Exhibit 10.27
THYMOSIN ALPHA 1
EXPANDED AND AMENDED
LICENSE,
DEVELOPMENT AND SUPPLY
AGREEMENT
BETWEEN
SCICLONE PHARMACEUTICALS, INC.
AND
SCHERING-PLOUGH K.K.
October 28, 1996
ARTICLE 1 DEFINITIONS............................................................................................2
ARTICLE 2 GRANT OF RIGHTS........................................................................................2
2.1. License Grants.....................................................................................2
2.1.1 Alpha Technology and SciClone Technology.................................................2
2.1.2 SciClone Sublicensee Technology..........................................................2
2.1.3 Alpha Sublicensee Technology.............................................................2
2.1.4 SciClone Inventions: Joint Inventions...................................................2
2.1.5 Trademarks...............................................................................2
2.2. License Grant Limitations..........................................................................3
2.2.1 Exclusivity..............................................................................3
2.2.2 Prior Licensors..........................................................................3
2.2.3 Manufacturing Rights.....................................................................3
2.2.4 Trademarks...............................................................................3
2.2.5 Development Program......................................................................3
2.3. Sublicensing.......................................................................................3
2.3.1 Co Marketing or Co Promotion Partner.....................................................3
2.3.2 Subcontracting...........................................................................4
2.3.3 Additional Indications...................................................................4
2.4. Transfer of Technology.............................................................................4
ARTICLE 3 DEVELOPMENT PROGRAM....................................................................................4
3.1. Coordination of the Development Program............................................................4
3.1.1 Development Coordinators.................................................................4
3.1.2 Meetings of Coordinators.................................................................5
3.1.3 Shared Reports...........................................................................5
3.1.4 Travel Costs.............................................................................5
3.2. Visits to Facilities...............................................................................5
3.3. Development Obligations of SPKK....................................................................6
3.3.1 SPKK Commitment..........................................................................6
3.3.2 Phase II Efficacy Trials.................................................................6
3.3.3 Chief Investigators; Study Centers.......................................................6
3.3.4 Intentionally Omitted....................................................................6
3.3.5 Development Reports; Notices.............................................................6
3.3.6 Trademarks...............................................................................6
3.4. Development Obligations of SciClone................................................................7
3.4.1 Supply of TA 1 For Development Purposes..................................................7
3.4.2 Technical Assistance.....................................................................7
3.4.3 Development Efforts......................................................................7
3.5. Regulatory Matters.................................................................................7
i
3.5.1 Compliance with Regulations..............................................................7
3.5.2 Regulatory Filings.......................................................................7
3.5.3 Adverse Events...........................................................................8
3.5.4 Maintenance of Records...................................................................8
3.6. [*REDACTED]........................................................................................8
3.7. Third Party Contracts..............................................................................8
3.8. Co-Developer Status................................................................................8
ARTICLE 4 PROGRAM DATA; IMPROVEMENTS AND INVENTIONS..............................................................8
4.1. Program Data Rights and Licenses...................................................................8
4.2. Improvements.......................................................................................9
4.2.1 Development of Improvements..............................................................9
4.2.2 Transfer of Information..................................................................9
4.3. Inventions.........................................................................................9
4.4. License to SPKK Inventions and Joint Inventions...................................................10
ARTICLE 5 LICENSE PAYMENTS......................................................................................11
5.1. Milestone Payment for CHB.........................................................................11
5.2. Milestone Payment for CHC.........................................................................11
5.3. Waiver of Certain Milestone Payments..............................................................11
ARTICLE 6 SUPPLY OF TA-1 MATERIAL AND MANUFACTURE OF LICENSED PRODUCTS..........................................11
6.1. Manufacture and Supply of TA 1 Material...........................................................11
6.2. Clinical Supply...................................................................................11
6.3. Commercial Supply.................................................................................11
6.3.1 Commercial Supply Agreement.............................................................11
6.3.2 Cutbacks in Supply......................................................................12
6.3.3 SPKK Contingent Manufacturing Rights....................................................12
6.3.4 Specifications..........................................................................13
6.3.5 Product Introduction....................................................................13
6.3.6 Commercial Price........................................................................13
6.3.7 Payment.................................................................................13
6.3.8 Minimum Purchase Order..................................................................13
6.3.9 Effect of Improvements..................................................................13
6.3.10 Audit Rights...........................................................................14
6.4. Final Processing of Licensed Products.............................................................14
ARTICLE 7 MARKETING AND SALES OF LICENSED PRODUCTS..............................................................14
7.1. Marketing Coordinators............................................................................14
7.2. Marketing Plan....................................................................................14
7.3. Product Launch....................................................................................14
---------------------------------
*Omitted and filed separately with the Commissioner.
ii
7.4. Marketing of Licensed Products....................................................................14
7.5. Pre-existing Royalties............................................................................15
ARTICLE 8 [INTENTIONALLY OMITTED................................................................................15
ARTICLE 9 REPRESENTATIONS AND WARRANTIES........................................................................15
9.1. Mutual Representations and Warranties.............................................................15
9.1.1 Corporate Power.........................................................................15
9.1.2 Due Authorization.......................................................................15
9.1.3 Binding Agreement.......................................................................15
9.2. Representations and Warranties of SPKK............................................................15
9.3. Representations and Warranties of SciClone........................................................15
ARTICLE 10 CONFIDENTIALITY......................................................................................16
10.1. Confidentiality..................................................................................16
10.2. Exceptions.......................................................................................16
10.3. Authorized Disclosure............................................................................17
10.4. Third Party Beneficiary..........................................................................17
10.5. Press Releases...................................................................................17
10.6. Agreement Confidential...........................................................................17
ARTICLE 11 INTELLECTUAL PROPERTY................................................................................18
11.1. Prosecution and Maintenance of Alpha Patents.....................................................18
11.2. Prosecution and Maintenance of SciClone Patents..................................................18
11.3. Joint Patent Applications or Inventions..........................................................19
11.3.1 Inventions.............................................................................19
11.3.2 Joint Inventions.......................................................................19
11.3.3 Abandonment............................................................................19
11.3.4 No Representation......................................................................19
11.4. Assignments......................................................................................19
11.4.1 Inventions or Program Data.............................................................19
11.4.2 Joint Inventions.......................................................................20
11.5. Patent Marking...................................................................................20
11.6. Enforcement......................................................................................20
11.7. Patent Term Extensions...........................................................................20
11.8. Trademarks.......................................................................................20
11.8.1 Ownership of Marks.....................................................................20
11.8.2 Defense of Marks.......................................................................20
11.8.3 Registration...........................................................................21
ARTICLE 12 TERM; TERMINATION....................................................................................21
12.1. Term.............................................................................................21
12.2. Extension or Renewal; Right to Marks.............................................................21
12.3. Termination by SciClone..........................................................................21
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12.4. Termination by SPKK..............................................................................21
12.4.1 Termination Without Cause..............................................................22
12.4.2 Termination For Breach.................................................................23
12.5. Effect of Termination............................................................................23
12.5.1 Survival...............................................................................23
12.5.2 Data Regulatory Filings................................................................23
12.6. SciClone Retained Rights.........................................................................23
ARTICLE 13 INDEMNIFICATION......................................................................................23
13.1. Indemnification by SPKK..........................................................................24
13.2. Indemnification..................................................................................24
ARTICLE 14 DISCLAIMER OF WARRANTIES; FURTHER ACTION.............................................................24
14.1. Disclaimers......................................................................................24
14.1.1 SciClone Disclaimer....................................................................24
14.1.2 SPKK Disclaimer........................................................................25
14.2. Additional Documents.............................................................................25
ARTICLE 15 DISPUTE RESOLUTION; VENUE AND GOVERNING LAW..........................................................25
15.1. Dispute Resolution...............................................................................25
15.2. Governing Law, Jurisdiction and Venue............................................................25
ARTICLE 16 [INTENTIONALLY OMITTED...............................................................................26
ARTICLE 17 MISCELLANEOUS........................................................................................26
17.1. Agreement Registration...........................................................................26
17.2. Waiver...........................................................................................26
17.3. Assignment.......................................................................................26
17.4. Payments; Reports................................................................................26
17.5. Notices..........................................................................................26
17.6. Headings and Title...............................................................................27
17.7. Amendment........................................................................................27
17.8. Force Majeure....................................................................................27
17.9. Government Approvals.............................................................................28
17.10. Official Language...............................................................................28
17.11. Independent Contractors.........................................................................28
17.12. Severability....................................................................................28
17.13. Cumulative Rights...............................................................................28
17.14. Parties Advised by Counsel......................................................................28
17.15. Entire Agreement................................................................................28
17.16. Future Agreements...............................................................................29
17.17. Counterparts....................................................................................29
iv
THYMOSIN ALPHA I
EXPANDED AND AMENDED LICENSE, DEVELOPMENT
AND SUPPLY AGREEMENT
THIS AGREEMENT (the "Agreement"), signed as of October 28, 1996 (the
"Signing Date") and dated as of January 2, 1993 (the "Effective Date"), is made
by and between SciClone Pharmaceuticals Inc., a California corporation
("SciClone"), and Schering Plough K.K., a Japanese corporation ("SPKK"), with
reference to the following:
BACKGROUND RECITALS
WHEREAS, SciClone has been granted certain license rights with respect
to the development, use, sale and distribution of Thymosin Alpha 1 (or "TA 1,"
as further defined in Exhibit A) by SciClone or its sublicensees, within a
specified territory, including Japan, and the manufacture and supply of TA 1,
pursuant to that certain License and Supply Agreement by and between SciClone
and Alpha 1 Biomedicals, Inc. ("Alpha"), dated as of September 21, 1990, as
amended and restated pursuant to that certain License Agreement between SciClone
and Alpha dated as of August 19, 1994 (collectively, the "Alpha Agreement"); and
WHEREAS, SciClone owns or has rights to certain patents and patent
applications relating to methods of treatment using TA 1, processes of making TA
1 and TA 1 composition of matter; and
WHEREAS, SciClone's business strategy is to sublicense certain of the
rights it possesses with respect to TA 1 to third parties for the development,
distribution and sale of TA 1 within SciClone's licensed territory, including
Japan; and
WHEREAS, SPKK possesses significant scientific, business and marketing
expertise and capabilities with respect to the research, development and
commercialization of human pharmaceutical products in Japan, including products
for the treatment of hepatitis in humans; and
WHEREAS, SciClone and SPKK desire to expand and amend their long term,
cooperative licensing and supply agreement, dated as of January 2, 1993, for the
development and marketing of products incorporating TA 1 in Japan; and this
Agreement supersedes and replaces said 1993 agreement in its entirety.
NOW, THEREFORE, in consideration of the foregoing premises and the
covenants and obligations set forth in this Agreement, the parties hereby agree
as follows:
1
ARTICLE 1
DEFINITIONS
The capitalized terms used herein but not separately defined herein
shall have the meanings set forth in Exhibit A hereto.
ARTICLE 2
GRANT OF RIGHTSARTICLE 2 GRANT OF RIGHTS
2.1. License Grants.
2.1.1 Alpha Technology and SciClone Technology. Subject to
the terms of this Agreement, SciClone hereby grants to SPKK a right and license
to practice and use the Alpha Technology and the SciClone Technology in the
Field and in the SPKK Territory, (i) to use, test, evaluate and develop TA 1,
and (ii) to use, perform Final Processing of, sell and distribute Licensed
Products.
2.1.2 SciClone Sublicensee Technology. Subject to the
terms of this Agreement, SciClone hereby grants to SPKK a right and license to
practice and use the SciClone Sublicensee Technology in the SPKK Territory and
in the Field, (i) to use, test, evaluate and develop TA 1, and (ii) to use,
perform Final Processing of, sell and distribute Licensed Products.
2.1.3 Alpha Sublicensee Technology. Subject to the terms
of this Agreement, SciClone hereby grants to SPKK a right and license to
practice and use the Alpha Sublicensee Technology in the SPKK Territory and in
the Field, (i) to use, test, evaluate and develop TA 1, and (ii) to use, perform
(or have performed) Final Processing of, sell and distribute Licensed Products.
2.1.4 SciClone Inventions: Joint Inventions. Subject to
the terms of this Agreement, SciClone hereby grants to SPKK a right and license
to practice and use SciClone Inventions and Joint Inventions (as defined in
Article 4) in the SPKK Territory and in the Field, in the course of testing,
evaluating and developing TA 1 or using, performing (or having performed) Final
Processing and all other activities necessary for the promoting, marketing,
distributing and selling of Licensed Products.
2.1.5 Trademarks. Subject to the terms of this Agreement,
SciClone hereby grants to SPKK a royalty free right and license to use the Marks
in the SPKK Territory in connection with SPKK's development, testing,
evaluating, using, promoting, marketing, distributing and selling of Licensed
Products pursuant to Article 7.
2.2. License Grant Limitations.
2.2.1 Exclusivity. Except as otherwise expressly set forth
in this Agreement, the rights and licenses granted pursuant to Section 2.1 shall
be exclusive, even as to SciClone in the SPKK Territory.
2
2.2.2 Prior Licensors. SPKK acknowledges and understands
that the Alpha Technology is licensed to SciClone by Alpha pursuant to the Alpha
Agreement, and accordingly, that the rights to the Alpha Technology granted to
SPKK hereunder are subject to the terms and conditions of the Alpha Agreement,
including the retention of certain rights retained by Roche pursuant to the
Roche Agreement and by the Universities pursuant to the Universities Agreement.
SPKK further acknowledges that in no event shall the license grant contained in
Section 2.1.1 with respect to the Alpha Technology be construed as conferring
upon SPKK any greater rights than are conferred upon SciClone by Alpha under the
Alpha Agreement.
2.2.3 Manufacturing Rights. Excepting only as to the
extent specified in Section 6.3.3 of this Agreement, no rights are granted to
SPKK to make, have made or manufacture TA 1 Material. The parties acknowledge
that Final Processing by SPKK is permitted and licensed pursuant to this
Agreement, and Final Processing is not deemed to be an unlicensed manufacturing
activity.
2.2.4 Trademarks. During the term of this Agreement,
SciClone reserves the right to use the Marks worldwide in trade shows,
scientific presentations, marketing presentations, general global advertising
campaigns, and other circumstances to support and benefit the identity and
marketing of Licensed Products.
2.2.5 Development Program. As specified in Article 3 of
this Agreement, SciClone (or its permitted designee) is to participate in the
Development Program in Japan, and SciClone therefore reserves the non-exclusive
right in Japan to use any and all of the Alpha Technology, SciClone Technology,
SciClone Sublicensee Technology, Alpha Sublicensee Technology, SciClone
Inventions and Joint Inventions, but only to the extent it may be necessary to
enable SciClone (or its permitted designee) to perform the obligations imposed
on SciClone under Article 3 of this Agreement for completing the Development
Program in Japan.
2.3. Sublicensing.
2.3.1 Co Marketing or Co Promotion Partner. Subject to
obtaining consent from SciClone as set forth herein, SPKK shall have the right,
in the SPKK Territory, (i) to enter into a Co Promotion or Co Marketing
arrangement with any third party with respect to the sale and distribution of
Licensed Products and to sublicense the rights granted pursuant to Section 2.1
to the extent necessary to effectuate such arrangement; and (ii) to sublicense
any of the rights granted herein to any third party, with respect to any or all
Licensed Products for any or all indications; provided, however, that SPKK shall
give SciClone written notice of any such proposed Co Marketing or Co Promotion
partner, or of any such sublicense, [*REDACTED]
2.3.2 Subcontracting. SPKK shall have the right to
sublicense the rights granted in Sections 2.1.1(i), 2.1.2(i), 2.1.3(i), 2.1.4
and 2.1.5 to third parties for the purpose of subcontracting all or part of the
commercial development, evaluation, testing and Final Processing of TA 1, and to
sublicense the rights granted in Section 2.1.1(ii), 2.1.2(ii), 2.1.3(ii), 2.1.4
and
----------------------
*Omitted and filed separately with the Commissioner.
3
2.1.5 to the extent necessary to allow distributors, wholesalers and similar
entities to market and sell Licensed Products and to allow end users to use
Licensed Products.
2.3.3 Additional Indications. Pursuant to the Development
Program described in Exhibit D hereto, SPKK and SciClone are pursuing
development efforts for CHB and CHC indications. While SPKK is still pursuing
development and/or commercialization of either CHB or CHC, if SciClone presents
to SPKK all data then available to SciClone as to the use of the Alpha
Technology and/or the SciClone Technology to reasonably support an additional
indication within the Field in the SPKK Territory, then SPKK shall decide within
one hundred twenty (120) days if SPKK wants to add to the Development Program
the development work for said additional indication; and if SPKK decides not to
so add said additional indication, then SPKK and SciClone shall consider the
suitability and desirability of a sublicense arrangement for the development and
commercialization of the Alpha Technology and/or the SciClone Technology for
said indication in the SPKK Territory, taking into account the business needs of
each party and to the extent practicable fully protecting SPKK's market for all
Licensed Products, and SciClone shall not grant any such sublicense rights for
said additional indications without SPKK's prior written consent, which consent
may be withheld in SPKK's sole discretion.
2.4. Transfer of Technology
Following the Effective Date and through the term of this Agreement,
SciClone shall make available to SPKK all Alpha Technical Information, SciClone
Technical Information, Alpha Improvements, Alpha Sublicensee Technology and
SciClone Sublicensee Technology in SciClone's possession, subject to the terms
of this Agreement.
ARTICLE 3
DEVELOPMENT PROGRAMARTICLE 3 DEVELOPMENT PROGRAM
3.1. Coordination of the Development Program.
3.1.1 Development Coordinators. To facilitate and
coordinate the relationship of SciClone and SPKK with regard to the development
work to be performed hereunder by SPKK and SciClone (the "Development Program",
set forth in Exhibit D), SPKK and SciClone shall each appoint one (1) authorized
representative (hereafter "Development Coordinators"). Except as otherwise
agreed by the parties in writing, or as set forth in Section 7.1 hereof, all
communications between the parties shall be made through the Development
Coordinators. The Development Coordinators shall determine mechanisms required
for the exchange of technical, business and regulatory information with respect
to the Development Program, to the extent not fully set forth herein. From time
to time as appropriate, the Development Coordinators may also determine and add
to the Development Program (Exhibit D) by mutual agreement in writing the
further implementing details, projects and tasks necessary to complete the
development and to obtain the required regulatory approvals for sale and use of
the Licensed Products in Japan. If the Development Coordinators deadlock for at
least sixty (60) days on reaching a decision as to such implementing details,
projects or tasks, then the subject of the deadlock shall be referred to the
Chief Executive Officers of the parties (or their designees) for an additional
sixty (60) days of
4
negotiations, and if the deadlock is still not then resolved, the deadlock shall
be resolved by binding arbitration in accordance with the provisions set forth
in Exhibit J hereto.
3.1.2 Meetings of Coordinators. The Development
Coordinators or such other representatives of the parties as are agreed shall
meet in person (or by telephone if mutually agreed) as needed, but no less than
once a month for one year after the Signing Date, and once every three (3)
months thereafter, unless mutually agreed otherwise. Such meetings shall
alternate between Japan and California except as otherwise agreed by the
Development Coordinators. At such meetings, among other things, the parties will
review the objectives (including the development of Licensed Products for
indications other than CHC and CHB if mutually approved in writing by both
parties), review funding requirements, protocols or procedures of or used in the
Development Program, will discuss any additional objectives or funding
requirements necessary for the implementation of the Development Program and
commercialization of Licensed Products, and determine the occurrence of the
milestone events described in Sections 5.1 and 5.2. SPKK (and to the extent
applicable, SciClone) shall present an evaluation of the status of the
Development Program at such meetings. Such meetings shall be in English, and at
such times and places (alternating between Japan and California) as are agreed
to by the parties and shall be conducted in person (or by telephone, facsimile
or in any other manner as the parties shall agree). At such meeting, SPKK and
SciClone shall each give their evaluation as to the progress of the implementing
work for the Development Program, and SPKK and SciClone shall respond to each
other's questions concerning the progress of the Development Program.
3.1.3 Shared Reports. Subject to the confidentiality
provisions of Article 10, the parties shall freely share copies of technical
reports and other written documentation, in Japanese, with English summaries at
SPKK's expense, and make such oral presentations as may be necessary to fully
evaluate the progress of the Development Program.
3.1.4 Travel Costs. The costs for travel and lodging to
attend all meetings, including pursuant to Sections 3.1 and 7.1, shall be borne
by the traveling party.
3.2. Visits to Facilities Representatives of SciClone may, upon
reasonable request and notice and at times and intervals reasonably acceptable
to SPKK, (i) visit SPKK's or its sublicensee's facilities where the Development
Program is being conducted, and (ii) in conjunction with SPKK's Development
Coordinator, consult informally with personnel of SPKK conducting the
Development Program during such visits, by telephone, facsimile transmission or
such other manner as the parties shall agree.
3.3. Development Obligations of SPKK.
3.3.1 SPKK Commitment Conditioned upon the availability to
SPKK of necessary TA 1 Material, SPKK hereby commits to use diligent efforts and
to work diligently with SciClone (or its designee), consistent with accepted
business practices and legal requirements in Japan, to develop Licensed Products
for CHB and CHC in the SPKK Territory as set forth herein and in Exhibit D
hereto and as the Development Program is supplemented in the future as specified
in Section 3.1.1 hereof; provided, however, that where SPKK can demonstrate to
5
SciClone's reasonable satisfaction that sound medical and scientific grounds
exist for SPKK not to complete such development of any such Licensed Product(s),
SPKK shall not be so obligated; and provided further, [*REDACTED] SPKK agrees to
provide scientific, technical, clinical and regulatory personnel, equipment,
time and resources to the development of Licensed Products sufficient to meet
its obligations hereunder. Further, SPKK agrees to communicate promptly to
SciClone the progress and status of said development activities.
3.3.2 Phase II Efficacy Trials. The parties acknowledge
and understand that SPKK initiated development efforts with respect to TA 1 in
CHB prior to the Signing Date, and has nearly completed a Phase II efficacy
clinical trial for CHB. SPKK agrees to use diligent efforts [*REDACTED] for CHC
as set forth in the Development Program in Exhibit D.
3.3.3 Chief Investigators; Study Centers. For any multi
center Phase II and Phase III clinical trials which may be agreed upon by the
parties hereto, one or more chief investigators shall be selected [*REDACTED] as
well as the identity of such centers.
3.3.4 Intentionally Omitted.
3.3.5 Development Reports; Notices. SPKK will prepare and
deliver to SciClone, in English, beginning January 30, 1997, and on or before
January 30 of each year thereafter, an annual development plan for TA 1 in CHC
and CHB and such other indications as are agreed upon by the parties, as well as
quarterly progress reports within thirty (30) days after the end of each
calendar quarter. SPKK shall notify SciClone upon the conclusion of each phase
of clinical trials with respect to a given indication.
3.3.6 Trademarks. Except as otherwise agreed in writing,
SPKK agrees and acknowledges that SPKK and its permitted sublicensees shall use
only the Marks and no other trademarks in connection with the development and
testing of Licensed Products.
3.4. Development Obligations of SciClone.
3.4.1 Supply of TA 1 For Development Purposes. SciClone
agrees to supply SPKK with its requirements for TA 1 Material for SPKK's
development efforts [*REDACTED] in accordance with Section 6.2.
3.4.2 Technical Assistance. SciClone shall provide
technical assistance as requested by SPKK, as agreed upon by the parties and
subject to reasonable availability of resources. SPKK and SciClone shall
[*REDACTED] incurred by SciClone after the Signing Date in supplying such
technical assistance. SciClone agrees and acknowledges that the costs associated
with SciClone's attendance at all other meetings which take place, including,
without limitation, pursuant to Sections 3.1 and 7.1 hereof, shall not be the
responsibility of SPKK, but shall be borne by SciClone.
3.4.3 Development Efforts. SciClone (or its designee)
shall work diligently with SPKK, consistent with the terms of this Agreement and
with accepted business practices and legal
----------------------
*Omitted and filed separately with the Commissioner.
6
requirements in Japan, to develop Licensed Products, and agrees to provide
scientific, technical, clinical and regulatory personnel, time and resources
sufficient to meet its obligations hereunder.
3.5. Regulatory Matters.
3.5.1 Compliance with Regulations. Both parties hereto
shall conduct their efforts hereunder in compliance with all applicable GLPs,
GMPs and GCPs and other applicable regulatory requirements.
3.5.2 Regulatory Filings. SPKK shall prepare and file, and
shall be the owner of all filings with the MHW and any other Japanese regulatory
authorities with respect to the Licensed Products (the "Regulatory Filings"),
and SPKK shall be responsible for processing such applications through the
approval process; provided, however, that, to the extent permitted under
Japanese law and regulations, both SPKK and SciClone (or its designee) shall be
co-parties of record with the MHW for all such Regulatory Filings. SciClone
shall have rights of consultation with SPKK personnel responsible for Regulatory
Filings with respect to the preparation and submission of such Regulatory
Filings, and SciClone shall cooperate with SPKK in such manner as SPKK may
reasonably request to assist in obtaining regulatory approval for such Licensed
Products or Improvements. SPKK shall promptly deliver to SciClone copies, in
Japanese, of all Regulatory Filings and correspondence with the Japanese
regulatory authorities related thereto, and summaries of all such Regulatory
Filings and correspondence, in English, [*REDACTED]. SPKK shall deliver English
language translations of significant and relevant portions of any Regulatory
Filings and correspondence at which SciClone may reasonably require in
connection with its rights or obligations in Japan under this Agreement, at the
joint and equal expense of SPKK and SciClone.
3.5.3 Adverse Events. The parties shall advise each other
of any Adverse Event to the use of TA 1, either as a result of its development
efforts hereunder, or otherwise, as set forth in Exhibit E hereto.
3.5.4 Maintenance of Records. SPKK shall maintain records
with respect to the Program Data in sufficient detail and in good scientific
manner appropriate for Japanese regulatory approval purposes and as will reflect
all studies conducted and results achieved by SPKK in the course of the
Development Program.
3.6. [*REDACTED]
3.7. Third Party Contracts. As to any contract for work to be performed
by third parties [*REDACTED], said contract shall be submitted to both parties
(in an English translation) for review, comment and approval prior to a party
entering into the contract, which approval shall not be withheld or delayed
unreasonably.
3.8. Co-Developer Status. Notwithstanding SPKK's ownership interests,
to the extent permitted by applicable Japanese law or regulations, it is the
intention and agreement of the
----------------------
*Omitted and filed separately with the Commissioner.
7
parties that SciClone (or its designee) and SPKK shall be co developers and co
parties of record for the Program Data, the Regulatory Filings, and any
applicable governmental approvals or licenses for the manufacture, use and/or
sale of Licensed Products in Japan. To the extent that applicable Japanese law
or regulation permits such co developer status or co parties of record status
only through some special arrangement or mechanism (such as SciClone using an in
country caretaker or CRO agent, or SciClone or its designee performing at least
10% of the work, or SciClone assigning or sublicensing certain obligations to a
designee, or some other arrangement), then SciClone may implement such an
arrangement or mechanism, notwithstanding anything to the contrary contained
elsewhere in this Agreement. The intention and effect of said co developer
status or co parties of record status is to enable SciClone (or its designee) to
be in a position, immediately upon any termination of SPKK's exclusive license
rights under this Agreement, to market and sell Licensed Products in Japan
without any delay.
ARTICLE 4
PROGRAM DATA; IMPROVEMENTS AND INVENTIONS
4.1. Program Data Rights and Licenses All right, title and interest in
and to the Program Data shall reside solely with SPKK; provided, however, that
SPKK hereby grants to SciClone:
(a) an exclusive, even as to SPKK, royalty free, perpetual
license, with the right to sublicense to the SciClone Sublicensees, to use such
Program Data within the SciClone Territory solely for SciClone's development,
marketing and sale of TA 1 products in the SciClone Territory, including
marketing activities and governmental filings for regulatory approvals and
patent filing, prosecution and maintenance;
(b) a perpetual, exclusive (even as to SPKK) license to
use such Program Data outside the SPKK Territory and the SciClone Territory
solely for the development, marketing and sale of TA 1 products, with the right
to sublicense to Alpha, the Alpha Sublicensees and Roche, subject to the
negotiation in good faith of the consideration for such sublicense (whether in
the form of royalties or license fees) by SciClone and SPKK, at the time of any
such sublicense grant, based upon the commercial value of such Program Data and
SPKK's overall licensing policies; and
(c) with respect to any license granted to SciClone under
Sections 4.1(a) or (b) above which relates to or is derived from Intron A, said
license shall be only to develop (including the governmental filings set forth
in Paragraph 4.1(a) above), market and sell TA-1, and said license is subject to
the consent of SPKK, which consent can be withheld only if SPKK (or any of its
Affiliates) reasonably determines that such license would have a significant
negative impact on the sales of Intron A either in Japan or worldwide.
8
SPKK will make available to SciClone any and all Program Data it
generates or acquires, in its original form, together with an English
translation paid for equally by SPKK and SciClone. The foregoing grants to
SciClone shall not inhibit or otherwise impair rights of SPKK or any of its
Affiliates to use the program data to develop, market, sell and use INTRON-A in
any country in the world.
4.2. Improvements.
4.2.1 Development of Improvements. Subject to and
consistent with the other terms of this Agreement, SPKK and SciClone each agree
to cooperate with respect to Improvements, including expansion of the
indications for TA l, improving TA l's efficacy and enhancing TA l's proprietary
position.
4.2.2 Transfer of Information. SPKK and SciClone shall
each cooperate to fully disclose to the other (but only where such disclosure
would not adversely affect attainment of patent protection), within sixty (60)
days after the Signing Date and on an ongoing basis, any and all Improvements,
including, without limitation, all data, materials, copies of notebooks, know
how, related patent applications and the like related thereto.
4.3. Inventions. Each party acknowledges and agrees that any and all
Inventions arising from any Improvements that are made or discovered pursuant to
this Agreement solely by its employees or agents shall be owned solely by it
(the "SPKK Inventions" or the "SciClone Inventions" as the case may be) and that
any and all Inventions made jointly by employees or agents of each pursuant to
this Agreement shall be jointly owned ("Joint Inventions"), all as determined in
accordance with U.S. laws of inventorship; provided, however, that in the event
of any conflict between U.S. law and the applicable laws of Japan which arises
in the course of the prosecution in Japan of any patent application on any SPKK
Invention or Joint Invention, the applicable laws of Japan shall control.
Notwithstanding the foregoing, with respect to Japan, any Inventions arising
from Improvements made or discovered pursuant to this Agreement relating to or
derived from Intron A or treatment, alone or in combination with other
pharmaceutical compositions, with Intron A, shall be solely owned by SPKK,
provided, however, said ownership by SPKK is not necessarily indicative of, or
is to be construed as an admission as to, inventorship or priority of
inventorship of any invention, including without limitation, existing patents
and pending patent applications worldwide to which SciClone has rights.
4.4. License to SPKK Inventions and Joint Inventions.
(a) Subject to the terms and conditions of this Agreement,
including, in particular, Sections 4.4(b) and 6.3.9, SPKK hereby grants to
SciClone:
(i) an exclusive, even as to SPKK, royalty free,
perpetual license to practice and use the SPKK Inventions and the Joint
Inventions, within the SciClone Territory, with the right to sublicense to the
SciClone Sublicensees which use shall include, without limitation, marketing
activities and governmental filings for regulatory approvals and patent filing,
prosecution and maintenance, for SciClone's development and marketing of TA 1
products in the SciClone Territory; and
9
(ii) a perpetual, non exclusive license to practice
and use the SPKK Inventions and the Joint Inventions, outside the SPKK Territory
and the SciClone Territory, with the right to sublicense to Alpha, the Alpha
Sublicensees and Roche.
The foregoing grants to SciClone shall not inhibit or otherwise impair
the rights of SPKK or any of its Affiliates to use SPKK inventions and/or the
Joint Inventions to develop, market, sell and use INTRON-A in any country in the
world. As to any sublicenses granted after the Signing Date under subparagraphs
(i) or (ii) above, SciClone shall diligently seek to obtain fair and reasonable
compensation for the granting of such sublicenses, and shall share with SPKK a
fair and reasonable portion of any compensation which SciClone receives from any
such sublicensee, [*REDACTED] and a reasonable portion of any other non-royalty
consideration received by SciClone from such sublicensee. SciClone and SPKK
shall negotiate in good faith to determine the reasonable portion of said
consideration to be paid to SPKK, based upon, and taking into full account, all
relevant legal and factual matters, considerations, and relative contributions
related to the sublicense transaction. If the parties are unable to reach
agreement as to the proportion to be paid by SciClone to SPKK, then said portion
shall be determined pursuant to the dispute resolution provisions set forth in
Article 15 of this Agreement.
The parties acknowledge that the rights granted in clause (ii) above
have been extensively negotiated, reflect SPKK's expressed concern that the SPKK
Inventions and the Joint Inventions not flow into the hands of its competitors
or potential competitors without compensation, and reflect SciClone's
commercially reasonable efforts to obtain for Alpha, Roche and the Alpha
Sublicensees rights to the SPKK Inventions and the Joint Inventions in
accordance with the Alpha Agreement.
(b) With respect to any license granted to SciClone under
Section 4.4 (a) above which relates to or is derived from Intron A, said license
shall be only to develop, market and sell TA-1, and said license is subject to
the consent of SPKK, which consent can be withheld only if SPKK (or any of its
Affiliates) reasonably determines that such license would have a significant
negative impact on the sales of Intron A either in Japan or worldwide.
ARTICLE 5
LICENSE PAYMENTS
5.1. Milestone Payment for CHB. Except as provided in Section 5.3, SPKK
shall make to SciClone the following non refundable CHB milestone payment
[*REDACTED].
5.2. Milestone Payment for CHC. Except as provided in section 5.3, SPKK
shall make to SciClone the following non refundable CHC milestone payment
[*REDACTED].
5.3. Waiver of Certain Milestone Payments. In the event SPKK is
successful in obtaining an extension to Japanese Patent No. [*REDACTED],
contained in the Alpha Patents (whether by actions relating solely to such
patent or by more general lobbying efforts with respect
----------------------
*Omitted and filed separately with the Commissioner.
10
to changes in Japanese patent law), [*REDACTED]. SPKK acknowledges and agrees
that in the event such an extension is obtained primarily for reasons unrelated
to actions on the part of SPKK, the waiver set forth above shall not apply.
ARTICLE 6
SUPPLY OF TA-1 MATERIAL AND MANUFACTURE OF LICENSED PRODUCTS
6.1. Manufacture and Supply of TA 1 Material. SciClone warrants and
represents that as of the Signing Date it has the right under the terms of the
Alpha Agreement (as amended) to make, manufacture, synthesize or otherwise
produce or have made, manufactured, synthesized or otherwise produced TA 1
Material.
6.2. Clinical Supply. SciClone shall use diligent efforts to cause to
be supplied to SPKK, [*REDACTED] such amounts of TA-1 Material necessary to
conduct preclinical and clinical studies pursuant to the Development Program and
to obtain regulatory approval for Licensed Products. SPKK will provide SciClone
with rolling six (6) month forecasts of its clinical requirements for TA-1
Material on a quarterly basis, beginning within thirty (30) days after the
Signing Date.
6.3. Commercial Supply.
6.3.1 Commercial Supply Agreement. SciClone agrees that it
will use diligent efforts for it or its designated Affiliate to manufacture and
sell, and SPKK will purchase from SciClone or SciClone's designated Affiliate,
all of SPKK's reasonable commercial requirements of (i) TA 1 Material; and (ii)
in the event that SPKK notifies SciClone that it is unable to perform all
aspects of the Final Processing of TA 1 Material to produce Licensed Products,
such other unfinished materials prepared from TA 1 Material (e.g., lyophilized
TA 1 Material) as to enable SPKK to produce Licensed Products, regardless of the
number of filed NDA(s) and marketing methods used for Licensed Products. Such
supply shall be pursuant to a commercial supply agreement to be negotiated in
good faith between the parties, which agreement adequately reflects both SPKK's
needs for TA 1 Material and SciClone's available resources and commitments (the
"Commercial Supply Agreement"). Negotiation for said Commercial Supply Agreement
shall be commenced within thirty (30) days after, and shall be completed within
twelve (12) months after, the filing of the first NDA with respect to a Licensed
Product. Such Commercial Supply Agreement will incorporate those terms
substantially as set forth below with respect to commercial supply of TA 1
Material and other unfinished material to be supplied by SciClone, if any, as
well as certain additional terms related to ordering and delivery of TA 1
Material and other unfinished material to be supplied by SciClone, if any,
forecasts, compliance with specifications, and inspection, acceptance, and
return of TA 1 Material and other unfinished material to be supplied by
SciClone, if any, as outlined in Exhibit H, and other provisions customary to
this kind of contract in the pharmaceutical industry.
----------------------
*Omitted and filed separately with the Commissioner.
11
6.3.2 Cutbacks in Supply. In the event SciClone is unable
to supply, or cause to be supplied, to SPKK and the SciClone Sublicensees all of
each of their reasonable commercial requirements of TA 1 Material, SciClone
shall decrease the amount to be supplied to each SciClone Sublicensee and SPKK
proportionately according to the prior sales of each of them.
6.3.3 SPKK Contingent Manufacturing Rights. Subject to the
terms of the Alpha Agreement, and to the terms of this Agreement, SciClone
hereby grants to SPKK a sublicense of its rights under the Alpha Agreement to
make, manufacture, synthesize or otherwise produce or have made, manufactured,
synthesized or otherwise produced, SPKK's commercial requirements of TA 1
Material, which sublicense shall become effective if and only if:
(i) either:
(a) SciClone determines that it is not reasonably able to
supply, or arrange to supply, all of SPKK's reasonable commercial requirements
of TA 1 Material; or
(b) SciClone is unable to supply SPKK's reasonable
commercial requirements of TA 1 Material in such amounts and for such period of
time as is agreed upon by the parties at the time of negotiation of, and as set
forth in, the Commercial Supply Agreement; or
(c) SciClone and SPKK have reasonably agreed such
sublicense shall become effective; and
(i) the parties have agreed, pursuant to good
faith negotiations, to a mechanism (including the royalty payable to SciClone as
set forth in Section 6.3.6 hereof) for minimizing any adverse financial effects
to either party that may result from the cessation of supply of TA 1 Material by
SciClone and the conferral of such contingent manufacturing rights upon SPKK;
and
(ii) SciClone shall be permitted to resume being
the exclusive manufacturer and supplier of TA 1 Material as soon as is
reasonably feasible, subject to: (i) reasonable and appropriate arrangements
being made to enable SPKK to recover or amortize its start up costs (including
without limitation the costs of additional clinical or other trials)incurred to
replace on a temporary basis SciClone as the manufacturer and supplier of the TA
1 Material; and (ii) the requirements of Japanese law or regulations.
6.3.4 Specifications. All TA 1 Material manufactured and
supplied hereunder shall be manufactured in conformity with the Specifications
and in compliance with applicable Japanese rules and regulations, including
cGMPs. The parties understand and agree that the Specifications may be revised
or supplemented from time to time and as agreed by the parties, or in order to
comply with government regulations or to take into account Improvements, Alpha
Improvements, Alpha Sublicensee Improvements and SciClone Sublicensee
Improvements, where and to the extent the same has been licensed to the party
then manufacturing TA 1 Material.
6.3.5 Product Introduction. During the first six (6)
months after the first public announcement of the introduction of a Licensed
Product for commercial use, SPKK shall
12
purchase from SciClone TA 1 Material to be used for marketing and promotion of
such Licensed Product[*REDACTED] and in such amounts and at such prices as are
set forth in the Commercial Supply Agreement.
6.3.6 Commercial Price. [*REDACTED] SPKK shall use good
faith and commercially reasonable efforts to obtain from MHW the most favorable
price for Licensed Products and SPKK shall consult with SciClone and keep
SciClone fully informed concerning these efforts with MHW. [*REDACTED]
6.3.7 Payment. Payment for commercial requirements of TA
1 Material ordered hereunder shall be made in accordance with the terms of the
Commercial Supply Agreement.
6.3.8 Minimum Purchase Order. SPKK acknowledges and
agrees that during the term of this Agreement it shall be obligated to purchase
from SciClone such quantities of TA 1 Material as are consistent with
commercially reasonable efforts to market and sell Licensed Products. The
Commercial Supply Agreement for each Licensed Product shall set forth SPKK's
estimated purchase requirements for TA 1 Material for [*REDACTED]. During the
term of the Commercial Supply Agreement SPKK will, at least [*REDACTED] prior to
the beginning of each calendar quarter prepare and provide to SciClone rolling
estimated purchase requirements for TA 1 Material for [*REDACTED] period
beginning on the first day of the quarter [*REDACTED]. Estimated purchase
requirements will be based on past sales and future sales forecasts generated by
SPKK for Licensed Products. Each of SPKK and SciClone acknowledge and agree that
for each such estimate the [*REDACTED] purchase requirements set forth therein
shall be binding on both parties, and that the remainder of such estimates shall
be non binding and are provided for information purposes only.
6.3.9 Effect of Improvements. The parties agree that in
the event any Improvement, Alpha Improvement, SciClone Sublicensee Improvement
or Alpha Sublicensee Improvement has the effect of reducing the cost of
processing, manufacturing or producing TA-1 Material, the parties shall
negotiate a new Commercial Price so as to ensure, so far as is practicable, that
the parties share equally in the economic benefit of such Improvement.
6.3.10 Audit Rights. SciClone and SPKK each agree to keep
proper records and books of account and all proper entries therein relating to
the manufacture, supply and Final Processing of Licensed Products. Either party
may cause an audit to be made of the applicable records of the other party in
order to verify any price, costs or statements rendered hereunder, at the
auditing party's expense.
6.4. Final Processing of Licensed Products SPKK will be responsible for
and assume all costs associated with Final Processing, quality control, and
storage of Licensed Products. [*REDACTED]
----------------------
*Omitted and filed separately with the Commissioner.
13
ARTICLE 7
MARKETING AND SALES OF LICENSED PRODUCTS
7.1. Marketing Coordinators. No later than six months before the
estimated date of first commercial sale of the first Licensed Product hereunder,
the parties shall each appoint one authorized representative (hereinafter
"Marketing Coordinator") for the exchange of all communications related to the
promotion and marketing of Licensed Products in the SPKK Territory. To
facilitate the commercialization of each Licensed Product in the SPKK Territory,
the Marketing Coordinators, or such other representatives of the parties as are
agreed, shall meet as needed, but no less than once every six (6) months. Such
meetings shall be at times and places agreed to by SPKK and SciClone. At such
meetings the parties will review the Budget, discuss the Marketing Plan,
coordinate the marketing objectives therein, set priorities thereunder, discuss
and define the Specifications and quality control of Licensed Products. SciClone
agrees that final decisions as to the promotion and marketing of Licensed
Products shall be made by SPKK, after giving due consideration to SciClone's
input.
7.2. Marketing Plan. SPKK will prepare and deliver to SciClone
[*REDACTED] a marketing plan for each of the Licensed Products (the "Marketing
Plan").
7.3. Product Launch. Upon gaining the necessary regulatory, pricing and
reimbursement approvals, SPKK agrees to work diligently, consistent with
accepted business practices and legal requirements, to launch, promote, and
commercialize each Licensed Product, devoting a comparable degree of attention
and diligence to such promotion efforts as it devotes to the promotion of its
other pharmaceutical products of comparable market potential.
7.4. Marketing of Licensed Products. SPKK agrees and acknowledges that
as a condition to the license rights contained in this Agreement, SPKK and its
permitted sublicensees shall use only the Marks in connection with the sale or
advertising of Licensed Products, provided, however, that where SPKK offers good
cause as to why a ▇▇▇▇ is unsuitable for commercialization of Licensed Products
in the SPKK Territory, SciClone shall file for and maintain, at its expense,
during the term of this Agreement, variations on any ▇▇▇▇ [*REDACTED] to ensure
the optimal trademark for the SPKK Territory. SPKK and SciClone will discuss and
decide jointly prior to filing of the initial NDA with respect to a Licensed
Product whether it is most advantageous to the parties to market Licensed
Products under a single or multiple ▇▇▇▇.
7.5. Pre-existing Royalties. SPKK, or its designee, shall pay directly
to such third parties all royalties due to third parties on SPKK's Net Sales of
Licensed Products, including those due to the Universities, Roche and Alpha
pursuant to the Alpha Agreement, as set forth in Exhibit I; provided,
[*REDACTED] of SPKK's Net Sales in any calendar year; and provided, further,
that in the event any such third party royalty shall expire or decline, SPKK's
obligation hereunder shall be adjusted accordingly.
----------------------
*Omitted and filed separately with the Commissioner.
14
ARTICLE 8
[INTENTIONALLY OMITTED]
ARTICLE 9
REPRESENTATIONS AND WARRANTIES
9.1. Mutual Representations and Warranties. Each party hereby
represents and warrants:
9.1.1 Corporate Power. Such party is duly organized and
validly existing under the laws of the state or country of its incorporation and
has full corporate power and authority to enter into this Agreement and to carry
out the provisions hereof.
9.1.2 Due Authorization. Such party is duly authorized to
execute and deliver this Agreement and to perform its obligations hereunder.
9.1.3 Binding Agreement. This Agreement is a legal and
valid obligation binding upon it and enforceable in accordance with its terms.
The execution, delivery and performance of this Agreement by such party does not
conflict with any agreement, instrument or understanding, oral or written, to
which it is a party or by which it may be bound, nor violate any law or
regulation of any court, governmental body or administrative or other agency
having jurisdiction over it.
9.2. Representations and Warranties of SPKK. SPKK represents and
warrants that it has had the opportunity to fully review, and has finally
reviewed the Alpha Agreement and the Prior Agreements and understands the terms
and conditions stated therein.
9.3. Representations and Warranties of SciClone. SciClone represents
and warrants that it will use its best efforts to comply with the Alpha
Agreement to the extent necessary to avoid termination of the rights of SPKK to
develop and commercialize Licensed Products in the SPKK Territory. SciClone
further represents and warrants that to its best knowledge the Marks are valid
and subsisting and that SciClone has received no actual notice that any of the
Marks infringe the rights of any third party.
ARTICLE 10
CONFIDENTIALITY
10.1. Confidentiality. During the term of this Agreement, and
thereafter, each party hereto will maintain in confidence all Confidential
Information disclosed by the other party hereto. Neither party will use,
disclose or grant use of such Confidential Information except as expressly
authorized by this Agreement. To the extent that disclosure is authorized by
this Agreement, the disclosing party will obtain prior written agreement from
its employees, agents, consultants or clinical investigators to whom disclosure
is to be made to hold in confidence and not make use of
15
such information for any purpose other than those permitted by this Agreement.
Each party will use at least the same standard of care as it uses to protect its
own trade secrets or proprietary information to ensure that such employees,
agents, consultants and clinical investigators do not disclose or make any
unauthorized use of such Confidential Information. Each party will promptly
notify the other upon discovery of any unauthorized use or disclosure of the
Confidential Information.
10.2. Exceptions. Confidential Information shall not include any
information which:
(i) was already known to the receiving party,
other than under an obligation of confidentiality to the disclosing party, at
the time of disclosure by the other party;
(ii) was generally available to the public or
otherwise part of the public domain at the time of its disclosure to the other
party;
(iii) becomes generally available to the public
or otherwise part of the public domain after its disclosure other than through
any act or omission of the receiving party in breach of this Agreement;
(iv) was disclosed to the receiving party, other
than under an obligation of confidentiality, by a Third Party who had no
obligation to the other party not to disclose such information to others;
(v) is required to be disclosed in a judicial or
administrative proceeding after all reasonable legal remedies for maintaining
such information in confidence have been exhausted; or
(vi) is subsequently and independently developed
by employees, consultants or agents of the disclosing party without the aid,
application or use of any Confidential Information.
10.3. Authorized Disclosure. Each party may disclose the Confidential
Information to the extent such disclosure is reasonably necessary in filing or
prosecuting patent applications, prosecuting or defending litigation or
complying with applicable governmental regulations, provided that if such party
is required to make any such disclosure of the Confidential Information it will
to the extent practicable give reasonable advance notice to the other party of
such disclosure requirement and, except to the extent inappropriate in the case
of patent applications, will use its best efforts to secure confidential
treatment of such information required to be disclosed. To the extent necessary
to perform its obligations under this Agreement, SPKK may disclose (subject to
the confidentiality restrictions contained herein) Confidential Information to
investigators and third party contractors, such as potential lyophilization
contractors, or suppliers of materials required for lyophilization and finishing
of TA l Material for preclinical and clinical studies (provided such
investigators and third parties execute confidentiality agreements containing
terms no less strict than those contained herein).
10.4. Third Party Beneficiary. The parties agree that Alpha is a third
party beneficiary of this Agreement, but only as it relates to "Confidential
Information" as defined under the Alpha
16
Agreement, and that Alpha is entitled to enforce each and every provision of
this Agreement pertaining to such "Confidential Information" as if it were a
party hereto.
10.5. Press Releases. Prior to the Signing Date, SciClone has furnished
to SPKK a form of press release which SciClone is required by law to make with
respect to this Agreement, which press release has been approved by SPKK. Any
additional or subsequent press releases by SciClone or SPKK with respect to this
Agreement or the subject matter hereof, or any right, obligation or development
thereunder (including, without limitation, any result of or development under
the Development Program), shall be subject to the prior review and approval by
the other party, which approval shall not be unreasonably withheld or delayed.
Under no circumstance shall either party hereto quote or speak on behalf of the
other party without the specific written permission of such other party.
Notwithstanding anything to the contrary, if the applicable laws or governmental
regulations obligate a party to issue a press release, the party shall be
entitled to do so, although the party first shall use good faith efforts to
submit to the other party a draft of the proposed press release and to give due
consideration to any suggested revisions recommended by the other party.
10.6. Agreement Confidential. The parties agree that the contents of
this Agreement shall constitute Confidential Information, and as such, will not
be disclosed by either party without the prior written consent of the other,
except as required by law or prior contractual obligation, and provided that
such written consent will not be unreasonably delayed or withheld. SPKK
understands and acknowledges that SciClone is obligated to file a copy of this
Agreement with the United States Securities and Exchange Commission, and
SciClone is authorized to do so without prior consent from SPKK. SciClone shall
request the Securities and Exchange Commission to give confidential treatment to
sensitive provisions of this Agreement, and will consult with SPKK concerning
such provisions. The parties agree that information concerning this Agreement
which is made public in accordance with the provisions of Sections 10.5 and 10.6
hereof may be repeated at subsequent times and in subsequent forms without the
need for prior consent from either party.
ARTICLE 11
INTELLECTUAL PROPERTY
11.1. Prosecution and Maintenance of Alpha Patents. The Alpha Patents
shall be prosecuted and maintained by SciClone, Alpha or Roche, as provided
under the Alpha Agreement. In the event SciClone receives notification from
Alpha that it does not choose to continue prosecution of one or more of the
Alpha Patents and is able to transfer such rights to SciClone, SciClone shall
either take such actions as are necessary to prosecute or maintain such patent
application or patent, at its expense, or, where practicable, shall give SPKK
not less than two (2) months' notice before any relevant deadline and SPKK shall
have the right to pursue, at its expense, prosecution of such patent application
or maintain such patent. In such event SciClone shall promptly assign its rights
therein to SPKK, subject to the rights retained by Alpha and Roche pursuant to
Section 10.1 of the Alpha Agreement. The transfer of any patent rights hereunder
shall not effect in any way SPKK's obligations to make all payments set forth in
this Agreement. In the event of termination or expiration of this Agreement
pursuant to Article 12, SPKK shall re
17
assign any such patent or patent application to SciClone upon SciClone's request
and pursuant to Alpha's request of the same from SciClone, to the extent
practicable within thirty (30) days after the date of such termination or
expiration and upon reimbursement by SciClone to SPKK of all costs incurred by
it for the prosecution and maintenance of such patents or patent applications.
11.2. Prosecution and Maintenance of SciClone Patents. SciClone Patents
shall be prosecuted and maintained by SciClone, at its expense; provided, that
in the event SciClone elects not to pursue prosecution of any patent or patent
application contained in the SciClone Patents, SciClone shall give SPKK not less
than two (2) months' notice before any relevant deadline and SPKK shall have the
right to pursue, at its expense, prosecution of such patent application. In such
event SciClone shall promptly assign its rights therein to SPKK. The transfer of
any patent rights hereunder shall not effect in any way SPKK's obligations to
make all payments set forth in this Agreement.
11.3. Joint Patent Applications or Inventions.
11.3.1 Inventions. Each of SciClone and SPKK shall be free
to determine those SciClone Inventions or SPKK Inventions, respectively, upon
which it chooses to file one or more patent applications in accordance herewith.
In the event SciClone or SPKK determines to file a patent application with
respect to any SciClone Invention or SPKK Invention, respectively, that party
shall conduct such patent prosecution process (including interferences and
foreign oppositions) according to its own internal standards so as to most
effectively cover such Invention for use by both SciClone and SPKK. The other
party shall have full rights of consultation with the filing party's counsel and
any outside patent attorney with respect to a patent application on any
Invention. The filing party shall also promptly deliver to the other party
copies of all patent applications, amendments, related correspondence and other
related matters. All expenses associated with the prosecution and maintenance of
all patent applications described herein shall be borne by the filing party.
11.3.2 Joint Inventions. The parties will jointly determine
whether to seek patent protection for any Joint Invention. SciClone shall have
the responsibility for promptly filing patent applications on Joint Inventions.
The expense of preparing, filing, prosecuting and maintaining patent
applications on Joint Inventions shall be borne [*REDACTED]. All such joint
patent applications shall be mutually approved by the parties and filed in the
name of SciClone and SPKK, or their designees, [*REDACTED]. In the event the
parties do not mutually agree to proceed with a patent application on a Joint
Invention, the party wishing to file may do so at its own expense.
11.3.3 Abandonment. In the event either party elects not to
pursue prosecution of a patent application described in Section 11.3.1 or 11.3.2
above (including any foreign counterpart application of a U.S. patent
application filed) or pay any annuity as it becomes due, such party shall give
the other party not less than two (2) months' notice before any relevant
deadline and such other party shall have the right to pursue, at its expense,
prosecution of such
----------------------
*Omitted and filed separately with the Commissioner.
18
patent application. In such event the abandoning party shall promptly assign its
rights therein to the other party.
11.3.4 No Representation. Each party specifically excludes
any representation or warranty, express or implied, that it will successfully
obtain any patent on any Invention or Joint Invention.
11.4. Assignments.
11.4.1 Inventions. or Program Data Each party to which any
portion of the Inventions or Program Data vests other than as intended and set
forth in this Agreement shall, to the extent required by the intent or
provisions herein, immediately assign to the other such right, title, and
interest therein. Each party agrees to cooperate with the other and take all
reasonable additional actions and execute such agreements, instruments, and
documents as may be reasonably required to perfect the other's ownership
interest in accordance with the intent of this Article 11, including, without
limitation, the execution of necessary and appropriate instruments of
assignment.
11.4.2 Joint Inventions. Each party agrees not to assign
any rights to the Joint Inventions (except to its Affiliates) without the prior
written consent of the other party.
11.5. Patent Marking. SPKK shall ▇▇▇▇ all Licensed Products
manufactured, used or sold under the terms of this Agreement, or their
containers, in accordance with the applicable patent marking laws, as required.
11.6. Enforcement. In the event SciClone or SPKK becomes aware of any
actual or threatened infringement or misappropriation of any Alpha Technology,
SciClone Technology, Alpha Sublicensee Technology, SciClone Sublicensee
Technology or Improvements, that party shall promptly notify the other. In the
case of infringement of Alpha Technology, the parties acknowledge that pursuant
to Section 13.2 of the Alpha Agreement, SciClone shall have the first right to
bring an infringement action against the third party infringer. To the extent
allowed under Section 13.2 of the Alpha Agreement, Alpha shall have the right to
bring such an action in the event SciClone elects not to bring such an
infringement action. In the further event that Alpha elects not to pursue such
infringement action, it shall so notify SPKK, in which event SPKK shall have the
right to bring such action, at its own expense, and in accordance with the
requirements of Section 13.2 of the Alpha Agreement.
11.7. Patent Term. Extensions SciClone and SPKK shall reasonably
cooperate to obtain the benefits of any patent term extension which may be
available for any patent subject to this Agreement.
11.8. Trademarks.
11.8.1 Ownership of Marks. SPKK hereby acknowledges
SciClone's ownership of the Marks and covenants that SPKK shall not contest or
challenge, directly or indirectly, the validity of the Marks at any time. Such
Marks shall bear the designation TM or the designation R within a circle, as
specified by SciClone. If SPKK, in the course of marketing and distribution of
19
the Licensed Products, acquires any goodwill or reputation in the Marks, all
such goodwill or reputation shall automatically vest in SciClone upon
termination or expiration of this Agreement, without separate payment or other
consideration to SPKK.
11.8.2 Defense of Marks. In the event SPKK becomes aware of
any actual or threatened infringement of the Marks in the SPKK Territory, SPKK
shall promptly notify SciClone. SPKK shall, at the request and expense of
SciClone, do such acts or things as SciClone may reasonably require for the
purpose of obtaining, maintaining, enforcing and preserving any of the Marks in
the SPKK Territory; provided, however, that SPKK agrees that only SciClone has
the right to enjoin any infringement or registration by a third party of the
Marks; except that, in the event SciClone elects not to seek to enjoin any such
infringement or registration, SPKK shall have the right, at its election and
expense, to do so. SPKK agrees to cooperate fully with SciClone at the expense
of SciClone if SciClone sues to enjoin such infringements or to oppose or
invalidate any such registration.
11.8.3 Registration. SciClone acknowledges and agrees that
within fourteen (14) business days after the Signing Date it shall file this
Agreement with the Japanese Trademark Authorities for the purpose of registering
SPKK therewith as a licensee of the Marks. If any additional filing or
registration is required by applicable Japanese law to so register SPKK as a
licensee of the Marks, SciClone shall do so. Costs for the foregoing shall be
borne by SPKK as specified in Section 17.1 hereof.
ARTICLE 12
TERM; TERMINATION
12.1. Term. The term of this Agreement shall commence upon the
Effective Date and expire upon the last to occur of: (i)) [*REDACTED] or (ii)
[*REDACTED] or (iii) [*REDACTED]. Upon the expiration of this Agreement (as
distinguished from an early termination of this Agreement), SPKK shall enjoy a
non exclusive, royalty free, paid up license to all licenses from SciClone
granted pursuant to this Agreement (including, without limitation, the right to
use the Marks upon expiration), subject to Sections 2.2.2 and 12.2 hereof.
12.2. Extension or Renewal; Right to Marks. Prior to expiration of this
Agreement, SPKK and SciClone shall, where mutually beneficial, negotiate in good
faith to extend or renew this Agreement and/or the Commercial Supply Agreement
with the objective of continuing the relative economic benefits enjoyed by the
parties prior to expiration, but taking into account the expiration of the
relevant patents. In the event this Agreement is terminated by SPKK pursuant to
Section 12.4.2, SPKK shall retain the right and license to use the Marks as
provided for in this Agreement. In the event this Agreement is terminated by
SPKK pursuant to Section 12.4.1 or is terminated by SciClone pursuant to Section
12.3, then SPKK shall not have any further right or license to use the Marks.
----------------------
*Omitted and filed separately with the Commissioner.
20
12.3. Termination by SciClone. SciClone may, in its sole discretion,
terminate this Agreement, effective after the grace periods described below, by
giving written notice of such termination to SPKK, if SPKK fails to comply with
any material obligation of this Agreement, including without limitation, failure
of SPKK to perform any of its material development obligations under Section 3.3
and Exhibit D, or failure of SPKK to make any payments when due and payable
hereunder (except payment of amounts that are under bona fide dispute by SPKK,
which dispute shall then be resolved promptly under the provisions of Article 15
hereof), and SPKK fails to cure such failure within sixty (60) days after
written notice thereof by SciClone; provided, however, that if SPKK is unable to
cure a failure for causes beyond its reasonable control pursuant to Section
17.8, then such sixty (60) day period shall be extended for a period of time
reasonable under the circumstances. Upon effective termination by SciClone, all
payments then outstanding under this Agreement shall become immediately due and
payable. Upon any such termination by SciClone, all licenses from SciClone shall
terminate.
12.4. Termination by SPKK.
12.4.1 Termination Without Cause.
(a) Notwithstanding any provision in this Agreement to the
contrary, SPKK shall have the right to terminate this Agreement [*REDACTED]
SciClone of SPKK's intent to so terminate. Within [*REDACTED] days after said
notice of intent, the CEOs of SPKK and SciClone shall meet in Japan to discuss
said notice of intent to terminate (unless such CEOs have agreed in writing to
an alternative process).
(b) If SPKK gives notice of intent to terminate this
Agreement with respect to both the CHB and CHC indications, then at any time(s)
after the [*REDACTED], SciClone shall give to SPKK all data then available which
reasonably supports the commercial and/or scientific feasibility of the use of
TA-1 for other indications in Japan and a written plan and budget as to the
development of such other indication(s) (excluding CHB and CHC), of which
SciClone is aware, whereupon SPKK shall have sixty (60) days to deliver to
SciClone a written commitment to so develop and commercialize the SciClone
Technology for said indication(s); and if SPKK does not so commit, then SPKK
shall have no further rights with respect to said indication(s).
(c) During the [*REDACTED] period following any notice of
intent to terminate given hereunder by either party, [*REDACTED].
(d) After receipt of any SPKK notice of intent to
terminate, SciClone shall have the right to offer to any third party, whether in
or outside of the SPKK Territory, the right to develop, use and sell TA 1 based
products for any such rejected indication, although such rights may be granted
to the third party only upon the effective date of the termination of SPKK's
rights to said indication(s).
----------------------
*Omitted and filed separately with the Commissioner.
21
(e) If SPKK terminates this Agreement with respect to both
the CHB and CHC indications, then SPKK shall have no further rights with respect
to CHB and CHC indications; and SPKK's rights for all additional indications
shall cease [*REDACTED] following said termination as to both the CHB and CHC
indications, excepting only that SPKK's rights under this Agreement shall
continue in full effect for any indication(s) with respect to which SPKK is
pursuing and continues to pursue diligent development and/or commercialization
efforts.
(f) At the time SPKK terminates this Agreement with
respect to a particular indication(s), if SPKK has already then obtained the
required regulatory and pricing approvals for marketing and selling Licensed
Products for said rejected indication(s), then SciClone [*REDACTED] of net sales
(defined according to the definition of Net Sales, mutatis mutandis) in Japan by
SciClone or any new third party licensee of any such product(s) for the rejected
indication(s). The rate of said [*REDACTED] shall depend upon the economic
feasibility for SciClone and/or such new third party licensee to make a fair and
customary profit and return of investment, and still have revenues from the sale
of Licensed Products available to fund said [*REDACTED]. If SciClone and SPKK
are not able to reach mutual agreement as to the amount of [*REDACTED] then such
[*REDACTED] shall be determined pursuant to binding arbitration in accordance
with the provisions of Exhibit J hereof. SciClone's [*REDACTED] incurred
pursuant to this Section 12.4.1 shall be [*REDACTED] incurred by SPKK for the
rejected indication(s) during the period commencing on the Signing Date and
ending on the effective date of termination of this Agreement with respect to a
particular indication(s) under this Section 12.4.1.
12.4.2 Termination For Breach. SPKK, in its sole
discretion, may terminate this Agreement at any time, effective after the cure
period described below, by giving written notice of such termination to
SciClone, if SciClone fails to comply with any material obligation of this
Agreement and SciClone fails to cure such failure within [*REDACTED] after
written notice thereof by SPKK, provided, however, that if SciClone is unable to
cure a failure for causes beyond its reasonable control pursuant to Section 17.8
hereof, then such [*REDACTED] shall be extended for a period of time reasonable
under the circumstances. Upon any termination of this Agreement pursuant to this
Section 12.4.2, all licenses from SciClone shall continue in effect, subject to
SPKK making payments to SciClone as contemplated by Section 6.3.6 hereof, and
subject to reasonable renegotiation of Section 6.3.6 to reflect the changed
contributions of the parties.
12.5. Effect of Termination.
12.5.1 Survival. Notwithstanding any termination or
expiration, the provisions of Article 4, other than Sections 4.2 and 4.4, and
Articles 9, 10, 11, 12, 13, 14, 15 and 17, and Section 7.4 shall survive to the
extent required therein.
12.5.2 Data Regulatory Filings. Upon termination of this
Agreement by SciClone in accordance with 12.3, or upon termination of this
Agreement by SPKK in accordance with Section 12.4.1, SPKK shall promptly
transfer or assign to SciClone (or its designee), to the extent
----------------------
*Omitted and filed separately with the Commissioner.
22
permitted by law, any and all licenses issued by the Japanese regulatory
authorities with respect to the Licensed Products, and shall deliver to SciClone
any and all Program Data and Improvements, and any and all Licensed Products and
TA 1 Material in its possession. SciClone shall pay to SPKK SPKK's actual cost
of such Licensed Products and TA 1 Material.
12.6. SciClone Retained Rights. Notwithstanding anything to the
contrary contained in this Agreement, in the event that this Agreement is
terminated pursuant to Sections 12.3 or 12.4.1, then: (a) SciClone shall have
full rights (and SPKK shall have no rights) to (i) develop, commercialize, make
and sell Licensed Products, (ii) use Alpha Technology, SciClone Technology,
SciClone Sublicensee Technology, Alpha Sublicensee Technology, SciClone
Inventions and Joint Inventions, (iii) own and use all Regulatory Filings and
Program Data, and (iv) own and use exclusively all Marks; and (b) the license to
the SPKK Inventions set forth in Section 4.4 hereof shall survive such
termination.
ARTICLE 13
INDEMNIFICATION
13.1. Indemnification by SPKK. SPKK expressly and unequivocally agrees
to and hereby does indemnify, release, defend and hold SciClone harmless from
and against all claims, damages, losses, costs and expenses, including
attorneys' fees, arising in favor of any person, firm or corporation resulting
from or arising out of SPKK's liability in any way relating to the Licensed
Products ("Claims"), including without limitation, the manufacture, packaging,
use, sale or other distribution of Licensed Products by SPKK, or any
representation made or warranty given by SPKK with respect to any Licensed
Product, provided that SciClone (i) gives SPKK notice of such claim, (ii)
cooperates with SPKK, at SPKK's expense, in the defense of such claim, and (iii)
gives SPKK the right to control the defense and settlement of any such claim,
except that SPKK shall not enter into any settlement which affects SciClone's
rights or interest without SciClone's prior written approval; provided, however,
that SPKK shall not so indemnify and hold SciClone harmless for any Claims
arising from defects in any TA 1 Material supplied by SciClone which are present
at the time of acceptance of such TA 1 Material by SPKK. SciClone shall have no
authority to settle any claim on behalf of SPKK.
13.2. Indemnification. SciClone expressly and unequivocally agrees to
and hereby does indemnify, release, defend and hold SPKK harmless from and
against all claims, damages, losses, costs and expenses, including attorneys'
fees, arising in favor of any person, firm or corporation arising out of
liability based on: (a) claims arising from defects in any TA 1 Material
supplied by SciClone which are present at the time of acceptance of such TA 1
Material by SPKK; (b) a claim that the use by SPKK of the SciClone Technical
Information infringes any proprietary rights of third parties; or (c) a claim
that the use of the Marks by SPKK in accordance with this Agreement infringes
any proprietary rights of third parties. SciClone shall be liable for all such
claims, damages, losses and the like incurred by SPKK, provided that SPKK (i)
gives SciClone prompt notice of such claim, (ii) cooperates with SciClone, at
SciClone's expense, in the defense of such claim, and (iii) gives SciClone the
right to control the defense and settlement of any such claim, except that
SciClone shall not enter into any settlement that affects SPKK's rights or
interest
23
without SPKK's prior written approval. SPKK shall have no authority to settle
any claim on behalf of SciClone.
ARTICLE 14
DISCLAIMER OF WARRANTIES; FURTHER ACTION
14.1 Disclaimers.
14.1.1 SciClone Disclaimer. THE ALPHA TECHNOLOGY, SCICLONE
TECHNOLOGY, ALPHA SUBLICENSEE TECHNOLOGY AND SCICLONE SUBLICENSEE TECHNOLOGY
PROVIDED BY SCICLONE HEREUNDER ARE PROVIDED "AS IS" AND, EXCEPT AS PROVIDED IN
Section 13.2 ABOVE, SCICLONE HEREBY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES
OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF
DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT OF
THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES OR ARISING FROM A COURSE OF
DEALING, USAGE OR TRADE PRACTICES, IN ALL CASES WITH RESPECT THERETO. Without
limiting the generality of the foregoing, SciClone expressly does not warrant
(i) the success of any study or test commenced pursuant to the Development
Program, or (ii) the safety or usefulness for any purpose of TA 1, Alpha
Technology, SciClone Technology, Alpha Sublicensee Technology, SciClone
Sublicensee Technology, or Program Data.
14.1.2 SPKK Disclaimer. THE PROGRAM DATA, IMPROVEMENTS,
SPKK INVENTIONS AND JOINT INVENTIONS PROVIDED BY SPKK HEREUNDER ARE PROVIDED "AS
IS" AND, EXCEPT AS PROVIDED IN SECTION 13.1 ABOVE, SPKK HEREBY EXPRESSLY
DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES, IN ALL
CASES WITH RESPECT THERETO. Without limiting the generality of the foregoing,
SPKK expressly does not warrant the safety or usefulness for any purpose of the
Program Data, or any Improvement, SPKK Invention or Joint Invention.
14.2. Additional Documents. Each party agrees to execute such further
papers or agreements as may be necessary to effect the purposes of this
Agreement.
ARTICLE 15
DISPUTE RESOLUTION; VENUE AND GOVERNING LAW
15.1. Dispute Resolution. In the event that at any time during the term
of this Agreement a disagreement, dispute, controversy or claim should arise out
of or relating to the interpretation of or performance under this Agreement, or
the breach, or invalidity thereof, the
24
parties will attempt in good faith to resolve their differences before resorting
to the termination procedures provided in Article 12 of this Agreement. If the
dispute relates primarily to regulatory issues or the Development Program, it
shall be negotiated by the Development Coordinators, and if it relates primarily
to commercial or marketing issues, it shall be negotiated by the Marketing
Coordinators. If the appropriate Coordinators cannot resolve the disputed matter
within thirty (30) days, such matter shall be referred to the Chief Executive
Officers of the parties (or their designees) for an additional thirty (30) days
of negotiating, following which, subject to the provisions of Sections 15.2,
17.8 and Exhibit J hereof, the dispute shall be resolved by binding arbitration
pursuant to Exhibit J, subject to the right of either party to take any action
and seek any remedy it may have at law or in equity, including specific
performance and injunctive relief, to protect the party's rights pending the
outcome of the arbitration.
15.2. Governing Law, Jurisdiction and Venue. This Agreement is made in
accordance with and shall be governed and construed under the laws of the State
of California, U.S.A., as applied to agreements executed and performed entirely
in California by California residents, without regard to conflicts of laws
rules, and in no event shall this Agreement be governed by the United Nations
Convention on Contracts for the International Sale of Goods. The parties each
acknowledge and agree in the event that any disagreement, dispute, controversy
or claim that is not resolved pursuant to Section 15.1 shall be resolved through
binding arbitration under the provisions set forth in Exhibit J, which is
attached hereto and incorporated herein by reference.
ARTICLE 16
[INTENTIONALLY OMITTED]
ARTICLE 17
MISCELLANEOUS
17.1. Agreement Registration SPKK shall [*REDACTED].
17.2. Waiver. No waiver by either party hereto of any breach or default
of any of the covenants or agreements herein set forth shall be deemed a waiver
as to any subsequent or similar breach or default.
17.3. Assignment. Except as otherwise provided herein, neither this
Agreement nor any interest hereunder will be assignable in part or in whole by
any party without the prior written consent of the other; provided, however,
that either party may assign all or part of this Agreement to any of its
Affiliates, and either party shall assign this Agreement to any successor by
merger or sale of substantially all of its business unit to which this Agreement
relates in a manner such that both the assignor and the assignee will be liable
and responsible for the performance and observance of all its duties and
obligations hereunder. This Agreement will be binding upon the
----------------------
*Omitted and filed separately with the Commissioner.
25
successors and permitted assigns of the parties and the name of a party
appearing herein will be deemed to include the names of such party's successors
and permitted assigns to the extent necessary to carry out the intent of this
Agreement. Any assignment which is not in accordance with this Section will be
void.
17.4. Payments; Reports. All payments due hereunder shall be paid by
SPKK to SciClone in U.S. Dollars. During each quarter during which any amount is
due hereunder from SPKK to SciClone, SPKK shall prepare and deliver to SciClone
a report of a financial officer of SPKK detailing the basis for all calculations
of amounts due in such quarter. [*REDACTED]. SPKK shall obtain a receipt from
[*REDACTED] for all [*REDACTED] and forward such receipts to SciClone. In
addition, SPKK agrees to take all reasonable steps which may be necessary or
appropriate to enable or assist SciClone to make appropriate claims under any
double taxation or similar agreement or treaty from time to time in force.
17.5. Notices. Any notice or other communication required or permitted
to be given to either party hereto shall be in writing and shall be deemed to
have been properly given and to be effective on the date of delivery if
delivered in person or by facsimile or five days (5) after mailing by registered
or certified mail, postage paid, to the other party at the following address:
In the case of SciClone:
SciClone Pharmaceuticals, Inc.
▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, #▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Telephone: 415/▇▇▇ ▇▇▇▇
FAX: 415/▇▇▇ ▇▇▇▇
Attn.: Chief Executive Officer
In the case of SPKK:
Schering Plough K.K.
Urban Ace Kitahama Building
2 3 7 ▇▇▇▇▇▇▇▇▇▇▇
▇▇▇▇ ▇▇, ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇
Telephone: ▇▇ ▇ ▇▇▇ ▇▇▇▇
FAX: ▇▇ ▇ ▇▇▇ ▇▇▇▇
Attn.: President
with a copy to:
Schering Corporation
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Telephone: 908/▇▇▇ ▇▇▇▇
FAX: 908/▇▇▇ ▇▇▇▇
Attn.: Vice President, Business Development
----------------------
*Omitted and filed separately with the Commissioner.
26
Either party may change its address for communications by a notice to the other
party in accordance with this section.
17.6. Headings and Title. The title of this Agreement and the headings
of the several sections are inserted for convenience of reference only and are
not intended to be a part of or to affect the meaning or interpretation of this
Agreement.
17.7. Amendment. No amendment or modification hereof shall be valid or
binding upon the parties unless made in writing and signed by both parties.
17.8. Force Majeure. Any delays in performance by any party under this
Agreement shall not be considered a breach of this Agreement if and to the
extent caused by occurrences beyond the reasonable control of the party
affected, including but not limited to acts of God, embargoes, governmental
restrictions or other governmental action or inaction, strikes or other
concerted acts of workers, fire, flood, weather, unavoidable accident,
explosion, riots, wars, civil disorder, rebellion or sabotage. The party
suffering such occurrence shall immediately notify the other party and any time
for performance hereunder shall be extended by the actual time of delay caused
by the occurrence.
17.9. Government Approvals. All governmental approvals or consents
required for the export of TA l Material as provided hereunder shall be the
responsibility of SciClone, and all governmental approvals or consents required
for the importation of TA l Material as provided hereunder shall be the
responsibility of SPKK, provided, that each party agrees to cooperate fully, at
its own expense, with the other party in obtaining such approvals or consents.
17.10. Official Language. The official text of this Agreement and any
appendices, exhibits and schedules hereto, or any notice given or accounts or
statements required by this Agreement shall be in English. In the event of any
dispute concerning the construction or meaning of this Agreement, reference
shall be made only to this Agreement as written in English and not to any other
translation into any other language.
17.11. Independent Contractors. In making and performing this
Agreement, SPKK and SciClone act and shall act at all times as independent
contractors and nothing contained in this Agreement shall be construed or
implied to create an agency, partnership or employer and employee relationship
between SciClone and SPKK. At no time shall one party make any commitment or
incur any charge or expense for or in the name of the other party.
17.12. Severability. If any term, condition or provision of this
Agreement is held to be unenforceable for any reason, it shall, if possible, be
interpreted rather than voided, in order to achieve the intent of the parties to
this Agreement to the extent possible. In any event, all other terms, conditions
and provisions of this Agreement shall be deemed valid and enforceable to the
full extent.
17.13. Cumulative Rights. The rights, powers and remedies hereunder
shall be in addition to, and not in limitation of, all rights, powers and
remedies provided at law or in equity, or under
27
any other agreement between the parties. All such rights, powers and remedies
shall be cumulative, and may be exercised successively or cumulatively.
17.14. Parties Advised by Counsel. No Interpretation Against Drafter.
This Agreement has been negotiated between unrelated parties who are
sophisticated and knowledgeable in the matters contained in this Agreement and
who have acted in their own self interest. In addition, each party has been
represented by legal counsel. Accordingly, any rule of law, including Section
1654 of the California Civil Code, as well as any other statute, law, ordinance,
or common law principle or other authority of any jurisdiction of similar
effect, or legal decision that would require interpretation of any ambiguities
in this Agreement against the party who has drafted it is not applicable and is
hereby waived. The provisions of this Agreement shall be interpreted in a
reasonable manner to effect the purpose of the parties, and this Agreement shall
not be interpreted or construed against any party to this Agreement because that
party or any attorney for or representative of that party drafted this Agreement
or participated in the drafting of this Agreement.
17.15. Entire Agreement. This Agreement together with any and all
Schedules and Exhibits referred to herein embodies the entire understanding of
the parties with respect to the subject matter hereof and shall supersede all
previous communications, representations or understandings, either oral or
written, between the parties relating to the subject matter hereof, including
the previously existing License, Development and Supply Agreement dated as of
January 2, 1993.
17.16. Future Agreements. Whenever in this Agreement it is specified
that the parties will mutually agree on a matter, the parties shall use diligent
and good faith efforts to agree upon commercially reasonable terms, taking into
consideration all relevant facts and circumstances. In the event that the
parties are unable to reach such an agreement, then either party may submit the
unresolved matter to binding arbitration, in accordance with the provisions set
forth in Exhibit J.
17.17. Counterparts. This Agreement may be signed in counterparts, and
signatures may be transmitted by facsimile.
IN WITNESS WHEREOF, both SPKK and SciClone have executed this Agreement
by their respective officers hereunto duly authorized.
SCHERING PLOUGH K.K. SCICLONE PHARMACEUTICALS, INC.
By:_________________________ By:__________________________
▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇
President President
28