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EXHIBIT
10.18
CONFIDENTIAL PROVISIONS
REDACTED
AMENDED AND
RESTATED
LICENSE
AGREEMENT
This Agreement, dated as of
April 25, 2007 (“2007 Effective Date”), is by and
between (i) SciClone Pharmaceuticals, Inc.
(“SciClone”), a Delaware corporation having its
principal place of business at 901 Mariners Island Blvd., San
Mateo, California 94404, and (ii) RESprotect GmbH, a German
corporation having an office at Fiedlerstr. 34, D-01307 Dresden,
GERMANY (hereinafter “RESprotect”).
RECITALS
WHEREAS, RESprotect possesses
certain intellectual property rights related to RP101
((E)-5-(2-bromovinyl-)2’-deoxyuridine – also known as
BVDU); and
WHEREAS, Resistys INC.,
having an office at 2121 Avenue of the Stars, Suite 2550, Los
Angeles, California 90067 including any Affiliates of Resistys
(“Resistys”), Australian Cancer Technology Limited, an
Australian corporation having an office at Aurora Place, Suite 4,
Level 36, 88 Philip Street, Sydney 2000, Australia including any
Affiliates of ACT, and RESprotect GmbH, entered into a license
agreement, effective as of September 13, 2004 (“2004
License Agreement”) and, effective on the same date, Resistys
and RESprotect entered into a supply agreement for Clinical Trial
Material related to the 2004 License Agreement (“2004 Supply
Agreement”);
WHEREAS, effective
May 31, 2005, Australian Cancer Technology, Ltd. underwent a
name change to “Avantogen Limited”
(“Avantogen”);
WHEREAS, effective
August 30, 2004, Resistys, was formed as a wholly-owned
subsidiary of Avantogen for the principal purpose of entering into
the 2004 License Agreement and 2004 Supply Agreement and, after
several share transfers, the sole shareholder of Resistys is now
Avantogen Oncology Ltd (“AOI”);
WHEREAS, Resistys and
Avantogen, immediately prior to the entering into this Agreement
assigned their respective interest in the 2004 License Agreement
and the 2004 Supply Agreement to SciClone as of the 2007 Effective
Date;
WHEREAS, SciClone desires to
engage in research, development, marketing, sale and distribution
of BVDU; and
WHEREAS, SciClone desires to
acquire from RESprotect, and RESprotect is willing to grant to
SciClone, an exclusive license in the Territory, as hereinafter
defined, under RESprotect’s intellectual property rights
relating to BVDU, including patents and know-how, upon the terms
and conditions set forth herein.
WHEREAS, on March 15,
2007, RESprotect, Resistys, Avantogen , AOI and SciClone, signed a
non-binding Term Sheet (the “March 2007 Term Sheet”)
agreeing to complete certain definitive agreements by the 2007
Effective Date, including: (1) an assignment by Resistys and
Avantogen to SciClone of the (a) 2004 License Agreement;
(b) all assets owned or controlled by them
related to the 2004 License Agreement or
the RP101 program, including, without limitation, all
(i) intellectual property rights, including inventions and
know-how, whether or not patentable, (ii) data and
information, (iii) regulatory filings, and
(iv) agreements; (2) an assignment by Resistys to
SciClone of the 2004 Supply Agreement; and (3) an agreement
between Resistys/AOI and RESprotect relating to certain
consideration to be paid by Resistys/ AOI to RESprotect and
(4) this Agreement and the 2007 Supply Agreement between
RESprotect and SciClone.
NOW, therefore, in
consideration of the promises and mutual covenants herein,
RESprotect and SciClone hereby amend and restate the 2004 License
Agreement in its entirety to read in full as follows:
ARTICLE I
GENERAL
DEFINITIONS
SECTION 1.1 The term “2007
Effective Date” shall mean the date set forth in the first
and opening paragraph of this Agreement. The term “2004
Effective Date” shall mean the Effective Date of the 2004
License Agreement which was September 13, 2004.
SECTION 1.2 The term “2007
Supply Agreement” shall mean the Supply Agreement between
RESprotect and SciClone concluded with equal date as this
Agreement.
SECTION 1.3 The term
“Affiliate” shall mean any corporation or other entity,
which directly or indirectly controls, is controlled by or is under
common control with a party to this Agreement. A corporation or
other entity shall be regarded as in control of another corporation
or entity if it owns or directly or indirectly controls more than
[****] of the voting stock or other ownership interest of the other
corporation or entity, or if it possesses, directly or indirectly,
the power to direct or cause the direction of the management and
policies of the corporation or other entity or the power to elect
or appoint [****] or more of the members of the governing body of
the corporation or other entity.
SECTION 1.4 The term
“API” shall mean active pharmaceutical
ingredient.
SECTION 1.5 The term
“Asia” shall mean the countries listed under
“Asia” in Exhibit A.
SECTION 1.6 The term
“Clinical Trial Costs” shall mean [****].
SECTION 1.7 The term
“Development” shall have the meaning set forth under
Section 4.1(a).
SECTION 1.8 The term
“Development Plan” shall have the meaning set forth
under Section 4.1(a).
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SECTION 1.9 The term
“Europe” shall mean the countries listed under
“Europe” in Exhibit A .
SECTION 1.10 The term
“FDA” shall mean the United States Food and Drug
Administration and its successor agencies, if any.
SECTION 1.11 The term
“First Commercial Sale” shall mean the first sale of
Licensed Product by SciClone, and/or it’s
Sublicensees.
SECTION 1.12 The term
“Grant-Back License” shall have the meaning set forth
in Section 8.1.
SECTION 1.13 The term
“Improvements” shall mean any amendments, modifications
of and additions to the RESprotect Patent Rights and RESprotect
Know-How which are made, developed, reduced to practice or acquired
by RESprotect during the term of this Agreement, including, but not
limited to, such that: (i) improve the performance or efficacy
of the Licensed Product, (ii) reduce any side effects, drug
interactions or other adverse effects of the Licensed Product,
(iii) reduce the cost and/or increase the efficiency or
productivity of the manufacturing and production processes for the
Product, or (iv) increase bio-availability or improve drug
delivery.
SECTION 1.14 The term
“Initiation of a Phase II Trial” shall mean the date
when the first patient is enrolled in a Phase II Trial.
SECTION 1.15 The term
“Joint Technology” shall mean any inventions made
jointly by employees of SciClone or any of its Sublicensees and
RESprotect or any of its Affiliates and/or it’s Other
Licensees.
SECTION 1.16 The term
“License” shall have the meaning set forth in
Section 2.1.
SECTION 1.17 The term
“Licensed Finished Product” shall mean the finished
form medicinal product including the Licensed Product.
SECTION 1.18 The term
“Licensed IP Rights” shall mean, collectively, the
RESprotect Patent Rights and the RESprotect Know-How.
SECTION 1.19 The term
“Licensed Product” shall mean the API RP101 ((E)-5-(2-
bromovinyl-)2’-deoxyuridine—also known as BVDU), a salt
of BVDU or a prodrug of BDVU (if developed by RESprotect) for use
under the RESprotect Patent Rights, (i) which incorporates,
embodies, utilizes or is based on RESprotect Know-How or
(ii) the manufacture, use, importation or sale of which would,
but for the rights granted hereunder, constitute infringement of a
Valid Claim under the RESprotect Patent Rights.
SECTION 1.20 The term
“Market Sales” shall mean with regard to all sales of
Licensed Product in the Territory, the gross amount invoiced for
sales of Licensed Product only and does not include any amounts
invoiced to customers for customs duties or sales taxes directly
related to the sale of Licensed Product, or for transportation,
shipping and insurance costs.
SECTION 1.21 The term “Net
Sales” shall mean with respect to all sales of Licensed
Product by SciClone or Sublicensees in the Territory, the gross
invoiced sales price of Licensed Product less [****].
SECTION 1.22 The term
“Other Licensee” shall mean any Third Party who
receives a license from RESprotect under the RESprotect Patent
Rights and RESprotect Know-How in relation to the Licensed Product
for the territory of Europe and/ or Asia.
SECTION 1.23 The term
“Patent Rights” shall mean the rights under any patent
applications, issued patents and any and all substitutions,
divisions, continuations, continuations-in-part, reissues,
renewals, reexaminations or extensions that have issued or in the
future issue from such patent applications, including utility model
and design patents and certificates of invention as well as any
patent term extensions, such as pursuant to the Drug Price
Competition and Patent Term Restoration Act of 1984 and any
foreign equivalents.
SECTION 1.24 The term
“Phase II Trial” shall mean a phase II clinical trial
as defined by the FDA rules and regulations.
SECTION 1.25 The term
“Preclinical and Clinical Data” shall have the meaning
set forth in Article V.
SECTION 1.26 The term
“RESprotect Know-How” shall mean any of
RESprotect’s confidential proprietary information and
materials relating to the research, development, manufacture,
approval, marketing, use or sale of Licensed Product which during
the term of this Agreement are or prior to this Agreement were
developed by RESprotect and which RESprotect is permitted to
disclose to SciClone without violating any Third Party
agreements.
SECTION 1.27 The term
“RESprotect Patent Rights” shall mean any Patent Rights
under U.S. Patent No. 6,589,941, a patent or patents issuing
on U.S. patent applications published as 20040127454 and
20060178338 only to the extent they relate to RP 101 and any US
and/or Canadian patents or patent applications claiming priority
to, or directly related to, the above patents or patent
applications filed by RESprotect only to the extent they relate to
RP 101.
SECTION 1.28 The term
“SciClone Invention(s)” shall have the meaning set
forth in Section 8.1.
SECTION 1.29 The term
“Scale-Up Plan” shall have the meaning set forth in the
2007 Supply Agreement.
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SECTION 1.30 The term
“Sublicensee” shall mean any Affiliate of SciClone or
Third Party who receives a sublicense from SciClone relating to the
License upon entering into any of the following agreements with
SciClone: a sublicense agreement, research and development
agreement, or alternative form of collaboration or
commercialization agreement, such as, but not limited to, a
co-promotion or co-marketing arrangement to research, develop,
import, make (subject to Article VI of this Agreement and the
provisions of the 2007 Supply Agreement), use, offer for sale,
and/or sell Licensed Product in the Territory.
SECTION 1.31 The term
“Territory” means the United States of America and
Canada.
SECTION 1.32 The term
“Third Party” shall mean any entity other than
RESprotect or SciClone and their respective Affiliates.
SECTION 1.33 The term
“USPTO” shall mean the United States Patent and
Trademark Office
SECTION 1.34 The term
“Valid Claim” shall mean a claim of an issued and
unexpired patent within the RESprotect Patent Rights, which has not
been held permanently revoked, unenforceable or invalid by a
decision of a court or other governmental agency of competent
jurisdiction, unappealable or unappealed within the time allowed
for appeal, and which has not been admitted to be invalid or
unenforceable through reissue or disclaimer or
otherwise.
ARTICLE II
GRANT OF
LICENSE/OPTION
SECTION 2.1 Grant of License
Rights by RESprotect to SciClone . RESprotect hereby grants to
SciClone the exclusive license to use the RESprotect Patent Rights
and the RESprotect Know-how to develop, use, make (subject to
Article VI of this Agreement and the provisions of the 2007 Supply
Agreement), have made (subject to Article VI of this Agreement and
the provisions of the 2007 Supply Agreement), sell, offer for sale
and import the Licensed Product and Improvements under the
RESprotect Patent Rights in the Territory
(“License”).
SECTION 2.2 Sublicenses .
SciClone shall have the right to grant sublicenses to the License
to Sublicensees upon notification to RESprotect. Any such
sublicense shall be at arm’s length and conform to the terms
hereof, and SciClone shall be responsible for the performance by
its Sublicensee of all obligations imposed under the terms of this
Agreement.
SECTION 2.3 [****]
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ARTICLE III
PAYMENTS
SECTION 3.1 Milestone
Payments . In consideration of the License provided hereunder,
SciClone shall compensate RESprotect by paying to RESprotect by
wire transfer within fifteen (15) business days after the
achievement of each of the milestones set forth below, the
following payments:
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Payment to RESprotect |
| Initiation
of a Phase II Trial by SciClone or Sublicensees in the Territory or
outside the Territory covering Licensed Product |
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$1.32
million US |
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[****] |
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[****] |
Payments made by SciClone to
RESprotect pursuant to this Section 3.1 are not refundable
under any circumstances, will not be credited against royalty
payments due to RESprotect pursuant to Section 3 and apply as
well in the event SciClone sublicenses to a Sublicensee.
SECTION 3.2 Royalties .
Following the First Commercial Sale of a Licensed Product, SciClone
will pay, on a calendar quarterly basis, without offset or
deduction except as set forth in this Agreement, a royalty in the
amounts set forth in Section 3.3 below on Net Sales of the
Licensed Product, as the case may be, during the previous quarter,
calculated in U.S. Dollars.
SECTION 3.3 Royalty
Calculation .
(a) In consideration of the
License granted to SciClone, SciClone shall pay to RESprotect a
royalty at the rates set forth below of the Net Sales of Licensed
Product sold by SciClone or its Sublicensees as follows:
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Market Sales |
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[****] |
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[****] of
Net Sales |
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Market Sales |
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[****] |
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[****] of
Net Sales |
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(b) Royalty Payment
Reports; Exchange Rates . During the term of this Agreement
following the First Commercial Sale of a Licensed Product, SciClone
shall within forty-five (45) days after each calendar quarter
pay to RESprotect the royalties due under the Agreement for such
quarter and furnish to RESprotect a written quarterly report
showing: (i) the Market Sales of the Licensed Product sold by
SciClone and its Sublicensees during the reporting period and the
calculation of Net Sales from such Market Sales; (ii) the
royalty due thereon; (iii) withholding taxes, if any, required
by law to be deducted in respect of such royalties (for the sake of
clarification withholding taxes shall not be deducted from the
Market Sales); and (iv) the exchange rates used in determining
the amount of United States dollars. All sales in currencies other
than United States dollars shall be converted into United States
dollars calculated at the exchange rate published in THE WALL
STREET JOURNAL on the last day of the calendar quarter. If no
royalty is due for any royalty period hereunder, SciClone shall so
report. SciClone shall keep complete and accurate records in
sufficient detail to properly reflect all Market Sales and Net
Sales to enable the royalties payable hereunder to be
determined.
(c) Audits . Upon
written request and advance notice of not less than thirty
(30) days, SciClone shall permit an internal auditor or
independent public accountant selected by RESprotect and acceptable
to SciClone, which acceptance shall not be unreasonably withheld or
delayed, to have access during normal business hours to such
records of SciClone as may be reasonably necessary to verify the
accuracy of the royalty reports described herein, in respect of any
calendar year ending not more than thirty-six (36) months
prior to the date of such request. All such verifications shall be
conducted at RESprotect’s expense and not more than once in
each calendar year. In the event such RESprotect representative
concludes, providing sufficient evidence, that additional royalties
were owed to RESprotect during such period, the additional royalty
shall be paid by SciClone within thirty (30) days of the date
RESprotect delivers to SciClone such representative’s written
report so concluding. The fees charged by such representative shall
be paid by RESprotect unless the audit discloses that the royalties
payable by SciClone for the audited period are underpaid by more
than 5%, in which case SciClone shall pay the reasonable fees and
expenses charged by such representative and a further amount equal
to the amount of the additional royalty. Any overpay will be
refundable or credited against future royalties. SciClone shall
include in each sublicense granted by it pursuant to this Agreement
a provision requiring the Sublicensee to make reports to SciClone,
to keep and maintain records of sales made pursuant to such
sublicense and to grant access to such records by
RESprotect’s representatives to the same extent required of
SciClone under this Agreement. RESprotect agrees that all
information subject to review under this Section 3.3(c) or
under any sublicense agreement will be confidential and that
RESprotect will cause its representatives to retain all such
information in confidence.
SECTION 3.4 Form of
Payment .
(a) Any milestone payment
required to be made by SciClone to RESprotect pursuant to the terms
of Section 3.1, shall be made in U.S. Dollars. SciClone shall
make each milestone payment in cash when due and payable by wire
transfer in immediately available funds to an account designated by
RESprotect reasonably prior to the time of such payment.
(b) All royalties payable
pursuant to Section 3.2 and 3.3 are calculated in U.S. Dollars
and all royalty payments made by SciClone to RESprotect will be
paid in cash in US dollars ($) calculated on the basis of the
exchange rate as published in THE WALL STREET JOURNAL on the last
day of the calendar quarter.
SECTION 3.5 Third-Party
License .
(a) In the event that a
license from a Third Party [****] is necessary, in the sole opinion
of SciClone, for SciClone to fully use the RESprotect Patent Rights
under the License, SciClone shall so inform RESprotect in writing
and thereafter SciClone and RESprotect will cooperate in order to
conclude a license agreement with the Third Party which is
reasonably acceptable to SciClone and RESprotect. RESprotect
undertakes not to unreasonably withhold its acceptance and consent.
The Parties shall also agree on who shall lead the negotiations
with the Third Party, taking into consideration, inter alia, their
respective experience and/or standing with this Third Party, if
any, and geographic, language and nationality advantages. In the
event that upon the consent of RESprotect SciClone enters into a
license agreement with a Third Party for the Territory and is
obligated to pay royalties to such Third Party [****],
[****].
[****]
However, in no event shall the royalties
due to RESprotect under Section 3.3 of this Agreement be
reduced to less than [****] of total Net Sales.
(b) [****]
(c) For the sake of
clarification, this Section 3.5 does not apply in case
SciClone decides to take a Third Party license which has the
purpose of combining the Licensed Product with [****]. For all
costs related to any such Third Party license, SciClone shall bear
the sole financial and commercial responsibility.
SECTION 3.6 Interest . Any
late payment by SciClone shall bear interest at 2 percentage points
over the 1 year LIBOR rate applicable at the time the payment is
made.
ARTICLE IV
SCICLONE’S
DEVELOPMENT OBLIGATIONS
SECTION 4.1 SciClone
Diligence .
(a) At its own cost and
expense, SciClone shall conduct such clinical trials and apply for
all governmental approvals necessary to manufacture (unless
otherwise provided herein), sell, market, and distribute Licensed
Product, and to develop, submit regulatory applications for,
manufacture and commercialize the Licensed Product (such activities
cumulatively referred to as “Development”). SciClone is
fully committed to expediting the clinical development of the
Licensed Product. To that end, SciClone will undertake
the
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development of the Licensed Product
according to Protocol Number RP101-II, incorporated in IND [****]
(“Phase 2 Protocol”). The development plan which is
attached as Exhibit B (“Development Plan”) is a
proposal by RESprotect for purposes of discussion at the first
meeting of the Development Committee. SciClone and RESprotect agree
to work diligently to complete the initial Development Plan at the
first meeting of the Development Committee. The Development Plan
may be amended from time to time in response to additional clinical
and non-clinical studies which may be required by the FDA. Topics
related to the Development Plan will be determined in the
Development Committee (Section 4.2.)
(b) The parties acknowledge
that lack of diligence in Development of the Licensed Product will
diminish the value of this Agreement to RESprotect; accordingly,
SciClone shall at all times put forth good faith commercially
reasonable efforts in connection with Development of the Licensed
Product in the Territory. SciClone agrees to make good faith
commercially reasonable efforts and to use sound scientific
judgment in Development of the Licensed Product; provided, however,
that the parties understand and agree that the Development process
and Development Plan may from time to time be subject to reasonable
adjustment by SciClone in coordination with RESprotect as set forth
in Section 4.2. Any substantial deviation from the Development
Plan shall be submitted to the Development Committee for
consideration and decision as set forth in
Section 4.2.
(c) In addition, SciClone
shall use good faith commercially reasonable efforts and sound
scientific judgment to fully exploit the Licensed Product to the
extent of its commercial potential in the Territory.
(d) Subject to
Section 4. l(b) above, the parties acknowledge and agree that
all decisions including, without limitation, decisions relating to
SciClone’ research, development, registration, manufacture
(unless otherwise provided herein), sale, commercialization,
design, price, distribution, marketing and promotion of the
Licensed Product in the Territory, shall be within the sole
discretion of SciClone. Notwithstanding Section 4.1(b),
nothing in this Agreement shall be construed as imposing on
SciClone the duty to market and/or sell and exploit Licensed
Product for which royalties are payable hereunder to the exclusion
of, or in preference to, any other product, or in any way other
than in accordance with its normal commercial practices and subject
to Section 4.1(b) above.
SECTION 4.2 Development
Committee .
(a) General . SciClone
and RESprotect shall establish a Development Committee consisting
of two representatives for each of SciClone and RESprotect. The
responsibilities of the Development Committee shall be to oversee
the Development Plan and the Scale-up Plan and render periodic
reports at least every calendar quarter covering the status of
SciClone’ Development of Licensed Product, RESprotect’s
execution of the Scale-up Plan and related matters. The
representatives of the Development Committee of SciClone and
RESprotect shall be in a position to report on behalf of the
represented parties about these matters. The Development
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Committee shall hold meetings at least
one time every calendar quarter. The meetings may be conducted
either in person or by conference call; provided, however, that at
least one meeting in each calendar year will be held in person in
the United States at a location to be determined by the Development
Committee. Each party shall bear its costs related to participation
on the Development Committee. The Development Committee shall also
coordinate the development efforts by SciClone within the Territory
and RESprotect’s scale-up efforts. RESprotect shall report to
the Development Committee its development efforts with regard to
the Licensed Product outside the Territory unless it is prevented
from this by law or by confidentiality or other agreements with
Third Parties.
(b) Decision-Making .
The Development Committee shall have the initial right to consider
any adjustments of and deviation by SciClone from the Development
Plan. If within thirty (30) days after submission, the
Development Committee does not reach a unanimous decision in the
proposed change in the Development Plan, the proposed change in the
Development Plan shall be submitted to the CEOs of SciClone and
RESprotect for their consideration. If they do not agree within
thirty (30) days following submission of the proposed change
by the Development Committee, SciClone shall have the right of
final decision.
ARTICLE V
ACCESS TO CLINICAL
TRIAL DATA
The results and other data
from any preclinical and clinical trials (“Preclinical and
Clinical Data”) undertaken by SciClone and/ or its
Sublicensees and/ or Third Parties in the United States or
elsewhere in relation to the Licensed Product or otherwise
generated in relation to this Agreement will be available at no
cost for RESprotect for its research, regulatory and
commercialization purposes outside of the Territory. SciClone will
share Preclinical and Clinical Data with RESprotect’s Other
Licensees in Asia and Europe for their research, regulatory and
commercialization purposes in their respective territories on the
following terms: (i) with respect to Asia, the Other Licensee
will pay SciClone a fee equal to [****], and (ii) with respect
to Europe, the Other Licensee will pay SciClone a fee equal to
[****]; provided that SciClone will have thirty (30) days to
review and approve all regulatory filings or other use involving
Third Parties of RESprotect and its Other Licensees which rely on
Preclinical and Clinical Data to ensure that such regulatory
filings or other use involving Third Parties do not conflict with
or otherwise adversely effect SciClone’s regulatory filings
in the Territory, such approval to be provided in writing, not to
be unreasonably withheld. The fee payable by RESprotect’s
Other Licensees for the Preclinical and Clinical Data will be due
upon receipt of the Preclinical and Clinical Data by the
RESprotect’s Other Licensee, and shall be payable in
installments over a period of five years from the due date. Should
a RESprotect Other Licensee for
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CONFIDENTIAL TREATMENT |
Europe and/or Asia license only part of
the applicable territory, the [****] (for Asia) and [****] (for
Europe) fee will be adjusted in view of the actual market size of
the particular territory versus the full market size of Asia or
Europe, as applicable. Except as set forth above, neither
RESprotect nor its permitted Other Licensees will share or
otherwise transfer Preclinical and Clinical Data to any Third Party
without the prior written permission of SciClone.
ARTICLE VI
SUPPLY OF LICENSED
PRODUCT; MANUFACTURE AND SUPPLY OF API
SECTION 6.1 Supply of Licensed
Product for Clinical Trials . Until the appropriate
application(s) are filed with the FDA and FDA approval of the
Licensed Finished Product is obtained, it is agreed that RESprotect
will manufacture and supply SciClone with the Licensed Product as
required by SciClone for conducting clinical trials and SciClone
will purchase Licensed Product from RESprotect. The Licensed
Product for Phase II Clinical Trials will be supplied in [****],
the Licensed Product for other phases of Clinical Trials will be
supplied as API prior to tableting. The details of such purchase
are set forth in the 2007 Supply Agreement.
SECTION 6.2 Supply of Licensed
Product for Commercial Purposes . SciClone will purchase from
RESprotect the Licensed Product which it requires for the
manufacture of the Licensed Finished Product after FDA approval of
the Licensed Product. The details of such purchase are set forth in
the 2007 Supply Agreement.
SECTION 6.3 [****]
ARTICLE VII
REPRESENTATIONS AND
WARRANTIES
SECTION 7.1 Mutual
Representations . SciClone and RESprotect each represent and
warrant to the other on the 2007 Effective Date as
follows:
(a) Organization . It
is a corporation duly organized, validly existing and, as for
SciClone, in good standing under the laws of the jurisdiction of
its incorporation and has all requisite power and authority,
corporate or otherwise, to execute, deliver and perform this
Agreement.
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CONFIDENTIAL TREATMENT |
(b) Authorization .
The execution, delivery and performance by it of this Agreement has
been duly authorized by all necessary corporate action and does not
violate any provision of any law, rule, regulation, order, writ,
judgment, injunction, decree, determination or award presently in
effect having applicability to it or any provision of its charter
documents or any agreement or other instrument or obligation to
which it is bound or its assets are subject.
(c) Binding Agreement
. This Agreement is a legal, valid and binding obligation of it
enforceable against it in accordance with its terms and
conditions.
(d) No Inconsistent
Obligation . It is not under any obligation to any person, or
entity, contractual or otherwise, that is conflicting or
inconsistent in any respect with the terms of this Agreement or
that would impede the diligent and complete fulfillment of its
obligations hereunder.
SECTION 7.2 Representation of
RESprotect regarding Title to Licensed Product; Mutual
Representation regarding Performance .
(a) RESprotect is the sole
owner of the RESprotect Patent Rights and RESprotect Know-how, free
and clear of all liens, charges, encumbrances of Third Parties and
RESprotect owns the exclusive, worldwide, royalty free,
sublicensable, transferable right to use the Licensed Product under
the RESprotect Patent Rights and RESprotect Know-how. To
RESprotect’s knowledge the patentability or validity of the
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