EXHIBIT 10.13
CERTAIN INFORMATION IN THIS EXHIBIT IS SUBJECT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. IN ACCORDANCE WITH RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED, SUCH INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. THE LOCATION OF SUCH OMITTED INFORMATION HAS
BEEN INDICATED WITH AN ASTERISK(*).
LICENSE AGREEMENT
This License Agreement (hereinafter "Agreement") is made and entered into as
of the 1st day of June (the "Effective Date") between Biogen, Inc., a
Massachusetts corporation having a principal place of business at ▇▇ ▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇ ("Biogen") and Tanox Biosystems, Inc., a Texas
corporation, having a principal place of business at ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇ ("Tanox").
NOW THEREFORE, the parties hereby agree as follows:
BACKGROUND
Biogen owns certain patent rights identified in Appendix A hereto, relating
to ANTI-CD4 MONOCLONAL ANTIBODIES.
Biogen has additional rights to technical data and information pertaining to
anti-CD4 monoclonal antibodies.
Tanox wishes to be licensed under certain of the TECHNOLOGY (as defined
below) and patent rights and Biogen is willing to grant Tanox such a license,
for the consideration and under the terms set forth in this Agreement.
1. DEFINITIONS
1.1 "AFFILIATE", as applied to either party, shall mean any corporation,
firm, partnership or other entity which directly or indirectly owns, is
owned by, or is under common control with, a party to the Agreement to
the extent of at least fifty percent (50%) of the equity or other
ownership interests (or such lesser percentage which is the maximum
allowed to be owned by a foreign corporation in a particular
jurisdiction) having the power to vote on, or direct the affairs of, the
entity.
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1.2 "DISTRIBUTOR(S)" shall mean a person or entity in a country who buys
LICENSED PRODUCT from Tanox or its AFFILIATES or SUBLICENSEES and who,
under an implied license, sells such LICENSED PRODUCT in that country.
1.3 "FIELD" shall mean the manufacture, use, importation, offer for sale or
sale of LICENSED PRODUCT for human use only, including therapeutic,
prophylactic and diagnostic use.
1.4 "FIRST COMMERCIAL SALE" shall mean in each country of the TERRITORY, the
first sale of a LICENSED PRODUCT by Tanox or any of its AFFILIATES,
DISTRIBUTOR(S) or its SUBLICENSEES to a third party in connection with
the nationwide introduction of LICENSED PRODUCT by Tanox or any of its
AFFILIATES, DISTRIBUTOR(S) or its SUBLICENSEES following marketing and/or
pricing approval by the appropriate governmental agency for the country
in which the sale is made. When governmental approval is not required or
when sales can be made through named patient sales (also including
"compassionate use sales", "treatment INDs" or their equivalents) prior
to governmental approval, such FIRST COMMERCIAL SALE in that country
shall be the first sale in connection with the nationwide introduction of
LICENSED PRODUCT.
1.5 "IND" shall mean an Investigational New Drug Application filed with the
U.S. Food and Drug Administration ("FDA") or an equivalent filing in the
TERRITORY.
1.6 "LICENSED PRODUCT(S)" shall mean any composition(s) (i) the manufacture,
use, importation, offer for sale, or sale of which, but for this license,
infringes a VALID CLAIM of one or more PATENTS or (ii) which embodies any
of the TECHNOLOGY.
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1.7 "MAA" shall mean an application for regulatory approval to sell LICENSED
PRODUCT in the European Union and is similar in purpose to an NDA in the
United States.
1.8 "NDA" shall mean a New Drug Application or Biologic License Application
("BLA") or equivalent filed for LICENSED PRODUCT with the U.S. Food and
Drug Administration ("FDA").
1.9 "NET SALES" shall mean the total gross invoice amount actually received
by Tanox on the sale of LICENSED PRODUCT in the TERRITORY by Tanox and
its AFFILIATES, SUBLICENSEES and DISTRIBUTOR(S) to third parties less the
following items, as determined from the books and records of Tanox or its
AFFILIATES, SUBLICENSEES or DISTRIBUTOR(S): (i) insurance and transport
charges actually invoiced; (ii) amounts repaid or credited for rejection
or return of LICENSED PRODUCT; (iii) sales or other excise taxes or other
governmental charges levied on the invoiced amount and actually paid by
the seller; (iv) custom duties and charges actually paid by the seller;
(v) normal and customary trade and quantity discounts actually allowed
and actually taken which relate to LICENSED PRODUCT.
Sales of LICENSED PRODUCT between or among Tanox, its AFFILIATES,
DISTRIBUTOR(S) or the SUBLICENSEES shall be excluded from the computation of NET
SALES. Notwithstanding the previous sentence, the resale of the LICENSED PRODUCT
by the AFFILIATE, DISTRIBUTOR(S) or SUBLICENSEES to a third party who is not an
AFFILIATE, DISTRIBUTOR(S) or SUBLICENSEES of Tanox, shall be included in the
definition of NET SALES for the purposes of this Agreement.
In the event that Tanox, its AFFILIATES, DISTRIBUTOR(S) or its
SUBLICENSEES receives in any transaction included within the definition of NET
SALES, any non-cash compensation or lower prices on other products in exchange
for any LICENSED PRODUCT, or sells LICENSED PRODUCT in other than an arms length
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transaction, then the gross amount invoiced in such transaction shall be deemed
to be the gross amount that would have been paid had there been such a sale at
the average sale price of such LICENSED PRODUCT during the applicable royalty
reporting period in the country in which such disposition took place. The
preceding sentence shall not apply to the distribution at no cost of LICENSED
PRODUCT to physicians, hospitals or clinics for promotional purposes or academic
investigators for research and clinical trial purposes, which are not included
in the definition of NET SALES.
In the event that LICENSED PRODUCT is sold in combination with one or more
other active ingredients, including one or more other antibodies having a
therapeutic effect (such antibody(ies) defined as an "Antibody Active
Ingredient"), the NET SALES on the combination product shall be calculated by
multiplying actual NET SALES of the combination product by the fraction obtained
after dividing A by the sum of A+B, in which "A" is the average selling price of
LICENSED PRODUCT sold separately by the same party during the same accounting
period in the country in which the sale of the combination product was made and
"B" is the average selling price of the other active ingredient(s) sold
separately by the same party during the same accounting period in the country in
which the sale of the combination product was made.
If, however, no separate sales of LICENSED PRODUCT or Antibody Active
Ingredient(s) or other active ingredients are made then:
A. If the combination product includes one or more Antibody Active
Ingredients (the combination product defined for the purpose of this sentence as
a "TRUE ANTIBODY COMBINATION PRODUCT"), the NET SALES of such TRUE ANTIBODY
COMBINATION PRODUCT shall be reduced by 50%; or
B. If the combination product includes one or more active ingredients that
are not Antibody Active Ingredients, the parties shall negotiate in good faith a
mutually agreeable formula for determining appropriate reduction in NET SALES
with the goal of equitably determining the appropriate percentage value
represented by the components.
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The parties agree that in no event shall NET SALES of LICENSED PRODUCT or
any combination product of this Article 1.9 be reduced to less than fifty
percent (50%) of actual NET SALES of such LICENSED PRODUCT or combination
product by reason of any adjustment set forth in this Article 1.9.
The parties further agree that if Tanox becomes (a) an AFFILIATE of; or
(b) merged with; or (c) acquired by: or (d) an acquirer of, a third party having
a market capitalization equal to, or greater than ten billion dollars ($10B) at
the time of such AFFILIATE formation or merger or acquisition, then NET SALES as
defined in the first sentence of this Article shall be redefined to mean the
total gross invoice amount (not dependent on whether the invoices were actually
paid) on the sale of LICENSED PRODUCT in the TERRITORY by Tanox and its
AFFILIATES, SUBLICENSEES and DISTRIBUTOR(S) to third parties, less the items
recited in the first sentence of this Article. All other provisions of the
definition of NET SALES shall remain unaffected by such AFFILIATE formation,
merger or acquisition.
1.10 "PATENTS" shall mean: (a) the patent applications and patents listed in
Appendix A to this Agreement, any extensions, supplemental protection
certificates, reissues, renewals, re-examinations, divisionals,
continuations or continuations-in-part thereof, any foreign counterparts
thereof, any patent issuing from any of the foregoing, which Biogen
presently or hereafter owns and (b) such other patent applications and
patents which Biogen presently or hereafter owns or controls that is
required for the manufacture, use or sale of LICENSED PRODUCT.
1.11 "PROTEIN DESIGN LABS PATENTS" shall mean the patents and patent
applications listed in Appendix B hereto.
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1.12 "ROYALTY QUARTER" shall mean the three (3) months ending on the last day
of March, June, September and December of each year.
1.13 "SUBLICENSEES" shall mean a third party (but not an AFFILIATE of Tanox)
licensed by Tanox to make, use, import, offer for sale and sell LICENSED
PRODUCT.
1.14 "TECHNOLOGY" shall mean any data, know-how, or other information, or any
material, reagent or other substance relating to LICENSED PRODUCT or to
anti-CD4 monoclonal antibodies which may be useful in the discovery,
research, development, manufacture, use or sale of LICENSED PRODUCT or to
anti-CD4 monoclonal antibodies and which is known to, and/or in the
possession of, Biogen on the Effective Date and to which Biogen has a
transferable right.
1.15 "TERRITORY" shall mean the entire world.
1.16 "VALID CLAIM" shall mean (i) any claim(s) in an issued, unexpired patent
which has not been held unenforceable, unpatentable, or invalid by a
court or other governmental agency of competent jurisdiction, in a
decision that is unappealable or unappealed, within the time allowed for
appeal, and which has not been abandoned or admitted to be invalid or
unenforceable through reissue or disclaimer or (ii) a claim of a pending
patent application which is pending as of the Effective Date and for
which examination has been requested or, in the case of Japan and Canada,
will be timely requested, and which claim shall not have been canceled,
withdrawn, abandoned or rejected by an administrative agency from which
no appeal can be taken. If in the TERRITORY there should be two or more
such decisions conflicting with respect to the validity of the same
claims, the decision of the higher or highest tribunal shall thereafter
control. However, should the tribunals be of equal rank, then the
decision or decisions upholding the claim shall prevail
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when the conflicting decisions are equal in number, and the majority of
decisions shall prevail when conflicting decisions are unequal in number.
2. LICENSES AND TECHNOLOGY TRANSFER
2.1 Biogen hereby grants Tanox a TERRITORY-wide, exclusive, royalty-bearing
license under the TECHNOLOGY and PATENTS to make, have made, import, use,
offer for sale, and sell LICENSED PRODUCT for use in the FIELD. As soon
as reasonably possible following execution of this Agreement, Biogen will
transfer all TECHNOLOGY listed on Appendix C that is in its control or
possession to Tanox, and shall cooperate with Tanox in its initial use of
the TECHNOLOGY to develop a LICENSED PRODUCT by making Biogen personnel
with knowledge of the TECHNOLOGY available for initial meetings at Biogen
as agreed, not to exceed two working days, and subsequent telephone
conference(s) with Tanox during Biogen's normal business hours under the
following conditions:
(a) Biogen personnel are given at least reasonable advance notice of such
conference(s);
(b) Tanox shall direct all telephone calls to a Technology Liaison who
will direct Tanox's attention to the appropriate person responsible for a
particular TECHNOLOGY. Biogen shall provide Tanox with all available
TECHNOLOGY within 3 months from the Effective Date of this Agreement;
(c) Telephone conferences shall not exceed 5 hours per month for the
first three months,
(d) Any time spent by Biogen personnel on retrieval of information
requested shall, except for information previously requested and not
provided, be limited to the three month period after the Effective Date
and shall be reasonably based upon pre-existing commitments and the time
required to complete the tasks requested by Tanox; and
(e) Telephone conferences subsequent to the time period of subpart (b)
(other than for pursuing information or TECHNOLOGY previously requested
but not provided) shall not exceed 1 hour per month.
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2.2 The term "exclusive" in Article 2.1 shall mean that Biogen cannot grant
further licenses hereunder for LICENSED PRODUCT in the TERRITORY in the
FIELD, subject only to:
*
(b) Biogen's reserved right to use the TECHNOLOGY and PATENTS for internal
research and educational purposes.
2.3 The license granted to Tanox hereunder shall include the right to grant a
sublicense to one SUBLICENSEE in each country. A copy of the sublicense
shall be provided to Biogen. Tanox shall ensure that its AFFILIATE(S) and
SUBLICENSEES to whom Tanox has extended or sublicensed its rights under
this Article 2, shall comply with all of the terms of this Agreement to
which Tanox is bound.
Any sublicense granted by Tanox under this Agreement shall be subject and
subordinate to the terms and conditions of this Agreement except that:
(a) the sublicense terms and conditions shall reflect that the
SUBLICENSEES shall not have the right to further sublicense;
(b)the sublicense shall include a requirement that the SUBLICENSEES use
the same efforts to bring the subject matter of the sublicense into commercial
use as those efforts of Tanox under Article 9.1 of this Agreement; and
(c) the sublicense shall expressly provide for the transfer of all
obligations, including the payment of royalties specified in the sublicense, to
Biogen or its designee, in the event that the present Agreement is terminated.
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2.4 Except as expressly provided herein, nothing in this Agreement shall be
deemed to grant either party any rights or license to any patent, patent
application, technology, know-how or invention of the other party.
3. PAYMENTS AND REPORTING
In consideration of the license rights granted to Tanox under this Agreement,
Tanox shall make the following payments to Biogen:
3.1 *
3.2 Tanox shall pay Biogen a royalty on NET SALES of LICENSED PRODUCT sold by
Tanox, its AFFILIATES, SUBLICENSEES and DISTRIBUTOR(S) in the TERRITORY
at the following rates:
PORTION OF
ANNUAL NET SALES ROYALTY RATE OFFSET (ARTICLE 3.3)
---------------- ------------ --------------------
* * *
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3.3 If Tanox licenses PROTEIN DESIGN LABS PATENT(S) to make, have made, use,
sell, offer for sale, or import LICENSED PRODUCT, then so long as a VALID
CLAIM of a PROTEIN DESIGN LABS PATENT encompasses the LICENSED PRODUCT in
the United States, the royalty otherwise payable to Biogen under Article
3.2 on sales in the respective countries in which there are such VALID
CLAIMS shall be reduced by the amounts set forth in the above Table of
Article 3.2 under the heading "Offset" determined by reference to the
amount of annual NET SALES in such countries.
3.4 As further consideration of the rights granted to Tanox under this
Agreement, Tanox shall make the following nonrefundable, noncreditable
payments to Biogen upon the first achievement of each of the following
milestones.
MILESTONE PAYMENT
--------- -------
Upon filing an IND or equivalent
filing for first LICENSED PRODUCT *
Commencement of Phase III Clinical
Trial (or equivalent pivotal trial)
of first LICENSED PRODUCT *
Filing BLA/MAA or equivalent filing
for first LICENSED PRODUCT *
Regulatory approval anywhere
in the TERRITORY of first LICENSED
PRODUCT *
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3.5 If, after executing this Agreement, Tanox becomes (a) an AFFILIATE of; or
(b) merged with; or (c) acquired by: or (d) an acquirer of, a third party
having an equal or greater number of employees than Biogen at the time of
such AFFILIATE formation or merger or acquisition, then Tanox shall be
obligated to make additional milestone payments in addition to those
recited above in Article 3.4. Following such a merger or acquisition, the
additional nonrefundable, noncreditable retroactive milestones are due
thirty (30) days after the later of: (i) being triggered by the events
described in the Table below or (ii) the date of the acquisition, or
merger transaction and are as follows:
MILESTONE PAYMENT
--------- -------
Commencement of Phase II
Clinical Trial of first LICENSED PRODUCT *
Commencement of Phase III
Clinical Trial (or equivalent pivotal trial)
of first LICENSED PRODUCT *
Regulatory approval by FDA of first LICENSED PRODUCT *
Regulatory approval by EMEA of first LICENSED PRODUCT *
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3.6 All royalties accrued pursuant to this Article 3 shall be paid to Biogen
on a quarterly basis within forty five (45) days after the end of each
calendar quarter with respect to NET SALES on sales of LICENSED PRODUCT
made in such quarter.
3.7 Together with each royalty payment due under this Article 3, Tanox shall
provide Biogen with a signed written statement certifying, separately for
each type of LICENSED PRODUCT, the following information: (i) gross sales
by Tanox, its AFFILIATES, SUBLICENSEES, and DISTRIBUTOR(S), by country;
(ii) NET SALES separately by country and in total; (iii) quantity sold by
Tanox, its AFFILIATES, SUBLICENSEES, and DISTRIBUTOR(S); and (iv) average
sales price in each country. Tanox shall maintain, and shall use
reasonable efforts to ensure that its AFFILIATES, SUBLICENSEE and
DISTRIBUTOR(S) maintain, appropriate books of account and records of all
sales of LICENSED PRODUCT in any calendar year for a period of three (3)
full years after such calendar year. At Biogen's request, Tanox shall
make such books of account and records available for inspection during
normal business hours by independent public accountants appointed by
Biogen for the purpose of verification of the amounts paid to Biogen
under this Agreement. Biogen shall not conduct more than one audit in any
calendar year.
The cost of such audit shall be borne by BIOGEN unless it is established by
the audit that there has been an error which has caused Tanox to underpay by ten
percent (10%) or more for the period under audit, in which case the cost of such
audit shall be borne by Tanox. Tanox shall pay to Biogen any underpaid
compensation that is confirmed by the audit promptly and with interest at a rate
not to exceed the interest rate defined in Article 3.9 hereunder.
3.8 The amounts computed or specified under this Article 3 as due to Biogen
are the actual amounts to be received by BIOGEN and shall not be reduced
in any way, including but
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not limited to, withholding taxes and reduction by any liabilities
incurred by Tanox or its SUBLICENSEES or DISTRIBUTOR(S) on Tanox's behalf
(but not on Biogen's behalf) upon remittance to BIOGEN of the payments
due hereunder, provided, however, that if required, Tanox shall be
allowed to withhold taxes incurred by Biogen.
3.9 All payments made to either party hereunder shall be paid in U.S.
Dollars. Monetary conversion from the currency of a foreign country into
U.S. currency shall be made at the exchange rate in force on the last
business day of the quarter in which the payment obligations were
incurred as reported in The Wall Street Journal, or on such other basis
as mutually agreed upon by both parties. Any amounts due under this
Agreement that are not paid when due shall bear interest at the lesser of
(i) *.
3.10 The obligation to pay royalties shall continue on a country-by-country
basis from the date of first sale of LICENSED PRODUCT in that country
until the later of (i) twelve (12) years from the date of FIRST
COMMERCIAL SALE of such LICENSED PRODUCT in that country or (ii) the date
on which the manufacture, use, sale, offer for sale or import of LICENSED
PRODUCT is no longer covered by a VALID CLAIM of any PATENT in such
country or in the country of manufacture.
4. *
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5. PATENT PROSECUTION AND LITIGATION
5.1 Biogen shall be solely responsible for prosecution and maintenance of the
PATENTS. Tanox shall bear the cost of all matters relating to the
maintenance and prosecution of the PATENTS, such costs to be creditable
against any payments due Biogen. Biogen shall promptly notify Tanox of
all information received by Biogen relating to the prosecution and
maintenance of PATENTS, including, without limitation, any lapse,
revocation, surrender, invalidation or abandonment of any of the PATENTS.
Biogen may, in its sole discretion, decide to refrain from, or cease to
prosecute, or maintain any of the PATENTS. In such an event, Biogen shall notify
Tanox promptly and in sufficient time to permit Tanox at its sole discretion to
continue such prosecution or maintenance at Tanox's expense. If Tanox elects to
continue such prosecution or maintenance, Biogen shall execute such documents
and perform such acts at Biogen's expense as may be reasonably necessary for
Tanox to so continue such prosecution or maintenance.
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5.2 In the event either party or its AFFILIATES, DISTRIBUTORS (or Tanox's
SUBLICENSEES) becomes aware of any actual or probable infringement of a
PATENT claim licensed to Tanox under this Agreement, it shall notify the
other party in writing of the details to the extent known of such
infringement. Tanox, in its sole discretion and at its sole expense, may
take action against any alleged infringer but would be required to take
such action in the name of Biogen, if legally permissible, and if Biogen
consents thereto. In determining whether to bring an action to enforce
any such PATENT, Tanox shall act in a commercially reasonable manner,
giving due consideration to the threat represented by the infringement
and the potential risk to the PATENT involved. In the event Tanox
declines within six (6) months of notification of such infringement to
either (i) cause infringement to cease such as, for example, by
settlement, or (ii) initiate legal proceedings against the infringer.
Biogen may, but is not obligated to (upon notice to Tanox) initiate legal
proceedings against the infringer, at Biogen's expense and in its own
name. Biogen, under the circumstances of the previous sentence, is not
obligated to initiate proceedings against more than one infringer at a
time.
5.3 In the event either Tanox or Biogen shall initiate or carry out legal
proceedings to enforce any of the PATENTS licensed under this Agreement
against an alleged infringer, the party not initiating or carrying out
such proceedings shall fully cooperate with, and supply all reasonable
assistance requested by, the other party. Except as described hereunder,
any party that institutes any suit to protect or enforce any such PATENTS
shall have control of that suit and shall bear the reasonable expenses
incurred by the non-initiating party in providing such assistance and
cooperation as is requested pursuant to this Article.
5.4 Any recovery obtained by Tanox as the result of legal proceedings
initiated and paid for by Tanox to enforce any of the PATENTS licensed
under this Agreement against an
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alleged infringer, whether obtained by settlement or otherwise, shall
(after reimbursement of all otherwise unreimbursed legal fees and
expenses incurred by either Tanox or Biogen) be paid 100% to Tanox, and
such recovery obtained by Tanox shall be treated as NET SALES so that
Tanox shall pay a royalty to Biogen commensurate with the recovery as
specified under Article 3.2. Any recovery obtained by Biogen as the
result of legal proceedings initiated and paid for by Biogen to enforce
such PATENTS against an alleged infringer, whether obtained by settlement
or otherwise, shall (after reimbursement of all otherwise unreimbursed
legal fees and expenses incurred by either Biogen or Tanox) be paid 100%
to Biogen.
6. INDEMNIFICATION
6.1 Tanox and its AFFILIATES and its SUBLICENSEES assume all risk of damage
or injury to persons or property arising out of the clinical testing,
manufacture, use, marketing, promotion, distribution, or sale of LICENSED
PRODUCT(S). Tanox shall hold harmless and indemnify Biogen, its officers,
directors, agents, shareholders and employees (the "Biogen Indemnitees")
from and against any and all liabilities, damages, losses, costs and
expense incurred or imposed upon Biogen Indemnitees or any one of them in
connection with any claims, suits, actions, demands, proceedings, causes
of action or judgments resulting from arising out of: (i) the
development, design, preclinical or clinical testing, manufacture, use,
marketing, promotion, distribution or sale of the LICENSED PRODUCT(S) by
Tanox or any of its AFFILIATES, SUBLICENSEES or DISTRIBUTOR(S) or any of
their respective agents or employees; (ii) any other activities carried
out by Tanox or any of its AFFILIATES, SUBLICENSEES or DISTRIBUTOR(S) or
any of their respective agents or employees, including failure to comply
with applicable law.
Biogen shall give prompt notice to Tanox of any claim that may be subject to
indemnification upon Biogen's receipt of notice to such claim, and Tanox shall
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assume the defense thereof, including the employment of counsel reasonably
satisfactory to Biogen, provided, however, that Tanox shall act reasonably and
in good faith with respect to all matters related to settlement or disposition
of any claim as the settlement or disposition thereof relates to Biogen, and
further provided that Tanox shall not settle or otherwise dispose of any claim
without prior written notice to Biogen. Biogen shall have the right to employ
separate counsel in any such action and to participate in the defense thereof,
but the fees and expenses in this situation shall be Biogen's.
6.2 Following the FIRST COMMERCIAL SALE, Tanox shall purchase and maintain in
effect, and require its AFFILIATES and SUBLICENSES to purchase and
maintain in effect, a policy of product liability insurance in the amount
of at least * covering all claims with respect to any LICENSED PRODUCT
used, made, sold, imported, licensed or otherwise distributed by Tanox or
any of its AFFILIATES, DISTRIBUTOR(S) or SUBLICENSES within the term of
this Agreement. Each policy obtained under this Article shall specify
Biogen as an additional insured and Tanox shall furnish to Biogen upon
Biogen's request, a certificate evidencing such insurance.
7. REPRESENTATIONS, WARRANTIES AND LIABILITY
7.1 BIOGEN warrants that it owns title to the PATENTS listed in Appendix A
and the TECHNOLOGY and has the right to enter into this Agreement. BIOGEN
MAKES NO REPRESENTATION OR WARRANTY AS TO THE VALIDITY OF THE PATENTS.
7.2 BIOGEN MAKES NO REPRESENTATION OR WARRANTY THAT THE MANUFACTURE, USE,
IMPORTATION OR SALE OF LICENSED PRODUCTS BY TANOX OR ITS SUBLICENSEES OR
THEIR CUSTOMERS WILL NOT CONSTITUTE AN INFRINGEMENT OF THE INTELLECTUAL
PROPERTY RIGHTS OF OTHERS.
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7.3 BIOGEN MAKES NO REPRESENTATIONS, EXTENDS NO WARRANTIES OF ANY KIND,
EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED
WARRANTIES OF MERCHANT ABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND
ASSUMES NO RESPONSIBILITY WHATEVER WITH RESPECT TO DESIGN, DEVELOPMENT,
MANUFACTURE, USE, SALE, IMPORTATION OR OTHER DISPOSITION OF LICENSED
PRODUCT BY TANOX OR ITS AFFILIATES, SUBLICENSEES OR DISTRIBUTOR(S) TO
THEIR RESPECTIVE CUSTOMERS.
7.4 The entire risk as to performance of LICENSED PRODUCTS is assumed by
Tanox and its AFFILIATES, DISTRIBUTOR(S) and SUBLICENSEES. Except as set
forth under Article 6, in no event shall either party be responsible or
liable to the other, its AFFILIATES or DISTRIBUTOR(S) (or Tanox's
SUBLICENSEES), end users (or any other individual or entity regardless of
legal theory), for any DIRECT, INDIRECT, SPECIAL, INCIDENTAL OR
CONSEQUENTIAL DAMAGES OR LOST REVENUES OR PROFITS arising out of this
Agreement. The provisions of this Article 7.4 shall apply even though a
party may have been advised of the possibility of such damage.
7.5 Tanox covenants and agrees that in conducting activities contemplated
under this Agreement, it shall comply with all applicable laws and
regulations including those related to the manufacture, use, labeling,
importation and marketing of LICENSED PRODUCT.
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7.6 Tanox shall make no statements, representations or warranties or accept
any liabilities or responsibilities to, or with regard to any person or
entity, which are inconsistent with any disclaimer or provisions of this
Article 7 and Tanox shall take reasonable steps to ensure that its
AFFILIATES and its SUBLICENSEES do not do so.
7.7 Tanox and Biogen agree that, except for the obligations contained within
this Agreement, there are no other express and/or implied obligations on
either party that can be created by the activities contemplated
hereunder.
8. CONFIDENTIALITY
8.1 During the term of this Agreement, and for a period of seven (7) years
after termination, Biogen and Tanox shall treat all confidential
information (including confidential TECHNOLOGY) received from the other
hereunder as the exclusive property of the disclosing party and each
party agrees not to use or disclose to any third party any such
information, except as permitted hereunder, without first obtaining the
disclosing party's written consent. Each party further agrees to take all
practicable steps to ensure that any such information shall not be used
by its directors, officers, employees, or agents and that it shall be
kept fully private and confidential by them.
8.2 The above provision of confidentiality shall not apply to that part of
such information which a receiving party is clearly able to demonstrate:
(a) was fully in its possession prior to receipt from the other; or
(b) was in the public domain at the time of receipt from the other; or
(c) became part of the public domain through no fault of the party
receiving such information, its director, officers or employees;
(d) was lawfully received without obligations of confidentiality or non-use
from some third party having a right of further disclosure; or
(e) other than information submitted pursuant to obtaining regulatory
approval for LICENSED PRODUCT, is required to be disclosed by law or
applicable government or European Community regulations; provided,
however, that the disclosing party is given prior written notice of
such required disclosure and afforded an opportunity to participate in
drafting a protective order or otherwise limiting the disclosure to the
extent possible.
19
9. COMMERCIALIZATION
9.1 Tanox undertakes to use reasonable commercial efforts to diligently
develop and market LICENSED PRODUCT in the major market countries for the
LICENSED PRODUCT in the TERRITORY and, with Biogen's reasonable
assistance, to diligently obtain regulatory approval for LICENSED PRODUCT
in the major market countries for the LICENSED PRODUCT in the TERRITORY.
Tanox shall provide Biogen with summaries of such efforts, including the
clinical development status of LICENSED PRODUCTS in the FIELD, before
January 1 of each calendar year and shall provide Biogen with notice of
the date Tanox and/or its SUBLICENSEES makes the FIRST COMMERCIAL SALE of
LICENSED PRODUCT. For the purposes of this Article 9.1, "reasonable
commercial efforts" means the usual practice followed by a
biopharmaceutical company in pursuing commercialization of its products.
9.2 Tanox shall take reasonable steps to ensure the compliance of its
SUBLICENSEES with all applicable laws and regulations, including, without
limitation any labeling requirements relating to the sale of LICENSED
PRODUCT by the SUBLICENSEES.
10. PUBLICITY
20
10.1 Neither Tanox nor its AFFILIATES nor its SUBLICENSEES shall make any use
of the name of Biogen in connection with the exercise of its rights
hereunder (including in any advertising, promotional or sales
literature), without the prior written consent of Biogen, except as
required by law or regulation. Upon request, Tanox or its AFFILIATES or
its SUBLICENSEES shall ensure that LICENSED PRODUCT will be labeled "sold
under license" from Biogen.
10.2 Any initial announcements or similar publicity with respect to this
Agreement shall be at such time and in such manner and such form as
Biogen and Tanox shall mutually agree. Thereafter, either party may
subsequently publicize the terms and subject matter of this Agreement in
its sole discretion as long as the content of subsequent disclosures is
consistent with the approved form. To the extent that any such
publication or the terms and subject matter of this Agreement is
inconsistent with the agreed announcement AND/or includes additional
disclosure relating thereto, the party submitting any such subsequent
announcement or similar publicity shall first send it to the other party
for review. The other party agrees to review and return such announcement
or similar publicity to the sending party within 24 hours of receipt.
11. PATENT EXTENSIONS
11.1 Subject to the applicable governmental laws and regulations in the
TERRITORY regarding extension of patent terms, Tanox and its SUBLICENSEES
shall cooperate fully with Biogen in providing Biogen, at Biogen's
request, all facts and documentation which may assist Biogen in its
procurement of term extension for the PATENTS. Biogen shall be
responsible for, and shall bear the expense, of obtaining such patent
term extension as to patent rights encompassing LICENSED PRODUCT.
21
11.2 Upon termination of this Agreement by Biogen pursuant to Article 12.2,
information related to government approvals for LICENSED PRODUCT and
safety, efficacy, and toxicity studies of the LICENSED PRODUCT (provided
that the above is accessible to Tanox and/or its SUBLICENSEES in the
TERRITORY) shall be shared by Tanox and/or its SUBLICENSEES with Biogen
and such information may be transmitted to a governmental agency for use
by Biogen if necessary.
12. TERM AND TERMINATION
12.1 This Agreement shall commence on the Effective Date and shall continue
until Tanox's obligation to pay royalties pursuant to Article 3
terminates.
12.2 If the parties agree that this Agreement has been breached as to a
material covenant, undertaking, representation or obligation and that the
allegedly breaching party has not pursued steps to correct or cure such
breach within sixty (60) days of notification from the other party, or if
a court of competent jurisdiction so determines in a decision that is
unappealable or unappealed within the time allowed for appeal, or if the
decision is affirmed on appeal, by the highest court with jurisdiction,
then the non-breaching party shall have the right, by notice in writing,
to terminate this Agreement. A party shall also have the right to
terminate this Agreement in the event that the other party shall enter
into any arrangement or composition with its creditors, or enter or be
put into voluntary or compulsory liquidation or bankruptcy (except for
the purpose of any reorganization reasonably acceptable to the other
party), or have its business enjoined into receivership by executive or
judicial authorities.
12.3 Tanox shall have the right to terminate this Agreement on thirty (30)
days written notice to Biogen, provided that Tanox supplies to Biogen
within 180 days of termination hereunder, and sooner if feasible, all
preclinical, clinical and other data reasonably related to Biogen's
22
relicensing of the LICENSED PRODUCT as well as a royalty-free,
nonexclusive license to any Tanox-owned patents necessary to make, use,
or sell the LICENSED PRODUCT. Any termination under this Article 12 shall
be without prejudice to the rights of either party against the other then
accruing or otherwise accrued under the Agreement.
12.4 Expiration of this Agreement pursuant to Article 12.1 shall result in the
exclusive license to Tanox under Article 2.1 being converted to a
non-exclusive and cost and royalty-free license. Both expiration of the
Agreement under Article 12.1 and termination of this Agreement by either
party pursuant to Articles 12.2 and 12.3 shall terminate all outstanding
obligations and liabilities between Biogen and Tanox arising from this
Agreement except:
(a) obligations to pay royalties and other sums accruing hereunder up to
the day of such termination or expiration;
(b) obligations for record keeping and accounting reports for so long as
LICENSED PRODUCT is sold pursuant to this Agreement up to the date
of termination or expiration. Tanox shall render a final report
along with any royalty payment at such time after termination or
expiration of this Agreement;
(c) Biogen's right to inspect books and records up to the date of
termination or expiration as in Article 3.7;
(d) obligations of defense and indemnity under Article 6;
(e) any cause of action or claim of Tanox or Biogen accrued as of the
date of termination or expiration because of any breach or default
by the other party hereunder;
(f) the confidentiality provisions of Article 8;
(g) the disclosure obligations of Article 11.2, as applicable.
(h) all other terms, provisions, representations, rights and obligations
contained in this Agreement that by their sense and context are
intended to survive until performance thereof by either or both
parties; and
(i) the right to complete the manufacture and sale of LICENSED PRODUCTS
which qualify as "work in progress" under generally accepted cost
accounting standards or which are in stock at the date of
termination, and the obligation to pay royalties on NET SALES of
such LICENSED PRODUCTS.
23
13. NOTICES
13.1 Any notice required or permitted to be given hereunder shall be sent in
writing by registered or certified airmail, postage prepaid, return
receipt requested, or by telecopier, air courier or hand delivery,
addressed to the party to whom it is to be given as follows:
If to BIOGEN: Biogen, Inc.
▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Telephone (▇▇▇) ▇▇▇-▇▇▇▇; Fax (▇▇▇) ▇▇▇-▇▇▇▇
Attention: Vice President-General Counsel
If to TANOX:
Tanox Biosystems, Inc.
▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Telephone: (▇▇▇) ▇▇▇-▇▇▇▇; Fax: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: ▇▇▇▇▇ ▇. ▇▇▇▇▇, Ph.D., President
and CEO
or to such other address or addresses as may from time to time be given in
writing by either party to the other pursuant to the terms hereof.
24
13.2 Any notice sent pursuant to this Article shall be deemed delivered within
five (5) days if sent by registered or certified airmail and within
twenty-four (24) hours if sent by telecopier, air courier or hand
delivery.
14. EXPORT LAWS AND REGULATIONS OF THE UNITED STATES
The Export regulations of the United States Department of Commerce
prohibit the exportation from the United States of certain types of technical
data and commodities unless the exporter (i.e., Tanox, AFFILIATES,
DISTRIBUTOR(S) or the SUBLICENSEES) has received the required license. In
addition, the exporter may be required to obtain certain written assurances
regarding re-export from the foreign importer for certain types of technical
data and commodities. Tanox agrees to comply with (and shall take reasonable
steps to ensure the compliance of its AFFILIATES, DISTRIBUTOR(S) and its
SUBLICENSEES with) the Export Administration Regulations of the United States
Department of Commerce.
15. MISCELLANEOUS
15.1 ENTIRE AGREEMENT:
This Agreement constitutes the entire understanding between the parties
with respect to the subject matter between the parties with respect to the
subject matter hereof, and supersedes and replaces all prior agreements,
understandings, writings and discussions between parties relating to said
subject matter.
15.2 AMENDMENTS: WAIVERS:
This Agreement may be amended and any of its terms or conditions may be
waived only by a written instrument executed by both parties, or, in the case of
a waiver, by the party waiving compliance. The failure of either party at any
time to require performance of any provision hereof shall in no manner affect
its rights a later time to enforce the same. No waiver by either party of any
condition or term in any instance shall be construed as a further or continuing
waiver of such condition or term or of another condition or term.
25
15.3 NO AGENCY:
The relationship between Tanox and Biogen is that of independent
contractor. Nothing herein shall be deemed to constitute Tanox, on the one hand,
or Biogen, on the other hand, as the agent or representative of the other, or as
master and servant, employer and employee, joint venturers or partners for any
purpose.
15.4 ASSIGNMENT:
This Agreement shall not be assigned by Tanox without the prior written
consent of Biogen, except to an AFFILIATE or a successor Tanox's entire
business. This Agreement shall be binding upon and inure to the benefit of and
be enforceable by the parties hereto and their respective successors and
permitted assigns.
15.5 LAW OF THE CONTRACT:
This Agreement shall be governed by and construed and interpreted in
accordance with the law of the Commonwealth of Massachusetts.
15.6 SEVERABILITY:
In the event one or more provisions of this Agreement should for any
reason be held by any court or authority having applicable jurisdiction to be
invalid, illegal or unenforceable, such provision(s) shall either be reformed to
comply with applicable law or stricken if not so conformable, so as not to
affect the validity or enforceability of the remainder of this Agreement.
26
15.7 AGREEMENT TO PERFORM NECESSARY ACTS:
Each party agrees to perform further acts and execute and deliver any and
all further documents, agreements, and/or instruments which may be reasonable to
carry out or effect the provisions of this Agreement.
15.8 COUNTERPARTS:
This Agreement may be executed in counterparts, and each such counterpart
shall be deemed an original for all purposes.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their duly authorized officers on the date and year first above
written.
BIOGEN, INC. TANOX BIOSYSTEMS, INC.
By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇, Ph.D.
Name: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ Name: ▇▇▇▇▇ ▇. ▇▇▇▇▇, Ph.D.
Title: Vice President-General Counsel Title: President and CEO
Date: June 18, 1998 Date: June 23, 1998
27
APPENDIX A
COUNTRY NUMBER FILED ISSUED # EXPIRES BIOGEN NO.
Australia * 11/27/91 662891 11/27/011 *
Canada * 11/27/91 -- -- *
EPO* 92903295.1 11/27/91 512112 11/27/011 *
Japan * 11/27/91 -- -- *
United 07/916,098 11/27/91 -- *
States to issue
Q2 ▇▇▇▇
*▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, Germany, Denmark, Spain, France, Great
Britain, Greece, Italy, Liechtenstein, Luxembourg, Netherlands, Sweden
▇▇
▇▇▇▇▇▇▇▇ ▇
The following are patents and patent applications defined as PROTEIN DESIGN
LABS PATENTS and shall expressly include any United States continuations,
continuations-in-part or divisions thereof or any substitute applications
therefor; or foreign counterparts thereof, any patents issued with respect to
such patent applications, any reexaminations, reissues, extensions or patent
term extensions of any such patents.
1. United States Patent Numbers 5,585,089, 5,693,761, 5,693,762, and U.S.
patent divisional application numbers 08/477,728, 08/474,040 and 08/487,200 of
issued United States Patent No. 5,530,101.
2. European Patent ▇▇▇▇▇▇▇
3. Japanese Patent application No. 4-503758
29
APPENDIX C
TECHNOLOGY TO BE PROVIDED BY BIOGEN
*
30
*
31
FAX TRANSMISSION
To: ▇▇. ▇▇▇▇▇ ▇▇▇▇▇▇
Biogen, Inc.
Date: December 11, 1996
From: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
Division of Viral Pathogenesis
Department of Medicine
▇▇▇▇ Israel Hospital - RE-113
▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Phone- ▇▇▇-▇▇▇-▇▇▇▇
Fax ▇▇▇-▇▇▇-▇▇▇▇
E-mail ▇▇▇▇▇▇▇▇@▇▇▇.▇▇▇▇▇▇▇.▇▇▇
Re: Hu5A8 IN VIVO summary
*
*
