Harmonization, as such regulations may be interpreted by governing
regulatory agencies or as may be amended from time to time, and in
conformity with equivalent regulations and interpretations in
regulatory jurisdictions in the Territory.
1.21 "GLPs" shall mean laboratory practices in conformity with the FDA's
regulations and regulatory interpretations of such regulations
governing current good laboratory practices set forth in 21 C.F.R. Part
58 et seq., as such regulations may be amended and interpreted by FDA
from time to time, and in conformity with equivalent regulations in
regulatory jurisdictions in the Territory.
1.22 "GMPs" shall mean manufacturing practices in conformity with the
FDA's regulations and regulatory interpretations of such
regulations governing current good manufacturing practices set forth in
21 C.F.R. Part 210 et seq., as such regulations may be amended and
interpreted by FDA from time to time, and in conformity with equivalent
regulations in regulatory jurisdictions in the Territory.
1.23 "Initial Indication" shall mean the use of Product for the in vivo
therapeutic prevention, treatment, cure or mitigation of
Xxxxxxxxx'x Disease and / or Parkinsonian Movement Disorders.
1.24 "Joint Development Committee" or "JDC" shall mean the committee
established pursuant to Section 3.1 below.
1.25 "Joint Patents" shall have the meaning set forth in Section 8.3(a).
1.26 "Know-How" shall mean techniques and data relating to the Compound or
the Product, including but not limited to inventions, practices,
methods, knowledge, know-how, skill, trade secrets, experience, test
data including pharmacological, toxicological, preclinical and clinical
test data, regulatory submissions, adverse reactions, analytical and
quality
3
control data, assays, marketing, pricing, distribution, cost, sales
and manufacturing data or descriptions.
1.27 "Net Sales" shall mean the amount invoiced by or on behalf of a Party,
its Affiliates or its sublicensees from sales of the Product by or on
behalf of such Party to Third Parties in the Territory, less the
following deductions applicable to the Product for (i) all trade, cash
and quantity credits, discounts, refunds or rebates, including premiums
or chargebacks; (ii) allowances or credits to customers on account of
governmental requirements, price differences, rejection, outdating,
returns, or recalls of Product; (iii) sales commissions; (iv) sales
taxes (including value added tax) or other governmental charges imposed
upon sales of the Product and paid by Schering; (v) transportation
charges and insurance charges paid by Schering estimated not to exceed
1% (one per cent) of invoice; (vi) price adjustments actually made; and
(vii) deductions for uncollectible invoices. For the purpose of
calculating Net Sales, the Parties recognize that (a) Schering's
customers may include persons in the chain of commerce who enter into
agreements with Schering as to price even though title to the Product
does not pass directly from Schering to such customers and even though
payment for such Product is not made by such customers directly to
Schering; and (b) in such cases, chargebacks paid by Schering to or
through a third party (such as a wholesaler) can be deducted by
Schering from gross revenue in order to calculate Net Sales. Any
deductions above which involve a payment by Schering shall be taken as
a deduction against aggregate sales for the period in which the payment
or deduction is made. In the event that a Product is sold in the form
of a combination product containing one or more active ingredients in
addition to a Product, Net Sales for such combination product will be
adjusted by multiplying actual Net Sales of such combination product by
the fraction A/(A+B) where A is the invoice price of the Product, if
sold separately, and B is the invoice price of any other active
ingredient or ingredients in the combination, if sold separately. If,
on a country-by-country basis, the other active ingredient or
ingredients in the combination are not sold separately in that country,
Net Sales shall be calculated by multiplying actual Net Sales of such
combination product by the fraction A/C where A is the invoice price of
the Product if sold separately and C is the invoice price of the
combination product. If, on a country-by-country basis, neither the
Product nor the other active component or components of the combination
product is sold separately in said country, Net Sales shall be
determined between the Parties in good faith.
1.28 "NYU License" shall mean the Agreement effective November 20, 1992
between New York University and Theracell Corporation (predecessor
corporation to Titan), as amended from time to time, attached hereto
and incorporated herein by reference in Exhibit B.
1.29 "Packaged Product" shall mean the Product packaged and labeled in
compliance with the specifications and requirements of the Regulatory
Approval of the country of commercial distribution, in a form ready for
delivery to the customer.
1.30 "Patents" shall mean all existing patents and patent applications and
patent applications hereafter filed covering Compound or Product within
the Field, including any continuation, continuation-in-part, division,
provisional or any substitute applications,
4
any patent issued with respect to any such patent applications, any
reissue, re-examination, renewal or extension (including any
supplemental protection certificate) of any such patent and
confirmation patent or registration patent or patent of addition
based on any such patent. The term "cover" or "covering", when used
in this Agreement in connection with a Patent shall signify that the
manufacture, use, sale, or import of a Compound or a Product by an
unlicensed party would infringe such a Patent for use in the Field.
1.31 "Patent Expenses" shall mean the fees, expenses and disbursements and
outside counsel fees and payments to Third Party agents incurred in
connection with the preparation, filing, prosecution and maintenance of
Titan Patents covering the Compound or Product within the Field,
including Titan's costs of patent interference and opposition
proceedings and actions at law and equity for patent infringement.
1.32 "Pivotal Clinical Trial" shall mean any clinical trial designed by
Schering and discussed with the respective regulatory authorities
(e.g., FDA, EMEA) within a country which can be expected to fulfill the
criteria for a grant of a marketing approval by the respective
regulatory authorities.
1.33 "Preclinical Development" shall refer to all activities relating to the
planning and execution of non-human studies conducted in in vitro or in
relevant in vivo animal models directed toward obtaining Regulatory
Approval of a Product in each regulatory jurisdiction in the Territory.
This includes preclinical testing, pharmacokinetics, toxicology,
documentary and medical writing directly related to Preclinical
Development activities, and related regulatory affairs and outside
counsel regulatory legal services.
1.34 "Product" shall mean any pharmaceutical composition which
pharmaceutical composition contains Compound as a pharmaceutically
active ingredient (either alone or in combination with one or more
other pharmaceutically active ingredients) suitable to deliver dopamine
and possibly other therapeutic materials after transplantation into
patients in the Field.
1.35 "Regulatory Approval" shall mean any approvals, product and / or
establishment licenses, registrations or authorizations of any federal,
state or local regulatory agency, department, bureau or other
governmental entity, necessary for the manufacture, use, storage,
importation, export, transport or sale of Product in a regulatory
jurisdiction.
1.36 "Research Reimbursement" shall have the meaning set forth in Section
5.1.
1.37 "Royalty Percentage" shall have the meaning set forth in Section 5.2.
1.38 "Schering Patents" shall mean any Patents owned or Controlled by
Schering or its Affiliates covering the research, development,
manufacture, use, importation, sale, or offer for sale of the Compound
or the Product.
1.39 "Titan Know-How" shall mean all Know-How, whether currently existing or
developed or obtained during the course of this Agreement, and whether
or not patentable or confidential that is now Controlled or hereinafter
becomes Controlled by Titan or its
5
Affiliates and that relates to the research, development,
utilization, manufacture or use of the Compound or the Product.
Notwithstanding anything herein to the contrary, Titan Know-How
shall exclude Titan Patents.
1.40 "Titan Patents" shall mean any Patents owned or Controlled by Titan or
its Affiliates covering the research, development, manufacture, use,
importation, sale or offer for sale of the Compound or the Product.
1.41 "Territory" shall mean all countries of the world.
1.42 "Third Party" shall mean any entity other than Titan or Schering and
their respective Affiliates and sublicensees.
1.43 "Valid Claim" shall mean a claim of any issued, unexpired United States
or foreign patent which shall not have been withdrawn, canceled or
disclaimed, or held invalid or unenforceable by a court of competent
jurisdiction in an unappealed or unappealable decision.
1.44 "Written Disclosure" shall have the meaning set forth in Section 7.6.
2. LICENSES AND ASSIGNMENT
2.1 EXCLUSIVE LICENSE: Subject always to the NYU License (with which this
Agreement must be consistent), and subject to the last sentence of this
paragraph, Titan grants to Schering an exclusive (even as to Titan)
worldwide license and / or sublicense, with a right to sublicense,
under the Titan Patents, the Titan Know-How and the Joint Patents to
use, develop, manufacture, have manufactured, market, sell, import for
sale and distribute the Compound and / or the Product in the Territory
for use in the Field, subject to the terms and conditions hereof and
the terms and conditions of the NYU License. Notwithstanding the
foregoing, Titan shall retain the right to conduct Development and
related activities to the extent specifically provided for in this
Agreement, subject to the terms and conditions hereof. Should an
existing agreement preclude the granting of a sublicense by Schering,
then upon written request by Schering, Titan will grant additional
sublicenses to third parties designated by Schering; provided, however,
that the terms and conditions of such further sublicenses shall not be
inconsistent with the terms and conditions of this Agreement, and that
the terms and conditions of the further sublicenses shall not be less
favorable to Titan than those of this Agreement; provided further that
any consideration payable by such designated sublicensees for or in
connection with the grant of such sublicenses shall be exclusively for
Schering's account; and provided further that, until Schering has paid
Titan the Research Reimbursements under Sections 5.1(a) through 5.1(c),
any consideration paid by such designated sublicensees shall (except in
the case of sublicenses to Affiliates where such consideration is
always exclusively for Schering's account) be shared equally by
Schering and Titan after deduction of any amount due to New York
University. A list of the Titan Patents identified as of the Effective
Date is attached hereto as Exhibit A. Such list shall be modified from
time to time to reflect any changes to Titan Patents and to include any
6
Titan Patents acquired by or coming under the Control of Titan during
the term of this Agreement.
2.2 EXISTING LICENSES: The licenses granted under Section 2.1 include
sublicenses of Third Party Know-How and Patents existing and licensed
to Titan on the Effective Date. A list of all such agreements as of the
Effective Date is attached hereto as Exhibit B, true, correct and
complete copies of which have been provided to Schering prior to the
Effective Date. Any royalties payable to Third Parties (except for any
that may be due under the Xxxxxxx Biolytica AB Agreement, as defined in
Section 6 of this Agreement) pertaining to technology discussed in the
previous sentence shall be paid by Titan and, if not so paid, may be
paid by Schering and offset or deducted from royalty payments under
Section 5. From time to time at Schering's request, Titan will use
its commercially reasonable efforts to obtain a consent (a "Consent")
from existing licensors and other contractual counterparties with
Titan. Such Consent shall contain the agreement of such licensor to (i)
give reasonable written notice to Schering prior to terminating the
underlying license or contract, (ii) provide Schering a reasonable
period to cure any default under such license or contract, and (iii)
permit Schering or one or more of its Affiliates to assume Titan's
obligations thereunder as sublicensee or assignee of Titan's rights
thereunder, in each case at Schering's option.
2.3 ORPHAN DRUG ACT: To the fullest extent permitted by law,
(a) Promptly upon Schering's decision to initiate Pivotal Clinical
Trial of the Product and upon Schering's making the Research
Reimbursement payment described in Section 5.1(a), Titan shall
transfer to Schering legal title to and possession of any and
all Orphan Drug Act applications, including FDA-designated
Orphan Biological Application 97-1057, and other requests for
designation by FDA of the Product as an orphan drug, and / or
any and all Orphan Drug Act designations by FDA of the Product
as an Orphan Drug. The Parties confirm that Schering will have
the right to claim and use any taxation credits, deductions or
other benefits available as a result of Orphan Drug Act
designation by FDA of the Product or a grant of marketing
exclusivity by FDA for the Product pursuant to the Orphan Drug
Act.
(b) Subject always to the provisions of Section 11.2 below,
Schering shall use commercially reasonable best efforts to
obtain Orphan Drug exclusivity for the Product for the Initial
Indication. Titan agrees to cooperate with and assist Schering
to the extent reasonably requested by Schering in the
preparation, amendment and / or prosecution of petitions or
other requests for Orphan Drug Act designation or Orphan Drug
Act exclusivity for Product, and any other marketing
exclusivity available in the United States or any other
country of the Territory. Such assistance shall include
without limitation participation by Titan representatives in
meetings with U.S. governmental authorities as reasonably
requested by Schering, and subject to the availability of
Titan personnel. Schering shall keep Titan apprised of its
progress in obtaining Orphan Drug Act exclusivity and any
other marketing exclusivity that becomes available in the
United States or any other country of the Territory. Schering
shall be the legal
7
and beneficial owner of Orphan Drug exclusivity or any
other marketing exclusivity obtained in regard to any
Product in the United States or any other country of the
Territory.
2.4 As long as this Agreement remains in effect, and for so long as
Schering remains actively engaged in the development or
commercialization of a Product for use in the Field, Titan shall not
develop, manufacture, or commercialize a product that utilizes
cell-coated microcarrier technology and that competes with the Product.
The provisions of this Section 2.4 shall have no force or effect in the
European Union or in any other country where it may contravene any
antitrust directive or law.
3. DEVELOPMENT
3.1 JDC
(a) FORMATION OF THE JDC: Within fifteen (15) days after the
Effective Date (or such later time as may be mutually agreed
to by the Parties), the Parties shall establish the JDC. The
JDC shall consist of an equal number of representatives of
Titan and Schering to be agreed upon by the Parties from time
to time. Either Party may designate a substitute for a member
unable to be present at a meeting. One of the Schering members
of the JDC, chosen at the sole discretion of Schering, along
with one of the Titan members of the JDC, chosen at the sole
discretion of Titan, shall serve as co-chairs of the JDC.
Regardless of the number of representatives from each Party on
the JDC, each Party shall have one vote on any issue. Meetings
of the JDC shall be held quarterly, and may be called by
either Party with not less than twenty (20) business days
notice to the other unless such notice is waived, and meetings
shall be held alternately at the offices of Titan or of
Schering or an Affiliate as may be designated by Schering. The
JDC may be convened, polled or consulted from time to time by
means of telecommunication or correspondence. Each Party will
disclose to the other proposed agenda items reasonably in
advance of each meeting of the JDC. Each Party shall bear its
own costs for participation in the JDC.
(b) FUNCTIONS OF THE JDC: The JDC shall function as a forum for
the Parties to inform and consult with one another concerning
progress of and changes to Development and the Development
Plan, meeting Development goals, dealing with obstacles to
successful Development, and the status of obtaining Regulatory
Approvals. The JDC shall have no role, consultative or
otherwise, with regard to Commercialization other than those
reasonably necessary to transition from Development to
Commercialization. The following specific functions shall be
delegated to the JDC:
(i) plan, coordinate and oversee the Development of the
Product in order to obtain Regulatory Approval in the
Territory;
(ii) assume responsibility for the Development Plan as
established in Section 3.2(b);
8
(iii) propose updates yearly to the Development Plan, which
plan will specify a reasonable level of detail by
which Titan and Schering will conduct Preclinical
Development, Clinical Development and CMC /
Manufacturing;
(iv) propose any amendments of the Development Plan which
are not covered in the yearly updates;
(v) prepare detailed budgets consistent with the
Development Plan and allocate such budgets to
particular Development tasks; and
(vi) subject to Section 3.4, evaluate any proposal to
contract with any Third Party to perform any
Development activities.
(c) LIMITATION ON JDC AUTHORITY: Notwithstanding the creation of
the JDC, each Party to this Agreement shall retain the rights,
powers and discretions granted to it hereunder, and the JDC
shall not be delegated or vested with any such rights, powers
or discretion unless such delegation or vesting is expressly
provided for herein or the Parties expressly so agree in
writing. The JDC shall not have the power to amend or modify
this Agreement which may be amended or modified only as
provided in Section 13.11.
(d) RESOLUTION OF DISPUTES: If the JDC cannot reach a unanimous
decision with respect to the Development matters delegated to
it within ten (10) days then the disputed matter shall be
promptly referred to a senior manager of each Party designated
by such Party. If the senior managers are unable to resolve
such matter within ten (10) days after one Party notifies the
other of its desire to have the matter referred to such senior
managers, the decision of Schering's senior manager shall
control.
3.2 DEVELOPMENT
(a) Titan and Schering each agree to cooperate in the Development
of the Product and to use commercially reasonable efforts to
develop and bring the Product to market. Subject always to
Section 11.2 of this Agreement, Titan and Schering each agrees
to use commercially reasonable efforts to execute and
substantially perform the obligations assumed by it under the
Development Plan, exercising the same degree of diligence in
Commercialization of the Product as it exercises with respect
to proprietary products of comparable commercial potential.
(b) The Development of the Product shall, subject to Section 11.2
of this Agreement, be governed by a development plan
("Development Plan"), which shall provide for the Development
of the Product in the Territory and shall be updated, amended,
supplemented and otherwise modified from time to time by the
JDC. The Parties have agreed upon and approved the Initial
Development Plan which is attached hereto as Exhibit C.
Subject to Schering's obligation to provide the development
funding referred to in Section 3.3 below, Titan and Schering
shall
9
each be responsible for the costs of the Development
activities allocated to that Party pursuant to the Initial
Development Plan.
(c) Applications to carry out clinical studies: Schering shall be
responsible for preparing, filing and prosecuting applications
for permission to conduct Clinical Development in such
countries of the Territory which require such applications to
be filed. With respect to the United States and any other
country where Titan has such an application on file with the
appropriate regulatory authorities, Titan shall transfer such
application to Schering upon Schering's written request
following Schering's decision to initiate the Pivotal Clinical
Trial of the Product and upon Schering's making the Research
Reimbursement payment described in Section 5.1(a) of this
Agreement. Prior to the transfer to Schering, all
communications and interactions with regulatory authorities by
Titan with respect to such applications shall be reviewed and
approved in advance by Schering.
(d) Drug Approval Applications: Schering shall be responsible for
preparing, filing and prosecuting Drug Approval Applications
and seeking Regulatory Approvals for the Product in all
countries of the Territory wherein Schering, in good faith and
in the exercise of reasonable business judgment, considers it
is commercially reasonable to do so, including preparing all
reports necessary as part of a Drug Approval Application.
Schering shall file first for Regulatory Approval in the U.S.,
the European Union, Canada and Japan, in an order acceptable
to Schering. All such Drug Approval Applications shall be
filed in the name of Schering and a copy of each such Drug
Approval Application shall be promptly provided to Titan. In
connection with all Drug Approval Applications being
prosecuted by Schering under this Section 3.2, Schering agrees
to provide Titan with a copy (which may be wholly or partly in
electronic form) of all filings to regulatory agencies that it
makes hereunder within thirty (30) days after written request
by Titan, at no cost to Titan, and Titan shall thereafter, on
reasonable advance notice to Schering, have the right freely
to utilize such filings for its Drug Approval Applications
outside the Field. Titan will inform Schering of all such
utilization of Schering filings for Titan's Drug Approval
Applications outside the Field and shall provide Schering with
such information on such filings as Schering considers
reasonably necessary to safeguard Schering's interests in the
Product.
(e) Cooperation: The Parties shall consult and cooperate
(including in the case of Titan providing such commercially
reasonable assistance as Schering shall reasonably request) in
the preparation of each regulatory submission and in obtaining
and maintaining Regulatory Approvals within the Territory,
provided however, that, except with regard to the pilot U.S.
trial, prior to and following approval of a Drug Approval
Application, Schering shall be solely responsible for
interactions with regulatory authorities throughout the
Territory. In order to facilitate consultation on submissions,
a shared database will be set up using the Schering Globe Doc
System, and the Parties will agree upon the format of
individual reports. Subject to the foregoing, Schering shall
provide Titan and Titan shall provide Schering with reasonable
advance notice of any scheduled meeting with the FDA, EMEA or
any other regulatory authority in a major
10
Certain portions of this Exhibit have been omitted pursuant to a request for
confidentiality. Such omitted portions, which are marked with brackets [ ]
and/or an asterisk *, have been separately filed with the Commission.
regulatory jurisdiction relating to any Drug Approval
Application, and Titan and Schering shall have the right to
participate in any such meeting. Schering shall from time
to time promptly inform Titan about any significant
Regulatory Approval milestones achieved. In connection with
all Drug Approval Applications being prosecuted by Schering
under this Section 3.2, Schering agrees to provide Titan
with a copy (which may be wholly or partly in electronic
form) of all filings to regulatory agencies that it makes
hereunder within thirty (30) days after written request by
Titan, at no cost to Titan. In the event that any
regulatory agency threatens or initiates any action to
remove a Product from the market or there is any recall or
equivalent action (whether voluntary of involuntary) in any
country of the Territory, Schering shall notify Titan of
such communication within three (3) business days of
receipt by Schering. As between the Parties, Schering shall
be the legal and beneficial owner of all Drug Approval
Applications and related approvals in the Territory.
(f) Each Development Plan shall provide a reasonably detailed
written time line for each step to be achieved with respect to
the Development and Regulatory Approval of the Product, the
estimated Development Expenses of obtaining such Regulatory
Approval and the description of a final Product.
(g) Each Development Plan shall be updated annually by the JDC and
submitted by October 1 of each calendar year to the Parties
for review and approval not later than sixty (60) days after
such submission.
3.3 DEVELOPMENT FUNDING: Schering undertakes to provide the following
funding to Titan in order to partially support the conduct by Titan of
the Preclinical and pilot CMC / Manufacturing Development activities
allocated to Titan pursuant to the Development Plan.
In the first Agreement Year: [ * ]
In the second Agreement Year: [ * ]
In the third Agreement Year: [ * ]
The funding referred to in this Section 3.3 will be provided to Titan
by Schering in equal monthly installments in advance, the first payment
to be made within five business days of the Effective Date. Titan
undertakes to use such Development funding exclusively for the purposes
of carrying out its Development obligations hereunder.
3.4 RIGHT TO ENGAGE THIRD PARTIES
Titan may, with the prior written consent of Schering, such consent not
to be unreasonably withheld, engage Third Parties to conduct
Preclinical and CMC / Manufacturing Development assigned to Titan in
the Development Plan as defined in Section 3.2(b).
11
3.5 SCHERING STEP-IN RIGHTS: Without prejudice to any other remedies
available to Schering under this Agreement or at law, if Titan
materially fails to undertake the reasonable Development tasks
allocated to it under this Agreement in accordance with the time lines
and other conditions allocated to it under this Agreement and in
accordance with the time lines and other conditions allocated to it
under the Development Plan and this Agreement generally, Schering may,
after ninety (90) days prior written notice to Titan, undertake that
particular task ("Work") and complete it at its own expense if Titan
has not at such time begun to carry out such Work in a reasonable
manner. Schering shall be entitled to commercially reasonable
cooperation and assistance from Titan to accommodate its efforts,
including assignments to Schering of sponsorship of regulatory filings
if necessary to permit the exercise by Schering of its rights under
this Section 3.5. Costs reasonably incurred by Schering in carrying out
such Work will be reimbursed by Titan on a quarterly basis or may, at
Schering's option, be set off against any payments otherwise due to
Titan under this Agreement; provided, however, that the amount of
reimbursement shall be limited to that portion of the Development
Funding of Section 3.3 allocated to the specific task.
4. COMMERCIALIZATION
4.1 Subject always to Section 11.2 of this Agreement, Schering undertakes
to use commercially reasonable efforts to begin the regular commercial
production, use, and sale of the Product in good faith and as soon as
commercially practicable, and in no event later than six (6) months
from obtaining Regulatory Approval, and to continue diligently
thereafter to commercialize the Product, exercising the same degree of
diligence in Commercialization of the Product as it exercises with
respect to proprietary products of comparable commercial potential.
4.2 Subject to applicable laws and regulations, labeling on all Product
sold by or on behalf of Schering pursuant to this Agreement, and all
advertising, marketing and promotional materials used in connection
therewith, will identify Titan as the licensor of the Product.
5. PAYMENTS
5.1 RESEARCH REIMBURSEMENT: Schering shall make the following payments
("Research Reimbursement") to Titan within thirty (30) business days
after the first achievement of each of the following milestones. Each
of these Research Reimbursement payments shall be paid only once for
Product(s) in the Field regardless of the number of times the
milestones are achieved by the Product or the number of indications for
which the Product is developed or commercialized.
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EVENT PAYMENT
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12
Certain portions of this Exhibit have been omitted pursuant to a request for
confidentiality. Such omitted portions, which are marked with brackets [ ]
and/or an asterisk *, have been separately filed with the Commission.
--------------------------------------------------------------------------------
(a) Schering's decision to initiate Pivotal Clinical [ * ]
Trial of the Product, such decision to be made
within thirty (30) days of delivery of the safety
and efficacy report on the pilot clinical trials
as specified in the Development Plan.
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(b) Regulatory Approval of the Product by [ * ]
the FDA.
--------------------------------------------------------------------------------
(c) Upon Regulatory Approval by EMEA [ * ]
--------------------------------------------------------------------------------
5.2 ROYALTIES:
(a) GENERAL: Subject as hereinafter provided, Schering shall pay
to Titan, on a country-by-country basis, a royalty equal to [
* ] of Net Sales of the Product (the "Royalty Percentage") in
each country for which a Valid Claim of a Titan Patent exists,
such Royalty Percentage to be payable for as long as such a
Valid Claim exists in the country in question.
(b) EXPIRY OF VALID CLAIM: In any country of the Territory in
which a Valid Claim of a Titan Patent existed at the date of
First Commercial Sale but ceases to exist at any time before
the expiry of fifteen (15) years from First Commercial Sale,
the Royalty Percentage will be reduced to [ * ] and will be
payable for the shorter of:
(i) five years from the date on which the Valid Claim
ceased to exist; and
(ii) the period between the date on which the Valid Claim
ceased to exist and the date fifteen years after
First Commercial Sale.
On expiry of the shorter of the above periods, Schering shall
have no obligation to pay any Royalty Percentage to Titan
under this Section 5.2 for the country in question.
(c) NO VALID CLAIM: In each country of the Territory in which a
Valid Claim does not exist at the date of First Commercial
Sale, the Royalty Percentage will be [ * ] of Net Sales, such
Royalty Percentage to be payable to Titan for a period of five
(5) years from First Commercial Sale whereupon Schering's
obligation to pay the Royalty Percentage will cease; provided
however that if, during the five (5) years following First
Commercial Sale, a Valid Claim of a Titan Patent comes into
being in the relevant country, the Royalty Percentage set out
in Section 5.2(a) above shall apply from the date that such
Valid Claim of a Titan Patent exists until the date of expiry
of such Valid Claim.
(d) LICENSE FOLLOWING EXPIRATION: Following the expiration of the
royalty obligations on a country-by-country basis, Schering
shall thereafter have an exclusive (even
13
as to Titan), paid-up license under Titan Know-How to make,
have made, use, sell, offer for sale, have sold and import
the Compound and / or the Product in that country.
(e) ROYALTY REPORTS AND PAYMENTS: Schering shall make royalty
payments to Titan quarterly within fifty-five (55) days after
the end of each calendar quarter in which Net Sales occurred.
A report summarizing the Net Sales of the Products during the
relevant quarter on a country-by-country basis shall be
delivered to Titan within fifty-five (55) days following the
end of each calendar quarter for which royalties are due.
(f) PAYMENTS; INTEREST: Any payments due under this Agreement
shall be due on such date as specified in this Agreement and,
in the event such date is a day on which commercial banks are
not authorized to conduct business in either San Francisco,
California, or Berlin, Germany, then the next succeeding
business day, and shall be made by wire transfer to a
designated bank account of the receiving Party. Any failure by
a Party to make a payment within five days after the date when
due shall obligate such Party to pay interest to the receiving
Party at a rate per annum equal to 2% (two per cent) over the
prime rate as quoted by Bank America on Reuters screen
"USPRIME1" as of the date such payment is due or the following
business day, from the due date until the payment date, such
interest also being due on the payment date.
5.3 TAXES: The Party receiving royalties shall pay any and all taxes levied
on account of royalties it receives under this Agreement. If laws or
regulations require that taxes be withheld, the Party remitting
royalties will (a) deduct those taxes from the remittable royalty, (b)
timely pay the taxes to the proper taxing authority, and (c) send proof
of payment to the other Party within thirty (30) days of receipt of
confirmation of payment from the relevant taxing authority. The Party
remitting royalties agrees to make all lawful and reasonable efforts to
minimize such taxes to the other Party.
5.4 PAYMENTS TO OR REPORTS BY AFFILIATES: Any payment required under any
provision of this Agreement to be made to either Party or any report
required to be made by any Party shall be made to or by an Affiliate of
that Party if designated by that Party as the appropriate recipient or
reporting entity without relieving such Party from responsibility for
such payment or report.
5.5 PAYMENT CURRENCY: Payments by Schering under this Agreement shall be
made in U.S. dollars. Except for Net Sales in the United States, where
payments are based on Net Sales in countries other than the member
states of the European Currency Union, the amount of such payments
expressed in the currency of each country shall be converted into Euros
at the exchange rate of the last date of the applicable calendar
quarter. The applicable exchange rate will be the Euro foreign exchange
reference spot rate published daily by the European Central Bank,
Frankfurt/Main. If no Euro foreign exchange reference spot rate is
determined for the relevant currency, the Parties shall agree upon
another reference rate. Finally, the payable Euro amount shall be
converted into US dollars by the Euro foreign exchange reference spot
published by the European Central
14
Bank, Frankfurt/Main, at the last day of the applicable calendar
quarter. These Euro foreign exchange reference spot rates are
currently published by Reuters on screen "ECB37."
6. MANUFACTURE AND SUPPLY
Schering will be responsible for the manufacture of Compound and
Product for use and sale in the Field in the Territory. Titan will
grant to Schering a sublicense under the License and Supply Agreement
effective January 1, 1999, between Theracell Inc. and Xxxxxxx Biolytica
AB, as may be required for the Development and Commercialization of the
Product in the Field. Schering shall thereafter be responsible for
payment of all royalties to Xxxxxxx Biolytica AB. If and when, but only
if and when, Schering exercises the specific option set forth in
Section 13.15(b)(iv) (and not any other option set forth in Section
13.15), then Titan agrees that it will work with Xxxxxxx Biolytica AB
to arrange for assignment of the License and Supply Agreement of
January 1, 1999, to Schering, or alternatively, at Titan's option, for
the right of Schering to negotiate its own supply agreement with
Xxxxxxx Biolytica AB. Titan agrees to take any actions and execute any
documents that Schering may reasonably request to accomplish the intent
of this Section.
7. CONFIDENTIALITY
7.1 CONFIDENTIALITY; EXCEPTIONS: Except to the extent expressly authorized
by this Agreement or otherwise agreed in writing, the Parties agree
that the receiving Party and its employees (who shall be bound in
writing to observe the confidentiality provisions of this Agreement)
shall keep confidential and shall not publish or otherwise disclose or
use for any purpose other than as provided for in this Agreement any
information and other information and materials furnished to it by the
other Party pursuant to this Agreement or any information developed
during the course of the collaboration hereunder, or any provisions of
this Agreement that are the subject of an effective order of the U.S
Securities and Exchange Commission granting confidential treatment
pursuant to the Securities Act of 1934, as amended (collectively,
"Confidential Information"), except to the extent that it can be
established by the receiving Party that such Confidential Information:
(i) was already known to the receiving Party, other than
under an obligation of confidentiality, at the time
of disclosure by the other Party;
(ii) was generally available to the public or otherwise
part of the public domain after its disclosure and
other than through any act or omission of the
receiving Party in breach of this Agreement;
(iii) became generally available to the public or otherwise
part of the public domain after its disclosure and
other than through any act or omission of the
receiving Party in breach of this Agreement;
(iv) was disclosed to the receiving Party, other than
under an obligation of confidentiality, by a Third
Party who had no obligation to the disclosing Party
not to disclose such information to others; or
15
(v) was independently discovered and / or developed by
the receiving Party as documented in its corporate
records.
7.2 AUTHORIZED DISCLOSURE: Each Party may disclose Confidential Information
hereunder to the extent such disclosure is reasonably necessary in
filing or prosecuting patent applications, prosecuting or defending
litigation, filing or updating any Drug Approval Application, complying
with applicable governmental laws, rules and regulations or conducting
preclinical or clinical trials or, in the case of Schering, engaging in
marketing, sales, professional services, professional education, or
adverse events or complaint collecting analysis or reporting
activities; provided, that if a Party is required by law or regulation
to make any such disclosures of the other Party's Confidential
Information it will, except where impracticable for necessary
disclosures, for example in the event of medical emergency, give
reasonable advance notice to the other Party of such disclosure
requirement and, except to the extent inappropriate in the case of
patent applications, will use its reasonable efforts to secure
confidential treatment of such Confidential Information required to be
disclosed. In addition and with prior written notice to the other Party
of each Third Party with whom a confidential disclosure agreement is
being entered into, each Party shall be entitled to disclose, under a
binder of confidentiality, Confidential Information to any Third Party
for the purpose of carrying out the purposes of this Agreement. Where
materiality of disclosure requires a press release or other disclosure
pertaining to this Agreement by one Party, the disclosing Party shall
give the other Party a copy of the proposed disclosure and afford that
Party at least two (2) business days.
7.3 SURVIVAL: This Article 7 shall survive the termination or expiration of
this Agreement for a period of five (5) years.
7.4 TERMINATION OF PRIOR AGREEMENT: This Agreement supersedes the
Confidentiality Agreement between Titan and Schering dated as of
January 22, 1999. All Information exchanged between the Parties under
the said Confidentiality Agreement shall be deemed to be Confidential
Information and shall be subject to the terms of this Article 7, and
shall be included within the definition of Confidential Information.
7.5 PUBLICATIONS: Schering shall determine the overall strategy
for publication in support of the Product in the Territory.
7.6 PUBLICITY REVIEW: Subject to the other provisions of this Section 7, no
Party shall originate any written publicity, news release, or other
announcement or statement relating to this Agreement or to performance
hereunder or the existence of an arrangement between the Parties
(collectively "Written Disclosure") without the prior prompt review and
written approval of the other Party, which approval shall not be
unreasonably withheld or delayed. Notwithstanding the foregoing
provisions of this Section 7.6, any Party may make any public Written
Disclosure it believes in good faith based upon the advice of counsel
is required by applicable law or any listing or trading agreement
concerning its publicly traded securities, provided that prior to
making such Written Disclosure, the disclosing Party shall provide the
other Party with a copy of the materials
16
Certain portions of this Exhibit have been omitted pursuant to a request for
confidentiality. Such omitted portions, which are marked with brackets [ ]and/or
an asterisk *, have been separately filed with the Commission.
proposed to be disclosed and provide the receiving Party with at least
two (2) business days to review the proposed Written Disclosure.
8. OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS
8.1 OWNERSHIP: Each Party shall solely own any inventions made solely by
that Party's employees or consultants in the course of performing
work under this Agreement. Inventions made jointly by employees or
consultants of Titan and Schering and any Patents resulting therefrom
shall be owned by Schering subject to the licenses granted to Titan
pursuant to Section 11.2. However, Titan will have a worldwide
non-exclusive license to such Patents for use outside the Field, with
royalties under the license to be negotiated by the parties in good
faith (but in no event shall the royalties exceed [ * ] of net sales).
8.2 DISCLOSURE OF JOINT INVENTIONS: Any such patent application disclosing
inventions made jointly by the Parties shall be provided by one Party
to the other reasonably in advance of the intended date for submission
of such application to a governmental patent authority.
8.3 PATENT FILINGS
(a) Each Party, at its sole discretion, cost and responsibility,
shall prepare, file, prosecute and maintain Patents to cover
discoveries and inventions made solely by its own employees or
consultants relating to Compound or Product and use
commercially reasonable efforts to file initially all such
applications in the Territory or the appropriate forum under
the circumstances wherein such a Party determines it is
commercially reasonable to do so. Schering shall file,
prosecute and maintain Patents to cover inventions relating to
the discovery, evaluation, manufacture, use or sale of the
Compound or the Product that are made jointly by personnel of
Titan and Schering in the course of the collaboration (herein
referred to as "Joint Patents"). The determination of the
countries in the Territory in which to file Joint Patents
shall be made by Schering. Schering shall have the right to
direct and control all material actions relating to the
prosecution or maintenance of Joint Patents in the Territory,
including interference proceedings, reexaminations, reissue
opposition and revocation proceedings.
(b) The Parties agree to use commercially reasonable efforts to
ensure that any Patent filed outside the United States prior
to a filing in the United States will be in a form sufficient
to establish the date of original filing as a priority date
for the purposes of a subsequent filing in the United States.
Schering shall bear all costs related to the filing of Joint
Patents. The Parties agree to use commercially reasonable
efforts to ensure that any Patent filed in the United States
prior to filings outside of the United States will be in a
form sufficient to establish the date of original filing as a
priority date for the purpose of a subsequent filing in any
contracting state of the Paris Convention.
17
8.4 THIRD PARTY PATENTS: Each Party agrees to bring to the attention of the
other Party any Third Party Patent it discovers or has discovered and
which relates to the subject matter of this Agreement.
8.5 ENFORCEMENT RIGHTS:
(a) NOTIFICATION OF INFRINGEMENT: If either Party learns of any
infringement or threatened infringement by a Third Party of
Titan Patents, Schering Patents or Joint Patents, such Party
shall promptly notify the other Party and shall provide such
other Party with all available evidence of such infringement.
(b) ENFORCEMENT IN THE TERRITORY: Subject to the next sentence,
Titan shall be obligated, at its own expense, to defend Titan
Patents and Schering shall be obligated, at its own expense,
to defend Joint Patents in the Territory. Schering shall have
the right but not the obligation to institute, prosecute and
control at its own expense any action or proceeding with
respect to infringement of any Titan Patents or Joint Patents
covering the manufacture, use, importation, sale or offer for
sale of the Product in the Territory, by counsel of its own
choice. Titan shall have the right, at its own expense, to be
represented in any action by counsel of its own choice. If
Schering fails to bring an action or proceeding or otherwise
take appropriate action to xxxxx such infringement within a
period of one hundred eighty (180) days of notice by Titan to
Schering requesting action, Titan will have the right to bring
and control any such action or proceeding relating to Titan
Patents by counsel of its own choice and Schering will have
the right to be represented in any such action by counsel of
its own choice and at its own expense. If one Party brings any
such action or proceeding, the other Party agrees to be joined
as a party plaintiff if necessary to prosecute the action or
proceeding and to give the first Party commercially reasonable
assistance and authority to file and prosecute the suit. Any
damages or other monetary awards recovered pursuant to this
Section 8.5(b) shall be allocated first to the costs and
expenses of the party bringing suit, then to the costs and
expenses, if any, of the other Party. In the event that
Schering brings such action, any amounts remaining shall be
distributed as follows: compensatory damages shall be treated
as Net Sales in the country and calendar quarter received and
punitive and exemplary damages shall be paid equally to
Schering and Titan. In the event that Titan brings such
action, any damages or other monetary awards recovered shall
be divided equally between the Parties.
(c) SETTLEMENT WITH A THIRD PARTY: The Party that controls the
prosecution of a given action shall also have the right to
control settlement of such action, provided however, that if
one Party controls, no settlement shall be entered into
without the written consent of the other Party (which consent
shall not be unreasonably withheld) if such settlement would
materially and adversely affect the interests of the other
Party.
18
8.6 DEFENSE AND SETTLEMENT OF THIRD PARTY CLAIMS: If a Third Party asserts
that a patent owned by it is infringed by any Product, Titan will be
solely responsible for defending against any such assertions at its
cost and expense (subject to the provisions of Section 8.5(b)), but no
settlement may be entered into without the written consent of Schering,
which shall not be unreasonably withheld. The costs of any such
settlement (including, without limitation, damages, expense
reimbursements, compliance, future royalties or other amounts) shall be
paid exclusively by Titan. If any Third Party is successful in any such
claim and Schering is ordered to make any payments to such Third Party
in connection therewith, any such payments may be offset or deducted
from the payment obligations of Schering under the Agreement.
8.7 PATENT EXPENSES: All worldwide Patent Expenses with respect to Titan
Patents shall be borne by Titan and all worldwide Patent Expenses with
respect to Joint Patents shall be borne by Schering, subject in both
cases to the terms of this Agreement.
8.8 TRADEMARKS: Schering shall be responsible for the selection,
registration and maintenance of all trademarks which it employs in
connection with the Product and shall own and control such trademarks
and pay any costs in connection therewith. Titan recognizes the
exclusive ownership by Schering of the proprietary Schering name,
logotype or trademark furnished by Schering (including Schering's
Affiliates) for use in connection with the Product. Titan shall not,
either while this Agreement is in effect or at any time thereafter
register, use or attempt to obtain any right in or to any such name,
logotype or trademark or in and to any name, logotype or trademark
confusingly similar thereto. Only Schering will be authorized to
initiate, at its own discretion and at its own cost, legal proceedings
against any infringement or threatened infringement of the trademarks
applicable to the Product.
8.9 USE OF NAMES: Neither Party shall use the name of the other Party in
relation to this transaction in any public announcement, press release
or other public document without the written consent of such other
Party, which consent shall not be unreasonably withheld or delayed,
provided however, that either Party may use the name of the other Party
in any document filed with any regulatory agency or authority,
including the FDA and the Securities and Exchange Commission, in which
case Schering shall be referred to as "Schering AG, Germany". The
Parties agree not to use the name of the other Party in relation to
this transaction in any press release, public announcement or other
public document without the approval of such other Party, which
approval shall not be unreasonably withheld or delayed.
8.10 NO TRADEMARK RIGHTS: Except as otherwise provided herein, no right,
express or implied, is granted by this Agreement to use in any manner
the name "Schering" or "Titan" or any other trade name or trademark of
the other Party or its Affiliates in connection with the performance of
this Agreement.
9. REPRESENTATIONS AND WARRANTIES
9.1 REPRESENTATIONS AND WARRANTIES:
19
(a) Each of the Parties hereby represents and warrants to the
other Party as follows:
(i) The Agreement is a legal and valid obligation binding
upon such Party and enforceable in accordance with
its terms. The execution, delivery and performance of
the Agreement by such Party does not conflict with
any agreement, instrument or understanding, oral or
written, to which it is a party or by which it is
bound, nor to such Party's knowledge, violate any
law or regulation of any court, governmental body or
administrative or other agency having jurisdiction
over it;
(ii) Titan has not granted and during the term of the
Agreement neither Party will grant any right to any
Third Party relating to the Titan Patents, Titan
Know-How and Joint Patents in the Field which would
conflict with the rights granted to either Party
hereunder.
(b) Titan hereby represents and warrants to Schering that Titan:
(i) Has provided or shown to Schering all information in
its possession or control or of which it is aware as
of the Effective Date, concerning efficacy, side
effects, injury, toxicity or sensitivity, reaction
and incidents of severity thereof, associated with
any clinical use, studies, investigations or tests
with the Product (animal or human), whether or not
determined to be attributable to the Product.
(ii) Has conducted or has caused its contractors or
consultants to conduct, and will in the future
conduct, the preclinical and clinical studies of the
Product in accordance with applicable United States
law, known or published standards of the FDA, and the
scientific standards applicable to the conduct of
studies in the United States.
(iii) Has employed and will in the future employ
individuals of appropriate education, knowledge, and
experience to conduct or oversee the conduct of
Titan's clinical and preclinical studies of the
Product.
(iv) Has not employed (and, to the best of its knowledge,
has not used a contractor or consultant that has
employed) and in the future will not employ (or, to
the best of its knowledge, use any contractor or
consultant that employs) any individual or entity
debarred by the FDA or, to the best knowledge of
Titan, any individual who or entity which is the
subject of an FDA debarment investigation or
proceeding (or similar proceeding of the EMEA), in
the conduct of the preclinical or clinical studies of
the Product.
(v) In the course of developing the Product, has not
conducted, and during the course of this Agreement it
will not conduct, any Development activities in
violation of applicable GCPs, GLPs or GMPs;
20
(vi) As of the Effective Date, except as it may have
previously disclosed to Schering in writing, has not
received any notices of infringement or any written
communications relating in any way to a possible
infringement with respect to the Compound or any
potential Products, and that it is not aware that the
manufacture, use or sale of Compound or any potential
Products infringes any Third Party patent rights.
(vii) As of the Effective Date, it is not aware of any
prior act or any fact which causes it to conclude
that any Titan patent is invalid or unenforceable.
(viii) Has complied in all material respects with each
license listed on Exhibit B hereto, and during the
term hereof will comply in all material respects and
use all reasonable efforts to keep in full force and
effect each such license; neither this Agreement nor
any of the transactions contemplated hereby will,
with the giving of notice or the lapse of time or
both constitute a default or breach of any such
license.
(ix) Titan has obtained or licensed all rights to the
Compound and the Titan Patents and the Titan Know-How
free and clear of any liens, encumbrances or rights
to repurchase.
(x) During the term hereof, Titan will not xxxxx x xxxx
on this Agreement or on any of Titan's rights or
obligations hereunder or on the Titan Patents or
Titan Know-How related to the Product.
(c) Schering hereby represents and warrants that Schering:
(i) Will conduct or cause its contractors and consultants
to conduct, the preclinical and clinical studies of
the Product in accordance with applicable United
States law, known or published standards of the FDA
and EMEA, and the scientific standards applicable to
the conduct of studies in the United States and the
European Union.
(ii) Will not employ (or, to the best of its knowledge,
use any contractor or consultant that employs) any
individual or entity debarred by the FDA (or subject
to a similar sanction of EMEA) or, to the best
knowledge of Schering, any individual who or entity
which is the subject of an FDA debarment
investigation or proceeding (or similar proceeding of
the EMEA), in the conduct of the preclinical or
clinical studies of the Product.
(iii) In the course of developing the Product, will not
conduct any Development activities in violation of
applicable GCPs, GLPs, or GMPs.
9.2 INDEMNIFICATION FOR BREACHES OF REPRESENTATIONS AND WARRANTIES: Without
prejudice to any other right or remedy available to either Party
arising out of the breach by the other of any of the representations
and warranties set out in Section 9.1 above, each Party hereby agrees
to indemnify, defend, and hold the other Party and its shareholders,
directors, officers, agents and employees harmless from and against any
and all losses
21
resulting directly or indirectly from the breach of any
representation or warranty made by such Party hereunder. In the event
that a Party is seeking indemnification under this Section 9.2, it
shall inform the other Party of a claim as soon as reasonably
practicable after it receives notice of the claim, shall permit the
indemnifying Party to assume direction and control of the defense of
the claim (including the right to settle the claim solely for monetary
consideration), and shall cooperate as requested (at the expense of the
indemnifying Party) in defense of the claim.
9.3 PERFORMANCE BY AFFILIATES: The Parties recognize that each Party may
perform some or all of its obligations under this Agreement through
Affiliates, provided however, that each Party shall remain responsible
for and be a guarantor of the performance by its Affiliates and shall
cause its Affiliates to comply with the provisions of this Agreement in
connection with such performance.
10. INFORMATION AND REPORTS
10.1 INFORMATION AND REPORTS DURING DEVELOPMENT AND COMMERCIALIZATION:
Schering and Titan will disclose and make available (subject to any
confidentiality agreements or requirements of law) to each other
without charge all preclinical, clinical, regulatory and other
Information, including copies of all preclinical and clinical reports
known by Schering or Titan directly concerning the Product within the
Field at any time during the term of this Agreement. Each Party shall
own and maintain its own database of clinical trial data accumulated
from all clinical trials of the Product for which it was responsible
and of adverse drug event information for the Product. At the option of
the requesting Party, such data shall be provided in a computer
readable or other electronic format by the providing Party, to the
extent available, which shall also assist in the transfer and
validation of such data to the receiving Party. Without limitation of
the foregoing, each Party shall supply to the other the information
required by the other Party and requested by it (either as a routine
practice or as a specific request) for purposes of compliance with
regulatory requirements. With respect to information concerning
Commercialization, Schering agrees to keep Titan regularly informed on
all post marketing activities but shall have no obligation, except as
specifically set out in this Agreement, to share pricing, marketing or
sales information with Titan.
10.2 ADVERSE DRUG EXPERIENCES; COMPLAINTS: The Parties agree to enter into a
standard operating procedure by and between the Parties to govern the
exchange of information relating to adverse drug experiences, Product
quality and Product complaints.
10.3 RECORDS OF REVENUES AND EXPENSES: Each Party will maintain complete and
accurate records which are relevant to revenues, costs, expenses and
payments on a country-by-country basis in the Territory under this
Agreement and such records shall be open during reasonable business
hours for a period of three (3) years from creation of individual
records for examination at the other Party's expense and not more often
than once each year by a firm of certified public accountants selected
by the other Party, or the other Party's internal accountants unless
the first Party objects to the use of such internal accountants, for
the sole purpose of verifying for the inspecting Party the correctness
of calculations and classifications of such revenues, costs, expenses
or payments made
22
under this Agreement. Each Party shall bear its own costs related to
such audit; provided that, for any underpayments greater than five
(5) percent by Schering, Schering shall pay Titan the amount of
underpayment, interest as provided for in Section 5.2(f) from the
time the amount was due and Titan's out-of-pocket expenses. For any
underpayments less than five (5) percent by Schering found under
this Section, Schering shall pay Titan the amount of underpayment.
Any overpayments by Schering will be credited to future royalties.
Any records or accounting information received from the other Party
shall be Confidential Information for purposes of Article 7. Results
of any such audit shall be provided to both Parties, subject to
Article 7.
10.4 If there is a dispute between the Parties following any audit performed
pursuant to Section 10.3, either Party may refer the issue (an "Audit
Disagreement") to an independent certified public accountant for
resolution. In the event an Audit Disagreement is submitted for
resolution by either Party, the Parties shall comply with the following
procedures: (a) the Party submitting the Audit Disagreement for
resolution shall provide written notice to the other Party that it is
invoking the procedures of this Section 10.4; (b) within thirty (30)
days of the giving of such notice, the Parties shall jointly select a
recognized international accounting firm to act as an independent
expert to resolve such Audit Disagreement; (c) the Audit Disagreement
submitted for resolution shall be described by the Parties to the
independent expert, which description may be in written or oral form,
within ten (10) business days of the selection of such independent
expert; (d) the independent expert shall render a decision on the
matter as soon as practicable but in no event more than sixty (60) days
after submission of the Audit Disagreement to the expert; (e) the
decisions of the independent expert shall be final and binding unless
such Audit Disagreement involves alleged fraud, breach of this
Agreement, or construction or interpretation of any of the terms and
conditions thereof; (f) all fees and expenses of the independent
expert, including any third party support staff or other costs incurred
with respect to carrying out the procedures specified at the direction
of the independent expert in connection with such Audit Disagreement,
shall be borne by each Party in inverse proportion to the disputed
amounts awarded to the Party by the independent expert through such
decision (e.g., Party A disputes $100, the independent expert awards
Party A $60, then Party A pays forty percent (40%) and Party B pays
sixty percent (60%) of the independent expert's costs.)
11. TERM AND TERMINATION
11.1 TERM: This Agreement shall commence as of the Effective Date and,
unless sooner terminated as provided herein shall continue in effect
until such time as no royalties are payable under Article 5 hereunder
to Titan, provided that the license to Titan Know-How granted pursuant
to Section 2 shall survive such termination.
11.2 TERMINATION
(a) EARLY TERMINATION: In the event that Schering elects not to
initiate the Pivotal Clinical Trial of the Product pursuant to
Section 5.1(a), this Agreement shall terminate, and all
payments made by Schering to Titan shall be retained by Titan;
and Titan shall retain full rights to use any data and
information generated, up to
23
the date of termination, by Titan, Schering, or jointly
pertaining to the Compound and the Product.
(b) TERMINATION AT WILL: Schering will have the right to terminate
this Agreement for the Territory or on a country-by-country
basis and be fully released of all obligations hereunder
(except as expressly provided for herein) by ninety (90) days'
notice given at any time, and Titan shall thereafter retain
full rights to use any data and information generated, up to
the date of termination, by Titan, Schering, or jointly
pertaining to the Compound and the Product.
(c) TERMINATION FOR MATERIAL BREACH: Failure by Schering or Titan
to comply with any of the respective material obligations and
conditions contained in this Agreement shall entitle the other
Party to give the Party in default notice requiring it to cure
such default. If such default is not cured within ninety (90)
days after receipt of such notice, the notifying Party shall
be entitled (without prejudice to any of its other rights
conferred by this Agreement) to terminate this Agreement or,
in the event of an uncured material breach by Titan, to invoke
the rights of Schering set forth in Section ll.2(f) by giving
a notice to take effect immediately. The right of either Party
to terminate this Agreement as hereinabove provided shall not
be affected in any way by its waiver of, or failure to take
action with respect to, any previous default.
(d) TERMINATION FOR INSOLVENCY: In the event that one of the
Parties hereto shall go into liquidation, a receiver or a
trustee be appointed for the property or estate of that Party
and said receiver or trustee is not removed within sixty (60)
days, or the Party makes an assignment for the benefit of
creditors (collectively, a "Bankruptcy Event"), and whether
any of the aforesaid Bankruptcy Events be the outcome of the
voluntary act of that Party or otherwise, the other Party
shall be entitled to terminate this Agreement (or in the event
Titan suffers such a Bankruptcy Event, Schering may effect its
rights described in Section 11.2(f) forthwith by giving a
written notice to Titan.
(e) EFFECT OF TERMINATION: In the event that this Agreement is
terminated by Schering in one or more countries or in its
entirety in accordance with Section 11.2(b), or this Agreement
is terminated by Titan pursuant to Section 11.2(c) either in
one country or in its entirety, Schering will, with respect to
each country to which the termination applies:
(i) deliver to Titan the Titan Know-How and assign to
Titan its rights in said Titan Know-How and Titan
Patents, if any, in either case relating solely to
the country that is the subject of the termination;
(ii) not use the Titan Know-How as long as it has to be
kept confidential pursuant to Article 7 hereof in
such country;
(iii) not infringe any of the Titan Patents in such
country;
24
(iv) transfer all regulatory filings and approvals related
to the Product in such country to Titan upon
Titan's written request for same;
(v) sell to Titan, at any time within ninety (90) days of
such termination, at Titan's election, all or any
portion of the inventory of the Compound or Product
owned by Schering or its Affiliates which are
intended for sale in such country at a price equal to
Schering's or its Affiliate's cost for such
inventory; such election shall be made by Titan in
writing and within thirty (30) days of such election
Schering shall ship, at Titan's cost and
direction such inventory to Titan. Titan shall pay
for such inventory within forty-five (45) days of
receipt of such inventory.
(f) EFFECT OF TERMINATION BY SCHERING PURSUANT TO SECTIONS 11.2(C)
AND (D): In the event of a Bankruptcy Event or a material
default described in Sections 11.2(c) and (d) by Titan, which
default is not cured as provided therein, Schering may elect
in lieu of terminating this Agreement to declare the license
granted pursuant to this Agreement to be irrevocable. From the
date of receipt of notice of such election, Titan shall have
no further rights or obligations (except for those arising
under Section 7.3) under this Agreement except that Titan may
enforce any financial obligations of Schering provided that if
such election occurs prior to the First Commercial Sale of the
Product, any additional Development Expenses and any
reasonable costs incurred by Schering to Commercialize the
Product as a result of such election shall be credited against
amounts payable by Schering to Titan.
(g) GENERAL: Except where expressly provided for otherwise in this
Agreement, termination of this Agreement shall not relieve the
Parties hereto of any liability, including any obligation to
make payments hereunder, which accrued hereunder prior to the
effective date of such termination nor preclude any Party from
pursuing all rights and remedies it may have hereunder or at
law or in equity with respect to any breach of this Agreement
nor prejudice any Party's right to obtain performance of
any obligation.
(h) SURVIVING RIGHTS: The rights and obligations set forth in this
Agreement shall extend beyond the term or termination of the
Agreement only to the extent expressly provided for herein, or
the extent that the survival of such rights or obligations are
necessary to permit their complete fulfillment or discharge.
12. INDEMNIFICATION
12.1 Sections 14 and 15, the indemnification and insurance provisions of the
NYU License (Exhibit B), are incorporated herein by reference. NYU is
an intended third party beneficiary of this Agreement for purposes of
enforcing such indemnification and insurance provisions.
12.2 INDEMNIFICATION BY SCHERING FOR NEGLIGENCE, WILLFUL MISCONDUCT, OR
BREACH: Schering shall indemnify, defend and hold harmless Titan and
its shareholders, employees, agents,
25
officers, managers, partners and directors and each of them (a
"Titan Indemnified Party") from and against any and all Third Party
claims, causes of action, losses, damages and costs (including
reasonable attorneys' fees regardless of outcome) of any nature made
or asserted against a Titan Indemnified Party or lawsuits or other
proceedings filed or otherwise instituted against a Titan
Indemnified Party, in each case by a Third Party (hereinafter
individually and collectively (a) "Titan Loss(es)") resulting from
or arising out of the development, manufacture, sale or marketing of
Product in the Territory but solely to the extent that such Titan
Loss(es) arise out of or result from the negligence or willful
misconduct of Schering, its Affiliates or sublicensees or the breach
by Schering, its Affiliates or sublicensees of any of its or their
representations or warranties or obligations or covenants hereunder.
12.3 INDEMNIFICATION BY TITAN FOR NEGLIGENCE, WILLFUL MISCONDUCT, OR BREACH:
Titan shall indemnify, defend and hold harmless Schering and its
Affiliates and their respective shareholders, employees, agents,
officers, managers, partners and directors and each of them (a
"Schering Indemnified Party") from and against any and all Third Party
claims, causes of action, losses, damages and costs (including
reasonable attorney's fees regardless of outcome) of any nature
made or asserted against a Schering Indemnified Party, in each case by
a Third Party (hereinafter individually and collectively (a) "Schering
Loss(es)" resulting from or arising out of the manufacture, use,
marketing or sale of Product in the Territory but solely to the extent
that such Schering Loss(es) arise out of or result from the negligence
or willful misconduct of Titan or its Affiliates, or the breach by
Titan or its Affiliates of any of its or their representations or
warranties or obligations or covenants hereunder.
12.4 CONDITIONS TO INDEMNIFICATION: A person or entity that intends to claim
indemnification under this Article 12 (the "Indemnitee") shall promptly
notify the other party (the "Indemnitor") of any Schering Loss(es) or
Titan Loss(es) as the case may be in respect of which the Indemnitee
intends to claim such indemnification. Indemnitor shall have the right
to control the defense of any Schering Loss(es) or Titan Loss(es) as
the case may be as to which the obligation to indemnify the Indemnitee
has been acknowledged by the Indemnitor in writing under Section 12.2
or 12.3. The indemnity agreement in this Article 12 shall not apply to
amounts paid in settlement of any loss, claim, damage, liability or
action if such settlement is effected without the consent of the
Indemnitor, which consent shall not be withheld or delayed
unreasonably. The failure to deliver notice to the Indemnitor within a
reasonable time after the commencement of any such action, only if
prejudicial to its ability to defend such action, shall relieve such
Indemnitor of any liability to the Indemnitee under this Article 12,
but the omission so to deliver notice to the Indemnitor will not
relieve it of any liability that it may have to any Indemnitee
otherwise than under this Article 12. The Indemnitee under this Article
12, its employees and agents shall cooperate fully with the Indemnitor
and its legal representatives in the investigations and defense of any
action, claim or liability covered by this indemnification. The
Indemnitee shall have the right to participate in the defense of such
action.
13. MISCELLANEOUS
26
13.1 ASSIGNMENT:
(a) Schering may assign any of its rights or obligations under
this Agreement in any country to any of its Affiliates,
provided that such assignment shall not relieve Schering of
its responsibilities for performance of its obligations under
this Agreement.
(b) Titan may assign any of its rights or obligations under this
Agreement in any country to any of its Affiliates, and Titan
may assign its rights or obligations under this Agreement as
part of a transaction such as a merger, acquisition, or sale
of all or substantially all of the assets of Titan; provided
that such assignment shall not relieve Titan of its
responsibilities for performance of its obligations under this
Agreement; and provided further that the financial obligations
of Schering shall survive any such assignment.
(c) This Agreement shall be binding upon and inure to the benefit
of the successors and permitted assigns of the Parties. Any
assignment not in accordance with this Agreement shall be
void.
13.2 RETAINED RIGHTS: Nothing in this Agreement shall limit in any respect
the right of either Party to conduct research and development and to
market products using such Party's technology other than as herein
expressly provided.
13.3 FURTHER ACTIONS: Each Party agrees to execute, acknowledge and deliver
such further instruments, and to do all such other acts as may be
necessary or appropriate in order to carry out the purposes and intent
of this Agreement.
13.4 NOTICES: All notices hereunder shall be in writing and shall be deemed
given if delivered personally or two days after mailed by registered or
certified mail (return receipt requested), postage prepaid, or sent by
express courier service, to the Parties at the following addresses (or
at such other address for a Party as shall be specified by like notice;
provided that notices of a change of address shall be effective only
upon receipt thereof).
(a) If to Titan:
Titan Pharmaceuticals, Inc.
000 Xxxxxx Xxxxx Xxxxxxxxx, Xxxxx 000
Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 94080
U.S.A.
Attn.: President and CEO
27
(b) If to Schering:
Schering AG
Xxxxxxxxxxxxxx 000
Xxxxxx-Xxxxxxx
X-00000 Xxxxxx
Xxxxxxx
Attn.: Legal Department
13.5 WAIVER: Except as specifically provided for herein, the waiver from
time to time by either of the Parties of any of their rights or their
failure to exercise any remedy shall not operate or be construed as a
continuing waiver of same or any other of such Party's rights or
remedies provided in this Agreement.
13.6 SEVERABILITY: If any term, covenant or condition of this Agreement or
the application thereof to any Party or circumstances shall, to any
extent or in any country, be held to be invalid or unenforceable, then
(i) the remainder of this Agreement, or the application of such term,
covenant or condition of this Agreement shall be valid and be enforced
to the fullest extent permitted by law; and (ii) the Parties hereto
covenant and agree to renegotiate any such term, covenant or
application thereof in good faith in order to provide a reasonably
acceptable alternative to the term, covenant or condition of this
Agreement or the application thereof that is invalid or unenforceable,
it being the intent of the Parties that the basic purposes of this
Agreement are to be effected.
13.7 AMBIGUITIES: Ambiguities, if any, in this Agreement shall not be
construed against any Party, irrespective of which Party may be deemed
to have authored the ambiguous provision.
13.8 GOVERNING LAW AND JURISDICTION: This Agreement shall be governed by and
interpreted under the laws of the State of New York as applied to
contracts entered into and performed entirely in New York by New York
residents.
13.9 HEADINGS: The sections and paragraph headings contained herein are for
the purposes of convenience only and are not intended to define or
limit the contents of said sections or paragraphs.
13.10 COUNTERPARTS: This Agreement may be executed in one or more
counterparts (and by facsimile), each of which shall be deemed an
original but all of which together shall constitute one and the same
instrument.
13.11 ENTIRE AGREEMENT; AMENDMENTS: This Agreement, including all Exhibits
attached hereto and thereto, and all documents delivered concurrently
herewith and therewith, set forth all the covenants, promises,
agreements, warranties, representations, conditions and understandings
between the Parties hereto and supersede and terminate all prior
agreements and understandings between the Parties. There are no
covenants, promises, agreements, warranties, representations,
conditions or understandings, either oral or written, between the
Parties other than as set forth herein and therein. No subsequent
28
Certain portions of this Exhibit have been omitted pursuant to a request for
confidentiality. Such omitted portions, which are marked with brackets [ ]
and/or an asterisk *, have been separately filed with the Commission.
alteration, amendment, change or addition to this Agreement shall be
binding upon the Parties hereto unless reduced to writing and signed by
the respective authorized officers of the Parties. This Agreement,
including without limitation the exhibits, schedules and attachments
thereto, are intended to define the full extent of the legally
enforceable undertakings of the Parties hereto, and no promise or
representation, written or oral, which is not set forth explicitly
herein or therein is intended by either Party to be legally binding.
Both Parties acknowledge that in deciding to enter into the Agreement
and to consummate the transaction contemplated hereby neither has
relied upon any statement or representations, written or oral, other
than those explicitly set forth herein.
13.12 EXPENSES: Except as otherwise specified in this Agreement, all costs
and expenses including, without limitation, fees and disbursements of
counsel, financial advisors and accountants, travel, lodging, meals and
entertainment incurred in connection with this Agreement and the
transactions contemplated hereby shall be paid by the Party incurring
such costs and expenses.
13.13 INDEPENDENT CONTRACTORS: The status of the parties under this Agreement
shall be that of independent contractors. Neither Party shall have the
right to enter into any agreements on behalf of the other Party, nor
shall it represent to any person that it has any such right or
authority. Nothing in this Agreement shall be construed as establishing
a partnership or joint venture relationship between the Parties. This
Agreement is not intended to be a partnership between Titan and
Schering for federal, state or local income tax purposes.
13.14 EQUITY INVESTMENT: Upon successful completion of pilot clinical trials
and Schering's decision to enter into Pivotal Clinical Trials, Schering
may make an equity investment of up to [ * ] in Titan on terms to be
mutually agreed upon by the Parties.
13.15 In further consideration for the payments made hereunder, and for other
good and valuable consideration the receipt of which is hereby
acknowledged, Titan extends to Schering a one year worldwide exclusive
option, which option expires on the first anniversary of the Effective
Date of this Agreement ("Option Period"), to enter into a further
License Agreement for any expanded Compound(s) consisting of cells,
other than RPE cells, on microcarriers used in Product(s) for all
indications. Should Schering exercise an Option in this Section 13.15,
the Parties agree to enter into good faith negotiations to conclude a
further definitive License Agreement(s) which, in addition to the terms
and conditions usual and customary in such agreements, shall include at
least the following provisions obligating Schering to take the
following actions:
(a) Prepare and execute a Development Plan for the Product(s) of
the expanded Compound(s) in a manner similar to that set forth
in Section 3.2 of this Agreement.
(b) Pay to Titan a license fee between [ * ], the amount of which
fee shall be mutually agreed upon in good faith and shall be
dependent upon the breadth of the Field, e.g.:
(i) For expanded Compound(s) for a single therapeutic
indication; or
29
Certain portions of this Exhibit have been omitted pursuant to a request for
confidentiality. Such omitted portions, which are marked with brackets [ ]
and/or an asterisk *, have been separately filed with the Commission.
(ii) For expanded Compound(s) for all CNS indications; or
(iii) For expanded Compound(s) for all non-CNS indications;
or
(iv) For expanded Compound(s) for all indications.
Such license fee shall additionally be dependent upon the relative contribution
of each Party to the development of supportive data for such Additional
Indications during the Option Period.
(c) Pay to Titan milestone payments, in amounts to be determined
in good faith negotiations between the Parties, upon the
occurrence of each of the following events:
(i) The submission of an IND to the FDA for a Product
containing an expanded Compound; and
(ii) Regulatory Approval by FDA of a Product containing an
expanded Compound; and
(iii) Regulatory Approval by the EMEA of a Product
containing an expanded Compound.
(d) Pay to Titan royalties on Net Sales of Products covered by the
further License Agreement, on a Product by Product and
country-by-country basis, as follows: [ * ] of Net Sales if
the Product is covered by both a Patent and Titan Know-How; or
[ * ] of Net Sales if the Product is covered only by Titan
Know-How.
IN WITNESS WHEREOF Titan and Schering have caused this
agreement to be executed as of the date first written above by their respective
officers thereunto duly authorized.
SCHERING AG TITAN PHARMACEUTICALS, INC.
BY: /s/ Professor Dr. G. Stock BY: /s/ Xxxxx X. Xxxxxx
---------------------------- ----------------------------
TITLE:____________________________ TITLE:____________________________
SCHERING AG
BY: /s/ Xx. X. Xxxx
--------------------------
TITLE:____________________________
30
EXHIBIT A
U.S. PATENTS AND PATENT APPLICATIONS
Pursuant to Section 2.1 of this Agreement, the following U.S. Patents and Patent
Applications are currently under the control of Titan:
Issued U.S. Patents:
US 5,618,531 Issued April 8, 1997
Method of Increasing Viability of Cells which are Administered to the
Brain or Spinal Cord.
US 5,750,103 Issued May 12, 1998
Method of Transplanting Cells into the Brain and Therapeutic Uses
Therefor.
US Patent Applications:
US 08/460,706 Filed June 2, 1995
Method for Transplanting Cells into the Brain and Therapeutic Uses
Therefor.
US 08/629,308 Filed April 8, 1996
Method for Gene Transfer to the Central Nervous System.
US 09/002,413 Filed January 2, 1998
Use of Pigmented Retinal Epithelial Cells for Creation of an Immune
Privileged Site.
US 09/289,576 Filed April 9, 1999
Methods of Treating Schizophrenia.
31
EXHIBIT B
EXISTING LICENSES
Agreement between New York University and Theracell Corporation, effective
November 20, 1992, with First Amendment to that Agreement effective February 21,
1995, and Second Amendment to that Agreement effective December 1, 1995.
License and Supply Agreement between Theracell Inc. and Xxxxxxx Biolytica AB,
effective January 1, 1999.
32
Certain portions of this Exhibit have been omitted pursuant to a request for
confidentiality. Such omitted portions, which are marked with brackets [ ]
and/or an asterisk *, have been separately filed with the Commission.
EXHIBIT C
INITIAL DEVELOPMENT PLAN
***
33
Certain portions of this Exhibit have been omitted pursuant to a request for
confidentiality. Such omitted portions, which are marked with brackets [ ]
and/or an asterisk *, have been separately filed with the Commission.
***
34
