CO-DEVELOPMENT AGREEMENT
THIS AGREEMENT (the "Agreement") is entered into and effective this 19 day of
May 1998, the same date affixed hereto by the party last signing this Agreement,
by and between Bioheal Ltd ("Bioheal") of Xxxxxxxxxxxxx Xxxxx, Xxxxxx Xxxx,
Xxxxxx, Xxxxxx and Xxxxxxxxxxx Xxxx ("X X Xxxx") of Xxx Xxxxxx, Xxxxxxxxx Xxxx,
Xxxxx Xxxxx, Xxxxx XX0 0XX
WITNESSETH
WHEREAS, X X Xxxx has rights in patents and technical information relating to
the development and uses of a a gene marker and immunomodulator system for use
in gene therapy and related technologies [Technology(s)];
WHEREAS, Bioheal recognizes that its anticipated business activity will
encompass the practice of technology that requires a license under intellectual
property owned by X X Xxxx; and
WHEREAS, Bioheal wishes to acquire certain rights to practice the inventions of
such patents and technical information; and
NOW THEREFORE, in consideration of the mutual covenants herein contained and
intending to be legally bound thereby, the parties agree as follows:
1. DEFINITIONS
As usual herein the following terms shall have the meanings set forth below:
Co-Development Program means the joint development of the Technology by X X Xxxx
and Bioheal.
B. Field means, and is limited to, the practice of the Patent, Invention and
Technical information licensed hereunder for use in human and animal health
applications.
C. Net Sale Price means the gross amount recognized by Bioheal or its affiliates
for the sale of a Product(s) through normal distribution channels (as determined
by generally accepted accounting principles), less any discounts or deductions
for value added taxes incurred and not recovered by Bioheal or the equivalent in
Great Britain or elsewhere in the Territory.
D. Invention means patented and unpatented, patentable and unpatentable,
proprietary technology ("Technology") related to a cell-based vector system for
use in gene therapy and related technologies, developed by or on behalf of X X
Xxxx, that is (i) related to human and animal health applications of the
Technology or (ii) necessary for the practice of Technology for human and animal
health applications as disclosed and claimed in the Patent(s).
2. LICENSE AND CO-DEVELOPMENT PROGRAM
The parties to this Agreement hereby agree to jointly co-develop the Technology
according to the terms of this Agreement which supersedes all other written or
verbal agreements, express or implied, between Bioheal and X X Xxxx relating to
co-development of the Technology.
X X Xxxx hereby grants to Bioheal, to the extent of the Field for the Territory,
an exclusive license to make, have made, use and sell Product(s), provided
Bioheal sells Product(s) under existing trade-marks or under new trade-xxxx(s)
to be agreed by both parties and the terms of clause 6H shall apply to such new
trade-xxxx(s).
The exclusive license set forth herein shall remain exclusive for so long as
Bioheal meets the payments and other obligations set forth with regard to the
development and commercialization of the Licensed Technology or a Product. If
such conditions are not met, X X Xxxx, in his sole discretion, may elect to
terminate the Co-Development Agreement or take whatever actions it deems
necessary.
The licence shall continue in force until expiry of the last patent for
which the product is covered, this term to include new patents applied for
during the course of this Agreement.
3. TECHNICAL INFORMATION LICENSE
A. To the extent it is able to do so, X X Xxxx hereby grants to Bioheal, to the
extent of the Field for the Territory, an exclusive license to use the Technical
Information necessary to practice the Technology such that Bioheal may make,
have made, use and sell Product(s), including disclosures of the Technical
Information as needed to obtain patent rights or authorization to sell or
manufacture Products or services in the Field within any political jurisdiction
requiring such disclosure.
B. The exclusive license set forth herein shall remain exclusive for so long as
Bioheal meets the payments and other obligations set forth with regard to the
development and commercialization of the Licensed Technology or a Product. If
such conditions are not met, X X Xxxx in his sole discretion may elect to
terminate the Co-Development Agreement or take whatever action it deems
necessary
C. (1) X X Xxxx shall make efforts to make available to Bioheal Technical
Information in his possession related to the Technology that X X Xxxx has the
obligation to disclose under this Agreement. Bioheal shall not disclose to third
parties any Technical Information furnished by XX Xxxx during the term of this
Agreement, or any time thereafter, provided, however, that disclosure may be
made of any such Technical Information at any time: (i) with the prior written
consent of X X Xxxx, or (ii) to the extent necessary, to Bioheal's sublicensees
and
purchasers of Bioheal's Product(s) or services, or (iii) after the same shall
have entered into the public domain through no fault of Bioheal or Bioheal's
subsidiaries. Disclosure of Technical Information is permitted without a prior
written consent of X X Xxxx to the extent required by statute, rule or
regulation of a governing body during the course of Bioheal's normal business
practices, or in the application or prosecution of an application for patent
rights, or in connection with securing financing for the development or
commercialization of the Technology or a Product. Bioheal shall inform X X Xxxx
of any such disclosure and use its best efforts to protect its confidentiality
under such disclosure. Any combination of Technical Information shall not be
considered in the public domain merely because individual elements thereof are
in the public domain. To the extent that any such Technical Information is
disclosed to Bioheal's sublicensees and purchasers of Bioheal's Product(s) or
services, the agreements contained in this Section shall be made by Bioheal
under a confidentiality agreement to apply to and be made binding upon all such
parties.
(2) The fact that some or all of the Technical Information becomes public
knowledge shall not affect the financial obligations for use of the Technical
Information licensed under this Agreement if such Technical Information was used
or usable in the discovery, development, manufacture, or approval for sale of a
Product within the Field.
4. LICENSE FEE AND RESEARCH AND DEVELOPMENT FUNDING
Bioheal shall pay the costs of any further pre-clinical development work deemed
necessary prior to commencing clinical trials, and this shall include the
development of the Product for other therapeutic applications, the use of
different formulations and preparations of the Product. The pre-clinical costs
not to exceed $1.5 million, unless agreed to buy both parties.
B. Bioheal shall pay the costs of clinical trials of the Product. The costs of
such development will not exceed $4 million (four million U.S. dollars).
C Bioheal shall pay the cost of prosecuting, filing and maintaining patents and
defending revocation proceedings on patents and patent applications, on the
Product within the Territory.
5. ACQUISITION
Acquisition of the Licensed Technology is meant in its broadest sense
including assignment, transfer, sublicense, merger, joint venture and so on and
so forth.
A. If all or part of the rights granted to Bioheal are acquired by a third party
all current or future payments derived by Bioheal from the transfer, whether in
cash, shares, property or any other form of payment, including but not limited
to up-front payments, milestone payments and royalties will be divided equally
between
X X Xxxx and Bioheal, after repayment to Bioheal of all development costs
incurred by Bioheal.
ROYALTY PAYMENTS
A. Bioheal shall have exclusive rights to market the Product in the Territory
under the following terms: For the Patent and Technical Information licenses
granted herein, Bioheal shall pay to X X Xxxx a royalty of 10% of the Net Sale
Price of all Product(s) sold to an unaffiliated third party, likely to be a
distributor or wholesaler, but not limited to such, where Bioheal is responsible
for the marketing of the Product.
B. If the Product incorporates inventions, patents, or technical information
that is necessary for the successful commercialization of the Product and that
is obtained from sources other than X X Xxxx, the Parties agree to negotiate in
good faith a new royalty rate to reflect the contribution of such third party
inventions, patents, or technical information, but in no event shall the royalty
rate be reduced by more than 50%.
C. If this Agreement is for any reason terminated before all the earned
royalties herein provided for have been paid, Bioheal shall immediately pay to X
X Xxxx any remaining unpaid balance of earned royalties even though the due date
provided in Article 8 has not been reached.
If Bioheal shall sell the rights to the Technology in combination with the sale,
acquisition, merger or disposition of Bioheal Ltd., Bioheal, X X Xxxx and the
third party(ies) shall negotiate in good faith the specific details for such
sale of rights, subject to the approval of X X Xxxx which shall not be
unreasonably withheld.
7. SUBLICENSING
A. Bioheal shall have the right to sublicense in the Field for the Territory.
B. Bioheal will keep X X Xxxx routinely updated on progress of discussions and
negotiations with potential sub-licensees. X X Xxxx shall have the right to
review the form of sublicenses to be granted hereunder prior to the execution of
the same by Bioheal. Bioheal agrees that sublicense agreements shall conform in
all material respects to the terms and conditions of this Agreement. If X X Xxxx
has not objected within thirty (30) days of receiving the form of such agreement
describing the material terms, Bioheal may proceed to negotiate and grant
sublicenses without further review by X X Xxxx if the form of the sublicense has
not materially changed. Bioheal shall provide X X Xxxx with a copy of each
sublicense within thirty (30) days of execution, and shall not grant to its
sublicensees any rights not conveyed by this Agreement.
C. If this Agreement is terminated for any reason, except breach of contract by
Bioheal, any sublicense shall automatically transfer to X X Xxxx, unless
sublicensee is in breach or default of sublicense, and remain in full force and
effect so long as
the sublicensees performs the obligations of the sublicense, and Bioheal will
execute such documents as may be requested by X X Xxxx to attest to the transfer
to X X Xxxx of all sublicense rights, including the right to receive future
payments.
8. PAYMENTS AND REPORTS
Payments owed to X X Xxxx shall be payable within thirty (30) days of receipt by
Bioheal except as stated otherwise elsewhere in this Agreement and except for
royalties and profit-sharing compensation as a result of direct marketing of
Product by Bioheal.
B. Royalties and profit-sharing compensation owed to X X Xxxx as a consequence
of direct marketing of Product by Bioheal shall be due for each calendar quarter
beginning with the first calendar quarter in which sales occur and shall be
payable to X X Xxxx within forty-five (45)days following the last day of the
applicable calendar quarter. All payments from Bioheal to X X Xxxx shall be made
in Pounds Sterling (pounds,) by bank credit transfer to X X Xxxx at the address
designated in writing by X X Xxxx from time-to-time.
C. In the event that Bioheal is prevented from making any payment to X X Xxxx
under this Agreement by virtue of restrictions on currency conversion or
repatriation under the statutes, laws, codes or governmental regulations of the
country from which the payment is to be made, then such payments may be paid by
depositing them in the currency in which accrued to X X Xxxx'x account in a bank
acceptable to X X Xxxx in the country whose currency is involved. If the local
currency cannot be converted or remitted to X X Xxxx within twelve (12) months
from the initial deposit, Bioheal shall pay X X Xxxx the equivalent of such
amount at the initially computed conversion rate (including any interest
earnings) in Pounds Sterling (pounds), and the local currency shall be
transferred to an account in a bank acceptable to X X Xxxx in that country.
D. Payments to X X Xxxx hereunder shall be deemed paid as of the day on which
they are received at the address designated. Any part of a payment which is not
paid on or before the date when due shall accrue interest thereon from such date
until the date of its payment in full at two (2) percentage points over the per
annum interest rate published as the "Prime Rate" in The Wall Street Journal
(Eastern Edition), but in no event shall such rate exceed the maximum rate
permitted by applicable law.
E. Bioheal shall deliver to X X Xxxx within forty-five (45) days after the end
of each calendar quarter a report, certified by the chief financial officer (or
equivalent) of Bioheal, setting forth in reasonable detail the calculation of
payments made during the quarter and for each calendar quarter, including gross
sales, value added taxes, number of units sold, unit price and the like on a
country-by-country basis by Bioheal, sublicensees, joint ventures and their
affiliates.
F. The Bioheal report to X X Xxxx shall be supported by and based upon a similar
financial report or, if permitted, a copy from each sublicensee and other
commercialization entity(ies).
G. The parties will promptly share all information generated under the
Co-Development Program pursuant to the confidentiality provisions of Article 21
and with particular respect to the pre-clinical studies and clinical trials.
9. RECORDS
Bioheal shall keep accurate records of all operations affecting payments
hereunder, and shall permit X X Xxxx or a duly authorized agent to inspect all
such records and to make copies of or extracts from such records during regular
business hours throughout the term of this Agreement and for a reasonable period
of not less than three (3) years thereafter. The fees charged for an audit shall
be paid by X X Xxxx; provided, however, that if an audit discloses an
underpayment by Bioheal of more than five percent (5%) for such audited period,
Bioheal shall pay the reasonable fees and expenses charged by the firm
conducting the audit.
10. OWNERSHIP OF THE TECHNOLOGY, TECHNICAL INFORMATION AND IMPROVEMENTS
X X Xxxx and Bioheal shall each retain full ownership of their existing
intellectual property rights including rights in the process of being protected
and rights conceived but not yet reduced to practice as of the effective date of
this Agreement.
All Improvements developed under projects funded, in whole or in part, by
Bioheal shall be owned by X X Xxxx and shall be included in the licenses granted
in this Agreement. In the event that a conflicting obligation prevents X X Xxxx
from including such an Improvement, X X Xxxx shall use reasonable efforts to
assist Bioheal to obtain rights from the appropriate third party or parties.
All Improvements made during the first three (3) years from the effective date
of the Agreement and not developed under projects funded, in whole or in part,
by Bioheal, shall be owned by X X Xxxx and if deemed reasonably necessary for
Bioheal's practice of the Technology, without which such practice would
constitute an infringement of Bioheal's rights, shall be included to the extent
necessary, as decided solely by X X Xxxx, in the licenses granted in this
Agreement, unless inclusion is not possible due to X X Xxxx'x obligations to a
third party. In the event that a conflicting obligation prevents X X Xxxx from
including such an Improvement, he shall use reasonable efforts to assist Bioheal
to obtain rights from the appropriate third party or parties.
Bioheal shall have the first right of negotiation to a license or other
commercial arrangement to any X X Xxxx intellectual property developed under
projects funded, in whole or in part, by Bioheal, which does not constitute an
Improvement.
11.PATENT PROSECUTION
A. Bioheal shall file, prosecute and maintain all of the Patent(s) that are the
property of X X Xxxx as of the date of this Agreement.
B. Bioheal shall bear all patenting expenses related to the filing, prosecution
or maintenance of all Patent and Improvement licensed hereunder in whole or in
part.
C. X X Xxxx shall furnish Bioheal with copies of all allowed claims when such
claims are allowed in the Field and in the Territory for all Patent and
Improvement licensed hereunder.
D. X X Xxxx shall provide Bioheal with draft copies of all correspondence and
filings and related prosecution documents on the Patent and Improvement licensed
hereunder and Bioheal shall promptly provide comments, if any, to X X Xxxx. X X
Xxxx shall xxxxxx with Bioheal, and make reasonable efforts to adopt Bioheal's
suggestions regarding prosecution tactics and strategy. Notwithstanding the
foregoing, Bioheal shall have the right to take such actions as are reasonably
necessary, in its good faith judgement, to preserve all rights under the Patent
and Improvement throughout the Territory. As soon as practical, subsequent to
the filing of any prosecution document, Bioheal shall provide X X Xxxx with a
copy of such document. In addition, Bioheal shall copy X X Xxxx with any
official office action and responses and submissions. Bioheal shall bear the
expenses of the activities noted in this Article 11.E.
.E. Bioheal will inform X X Xxxx at least sixty (60) days prior to any decision
having as a result the failure to file, or the abandonment of Patent
applications or failure to maintain a Patent, Patents and Improvements licensed
hereunder so that Bioheal may take over and maintain such Patent and
Improvements in force.
.F. Provided that Bioheal has been informed by Bioheal at least sixty (60) days
in advance, in the event that Bioheal decides not to pay patenting expenses in
any jurisdiction, X X Xxxx may elect to maintain such Patent and Improvements in
force and terminate Bioheal's licenses granted as for the jurisdiction in which
Bioheal abandoned or failed to file or maintain such Patent rights.
12. INFRINGEMENT BY THIRD PARTY
Either party shall notify the other party of any suspected infringement by a
third party of the Patent in the Field and the Territory, and each party shall
inform the other of any evidence of such infringement(s).
Bioheal shall have the first right to institute suit for infringement(s) in the
Field and Territory so long as this Agreement remains exclusive. At Bioheal's
expense, X X Xxxx will reasonably assist Bioheal in such prosecutions if so
requested by Bioheal, and will lend his name to such actions if requested by
Bioheal or required by law. Notwithstanding the foregoing X X Xxxx shall have
the right to
participate and be represented in any such prosecutions by his own counsel at
his own expense.
If X X Xxxx notifies Bioheal of his desire to institute suit for infringement(s)
and Bioheal fails to exercise its first right to do so within ninety (90) days
of such notice, then X X Xxxx may, at his own expense, bring suit or take any
other appropriate action. At Bioheal's expense, Bioheal will reasonably assist X
X Xxxx in such prosecutions if so requested by X X Xxxx, and will lend its name
to such actions if requested by X X Xxxx or required by law. Notwithstanding the
foregoing X X Xxxx shall have the right to participate and be represented in any
such prosecutions by his own counsel at his own expense.
No settlement of any suspected infringement(s), whether or not a suit has been
instituted, may be entered into without the express written consent of X X Xxxx
and Bioheal.
Any amounts recovered pursuant to an infringement suit, settlement or
otherwise shall be retained by and be the property of the party bringing the
action. In the event Bioheal receives any monies or other consideration from a
third party as a result of Bioheal's exercise of its rights under this
Agreement, Bioheal shall first be reimbursed for expenses incurred and paid for,
X X Xxxx shall then receive a portion of the remainder in accordance with the
applicable provision(s) of Article 6 as applied to all such monies or other
considerations whether such monies or other considerations are denoted as
"royalties," "damages," "releases" from prior acts, or any other designation.
If Bioheal fails to exercise its first right to institute suit for
infringement(s) and X X Xxxx elects not to institute suit, then X X Xxxx shall
provide Bioheal with at least sixty (60) days notice of its intention to
terminate Bioheal's licenses granted in those jurisdictions affected by the
infringement or to take any other action it sees fit in its best judgement.
13. REVOCATION PROCEEDINGS
In the event either party becomes aware of the institution by a third party of
any proceedings for the revocation of any Patent, patents or Improvements in any
country in the Territory licensed hereunder to Bioheal, such party shall notify
the other party promptly. Bioheal shall defend any such proceedings at its own
expense, in its own name.
B. X X Xxxx shall have the right to participate in such revocation proceedings
at Bioheal's expense, and will lend its name to such proceedings if requested by
X X Xxxx or required by law. Sublicensees of Bioheal shall also have the right
to participate in such revocation proceedings.
C. Settlement of any revocation proceedings shall be subject to the approval of
X X Xxxx; such approval shall not be unreasonably withheld.
14. INFRINGEMENT OF THIRD PARTY RIGHTS
X X Xxxx will reasonably assist Bioheal to defend or settle such third
party claim if so requested and at the expense of Bioheal.
B C B Wood shall have the right to participate and be represented in any such
claim by a third party by its own counsel.
C. No settlement of any third party claim may be entered into without the
express written consent of X X Xxxx.
D. In the event, by way of counterclaim or otherwise, either party or both
parties recover any damages or other sums in any action, suit, or proceeding
involving a claim by a third party, or in settlement thereof, such recovery
shall be applied and shared as mutually agreed.
15. REPRESENTATIONS
A. X X Xxxx represents that it has the right to grant all of the rights herein.
X X Xxxx is unaware of any claims asserted against X X Xxxx by any third
parties with respect to Patent infringement or any other type of liability
relevant to licensing of the Inventions, which have not been disclosed to
Bioheal as of the Effective Date of this Agreement.
X X Xxxx represents that he has full power, authority and legal right to
enter into this contemplated Agreement and to consummate the transactions
contemplated therein.
D. Bioheal represents that it has full power, authority and legal right to enter
into this contemplated Agreement and to consummate the transactions contemplated
therein.
E. Bioheal shall accept liability to the extent of the Field and for the
Territory for or on account of any injury, loss or damage, of any kind or nature
sustained by, or any damage assessed or asserted against, or any other liability
incurred by or imposed upon either party arising out of or in connection with or
resulting from (i) the production, use or sale of any Product(s) or (ii) the use
of any technical information, techniques, or practices disclosed by either
party, or (iii) any advertising or other promotional activities with respect to
any of the foregoing. If a sublicense is granted by Bioheal to a third party
that third party shall accept all liability for any injury, loss or damage as
defined above.
16. INDEMNIFICATION
Bioheal hereby agrees to indemnify, hold harmless and defend liability to
the extent of the Field and for the Territory X X Xxxx and his representatives
and
agents from and against any and all demands, claims, suits or actions of any
character presented or brought on account of any injuries, losses or damages
sustained by any person or property in consequence of (i) any act or omission of
Bioheal or its agents, employees or subcontractors, or (ii) any liability,
except for any injuries, losses or damages that specifically result from the
negligence or willful misconduct of Bioheal. The foregoing indemnity shall
include but not be limited to court costs, attorneys' fees, costs of
investigation and costs of defense associated with such demands, claims, suits
or actions. The foregoing indemnity shall apply only to the extent of the Field
and in the Territory.
17. INSURANCE
Bioheal shall maintain, during the term of this Agreement, reasonable amounts of
comprehensive general liability insurance, including products liability
insurance, with reputable and financially secure insurance carriers to cover the
activities of X X Xxxx and his affiliates. Such insurance shall be written to
cover claims incurred, discovered, manifested, or made during or beyond the
expiration or termination of this Agreement during the period that any product,
process, or service, relating to, or developed pursuant to, this Agreement is
being commercially distributed or sold by Bioheal or by a sublicensee, affiliate
or agent of Bioheal. Bioheal shall furnish to X X Xxxx a certificate of
insurance evidencing such coverage and periodically, upon request, provide
evidence that the coverage is still in effect.
18. TERM AND TERMINATION
A. This Agreement shall commence on the Effective Date and, unless sooner
terminated under this Article 18, shall expire upon the later of: (i) expiration
of the last to expire of all Patent(s), Improvement(s), and Patent(s) licensed
under this Agreement including any extensions thereof and any periods of
exclusivity granted by regulatory agencies or other governmental bodies; (ii) X
X Xxxx is no longer due any payments from Sublicensee(s); or (iii) Bioheal is no
longer directly marketing a Product.
The payment obligations under the licenses granted to Bioheal for Licensed
Patents and Technical Information shall continue throughout the term as defined
in this Agreement but would be subject to good faith renegotiations upon the
expiration of the last to expire of the Licensed Patents, or upon the
abandonment of the last to be abandoned of any patent applications if no patents
have been issued, whichever is the later, unless this Agreement is sooner
terminated. Such good faith renegotiations shall take into account on a
country-by-country or regional basis but not be limited to: (i) Product
competition; (ii) utilization, incorporation and value of Technical Information;
(iii) value of Technical Information if no longer confidential or proprietary
through no fault of Bioheal, its Sublicensee(s), contractors, financiers or any
other Bioheal agent(s) or purchasers of Product or services having access to
Technical Information; (iv) the applicable contract or patent law or (v) prior
payment commitments.
C. Bioheal may terminate this Agreement at any time upon ninety (90) days
written notice to X X Xxxx and upon payment of all amounts due X X Xxxx through
the effective date of the termination.
Upon termination of this Agreement, neither party shall be released from
any obligation that matured prior to the effective date of such termination.
Bioheal and any sublicensee may, however, after the effective date of such
termination, sell all Products in inventory provided that Bioheal shall pay to X
X Xxxx the royalties and profit-sharing thereon as required by Article 6 hereof
and submit the reports required by Article 8 hereof.
Except as provided in above, if either party shall be in default of any
obligation hereunder, the other party may terminate this Agreement by giving
Notice of Termination by Certified or Registered Mail to the party at fault,
specifying the basis for termination. If within sixty (60) days after the
receipt of such Notice of Termination, the party in default shall remedy the
condition forming the basis for termination such Notice of Termination shall
cease to be operative, and this Agreement shall continue in full force.
X X Xxxx shall have the right to terminate this Agreement if Bioheal shall
cease to carry out its business as related to the Product(s), become bankrupt or
insolvent, apply for or consent to the appointment of a trustee, receiver or
liquidator of its assets or seek relief under any law for the aid of debtors.
Bioheal shall inform X X Xxxx of its intention to file a voluntary petition
in bankruptcy or of another's intention to file an involuntary petition in
bankruptcy to be received at least thirty (30) days prior to filing such a
petition.
Notwithstanding anything else in this Agreement to the contrary, the
parties agree that Bioheal's obligation to pay X X Xxxx any payments or other
consideration accrued but unpaid prior to termination shall survive the
termination of this Agreement.
19. CONFIDENTIALITY; PUBLICATION; PUBLICITY
In fulfilling their obligations under this Agreement, it may be desirable
or necessary for the parties to disclose to one another certain of their
Confidential Information. In the event of receipt of such Confidential
Information, the receiving party agrees to preserve such information as
confidential and not to disclose it to third parties or to use it except in
connection with this Agreement during the term of this Agreement and for a
period of five (5) years following its termination. The foregoing obligations
shall not apply to any information that:
1. is now in the public domain or becomes generally available to the public
through no fault of the receiving party;
2. is already known to, or in the possession of, the receiving party as can
be demonstrated by documentary evidence;
3. is disclosed to the receiving party on a non-confidential basis by a
third party having the right to make such disclosure; or
4. is independently developed by the receiving party as can be demonstrated
by documentary evidence.
In addition, to the extent reasonably necessary to fulfil its obligations
or exercise its rights under this Agreement (i) a party may disclose
Confidential Information to its Affiliates, Sub-licensees, consultants, outside
contractors, research investigators and clinical investigators, on a
need-to-know basis on condition that such persons or entities agree to be bound
by the provisions of this Agreement, (ii) a party or its Affiliates or
Sub-licensees may disclose Confidential Information to governmental or other
regulatory authorities to the extent that such disclosure is reasonably
necessary to obtain patents or regulatory authorizations, provided the
disclosing party shall request confidential treatment thereof, and (iii) a party
may disclose Confidential Information as required by applicable law, regulation
or judicial process, provided that such party shall give the other party (x)
prior written notice thereof, (y) adequate opportunity to object to any such
disclosure or to request confidential treatment thereof, and (z) shall take all
steps reasonably possible to minimize the disclosure to that level mandated by
law.
B. (i) If either party desires to publish or present the results of the
Co-Development Program, the publishing/presenting party shall provide the
non-publishing/non-presenting party a copy of the manuscript of any proposed
publication or presentation. The non-publishing/non-presenting party shall then
have thirty (30) days to review and comment on the manuscript or presentation,
and the publishing/presenting party agrees to delete any information identified
by the non-publishing/non-presenting party as its Trade Secrets or Confidential
Information.
(ii) In the event the non-publishing/non-presenting party determines that a
Patent application covering information contained in the proposed publication or
presentation should be filed, the party proposing the publication or
presentation shall delay such publication or presentation for up to sixty (60)
days after the thirty (30) days outlined in clause B (i) above to allow such
filing to be made.
Each party shall provide the other party with the prior opportunity to
review and approve any press releases or similar public announcements concerning
this Agreement or clinical, regulatory and commercial developments related to
Products as soon as practicable, but in no event later than 24 hours before an
announcement is made. Bioheal shall not use the name of X X Xxxx or otherwise
refer to any organization related to X X Xxxx, except with the written approval
of X X Xxxx, such approval not to be unreasonably withheld.
20. DISPUTE RESOLUTION
A. The parties shall attempt to resolve through good faith discussions any
dispute which arises under this Agreement. Any dispute may, at the election of
either party, be referred to the chief executive officers, or the equivalent, of
each party. If they are unable to resolve the dispute, within thirty (30) days
after delivery of written notice of the dispute from one party to the other,
either party may seek to resolve it by referring the matter to an appropriate
arbitration service with experience in the field relevant to the dispute.
ASSIGNABILITY
X X Xxxx or Bioheal shall not assign any rights under this Agreement not
specifically transferable by its terms without prior written consent of the
other party
22. REFORM
The parties agree that if any part, form, or provision of this Agreement
shall be found illegal or in conflict with any valid controlling law, the
validity of the remaining provisions shall not be affected thereby.
In the event the legality of any provision of this Agreement is brought
into question because of a decision by a court of competent jurisdiction of any
country in which this Agreement applies, Bioheal, by written notice to X X Xxxx,
may revise the provision in question or may delete it entirely so as to comply
with the decision of the said court.
23. WAIVER AND ALTERATION
The failure of either party to insist, in any one or more instances, upon
the performance of any of the terms, covenants or conditions of this Agreement
and to exercise any right hereunder, shall not be construed as a waiver or
relinquishment of the future performance of any such term, covenant or condition
or the future exercise of such right, but the obligations of the other party
with respect to such future performance shall continue in full force and effect.
A provision of this Agreement may be altered only by a writing signed by both
parties.
24. MARKING
A. Bioheal shall place in a conspicuous location on any product or its
packaging, which is made or sold under any Patent coming within this Agreement,
a patent notice in accordance with the laws concerning the marking of patented
articles.
B. Bioheal shall include a marking provision similar to Paragraph A above in
every sublicense granted pursuant to Article 7 above.
25. IMPLEMENTATION
Each party shall execute any instruments reasonably believed by the other party
to be necessary to implement the provisions of this Agreement.
26. GOVERNING LAW
This Agreement shall be deemed to have been entered into and shall be governed
by, construed and enforced in accordance with laws of England and in the English
language, and any action brought to enforce any provision or obligation
hereunder shall be brought in a court of competent jurisdiction in the United
Kingdom.
27. HEADINGS
The headings of the articles, sections and paragraphs used in this Agreement are
included for convenience only and are not to be used in construing or
interpreting this Agreement.
28. PARTIES INDEPENDENT
In making and performing this Agreement, the parties act and shall act at all
times as independent entities and nothing contained in this Agreement shall be
construed or implied to create an agency, partnership or employer and employee
relationship between Bioheal and X X Xxxx. Except as specifically provided
herein, at no time shall either party make commitments or incur any charges or
expenses for or in the name of the other party.
29. COUNTERPARTS
This Agreement shall become binding when any one or more counterparts hereof,
individually or taken together, shall bear the signatures of each of the parties
hereto. This Agreement may be executed in any number of counterparts, each of
which shall be an original as against either party whose signature appears
thereon, but all of which together shall constitute but one and the same
instrument.
30. FORCE MAJEURE
The parties shall not be responsible for failure to perform any of the
obligations imposed by this Agreement (except an obligation to pay money),
provided the failure is not due to negligence and provided such failure is
caused by fire, storms, floods, strikes, lockouts, accidents, war, riots or
civil commotions, inability to obtain railroad cars or raw materials, embargoes,
any State or Federal regulation, law, or restriction, seizure or acquisition of
the Technology or the Product(s) by the Government of the United Kingdom or the
United States of America or of any state, or of any agency thereof or by reason
of any compliance with a demand or request for such Product for any purpose for
national defense, or any other cause or contingency beyond the reasonable
control of said party (whether or not of the
same kind or nature as the causes or contingencies above enumerated) shall not
subject the party so failing to any liability to the other.
31. EXECUTION
IN WITNESS WHEREOF the parties have caused this Agreement to be executed by
their duly authorized officers on the respective dates and at the respective
places hereinafter set forth.
BIOHEAL: X X XXXX:
By: /s/ [ILLEGIBLE] By: /s/ [ILLEGIBLE]
-------------------------- ----------------------------
Position: Director Position: Director
Date: 9/05/98 Date: 9/5/98
