License Agreement - Medisorb Technologies International LP and Janssen Pharmaceutica Inc.
LICENSE AGREEMENT
This Agreement is made as of the 13 day February of 1996, between MEDISORB
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TECHNOLOGIES INTERNATIONAL L.P., a Delaware limited partnership (hereinafter
"Medisorb") and JANSSEN PHARMACEUTICA INC., a New Jersey corporation ("Janssen
US").
WHEREAS, Medisorb and Janssen Pharmaceutica International, an affiliate of
Janssen US, have entered into a certain Development Agreement, dated December
23, 1993 (the "Development Agreement"), for the development of a Product (as
described below); and
WHEREAS, Janssen Pharmaceutica International has an option under the
Development Agreement to enter into this License Agreement for the Medisorb
technology required to make, use and sell the Product, which option Janssen
Pharmaceutica International has assigned to Janssen US with the consent of
Medisorb and which option Janssen US has elected to exercise; and
WHEREAS, the parties believe that it is in their mutual best interest for
Medisorb to license to Janssen US on an exclusive basis in the Territory,
Medisorb Patents and Technical Information within the Field, upon the terms and
conditions set forth herein;
NOW, IT IS HEREBY AGREED AS FOLLOWS:
(1) Definitions: The following terms shall have the meanings ascribed to
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them herein, unless the context otherwise requires:
(a) "Affiliate" shall mean any company controlling, controlled by, or
under common control with a party by ownership, directly or indirectly, of fifty
percent (50%) or more of the total ownership or by the power to control the
policies and actions of such company.
(b) "Development Program" shall mean the development activities
conducted by the parties pursuant to the Development Agreement.
(c) "Field" shall mean the treatment of [
].
(d) "Improvements" shall mean any improvements or developments to or of
the Patents and Technical Information in the Field which Medisorb may acquire,
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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discover, invent, originate, make, conceive or have a right to, in whole or in
part, during the term of this Agreement, whether or not such improvement or
development is patentable.
(e) "Medisorb Polymers" shall mean bioresorbable aliphatic polyesters
based on glycolide, lactide, caprolactone and combinations of such polymers,
which are manufactured by Medisorb and utilized in Product(s) licensed under
this Agreement.
(f) "NDA" shall mean a New Drug Application and all supplements filed
pursuant to the requirements of the United States Food and Drug Administration,
including all documents, data and other information concerning Product which are
necessary for, or included in, FDA approval to market a Product as more fully
defined in 21 C.F.R. 314.5 et seq. or any other similar application for
marketing authorization filed with the appropriate regulatory authorities in
other countries of the Territory (as defined hereinafter).
(g) "Net Sales" shall mean the gross amounts received from sales of
Products during a calendar quarter to third parties by Janssen US, its
Sublicensees or any Affiliate of either, less any: (i) applicable sales taxes;
(ii) cash trade or quantity discounts; (iii) amounts repaid or credited by
reason of rejections or return of goods; or (iv) freight, postage and duties
paid for. No deduction from the gross sales price shall be made for any item of
cost incurred by the seller in its own operations incident to the manufacture,
sale or shipment of the product sold. For purposes hereof, Net Sales shall not
include sales of a Product from Janssen US or an Affiliate of Janssen US to any
Affiliate or Sublicensee of either; it being intended that Net Sales shall only
include sales to unrelated third-parties.
(h) "Patents" shall mean (i) any and all existing issued patents and
patent applications or parts thereof which describe and claim a depot
formulation of [ ], or any chemical analogues of [ ] with similar
physiological activity, based on polymers of lactic and glycolic acids and the
production and use thereof; (ii) any other patents and patent applications filed
by or on behalf of Medisorb, or under which Medisorb has the rights to grant
licenses, which are needed to practice the inventions; and (iii) any reissues,
extensions, substitutions, confirmations, registrations, revalidations,
additions, continuations, continuations-in-part, or divisions of or to any of
the foregoing which are granted hereafter or any additional protection
certificate granted with respect thereto.
(i) "Product(s)" shall mean any and all depot formulations of [ ],
or any chemical analogues of [ ] with similar physiological activity,
based on polymers of lactic and glycolic acids which are designed to deliver
[ ], or any of its chemical analogues, over an extended period.
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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(j) "Sublicensees" shall mean any company or companies, other than
Janssen US's Affiliates, sublicensed by Janssen US.
(k) "Technical Information" shall mean all unpatented information,
know-how, practical experience, procedures, methodology, specifications,
formulae and data whether or not the same shall be patentable which have been
heretofore developed or acquired by Medisorb prior to the date of this Agreement
and which are necessary in order to use, manufacture or sell Products in the
Field.
(l) "Territory" shall mean the United States, its Territories,
Protectorates, Commonwealths, and all other political subdivisions of the United
States.
(2) License Grant
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(a) Medisorb hereby grants to Janssen US in the Territory an exclusive
license under the Patents and Technical Information existing prior to the
effective date of this Agreement, with the right to grant sublicenses
thereunder, for all purposes within the Field to practice and use the Patents
and Technical Information, including the rights to manufacture and have
manufactured, to use and have used, and to sell and have sold Products.
Medisorb exclusively retains all rights under the Patents and Technical
Information outside the Field and for use other than in Products. The right to
grant sublicenses granted hereunder is exclusive to Janssen US and shall not
extend to Janssen US Affiliates or Sublicensees.
(b) Medisorb shall offer to Janssen US for incorporation into this
License Agreement on reasonable terms and conditions, Medisorb Improvements in
the Field which, if incorporated into Janssen US's then current commercial
Product(s), would: (i) result in significant changes in either the
specifications for such Product(s) or the processes for producing such
Product(s), and (ii) would reasonably be expected to result in enhanced market
value and/or profitability of such Product(s). Examples of such Improvements
would include: (i) the development by Medisorb of a non-aqueous injection
vehicle which offers significant advantages with respect to ease of
administration and (ii) the development by Medisorb of technology enabling [
].
It is the parties' understanding that the effect of any such license amendment
would, in general, be either an extension of the term of this Agreement for a
mutually agreed period or a marginal increase in the then current royalty rate.
All other Medisorb Improvements shall be made available to Janssen US for its
use without further agreement. Proprietary rights to Improvements jointly
developed by Medisorb and Janssen US or any of its Affiliates shall be governed
by the terms of Section 5(c) of this Agreement.
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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(c) In the event that at any time during the term of this Agreement
Medisorb is unable for any reason whatsoever to supply the Medisorb Polymers
required by Janssen U.S. for use in Products, then the license granted under
paragraph 2(a) above shall be expanded to include the Medisorb Technology
required to make and use the Medisorb Polymers.
(3) Royalties:
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(a) Janssen US shall pay or cause to be paid to Medisorb a running
royalty with respect to all Products sold to customers in the Territory by
Janssen US, its Affiliates and Sublicensees, payable quarter-annually in arrears
within sixty (60) days following the end of Janssen US's regular fiscal quarters
in any year during the term hereof, as follows: (i) [ ]% of the Net Sales of
each unit of Product sold during the preceding calendar quarter during the term
hereof, if such unit of Product was manufactured by Medisorb pursuant to a
written contract for the supply of Product; or (ii) [ ]% of the Net Sales of
each unit of Product sold during the preceding calendar quarter during the term
hereof, if such unit of Product was not manufactured by Medisorb pursuant to a
written contract for the supply of Product. Any withholding or other tax that
Janssen US or any of its Affiliates or Sublicensees are required by statute to
withhold and pay on behalf of Medisorb with respect to the royalties payable to
Medisorb under this Agreement shall be deducted from said royalties and paid
contemporaneously with the remittance to Medisorb; provided, however, that in
regard to any tax so deducted Janssen US shall furnish Medisorb with proper
evidence of the taxes paid on its behalf.
(b) In the event that Product is not claimed in a valid Patent
effective in the Territory and a similar product obtains a market share greater
than [ ]% of the total market revenues for Products and similar products in
such country, the parties agree to meet and negotiate in good faith an
appropriate reduction in the royalty rate then in effect. In no event shall a
reduction in royalty rates pursuant to this section result in royalty rates
[ ] of the rates specified under Section 3(a)(i) and 3(a)(ii) of this
Agreement. For the purposes of this section, "similar product" shall mean a
generic version of the Product(s) where: (i) the active agent is
[ ], or a chemical analogue thereof and (ii) the excipient is
comprised of lactic and/or glycolic acids. In the event that patent protection
in the Territory for Product(s) becomes available subsequent to a royalty
reduction pursuant to this section, the parties agree to (i) reinstitute the
royalty otherwise applicable, and (ii) in the event that any recovery is
obtained for prior infringement of the subsequently issued patent, the parties
will first apply such recoveries to reimbursing Medisorb for royalties it would
otherwise have received.
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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(c) Janssen US shall keep complete and adequate records with respect to
the proceeds of Products on which it has to pay royalties payable hereunder for
at least two (2) years after expiry of the year they concern. Medisorb shall
have the right to have such records of Janssen US inspected and examined, at
Medisorb's expense, for the purpose of determining the correctness of royalty
payments made hereunder.
Such inspection shall be made by an independent, certified public accountant to
whom Janssen US shall have no reasonable objection. Such accountant shall not
disclose to Medisorb any information other than that necessary to verify the
accuracy of the reports and payments made pursuant to this Agreement. It is
understood that such examination with respect to any quarterly accounting period
shall take place not later than two (2) years following the expiration of said
period. Not more than one examination per year shall take place.
Based upon the verification of such reports and whenever there is reasonable
doubt about the accuracy of the sales of Product realized by an Affiliate or
sublicensee, Medisorb may reasonably request Janssen US to audit the books of
such Affiliate or such sublicensee in accordance with any applicable contractual
provision, in order to confirm the accuracy of such reports.
(4) Production of Product/Technology Transfer:
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(a) Janssen US shall use its reasonable efforts consistent with its
overall business practices and strategies to commercialize and market Product,
or to have the same commercialized and marketed in the Territory.
(b) In the event that Janssen US determines to manufacture Product
itself or through an Affiliate or have Product manufactured by a third party,
Medisorb shall transfer to Janssen US and/or Affiliate all relevant Technical
Information, and provide such technical assistance, upon mutually agreed terms
and conditions, as is required by Janssen US in order to enable the manufacture
of Product by Janssen US, its Affiliate or its designated third party
manufacturer. However, with respect to such third party manufacturers, except as
limited by a written Product manufacturing agreement between Janssen US and
Medisorb, Medisorb will have a right of first refusal as to the manufacture and
supply to Janssen US of all Product(s), and component bioabsorbable polymers
utilized in such Product(s). Medisorb will have a period of thirty (30) days
following written notice from Janssen US of terms it is offering to, or prepared
to accept from, a third party manufacturer to notify Janssen US of its intention
to exercise its right of first refusal to supply Product and/or component
bioabsorbable polymers thereof to Janssen US, its Affiliates and Licensees on
terms no less favorable to Janssen US than those offered by such
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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third party manufacturer. Such third party manufacturer cannot be an in-kind
competitor to Medisorb and must be reasonably acceptable to Medisorb with
respect to confidential protection of Medisorb's Technical Information. In the
event that at any time during the term of this Agreement Medisorb is unable for
any reason whatsoever to supply the Medisorb Polymers required by Janssen U.S.
for use in Products, then the right of first refusal under this paragraph
respecting the supply of the component bioabsorbable polymers shall be
eliminated. For the purposes of this section, an "in-kind" competitor shall mean
any organization which regularly engages in the contract development and/or
contract manufacture of injectable controlled release drug delivery systems
comprising a polymeric excipient based on lactic and/or glycolic acids and/or
other closely related monomers. This Section 4(b) specifically supersedes
Section 7(B) of the Development Agreement, which Section 7(B) shall be of no
further force or effect.
(5) Proprietary Rights
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(a) Medisorb will retain title to and ownership of all technology
(including, without limitation, all patents, inventions, and data relating
thereto) relating to absorbable polymers, controlled release of active agents,
and/or manufacturing methods or processes relating to such polymers and the
controlled delivery systems for active agents based on such polymers previously
owned by Medisorb or developed by Medisorb as a result of the Development
Program or otherwise. Medisorb will pay its own costs and expenses in connection
with the protection of any such technology, including all patent application and
maintenance costs and Janssen US agrees to provide Medisorb with any necessary
utility information.
Medisorb shall inform Janssen US of any patent application it wishes to
file to protect proprietary rights defined in Article 5, resulting from either
the Development Program or the preliminary Development Program and shall forward
a copy of any such patent application to Janssen US at least one month prior to
filing.
Medisorb shall consider any suggestions made by Janssen US for amplifying
such application and shall accordingly amend the application where in Medisorb's
opinion it is appropriate.
Medisorb shall not abandon part or whole of any of the patents or patent
applications without having first consulted Janssen US, which shall have the
right to further pursue any patents or patent applications which Medisorb wishes
to abandon, or parts thereof, in its own name and at its own expense.
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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(b) Janssen US and/or its Affiliate will retain title to and ownership
of all technology (including, without limitation, all patents, inventions, and
data relating thereto) relating to [ ] or any chemical analogues of
[ ] with similar physiological activity previously owned by Janssen US
and/or its Affiliate or developed by Janssen US and/or affiliate as a result of
this Agreement or otherwise. Janssen US and/or its Affiliate will pay its own
costs and expenses in connection with the protection of any such technology,
including all patent application and maintenance costs and Medisorb agrees to
provide Janssen US with any necessary utility information.
(c) Any inventions, other than those falling under either section 5(a)
or 5(b) hereof, having an inventorship jointly between at least one employee of
Janssen US or an Affiliate of Janssen US and one employee of Medisorb or an
Affiliate of Medisorb shall be jointly-owned by Janssen US or Janssen US
Affiliate as the case may be and Medisorb. Each party will cooperate fully in
the filing and prosecution of such patent applications.
Janssen US and Medisorb shall agree on which of both shall be responsible
for the filing, prosecution and maintenance of any such joint patent
applications and patents (hereinafter referred to as the "Responsible Party") in
Territory. In principle, the party having contributed the most to the invention
to be protected shall be the responsible party, unless agreed upon differently.
Upon mutual consent, the responsible party may select an agent for drafting,
filing and prosecuting a joint application. However, both parties shall agree
who shall be the agent and to what extent this agent shall be used.
The Responsible Party shall consult the other party when drafting any new
jointly owned patent application. The final draft shall be forwarded to the
other party at least one month prior to filing to give the opportunity to make
final comments.
The Responsible Party shall not abandon part or whole of any of the patents
or patent applications without having first consulted the other party, which
shall have the right to further pursue any patents or patent applications which
the responsible party wishes to abandon, or parts thereof, in its own name and
at its own expense.
All out-of-pocket costs made in relation to joint patent applications and
patents in the Territory shall be shared equally by Janssen US and Medisorb. A
statement of costs shall be made up on a quarterly basis and invoiced to the
other party.
Medisorb shall grant to Janssen US an exclusive fully-paid up royalty free
license with the right to sublicense to make, have made, use and sell under any
such patents or patent applications for the duration of the patents, any
continuations, continuations in part,
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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divisions, patents of addition, reissues, renewals or extensions thereof or any
supplementary protection certificates granted with respect thereto, in respect
of any claims concerning the application of [ ] or any chemical
analogues of [ ] with similar physiological activity. However, nothing
contained in this paragraph shall obviate Janssen US's obligation to pay
royalties under Section 3 hereof with respect to any Products developed
hereunder.
Janssen US shall grant to Medisorb an exclusive fully paid-up royalty free
license with the right to sublicense to make, have made, use and sell under any
such patents or patent applications for the duration of the patents, any
continuations, continuations in part, divisions, patents of addition, reissues,
renewals or extensions thereof or any supplementary protection certificates
granted with respect thereto, in respect of any claims concerning the
application of bioabsorbable polymers in the field of human and/or veterinary
medicine.
(d) In addition, each party will retain exclusive title to its
respective confidential information in accordance with the provisions of Article
9 below.
(6) Patent Infringement
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(a) In the event that either party becomes aware that any third party
is infringing in the Territory any patents included within the Patents, the
party becoming aware of such infringement shall promptly give notice of such
infringement to the other party. Any possible action against such alleged
infringement of the Patents will be carried out by either or both of the parties
in accordance with the provisions specified hereinafter in paragraphs (b), (c),
(d) and (e).
(b) Whenever it would concern a patent or patent application falling
within the definition of Patents and of which Medisorb retains full title and
ownership pursuant to Article 5 a), Medisorb shall use all reasonable efforts to
take action against such infringement in its own name, at its own expense and on
its own behalf.
If Medisorb fails to take action against such infringement, or if Medisorb
does not use reasonable efforts in carrying out such action after commencement
thereof, within thirty (30) days after the notice referred to in paragraph (a)
above or after having become aware of such infringement, Janssen US shall be
entitled at its own discretion and at its own expense, to take immediate action
against such infringement in its own name, at its own expense and on its own
behalf. Medisorb will give all reasonable assistance to Janssen in taking such
action in accordance with Article 6(e), including giving Janssen the authority
to file and prosecute such suit and, if necessary, being named a party in such
action. If Janssen US commences or assumes such action, Janssen US may credit
[ ] of
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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any royalty otherwise due to Medisorb for sales in such country or countries
against the amount of the expenses and costs of such action, including without
limitation, attorney fees actually incurred by Janssen US. The amount of
expenses so deducted shall be paid to Medisorb out of the recoveries, if any,
received by Janssen US as a result of such action. Except for such repayment of
royalties deducted, Janssen US shall be entitled to retain all recoveries
therefrom.
In no event shall Medisorb settle with such infringing third party in the
Field without the prior written consent of Janssen US.
(c) Whenever it would concern a patent or patent application falling
within the definition of Patents and of which Janssen US or any of its
Affiliates retains full title and ownership pursuant to Article 5 B), Janssen US
shall have the right but not the obligation to take action against such
infringement in its own name, at its own cost and on its own behalf. If Janssen
US fails to take action against such infringement, or if Janssen US does not use
reasonable efforts in carrying out such action after commencement thereof,
within thirty (30) days after the notice referred to in paragraph (a) above or
after having become aware of such infringement, Medisorb shall be entitled at
its own discretion and at its own expense, to take action against such
infringement. Medisorb shall be entitled to retain all recoveries, if any,
therefrom.
(d) Whenever it would concern a patent or patent application falling
within the definition of Patents and of which Janssen US or any of its
Affiliates and Medisorb jointly retain full title and ownership pursuant to
Article 5 (c), and whenever in such case the infringing product would be a drug
product falling within the definition of the Field, Janssen US shall have the
right but not the obligation to take action against such infringement in its own
name, at its own cost and on its own behalf. If Janssen US fails to take action
against such infringement, or if Janssen US does not use reasonable efforts in
carrying out such action after commencement thereof, within thirty (30) days
after the notice referred to in paragraph (a) above or after having become aware
of such infringement, Medisorb shall be entitled at its own discretion and at
its own expense, to take action against such infringement, it being understood
that Janssen US will have a continuing right to take over any such action at its
own expense and shall pay to Medisorb from any recoveries Janssen US receives
(i) Medisorb's expenses and (ii) from any sums remaining after deduction of
Medisorb's and Janssen US's expenses, an amount proportionate to Medisorb's
expenses in relation to Janssen US's expenses.
Whenever it would concern a patent or patent application falling within the
definition of Patents and of which Janssen US or any of its Affiliates and
Medisorb jointly retain full title and ownership pursuant to Article 5 (c), and
whenever in such case the
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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infringing product would be a drug product falling outside the definition of the
Field, Medisorb shall have the right but not the obligation to take action
against such infringement in its own name, at its own cost and on its own
behalf. If Medisorb fails to take action against such infringement, or if
Medisorb does not use reasonable efforts in carrying out such action after
commencement thereof, within thirty (30) days after the notice referred to in
paragraph (a) above or after having become aware of such infringement, Janssen
US shall be entitled at its own discretion and at its own expense, to take
action against such infringement, it being understood that Medisorb will have a
continuing right to take over any such action at its own expense. If Janssen US
commences or assumes such action, Janssen US may credit
[ ] of any royalty otherwise payable to Medisorb
payable hereunder against the amount of the expenses and costs of such action,
including without limitation, attorney fees actually incurred by Janssen US. The
amount of expenses so deducted shall be paid to Medisorb out of the recoveries,
if any, received by Janssen US as a result of such action. Except for such
repayment of royalties deducted, Janssen US shall be entitled to retain all
recoveries therefrom.
(e) Each party agrees to cooperate reasonably with the other party in
such litigation, including making available to the other party records,
information, and evidence relevant to the infringement of the Patent.
(7) Third Party Intellectual Property Rights
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(a) Medisorb warrants that to the best of its current knowledge and
belief the Products to be developed hereunder will not infringe the patent
rights of any third party.
(b) In the event that the manufacture, use or sale of the Product
would constitute an infringement of the rights of a third party in the Territory
because of the use of the Patents or Medisorb's know how, each party shall, as
soon as it becomes aware of the same, notify the other thereof in writing,
giving in the same notice full details known to it of the rights of such third
party and the extent of any alleged infringement. The parties shall after
receipt of such notice meet to discuss the situation, and, to the extent
necessary attempt to agree on a course of action in order to permit Janssen US
to practice the license granted hereunder. Such course of action may include:
(a) modifying the Product or its manufacture so as to be noninfringing; (b)
obtaining an appropriate license from such third party; or (c) fight the claim
or suit. In the event that within a short period of time, the parties fail to
agree on an appropriate course of action Janssen US may decide upon the course
of action in the interest of the further development, manufacturing or
commercialization of the Product.
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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(c) In the event that the parties cannot agree on modifying the
Product or in the case that such modification would not be economically viable
or regulatory feasible, Janssen US, whenever it relates to know how, whether
patented or not, owned by Janssen US in accordance with the provisions of
Article 5 (b) and (c), or Medisorb, whenever it relates to know how, whether
patented or not, owned by Medisorb in accordance with the provisions of Article
5 (a), will have the right to negotiate with such third party for such license.
Both parties hereto will in any event in good faith consult with each other with
respect to such negotiations and the party negotiating such license as indicated
above, will make every effort to minimize the amount of license fees and
royalties payable thereunder. In no event shall either party as a result of such
settlement, grant a sublicense or cross license to the third party to settle the
suit, without the prior written approval of the other party. In the event that
such negotiations result in a consummated agreement, any license fee and/or
royalties to be paid thereunder shall be paid by the party responsible for the
negotiations as indicated above, [ ] of any license fees
or royalties paid by Janssen US under such license will be creditable against
royalties due to Medisorb hereunder.
(d) In the event that either or both parties would further to such
notification under Paragraph 7 (b) decide to defend such suit or claim in which
a third party alleges that the manufacture, use or selling of the Product in the
Territory infringes said third party's patent in, Janssen US shall have the
right to apply [ ] of the royalties due to Medisorb
on the sales of the allegedly infringing Product against its litigation
expenses.
(8) Term:
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(a) Except as otherwise provided herein, this Agreement and the term
of the license granted to Janssen US hereunder shall commence on the date first
written above and shall expire (i) upon expiration of the last to expire Patent
or (ii) fifteen (15) years after the date of the first commercial sale of
Product in the Territory, whichever is later; provided, that in no event shall
the license granted hereunder expire later than the twentieth anniversary of the
first commercial sale of Product. After expiration of the license granted to
Janssen US hereunder, Janssen US shall retain a fully paid-up non-exclusive
license to manufacture, use and sell Products in the Field in the Territory.
(b) Medisorb may convert the exclusive license granted under this
Agreement to non-exclusive if Janssen US does not maintain the following minimum
annual royalty payments to Medisorb. With respect to the entire Territory, the
minimum royalty obligation will first apply to the twelve month period following
the anniversary of the end of the month in which the Product was launched.
During the first twelve month period and each subsequent twelve month period
that such minimum royalty obligation is applicable, the
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License Agreement
minimum royalty amount to be paid by Janssen US will be calculated by
multiplying the applicable royalty rate by [ ] percent of the actual aggregate
net sales of other [ ] products in the Territory during such twelve month
period.
Janssen US shall have the right to make up any shortfall in minimum royalty
payments from Product sales in the Territory provided, such make-up payment is
made at the same time and in the same manner as required for the underlying
minimum royalty obligation.
(c) In the event that either party shall enter or be put into
voluntary or compulsory liquidation or have a receiver appointed or default in
the observance or performance of its obligations under this Agreement and shall
fail to remedy such default within ninety (90) days after the delivery of
written notice from the other party, the other party shall be entitled upon
giving written notice to terminate this Agreement.
(d) Janssen US may terminate this Agreement without cause upon 30 days
prior written notice. Thereafter, Janssen US shall have no further rights or
privileges with respect to the use of Medisorb Technology in Products and
Medisorb shall be under no further obligation of non-competition or exclusive
dealing.
(e) Any early termination of the Agreement shall be without prejudice
to the rights of either party against the other accrued under this Agreement
prior to termination.
(f) Upon any termination of this Agreement, any remaining inventory of
Product may be sold, provided all royalties otherwise due hereunder are paid
with respect to such sales.
(g) All rights and licenses granted under or pursuant to this
Agreement by Medisorb to Janssen U.S. are, and shall otherwise be deemed to be,
for purposes of Section 365(n) of Title 11, U.S. Code (the "Bankruptcy Code"),
licenses to "intellectual property" as defined under section 101(60) of the
Bankruptcy Code. The parties agree that Janssen, as a licensee of such rights
under this Agreement, shall retain and may fully exercise all of its rights and
elections under the Bankruptcy Code.
(9) Confidentiality:
---------------
(a) Each party agrees to keep confidential and to not use for any
purpose other than as set forth herein all technical information and materials
supplied by the other hereunder and any information a party may acquire about
the other or its activities as a result of entering into this Agreement,
provided that such obligation shall not apply to
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License Agreement
technical information or material which: (i) was in the receiving party's
possession without restriction prior to receipt from the other party or its
Affiliates; (ii) was in the public domain at the time of receipt; (iii) becomes
part of the public domain through no fault of the receiving party; (iv) shall be
lawfully received from a third party with a right of further disclosure; (v)
shall be required to be disclosed by law, by regulation or by the rules of any
securities exchange.
(b) Except as may be otherwise provided herein, the confidentiality
obligations as set out in this Section shall continue so long as this Agreement
remains in force and thereafter for a period of seven (7) years.
(c) Janssen US shall cause its Affiliates and Sublicensees to abide by
the obligations of confidentiality with respect to unpublished information
within the Patents and Technical Information.
(d) Any confidential information relating to the subject matter of
this Agreement imparted to the other party prior to the execution of this
Agreement shall be considered to fall under the terms of this Agreement.
(10) Disclaimer of Warranty: Medisorb makes no representations or
----------------------
warranties, express or implied, with respect to the Medisorb Patents and
Technical Information licensed to Janssen US hereunder, including without
limitation any warranties of merchantability or fitness for a particular
purpose.
(11) Liability
---------
(a) Janssen US agrees to indemnify, defend and hold harmless Medisorb
from and against any liability, loss, damages and expenses (including reasonable
attorney fees) Medisorb may suffer as the result of claims, demands, costs or
judgments which may be made or instituted against Medisorb by reason of personal
injury or damage to property arising out or caused by Janssen US's promotion,
use and sale of the Product, except where such liabilities claims, demands,
costs or judgments are caused by Medisorb's failure to provide Janssen US with
any information as specified in Section 12 (c) and Article 13. Medisorb will
notify Janssen US as soon as it becomes aware of any such claim or action and
agrees to give reasonable assistance in the investigation and defense of such
claim or action it being understood that it shall allow Janssen US to control
the disposition of the same.
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
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License Agreement
(b) Medisorb agrees to indemnify, defend and hold harmless Janssen US
from and against any liability, loss, damages and expenses (including reasonable
attorney fees) Janssen US may suffer as the result of claims, demands, costs or
judgments which may be made or instituted against Janssen US by reason of
personal injury or damage to property arising out or caused by Medisorb's
failure to provide Janssen US with any information as specified in Section 12
(c) and Article 13.
(c) In no event shall either party be liable for loss of profits, loss
of goodwill or any consequential or incidental damages of any kind of the other
party.
(12) Product Information and Adverse Drug Events
-------------------------------------------
(a) As Janssen US has superior knowledge of the end-use applications
to which Products licensed hereunder will be put, Janssen US is responsible for
providing third parties with adequate information as to the medical profile of
such Products. Janssen US will provide Medisorb with copies of the product
information document which is part of the NDA for the Product.
(b) Medisorb does not claim the expertise to judge whether Product(s)
will perform acceptably in Janssen US's application(s). Janssen US is the sole
judge as to whether Product(s) will perform acceptably in Janssen US's
application(s). Janssen US represents and warrants on an on-going basis during
the term of this agreement that it has the capability to assess the suitability
of Product(s) in Janssen US's application(s) and agrees to conduct adequate
testing to confirm the safety and efficacy of Products prior to
commercialization.
(c) Medisorb will provide to Janssen US promptly after its discovery
by Medisorb, any information in its possession which indicates adverse effects
in humans associated with the Products, including the bioabsorbable polymeric
components thereof, licensed hereunder. For the purpose of this Agreement
"adverse event" shall mean an experience which is noxious and unintended and
which occurs at doses normally used in man for the prophylaxis, diagnosis or
therapy of a disease or for the modification of a physiological function and any
report of an overdose.
(13) Government Approvals
--------------------
Janssen US shall be responsible for conducting all necessary testing as
well as determining what, if any, government approvals are required for the use
and sale of Product licensed hereunder and shall comply with all such
requirements prior to and following the sale or distribution of such Products.
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TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
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License Agreement
Medisorb shall cooperate fully with Janssen US in obtaining regulatory
approvals for Product licensed hereunder and shall, at Janssen US's request,
provide appropriate regulatory authorities with any and all information
concerning Medisorb's technology, Medisorb polymers and Medisorb's manufacturing
process for such Product.
In this respect Medisorb undertakes that it has submitted or will as soon
as possible submit a type IV Drug Master File to the FDA identifying Medisorb's
method of manufacture, release specifications and testing methods used in the
manufacture of Medisorb Polymers and a type I Drug Master File of Medisorb's
manufacturing facilities where Product may be manufactured. Medisorb will
authorize Janssen U.S. at its request to cross-reference any Drug Master Files
relating to the Medisorb Polymers.
(14) Force Majeure: Neither party shall be liable for its failure to
-------------
perform any of its obligations hereunder if such failure is occasioned by a
contingency beyond its reasonable control including, but not limited to,
occurrences such as strikes or other labor disturbances, lock out, riot, war,
default by a common carrier, fire, flood, storm, earthquake, other acts of God,
inability to obtain raw materials, failure of plant facilities or government
regulation, act or failure to act. Each party shall notify the other immediately
upon occurrence or cessation of any such contingencies. If such contingency
continues unabated for at least 180 consecutive days, either party shall have
the right to terminate this Agreement without further obligation beyond those
actually incurred prior to such termination.
(15) Press Communications: Neither party shall originate any publicity,
--------------------
news release or public announcement, written or oral relating to this Agreement,
including its existence, without the prior written approval of the other party.
(16) Notices: Any legal notice required or permitted hereunder shall be
-------
considered properly given if in writing and sent by first class mail, certified
mail or by telefacsimile to the party being notified at the respective address
of such party as follows:
If to Medisorb:
Medisorb Technologies International L.P.
6954 Cornell Road
Cincinnati, OH 45242
Facsimile: 513-489-2348
If to Janssen US:
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License Agreement
Janssen U.S.
1125 Trenton-Harbourton Road
P.O. Box 200
Titusville, New Jersey 08560-0200
Facsimile: 609-630-2616
with a copy to Janssen Pharmaceutica International
Kollerstrasse 38
6300 Zug 6
Switzerland
Facsimile: 00-41-42449565
Such notice shall be effective upon receipt or upon refusal to accept such
notice. In any case, notice shall be presumed effective no later than five (5)
days after such notice is sent.
Neither party shall originate any publicity, news release or public
announcement, written or oral, relating to this Agreement, including its
existence, without the written approval of the other party.
(17) Assignment: This Agreement shall not be assigned by either party
----------
without the prior written consent of the other party; provided, however, that
assignment shall be permitted without such consent to any party, not less than
50% of the total interest of which owns, is owned by, or is under common control
with the assigning party. In the event of any such permitted assignment the
assignee shall be subject to and shall agree in writing to be bound by the terms
and conditions of this Agreement.
(18) Dispute Resolution: The parties shall amicably discuss and
------------------
negotiate any matters which arise under this Agreement and are not specifically
set forth hereunder. If any disputes arise under this Agreement, the parties
shall use their reasonable efforts to meet and resolve such disputes. In the
event that the parties are unable to resolve any such disputes, then both
parties hereby agree to submit said disputes to the jurisdiction of the
competent courts of the State of New Jersey and agree that any litigation in any
way related to this Agreement shall be submitted to such courts and that same
shall be subject to the laws of the State of New Jersey without regard to its
rules respecting choice of law.
(19) Severability: In the event any one or more of the provisions of
------------
this Agreement should for any reason be held by any court or authority having
jurisdiction over this Agreement or any of the parties hereto to be invalid,
illegal or unenforceable such provision or provisions shall be validly reformed
to as nearly approximate the intent of the
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
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License Agreement
parties as possible and, if unreformable; shall be divisible and deleted in such
jurisdiction, elsewhere this Agreement shall not be affected.
(20) Captions: The captions of this Agreement are for convenience
--------
only, and shall not be deemed of any force or effect whatsoever in construing
this Agreement.
(21) Waiver: The failure on the party of a party to exercise or
------
enforce any right conferred upon it hereunder shall not be deemed to be a waiver
of any such right, nor operate to bar the exercise or enforcement thereof at any
time thereafter.
(22) Survival: The following Articles of this Agreement shall survive
--------
the termination or expiration of this Agreement: 5, 9, 10, 11, 15, 17, and 18.
(23) Miscellaneous: This Agreement may be executed by the parties
-------------
hereto in counterparts, each of which when so executed and delivered shall be
considered to be an original, but all such counterparts shall together
constitute but one and the same instrument. This Agreement is the complete
agreement of the parties and supersedes all previous understandings and
agreements relating to the subject matter hereof. Neither this Agreement nor
any of the terms hereof may be terminated, amended, supplemented, waived or
modified orally , but only by an instrument in writing signed by the party
against whom enforcement of the termination, amendment, supplement, waiver or
modification is sought.
IN WITNESS WHEREOF, the duly authorized representatives of the parties
hereto have executed this Agreement as of the day and year first above written.
JANSSEN PHARMACEUTICA INC.
By: /s/ Paula F. Costa
------------------------------
Name: Paula F. Costa
----------------------------
Title: President
---------------------------
Date: 2/13/96
----------------------------
(Second Janssen Signatory)
---------------------------
By: /s/ Bruce D. Given
------------------------------
Name: Bruce D. Given
----------------------------
Title: Group Vice President
---------------------------
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
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License Agreement
Date: 2/16/96
----------------------------
MEDISORB TECHNOLOGIES INTERNATIONAL L.P.
by: Medisorb Technologies
International, Inc.,
its General Partner
By: /s/ David R. Lohr
------------------------------
Name: David R. Lohr
----------------------------
Title: President
---------------------------
Date: January 31, 1996
----------------------------
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.