EXHIBIT 10.8
["****" indicates material omitted and filed separately with Securities and
Exchange Commission pursuant to a request for confidential treatment.]
EXCLUSIVE LICENSE AGREEMENT (#5)
FOR VIRALLY INACTIVATED CELLULAR PRODUCTS
between
THE NEW YORK BLOOD CENTER, INC.
and
MELVILLE BIOLOGICS, INC.
-----------------------------------------
TABLE OF CONTENTS
PAGE
ARTICLE I. DEFINITIONS....................................................... 1
1.1. "AFFILIATE"............................................................ 1
1.2. "CONTRACT MANUFACTURING"............................................... 2
1.3. "CONTRACT MANUFACTURING SALES"......................................... 2
1.4. "DIRECT SALES"......................................................... 3
1.5. "EFFECTIVE DATE"....................................................... 3
1.6. "KNOW-HOW"............................................................. 3
1.7. "MILES AGREEMENTS"..................................................... 3
1.8. "NET PROCEEDS"......................................................... 4
1.9. "PATENT RIGHTS"........................................................ 4
1.10. "PRODUCT(S)"........................................................... 5
1.11. "SUBLICENSEE DIRECT SALES"............................................. 5
1.12. "SUBLICENSEE CONTRACT MANUFACTURING SALES"............................. 5
1.13. "SUPPLIERS/PURCHASERS"................................................. 6
1.14. "TERRITORY"............................................................ 6
1.15. "UNIT(S)".............................................................. 6
ARTICLE II. LICENSE GRANT .................................................. 6
ARTICLE III. DISCLOSURE, IMPROVEMENTS AND FDA
FILINGS......................................................... 7
ARTICLE IV. PAYMENTS AND ROYALTIES ......................................... 9
ARTICLE V. REPORTS, RECORDS AND ACCOUNTING FOR
ROYALTIES....................................................... 12
ARTICLE VI. REPRESENTATIONS................................................. 13
ARTICLE VII. COMPLIANCE; INDEMNIFICATION..................................... 14
ARTICLE VIII. INFRINGEMENT.................................................... 15
ARTICLE IX. CONFIDENTIALITY................................................. 16
ARTICLE X. TERM; TERMINATION............................................... 17
ARTICLE XI. NOTICES......................................................... 20
ARTICLE XII. ASSIGNMENT AND SUCCESSION....................................... 21
ARTICLE XIII. GOVERNING LAW................................................... 21
ARTICLE XIV. ENTIRE AGREEMENT; AMENDMENT..................................... 22
ARTICLE XV. SEVERABILITY.................................................... 22
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EXCLUSIVE LICENSE AGREEMENT
FOR VIRALLY INACTIVATED CELLULAR PRODUCTS
-----------------------------------------
AGREEMENT effective as of the EFFECTIVE DATE, by and between The New York
Blood Center, Inc. ("NYBC"), having an office at 000 Xxxx 00xx Xxxxxx, Xxx Xxxx,
Xxx Xxxx 00000, U.S.A., and Melville Biologics, Inc., a Delaware Corporation,
having an office at 000 Xxxxxx Xxxx, Xxxxxxxx, Xxx Xxxx 00000, X.X.X.
("LICENSEE").
WHEREAS, NYBC has developed know-how and patent rights relating to virus
inactivation technology for use with cellular products; and
WHEREAS, LICENSEE desires to acquire an exclusive license under such NYBC
know-how and patent rights for the manufacture and sale of such products; and
NOW, THEREFORE, in consideration of the mutual covenants herein contained
and other good and valuable consideration, the receipt of which is hereby
acknowledged, NYBC and LICENSEE mutually agree as follows:
ARTICLE I. DEFINITIONS
As used in this Agreement, the following terms shall be defined as set
forth below:
1.1. "AFFILIATE" shall mean a corporation or other business entity controlled
by, controlling or under common control with a party. For this purpose,
control of a corporation or other business entity shall mean direct or
indirect beneficial ownership of fifty percent (50%) or more of the
voting interest in, or a fifty percent (50%) or greater interest in the
equity of, such corporation or other business entity, or the maximum
percentage that a foreign investor may own, if equal to or less than
fifty percent (50%), pursuant to local laws, customs or regulations of
any country, but such corporation, or other business entity, shall be
deemed to be an AFFILIATE for only
so long as such ownership or control exists. Notwithstanding anything
herein to the contrary, for the purposes of this Agreement, NYBC is not
an AFFILIATE of LICENSEE.
1.2. "CONTRACT MANUFACTURING" shall mean the viral inactivation processing by
LICENSEE (or a sublicensee) of material supplied by or on behalf of
SUPPLIERS/PURCHASERS such that the material becomes PRODUCT, which
PRODUCT (or its equivalent) is intended for sale and/or distribution by
such SUPPLIERS/PURCHASERS.
1.3. "CONTRACT MANUFACTURING SALES" shall mean the product of the number of
UNITS produced by CONTRACT MANUFACTURING and shipped to
SUPPLIERS/PURCHASERS times the price at which each UNIT is sold by the
SUPPLIERS/PURCHASERS to third parties, less allowances for return of
PRODUCTS or adjustments for defective quality. PRODUCT shall be deemed
to have been sold when first shipped and billed; provided, however, that
when transfers thereof are made between SUPPLIERS/PURCHASERS and their
affiliates, such PRODUCT shall not be deemed to have been sold until
sold to a purchaser independent of SUPPLIERS/PURCHASERS and their
affiliates in a bona fide, arm's-length transaction between unrelated
parties. Payments shall accrue hereunder only once with respect to the
same UNIT of PRODUCT.
1.4. "DIRECT SALES" shall mean the total consideration received by LICENSEE
and/or its AFFILIATES from the sale, transfer or disposal of PRODUCT to
third parties, exclusive of amounts received by LICENSEE and its
AFFILIATES as a result of CONTRACT MANUFACTURING, less allowances for
return of PRODUCTS or adjustments for defective quality. PRODUCT shall
be deemed to have been sold when first shipped and billed; provided,
however, that when transfers thereof are made between LICENSEE and its
AFFILIATES, such PRODUCT shall not be deemed to have been sold until
sold to a purchaser independent of LICENSEE and its
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AFFILIATES in a bona fide, arm's-length transaction between unrelated
parties. Payments shall accrue hereunder only once with respect to the
same UNIT of PRODUCT.
1.5. "EFFECTIVE DATE" of this Agreement shall mean the date of closing of
the sale of shares of common stock of LICENSEE to one or more funds
controlled by Ampersand Ventures, so long as this occurs prior to
December 1, 1995.
1.6. "KNOW-HOW" shall mean the NYBC proprietary technical information
relating to the inactivation of viruses by the use of light and/or
certain compounds and the removal of process chemicals from labile
biological mixtures as described generally on Appendix A hereof.
1.7. "MILES AGREEMENTS" shall mean the following agreements:
(a) the Reimbursement and Security Agreement dated February 7, 1995
between Melville Biologics, Inc. and Miles Inc.;
(b) the Mortgage, Security Agreement and Fixture Filing dated
February 7, 1995 between Melville Biologics, Inc. and Miles Inc.;
(c) the Lease Agreement dated February 7, 1995 between Melville
Biologics, Inc. and Miles Inc.;
(d) the Agreement for Custom Processing dated February 7, 1995
between Melville Biologics, Inc. and Miles Inc.; and
(e) the Term Note dated February 7, 1995 between Melville Biologics,
Inc. and PNC Bank, National Association.
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1.8. "NET PROCEEDS" shall mean the total consideration received by LICENSEE
in any form (including without limitation upfront payments, license
signing and maintenance fees, minimum payments, royalties, research and
development funds, equipment and supplies, equity purchases in excess of
fair market value, etc.) from any third party or parties for a
sublicense (or other right, license, privilege or immunity) to make (or
have made by a third party), use and sell (or otherwise dispose of) a
PRODUCT. NET PROCEEDS does not include DIRECT SALES and amounts received
as a result of CONTRACT MANUFACTURING by LICENSEE.
1.9. "PATENT RIGHTS" mean the NYBC patents and patent applications listed on
Appendix A hereof relating to the inactivation of viruses by the use of
light and/or certain compounds and the removal of process chemicals from
labile biological mixtures.
1.10. "PRODUCT(S)" shall mean any product listed on Appendix B hereof, the
manufactures use or sale of which (1) involves the use of KNOW-HOW or
(2) is covered by a claim of PATENT RIGHTS.
1.11. "SUBLICENSEE DIRECT SALES" shall mean the total consideration received
by a sublicensee and/or its affiliates from the sale, transfer or
disposal of PRODUCT to third parties, exclusive of amounts received by
sublicensees and their affiliates as a result of CONTRACT Manufacturing,
less allowances for return of PRODUCTS or adjustments for defective
quality. PRODUCT shall be deemed to have been sold when first shipped
and billed; provided, however, that when transfers thereof are made
between a sublicensee and its affiliates, such PRODUCT shall not be
deemed to have been sold until sold to a purchaser independent of the
sublicensee and its affiliates in a bona fide, arm's-length transaction
between unrelated parties. Payments shall accrue hereunder only once
with respect to the same UNIT of PRODUCT.
1.12. "SUBLICENSEE CONTRACT MANUFACTURING SALES" shall mean the product of the
number of UNITS produced by CONTRACT MANUFACTURING by a sublicensee
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and shipped to SUPPLIERS/PURCHASERS times the price at which each UNIT
is sold by the SUPPLIERS/PURCHASERS to third parties, less allowances
for return of PRODUCTS or adjustments for defective quality. PRODUCT
shall be deemed to have been sold when first shipped and billed;
provided, however, that when transfers thereof are made between
SUPPLIERS/PURCHASERS and their affiliates, such PRODUCT shall not be
deemed to have been sold until sold to a purchaser independent of
SUPPLIERS/PURCHASERS and their affiliates in a bona fide, arms-length
transaction between unrelated parties. Payments shall accrue hereunder
only once with respect to the same UNIT of PRODUCT.
1.13. "SUPPLIERS/PURCHASERS" shall mean non-AFFILIATES of LICENSEE (or a
sublicensee) who receive PRODUCT from LICENSEE (or a sublicensee) as a
result of CONTRACT MANUFACTURING and who sell and/or resell PRODUCT to
third parties.
1.14. "TERRITORY" shall mean worldwide.
1.15. "UNIT(S)" shall mean PRODUCT packaged for sale in a single container and
intended for use by consumers/patients.
ARTICLE II. LICENSE GRANT
2.1. Subject to paragraph 2.4 hereof, NYBC grants to LICENSEE, under the
terms and conditions of this Agreement, an exclusive license, with the
right to grant sublicenses, under PATENT RIGHTS and KNOW-HOW (a) to
make, use, sell, or otherwise dispose of PRODUCT, and (b) to use the
methods covered by such PATENT RIGHTS and KNOW-HOW for the manufacture,
use and sale of PRODUCT. LICENSEE will not grant any sublicense under
KNOW-HOW and/or PATENT RIGHTS unless it first receives the prior written
consent of NYBC, which consent will not be unreasonably withheld.
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2.2. The license and sublicense grant herein is limited to making, using,
selling, or disposing of PRODUCT in the TERRITORY.
2.3. Nothing contained in this Agreement shall be construed or interpreted as
a grant, by implication or otherwise, of any license except as expressly
specified in paragraphs 2.1 and 2.2 hereof. LICENSEE agrees not to
utilize the PATENT RIGHTS and KNOW-HOW licensed under this Agreement in
the development, manufacture or use of any product not listed on
Appendix B hereof, unless first permitted to do so under a separate
written agreement with NYBC.
2.4. NYBC shall retain the right to make and use PRODUCTS in its own
laboratories for scientific purposes and for continued research.
Further, NYBC shall have the right to make PRODUCTS available to other
scientific institutions and researchers for scientific and research
purposes.
ARTICLE III. DISCLOSURE, IMPROVEMENTS AND FDA FILINGS
3.1. LICENSEE acknowledges receipt of KNOW-HOW.
3.2. NYBC shall have the right, but not the obligation, to inspect LICENSEE's
manufacturing sites, validation and/or processing records as they
pertain to the use and implementation of PATENT RIGHTS and KNOW-HOW.
3.3. For so long as LICENSEE has an exclusive license under paragraph 2.1,
NYBC hereby grants LICENSEE a right of first negotiation for a license
under any technology developed by NYBC after the EFFECTIVE DATE of this
Agreement (and not otherwise encumbered) in the field of viral
inactivation for use with PRODUCTS ("New Technology"). In implementation
of the foregoing, at least once a year during the term of this
Agreement, NYBC will notify LICENSEE in writing of any New Technology
developed by NYBC and, at LICENSEE's option, conduct good faith
negotiations with
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["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
LICENSEE for a license under such New Technology for PRODUCTS under
terms and conditions similar to those set forth herein. If NYBC and
LICENSEE are unable to reach an agreement with respect to such New
Technology within ******** of the first notification provided by
NYBC regarding such New Technology, then NYBC shall be free to license
such technology to a third party.
3.4. In each of calendar years ********, LICENSEE shall spend a minimum of
******** (direct costs only) per annum, exclusively in the further
development, evaluation and registration of PRODUCTS.
3.5. Within ninety days (90) of the end of calendar year 1996, 1997 and 1998,
LICENSEE shall provide NYBC with a report detailing the progress made in
the development, evaluation and registration of PRODUCTS and including a
detailed accounting of all expenditures made in the preceding year by
LICENSEE exclusively for the development, evaluation and registration of
PRODUCTS. NYBC shall have the unfettered right to confirm the accuracy
of all aspects of the detailed accounting provided by LICENSEE.
3.6. If LICENSEE does not fulfill its obligations under paragraph 3.4 above
for any one of calendar years ********, then NYBC, at its sole option,
may terminate this Agreement, upon ten days (10) written notice to
LICENSEE. Upon termination of this Agreement pursuant to this paragraph,
NYBC shall have an irrevocable, paid-up, non-exclusive license, with the
right to grant sublicenses, to make, use and sell within the TERRITORY
any improvements made by LICENSEE, whether patentable or not, so long as
the manufacture, use or sale of such improvements would infringe a claim
of the PATENT RIGHTS.
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["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
ARTICLE IV. PAYMENTS AND ROYALTIES
4.1. LICENSEE shall pay NYBC a running royalty at the rate of ******** of
DIRECT SALES and ******** of CONTRACT MANUFACTURING SALES.
4.2. LICENSEE shall pay to NYBC, on a quarterly basis, the greater of
******** of NET PROCEEDS received from each sublicensee or ******** of
the SUBLICENSEE DIRECT SALES and ******** of SUBLICENSEE CONTRACT
MANUFACTURING SALES.
4.3. LICENSEE shall make the following payments to NYBC during the term of
this Agreement in order to maintain the licenses granted hereunder:
(a) ******** per annum, payable in four equal installments on February
1, ****, May 1, ****, August 1, **** and November 1, ****. This
payment may be credited against royalties due to NYBC, if any, for
calendar year **** under paragraphs 4.1 and 4.2 hereof.
(b) ******** per annum, payable in four equal installments on February
1, ****, May 1, ****, August 1, **** and November 1, ****. This
payment may be credited against royalties due to NYBC, if any, for
calendar year **** under paragraphs 4.1 and 4.2 hereof.
(c) ******** per annum, payable each year in four equal installments on
February 1, May 1, August 1 and November 1, beginning in calendar
year **** and continuing for each calendar year thereafter until
termination of this Agreement. The payment for each calendar year
may be credited against royalties due to NYBC, if any, for such
calendar year under paragraphs 4.1 and 4.2 hereof.
-8-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
(d) NYBC, at its sole option, may terminate this Agreement if LICENSEE
fails to make any of the payments required by this paragraph after
notice of such failure to LICENSEE and a reasonable opportunity (ten
(10) days from receipt of notice) to cure.
4.4. LICENSEE shall make all payments due under paragraphs 4.1 and 4.2 of
this Agreement on a quarterly basis within thirty (30) days after the
end of each calendar quarter.
4.5. All payments due under this Agreement shall be made without deductions
for taxes, assessments or other charges of any kind which may be imposed
on NYBC by any foreign government or political subdivision thereof with
respect to any amounts payable to NYBC pursuant to this Agreement, and
such taxes, assessments or other charges shall be assumed by LICENSEE.
4.6. All payments due under this Agreement shall be made in United States
dollars. All royalty calculations hereunder shall be based on the
currency in which the sale was made, with total sales converted to
United States dollars based on the exchange rate of Citibank, New York,
on the first day of the month in which the royalty becomes due.
4.7. LICENSEE will make a reasonable quantity of PRODUCTS available for
purchase by NYBC, ** *** **** *********** *** ***** ** ***** *** *******
*** ***** **** ********* *** ******** **** ** ******** ** ***** ** *****
***** *** ***** ******* ** **** ***** ** ******* ** *** ******* *******
LICENSEE shall be relieved of its obligations under this paragraph if
elimination of NYBC's most favored customer status is required in order
to achieve a development and distribution agreement with a third party.
4.8. If it is necessary for LICENSEE to pay royalties under issued patents,
patent applications or know-how to any third party in order for LICENSEE
to make, have made, use or sell PRODUCTS, LICENSEE may offset ********
of the royalties payable to third
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["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
parties on LICENSEE's sales of PRODUCT against royalties payable to NYBC
on DIRECT SALES and CONTRACT MANUFACTURING SALES, provided that under no
circumstances may such royalties to NYBC be reduced by more than a total
of ******** (i.e. fall below ******** of DIRECT SALES and CONTRACT
MANUFACTURING SALES) in any calendar year as a result of such offsets.
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ARTICLE V. REPORTS, RECORDS AND ACCOUNTING FOR ROYALTIES
5.1. Within thirty (30) days after the end of each calendar quarter during
the term of this Agreement, LICENSEE shall forward to NYBC a written
report setting forth all NET PROCEEDS, SUBLICENSEE DIRECT SALES,
SUBLICENSEE CONTRACT MANUFACTURING SALES, DIRECT SALES and CONTRACT
MANUFACTURING SALES. All such information shall be presented on a
country-by-country basis and a sublicensee-by-sublicensee basis for the
previous calendar quarter and shall indicate the amount of royalties
due, together with sufficient supporting information to enable
confirmation by NYBC. LICENSEE shall also provide to NYBC a copy of all
reports received from sublicensees.
5.2. LICENSEE shall keep full and accurate books of accounts and other
records in accordance with generally accepted accounting practice,
showing all information necessary for NYBC to ascertain and verify the
royalties payable by LICENSEE hereunder. During the term of this
Agreement, and for three (3) years thereafter, NYBC shall have the right
to have, at its own expense and upon ten (10) days written notice, an
independent certified public accountant of its own choosing, inspect,
during regular business hours, said books, records, files and all
supporting data relating to records kept pursuant to this Agreement.
LICENSEE also agrees to permit NYBC, or its representatives, to make and
retain copies of any and all invoices, records and accounts kept by
LICENSEE pursuant to this Agreement. If the inspection of LICENSEE by
NYBC reveals an underpayment to NYBC of ten percent (10%) or greater,
then the costs of such inspection shall be borne by LICENSEE.
5.3. On or about April 1, 1997 and each year thereafter during the term of
this Agreement, LICENSEE shall provide a written report to NYBC
describing LICENSEE's efforts to commercialize PRODUCTS, including a
description of LICENSEE's efforts to obtain any required governmental
approval to market PRODUCTS and to grant sublicenses and, when required
by paragraphs 3.4 and 3.5, a detailed accounting of all monies spent by
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LICENSEE in the preceding calendar year exclusively for the development,
evaluation and registration of PRODUCTS. NYBC agrees to keep such
reports confidential.
ARTICLE VI. REPRESENTATIONS
6.1. Nothing in this Agreement is or shall be construed as:
(a) A warranty or representation by NYBC that anything made or used by
LICENSEE under any license granted in this Agreement is or will be
free from infringement of patents, copyrights, and other rights of
third parties; or
(b) Granting by implication, estoppel, or otherwise any license, right
or interest other than as expressly set forth herein.
6.2. Except as expressly set forth in this Agreement, the parties MAKE NO
REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, STATUTE OR OTHERWISE,
AND THE PARTIES SPECIFICALLY DISCLAIM ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR WARRANTY OF NON-
INFRINGEMENT.
6.3. LICENSEE represents and warrants that it shall not, directly or
indirectly, use NYBC's tradenames or trademarks in connection with
promotions, advertising or sales activity, without the prior written
consent of NYBC. Further, LICENSEE shall not make any use of NYBC's name
without NYBC's prior written consent, except if the use of NYBC's name
is required by law, regulation or judicial order, in which event
LICENSEE will promptly inform NYBC prior to any such required use.
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6.4. LICENSEE represents and warrants that it has adequate insurance and
financial resources to cover all liability for any failure including,
without limitation, failure in design, manufacture, production and/or
operation.
ARTICLE VII. COMPLIANCE; INDEMNIFICATION
7.1. NYBC shall not be liable to LICENSEE, its AFFILIATES, its sublicenses or
any third party for any injury, illness, disease, allergy, allergic
reaction, side effect, death, or other adverse experience arising out of,
or in connection with, or as a consequence of research, manufacture,
testing, advertising, sale, distribution, or other use of PRODUCT.
7.2. LICENSEE shall conduct all of its operations relating to PRODUCT in
accordance with all applicable laws, regulations, requirements, and other
standards, which may be in effect from time-to-time, of all pertinent
governmental authorities, including, without limitation, standards for the
validation and processing of PRODUCT.
7.3. LICENSEE agrees to exercise a reasonable standard of care in conducting its
activities relating to PRODUCT, including the testing, manufacture,
packaging, marketing, advertising, distribution and sale of PRODUCT.
7.4. LICENSEE agrees to indemnify, defend and hold harmless NYBC, its
directors, officers, employees and agents from and against any and all
loss, damage, demands, claims, actions and causes of action, assessments,
liabilities, costs and expenses which they may incur because of injury to
or death of any person or any other claim arising out of, or in connection
with, or as a consequence of, LICENSEE's manufacture, sale, or use of
PRODUCT.
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ARTICLE VIII. INFRINGEMENT
8.1. LICENSEE shall promptly provide written notification to NYBC in the event
of any third party infringement, or possible infringement, of PATENT RIGHTS
in the TERRITORY. Upon receipt of such notice, NYBC shall have the right,
at its sole discretion, to take appropriate legal action in connection
therewith. In the event that NYBC shall elect to take such action, the
conduct of the action shall be entirely directed by NYBC, and NYBC shall
pay all costs and expenses associated therewith and retain all recoveries
of any such action.
8.2. In the event NYBC decides that it will not take legal action against an
alleged infringer, LICENSEE shall have the right to take appropriate legal
action against the alleged infringer and shall pay all costs and expenses
associated therewith and retain all recoveries of any such action.
LICENSEE shall not initiate or settle or compromise any such legal action
without first obtaining the written consent of NYBC, which consent shall
not be unreasonably withheld.
8.3. In the event that either party initiates or carries on legal proceedings
against an alleged infringer, then the other party shall fully cooperate
with and supply all assistance reasonably requested by the litigating
party. The non-litigating party, at its own expense, may be represented by
counsel of their choice in any such proceeding.
8.4. LICENSEE agrees to report to NYBC, promptly and in written detail, each
claim of patent infringement made by a third party against LICENSEE as a
result of LICENSEE's manufacture, use or sale of PRODUCTS.
ARTICLE IX. CONFIDENTIALITY
9.1. LICENSEE agrees not to use or disclose to any third party any KNOW-HOW
provided to it pursuant to this Agreement except as contemplated herein.
This obligation shall not apply to any information which:
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(a) is or subsequently becomes known to the public through no fault of
LICENSEE;
(b) was in the possession of LICENSEE prior to disclosure by NYBC as
established by documentation provided by LICENSEE to NYBC within
thirty (30) days of disclosure of such information by NYBC to
LICENSEE;
(c) is obtained from a third party who or which has the lawful right to
disclose same to LICENSEE;
(d) is disclosed to governmental authorities in response to a lawful
order or demand for disclosure, or in order to obtain required
consents, permits, licenses, or other approvals relating to the
manufacture, use or sale of PRODUCT.
9.2. LICENSEE agrees to treat as confidential the terms and conditions of this
Agreement. Further, LICENSEE agrees not to issue any press release or
other public statement disclosing the existence of, or relating to, this
Agreement without the prior written consent of NYBC.
9.3. The provisions of this Article shall survive termination, cancellation,
or expiration of this Agreement.
ARTICLE X. TERM; TERMINATION
10.1. The term of this Agreement shall be from the EFFECTIVE DATE until the
later of the seventeenth anniversary of the EFFECTIVE DATE or the last to
expire patent of PATENT RIGHTS, unless this Agreement is terminated
earlier in accordance with the provisions of this Article.
10.2. NYBC may terminate this Agreement at any time upon notice to LICENSEE if:
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(a) LICENSEE fails to cure a breach of this Agreement within thirty (30)
days after notice thereof; or
(b) LICENSEE fails to make payments due under paragraphs 4.1, 4.2 or 4.3
of this Agreement within ten (10) days after notice thereof; or
(c) LICENSEE fails to meet its obligations under paragraphs 3.4, 3.5 or
3.6 of this Agreement; or
(d) LICENSEE fails in the performance of its obligation to conform to
applicable standards, regulations, or guidelines of the applicable
governmental agency, as determined by NYBC or governmental agency
review and fails to cure such breach within ninety (90) days after
notice thereof; or
(e) LICENSEE becomes insolvent, is adjudged bankrupt, files a petition
in bankruptcy, makes an assignment for the benefit of creditors or
seeks relief generally from its debts and obligations in accordance
with a similar or analogous procedure; or
(f) LICENSEE fails to make and sell PRODUCT within seven (7) years of
the EFFECTIVE DATE; or
(g) an Event of Default or a default occurs prior to February 1, 1997
under any one or more of the MILES AGREEMENTS.
Upon such termination, (1) all rights in KNOW-HOW and PATENT RIGHTS shall
revert to NYBC and (2) LICENSEE will not use KNOW-HOW and PATENT RIGHTS
for any purposes whatsoever, unless permitted to do so under a separate
agreement with NYBC. Further, upon such termination, NYBC shall have an
irrevocable paid-up, non-exclusive license, with the right to grant
sublicenses, to make, use and sell within the TERRITORY any improvements
made by LICENSEE, whether patentable or not, so long as the
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manufacture, use or sale of such improvements would infringe a claim of
the PATENT RIGHTS.
10.3. The expiration or earlier termination of this Agreement will not:
(a) affect the right of LICENSEE to sell PRODUCT manufactured prior to
the date of expiration or termination, provided that such sales,
notwithstanding expiration or termination, will be subject to
royalties in accordance with the provisions of Article IV and
provided further that such termination is not due to the reasons set
forth in, paragraph 10.2(d) hereof; or
(b) relieve LICENSEE from any other obligation under this Agreement,
including, without limitation, obligations to forward reports,
maintain records, permit an audit or inspection and to maintain
confidentiality; or
(c) release LICENSEE from any liability resulting from an act or
omission prior to expiration or termination or an act or omission,
whenever arising, relating to the provisions of Article VII.
10.4. Invalidation by a court of last resort of any claim(s) of any or all of
the patents comprising PATENT RIGHTS shall relieve LICENSEE of its
obligations with respect to such claims; but, notwithstanding any other
clause herein, shall not terminate this Agreement.
10.5. LICENSEE may terminate this Agreement upon providing ninety (90) days
prior written notice to NYBC. Upon such termination, (1) all rights in
KNOW-HOW and PATENT RIGHTS shall revert to NYBC and (2) LICENSEE will not
use KNOW-HOW and PATENT RIGHTS for any purposes whatsoever, unless
permitted to do so under a separate agreement with NYBC. Further, upon
such termination, NYBC shall have an irrevocable paid-up, non-exclusive
license, with the right to grant sublicenses, to make, use and sell
within the TERRITORY any improvements made by LICENSEE, whether
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patentable or not, so long as the manufacture, use or sale of such
improvements would infringe a claim of the PATENT RIGHTS.
ARTICLE XI. NOTICES
11.1. Any notice, report or other communication required or permitted to be
given or made under this Agreement by one of the parties to the other
shall be in writing and shall be deemed to have been sufficiently given
or made for all purposes if mailed by Certified Mail, postage prepaid, or
sent by facsimile, confirmed forthwith in written dispatch as described
herein, addressed to such other party at its respective address as
follows:
If to NYBC:
----------
The New York Blood Center, Inc.
000 Xxxx 00xx Xxxxxx
Xxx Xxxx, XX 00000-0000
U.S.A.
Attention: Office of Patents And Licensing
cc: General Counsel
If to LICENSEE:
--------------
Melville Biologics, Inc.
000 Xxxxxx Xxxx
Xxxxxxxx, Xxx Xxxx 00000
X.X.X.
Attention: President
ARTICLE XII. ASSIGNMENT AND SUCCESSION
12.1. The rights and licenses granted by NYBC in this Agreement are personal to
LICENSEE and may not be assigned or otherwise transferred without the
prior written consent of NYBC. Any attempted assignment or transfer
without such consent shall be void and without effect.
-18-
12.2. NYBC may assign or otherwise transfer this Agreement to any third party
or to a subsidiary of NYBC. NYBC shall give LICENSEE written notice of
such assignment or transfer and the written agreement of such assignee or
transferee to be bound by the terms and conditions of this Agreement.
Upon such assignment or transfer and agreement by such assignee or
transferee, the term NYBC as mused herein shall mean such assignee or
transferee.
ARTICLE XIII. GOVERNING LAW
13.1. This Agreement shall be construed and the rights of the parties governed
in accordance with the laws of the State of New York, excluding its law
of conflict of laws. Any dispute or issue arising hereunder, including
any alleged breach by LICENSEE, shall be heard, determined and resolved
by an action commenced in the federal courts in New York City, New York,
which the parties hereby agree shall have proper jurisdiction over the
issues and the parties.
LICENSEE hereby agrees to submit itself to the jurisdiction of the
federal courts in New York and waives the right to make any objection
based on jurisdiction or venue. The New York courts shall have the right
to grant all relief to which each party is or shall be entitled
hereunder, including all equitable relief as the Court may deem
appropriate.
13.2. This Agreement has been prepared jointly and shall not be strictly
construed against any party.
ARTICLE XIV. ENTIRE AGREEMENT; AMENDMENT
14.1. This Agreement supersedes all prior written and oral communications
between the parties with respect to PRODUCT and sets forth the entire
Agreement of the parties with respect to the subject matter contained
herein and may not be modified or amended except as expressly stated
herein or by a written agreement duly executed by both parties hereto.
-19-
ARTICLE XV. SEVERABILITY
15.1. If any term or provision of this Agreement or the application thereof to
any person or circumstance shall to any extent be invalid or
unenforceable, the remainder of this Agreement or the application of such
term or provision to persons or circumstances other than those as to
which it is held invalid or unenforceable shall not be affected thereby
and each term and provision of this Agreement shall be valid and enforced
to the fullest extent permitted by law.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed in duplicate by their duly authorized representatives.
THE NEW YORK BLOOD CENTER, INC.
By: /s/ Xxxx X. Xxxxxxx, M.D.
--------------------------------
Name: Xxxx X. Xxxxxxx, M.D.
--------------------------------
Title: President
-------------------------------
Date: 9/21/95
--------------------------------
MELVILLE BIOLOGICS, INC.
By: /s/ Xxxxxx X. Xxxxxxxxxxxx
--------------------------------
Name: Xxxxxx X. Xxxxxxxxxxxx
---------------------------------
Title: President
-------------------------------
Date: 9/21/95
-------------------------------
-20-
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
APPENDIX A
FOR EXCLUSIVE LICENSE AGREEMENT (#5)
FOR VIRALLY INACTIVATED CELLULAR PRODUCTS
between
THE NEW YORK BLOOD CENTER, INC.
and
MELVILLE BIOLOGICS, INC.
KNOW-HOW - 1 Page
PATENTS - 2 Pages
**************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************[3 pages omitted]****************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
**********************************************************
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
APPENDIX B
----------
PRODUCTS
--------
** **** ********* ** ***** ****** *** ***** **** ************ *** ********
*************
-25-
[EXECUTION COPY]
AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT (#5)
FOR VIRALLY INACTIVATED CELLULAR PRODUCTS
between
THE NEW YORK BLOOD CENTER, INC. ("NYBC")
and
V.I. TECHNOLOGIES, INC. (Formerly known as Melville Biologics, Inc.)("LICENSEE")
Whereas the above parties have executed the above-captioned Exclusive
License Agreement (#5) For Virally Inactivated Cellular Product on September 21,
1995, which agreement remains in full force and effect as of the date of this
AMENDMENT (the "EXCLUSIVE LICENSE AGREEMENT").
Whereas the above parties mutually desire to amend the EXCLUSIVE LICENSE
AGREEMENT so as to reflect current business opportunities available to LICENSEE,
utilizing the viral inactivation technology and to facilitate LICENSEE's entry
into a Joint Development, Marketing and Distribution Agreement (the "JOINT
DEVELOPMENT AGREEMENT") with Pall Corporation, a New York corporation, having
principal offices at 0000 Xxxxxxxx Xxxx., Xxxx Xxxxx, Xxx Xxxx 00000 ("PALL
CORPORATION"), this AMENDMENT to remain in effect for the duration of the JOINT
DEVELOPMENT AGREEMENT (and any amendments thereto and extensions thereof)
between LICENSEE and PALL CORPORATION or the term of the EXCLUSIVE LICENSE
AGREEMENT, whichever shall be shorter.
NOW, THEREFORE, in consideration of the mutual covenants herein
contained and other good and valuable consideration, the receipt of which is
hereby acknowledged, NYBC and LICENSEE mutually agree as follows (all terms in
capitals retaining their original meanings unless otherwise defined herein):
1
["**** indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
A. For the purpose of this AMENDMENT and to facilitate LICENSEE's
entry into the JOINT DEVELOPMENT AGREEMENT, the EXCLUSIVE LICENSE AGREEMENT is
hereby amended and supplemented as follows:
i) *** **** ********** ******** ***** **** * ***** ** **********
********** ************ ******* *** *** ******** *** ******* ****** ***********
** ***** ****** *** ***************** ******** ** ***** ***** ******** *** ***
** * ***** ***** ******* ** *** ***** ***** ******** ** *********** **** ****
************* ******* *** *********** ********** *** ******* ** ***** ******
********* ********* ******* ***** ******* ******* ** *** ***** *************
******** ** **** *********** **** ***** ************* ** ** *** ** ****
********* ** ***** ****** *** ***** **** ************ *** ******** *************
*** *** ************ *** ** **** ** ***** *** ******** *** *** ** ******** **
*** ** ******* ** * ***** ** ****** ******* ********* ******* **** *** ********
*** ***** *** ** *********** ** ******** *** **** ********** **********
********* ********* ******* ***** ******* ******* ** *** ***** **************
ii) the term "CONTRACT MANUFACTURER" shall mean a third party
manufacturing INACTIVATION PRODUCT for PALL CORPORATION's account.
iii) the term "FISCAL QUARTER" shall mean a fiscal quarter which ends
on the Saturday nearest to the last day of January, April, July or October in
each year.
iv) the term "INACTIVATION PRODUCT" shall mean a viral inactivation
compound, developed for and transferred to PALL CORPORATION by LICENSEE or
CONTRACT MANUFACTURER, for the ex vivo treatment of whole blood, red blood cell
concentrates and platelet concentrates the manufacture, use or sale of which (1)
involves the use of KNOW-HOW or (2) is covered by a claim of PATENT RIGHTS.
v) the term "PALL INFORMATION" shall mean all information made
available to NYBC, by PALL CORPORATION or by LICENSEE which is either non-
public, confidential or
2
proprietary in nature, including but not limited to equipment, processes,
methods, trade and business secrets, know-how, technical and non-technical
materials, notes, memoranda, drawings, product samples and specifications,
financial information, reports, employee and contractor information, price and
quotations information, sources of supply, customer lists, business plans and
all data and other information which is furnished by PALL CORPORATION, or by
LICENSEE, to NYBC in connection with, relating to or regarding INACTIVATION
PRODUCT, AMENDMENT PRODUCT, or the JOINT DEVELOPMENT AGREEMENT between LICENSEE
and PALL CORPORATION and any other information designated by LICENSEE or PALL
CORPORATION as confidential or proprietary, regardless of whether such
information is furnished to NYBC by LICENSEE under the terms of this AMENDMENT
and whether such information is transmitted orally or in writing.
PALL INFORMATION shall not include any information that (i) was
rightfully in the possession of NYBC prior to the date of disclosure by PALL
CORPORATION, or by LICENSEE, to NYBC of such information, as evidenced by
written documents; (ii) was in the public domain prior to disclosure by PALL
CORPORATION, or by LICENSEE to NYBC; (iii) becomes part of the public domain by
publication or otherwise, except by an unauthorized act or omission of NYBC or
its officers, directors, employees, agents or representatives; (iv) is supplied
to NYBC by a third party, who is under no obligation to LICENSEE or PALL
CORPORATION to maintain such information in confidence; (v) is required to be
disclosed pursuant to applicable law, provided that if NYBC believes it is
required to disclose any PALL INFORMATION pursuant to applicable law, it shall
give timely written notice to LICENSEE and PALL CORPORATION so they may have an
opportunity to obtain a protective order or other appropriate relief.
B. In addition to the rights granted to LICENSEE under Article II of
the EXCLUSIVE LICENSE AGREEMENT, NYBC hereby grants to LICENSEE, under the terms
and conditions of this AMENDMENT, an exclusive, worldwide license, under PATENT
RIGHTS and KNOW-HOW (a) to make, have made, use, sell, or otherwise dispose of
AMENDMENT PRODUCT and (b) to use the methods covered by such PATENT RIGHTS and
3
KNOW-HOW for the manufacture, use and sale of AMENDMENT PRODUCT. LICENSEE shall
also have the right without NYBC's consent to grant sublicenses under PATENT
RIGHTS and KNOW-HOW for the manufacture, use and sale of AMENDMENT PRODUCT to
PALL CORPORATION and to extend the right to use the methods covered by such
PATENT RIGHTS and KNOW-HOW to end-user purchasers of AMENDMENT PRODUCT or any
product utilizing, including or incorporating AMENDMENT PRODUCT. If LICENSEE
fails to meet PALL CORPORATION's requirements, PALL CORPORATION shall have the
right to have INACTIVATION PRODUCT made by a CONTRACT MANUFACTURER which has
been approved by NYBC, which approval shall not be unreasonably withheld or
delayed. LICENSEE shall remain responsible for the activities of PALL
CORPORATION pursuant to a sublicense granted to PALL CORPORATION under this
Paragraph B.
C. The negotiation right to New Technology under Section 3.3 of the
EXCLUSIVE LICENSE AGREEMENT shall be limited to apply to any New Technology
which competes directly or indirectly through a different channel of trade with
AMENDMENT PRODUCT or INACTIVATION PRODUCT in the inactivation of viruses and
pathogens for the decontamination of red blood cells and/or platelets in either
whole blood, packed red cells, platelet concentrates or apheresis platelets.
D. At LICENSEE's option it may substitute reports regarding the
progress, development and evaluation of INACTIVATION PRODUCT and AMENDMENT
PRODUCT for reports required with respect to the progress, development and
evaluation of PRODUCTS under Section 3.5 of the EXCLUSIVE LICENSE AGREEMENT. If
LICENSEE shall exercise its option under the terms of this Paragraph D (i) it
shall submit such reports every FISCAL QUARTER; and (ii) NYBC agrees that any
information contained in such reports is subject to the confidentiality
requirements set forth in Paragraph I of this AMENDMENT.
E. (i) LICENSEE shall pay or cause to be paid to NYBC on a FISCAL
QUARTER basis, within 30 days after the end of each FISCAL QUARTER, the
following royalties (the "ROYALTIES"): with respect to each sale by PALL
CORPORATION or its
4
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
AFFILIATES of AMENDMENT PRODUCT, ******** of the average price invoiced
during the preceding FISCAL QUARTER by PALL CORPORATION for sales of AMENDMENT
PRODUCT to independent third parties in arm's-length transactions, less credits
or allowances, if any, for rejections or returns; less customary trade discounts
actually given; less customs and duties paid; less bad debts; less separately
invoiced and actually incurred taxes and other charges of any governmental
authority that are imposed directly on or measured by the sale, transfer,
transportation, delivery or use (but excluding taxes on net income).
(ii) LICENSEE shall pay NYBC minimum royalties as set forth in
Section 4.3 of the EXCLUSIVE LICENSE AGREEMENT at a rate of ******** the
amounts specified in Sections 4.3(a), 4.3(b) and 4.3(c).
F. NYBC agrees that the ROYALTIES set forth in Paragraph E(i) of
this AMENDMENT shall be in lieu of any payments due under Paragraphs 4.1 and 4.2
of the EXCLUSIVE LICENSE AGREEMENT with respect to AMENDMENT PRODUCT and shall
be creditable against payments due to NYBC under Paragraph 4.3 of the EXCLUSIVE
LICENSE AGREEMENT.
G. LICENSEE agrees that it shall cause PALL CORPORATION, pursuant to
an agreement between LICENSEE and PALL CORPORATION, to make available to NYBC,
for its own use and not for resale, a reasonable quantity of AMENDMENT PRODUCT
at the lowest price paid by any third party to PALL CORPORATION in the U.S. and
in Canada for such AMENDMENT PRODUCT. NYBC, at its sole discretion, may agree to
waive all ROYALTIES due under this AMENDMENT in connection with such AMENDMENT
PRODUCT sold to NYBC, in which event, the lowest price charged to NYBC shall be
reduced by such ROYALTIES. LICENSEE and NYBC agree that the last sentence of
Section 4.7 of the EXCLUSIVE LICENSE AGREEMENT is hereby deleted.
H. LICENSEE shall be entitled to offset against ROYALTIES, ********
payable to third parties with respect to AMENDMENT PRODUCT, except
those paid to ********
5
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
********** **** ****** ******** ** *** ********* ********* ***** ******* ** ****
******* ********* **** *** ** to the same extent that it is entitled to with
respect to PRODUCT under the terms of Section 4.8 of the EXCLUSIVE LICENSE
AGREEMENT.
I. In addition to the confidentiality requirements set forth in
Sections 9.1, 9.2 and 9.3 of the EXCLUSIVE LICENSE AGREEMENT, NYBC and LICENSEE
agree as follows:
i) NYBC agrees that during the term of this AMENDMENT and for five
(5) years following the termination or expiration of this AMENDMENT, NYBC will
maintain in strictest confidence and shall not disclose, distribute or use
without PALL CORPORATION's prior written consent, and shall cause their
directors, officers, employees, agents, counsel and representatives to maintain
in strictest confidence, not disclose, distribute or use any PALL INFORMATION,
without PALL CORPORATION's prior written consent, for any purpose or in any
manner other than a purpose or manner approved in writing by PALL CORPORATION.
ii) Upon the expiration or termination of this AMENDMENT, all PALL
INFORMATION will be returned to PALL CORPORATION, or, at PALL CORPORATION's
election, destroyed.
iii) The provisions of this Paragraph I will survive the expiration or
termination of this AMENDMENT.
J. NYBC agrees that, prior to exercising its termination rights set
forth in Section 10.2 of the EXCLUSIVE LICENSE AGREEMENT, it shall give PALL
CORPORATION notice of its intent to terminate simultaneously with the notice
given to LICENSEE under the terms of Section 10.2, which notice shall expressly
describe the event entitling NYBC to exercise its termination rights, and NYBC
shall not terminate the EXCLUSIVE LICENSE AGREEMENT and/or this AMENDMENT if
within sixty days of receipt of such notice by PALL CORPORATION, PALL
CORPORATION cures the breach or eliminates the event or causes LICENSEE to cure
the breach or eliminate the event giving rise to NYBC's termination rights, to
6
the reasonable satisfaction of NYBC.
K. NYBC agrees that, notwithstanding the terms of Sections 10.2 and
10.5 of the EXCLUSIVE LICENSE AGREEMENT, (i) if LICENSEE or PALL CORPORATION
have not satisfactorily, under the terms of Paragraph J of this AMENDMENT or the
terms of Section 10.2 of the EXCLUSIVE LICENSE AGREEMENT, cured the breach or
eliminated the event giving rise to NYBC's termination rights and NYBC exercises
its right to terminate the EXCLUSIVE LICENSE AGREEMENT and/or this AMENDMENT, or
(ii) if LICENSEE exercises its right to terminate the EXCLUSIVE LICENSE
AGREEMENT in accordance with the terms of Section 10.5 of the EXCLUSIVE LICENSE
AGREEMENT, NYBC shall not acquire any rights in or with respect to (x) any
patents, patent applications, know-how, inventions, data, processes, methods for
manufacture or use, techniques, or other technical information or intellectual
property, now owned or controlled by or licensed to or hereafter developed by or
for PALL CORPORATION, independently from LICENSEE (collectively the "PALL KNOW-
HOW"), (y) any products which utilize, include or incorporate any PALL KNOW-HOW,
and (z) any "Joint Patents" and "Joint Inventions" as such terms are defined in
the JOINT DEVELOPMENT AGREEMENT. PALL CORPORATION agrees that all rights in
KNOW-HOW and PATENT RIGHTS will revert to NYBC, and PALL CORPORATION will not
use KNOW-HOW and PATENT RIGHTS for any purpose whatsoever, unless permitted to
do so under a separate agreement with NYBC. Nothing herein shall alter
LICENSEE's obligations to NYBC in the event of a termination under Sections 10.2
and 10.5 of the EXCLUSIVE LICENSE AGREEMENT.
L. Notices to PALL CORPORATION shall be sent to:
PALL CORPORATION
0000 Xxxxxxxx Xxxx.
Xxxx Xxxxx, Xxx Xxxx 00000
Attention: Xxxxxx X. Xxxxxxx
7
with a copy to:
Xxxxxx, Xxxxxxx & Xxxxxxx
Xxx Xxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: Xxxxxx X. XxXxxxxxx, Esq.
M. All other terms and conditions of the EXCLUSIVE LICENSE AGREEMENT
shall apply to AMENDMENT PRODUCT and INACTIVATION PRODUCT as they apply to
PRODUCT thereunder, provided however, that to the extent of any conflict between
the terms and conditions of this AMENDMENT and the terms and conditions of the
EXCLUSIVE LICENSE AGREEMENT, the terms and conditions of this AMENDMENT shall
govern, supersede and prevail.
N. This AMENDMENT shall remain in effect for (i) the term of the
JOINT DEVELOPMENT AGREEMENT (and any amendments thereto and extensions thereof),
provided a copy of same is provided to NYBC, or (ii) the term of the EXCLUSIVE
LICENSE AGREEMENT, whichever is shorter. Termination of this AMENDMENT shall not
release either party from any liability which at the time of termination had
already accrued to the other party or which thereafter may accrue in respect of
any act or omission prior to such termination.
8
IN WITNESS WHEREOF, the parties hereto have caused this AMENDMENT to be
executed by their duly authorized representatives.
THE NEW YORK BLOOD CENTER, INC.
By: /s/ Xxxxxx Xxxxx
-----------------------------
Name: Xxxxxx Xxxxx
---------------------------
Title: President
--------------------------
Date: February 16, 1998
---------------------------
V.I. TECHNOLOGIES, INC.
By: /s/ Xxxx X. Xxxx
-----------------------------
Name: Xxxx X. Xxxx
---------------------------
Title: President
--------------------------
Date: February 16, 1998
---------------------------
9
