EXHIBIT 10.11
* Portions of this document have
been omitted and are subject to a
request for confidential treatment
with the Securities and Exchange
Commission.
LICENSING &
TECHNOLOGY TRANSFER
AGREEMENT
BIONOVO INC.
UNITED BIOTECH CORPORATION
1
NOVEMBER 6, 2003
LICENSING & TECHNOLOGY TRANSFER
AGREEMENT
THIS AGREEMENT (this "Agreement") is entered into as of the 6th day of
November, 2003 (the "Effective Date"), between:
BIONOVO INC., U.S.A. ("Bionovo"), located at 0000 Xxxxxxx Xx. Xxxxx 000,
Xxxxxxxx, XX 00000, U.S.A., and
UNITED BIOTECH CORPORATION. ("UBC"), a member of Maywufa Enterprise Group,
located at Fl.5-2, Xx. 000 Xx Xxxx Xxxxx Xxxx, Xxxxxx 000, Xxxxxx, X.X.X.
(Bionovo and UBC are referred to individually as a "Party" and collectively
as the "Parties".)
WHEREAS
A. Bionovo possesses technology and know-how referred to as MF101 (FDA
IND#58267) for the indication of hot flashes and other symptoms of the
climacteric, osteoporosis, breast cancer prevention, prevention of
cardiovascular disease and osteoarthritis in women with menopause and
BZL101 (or FDA IND#59521) for the indication of breast cancer and all
other solid tumors, as described in more detail on Exhibit A (the
"Technology");
B. UBC desires to license the Technology in Territory; and
C. Bionovo is willing to grant UBC an exclusive, non-transferable license
unless the transfer is made to a member of Maywufa Enterprise Group,
license of the Technology if the Technology is developed in the manner
and on the time table specified in this Agreement.
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NOW THEREFORE in consideration of the mutual promises and covenants
contained herein, the parties to this Agreement agree as follows:
ARTICLE 1 DEFINITIONS
1.1 "Territory" means Taiwan with the opportunity to license for Asian
countries (including South Korea, People's Republic of China, Indonesia,
Thailand, Malaysia, Singapore, Vietnam, and Philippines) exclusive of
Japan.
ARTICLE 2 LICENSE
2.1 Bionovo hereby grants to UBC the exclusive, non-transferable,
unless the transfer is made to a member of Maywufa Enterprise
Group, Licensing Rights with respect to both MF101 for the
indication of hot flash with menopause and BZL101 for the
indication of breast cancer in the Territory.
2.2 Bionovo warrants that, except for this Agreement, it has not
entered into any agreement transferring any rights in the
Technology in the Territory.
ARTICLE 3 INDs; CLINICAL TRIALS; SUPPLY
3.1 Bionovo will provide detailed information to UBC regarding the
Technology as reasonably necessary to allow UBC to fulfill its
obligations under this Agreement.
3.2 Bionovo using the license fee, paid by UBC (as detailed in 4.1 of
this agreement), will file for intellectual property protection
("patent application") at any relevant jurisdiction.
3.3 During the development phase of this Agreement, Bionovo will
supply MF101 and BZL101 for oral administration (either of them,
individually, a "Pharmaceutical", and collectively, the
"Pharmaceuticals") to UBC at cost, at UBC's expense, as necessary
to allow UBC to fulfill its obligation under this Agreement.
Before the development phase is completed, the Parties will enter
into a mutually agreeable supply agreement for the
Pharmaceuticals, which the Parties will negotiate in good faith.
Bionovo assures UBC that the supply of Pharmaceuticals will be at
least equal to those offered by Bionovo to any of its customers.
Bionovo shall provide verifiable cost information to UBC.
3.4 At UBC's expense, within 120 calendar days after the Effective
Date, UBC
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with the help of Bionovo will apply to the Taiwan DOH for an
investigational new drug license ("IND") for a phase II trial
(the "Phase II Trial") for MF101 for the indication of hot
flashes in peri-menopausal and menopausal women and an IND for a
Phase I trial (the "Phase I Trial") for BZL101 for the indication
of the treatment of advanced measurable breast cancer
(collectively, the Phase I Trial and the Phase II Trial are
referred to as the "Trials"). The IND's will be filed under the
UBC's sponsorship.
3.5 Within 30 calendar days after the Effective Date, the Parties
will mutually agree of the principal investigators for the
Trials.
3.6 UBC will execute the Trials, at its expense, according to
Bionovo's protocols as approved by the in Taiwan. Bionovo will
act as an independent auditor of the Trials and will supervise
the on going data collection.
3.7 Bionovo is responsible for conducting independent quality
assurance studies of the Pharmaceuticals to ensure compliance
with US and Taiwan FDA pharmaceutical GMP guidelines. Those
quality assurance studies will include: (i) microbiological
panels, (ii) heavy metals, (iii) silica gels of primers and
active fractions, (iv) HPLC/ MS and NMR analysis, and (v) bio
analytical assays of activity.
3.8 UBC will begin to execute each of the Trials, at its expense, no
later than 90 days after Taiwan DOH approval of the IND for the
respective Trial. UBC will ensure that the principal investigator
and the clinical investigators, inform Bionovo of any grade III
or IV toxicity as defined by the US NCI common toxicity criteria
within 72 hours of any evidence of that toxicity. UBC will file
all grade III and IV toxicities reports and all annual reports to
the Taiwan DOH. After each of the Trials is complete, Bionovo
will conduct an independent data analysis and upon UBC's request
Bionovo will provide UBC with a final Phase report for the Taiwan
DOH.
3.9 After each of the Trials is complete, the Parties will discuss in
good faith whether to continue to develop either or both of the
Pharmaceuticals. If the Parties agree to continue with a Phase
III trial for MF101 or a Phase II trial for BZL101, the Parties
will have the same respective responsibilities (as described in
this Article 3) for those trials as for the Trials.
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3.10 Before UBC executes any phase III trial for MF101 or BZL101,
Bionovo, at UBC's expense, will conduct complete Chemistry,
Manufacturing and Control ("CMC") and absorption, distribution,
metabolism, elimination and toxicology ("ADMET") studies to
satisfy the additional Taiwan DOH guidelines for Phase III-level
drug-manufacturing protocols and a final New Drug Application
("NDA") process separate and different from any other regulatory
authoritiy. Bionovo will provide all available CMC and ADMET
data, at that time, at no additional expense to UBC.
3.11 After Taiwan DOH approves [the results of the Phase III trial
of] a Pharmaceutical, UBC will comply, at its expense, with any
Taiwan DOH requirements necessary to permit the commercial
marketing of that approved Pharmaceutical.
ARTICLE 4 LICENSE FEE & ROYALTIES
4.1 At the signing of this Agreement, the UBC Parties will pay
Bionovo a one-time, non-refundable fee of [*] at the signing of
this agreement. Bionovo acknowledges that it received [*] of
that payment before signing this Agreement, in consideration of
its ongoing negotiation with the UBC Parties.
4.2 Upon the completion of the phase II trial, UBC will pay Bionovo
an amount to be discussed at that time in US$ in order to
complete the additional specific requirements for CMC by Taiwan
DOH. The schedule for the payment of the amount US$ will be
determined by a mutually agreed upon timeline. In the event
Bionovo did not secure additional funding for the complete
required CMC and ADMET, as required by US FDA, UBC will have the
option to negotiate with Bionovo the independent completion the
above mentioned CMC and ADMET work. The terms of exercising this
option will be mutually agreed upon based on expense and
scientific evaluation of the process by both parties.
4.3 UBC will pay to Bionovo a royalty fee (the "Royalty Fee") in the
amount of [*] of total monetary consideration received by UBC
for
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* This information has been omitted and is subject to a request for
confidential treatment with the Securities and Exchange Commission.
5
Pharmaceuticals sold ("Net Sales"). However, if no patent(s) is
granted in the territory to one of the Pharmaceuticals, the
Royalty Fee for the said Pharmaceutical shall be [*] after five
years from the time the product was launched.
4.4 Bionovo and its representatives (including auditors) will have
the right to examine UBC's books and record at any reasonable
time on reasonable notice for the purpose of verifying Net
Sales. All expenses arising from the examination of UBC's
accounts will be borne by Bionovo. However, if Net Sales
reported to Bionovo are more than [*] less than Net Sales
determined by independent auditors engaged by Bionovo, UBC will
pay 100% of the expenses of the examination of UBC' accounts.
All information and documents examined will be kept strictly
confidential.
4.5 UBC will pay the Royalty Fee to Bionovo quarterly, within [45
calendar] days after the end of each calendar quarter.
4.6 All payments and transfers made by UBC to Bionovo will be
subject to the relevant withholding taxes prescribed by R.O.C.
law.
4.7 UBC will pay pursuant to Article 3, within 30 calendar days of
the date of any reimbursement request, Bionovo's expenses
related to (i) quarterly site visit of each of the clinical
trials, (ii) semi annual investigator's meeting for each of the
clinical trials (iii) quarterly data review, (iv) any additional
quality assurance work for the drugs in trial, (v) protocol
review and amendments of conferences, (vi) future trial design,
(vii) any Taiwan DOH correspondence that requires Bionovo to
conference with at least two senior scientists for more than two
hours, (viii) end of data analysis. The fee schedule will be
[*]/ day or [*]/ hour for senior personnel, [*]/day or [*]/ hour
for junior personnel and [*]/ day or [*]/ hour for data manager.
In addition UBC will pay all travel, accommodations and daily
allowance. UBC will pay any additional up to [*] annually for
the duration of the development. In the event additional
expenses are accrued by Bionovo on UBC's behalf UBC and Bionovo
will mutually agree to pay these expenses. The maximum total
expenses anticipated to be paid by UBC to Bionovo amount to [*]
annually, for the duration of the drugs development.
--------
* This information has been omitted and is subject to a request for
confidential treatment with the Securities and Exchange Commission.
6
ARTICLE 5 USE OF LICENSE AND TECHNOLOGY
5.1 UBC guarantees that it will use the License Rights it obtains
pursuant to this Agreement exclusively for the purposes
contemplated in this Agreement, and will not compete with itself
in the Territory with respect to MF101 and/or BZL101 through a
related party.
5.2 Bionovo and UBC will promptly inform each other of any
improvements or new indication(s) to MF101 and/or BZL101, or
technology relating to either of them (hereinafter the
"Improvements") that they may develop or be aware of and make
available for future use by each of the parties at no cost to
any of the parties. UBC is authorized to use the License, any of
their rights under this Agreement, or any of the Pharmaceuticals
to develop and utilize any Improvements to MF101 and/or BZL101.
Bionovo will own all Improvements, and UBC will promptly execute
any agreements, assignments, or other documents necessary to
transfer ownership of any Improvements.
5.3 UBC will obtain and bear the cost of all regulatory licenses,
authorizations, and consents required to fully utilize its
Licensing Rights in the Territory.
ARTICLE 6 OWNERSHIP OF PATENTS AND INTELLECTUAL PROPERTY RIGHTS
6.1 As stated in article 4.1, Bionovo at its expense will file
patents relating to the Technology in Taiwan no later than 2
months after the Effective Date. Bionovo will remain the owner
of all patents, continuations, improvements, and all other
intellectual property related to the Technology. Nothing in this
Agreement will transfer any intellectual-property rights to UBC
other than the License.
6.2 If there is any infringement on the intellectual property rights
regarding the Technology in the Territory by a third party, the
Parties will use reasonable efforts to collaboratively enforce
the patent protection received of MF101 and BZL101. If both
Parties agree to take action to remedy the infringement, the
Parties will agree on the allocation of the related expenses and
compensation before taking any action. UBC may not initiate any
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enforcement proceeding without Bionovo's consent, which will not
be unreasonably withheld.
6.3 If there is any claim or action alleging that UBC' activities
relating to the License are infringing upon the intellectual
property rights of a third party, the Parties will use
reasonable efforts to collaboratively defend the rights granted
to UBC in the License. UBC will fund the defense of an
infringement claim relating to the License.
ARTICLE 7 CONFIDENTIALITY
7.1 The Parties acknowledge and agree that, in performing this
Agreement's terms, each Party might disclose to the other
valuable proprietary information, including this Agreement's
terms, unpublished patent applications and related information,
know-how, technology, technical and non-technical data,
including but not limited to research, products, services,
development, inventions, processes, designs, specifications,
photographs, samples of Pharmaceuticals or other items ,
documents, marketing information, or financial information
(collectively, "Confidential Information"). The Parties will
keep all Confidential Information confidential, will not
disclose any Confidential Information to any third party, and
will use Confidential Information only for the purposes
specified in this Agreement. This article will survive
termination of this Agreement.
7.2 Section 7.1's confidentiality obligations will not apply to
Confidential Information where it can be demonstrated and
documented that: (i) the Confidential Information is or already
has become, part of the public domain at the time of disclosure,
except by breach of the provisions of this Agreement; (ii) the
Confidential Information can be established by written evidence
to have been already in the lawful possession of the receiving
party, prior to the disclosure by the other party and was not
acquired, directly or indirectly, from the disclosing party;
(iii) the Confidential Information is received by either party
from a third party without restrictions of disclosure or use,
who has legitimate and lawful possession thereof and the
unrestricted right to disclose such Confidential Information; or
(iv) the Confidential Information is approved and authorized for
release by the disclosing party in writing.
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ARTICLE 8 WARRANTIES & REPRESENTATIONS
8.1 Bionovo warrants and represents as of the Effective Date:
8.1.1 that it has been duly incorporated and is in good standing
pursuant to the laws of its jurisdiction of incorporation,
and it has the legal right and full power and authority to
execute and deliver and to perform its obligations under
this Agreement;
8.1.2 that it either owns or otherwise has the right to deliver
the Technology and supply MF101 and BZL101 to UBC and such
delivery or supply does not infringe any contractual or
intellectual property rights of any third party;
8.1.3 that except for this Agreement, it has not entered into
any agreement transferring any rights in the Technology in
the Territory; and
8.1.4 that it has obtained all licenses, authorizations and
consents required for the proper carrying on of its
business, including the delivery of the Pharmaceuticals,
and all such licenses, authorizations and consents if any,
are valid and subsisting and there are no existing
circumstances that can be reasonably foreseen as likely to
lead to their cancellation or suspension;
8.1.5 that, to the best of Bionovo's knowledge, the delivery of
the Technology transfer or supply of MF101 and BZL101 in
accordance with the provisions of this agreement will not
infringe, invalidate or otherwise contravene the terms of
any of the licenses, authorizations, or consents referred
to in Article 8.1.4 nor of any applicable U.S. statutes,
laws, rules or all regulations; and
8.1.6 that the information, materials, technical data, and
know-how delivered to UBC is current, accurate, and
complete for the purposes of this Agreement.
8.2 UBC warrants and represents as of the Effective Date:
8.2.1 that it has been duly incorporated and is in good standing
pursuant to the laws of its jurisdiction of incorporation,
and it has the legal right and full power and authority to
execute and deliver and to perform its
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obligations under this Agreement; and
8.2.2 that it has obtained all licenses, authorizations and
consents required for the proper carrying on of its
business, including the receipt of the Pharmaceuticals and
the execution of the Trials, if any, and all such
licenses, authorizations and consents are valid and
subsisting and there are no existing circumstances which
can be reasonably be foreseen as likely to lead to their
cancellation or suspension or to a violation of any
applicable R.O.C. statute, law, rule or regulation.
8.3 Bionovo and UBC will indemnify and hold harmless the other party
from and against all loss, damage, and expense, including but
not limited to legal fees, arising out of or in connection with
any claims or proceedings resulting from a breach of their
respective warranties and representations contained in this
Agreement, and will provide all reasonable assistance requested
by the other Party in response to said claims or proceedings.
ARTICLE 9 TERM & TERMINATION
9.1 This Agreement's term (the "Term") will begin on the Effective
Date and will continue in force for 10 years, automatically
renewing for successive periods of 3 years, unless either party
gives the other party 12 months written notice of its intention
not to renew.
9.2 Either Party has the right to terminate this Agreement if the
applications for the necessary Taiwanese government approvals
for the sale of either Pharmaceutical are rejected.
9.3 Either Party has the right to terminate this Agreement if the
other Party is in material breach of any obligation, warranty,
or representation under this Agreement by giving 60 calendar
days written notice of its election to terminate, stating the
nature of the default claimed. The defaulting Party has the
right, during the 60-day period, to correct the default and if
that default is so corrected, this Agreement will continue in
full force and effect as if that notice had not been given. If
the default is not corrected within that sixty-day period, the
Party that provided notice of the default has the right to
terminate this Agreement immediately upon notice to the
defaulting Party.
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9.4 Either Party has the right to terminate this Agreement
immediately and without notice if: (i) an order is made for the
winding-up of the other Party; (ii) an effective resolution is
passed for the winding-up of a Party, other than that Party's
voluntary winding-up solely for the purposes of amalgamation or
reorganization; or (iii) an administrative receiver or receiver
is appointed over the whole or substantially all of the other
Party's assets.
ARTICLE 10 EFFECT OF TERMINATION
10.1 This Agreement's termination or expiration will not affect any
rights that have accrued to a Party during the Term.
10.2 This Article 10 will survive this Agreement's termination.
ARTICLE 11 DISPUTE RESOLUTION & GOVERNING JURISDICTION
11.1 This Agreement is governed by and will be interpreted in
accordance with California law, and the parties irrevocably
agree that the state and federal courts of California will have
jurisdiction to enforce any award of the arbitral tribunal
described in Section 11.2.
11.2 The Parties will resolve any dispute, controversy, or claim
related to this Agreement or the transactions contemplated by
this Agreement (a "DISPUTE") using the procedures set forth in
this Article 11, as the sole and exclusive remedy in lieu of any
other available remedies.
11.3 The Parties will attempt in good faith to resolve any Dispute
promptly by negotiation. All negotiations pursuant to this
clause will be confidential, and with respect to claims
involving litigation or anticipated litigation with third
parties, will be subject to the joint defense or common interest
privilege and/or other privileges. The negotiations will also be
treated as compromise and settlement negotiations pursuant to
the full extent of the rules of evidence applicable in any
proceeding regarding the Dispute. If the Parties are unable to
resolve a Dispute within five business days after a Party
receives a request in writing to begin negotiating regarding
that Dispute, either Party may give notice requiring
arbitration. The arbitration
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will be conducted according to the provisions of this Article
11.
11.4 Any Dispute that the Parties have not resolved by negotiation
will be settled by an arbitral tribunal in San Francisco,
California. The arbitral tribunal will conduct the arbitration
in accordance with the Commercial Arbitration Rules of the
American Arbitration Association (the "AAA") as supplemented by
(A) the AAA optional rules for emergency measures of protection
and (B) if the amount of disclosed aggregate value of all claims
exceeds $1 million (excluding interest, arbitration fees and
costs), the AAA optional procedures for large disputes. The
foregoing rules and procedures as in effect (including any
amendments throughout the period of the arbitration) will be
deemed to be incorporated by reference into this Section 11.4.
The arbitral tribunal will be composed of a single arbitrator
mutually agreed by the Parties. If the Parties are unable to
reach an agreement on the person to appoint as the arbitrator
within 30 calendar days after the arbitration is filed, either
Party may request the Center for Dispute Resolution appoint the
arbitrator. If the arbitrator is unable to serve, his or her
replacement will be selected in the same manner provided in this
Section 11.4.
11.5 The parties will have the right to enforce any awards determined
by the arbitral tribunal by filing suit only in any state or
federal court in the state of California and to enter that
judgment in any court necessary or appropriate to enforce same.
By execution and delivery of this agreement, each of the parties
(on behalf of itself and its affiliates) accepts the
jurisdiction of those courts and irrevocably agrees to be bound
by any action of those courts in connection with this agreement.
Each party hereby waives any objection it may have based upon
lack of personal jurisdiction, improper venue, or forum
non-conveniens.
ARTICLE 12 MISCELLANEOUS
12.1 NOTICE. Any notice, consent or communication authorized or
required to be given under or for the purposes of this Agreement
will be sent by registered airmail, e-mail, or fax to the
recipient at the following addresses:
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To Bionovo at: 0000 Xxxxxxx Xx, Xxxxx 000, Xxxxxxxx, XX 00000,
XXX
Contact: Xxxxx Xxxxx
Address: 0000 Xxxxxxx Xx, Xxxxx 000, Xxxxxxxx, XX
00000, XXX
Fax: +1-510- 000- 0000
E-mail: Xxxxx@xxxxxxx.xxx
To UBC at:
Contact: Xxxxxxx Xxxx
Address: Fl.5-2, Xx. 000 Xx Xxxx Xxxxx Xxxx,
Xxxxxx 000, Xxxxxx, X.X.X.
Fax: x000-0-0000-0000
E-mail: xxxxx@xxx.xxx.xx
Any such notice, consent, or communication is deemed to have been
received by the addressee: (i) if sent by registered airmail , on the
seventh business day after posting and (ii) if sent by e-mail or fax,
with confirmation of the reception.
12.2 ENTIRE AGREEMENT. This Agreement supersedes any previous written
or oral agreement between the Parties in relation to the matters
dealt with in this Agreement and contains the whole agreement
between the parties relating to the subject matter of this
Agreement at the date hereof to the exclusion of any terms
implied by law which may be excluded by contract. Each Party
acknowledges that it has not been induced to enter into this
Agreement by any representation, warranty or undertaking not
expressly incorporated into it. No supplement, modification or
discharge of this Agreement is binding unless executed in
writing by authorized officers of both parties.
12.3 NO WAIVER. Any failure or delay by either party in exercising,
any right, power or remedy in connection with this Agreement
will not be construed as a waiver of that right, power or
remedy. The rights, powers, and remedies in connection with this
Agreement are cumulative and not exclusive of any other rights,
powers, or remedies provided by law or otherwise.
12.4 SEVERABILITY. The invalidity or unenforceability for any reason
of any part of this Agreement will neither prejudice nor affect
the validity or
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enforceability of any other part of this Agreement.
12.5 ASSIGNMENT. Except as otherwise provided in this Agreement,
during the Term, any content, rights and obligations under this
Agreement will not be assigned or transferred in whole or in
part by either party without the prior written consent of the
other party. Any attempted assignment in contravention of this
Agreement will be void and of no effect.
12.6 COUNTERPARTS. This Agreement will be executed in two
counterparts each of which when executed will be an original and
together will constitute one and the same instrument.
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IN WITNESS WHEREOF, Bionovo and UBC have caused this Agreement to be executed by
their respective duly authorized representatives as of the date first above
written.
Signed on behalf of: Signed on behalf of:
BIONOVO INC., U.S.A. UNITED BIOTECH CORPORATION
By: By:
--------------------------- -----------------------------
Xxxxx Xxxxx X.X. Xxx
Co-Founder and Chief Chairman
Scientific Officer
Date: November 6, 2003 Date: November 6, 2003
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EXHIBIT A
DESCRIPTION OF THE TECHNOLOGY
The technology is the production procedure for MF101 and BZL101 as indicated in
the U.S. FDA- IND and the complete IND package submitted to the US FDA.
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