LICENSE AND COLLABORATIVE RESEARCH
AGREEMENT
BETWEEN
ALEXION PHARMACEUTICALS, INC.
AND
GENETIC THERAPY, INC.
[Confidential treatment has been requested for portions of this Exhibit. The
Confidential Portions have been redacted and are denoted by [**]. The
Confidential Portions have been separately filed with the commission]
TABLE OF CONTENTS
Page
ARTICLE I: DEFINITIONS .................................................. 1
1.1 "Affiliate" .................................................... 1
1.2 "Alexion Know-How" ............................................. 1
1.3 "Alexion Patents" .............................................. 1
1.4 "GTI Know-How" ................................................. 1
1.5 "GTI Patents" .................................................. 2
1.6 "Control" ...................................................... 2
1.7 "Effective Date" ............................................... 2
1.8 "FDA" .......................................................... 2
1.9 "Field" ........................................................ 2
1.10 "FTE" .......................................................... 2
1.11 "IND" .......................................................... 2
1.12 "Information" .................................................. 2
1.13 "Joint Patents" ................................................ 2
1.14 "Joint Project Committee" ...................................... 2
1.15 "Know-How" ..................................................... 3
1.16 "Licensed Product" ............................................. 3
1.17 "Major Country" ................................................ 3
1.18 "Net Sales" .................................................... 3
1.19 "Patents" ...................................................... 4
1.20 "PLA" .......................................................... 4
1.21 "Project" ...................................................... 4
1.22 "Project Plan" ................................................. 4
1.23 "Project Term" ................................................. 4
1.24 "Third Party" .................................................. 4
1.25 "Valid Claim" .................................................. 4
ARTICLE II: PROJECT ..................................................... 4
2.1 General ........................................................ 4
2.2 Formation and Operation of the JPC ............................. 4
2.3 Information and Reports ........................................ 5
2.4 Alexion's Responsibilities ..................................... 6
2.5 GTI's Responsibilities ......................................... 6
2.6 Alexion's Project Commitments .................................. 6
2.7 Project Funding ................................................ 6
2.8 Extension of Project Term by Mutual Agreement .................. 7
2.9 Parallel Research .............................................. 7
2.10 No Solicitation of Employees ................................... 7
ARTICLE III: DILIGENCE .................................................. 7
3.1 Project Diligence .............................................. 7
3.2 Pre-Marketing Diligence ........................................ 8
3.3 Marketing Diligence ............................................ 8
3.4 Remedies ....................................................... 8
3.5 No Restrictions on Business .................................... 8
3.6 Commercialization of Licensed Product .......................... 8
3.7 GTI's Efforts .................................................. 8
ARTICLE IV: LICENSE GRANT ............................................... 9
4.1 Patent License to GTI for Commercialization of Licensed Products 9
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4.2 Know-How License to GTI ........................................ 9
4.3 Unpatented Technology .......................................... 9
4.4 Licenses to Joint Patents Outside the Field .................... 10
4.5 Non-Exclusive Licenses to Alexion .............................. 10
4.6 Affiliates ..................................................... 10
4.7 Certain Rights; No Implied License ............................. 10
4.8 Government ..................................................... 10
ARTICLE V: PAYMENTS ..................................................... 10
5.1 Fees ........................................................... 10
5.2 Project Funding ................................................ 11
5.3 Milestone Payments ............................................. 11
5.4 Royalty to Alexion ............................................. 11
5.5 No Multiple Royalties .......................................... 11
5.6 Minimum Annual Royalties ....................................... 11
5.7 Foreign Exchange ............................................... 12
5.8 Blocked Currency ............................................... 12
5.9 Taxes .......................................................... 12
5.10 Milestone and Royalty Payments and Reports ..................... 12
5.11 Duration of Royalty Obligations ................................ 12
5.12 Accounting ..................................................... 13
5.13 Sales by Affiliates ............................................ 13
5.14 Late Payments .................................................. 13
5.15 Change to Non-Exclusive ........................................ 13
5.16 Representation of Alexion ...................................... 13
ARTICLE VI: CONFIDENTIALITY; PUBLICATIONS ............................... 13
6.1 Confidentiality; Exceptions .................................... 13
6.2 Authorized Disclosure .......................................... 14
6.3 Termination of Prior Agreement ................................. 14
6.4 Publications ................................................... 14
6.5 Public Disclosure .............................................. 15
6.6 This Agreement ................................................. 15
ARTICLE VII: OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS ........ 15
7.1 Ownership of Patents ........................................... 15
7.2 Disclosure of Patentable Inventions ............................ 15
7.3 Patent Filings ................................................. 16
7.4 Enforcement Rights ............................................. 17
7.5 Unauthorized Use of Patent Rights .............................. 18
ARTICLE VIII: REPRESENTATIONS AND WARRANTIES; EXCLUSIVITY ................ 18
8.1 Representations and Warranties ................................. 18
8.2 Limitation on Warranties ....................................... 19
8.3 Negative Covenants ............................................. 19
ARTICLE IX: TERM AND TERMINATION ........................................ 19
9.1 Term ........................................................... 19
9.2 Early Termination .............................................. 20
9.3 Surviving Rights ............................................... 20
9.4 Accrued Rights, Surviving Obligations .......................... 20
9.5 Termination Not Sole Remedy .................................... 20
9.6 Failure to Enforce ............................................. 20
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9.7 Effect .......................................................... 20
9.8 Impossibility .................................................. 21
ARTICLE X: INDEMNIFICATION .............................................. 21
10.1 Indemnification ................................................ 21
10.2 Insurance ...................................................... 21
ARTICLE XI: DISPUTE RESOLUTION .......................................... 22
11.1 Disputes ....................................................... 22
11.2 Dispute Resolution Procedures .................................. 22
ARTICLE XII: MISCELLANEOUS .............................................. 22
12.1 Export Control ................................................. 22
12.2 Legal Compliance ............................................... 23
12.3 Required Consents .............................................. 23
12.4 Patent Marking ................................................. 23
12.5 Use of Names ................................................... 23
12.6 Assignment ..................................................... 23
12.7 Consents Not Unreasonably Withheld ............................. 23
12.8 Retained Rights ................................................ 24
12.9 Force Majeure .................................................. 24
12.10 Further Actions ................................................ 24
12.11 No Trademark Rights ............................................ 24
12.12 Notices ........................................................ 24
12.13 Waiver ......................................................... 24
12.14 Severability ................................................... 24
12.15 Ambiguities .................................................... 25
12.16 Counterparts ................................................... 25
12.17 Entire Agreement ............................................... 25
12.18 Governing Law .................................................. 25
12.19 Independent Contractor ......................................... 25
12.20 Subcontracting ................................................. 25
SCHEDULE A - Royalties
EXHIBIT A - Project Plan
EXHIBIT B - Alexion Patents as of Effective Date
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LICENSE AND COLLABORATIVE RESEARCH AGREEMENT
This License and Collaborative Research Agreement (the "Agreement") is
made effective as of the 20th day of December 1996, by and between Genetic
Therapy, Inc., 000 Xxxxxxx Xxxx, Xxxxxxxxxxxx, XX 00000 ("GTI") and Alexion
Pharmaceuticals, Inc., having its principal place of business at 00 Xxxxxxx
Xxxx, Xxxxx 000, Xxx Xxxxx, XX 00000 ("Alexion"). Alexion and GTI may be
referred to herein as a "Party" or, collectively, as "Parties".
WITNESSETH:
WHEREAS, Alexion has technologies, expertise and know-how in the area of
immunoprotected retroviral vector particles and retroviral vector producer cells
for use in gene therapy; and
WHEREAS, GTI has expertise in gene therapy research and product
development and desires to obtain a license under Alexion' s intellectual
property rights for immunoprotected retroviral vector particles and retroviral
vector producer cells for use in gene therapy; and
WHEREAS, GTI and Alexion desire to enter into this Agreement to facilitate
the development of gene therapy products incorporating this technology;
NOW, THEREFORE, in consideration of the mutual covenants herein contained,
the Parties agree as follows:
ARTICLE I
DEFINITIONS
The following terms shall have the following meanings as used in this
Agreement:
1.1 "Affiliate" means an individual, trust, business trust, joint venture,
partnership, corporation, association or any other entity which (directly
or indirectly) is controlled by, controls or is under common control with,
a Party. For the purposes of this definition, the term "control"
(including, with correlative meanings, the terms "controlled by" and
"under common control with") as used with respect to any Party, shall mean
the possession (directly or indirectly) of the power to direct or cause
the direction of the management and policies of the corporation or other
entity by voting securities, contract or otherwise.
1.2 "Alexion Know-How" means Information, in the Field, that (a) Alexion
discloses to GTI under this Agreement and (b) is within the Control of
Alexion, but excluding Alexion Patents and Joint Patents.
1.3 "Alexion Patents" means all Patents in the Field owned or controlled by
Alexion to the extent such Patents cover (a) inventions in the Field made
prior to the Effective Date of this Agreement, or (b) inventions in the
Field made in the course of the Project by employees of Alexion during the
Project Term. Exhibit B hereto sets forth a list of Alexion Patents filed
or issued as of the Effective Date.
1.4 "GTI Know-How" means Information, in the Field, that (a) GTI discloses to
Alexion under this Agreement and (b) is within the Control of GTI, but
excluding GTI Patents and Joint Patents.
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1.5 "GTI Patents" means all patents in the Field owned or controlled by GTI to
the extent such Patents cover inventions made solely by employees or
agents of GTI prior to the end of the Project Term.
1.6 "Control" or "controlled by" means, with respect to an item of information
or intellectual property right, possession or the ability to grant a
license or sublicense as provided for herein under such item or right
without the consent of any other third party and without violating the
terms of any agreements or other arrangements, express or implied, with
any Third Party.
1.7 "Effective Date" means the date first written above.
1.8 "FDA" means the United States Food and Drug Administration.
1.9 "Field" means [**]
1.10 "FTE" means a full-time professional person dedicated to the Project, or
in the case of a less than full-time dedicated professional person, a
combination of two or more part-time professional persons equivalent in
the aggregate to a professional person-year, based upon a total of forty
nine (49) weeks or one thousand nine hundred sixty (1,960) hours per year
of professional work on or directly related to the Project, carried out by
an employee. Professional work on or directly related to the Project to be
performed by Alexion employees may include, without limitation,
experimental laboratory work, recording and writing up results, developing
analytical methods and/or assays, reviewing literature and references,
holding scientific discussions, managing and directing professional staff
and carrying out management duties related to the Project. As used herein,
"professional" shall include, by way of example, scientists and laboratory
technicians, but shall exclude clerical workers.
1.11 "IND" means an Investigational New Drug Application and all supplements
filed pursuant to the requirements of the FDA, including all documents,
data and other information concerning the proposed conduct and plan of
clinical trials which is necessary for the commencement of clinical trials
to obtain Regulatory Approval to market a Licensed Product, or equivalent
application in any other Major Country.
1.12 "Information" means techniques and data useful in the Field, including,
without limitation, inventions, practices, methods, knowledge, know-how,
skill, experience, test data including pharmacological, toxicological and
clinical test data, analytical and quality control data and biological
materials, including, but not limited to, cell lines, vectors, and
plasmids.
1.13 "Joint Patents" means all Patents covering inventions made jointly by
employees or agents of Alexion and GTI prior to the end of the Project
Term directed towards or in pursuance of the Project Plan. In determining
inventorship and rights in joint inventions, the laws of the country of
invention shall apply to any particular patent.
1.14 "Joint Project Committee" or "JPC" means the committee established
pursuant to Section 2.2 herein.
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1.15 "Know-How" means individually and collectively Alexion Know-How and GTI
Know-How.
1.16 "Licensed Product" means any form or dosage of a pharmaceutical or other
product or any process which results from or is based on the use of
Alexion Know-How or which if not licensed, in the course of manufacture,
use or sale would, in the absence of this Agreement, infringe one or more
Valid Claims if issued, included within the Alexion Patents or Joint
Patents. A Licensed Product includes a product which is manufactured using
a process so covered by an Alexion Patent or Joint Patent within a
Licensed Product or a product which is used in such a process and has no
substantial use except in such a process.
1.17 "Major Country" means Germany, France, United Kingdom, Italy, Spain,
United States or Japan.
1.18 "Net Sales" means the gross sales by GTI or its Affiliates or sublicensees
attributable to Licensed Products determined by the gross selling price to
the purchaser, including, if applicable, the value of all properties and
services received in consideration of such sales of Licensed Products
(including, in the case of a licensed process, the amount payable as
consideration for the use of such process and, where product is supplied
for use in such process, the amount payable in respect of products
supplied in such process calculated as if the same constituted a Licensed
Product), less only (a) discounts, including cash discounts, rebates,
retroactive price reductions or allowances actually allowed or granted
from the billed amount with respect to the Licensed Product in question
(provided that any discounts, rebates, and allowances based on overall
purchases by the customer of the selling Party may be applied to reduce
Net Sales only to the extent of the pro rata amount of such discounts or
rebates attributable to the Licensed Products included in such overall
purchases), (b) credits or allowances actually granted upon claims,
rejections or returns of Licensed Products, including recalls, regardless
of the party requesting such, (c) freight, postage, shipping and insurance
charges separately invoiced, stated or itemized and (d) taxes, duties or
other governmental charges levied on or measured by the billing amount as
adjusted for rebates and refunds. If, after the failure of GTI to collect
any receivable included within Net Sales for at least 120 days after the
later of the shipment date or due date, GTI shall write-off such
receivable as uncollectible, then Net Sales for such quarter shall be
reduced to reflect such uncollectible receivable; provided that if such
receivable shall thereafter be paid or otherwise satisfied the face amount
thereof shall be added to Net Sales for the quarter in which so paid or
satisfied. A sale of a Licensed Product includes the sale, transfer,
exchange or other disposition, whether by gift or otherwise. Where a sale
is deemed consummated by the gift or other disposition of Licensed
Products for other than a selling price stated in cash, the term "Net
Sales" shall mean the average gross selling price billed by GTI or its
Affiliate, as the case may be, in consideration of the sale of comparable
Licensed Products during the three (3) month period immediately preceding
such sale, without reduction of any kind. GTI shall be permitted to
provide a reasonable number of samples as part of any promotional effort.
In the event that GTI shall transfer Licensed Products to an Affiliate of
GTI and such company retransfers the Licensed Products to a Third Party
within one year of its receipt, then the price charged by the Affiliate to
third parties shall constitute Net Sales for the purpose of calculating
royalties payable by GTI hereunder, and the price charged by GTI to such
Affiliate shall not be included within GTI's gross sales.
3
1.19 "Patent" means the rights granted under (a) valid and enforceable Letters
Patent, including any provisional, extension (including Supplemental
Protection Certificate), registration, confirmation, reissue,
continuation, divisional, continuation-in-part, reexamination or renewal
thereof, and (b) pending applications for any of the foregoing, subject in
the case of continuations-in-part of such Patents licensed in whole or in
part from [**] certain limitations contained in the license thereof.
1.20 "PLA" means a Product License Application and all supplements filed
pursuant to the requirements of the FDA, including all documents, data and
other information concerning a Licensed Product which is necessary for or
included in FDA approval to market a Licensed Product, as more closely
defined in the rules and regulations of the FDA, or the equivalent
application in any other Major Country.
1.21 "Project" means all work performed by the Parties or on their behalf in
the Field directed towards or in pursuance of the Project Plan during the
Project Term, the funding of which is to be borne by GTI.
1.22 "Project Plan" means the plan for conducting the Project as described in
Section 2.1 hereof and attached as Exhibit A, as such plan shall be
modified or amended from time to time by the JPC and approved by the
Parties.
1.23 "Project Term" means the period commencing on the Effective Date and
ending on the expiration of the funding of the Project Plan as set forth
in Section 2.7, unless terminated earlier pursuant to Sections 9.2 or
extended pursuant to Section 2.8.
1.24 "Third Party" means any entity or individual other than Alexion, GTI or
any Affiliate thereof.
1.25 "Valid Claim" means (i) a claim in a pending patent application which has
not been pending for more than five (5) years from the filing date of the
original subject matter covered by the claim, or (ii) a claim of an issued
patent that has not lapsed or become abandoned or been held invalid by a
non-appealed or unappealable decision of a court or other appropriate body
of competent jurisdiction.
ARTICLE II
PROJECT
2.1 General. Alexion and GTI agree that they will conduct the Project on a
collaborative basis. The Parties agree that the Project shall be conducted
as provided in the initial Project Plan, attached hereto as Exhibit A, as
such plan may be amended from time to time by the Joint Project Committee
(the "JPC") within the Field and the guidelines of this Article II.
2.2 Formation and Operation of the JPC.
a) Formation; Meetings. The Parties shall establish the JPC promptly
after the Effective Date. The JPC shall be comprised of an equal
number of representatives of each Party with the size of the JPC to
be agreed upon by the Parties from time to time (not to exceed four
(4) members from each Party).
4
One of the GTI representatives shall serve as chairman of the JPC.
The JPC shall meet at least once every six (6) months (or at such
other intervals as may decided by the JPC), alternating between the
offices of the Parties or at such other times and places as agreed
to by the Parties, until the end of the Project Term. Any approval,
determination or other action agreed to by the members of the JPC
present at the relevant JPC meeting shall be the approval,
determination or other action of the JPC; provided, however, that at
least one (1) representative of each party shall be present, in
person or by proxy, at such meeting and the approval, determination
or other action is unanimous. The party hosting each meeting of the
JPC promptly shall prepare, and deliver to the other Party within
thirty (30) days after the date of such meeting minutes of such
meeting setting forth all decisions of the JPC in form and content
reasonably acceptable to the other party. Each party may substitute
one or more of its representatives, from time to time in its sole
discretion, effective upon written notice to the other Party of such
change, provided that the parties shall only substitute such
representative for good faith business or scientific reasons
consistent with the efficient and expeditious conduct of the Project
Plan.
b) Purpose. The purpose of the JPC is to coordinate the Project effort
of the Parties, to expedite the progress of work being done under
the Project Plan, and to manage the Parties' respective involvement
in the Project. The JPC will set specific Project goals, evaluate
the results of the Project, will review and approve the research and
development program and generally monitor the progress of the
Project, discuss among its members information relating to the
Project and review scientific publications of the Parties concerning
the Project. The JPC may periodically modify the Project Plan,
within the scope of and in a manner consistent with this Agreement.
The Project Plan, among other things, shall define Project
milestones and allocate Project responsibilities and resources in a
manner consistent with this Agreement. Prior to January 1 of each
year of the Project Term, the JPC shall establish an annual plan and
budget for the following calendar year within the parameters set
forth in Section 2.7, establishing the general plan for the Project
to be conducted during the year and, subject to the minimum funding
levels set forth in Section 2.7, the specific amount of funding to
be provided by GTI to Alexion to fund the Project during that year.
Each Party shall bear its own expenses associated with meetings of
the JPC.
c) Dispute Resolution. Regardless of the number of representatives from
each Party, each Party shall represent one consolidated view on any
issue in dispute. Subject to compliance with the express terms of
this Agreement and the Project Plan attached hereto, disputes in the
JPC regarding the conduct or direction of the Project shall be
submitted, within 30 days following receipt of a request for a
meeting with the other, to the Chief Executive Officers of each of
Alexion and GTI, who shall meet to discuss either party's concerns
regarding such decision, although the Chief Executive Officer of GTI
shall retain the final decision-making authority provided in this
Section 2.2 within the scope of and in a manner consistent with this
Agreement.
2.3 Information and Reports. Each Party will make available and disclose to
the other Party promptly after the Effective Date all Information covering
matters within the Project Plan, known by such Party as of the Effective
Date, and will also disclose all Information covering matters within the
Project Plan learned, acquired or discovered by such Party at any time on
or before the end of the Project Term, promptly after
5
such Information is learned. All discoveries or inventions incorporating
the foregoing Information made by either Party in the Field, including
without limitation, Information regarding results of in vitro and in vivo
studies and discovery techniques will be promptly disclosed to the other,
with meaningful discoveries or advances being communicated promptly after
such Information is obtained or its significance is appreciated. The
Parties will exchange at a minimum semi-annually written reports
presenting a meaningful summary of Project work done under this Agreement
during the previous six (6) months. In addition, on reasonable request by
a Party, the other Party will make presentations to inform such Party of
the details of the work done under the Project Plan. Each Party will
provide the other with copies of raw data for work carried out in the
course of the Project, if reasonably necessary. Nothing herein shall
require either Party to disclose information received from a Third Party
which remains subject to a binder of confidentiality.
2.4 Alexion's Responsibilities. Alexion shall have specific responsibilities
as set forth in the Project Plan. Alexion, as determined by the JPC, will
share responsibility with GTI for preclinical research and development.
Additionally, and as permitted by the approved budget, Alexion will assist
GTI in GTI's development activities in the Field as reasonably requested
by GTI. If any specific research or developmental work in the Field not to
be performed by Alexion pursuant to the Project Plan is requested by GTI
of Alexion, the Parties will negotiate at that time compensation to
Alexion for carrying out the requested developmental work and modify the
Project Plan.
2.5 GTI's Responsibilities. Other than those responsibilities specifically
allocated to Alexion under the Project Plan, GTI shall have all
responsibilities for preclinical development, manufacture, process
development, clinical development, shall make all applications for and
hold all Regulatory Approvals on a worldwide basis and shall manufacture
or have manufactured, at its option, market and sell Licensed Product
worldwide. After the Project Term, GTI will prepare and furnish to Alexion
semi-annual written reports representing a meaningful summary, which may
include, as applicable, the development, manufacturing, regulatory and
marketing activities of GTI with respect to Alexion Patents and Alexion
Know-How during the previous six (6) months, shall afford one or more
Alexion employees the opportunity to ask questions and receive information
with respect to such report and will meet, at Alexion's request, annually
with Alexion at GTI for the expressed purpose of reviewing the development
progress of Licensed Products.
2.6 Alexion Project Commitments. In accordance with the recommendations made
by the JPC as provided for in this Agreement, Alexion shall conduct the
Project to be performed by it in good scientific manner, consistent with
its normal business practices and compliance in all material respects with
applicable laws and regulations. During the Project Term, Alexion shall
commit such FTE's in its employ to the Project as determined by the JPC on
an annual basis, subject to this Section 2.6 and Section 2.7. During the
Project Term, the JPC shall establish, by January 1 of any year, the
number of FTE's that Alexion shall dedicate under GTI's funding to conduct
the Project in the following year, subject to Section 2.7, and such number
shall be fixed for the entire year. At GTI's request, Alexion will provide
GTI with the names of the individual personnel conducting the Project and
the portion of time (on a percentage basis) each such person is devoting
to the Project.
2.7 Project Funding. GTI agrees to fund the Project at Alexion pursuant to the
Project Plan and budget established by the JPC and approved by GTI
pursuant to Section 2.6. Notwithstanding any re-allocation of research
effort or responsibility or any other changes to the Project Plan, but
subject to Section 9.2 below, GTI guarantees
6
that such funding shall be in the following minimum amounts during the
specified years of the Project Term:
Year Minimum FTE Commitment
---- ----------------------
1 [**] FTEs One of whom
2 [**] FTEs must be Ph.D.
Such funding shall be used to support the FTEs of Alexion conducting the
Project, as set by the JPC within the parameters of Section 2.6 and this
Section. Subject to maintenance of such minimum level of funding, for any
given year, the funding shall be at the minimum guaranteed reimbursement
rate of [**] FTE (inclusive of all direct and indirect costs) which the
Project Plan requires. Such funding shall be provided in four (4)
quarterly installments during each calendar year payable, in tranches as
nearly equal as practicable, in advance on or before January 1, April 1,
July 1 and October 1; provided, however, that the pro rata payment for
the first quarter of the Project will be made within thirty (30) days of
the Effective Date. Any payments for a portion of a quarter shall be made
on such pro rata basis. In addition to such FTE-based funding, GTI shall
reimburse Alexion for outside costs approved by the JPC and incurred on
behalf of the Project but such outside costs shall exclude the routine
costs of compensation, facilities, supplies and overhead of Alexion
FTE's. Alexion warrants that no other source of funding will be used on
the Project so as to adversely affect the rights of GTI hereunder without
the prior written consent of GTI.
2.8 Extension of Project Term by Mutual Agreement. The Parties may extend the
Project Term at any time on such terms as the Parties may mutually agree
in writing.
2.9 Parallel Research. Subject to the Parties' confidentiality obligations set
forth in Article VI below and subject to the terms and conditions of this
Agreement, each of the Parties shall have the right to engage in research
in the Field outside the Project Plan ("Parallel Research"); provided that
the right to use in the Field any inventions or discoveries made by
Alexion in the Field during the Project Term but outside the Project Plan,
including related Patents, shall be included in the licenses granted to
GTI under terms and conditions, including milestone payments and
royalties, similar to those included in the licenses granted to GTI under
this Agreement.
2.10 No Solicitation of Employees. During the Project Term and for a period of
two (2) years thereafter, neither Alexion nor GTI nor their respective
Affiliates shall, without the prior consent of the other Party, solicit
the employment of any person who during the course of employment with the
other party or its Affiliate was involved with activities relating to the
Project Plan or Parallel Research. For purposes of this Section 2.10,
"solicit" shall not be deemed to mean circumstances where any employee of
Alexion or GTI, as the case may be, initially contacts the other party
with regard to possible employment with such other Party.
ARTICLE III
DILIGENCE
3.1 Project Diligence. Both Parties shall use reasonable commercial efforts to
conduct the Project.
7
3.2 Pre-Marketing Diligence. GTI will use commercially reasonable and diligent
efforts (as defined in Section 3.7) which include but are not limited to
pursuing preclinical development and clinical development of Licensed
Products. Due to the exclusive nature of License, the Parties agree that
GTI shall be deemed to be using commercially reasonable and diligent
efforts by meeting the following performance milestones: [**] Within the
six month period prior to GTI filing a first IND for a Licensed Product,
GTI will notify Alexion of its intentions to file an IND. Within (90) days
of such notification, GTI will identify and inform Alexion of the next
Licensed Product to be developed by GTI and the Parties will agree on
reasonable performance milestones as in (i) and (ii) above. GTI will use
commercially reasonable efforts to develop additional Licensed Products.
3.3 Marketing Diligence. GTI will use commercially reasonable and diligent
efforts (as defined in Section 3.7) to commercialize each Licensed Product
that receives Regulatory Approval, taking into account the scientific and
commercial potential for such Licensed Product.
3.4 Remedies. In the event that Alexion reasonably believes that GTI is not
making reasonable efforts under the circumstances to research and develop
and then commercialize a selected Licensed Product then Alexion shall
provide written notice to GTI which specifies Alexion's basis for such
belief and what additional efforts Alexion believes should be made by GTI.
Upon receipt of such written notice, Alexion and GTI shall enter into good
faith negotiations in order to reach mutual agreement as to what efforts
by GTI shall satisfy the requirements of this Paragraph, and if such
mutual agreement is not reached within ninety (90) days after receipt of
such written notice, then the parties agree to submit to arbitration
pursuant to the rules of the American Arbitration Association to determine
the efforts which should be exerted by GTI. Thereafter, GTI shall exert
the efforts determined by the parties or in such arbitration. If GTI fails
to exert the efforts determined by the parties or in such arbitration,
Alexion's sole and exclusive remedy for GTI's failure to meet such efforts
is for the licenses granted hereunder to be converted from an exclusive
right and license to a non-exclusive right and license which shall take
effect sixty (60) days after written notice to GTI unless GTI cures such
failure prior to expiration of such sixty (60) day period.
3.5 No Restrictions on Business. Alexion acknowledges that GTI is in the
business of developing, manufacturing and selling of medical processes and
products and nothing in this Agreement shall be construed as restricting
such business or imposing on GTI the duty to market, and/or sell and
exploit Licensed Products for which royalties are due hereunder to the
exclusion of or in preference to any other product or process.
3.6 Commercialization of Licensed Product. Subject to Sections 3.2, 3.3 and
3.4, GTI shall have sole discretion for making all decisions relating to
the commercialization and marketing of Licensed Product.
3.7 GTI's Efforts. As used herein, the term commercially reasonable and
diligent efforts will mean, unless the Parties agree otherwise, those
efforts consistent with the exercise of prudent scientific and business
judgment, as applied to other GTI products of similar potential and market
size. In the event of any unanticipated and severe changes in regulatory
affairs or in the event of extreme market conditions or
8
similar unforeseen events, the Parties agree to discuss such changed
circumstances and appropriate mechanisms to address them.
ARTICLE IV
LICENSE GRANT
4.1 Patent License to GTI For Commercialization of Licensed Products. Subject
to Sections 6.1 and 6.2, Alexion hereby grants to GTI an exclusive, even
as to Alexion, royalty-bearing, worldwide license or sublicense in the
Field, under the Alexion Patents and Alexion's interest in Joint Patents
to make, have made, use, have used, offer for sale, sell, have sold,
import and have imported Licensed Products.
4.2 Know-How License to GTI. Subject to Sections 6.1 and 6.2, Alexion grants
to GTI a worldwide, exclusive license to use Alexion Know-How within the
Field in pursuance of the Project Plan during the Project Term subject to
the rights of Alexion to use Alexion Know-How. Thereafter, Alexion grants
to GTI a worldwide non-exclusive license to use Alexion Know-How within
the Field to the extent necessary to develop and commercialize Licensed
Products as herein provided. The patent license granted to GTI in Section
4.1 and the Know-How license granted to GTI in this Section 4.2 may be
sublicensed by GTI [**]. GTI shall notify Alexion promptly of its
intention to [**]. In the event Alexion does not respond within fifteen
(15) days or does not demonstrate to GTI's reasonable satisfaction as set
forth above, [**]. If the parties cannot agree upon the other terms
applicable to [**] either party may submit the matter to arbitration in
an expedited manner under the rules of the American Arbitration
Association.
4.3 Unpatented Technology. With respect to any discoveries or inventions in
the Field made in pursuance of the Project Plan during the Project Term
which are conceived and/or reduced to practice solely by Alexion or
jointly by Alexion and GTI (relative to Alexion's joint interest) and for
which in a given country:
a) the JPC has determined that no patent protection should be sought;
or
b) a patent application has been filed but the JPC has determined that
further prosecution should cease and the application should be
abandoned or allowed to lapse; or
c) a patent application has been filed but finally rejected by the
relevant patent office in a proceeding from which there is no
further appeal; or
d) an issued patent has been held invalid by the highest court of
competent jurisdiction or has been successfully opposed and no
further appeal is available;
then, subject to Sections 6.1 and 6.2, GTI shall have a worldwide
exclusive license in the Field to make and have made, use and have used,
import and have imported,
9
offer for sale, and sell and have sold such discoveries or inventions as
part of Licensed Products in the Field, subject to the rights of Alexion
to use Alexion Know-How.
4.4 Licenses to Joint Patents Outside the Field. In the event Alexion or a
licensee makes or sells products pursuant to Alexion's interest in Joint
Patents or joint inventions outside the Field, Alexion and its licensees
shall pay GTI a commercially reasonable royalty, to be negotiated, on Net
Sales of such products prior to the sales of such products.
4.5 Non-exclusive Licenses to Alexion. Subject to Sections 6.1 and 6.2, GTI
grants Alexion during the Project Term a non-exclusive worldwide royalty
free license to use GTI Patents and GTI Know-How, within the Field, in
pursuance of the Project Plan.
4.6 Affiliates. Each party shall be responsible for and indemnify and hold the
other party harmless from and against all acts and omissions of its
Affiliates, as if performed or failed to be performed by it under this
Agreement.
4.7 Certain Rights; No Implied License. In addition to all other rights of
Alexion under this Agreement, Alexion retains on behalf of itself the
perpetual, royalty free, non-transferable right and license to the Alexion
Patents in the Field licensed by it hereunder for research and educational
purposes. Except as otherwise provided in this Agreement, under no
circumstances shall a party hereto as a result of this Agreement obtain
any ownership interest or other right in any technology, know how, trade
secrets, patents, pending patent applications, products, vaccines,
antibodies, cell lines or cultures, or animals of the other party,
including items owned, controlled, developed by the other, or transferred
by the other to such party at any time pursuant to this Agreement. It is
understood and agreed by the parties that this Agreement does not grant to
either party any license or other right in basic technology of the other
party except to the extent necessary to enable the parties to carry out
their responsibilities under this Agreement. The license and rights
granted in this Agreement shall not be construed to confer any rights upon
a Party by implication, estoppel or otherwise as to any technology not
specifically identified in this Agreement as or included within such
license rights, and no other assignments or licenses are made or granted
by implication, estoppel or otherwise, by this Agreement. All rights
granted by Alexion to GTI under this Agreement which are now or in the
future licensed to Alexion are and shall be subject to the rights of the
licensors thereof.
4.8 Government. GTI acknowledges that the Patents and Information or a portion
thereof was developed with financial or other assistance from the United
States of America, and that applicable statutes, regulations and Executive
Orders of the United States of America may control, apply to or affect the
licenses granted hereunder. GTI acknowledges that it is responsible for
making its own determination about, and has made its own determination
about the applicability of any statutes, regulations or Executive Orders
and Alexion's compliance therewith.
ARTICLE V
PAYMENTS
5.1 Fees. In consideration of Alexion's commitment to conduct the Project and
for access to Alexion Patents and Alexion Know-How granted hereunder, GTI
agrees to pay,
10
and Alexion agrees to accept, a non-refundable, non-creditable fee of
Eight Hundred Fifty Thousand Dollars ($850,000) payable on the Effective
Date.
5.2 Project Funding. GTI shall make payments to Alexion to support Alexion's
Project efforts, pursuant to Section 2.7.
5.3 Milestone Payments.
a) GTI agrees to pay and Alexion agrees to accept the following
milestone payments for each of the first four (4) Licensed Products
developed by GTI. Milestone payments are creditable against future
royalties on sales:
i) [**] upon IND approval.
ii) [**] upon the start of a Phase 3 study.
iii) [**] upon PLA approval.
iv) [**] upon first country market launch in a Major Country.
5.4 Royalty to Alexion.
(a) GTI shall pay Alexion a royalty on Net Sales of Licensed Products
sold by GTI or its Affiliates or sublicensees and covered by a Valid
Claim of an Alexion Patent or Joint Patent in the country where sold
according to SCHEDULE A. Royalties where the only applicable patent
is a Joint Patent shall be [**] of royalties otherwise applicable.
(b) In the event that a Licensed Product includes both component(s)
covered by a Valid Claim of a Patent ("Patented Component(s)") and
an active component which does not require the Patented Component(s)
to be therapeutically active, is not administered in a physical
combination nor formulated to be used with the Patented
Component(s), and is not covered by a Valid Claim of a Patent
("Unpatented Component(s)") (such Licensed Product being a
"Multi-Component Product"), then Net Sales upon which a royalty is
paid shall be the Net Sales of the Multi-Component Product
multiplied by a fraction, the numerator of which is the difference
between (i) the inventory cost for producing the Multi-Component
Product and (ii) the inventory cost for producing the Unpatented
Component(s), and the denominator of which is the inventory cost for
producing the Multi-Component Product.
5.5 No Multiple Royalties. No multiple royalties shall be payable because any
Licensed Product is covered by more than one patent claim, patent or
patent application within the Licensed Patents; nor will additional
royalties be due as the result of any implied licenses granted to
customers as the result of the purchase of a Licensed Product.
5.6 Minimum Annual Royalties. In years in which GTI does not provide Alexion
the minimum [**] research funding pursuant to Section 2.7, GTI shall
pay Alexion a minimum annual royalty of [**] in Year 1, [**] in Year 2
increasing by [**] increments in each successive year to a maximum annual
royalty of [**] or until expiration of the
11
last to expire Alexion Patent or Joint Patent. Such minimum royalty shall
be fully creditable against earned royalties paid during the term of the
Agreement.
5.7 Foreign Exchange. All amounts payable hereunder shall be paid in U.S.
dollars. The remittance of royalties payable on Net Sales will be payable
in US. dollars to Alexion at a bank and to an account designated by
Alexion, using the selling rate of exchange for the currency of the
country from which the royalties are payable as published by The Wall
Street Journal, New York, New York, for the last business day of the
quarterly period for which the royalties are due.
5.8 Blocked Currency. In each country where the local currency is blocked and
cannot be removed from the country, at the election of GTI, royalties
accrued in that country shall be paid to Alexion in the country in local
currency by deposit in a local bank designated by Alexion.
5.9 Taxes. Alexion shall pay any and all taxes levied on account of such
payments it receives under this Agreement.
5.10 Milestone and Royalty Payments and Reports.
a) Milestone payments under this Agreement shall be earned upon the
occurrence of the milestone event set forth in Section 5.3, and
shall be payable within thirty (30) days of receipt by GTI of notice
thereof.
b) Quarterly Report. GTI shall prepare and deliver to Alexion within
forty-five (45) days after March 31, June 30, September 30, and
December 31 of each year during the term of this Agreement, after
the first commercial sale of Licensed Products, a true and accurate
report, giving such particulars of the calculations used to
determine Net Sales of Licensed Products by GTI during the previous
three (3) month period as is required to calculate the royalties due
Alexion hereunder. Such report shall include at least the following:
i) the total Net Sales of all Licensed Products sold by GTI
during the preceding three (3) month period and for the
calendar year to date;
ii) the royalties owed to Alexion pursuant to paragraph 5.4
with respect to the preceding three-month period and the
calendar year to date;
c) Royalty payments under this Agreement shall be made to Alexion or
its designee quarterly within forty-five (45) days following the end
of each calendar quarter for which royalties are due from GTI. Each
royalty payment shall be accompanied by such quarterly report on a
product-by-product and country by country basis. If no payments are
due, GTI shall so report.
5.11 Duration of Royalty Obligations. With respect to each Licensed Product
sold by GTI or its Affiliates or sublicensees, GTI shall pay Alexion
royalties hereunder, on a country by country basis until the expiration of
the last to expire applicable Valid Claim, of Alexion Patents or Joint
Patents, except that in the case when Alexion shall be required to make
royalty payments to a Third Party with respect to Licensed Products
covered by an unissued claim under the Alexion Patents, then GTI shall pay
Alexion royalties hereunder, on a country by country basis, in the
aggregate amount of royalties payable by Alexion to Third Parties with
respect to Licensed Products
12
until such obligation of Alexion to Third Parties shall terminate, but
such royalties shall not exceed GTI's royalty obligations hereunder.
5.12 Accounting. Each Party will maintain complete and accurate records which
are relevant to costs, expenses and payments under this Agreement and such
records shall be open during reasonable business hours for a period of
five years from creation of individual records for examination at the
other Party's expense and not more often than once each year by a
certified public accountant selected by the other Party and reasonably
acceptable to the Party being audited for the sole purpose of verifying
for the inspecting Party the correctness of calculations or such costs,
expenses or payments made under this Agreement. In the absence of material
discrepancies (in excess of 5%) in any request for reimbursement resulting
from such audit, the accounting expense shall be paid by the Party
requesting the audit. If material discrepancies adverse to the Party
requesting the audit do result, the audited Party shall bear the
accounting expense. Any records or accounting information received from
the other Party shall be Confidential Information for purposes of Article
VI.
5.13 Sales By Affiliates. GTI shall report sales of royalty-bearing products by
its Affiliates and pay royalties on such sales on the same basis as if
such sales had been made by GTI. GTI shall ensure that its Affiliate
sublicense agreements allow it to pay royalties and report on such a
basis, and shall further give Alexion a right to audit such Affiliates'
books, all substantially in accordance with each Party's rights under
Section 5.12 above.
5.14 Late Payments. Unless otherwise provided in this Agreement, GTI shall pay
interest to Alexion on the aggregate amount of any amounts payable by GTI
that are not paid within thirty (30) days following the date such payment
shall be due under this Agreement at a rate per annum equal to twelve
percent (12%), calculated on the number of days such payment is
delinquent.
5.15 Change to Non-Exclusive. Notwithstanding anything to the contrary herein,
in the event the license granted to GTI hereunder becomes non-exclusive
pursuant to Section 3.4, the minimum royalties due hereunder pursuant to
Section 5.6 shall not be payable thereafter and the milestone payments due
hereunder pursuant to Section 5.3 shall be reduced by fifty percent (50%)
of the amount otherwise payable thereafter. In such event, Alexion agrees
not to license the Alexion Patents in the Field to a Third Party at a
running royalty rate less than the royalty rate payable by GTI pursuant to
Section 5.4, without offering to GTI to reduce such royalty rate payable
by GTI hereunder to such lower rate.
5.16 Representation of Alexion. Alexion represents and warrants to GTI that the
royalties payable by GTI to Alexion pursuant to this Agreement are not
less than the royalties payable by Alexion to [**] a licensor of Alexion.
ARTICLE VI
CONFIDENTIALITY; PUBLICATIONS
6.1 Confidentiality; Exceptions.
a) Obligation. Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing, the Parties agree that,
during the periods set
13
forth in (b), the receiving Party 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 or other
materials furnished to it by the other Party pursuant to this
Agreement (collectively, "Confidential Information"), which is in
writing and identified as confidential or if oral, is reduced to
writing within thirty days and a copy provided to recipient.
b) Duration. The restrictions in Section 6.1(a) shall apply until the
fifth (5th) anniversary of the termination of this Agreement.
c) Exceptions. The restrictions under this Section 6.1 shall not apply
to the extent that it can be established by the receiving Party that
such Confidential Information:
i) was already known to the receiving Party as evidenced by
written records, 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 at the time of its disclosure to the receiving
Party;
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: or
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.
6.2 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,
complying with applicable governmental regulations or conducting
preclinical or clinical trials, or as required by a court order, provided
that a Party making any such disclosure gives prompt 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 and to minimize the extent of such disclosure.
Each Party may also disclose Confidential Information to its Affiliates,
consultants and collaborators under confidentiality and non-use
obligations, but only for the purposes of this Agreement.
6.3 Termination of Prior Agreement. This Agreement supersedes the
Confidentiality Agreement between the Parties dated November 22, 1995, as
amended and supplemented to date. All Information received by one Party
from the other under such agreement shall be deemed Confidential
Information and shall be subject to the terms of this Article VI.
6.4 Publications. Either Party may publish or present the results of the
Project subject to the prior review by the other party and its licensors
for patentability and protection of Confidential Information. Each Party
shall provide to the other Party the opportunity to review any proposed
abstracts, manuscripts or presentations which cover the results of the
research, and the other Party shall review such abstract, manuscript or
presentation promptly and in no event later than 30 days after submission
to the other
14
Party of such proposed publication or presentation for review. Such other
Party shall respond in writing promptly and in no event later than such
30-day time period with either approval of the proposed material or a
specific statement of concern, based upon either the need to seek patent
protection or concern regarding the protection of Confidential Information
or a concern about competitive disadvantage arising from the disclosure.
In the event of concern, the submitting Party agrees not to submit such
publication or to make such presentation that contains such information
until a reasonable period of time has been provided to seek patent
protection according to the provisions of this Agreement (not to exceed 90
days) or until Alexion shall have been provided assurances reasonably
satisfactory to it that such unpatentable information shall not be
disclosed. Each Party also agrees to delete from any such proposed
publication any Confidential Information of the other Party upon its
reasonable request based upon the commercial value of the secrecy of such
information.
6.5 Public Disclosure. The Parties shall jointly prepare and agree on the
public announcement of the execution of this Agreement. Thereafter, the
Parties shall consult with each other prior to the issuances of any press
release that discusses aspects of the Collaboration. In any event, each
party shall be entitled to make public disclosures required by law,
including compliance with securities laws and accounting requirements (in
which case the disclosing Party shall consult with the other Party prior
to the disclosure.)
6.6 This Agreement. Each of GTI and Alexion shall maintain the confidentiality
of this Agreement, and Alexion shall maintain the confidentiality of all
reports and all other information obtained by it from examination of GTI's
records and shall use such information from such reports and examination
of records only for the purposes of verifying the amount of royalties
payable to it pursuant to this Agreement. Without limiting the foregoing,
neither Alexion nor GTI shall disclose or make available to any person,
firm or entity a copy, summary or extract of this Agreement or any of the
terms hereof except to the extent reasonably required for compliance with
securities and other laws and accounting requirements.
ARTICLE VII
OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS
7.1 Ownership of Patents. Each Party shall own all right, title and interest
in and to patents arising from inventions made solely by its own employees
and agents in the course of the Project, subject to the licenses expressly
granted herein, and the Parties shall jointly own all right, title and
interest in and to any Joint Patents. Any dispute regarding the
inventorship of an invention made under the Project shall be resolved by
the decision of independent patent counsel, mutually acceptable to the
Parties, after consideration of all evidence submitted by the Parties,
except to the extent such decision is inconsistent with the subsequent
determination of the appropriate patent or judicial authorities.
7.2 Disclosure of Patentable Inventions. In addition to the disclosures
required under Article II, Alexion shall promptly disclose to GTI any
invention disclosure in the Field submitted in the normal course and
disclosing an invention arising in the course of the collaboration. In
addition, the JPC will from time to time provide information relating to
inventions arising in the course of the Project and will recommend to the
Parties the filing of applications for inventions it believes are
patentable.
15
7.3 Patent Filings.
a) General. The Parties intend to establish broad patent protection for
patentable inventions arising from the Project. The Parties will
discuss and agree on the appropriate countries in which patent
coverage should be sought. The Party filing an application shall
give the other Party an opportunity to review the text of the
application before filing, and in good faith shall consider and
incorporate the reasonable requests of the other Party, and shall
supply the other Party with a copy of all substantive correspondence
and the application as filed, together with notice of its filing
date and serial number. The Parties agree to use reasonable efforts
to ensure that any Patent filed outside of the United States prior
to a U.S. filing will be in a form sufficient to establish the date
of original filing as a priority date for the purposes of a
subsequent U.S. filing.
b) Joint Patents. GTI shall supervise and direct patenting of all
inventions covered by Joint Patents. GTI shall file and prosecute
all patent applications covering such Joint Patents respecting
Alexion's interests, using counsel reasonably acceptable to Alexion
and upon request, providing Alexion information pertaining to the
filing and prosecution of such patent applications. GTI and Alexion
shall bear equally all fees and expenses associated with the
preparation, prosecution and maintenance of such patent applications
and patents. Each Party shall bear all of its internal costs and
expenses of assisting the other Party under this Section 7.3(b).
c) Alexion Patents. Alexion shall supervise and direct patenting of all
inventions covered by any Alexion Patents. Alexion shall file and
prosecute all patent applications covering any Alexion Patents,
using counsel of its choice. GTI shall reimburse Alexion for a
pro-rata share of all reasonable out-of-pocket fees, costs and
expenses paid or incurred by Alexion after the Effective Date in
filing, prosecuting and maintaining the Alexion Patents during the
term of Agreement. Such pro-rata share shall be based upon the
number of other licensees of such Patents controlled by Alexion. GTI
shall deliver such reimbursement to Alexion within thirty (30) days
after Alexion notifies GTI from time to time of the amount of such
fees, costs and expenses which have been paid or incurred by Alexion
together with copy(ies) of the relevant invoice(s). GTI shall also
bear all of its internal costs and expenses of reviewing and
conferring with respect to Alexion Patents. Alexion shall make the
determination regarding the maintenance of all Alexion Patents that
issue on such applications. In addition, Alexion shall advise GTI in
writing thirty days in advance of the grant, lapse, revocation,
surrender or any threatened invalidation or of its intention to
abandon any such patent or patent application. If Alexion abandons
any patent or patent application under the Alexion Patents then it
will immediately notify GTI in writing of such decision and GTI, at
its option, shall be entitled to file or continue such patent
application or patent in GTI's name and for GTI's benefit at GTI's
own expense.
d) With respect to Alexion Patents or Joint Patents, each patent
application, office action, response to office action, request for a
terminal disclaimer, and request for reissue or reexamination of any
patent issuing from such application relating to the Field shall be
provided by the responsible Party to the other Party sufficiently
prior to the filing of such application, response or request to
allow for review and comment. The responsible Party shall have
16
the right to take any action that in its judgment is necessary to
preserve such Patent Rights in the Field provided that neither Party
shall adversely affect or impair any Patent Rights outside the Field
without the consent of the other Party.
7.4 Enforcement Rights.
a) Defense and Settlement of Third Party Claims. If a Third Party
asserts that a patent or other right owned by it is infringed by the
manufacture, use or sale of any Licensed Product, then Alexion shall
have the first right but not the obligation to defend against any
such assertions at its own expense. In the event that Alexion
declines to defend against such Third Party assertion, then GTI may
defend against such assertion at its own expense. In either event,
regardless of the time of the dispute or the Party defending against
it, no settlement shall be entered into by either Party without the
written consent of the other Party if such settlement may adversely
affect the interests of the other Party.
b) Infringement by Third Parties with Respect to Licensed Products. If
any Alexion Patent or Joint Patent is infringed by a Third Party in
any country in connection with the manufacture, use, offer for sale,
or sale of any Licensed Product or a functionally equivalent
competitive product in such country, the Party to this Agreement
first having knowledge of such infringement shall promptly notify
the other in writing. The notice shall set forth the facts of that
infringement in reasonable detail. Alexion shall have the primary
right, but not the obligation, to institute, prosecute, and control
any action or proceeding with respect to such infringement, by
counsel of its own choice, and GTI shall have the right, at its own
expense, to be represented by counsel of its own choice. If Alexion
fails to bring an action or proceeding within a period of one
hundred twenty (120) days after having knowledge of infringement of
an Alexion Patent or a Joint Patent, GTI shall have the right to
bring and control any such action by counsel of its own choice, and
Alexion shall have the right to be represented in any such action by
counsel of its own choice 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 and to
give the first Party reasonable assistance and authority to file and
prosecute the suit. No Party shall be obligated to bring or maintain
more than one such suit at any time with respect to claims directed
to any one method of manufacture or composition of matter or method
of use.
c) Infringement by Third Parties with Respect to Other Products. If an
Alexion Patent, GTI Patent or Joint Patent appears to be infringed
by a Third Party in any country in connection with the manufacture,
use, offer for sale, sale or import of any product other than a
Licensed Product or a functionally equivalent competitive product in
such country, the Party to this Agreement first having knowledge of
such infringement shall promptly notify the other in writing. The
notice shall set forth the facts of that infringement in reasonable
detail. Alexion shall have the primary right, but not the obligation
to institute, prosecute, and control any action or proceeding with
respect to such infringement of an Alexion Patent or Joint Patent by
counsel of its own choice, and GTI shall have the right, at its own
expense, to be represented in any action involving a Joint Patent by
counsel of its own choice. If Alexion fails to bring an action or
proceeding within a period of one hundred twenty (120) days after
having knowledge of infringement of a Joint Patent, GTI
17
shall have the right to bring and control any such action by counsel
of its own choice, and Alexion shall have the right to be
represented in any action by counsel of its own choice 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 and to give the first Party reasonable
assistance and authority to file and prosecute the suit. If the
Parties do not agree on a common course of action for any other such
Patent within sixty (60) days following the notice provided under
this Section 7.4, GTI may take such action with respect to a Joint
Patent and Alexion may take such action with respect to an Alexion
Patent or Joint Patent as it determines to be in its best interest
with respect to such apparent infringement.
d) Monetary Awards. Any damages or other monetary awards recovered by
reason of litigation under Section 7.4(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. Any amounts
remaining shall be allocated 80% to the Party bringing suit and 20%
to the other Party. A settlement or consent judgment or other
voluntary final disposition of a suit under Sections 7.4(b) or (c)
may be entered into without the consent of the Party not bringing
the suit; provided that such action affects only the Field and does
not or shall not waive or affect any rights of Alexion or any
licensor thereof outside the Field, and results only in the payment
of money by or other obligation of GTI or a third party (other than
Alexion or a licensor thereof).
e) Infringement of Joint Patents Outside the Field. With respect to
infringement of the Joint Patents outside of the Field, the Parties
shall consult with each other regarding the institution, prosecution
and control of any action or proceeding of any of the Joint Patents.
In the absence of agreement, each Party may proceed in such manner
as the law permits to protect its commercial interests. Each Party
shall bear its own expenses, with any recovery allocated pro rata
according to costs.
7.5 Unauthorized Use of Patent Rights. If either Party takes any action,
directly or indirectly, to challenge the validity of any issued Patent of
the other Party in the Field, then the other Party shall have the right
in its sole discretion to terminate the Project and to terminate the
licenses granted under Article IV above, to the extent permitted by law,
on a country by country basis. A party shall not be entitled to withhold
payment of any royalty accruing during any challenge to the validity of a
patent included within the patent rights of the other Party. For the
purposes hereof, any such challenge by Sandoz during such period of time
as it shall own or control GTI shall not be considered a challenge by GTI,
shall not be considered a challenge if such challenge shall be suggested,
initiated and conducted by and on behalf and for the full benefit of
Sandoz for strategic reasons unrelated or its technology, and shall not
be suggested, initiated or conducted by or on behalf or for the benefit
of GTI or for strategic reasons related to GTI or its technology.
ARTICLE VIII
REPRESENTATIONS AND WARRANTIES; EXCLUSIVITY
8.1 Representations and Warranties. Each of the Parties hereby represents and
warrants and covenants as follows:
18
a) This Agreement is an obligation binding upon such Party and
enforceable in accordance with its terms. Each Party has the right
and authority to grant the rights set forth herein to the other
Party. 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 knowingly violate any law or regulation of any
court, governmental body or administrative or other agency having
jurisdiction over it.
b) Each Party has not, and during the term of the Agreement will not,
grant any right to any Third Party relating to its respective
technology including Know-How and Patents in the Field which would
conflict with the rights granted to the other Party hereunder.
c) Each Party owns or Controls under valid licenses the requisite
rights to grant the licenses granted by it hereunder.
EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT, ALEXION MAKES NO
REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO THE LICENSED
TECHNOLOGY, LICENSED PRODUCTS, INFORMATION OR ALEXION PATENTS AND
EXPRESSLY DISCLAIMS ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE AND ANY OTHER IMPLIED WARRANTIES WITH RESPECT TO THE
CAPABILITIES, SAFETY, UTILITY OR COMMERCIAL APPLICATION OF LICENSED
TECHNOLOGY, LICENSED PRODUCTS, INFORMATION AND ALEXION PATENTS
NEITHER PARTY SHALL BE LIABLE FOR ANY CONSEQUENTIAL DAMAGES SUFFERED BY
THE OTHER PARTY OR ANY OTHERS RESULTING FROM THE USE OF THE LICENSED
TECHNOLOGY, LICENSED PRODUCTS, INFORMATION OR PATENTS.
8.2 Limitation on Warranties. GTI possesses the expertise and skill in the
technical areas in which the Alexion Patents, Information and Licensed
Products are involved necessary to make, and has made, its own evaluation
of the capabilities, safety, utility and commercial application of the
Alexion Patents, Information and Licensed Products. Nothing herein shall
be construed as a representation or warranty by either Party to the other
that any Patent or Know-How or other intellectual property right owned or
Controlled by such Party is valid, enforceable, or not infringed by any
Third Party, or that the practice of such rights does not infringe any
property right of any Third Party or that any Patent will issue based upon
a pending patent application or that any such patent which issues will be
valid.
8.3 Negative Covenants. Each Party hereby covenants to the other that such
Party shall not use or practice the other Party's Patents (except Joint
Patents) or Information in any field or in any manner except as
specifically licensed under this Agreement.
ARTICLE IX
TERM AND TERMINATION
9.1 Term. This Agreement shall commence as of the Effective Date and, unless
sooner terminated as provided herein, shall continue in effect until the
latest of (a) the end of the Project Term, (b) the date on which either
Alexion is no longer entitled to receive
19
a royalty on any Licensed Product or (c) the expiration of the last to
expire of the Alexion or Joint Patents.
9.2 Early Termination.
a) Breach by Alexion. If Alexion materially breaches this Agreement at
any time, and has not cured such breach within forty-five (45) days
after written notice thereof from GTI, then Alexion's rights under
GTI's Patents shall terminate, and GTI's licenses under this
Agreement shall remain in force, but as liquidated damages any
payments thereafter payable by GTI to Alexion pursuant to Article V
shall be reduced to, and in no event shall be lower than, the
aggregate royalties payable by Alexion to Third Parties with respect
to Licensed Products.
b) Breach by GTI. If GTI materially breaches this Agreement, and has
not cured such breach within forty-five (45) days after written
notice thereof from Alexion, then Alexion may, at its option
terminate this Agreement and in such event all rights thereunder
shall revert to Alexion.
c) By GTI. GTI may terminate this Agreement on a Licensed Product by
Licensed Product and country by country basis on or after the end of
the initial Project Term by providing Alexion ninety days (90) prior
written notice of such termination.
9.3 Surviving Rights. Except as modified above in Sections 9.2 hereof, the
obligations and rights of the Parties under Articles V (to the extent
applicable to royalties payable after such termination), VI, X and XII
shall survive termination or expiration of this Agreement.
9.4 Accrued Rights, Surviving Obligations. Termination or expiration of the
Agreement for any reason shall be without prejudice to any rights which
shall have accrued to the benefit of either party prior to such
termination or expiration, including, without limitation, the payment
obligations under Section 2.7 and Article V hereof and any and all damages
arising from any breach hereunder. Such termination or expiration shall
not relieve either Party from obligations which are expressly indicated to
survive termination or expiration of the Agreement.
9.5 Termination Not Sole Remedy. Termination is not the sole remedy under this
Agreement and, whether or not termination is effected, all other remedies
will remain available except as agreed to otherwise herein.
9.6 Failure to Enforce. The failure or delay of any Party at any time, or for
any period of time, to enforce any of the provisions of this Agreement
shall not be construed as a waiver of such provisions or the right of such
Party thereafter to enforce each and every such provision.
9.7 Effect. In the event this Agreement is terminated for any reason
whatsoever, GTI shall not have any right to return of any payments of any
kind theretofore made by it to Alexion pursuant to this Agreement, and GTI
shall deliver to Alexion, or at Alexion's direction destroy, all plans,
drawings, papers, notes, writings or other documents, samples, organisms,
biological materials and models comprising the licensed technology
furnished by Alexion or developed by Alexion employees, including all data
included within the Alexion Patents and Information and Licensed Products
furnished by Alexion or developed by Alexion employees, retaining no
20
copies (except one copy may be retained solely for compliance purposes),
and shall refrain from using or publishing any portion of the Alexion
Patents or Information as provided in Section 6.4 of this Agreement. Upon
termination of this Agreement, GTI shall cease manufacturing, processing,
producing, using, selling or distributing Licensed Products; provided,
however, that GTI may continue to sell in the ordinary course of business
for a period of ninety (90) days reasonable quantities of Licensed
Products which are fully manufactured and in GTI's normal inventory at the
date of termination if:
(a) all monetary obligations of GTI to Alexion have been satisfied, and
(b) royalties on such sales are paid to Alexion in the amounts and in
the manner provided in this Agreement.
9.8 Impossibility. In the event that any further lawful performance of this
Agreement or any part hereof by any party shall be rendered impossible or
impractical by or as a consequence of any law, regulation, order, rule,
direction, priority, seizure, allocation, requisition or any other
official action by any department, bureau, board, administration,
instrumentality, agency of any government or political subdivision thereof
having jurisdiction over such party, such party shall not be considered in
default hereunder by reason of any failure to perform occasioned thereby,
unless the party caused either directly or indirectly such action.
ARTICLE X
INDEMNIFICATION
10.1 Indemnification. Provided that Alexion or the indemnified party shall
promptly notify GTI in writing of any suit or action for which indemnity
is sought, GTI shall defend, indemnify, and hold harmless Alexion, its
licensors, their principal investigators and their officers, directors,
trustees, employees and agents and all of their heirs, executors,
administrators and legal representatives ("Indemnitees") from and against
any and all claims, demands, loss, liability, expense or damage (including
investigative costs, court costs and attorneys' fees) Indemnitees may
suffer, pay or incur as a result of third party claims, demands or actions
against any of the Indemnitees to the extent arising or alleged to arise
by reason of or in connection with any and all personal injury, economic
loss and property damage caused or alleged to be caused or contributed to
in whole or in part by the manufacture, use, handling, storage, lease,
sale or other disposition of Licensed Products by GTI or its agents,
whether asserted under a tort or contractual theory or any other legal
theory, including but not limited to any and all claims, demands, and
actions in which it is alleged that (1) an Indemnitee's negligence or
representations about the Licensed Products caused any defect in their
manufacture, design, labeling or performance, or (2) any alleged
infringement of any patent, trademark or copyright, caused or contributed
in whole or in part to the personal injury, economic loss or property
damage. GTI's obligations under this Section shall survive the expiration
or termination of this Agreement for any reason.
10.2 Insurance. Without limiting Alexion's indemnity obligations under the
preceding Section, prior to commencement of human testing of Licensed
Products, GTI shall obtain or have obtained for it and it shall maintain
or have maintained for it throughout the term of this Agreement general
liability insurance in comprehensive form with a combined single limit of
no less than $10,000,000, which shall cover at least bodily injury,
personal injury, liability, property damage and product liability
21
claims with respect to any licensed technology, Alexion Patents, Joint
Patents, Information or Licensed Products practiced, used, manufactured or
sold pursuant to any license granted hereunder and all activities involved
in the development, testing and commercialization of licensed technology,
Alexion Patents, Joint Patents, Information or Licensed Products, provided
that if and so long as an Affiliate of GTI shall have a consolidated net
worth of at least $250 million then the $10,000,000 insurance coverage may
be reduced to $5,000,000 by submission to Alexion by GTI of a copy of the
audited balance sheet of such Affiliate for the most recent fiscal year
certifying as to such consolidated net worth and referencing this section.
All such policies shall include a contractual endorsement naming
Indemnitees as additional insureds and providing coverage for all
liability which may be incurred by Indemnitees in connection with this
Agreement and require the insurance carrier(s) to provide Alexion with no
less than thirty (30) days written notice of any change in the terms or
coverage of the policy(ies) or its cancellation.
ARTICLE XI
DISPUTE RESOLUTION
11.1 Disputes. The Parties recognize that disputes as to certain matters may
from time to time arise during the term of this Agreement which relate to
either Party's rights and/or obligations hereunder or thereunder. It is
the objective of the Parties to establish procedures to facilitate the
resolution of disputes arising under this Agreement in an expedient manner
by mutual cooperation and without resort to litigation. To accomplish this
objective and subject to Section 3.4, the Parties agree to follow the
procedures set forth in this Article XI if and when a dispute arises under
this Agreement.
11.2 Dispute Resolution Procedures. Disputes arising out of the activities of
the JPC will be resolved as recited in Article II. If the Parties cannot
resolve any other dispute within twenty (20) days of formal request by
either Party to the other, any Party may, by written notice to the other,
have such dispute referred to their respective officers designated below
or their successors, for attempted resolution by good faith negotiations
within thirty (30) days after such notice is received. Said designated
officers are as follows:
For GTI: CEO
For Alexion: Chief Executive Officer
Any such dispute arising out of or relating to this Agreement which is not
resolved between the Parties pursuant to the terms of this Agreement shall
be submitted to a United States state or federal court of competent
jurisdiction and appropriate venue.
ARTICLE XII
MISCELLANEOUS
12.1 Export Control. GTI acknowledges that Alexion is subject to United States
laws and regulations controlling the export of technical data, computer
software, laboratory prototypes and other commodities and that its
obligations hereunder are contingent on compliance with all applicable
United States export and other laws and regulations. The transfer of
certain technical data and commodities may require a license from the
cognizant agency of the United States Government and/or written assurances
by GTI
22
that GTI shall not export data or commodities to certain foreign countries
without prior approval of such agency. Alexion neither represents that a
license shall not be required nor that, if required, it shall be issued.
12.2 Legal Compliance. GTI agrees that it will comply, in all material
respects, with applicable laws and regulations relating to its
manufacture, processing, producing, use, selling or distributing of
Licensed Products.
12.3 Required Consents. GTI shall obtain any and all licenses, permits,
approvals or authorizations ("Required Consents") required by any
governmental entity or agency having jurisdiction over the transactions
contemplated by this Agreement. Alexion shall cooperate with, and provide
reasonable assistance to, GTI in obtaining the Required Consents;
provided, however, that GTI shall reimburse Alexion for all of Alexion's
out-of-pocket expenses incurred in providing such assistance.
12.4 Patent Marking. GTI agrees to xxxx the Licensed Products sold in the
United States with all applicable United States patent numbers. All
Licensed Products shipped to or sold in other countries shall be to the
extent practical marked in such a manner as to conform with the patent
laws and practice of the country of manufacture or sale.
12.5 Use of Names. Except for disclosure required by applicable securities and
other laws, none of the names of any Party or any officers, trustees,
directors or employees of any of any Party or any licensors thereof may be
used by the other Party in any manner for announcing, advertising,
promoting or marketing Licensed Products, unless the written permission of
the other Party, or the individual, as the case may be, is obtained in
advance.
12.6 Assignment.
a) Notwithstanding any provision of this Agreement to the contrary,
either Party may assign any of its rights or obligations under this
Agreement in any country to any Affiliates; provided, however, that
such assignment shall not relieve the assigning Party of its
responsibilities for performance of its obligations under this
Agreement.
b) Either Party may also assign its rights or obligations under this
Agreement in connection with the sale of all or substantially all of
its assets, or otherwise with the prior written consent of the other
Party. This Agreement shall survive any merger of either Party with
or into another Party and no consent for a merger or similar
reorganization shall be required hereunder; provided, that in the
event of such merger or in the event of a sale of all assets, no
intellectual property rights of the acquiring corporation shall be
included in the technology licensed hereunder.
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.
12.7 Consents Not Unreasonably Withheld. Whenever provision is made in this
Agreement for either Party to secure the consent or approval of the other,
that consent or approval shall not unreasonably be withheld, and whenever
in this Agreement provision is made for one Party to object to or
disapprove a matter, such objection or disapproval shall not unreasonably
be exercised.
23
12.8 Retained Rights. Nothing in this Agreement shall limit in any respect the
right of either Party to conduct research and development with respect to
and market products outside the Field using such Party's own technology
including Know-How and Patents.
12.9 Force Majeure. Neither Party shall lose any rights hereunder or be liable
to the other Party for damages or losses on account of failure of
performance by the defaulting Party if the failure is occasioned by
government action, war, fire, explosion, flood, strike, lockout, embargo,
act of God, or any other similar cause beyond the control of the
defaulting Party, provided that the Party claiming force majeure has
exerted all reasonable efforts to avoid or remedy such force majeure;
provided, however, that in no event shall a Party be required to settle
any labor dispute or disturbance.
12.10 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.
12.11 No Trademark Rights. Except as otherwise provided herein, no right,
express or implied, is granted by the Agreement to use in any manner the
name "Alexion" or "GTI," or any other trade name or trademark of the other
Party in connection with the performance of the Agreement.
12.12 Notices. All notices hereunder shall be in writing and shall be deemed
given if delivered personally or by facsimile transmission (receipt
verified), telexed, 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):
If to Alexion, addressed to:
Alexion Pharmaceuticals, Inc.
00 Xxxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, XX 00000
Attention: Chief Executive Officer
If to GTI, addressed to:
Office of Business Development
Genetic Therapy, Inc.
000 Xxxxxxx Xxxx
Xxxxxxxxxxxx, XX 00000
12.13 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 of any other of such Party's rights or remedies provided
in this Agreement.
12.14 Severability. If any term, covenant or condition of this Agreement or the
application thereof to any Party or circumstance shall, to any extent, be
held to be invalid or unenforceable, then (a) the remainder of this
Agreement, or the application of such term, covenant or condition to
Parties or circumstances other than those as to which it is held invalid
or unenforceable, shall not be affected thereby and each term, covenant or
condition of this agreement shall be valid and be enforced to the fullest
24
extent permitted by law; and (b) 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 effectuated.
12.15 Ambiguities. Ambiguities, if any, in this Agreement shall not be construed
against any Party, irrespective of which Party may be deemed to have
authorized the ambiguous provision.
12.16 Counterparts. This Agreement may be executed 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.
12.17 Entire Agreement. This Agreement sets forth all the covenants, promises,
agreements, warranties, representations, conditions and understandings
between the Parties hereto and supersedes and terminates all prior
agreements and understanding 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 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.
12.18 Governing Law. Resolution of all disputes arising out of or related to
this Agreement or the performance, enforcement, breach or termination of
this Agreement and any remedies relating thereto, shall be governed by and
construed under the substantive laws of the State of Connecticut
12.19 Independent Contractor. For the purposes of this Agreement, each Party
shall be deemed to be an independent contractor of the other, without .
authority to make any statements, representations, or commitments of any
kind, or to take any action which shall be binding on the other without
prior written authorization .
12.20 Subcontracting. Alexion may not subcontract any portion or the entirety of
the research contemplated hereunder without the prior written consent of
GTI to do so.
IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate
originals by their proper officers as of the date and year first above written.
Genetic Therapy, Inc. Alexion Pharmaceuticals Inc.
By: /s/ Xxxx X. Xxxxxxxxxx By: /s/ Xxxxx Xxxxxx
Name: Xxxx X. Xxxxxxxxxx Name: Xxxxx Xxxxxx
Title: Sr. Vice President, Finance, Business Title: Exec. VP & COO
Development and Administration Date: Dec. 23, 1996
Date: December 23, 1996
25
SCHEDULE A
ROYALTIES
Constituting part of Section 5.4 of the License and Collaborative Research
Agreement dated December 20, 1996 between GTI and Alexion, the following
schedule lists royalty rates payable to Alexion as determined by the Licensed
Product sold by GTI or its Affiliates and the applicable Alexion Patent or Joint
Patent.
--------------------------------------------------------------------------------
Technology Included in Applicable Licensed Patent Royalty
Licensed Product Payable to
Alexion
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
26
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
27
EXHIBIT A
PROJECT PLAN
RESEARCH PROGRAM
Alexion and GTI
11/25/96
FOCUS: Immunoprotected Retroviral Vector Particles and Producer Cells for Human
Gene Therapy
PERIOD: 2 years with support [**] in year 1 [**] and a minimum of [**] in year 2
Objective 1: To generate [**]
Background:
o Alexion has demonstrated that [**]
o These [**] recognize the [**] and activate the classical complement
pathway leading to virolysis.
o [**] remodeling of the producer cell [**] down regulates [**] and allows
the cells [**]
Alexion Work Plan:
YEAR 1
A) Alexion will generate [**] The [**] be provided by GTI [**] Alexion will
provide [**] and will carry [**] screen [**] and evaluate [**]
B) Alexion will generate an [**] GTI will provide [**] Alexion will provide
[**] carry out the [**] will select [**] will evaluate the [**]
For A and B, Alexion will be responsible for [**]
1. [**] Alexion will demonstrate that [**].
28
2. [**] Alexion will identify [**]
3. [**] Alexion will show that [**]
4. [**] Alexion will demonstrate that [**]
YEAR 2
A) Alexion, collaboratively with GTI, will develop and test [**]
B) Alexion and GTI will collaborate to generate [**]
29
Objective 2: To generate [**]
Background:
o Alexion has demonstrated that [**]
o Alexion has also demonstrated, [**]
o Therefore, [**]
o Alexion has demonstrated that [**] Since the human complement inhibitors
proteins [**]
Alexion Work Plan:
YEAR 1
A) Alexion will generate [**] provided by and further engineered [**] Alexion
will provide [**]
For A, Alexion will be responsible for [**]
1. [**] Alexion will demonstrate that [**]
2. [**] Alexion, together with GTI, will [**]
3. [**] Alexion will demonstrate that [**]
4. [**] Alexion will demonstrate that [**]
YEAR 2
A) Alexion, collaboratively with GTI, will [**]
30
B) Alexion and GTI will collaboratively generate [**]
31
Objective 3: To generate [**]
Background:
o Alexion [**]
o The advantages of the [**] and characterized.
o Alexion, therefore, proposes [**] for the generation of [**]
Alexion Work Plan:
YEAR 1
A) Alexion will evaluate [**] This information
will [**]
B) Alexion will [**]
C) Alexion will [**]
D) Alexion will [**] will be required. Alexion will provide [**]
E) GTI will [**]
YEAR 2
A) Alexion and GTI will [**]
B) Alexion and GTI [**]
C) Alexion and GTI will [**] GTI will [**]
For B and C, Alexion will be responsible for [**]
32
1. [**] Alexion will [**]
2. [**] Alexion, together with GTI, will confirm [**]
3. [**] Alexion will [**]
4. [**] Alexion will [**]
33
EXHIBIT B
ALEXION PATENTS AS OF EFFECTIVE DATE
TITLE FILING NO.
Methods of Reducing Hyperacute [**]
Rejection of Xenografts
Retroviral Transduction of Cells in [**]
the Presence of Complement
Genetic Inhibition of Complement [**]
Mediated Inflammatory Response
Complement Regulatory Proteins [**]
of Herpes virus Saimiri
Chimeric Complement Inhibitor [**]
Proteins
Terminal Complement Inhibitor [**]
Fusion Genes and Proteins
Retroviral Particles Expressing [**]
Complement Inhibitor Activity
34
