Exhibit 10.14
*** Indicates portions subject to a request for confidential treatment and
filed separately with the Commission.
SECOND AMENDED AND RESTATED PRODUCT DEVELOPMENT
AND DISTRIBUTION AGREEMENT
This Second Amended and Restated Product Development and Distribution Agreement
(the "Agreement") is made as of this 1st day of May, 1996,
by and between
ASTRA AB, formerly known as AB ASTRA, a corporation organized under the laws of
Sweden, having its principal office at Vastra Malarehamnen 9, S-151 36
Sodertalje, Sweden ("ASTRA"),
and
T CELL SCIENCES INC., a corporation organized under the laws of the State
of Delaware, U.S.A., having its principal place of business at 119 Fourth
Avenue, Needham, MA 02194-0771 U.S.A. ("TCS").
R E C I T A L S:
This Agreement was originally made as of January 30, 1992, amended by Amendment
No. 1 dated as of June 30, 1992, and amended and restated by the First Amended
and Restated Product Development and Distribution Agreement dated as of December
10, 1993 ("First Amended and Restated Agreement"). The parties intend in this
Agreement to further amend and restate the prior Agreement and to supersede the
prior Agreement, as amended and restated, including the TCAR Division Amendment.
TCS possesses rights to developments and technology, patents, patent
applications and know-how (including without limitation patents, patent
applications and know-how relating to compounds described in Exhibit F hereto)
and certain biological processes, all of which constitute TCAR Technology.
ASTRA and TCS have been and are working jointly and exclusively with one
another, using their respective skilled personnel and facilities for the further
development of TCAR Technology into Products suitable for commercial sale in the
Field of Use.
1(28)
The parties have been and are cooperating with each other and using their
resources, expertise and capabilities to assist in the discovery and development
of Agents and Products, and they have been and are using their regulatory,
manufacturing and marketing expertise and capabilities in the pharmaceutical
industry to develop, manufacture, market and distribute Products as described
herein.
The parties now desire to restructure the collaboration by transferring with
exception for certain retained rights all rights in TCAR Technology held by TCS
to ASTRA and by ASTRA assuming responsibility for (a) maintaining and expanding
TCAR Technology, (b) developing Agents and Products, and (c) otherwise employing
its regulatory, manufacturing, marketing and sales expertise to develop,
manufacture, market and sell Products, subject to the rights of and obligations
to TCS and to the other conditions set forth herein.
Each party intends to perform its obligations under this Agreement in good
faith, in a commercially reasonable, diligent and workmanlike manner.
NOW, THEREFORE, for and in consideration of the mutual covenants contained
herein and for other consideration, the receipt and adequacy of which is hereby
acknowledged, the parties agree as follows:
1 CERTAIN DEFINITIONS
Certain capitalized terms used herein are defined as follows:
"Affiliate" shall mean, with reference to a particular Person, (i) any Person
owning or controlling, directly or indirectly, fifty-one percent (51%) or more
of the voting capital shares or similar voting rights of such Person; and (ii)
any Person fifty-one percent (51%) or more of the voting capital shares or
similar voting rights of which is owned or controlled, directly or indirectly,
by such Person. For the purpose of this Agreement the term ASTRA shall include
Affiliates of ASTRA and the term TCS shall include Affiliates of TCS.
"Agent" shall mean a TCAR molecule or an antibody, particularly a monoclonal
antibody reacting against a TCAR, as well as any fragment, derivative,
conjugate, analogue, salt or salt complex of either of the foregoing and leading
to inactivation, elimination or reduction of body levels of T cells carrying the
TCAR, such as the proteins conceptually described in the various TCS Patents and
University Patents.
2(28)
"Effective Date" shall mean May 1, 1996.
"Exclusive" shall mean, when used in connection with a specific grant of a right
hereunder, that the granting party shall have no further right to grant to Third
Parties or Affiliates the same right, and itself retains no such rights in
respect of same, and for the term of the grant, unless such rights are
specifically retained by the grantor.
"Field of Use" shall mean the therapeutic or prophylactic use of Agents and
Products for all indications of use. Field of Use shall not include diagnostic
uses of Agents, Products or TCAR Technology.
"IND" shall mean an Investigational New Drug application, as defined by the
United States Food and Drug Act, or its equivalent under the laws of any other
country.
"Institutes Standby License" shall mean the Stand-by licenses referred to in
Exhibit D.
"NDA" shall mean a New Drug application as defined by the United States Food and
Drug Act, or the equivalent application for approval to market and/or sell
Product under the laws of any other country.
"Net Sales" shall mean the gross amounts (i) invoiced by ASTRA for sales of
Products to any Person unrelated to ASTRA, such as a wholesaler or hospital, and
(ii) invoiced by ASTRA for royalty and lump-sum payments from licensing/sub-
licensing rights under the TCS Patents and/or University Patents to any Person
unrelated to ASTRA, all less the following:
- trade and/or quantity discounts actually allowed and taken
- returns and cash discounts
- retroactive price reductions
- sales and similar taxes
- freight handling, distribution costs separately billed
"Patent Period" shall mean on a country by country basis and with respect to
each Product or Agent the expiration of the last to expire of any issued TCS
Patent and University Patent in the market where the Product or Agent is
intended to be administrated to a patient and where such patent contains a valid
claim covering (i) Product or such Agent per se or (ii) a composition of matter
containing a therapeutically effective amount of such Product or Agent or (iii)
one or more genes or genetic material from which the Product or Agent is
expressed or (iv) the therapeutic use of such Agent or Product, as opposed to
3(28)
claims merely covering, e.g. production methods or pharmaceutical formulations.
"Person" shall mean any individual, estate, trust, partnership, joint venture,
association, firm, corporation, company or other legal entity.
"Product" shall mean each and any form of an Agent or combinations of Agents or
solely for purposes of Article 8 any other product covered by a valid claim in
the TCS Patents or University Patents anywhere in the Territory for which
material for non-exploratory, non-clinical or clinical documentary studies has
been produced not later than December 31, 2005 and which before or thereafter
has been approved by a regulatory authority of any country for commercial
marketing and sale in that country (including price approval if necessary) for
any indication in the Field of Use.
"Protected Agent" shall mean an Agent covered by a valid claim in the TCS
Patents or University Patents anywhere in the Territory prior to or after the
Effective Date.
"Service Agreement" shall mean the Agreement between the parties exhibited to
this Agreement as Exhibit E.
"TCAR" shall mean a T cell antigen receptor, which is a heterodimeric protein
molecule expressed by human T cells that is capable of recognition both of
antigens and major histocompatility proteins. The gene encoding the T cell
antigen receptor protein is encoded by DNA possessing at least three of the
following four gene segments: Variable, Joining, Diversity and Constant (as such
terms are defined in the Encyclopedia of Human Biology published by Academic
Press U.S.A (copyright 1991)).
"TCAR Technology" shall mean TCS Patents, University Patents and any and all
information, know-how, material or living material including without limitation
biological, pharmacological, preclinical, clinical, chemical, biochemical,
toxicological, formulation, manufacturing and production information and
know-how (in the form of laboratory notebooks, reports or in any other form and
whether or not patentable) developed, acquired or licensed to date by TCS and
relevant to an Agent or Product, or relevant to the manipulation or other use,
production or manufacture of either TCARs, Agents or Products. TCAR Technology
shall include, but not be limited to, all items listed in Exhibits A, B, C, D
and F.
"TCS Licenses" means the licenses referenced on Exhibit D hereto. It is
specifically agreed that the T Cell Antigen Receptor Monoclonal Antibody
License Agreement of February 6, 1990 between Dr. Arthur Boylston and T Cell
4(28)
Sciences, Inc is not included in the TCS Licenses.
"TCS Patents" shall mean issued patents and patent applications listed in
Exhibit A and future patents resulting from such applications as well as any and
all divisions, continuations, continuations-in-part, extensions including
Supplementary Protection Certificates and reissues of all such patents and
patent applications.
"Term" shall have the meaning set forth in Paragraph 9.1 hereof.
"Territory" shall mean the entire world.
"Third Party" shall mean any Person other than the parties to this Agreement and
their Affiliates.
"University Patents" shall mean issued patents and patent applications listed in
Exhibit B and future patents resulting from such applications as well as any and
all divisions, continuations, continuations-in-part, extensions including
Supplementary Protection Certificates and reissues of all such patents and
patent applications.
2 SCOPE OF THE AGREEMENT
2.1 Product Development Within the Field of Use
-------------------------------------------
ASTRA and TCS desire that ASTRA uses the technology, information
and know-how (a) developed by the parties' cooperative effort,
skilled personnel and facilities as of and prior to the Effective
Date, or (b) contributed by the parties to the collaboration,
including, but not limited to, the TCAR Technology, for the
further development of Agents and Products suitable for commercial
sale in the Field of Use, including, but not limited to:
(a) conducting research and development to identify and select
Agents; and
(b) developing such selected Agents into Products; and
(c) developing Agents and Products for different indications
for use; and
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(d) selecting indications for use of Agents and Products
consistent with market potential; and
(e) manufacturing, marketing and selling such Products.
3 TRANSFER OF RIGHTS
3.1 Assignment of Rights - TCAR Technology
--------------------------------------
TCS hereby transfers and assigns to ASTRA all of TCS' right, title
and interest in and to the TCAR Technology subject to Sections 3.5
and 3.6 herein. TCS further agrees to execute and deliver without
delay at its own cost unless herein explicitly otherwise set forth
all instruments and to perform all acts necessary to carry this
transfer and assignment into full effect.
3.2 Delivery of Data and Materials included in TCAR Technology
----------------------------------------------------------
As expeditiously as possible, and in no event later than May 31,
1997, TCS shall deliver to ASTRA the complete existing materials,
documents, reports, SOPs and reports of QA/QC prepared for the
TCAR Project, information and data (whether in written, electronic
or digital form) encompassing, describing or otherwise relating to
TCAR Technology, including but not limited to items in Exhibit C.
Items in Exhibit C that can not be found before May 31, 1997,
shall be transferred to ASTRA free of charge excluding shipping
costs if found at a later date. TCS may retain reserve samples of
items in Exhibit C for use according to the Agreement. If TCS
provides copies of any such materials, documents, information and
data, TCS shall maintain the originals as well as the retained
samples of items in Exhibit C free of charge excluding shipping
costs to ASTRA in secure and proper storage, available to ASTRA
under the Service Agreement as from time to time reasonably
requested by ASTRA. If TCS decides not to maintain the original
documents, information and data or the retained samples TCS shall
offer to transfer them to ASTRA free of charge excluding shipping
costs. TCS shall provide ASTRA as part of the transfer of TCAR
Technology as defined in the First Amended and Restated Agreement
originals or verified and accurate copies of laboratory notebooks
containing information from all work carried out by TCS and copies
of all reports of work carried out for TCS by contract
laboratories or any other Third Party relating to such TCAR
Technology. TCS shall have no obligation to complete or repeat any
experiments or perform any new studies.
6(28)
Delivery of materials, data, documents and information under this
section 3.2 shall be on a date mutually agreed upon by the
parties. Such materials shall be provided to ASTRA or its
designate representatives free of charge excluding shipping costs.
TCS shall be responsible for packaging, storing and handling these
materials under adequate and appropriate conditions prior to
delivery. ASTRA shall be responsible for all shipping costs and
risk of loss shall pass to ASTRA upon delivery to ASTRA or its
designated carrier F.O.B. TCS's place of business located at 119
Fourth Avenue, Needham, Massachusetts, 02194, U.S.A.
3.3 Summary Reports
---------------
With regard to existing scientific data, results, records and
relevant histories of studies TCS shall, to the extent not already
done, prepare and deliver to ASTRA as expeditiously as possible,
and in no event later than May 31, 1997, summary reports of the
studies, experiments or activities which have generated
information regarding the items listed in Attachment 1 to Exhibit
C. The summary reports will only include information that
currently exists and shall be sufficiently extensive in TCS's
judgement to describe the rationale for these studies, the main
results and conclusions, and references to where the raw data and
other pertinent information can be found.
3.4 Reports prepared by ASTRA
-------------------------
If required, TCS will review ASTRA prepared reports, and will have
them, or assist ASTRA in having them, signed by the appropriate
personnel at TCS if the report is a proper and accurate
representation of work completed by TCS personnel. The costs for
this will be reimbursed by ASTRA in accordance with the Service
Agreement.
3.5 TCS Licenses
------------
a) TCS hereby grants to ASTRA an Exclusive license under the TCAR
Technology and TCS Patents and University Patents subject to the
provisions of any license granted to TCS with respect to any
applicable University Patent to research and develop, make, have
made, use, sell and have sold products in all fields, subject to
Section 3.6.
b) TCS shall at its own cost cooperate with and assist ASTRA in (i)
assigning the TCS Licenses to ASTRA or (ii) instituting the
Institutes Standby Licenses or (iii) granting ASTRA a sub-license,
all as
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requested by ASTRA in its sole discretion. If any Person who has
granted a TCS License does not agree and consent to the assignment
of the applicable TCS License to ASTRA, then TCS shall cooperate
with and assist ASTRA in obtaining a direct license corresponding
to the TCS License granted to TCS in the Field of Use. Upon the
effective date of each Institutes Standby License or direct
license secured by ASTRA, TCS' rights under the parallel TCS
License shall cease and terminate except to the extent required
for TCS to exercise its retained rights according to Article 3.6.
Pending the assignment of the TCS Licenses, the Standby Licenses
being instituted or ASTRA securing direct licenses, (i) TCS agrees
not to terminate or surrender any TCS Licenses without ASTRA's
prior consent, and (ii) to the extent permitted under each TCS
License, TCS hereby grants to ASTRA an Exclusive sublicense under
each of the TCS Licenses to research and develop, make, have made,
use, sell and have sold Agents and Products in the Field of Use in
the Territory.
Regardless of the above, ASTRA may at its sole discretion and at
any time terminate any TCS License for any or all parts of the
Territory, subject to any provisions in any TCS License granted to
ASTRA or TCS.
3.6 Retained Rights
---------------
ASTRA hereby grants to TCS for the Term of this Agreement a
royalty-free license, with a right to sublicense, in the TCAR
Technology (to the extent permitted due to limitations in Third
Party licenses granted to ASTRA) to make, have made, use, sell and
have sold products in the field of diagnostic use. The license
shall be Exclusive, save that ASTRA and its sublicensees shall
always have non-exclusive royalty-free rights to use TCAR
Technology to make, have made and use products for diagnostic
purposes in connection with research and development of Agents and
Products in the Field of Use. ASTRA further hereby grants to TCS a
non-exclusive royalty-free license to make, have made and use TCAR
Technology for the research and development of non-TCAR
technologies, agents and products.
3.7 Non-Compete
-----------
TCS agrees that it prior to December 31, 2005, will not compete
with ASTRA in the development of TCAR Technology in the Field of
Use or in the development of Products and Agents, including that
TCS shall not prior to December 31, 2005, conduct any research,
development,
8(28)
manufacture, use or sales within the Field of Use of TCAR
Technology or of any TCAR molecule, including a TCAR gene or a
TCAR nucleic acid or an antibody, particularly a monoclonal
antibody reacting against a TCAR, or any fragment, derivative,
conjugate, analogue, salt or salt complex of either of the
foregoing.
4 DEVELOPMENT IN GENERAL
4.1 General Standards
-----------------
During the Term hereof and subject to the terms of the Service
Agreement attached as Exhibit E, TCS shall cooperate with ASTRA in
good faith, particularly with respect to unknowns or
contingencies, in order to achieve the objectives of this
Agreement.
The Service Agreement will continue to be valid after the
Effective Date for ten years from the Effective Date.
4.2 ASTRA's Efforts
---------------
ASTRA shall use reasonable diligence in employing its skilled
personnel and facilities for the further development of TCAR
Technology into at least one Product suitable for commercial sale
in the Field of Use and to use reasonable diligence in exploiting
the TCS Patent and University Patents. Upon developing a Product
or Products, ASTRA shall use reasonable diligence to commercialize
and market such Product or Products, subject to ASTRA's reasonable
judgment and discretion in determining appropriate marketing
plans, budgets and strategies. ASTRA's obligations under this
provision are subject to ASTRA's right, in its sole discretion, to
terminate development of any Agent or commercialization and
marketing of any Product, if ASTRA determines that a commercially
exploitable Product may not be developed or marketed, as the case
may be, at reasonable cost and rate of return in light of market
potential and market conditions.
4.3 Annual Reports
--------------
Until December 31, 2005, ASTRA agrees to provide TCS within sixty
(60) days of the close of each calendar year with a summary report
of the status of the development of Agents and Products,
regulatory approval of all Agents and Products.
9(28)
5 INTELLECTUAL PROPERTY RIGHTS
5.1 Ownership of Intellectual Property Rights
-----------------------------------------
As of the Effective Date, all rights to TCS TCAR Technology shall
be the sole and exclusive property of ASTRA except those rights
explicitly otherwise retained as set forth herein. Other
technology which is proprietary to TCS and was used to enable the
TCAR Technology shall remain TCS property and shall only be used
by ASTRA for TM27 and TP12.
5.2 Filing, Prosecuting and Maintaining Patents
-------------------------------------------
5.2.1 Subject to the provisions of the direct license or Stand-by
License to ASTRA for the University patents, ASTRA shall, from
and after the Effective Date, at its sole cost, prosecute,
maintain and enforce all TCS Patents and University Patents
listed in Exhibits A and B; provided, ---------------- however,
that ASTRA shall not be responsible for reimbursing TCS for
prorated costs incurred or paid by TCS prior to the Effective
Date in connection with prosecuting, maintaining or enforcing the
TCS Patents and University Patents.
Regardless of the above, ASTRA may at its sole discretion and at
any time abandon any TCS patent or University Patent in any or all
parts of the Territory, provided however, that ASTRA shall notify
TCS at least sixty (60) days prior to such abandonment, and ASTRA
shall, in such notice, offer TCS the right to acquire, without
charge, any such TCS Patent or University Patent, subject to the
provisions of any license granted to ASTRA with respect to any
applicable University Patent.
5.2.2 TCS shall not oppose ASTRA prosecuting present and
future patents relating to TCAR and TCAR technology
using patent agents used by TCS in the prosecution of
the TCS Patents and the University Patents.
5.3 Enforcement of Patents
----------------------
5.3.1 The parties shall promptly advise each other upon becoming aware
of:
a) any activities which such party believes may be an
infringement of any TCS Patent, University Patent or other
proprietary right transferred under this Agreement related
to the production, use or
10(28)
sale of Agents or Products (collectively, "Proprietary
Rights");
b) any attack on or appeal of the grant of any TCS Patent or
University Patent included in the Proprietary Rights;
c) any application made for letters patent by, or the grant of a
patent to, a Third Party in respect of rights which may claim
the same subject matter as or conflict with a TCS Patent or
University Patent included in the Proprietary Rights;
d) any application made for a compulsory license under any TCS
Patent or University Patent included in the Proprietary
Rights.
5.3.2 ASTRA shall have the initial right to take or cause to be taken
whatever legal or other action is required to defend, maintain or
enforce the TCS Patents and University Patents, to revoke or
obtain a declaration of non- infringement under Third Party
rights or to resist a compulsory license (the "Protective
Action"). If ASTRA engages in such Protective Action, TCS shall
cooperate fully with ASTRA in such action at ASTRA's expense. TCS
may be represented by separate counsel of its own selection at
its own expense in such Protective Action, but ASTRA shall have
the right to control such action.
5.3.3 If ASTRA fails to take any such Protective Action within three
months of receipt from TCS of such notice, then (subject to the
rights of Third Parties), TCS may, upon notice to ASTRA,
institute its own Protective Action. In such event, TCS may bring
such action in its name and/or that of ASTRA.
5.3.4 All expenses incurred by either party in connection with any
Protective Action shall be borne by such party. Any recovery
actually received (or, where the rights which are the subject of
the Protective Action have demonstrated utility outside the scope
of this Agreement, that portion of the recovery actually received
which is attributable to the practice of rights within the scope
of this Agreement) as a result of such Protective Action, whether
by judgement, award, decree or settlement, shall be applied:
a) first to repay to each party all of its expenses, fees and
costs (including without limitation all expenses, fees and
costs of expert witnesses, attorneys or other experts, court
costs, internal and external travel and living expenses for
all necessary parties, collectively the "Costs") incurred in
connection with the Protective Action; and
11(28)
b) second to compensate the party which initiates or defends
the Protective Action, an amount equal to twice its Costs.
c) The balance of the recovery, if any, shall be deemed to
reflect ASTRA's Net Sales in the countries wherein the
Protective Action was successful. There shall be deducted
and paid to TCS from such balance an amount determined by
multiplying the portion of such balance allocable to each
country covered by the Protective Action by the applicable
Royalty Percentage as described in Section 8 payable to TCS
in such country. The remainder of the recovery, after such
payments have been made to TCS, shall be paid to ASTRA.
5.4 Confidentiality
---------------
5.4.1 Non-Disclosure Agreement
------------------------
Each party recognizes that the TCAR Technology and other
information received by it from the other party in the course of
the collaboration constitute highly valuable, proprietary,
confidential information (collectively the "Secret Information").
Each party agrees that during the Term and for five (5) years
thereafter it will keep confidential, and will cause its
Affiliates, officers, employees, consultants and agents to keep
confidential, all Secret Information received from the other party
and disclose it only to those with a need to know. Neither party
shall disclose, or permit any of its Affiliates, officers,
employees, consultants and agents to disclose, Secret Information
received from the other party to any other Person, nor use the
same for any purpose, except as expressly permitted in this
Agreement or in a separate written agreement with the other party
regarding such disclosure or except as reasonably required for
ASTRA research, development, registration, supply and
commercialization of an Agent or Product in accordance herewith
and except that TCS shall have the right to disclose such Secret
Information to its licensee in the diagnostic field to conduct
research and to make, use and sell products for diagnostic
purposes subject to an undertaking of confidentiality by such
licensee in accordance with the undertakings by TCS in this
Agreement.
12(28)
5.4.2 Information in Public Domain
----------------------------
The restrictions contained in this Article 5.4 shall not apply to
any Secret Information that (i) is, at the time of its disclosure
to the receiving party, generally available to the public or
otherwise part of the public domain, or as evidenced by written
records of such party, is otherwise previously known to the
receiving party, (ii) becomes generally available to the public
or otherwise part of the public domain after its disclosure to
the receiving party, through no act or omission of the receiving
party or any other person owing an obligation of confidentiality
to the receiving party hereto, or (iii) is required to be
disclosed by any court or governmental agency having proper
jurisdiction, provided that the other party is given prior notice
of such disclosure to the extent reasonably practicable.
5.5 TCS non-disclosure of TCAR Technology
-------------------------------------
As of the Effective Date, TCS shall not disclose nor permit any of
its Affiliates, officers, employees, consultants or agents to
disclose to any Third Party any TCAR Technology, except that TCS
shall have the right to disclose TCAR Technology to its
licensee(s) in the diagnostic field to conduct research and to
make, use and sell products for diagnostic purposes provided
however, that such licensee(s) are subject to an agreement not to
use TCAR Technology for purposes other than use in the diagnostic
field and are subject to an agreement not to disclose TCAR
Technology to any Third Party during the Term..
6 FUNDING
As of the Effective Date, ASTRA shall have sole responsibility for
all costs and expenses of any development program with respect to
Agents or Products. TCS shall have no further financial
responsibility with respect to such development programs,
manufacturing, or marketing of Products, except as otherwise
explicitly set forth in this Agreement and ASTRA shall have no
obligation to reimburse TCS for any costs incurred on or before
the Effective Date, nor shall ASTRA have an obligation to
reimburse TCS for any costs on or after the Effective Date except
as provided in the Service Agreement.
6.1 Costs For Acquiring Rights Under Third Party Patents
----------------------------------------------------
As of the Effective Date, ASTRA shall be responsible for and bear
all
13(28)
costs to Third Parties for acquiring necessary rights under Third
Party patents including royalty and other payments for the
licenses listed in Exhibit D hereto, provided however that ASTRA
shall not be responsible for reimbursing TCS for prorated costs
incurred or paid by TCS prior to the Effective Date.
6.2 Non-Defined Costs
-----------------
All costs incurred by either party not otherwise allocated in this
Agreement or defined or provided for herein, or by separate
agreement between the parties, shall be borne solely by the party
incurring such cost.
6.3 Payment Schedule
----------------
Other than royalties, as provided in Section 8 and payments, if
any, under the Service Agreement, ASTRA shall be responsible to
pay TCS a total of four million ($4.000.000) USD to be paid in
installments upon the occurrence of the following events relating
to Agents and Products developed by or on behalf of ASTRA and in
the following amounts:
Event Amount
----- ------
6.3.1 Within five business days after the ***
Execution of this Second Amended
and Restated Product Development
and Distribution Agreement
6.3.2 a) Within thirty days after TCS has (i) ***
signed and delivered to ASTRA all
documents appropriate for the change of
registered ownership of the TCS Patents
to ASTRA and (ii) delivered to ASTRA
all materials, documents, information and
data as provided in Paragraphs 3.2 and 3.3
and (iii) January 1, 1997, whichever is later.
b) Within thirty days within the milestone completion ***
in 6.3.2.(a) provided ASTRA is satisfied of such
completion.
6.3.3 Within thirty days after (i) approval of ***
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the first IND in any country for the first Protected Agent or
(ii) within thirty days after injection of the first patient
with clinical grade material of the first Protected Agent,
whichever occurs first.
6.3.4 Within thirty days after (i) approval of ***
the first IND in any country for the
second Protected Agent (i.e a Protected Agent other than the first
Protected Agent) or (ii) within thirty days after injection of the
first patient with clinical grade material of the second Protected
Agent, whichever occurs first.
6.3.5 Within thirty days after submission of ***
the first NDA in any country for the
first Protected Agent.
6.3.6 Within thirty days after submission of ***
the first NDA in any country for the
second Protected Agent (i.e a Protected Agent other than the first
Protected Agent).
6.3.7 Within thirty days after approval of ***
the first NDA in any country of the
world for the first Product
6.3.8 Within thirty days after approval of ***
the first NDA in any country of the
world for the second Product (i.e a Product containing a Protected
Agent other than the Protected Agent included in the first
Product)
7 REGULATORY APPROVAL AND COMMERCIALIZATION OF
PRODUCTS
7.1 Regulatory Approval of Products
-------------------------------
7.1.1 ASTRA shall, at its sole cost, proceed reasonably diligently and
in a commercially reasonable manner to compile, analyze and file
in its own name (or its subdistributor's name) all applications
for regulatory
15(28)
approval (including all reports and submissions under any
applicable PLA), consistent with any Product's market potential,
as determined in ASTRA's sole discretion, ASTRA shall have
complete control of the management and direction of clinical
trials conducted by it necessary to obtain all regulatory
approvals, including selection of clinical investigators, sites
for trials and the monitoring of such clinical investigations.
7.2 Marketing and Distribution
--------------------------
7.2.1 Subject to special provisions in this Section 7, ASTRA shall
proceed reasonably diligently in a commercially reasonable manner
upon issuance of all necessary regulatory approvals to market
Products consistent with each Product's market potential in such
markets as ASTRA deems appropriate.
7.2.2 ASTRA shall have Exclusive right to use, sell and market all
Agents and Products for all indications in the Territory within
the Field of Use.
7.2.3 In countries where ASTRA has Affiliates for marketing of
pharmaceutical products, ASTRA shall market the Agents and
Products solely through such Affiliates. In other countries, ASTRA
shall market the Products through customary marketing channels.
7.2.4 The obligation on ASTRA under Paragraphs 7.2.1 and 7.2.3 will not
be applicable on sales of Agents and Products containing Agents
invented by Third Parties.
8 SCHEDULE OF ROYALTY PAYMENTS
8.1 Royalties during the Patent Period
----------------------------------
With respect to sales of Product during the Patent Period ASTRA
shall pay TCS a royalty on Net Sales of each Product (on a country
by country and Product by Product basis), based on the following
percentages:
Market Royalty Percentage
------ ------------------
United States and Canada ***
Japan ***
All other Countries ***
16(28)
ASTRA shall be entitled to a credit against the royalty payments
due to TCS in an amount equal to one-half the royalty payments
paid under any Third Party license, including but not limited to
the licenses listed on Exhibit D; provided, however, that in no
event shall the royalty percentage due to TCS be reduced to less
than 50% of the royalty percentage set forth above.
8.2 Royalties after the Patent Period
---------------------------------
With respect to sales of Products after the Patent Period and for
the remaining Term, ASTRA shall pay TCS a royalty (on a country by
country and Product by Product basis) on Net Sales of each Product
based on the following percentages:
Market Royalty Percentage
------ ------------------
United States and Canada ***
Japan ***
All other Countries ***
ASTRA shall be entitled to a credit against the royalty payments
due to TCS in an amount equal to one-half the royalty payments
paid under any Third Party license, including but not limited to
the licenses listed on Exhibit D; provided, however, that in no
event shall the royalty percentage due to TCS be reduced to less
than 50% of the royalty percentage set forth above.
8.3 Combination Products
--------------------
In the event that a product is sold in a combination dosage form
(e.g., in a single vial) together with a pharmaceutical Product
which is not a Product or in a package or kit comprising separate
dosage forms (e.g., vials) containing other active products, such
as one or more active products manufactured by ASTRA, the royalty
shall be calculated by subtracting from the Net Sales of the
Combination ASTRA's manufacturing cost of the other active
products (including any royalty costs which under the relevant
royalty agreement are based upon net sales by ASTRA of the
Combination) and then multiplying the remainder by the royalty
percentage of the Products set forth in paragraph 8.1 or 8.2, as
applicable, and then multiplying the result by a factor determined
as the ratio of (A/A+B), where A is the documented
17(28)
development costs of the Product(s) and B is the documented
allocable development costs of all other products included in the
Combination.
8.4 If a pharmaceutical formulation contains several Products covered
by one or more TCS Patents and/or University Patents or if a
pharmaceutical formulation contains only one Product but is
covered by several TCS Patents and/or University Patents, ASTRA
shall pay royalty to TCS only as if such formulation contains one
Product and is covered by one TCS Patent or one University Patent.
8.5 As from and including the calendar month of first sales of Product
in any country of the Territory, ASTRA shall provide TCS with
quarterly accounts containing the Net Sales of the Product in each
country of the Territory within 45 days after the end of each
calender quarter. At the same time, ASTRA shall pay to TCS the
royalty as stipulated above. Payment shall be made in the currency
of United States Dollars (USD) to a bank account designated by
TCS.
8.6 If ASTRA sells the Product in any other currency than USD,
then such payments shall for the purpose of calculating Net Sales
be converted to USD using the rate of exchange prevailing at a
first class foreign exchange bank in Sweden on the last working
day in the calendar quarter in question.
8.7 ASTRA shall keep accurate records of its Net Sales of the
Products. In order to permit verification of Net Sales of the
Product under this Agreement, such records shall be open to
inspection at any reasonable time within two (2) years after the
royalty period to which such records relate, by an independent
certified public accountant selected by and paid by TCS to whom
ASTRA shall have no reasonable objection.
9 TERM, EXPIRATION AND TERMINATION
9.1 Term and expiration
-------------------
This Agreement shall be for a term (the "Term") commencing on the
"Effective Date" and expiring on December 31, 2027 unless sooner
terminated in accordance with any provision of this Agreement.
Upon expiration of the Term, ASTRA's obligation to pay TCS the
royalty on Net Sales of any Product shall expire and the license
granted by TCS to ASTRA in Paragraph 3.5 shall be converted to a
fully paid
18(28)
up, perpetual, royalty-free, non-exclusive license.
9.2 ASTRA - Voluntary Termination
-----------------------------
ASTRA may at any time, in ASTRA's sole discretion, upon written
notice to TCS, terminate this Agreement, in which event ASTRA
shall offer to transfer to TCS at its own costs the TCAR
Technology and the TCS Licenses (subject to any approval necessary
from any Third Party) and ASTRA shall not be obligated to make any
payments under this Agreement not due and payable to TCS prior to
the date of the written notice.
9.3 Breach of the Agreement
-----------------------
Paragraphs 12 and 17.2 of the First Amended and Restated Product
Development and Distribution Agreement shall be applicable on any
Event of Termination or non-performance as defined in that
Agreement until the transfer of rights as provided in Paragraph 3
has been completed and the payment according to Section 6.3.2 has
been made. After the transfer of rights as provided in Paragraph 3
in this Second Amended and Restated Product Development and
Distribution Agreement has been completed, each party's remedy for
any breach of any obligation or warranty under this Agreement
shall be limited to money damages, to be determined in arbitration
as provided in paragraph 13.2.
9.4 Existing Obligations
--------------------
No termination of this Agreement shall affect any obligation of
any party which arose prior to the effective date of such
termination with respect to monies owed or as to Secret
Information. The right of any 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
Event of Termination.
10 REPRESENTATIONS AND WARRANTIES
10.1 General Representations
-----------------------
Each party hereby represents and warrants for itself as follows:
10.1.1 Duly Organized
--------------
19(28)
It is a corporation duly organized, validly existing and in good
standing under the laws of the jurisdiction of its incorporation,
is qualified to do business and is in good standing as a foreign
corporation in each jurisdiction in which the conduct of its
business or the ownership of its properties requires such
qualification and has all requisite power and authority,
corporate or otherwise, to conduct its business as now being
conducted, to own, lease and operate its properties and to
execute, deliver and perform this Agreement.
10.1.2 Due Execution
-------------
The execution, delivery and performance by it of this Agreement
have been duly authorized by all necessary corporate action and do
not and will not (i) require any consent or approval of its
stockholders, (ii) violate any provision of any law, rule,
regulation, order, writ, judgment, injunction, decree,
determination or award presently in effect having applicability to
it or any provision of its charter or by-laws or (iii) result in a
breach of or constitute a default under any material agreement,
mortgage, lease, license, permit or other instrument or obligation
to which it is a party or by which it or its properties may be
bound or affected.
10.1.3 No Government Approval
----------------------
No authorization, consent, approval, license, exemption of, or
filing or registration with, any court or governmental authority
or regulatory body is required for the due execution, delivery or
performance by it of this Agreement, except as provided herein.
10.1.4 Binding Agreement
-----------------
This Agreement is a legal, valid and binding obligation of such
party, enforceable against it in accordance with its terms and
conditions. It is not under any obligation to any Person,
contractual or otherwise, that is conflicting or inconsistent in
any respect with the terms of this Agreement or that would impede
the diligent and complete fulfilment of its obligations hereunder.
10.1.5 Governmental Status
-------------------
It is not debarred or suspended from receiving contracts from the
U.S. or Swedish government or other governmental authority or
agency.
20(28)
10.1.6 Full Disclosure
---------------
Each party has disclosed to the other in good faith any and all
material information relevant to the subject matter of this
Agreement and to such party's ability to observe and perform its
obligations hereunder.
10.2 TCS warrants that the T Cell Antigen Receptor Monoclonal Antibody
License Agreement of February 6, 1990 between Dr. Arthur Boylston
and T Cell Sciences, Inc does not cover ATM-027/TM27 and that
therefore Boylston will not be entitled to any royalty on Net
Sales of Product containing this Agent.
11 EXPORT CONTROL
11.1 Technical Data and Commodities
------------------------------
The parties hereby agree that any "Technical Data" (as that term
is defined in section 779.1 of the U.S. Export Administration
Regulations) exported from the United States pursuant to this
Agreement and any other related agreements, and any direct product
thereof, shall not be shipped, either directly or indirectly, to
the People's Republic of China or Afghanistan or any Group Q, S,
W, Y or Z countries (as specified in Supplement No. 1 to part 770
of the Export Administration Regulations), unless (i) separate
specific authorization to re-export such Technical Data or such
direct products is provided by the U.S. Office of Export
Administration or (ii) such specific authorization is not required
pursuant to Section 779.8 of the U.S. Export Administration
Regulations. The parties further agree that the export and
re-export of commodities pursuant to this Agreement and any other
related agreements shall be subject to the licensing requirements
of the U.S.
Export Regulations.
11.2 Laws of Other Countries
-----------------------
In the event that a specific authorization of, or a validated
license from, a government other than that of the exporting party
is required, the party within the jurisdiction of such other
government shall, upon the request of the party proposing to make
the export, use reasonable efforts to obtain as expeditiously as
practicable, the requisite authorization or license.
21(28)
12 INDEMNIFICATION
12.1 Indemnification
---------------
For purposes of this Section 12 "Indemnified Parties" refers to
TCS, its Affiliates and the officers, directors, employees, agents
and grantors under Third Party licenses of TCS and its Affiliates
when ASTRA is the indemnitor, and "Indemnified Parties" refers to
ASTRA its Affiliates and the officers, directors, employees,
agents and grantors under Third Party licenses of ASTRA and its
Affiliates when TCS is the indemnitor.
12.1.1 TCS, as indemnitor on behalf of itself and its officers,
directors, employees, agents and representatives (including all
contractors for which TCS is responsible undertaking work in any
Program) shall indemnify and hold harmless the ASTRA Indemnified
Parties and each of them from any and all liability arising out of
any suit, action, legal proceeding, claim or demand of whatever
kind or character based upon
(a) a claim or occurrence arising from any acts, whether of
omission or commission, by said officers, directors,
employees, agents or representatives prior to the Effective
Date; or
(b) any breach of any representation, warranty or agreement made
by TCS hereunder; or
(c) the failure by TCS in performing its obligations under this
Agreement.
12.1.2 ASTRA, as indemnitor on behalf of itself and its officers,
directors, employees, agents and representatives (including all
contractors for which ASTRA is responsible undertaking work in any
Program) shall indemnify and hold harmless the TCS Indemnified
Parties and each of them from any and all liability arising out of
any suit, action, legal proceeding, claim or demand of whatever
kind or character based upon
(a) a claim or occurrence arising from any acts, whether of
omission or commission, by said officers, directors,
employees, agents or representatives in connection with the
obligations undertaken by ASTRA or in connection with the
manufacture, use or sale of any Agent or Product prior to or
after the Effective Date by ASTRA; or
(b) any breach of any representation, warranty or agreement made
by
22(28)
ASTRA hereunder; or
(C) the failure by ASTRA in performing its obligations under this
Agreement.
12.1.3 Anything to the contrary in this Paragraph 12 notwithstanding,
neither party shall be obligated to indemnify an Indemnified Party
for such Indemnified Party's own acts of negligence or wilful
misconduct or for any violation of any warranty, representation or
agreement made by such Indemnified Party hereunder.
12.2 Scope of Indemnification
------------------------
12.2.1 The agreement to indemnify and hold harmless from liability set
forth herein shall include, without limitation, all damages of
every kind, reasonable attorney fees, all costs and expenses which
may be levied against and out of pocket costs incurred by the
Indemnified Parties in connection with any suit, action, legal
proceeding, claim or demand.
12.2.2 Each party acknowledges and hereby agrees that the obligations set
forth in this Paragraph 12 shall survive the termination or
expiration of this Agreement until the expiration of any
applicable statute of limitations.
12.2.3 The Indemnified Parties will cooperate with the indemnitor at the
indemnitor's expense in the defence of any suit. Neither party
shall be liable for any costs resulting from any settlement made
without its consent.
13 MISCELLANEOUS
13.1 Notices
-------
All notices or other written communications hereunder shall be
given in English and sent via certified mail, return receipt
requested, or commercial courier or shall be given by facsimile
transmission, confirmed by letter sent as provided above, or by
personal delivery, addressed as follows, or to such other address
as may be designated from time to time by notice given in the
manner provided in this Paragraph 13.1.
23(28)
If to ASTRA:
To ASTRA at its address as set forth at the beginning of this
Agreement
Attention: Legal Affairs
Fax No,: 011-46-8-553-28812
If to TCS:
To TCS at its address as set forth at the beginning of this
Agreement
Attention: President
Fax No.: 01-01-617-433-0262
Notices given personally shall be deemed delivered as of the date
delivered. All other notices shall be deemed delivered as of the
date of receipt for the notice by a messenger service, or on the
date of the first attempted delivery of the mailed notice, as
shown on the postal service return receipt, or by facsimile
transmission which produces a dated message of completed
confirmation. Notwithstanding any other provision of this
Paragraph 13 to the contrary, any notice shall be effective from
and after the date actually received by an addressee, however
addressed or delivered.
13.2 Governing Law; Arbitration
--------------------------
This Agreement is made and delivered in Boston, Massachusetts, USA
and shall be governed by and construed in accordance with the laws
of the Commonwealth of Massachusetts applicable to agreements made
and to be performed entirely within the Commonwealth of
Massachusetts. In the event of any dispute under this Agreement,
whether as to validity, construction, enforceability or
performance of this Agreement or any of its provisions or
otherwise, both parties shall endeavour to settle such dispute
amicably between themselves. In the event that the parties fail to
agree, such dispute shall be settled by arbitration as follows.
Either party may by notice in writing to the other require any
issue in dispute to be submitted to arbitration in accordance with
this Paragraph 13.2. Such notice shall contain a statement of the
arbitrable issue forming the basis of the dispute and the position
of the moving party as to the proper resolution of that issue.
Within 30 days after receipt of such notice, the responding party
shall submit to the moving party a statement of its conception of
the arbitrable issue in question and of its position as to the
proper resolution of that issue. Within 45 days of the responding
party's response, each party shall appoint an arbitrator and give
the other party written notice thereof. In the event a party shall
fail to appoint an arbitrator and provide written notice thereof
to the other party within such 45 day period, an arbitrator shall
be appointed for such party by the American Arbitration
24(28)
Association as promptly as practicable after request by the other
party. Thereafter, the two appointed arbitrators shall select a
third arbitrator within 30 days after receipt of a list of
arbitrators proposed by the American Arbitration Association. If
the two arbitrators designated by the parties are unable to agree
on the third arbitrator within 30 days, then either party with
notice to the other party, may call for such appointment by the
American Arbitration Association of the third arbitrator. Each
arbitrator shall agree prior to his or her appointment to hear the
dispute promptly and render a decision as soon as practicable
thereafter. Said arbitration shall be conducted in English in
Boston, Massachusetts, in accordance with the commercial
arbitration rules or successor rules then obtaining of the
American Arbitration Association to the extent not inconsistent
with this Paragraph 13.2. The agreement of 2 of the 3 arbitrators
shall be sufficient to render a decision. The decision of the
panel shall be final and binding upon the parties and enforcement
thereof may be obtained in any court of competent jurisdiction.
The unsuccessful party to such arbitration shall pay to the
successful party all costs and expenses, including reasonable
attorney's fees incurred therein by such successful party.
13.3 Binding Effect
--------------
This Agreement, and the rights and duties of the parties herein
contained, shall be binding upon, and shall inure to the benefit
of, the parties hereto and their respective legal representatives,
successors and permitted assigns.
13.4 Entire Agreement
----------------
This Agreement sets forth the entire agreement and understanding
of the parties with respect to the matters covered herein and as
of the Effective Date supersedes all prior agreements,
arrangements and understandings between them with respect to said
matters, including the First Amended and Restated Product
Development and Distribution Agreement dated as of December 10,
1993 and the TCAR Division Amendment and all rights and
obligations of either party therein.
13.5 Counterparts
------------
This Agreement may be executed simultaneously in two or more
counterparts, each of which shall be deemed an original, but all
of which together shall constitute one and the same instrument.
25(28)
13.6 Headings
--------
Headings are inserted herein for convenience of reference only and
do not form a part of this Agreement, and shall be given no effect
or meaning in the construction or interpretation of this
Agreement.
13.7 Amendment; Waiver
-----------------
This Agreement may be amended, modified, superseded or cancelled,
and any of the terms hereof may be waived, only by a written
instrument executed by each party hereto or, in the case of
waiver, by the party or parties waiving compliance. The delay or
failure of any party at any time or times to require performance
of any provision hereof shall in no manner affect the rights of
such party at a later time to require any performance. No waiver
by any party of any condition or of the breach of any term
contained in this Agreement, whether by conduct or otherwise, in
any one or more instances, shall be deemed to be or construed as a
further or continuing waiver of any such breach or the breach of
any other term of this Agreement.
13.8 No Third Party Beneficiaries
----------------------------
Except as otherwise specifically set forth in Paragraph 12
(Indemnification) hereof, no Person not a party to this Agreement,
including any employee of any party to this Agreement, shall have
or acquire any rights by reason of this Agreement, nor shall any
party hereto have any obligations or liabilities to such other
Person by reason of this Agreement. Nothing contained in this
Agreement shall be deemed to constitute the parties partners with
each other or any Person.
13.9 No Joint Venture
----------------
The relationship of the parties hereto is that of independent
contractors. Nothing in this Agreement shall be construed to
constitute, create, give effect or otherwise imply a joint
venture, agency, partnership or other formal business organization
or any employer/employee relationship of any kind between the
parties.
13.10 Force Majeure
-------------
If either party shall be delayed, interrupted in or prevented from
the performance of any obligation hereunder (other than the
payment of money due) by reason of the occurrence of an event
beyond the control
26(28)
of such party including fire, flood, other nature disasters, war
(declared or undeclared), public disaster, strike or labour
differences, governmental enactment, rule or regulation, or any
other cause beyond such party's control, such party shall not be
liable to the other therefor; and the time for performance of such
obligation shall be extended for a period equal to the duration of
the contingency which occasioned the delay, interruption or
prevention. The party invoking such Force Majeure rights of this
Paragraph 13.10 must notify the other party within a period of
fifteen (15) days following the first and the last day of the
Force Majeure unless the Force Majeure renders such notification
impossible, in which case notification will be made as soon as
possible.
13.11 English Language
----------------
This Agreement has been executed in the English language, the
official language of the Agreement shall be English, and any
interpretation or construction of this Agreement shall be based
solely on the English language official text. All notices,
documents and information to be delivered in connection with or
pursuant to the Agreement shall be in English.
13.12 Publicity
---------
The parties will agree with each other in advance of the public
release of information with respect to the transactions
contemplated herein, except that either party may release
information to the public regarding such transactions to allow
such party to meet its legal obligations.
13.13 Exhibits
--------
All exhibits attached hereto are made a part of this Agreement and
the terms thereof are incorporated into this Agreement by
reference.
13.14 Drafts
------
This Agreement shall not be binding or effective until properly
executed and delivered by both TCS and ASTRA.
13.15 Interest
--------
Interest shall accrue on any delinquent amounts owed by ASTRA
hereunder at ten percent (10%) per annum.
27(28)
13.16 No Assignment
-------------
This Agreement shall not be assignable without the prior written
approval of the other party except that (i) either TCS or ASTRA
may assign this Agreement to an Affiliate and (ii) TCS may assign
this Agreement to an assignee of all of its good will, business
and assets; provided however, that in case of any assignment
permitted by this Paragraph 13.16 and notwithstanding any such
assignment, the assigning party shall remain fully liable for all
of its obligations under this Agreement.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be amended
and restated by their duly authorized representatives as of the 1st day of May,
1996.
ASTRA AB
(publ)
By:
----------------------------
Hakan Mogren, President and
Chief Executive Officer
hereunto duly authorized
T CELL SCIENCES, INC.
By:
---------------------------
Una S Ryan, President and
Chief Executive Officer
hereunto duly authorized
28(28)