Exhibit 10.1

 

LICENSE AND OPTION AGREEMENT

 

THIS LICENSE AND OPTION AGREEMENT (the “Agreement”) is made this 22nd day of
October, 2002 (the “Effective Date”) by and between GENESOFT PHARMACEUTICALS,
INC., a Delaware corporation having its principal place of business at 7300
Shoreline Court, South San Francisco, CA, USA 94080 (“GS”) and LG LIFE SCIENCES,
LTD., a corporation organized under the laws of the Republic of Korea having its
principal place of business at LG Twin Tower, 20 yoido-dong, Youngdungpo-gu,
Seoul, 150-721, Republic of Korea (“LGLS”). LGLS and GS are sometimes referred
to herein individually as a “Party” and collectively as the “Parties”.

 

RECITALS

 

WHEREAS:

 

LGLS is the owner of all right, title and interest in certain patents and
know-how relating to Gemifloxacin (as hereafter defined); and

 

LGLS is the owner or licensee of certain patent rights, know-how, trademark
rights and other intellectual property related to Gemifloxacin; and

 

LGLS wishes to license to GS the foregoing intellectual property rights to
enable GS to develop and commercialize Gemifloxacin in the Territory (as
hereafter defined) and in the Field (as hereafter defined) and GS wishes to
obtain such a license, all on the terms and conditions set forth herein;

 

NOW, THEREFORE, in consideration of the premises and mutual covenants herein
contained, the Parties hereto agree as follows:

 

ARTICLE 1

DEFINITIONS

 

When used in this Agreement, the following terms shall have the meanings
indicated below.

 

1.1 “Active Pharmaceutical Ingredient” or “API” means Gemifloxacin in active
bulk form meeting the API Specifications.

 

1.2 “Additional Indication” means *****.

 

1.3 “Affiliate” means an individual, trust, business trust, joint venture,
partnership, corporation, association or any other entity which (directly or
indirectly) is controlled by, controls or is under common control with a Party.
For the purposes of this definition, the term “control” (including, with
correlative meanings, the terms “controlled by” and “under common control with”)
as used with respect to any Party, shall mean the possession (directly or
indirectly)

 

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of at least 50 percent of the outstanding voting securities of a corporation or
comparable equity interest in any other type of entity.

 

1.4 “API Specifications” shall mean the specifications for Active Pharmaceutical
Ingredient attached hereto as Schedule 1.4.

 

1.5 “Combination Product” means a product consisting of Gemifloxacin and at
least one other biologically active ingredient.

 

1.6 “Commercialization” means *****.

 

1.7 “Development” means:

 

(a) all activities relating to obtaining and/or maintaining Regulatory Approval
of the Product in the Territory for the Initial Indication including, without
limitation, clinical trials and the preparation, submission, review and
development of data or other information related thereto;

 

(b) Phase IV clinical trials supporting pre-launch and commercialization of the
Product but not contributing to obtaining and/or maintaining Marketing
Authorization Applications of the Product for the Initial Indication and any
Additional Indications in the Territory;

 

(c) all activities relating to *****, including Phase III clinical trials and
the preparation, submission, review and development of data or other information
related thereto; and

 

(d) all formulation studies for ***** and any other new formulation of the
Product.

 

The term “Development” shall not include process development or final finish or
fill of Product.

 

1.8 “EMEA” means the European Agency for the Evaluations of Medical Products.

 

1.9 “FDA” means the U.S. Food and Drug Administration.

 

1.10 “Field” means *****.

 

1.11 “Final Product” means the Product in final form for commercialization and
distribution, labeled in accordance with applicable regulatory requirements and
custom and meeting the Final Product Specifications.

 

1.12 “Final Product Specifications” means the specifications for Final Product
attached hereto as Schedule 1.12.

 

1.13 “Fully Burdened Cost of Manufacture” means: *****

 

1.14 “Gemifloxacin” means the racemic compound whose mesylate is represented on
Schedule 1.14 hereto as well as the pharmaceutically acceptable salts,
physiologically

 

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hydolyzable esters, and solvates thereof, but excluding either enantiomer alone.
The mesylate salt of Gemifloxacin is also known under the trademark Factive®.

 

1.15 “GLAXO” means GlaxoSmithKline plc and its Affiliates.

 

1.16 “GLAXO Agreement” means a certain Termination and Transfer Agreement dated
on or about October 14, 2002, by and among GLAXO (including certain of its
Affiliates) and LGLS (including its Affiliate LG Chem Investment, Ltd.).

 

1.17 “GLAXO Know-how” means that Information relating to the Product identified
on Schedule 1.17 hereto.

 

1.18 “GLAXO Patents” means those patents and patent applications shown on
Schedule 1.18 hereto and the equivalents thereof in all countries in the
Territory and patents issuing from such patent applications, as well as
divisionals, continuations, continuations-in-part, reissues, reexaminations,
renewals, extensions, utility models, additions and supplementary protection
certificates to any such patents and patent applications which are necessary or
useful for the development, use, importation, manufacture, formulation,
packaging, sale or offer for sale of Product in the Territory.

 

1.19 “GS” means Genesoft Pharmaceuticals, Inc. and its Affiliates.

 

1.20 “GS Know-how” means all Information relating to the Product developed by GS
as a result of its activities under this Agreement and any and all patent
applications and patents covering or claiming any such Information.

 

1.21 “Information” means, whether or not patentable: (i) techniques and data
including inventions, practices, methods, know-how, data (including
pharmacological, toxicological and clinical test data, regulatory submissions
and data and analytical and quality control data), marketing, distribution, and
sales data or descriptions, (ii) compounds, compositions of matter, assays and
biological materials, and (iii) dossiers of information necessary for Regulatory
Approvals.

 

1.22 “Initial Indication(s)” means *****.

 

1.23 “Launch” means the first commercial sale of a Product in a country in the
Territory by GS or any of its Affiliates or sub-licensees following receipt of
Regulatory Approval in such country.

 

1.24 “*****” shall mean that compound represented on Schedule 1.24 hereto, as
well as *****.

 

1.25 “LGLS” means LG Life Sciences, Ltd. and its Affiliates.

 

1.26 “LGLS Know-How” means all Information now or hereafter within the Control
of LGLS necessary or useful for the Development or Commercialization of the
Product in the Territory, or for the filling, labeling and packaging of the
Product anywhere in the world for use or sale in the Territory.

 

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1.27 “LGLS Patents” means: (i) those patents and patent applications shown on
Schedule 1.27 attached hereto and the equivalents thereof in all countries in
the Territory, (ii) all patents issuing from such patent applications,
divisionals, continuations, continuations-in-part, reissues, reexaminations,
renewals, extensions, utility models, additions and supplementary protection
certificates to any such patents and patent applications, and (iii) all patents
and patent applications now or hereafter owned or controlled by LGLS necessary
or useful for the development, use, importation, formulation, packaging, sale or
offer for sale of Product in the Territory.

 

1.28 “Marketing Authorization Application” means an application for Regulatory
Approval required before commercial sale or use of the Product in the Field in a
regulatory jurisdiction in the Territory.

 

1.29 “Memorandum of Understanding” means an agreement between the Parties so
titled and dated August 23, 2002.

 

1.30 “Net Sales” means *****.

 

1.31 “Patent Expenses” means governmental fees and the reasonable fees and
expenses of outside counsel and payments to Third Parties incurred after the
Effective Date in connection with the preparation, filing, prosecution and
maintenance of patents or patent applications, including the costs of patent
interference, opposition and revocation proceedings related thereto or to any
Third Party patents containing claims which cover the manufacture, use, sale,
offer for sale, importation or exportation of Product in the Territory.

 

1.32 “Product” means any compound including Gemifloxacin as an active
ingredient.

 

1.33 “Regulatory Approvals” means all approvals (including pricing and
reimbursement approvals) and licenses, registrations or authorizations of a
Regulatory Authority, necessary for the use, import, storage, export, transport,
filling, labeling, packaging (to the extent that filling, labeling or packaging
are carried out by GS or its Affiliates) or sale of a Product in a regulatory
jurisdiction in the Territory. “Regulatory Approval” shall not, however, include
any regulatory approvals related to the manufacture of API and supply of API by
LGLS to GS as contemplated herein.

 

1.34 “Regulatory Authority” means a governmental entity with the authority to
grant Regulatory Approvals.

 

1.35 “Steering Committee” means the entity described in Article 3, below.

 

1.36 “Territory” means the United States of America, Canada, Mexico, France,
Germany, the United Kingdom, Luxembourg, Ireland, Italy, Spain, Portugal,
Belgium, the Netherlands, Austria, Greece, Sweden, Denmark, Finland, Norway,
Iceland, Switzerland, Andorra, Monaco, San Marino and Vatican City.

 

1.37 “Third Party” means an entity or person other than LGLS or GS or their
respective Affiliates.

 

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1.38 “Trademarks” means those trademarks, trade names, domain names and logos
identified on Schedule 1.38 hereto.

 

ARTICLE 2

PRODUCT DEVELOPMENT

 

2.1 Scope of Development. Upon the Effective Date, GS will assume lead
responsibility for Development throughout the Territory for the Initial
Indication(s), in consultation with LGLS. Following the Effective Date GS shall
in good faith establish internal and external competence and controls
appropriate for the assumption of full responsibility for Development for the
Initial Indication and, on notice to LGLS not later than the date on which first
Regulatory Approval is received in the Territory LGLS shall, to the extent
permitted by law, transfer to GS ownership of all pending Marketing
Authorization Applications and Regulatory Approvals including, without
limitation, New Drug Application Nos. 21-158 and 21-376 (the “NDA”). Following
the Effective Date, GS shall have sole responsibility for *****; provided,
however, that GS shall notify LGLS prior to filing a Marketing Authorization
Application for any *****.

 

2.2 Development Effort. GS shall carry out its responsibilities under Section
2.1 using reasonable efforts consistent with prudent business judgment, and in
accordance with all applicable legal and regulatory requirements including,
without limitation, then-current Good Laboratory Practices, and Good Clinical
Practices.

 

2.3 Ownership of Regulatory Approvals. Following the transfer of ownership
provided in Section 2.1, above, all Marketing Authorization Applications shall
be filed and maintained in the name of GS and GS shall be the owner of all
resulting Regulatory Approvals. Through meetings of the Steering Committee, GS
shall: (i) keep LGLS informed regarding the schedule and progress for the
preparation and submission of Marketing Authorization Applications in the
Territory, and (ii) permit LGLS a reasonable opportunity to comment on such
Marketing Authorization Applications.

 

2.4 Communication with Regulatory Authorities. GS shall have primary
responsibility for dealing with Regulatory Authorities in the Territory,
including filing all supplements and other documents with such authorities with
respect to obtaining Regulatory Approvals, reporting all adverse drug
experiences related to the Product, and handling all Product complaints. At each
meeting of the Steering Committee, GS shall provide to the Steering Committee a
report describing the regulatory filing status of each Product throughout the
Territory.

 

2.5 Costs of Development. All Development expenses shall be borne by GS. Without
limiting the foregoing, within 30 days after receipt of an appropriate invoice
from LGLS, GS shall reimburse LGLS for Development expenses in the Territory
incurred between

 

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August 23, 2002 and the Effective Date, as contemplated by the Memorandum of
Understanding; provided, however, that the amount of reimbursement due for LGLS
activities during such period in the Territory but outside of the United States
of America shall not exceed ***** unless GS shall have previously approved such
excess.

 

ARTICLE 3

MANAGEMENT OF THE COLLABORATION

 

3.1 Steering Committee. Within 30 days after the Effective Date, LGLS and GS
shall create a Steering Committee consisting of *****qualified representatives
of each Party. A Party may change or replace its representatives on the Steering
Committee as it deems appropriate, by notice to the other Party. Each Party will
designate one of its members of the Steering Committee as co-chairperson. The
co-chairperson appointed by each Party shall be empowered to bind such Party to
decisions of the Steering Committee to the extent contemplated herein.

 

3.2 Meetings of the Steering Committee. The Steering Committee shall hold
meetings at such times and places as shall be determined by the co-chairpersons.
The meetings shall be held *****. Steering Committee meetings may be held in
person or by telephone or video conference. The co-chairpersons shall alternate
in keeping written minutes that shall reflect the decisions taken at the
meetings. Such minutes shall be circulated to the Steering Committee for review
and approval within two weeks after each meeting.

 

3.3 Function of the Steering Committee. The Steering Committee shall *****.

 

3.4 Decision Making. To the extent feasible, the Steering Committee shall make
decisions and take actions *****.

 

3.5 Limitations of Powers of the Steering Committee. The Steering Committee
shall *****. The Steering Committee is not a substitute for the rights or the
obligations of the Parties and, inter alia, shall not have the authority to
amend this Agreement.

 

3.6 Liaison Manager. Each Party will designate one of its members of the
Steering Committee to act as its liaison manager to facilitate the performance
of its rights and satisfaction of its obligations hereunder.

 

3.7 Development and Commercialization Outside the Territory. LGLS shall have the
sole responsibility for development and commercialization of the Product outside
of the Territory. LGLS shall regularly disclose to GS its plans for such
development and afford GS a reasonable opportunity to comment thereon. During
the term of this Agreement, LGLS shall

 

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assure that its development of Product outside of the Territory (whether
directly or through one or more sub-licenses) is conducted in a manner which
minimizes the risk of disruption of or other adverse effects on the development
and commercialization of the Product in the Territory by GS as contemplated
herein. Without limiting the foregoing: *****. At LGLS’s request, the Parties
shall in good faith discuss the matters for which GS approval or consultation is
required pursuant subsections (ii) and (iii), above, at each meeting of the
Steering Committee.

 

ARTICLE 4

COMMERCIALIZATION

 

4.1 Commercialization Efforts. Commencing on the Effective Date, and subject to
Section 4.3, below, GS shall be responsible for carrying out Commercialization,
at its sole expense, using *****. GS, directly or through one or more Affiliates
or sub-licensees, shall *****.

 

4.2 Pricing in the Territory. GS shall ***** obtain such Product pricing
approvals as may be required in each country of the Territory. GS shall be free
to set the sale price of the Product in the Territory as it deems appropriate.

 

4.3 Co-Promotion. (a) LGLS shall have the option, exercisable on notice to GS
*****, to co-promote Product in the Territory commencing on January 1, 2008. If
LGLS timely exercises this option, the Parties shall promptly and in good faith
negotiate a co-promotion agreement which establishes their respective rights and
obligations, which agreement shall become effective on January 1, 2008. *****

 

(b) If LGLS exercises its option pursuant to subsection (a), above, all GS
royalty obligations under Section 10.4, below, shall terminate with respect to
Product sales occurring on or after January 1, 2008, but GS’s obligations under
Section 10.2 shall remain in full force and effect.

 

ARTICLE 5

MANUFACTURE AND SUPPLY

 

5.1 General. (a) The intent of the Parties is that: (i) between the Effective
Date and July 1, 2004, LGLS shall supply to GS, and GS shall exclusively
purchase from LGLS all of GS’s requirements of Product in final form according
to the Final Product Specifications, and (ii) following July 1, 2004 LGLS shall
supply to GS, and GS shall purchase from LGLS all of GS’s requirements of
Product in bulk form according to the API Specifications, with final finish and
fill to be provided either by LGLS or a Third Party, as provided in Section
5.1(b). The terms and conditions of LGLS supply pursuant to subsection (i) are
as set forth in this Article 5. The terms and conditions of LGLS supply pursuant
to subsection (ii) shall be set forth in a supply agreement to be entered into
as provided in Section 5.2.

 

(b) The Parties acknowledge that secure long-term supply of Product for GS is
essential to the success of the relationship reflected herein. No later than
***** that Parties shall identify and, to the extent practicable, contractually
commit to a long-term final finish and fill facility for the Product. Either the
Parties will jointly agree on a Third Party or LGLS shall

 

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commit to provide these services, either directly through the acquisition of a
U.S.-based facility or by contract with a mutually acceptable third party. If
LGLS elects to provide these services, it shall notify GS to that effect no
later than *****. Regardless of whether final finish and fill is provided by
LGLS or through a Third Party, GS shall have the right to approve the site
selected for final finish and fill, which approval shall not be unreasonably
withheld.

 

5.2 Supply Agreement. Not later than *****, the Parties shall complete and enter
into a supply agreement covering the supply of API by LGLS for the remainder of
the term of this Agreement. Such supply agreement shall be consistent with the
terms and conditions of this Agreement with respect to supply of Final Product
and shall include such other terms and conditions as the Parties may mutually
agree including, without limitation, adequate provision for API shortages and
supply interruption events to assure GS a secure long-term source of supply of
API as well as license to GS or its designee of the right to manufacture API in
the event that LGLS fails to supply. The supply price for API provided under the
Supply Agreement shall be equal to ***** per kg. *****.

 

5.3 Manufacturing Approvals. GS shall be promptly notified of any proposed
change in the process for the manufacture of Product pursuant to this Article 5
which potentially impacts the Marketing Authorization Applications or Regulatory
Approval in the Territory including, without limitation, any proposed change as
to the site at which such manufacture is to occur. No Product incorporating any
such proposed change and no Product manufactured at any proposed new facility
shall be supplied by LGLS to GS hereunder without such changes having first been
approved by the appropriate Regulatory Authorities or by mutual agreement by the
Parties, which regulatory approvals the Parties agree to pursue diligently
following notice from LGLS of such proposed changes.

 

5.4 Specifications. LGLS warrants that the Product it supplies hereunder shall
meet the Final Product Specifications, and shall have been manufactured in
accordance with all applicable laws and regulations including, without
limitation, then-current Good Manufacturing Practice (“GMP”) compliance
standards.

 

5.5 Purchase Order and Forecasting. On ***** GS shall place a ***** for the
amount of Product produced to Final Product Specifications which *****. On
*****, GS shall provide to LGLS a ***** forecast of *****. As shall be provided
in the supply agreement, this forecast shall be updated by GS on ***** of each
calendar year for the following *****. Within ***** after receipt of each such
forecast, LGLS shall provide to GS a ***** forecast of the Fully Burdened Cost
of Manufacturing of the supply forecast by GS.

 

Without limiting the foregoing, GS shall use ***** to provide LGLS with supply
orders for the delivery of Final Product or API within the following dates:

 

*****

 

5.6 Delivery. The first order of ***** placed by GS pursuant to Section 5.5
shall be delivered to GS no more than ***** to the date on which the Parties in
good faith anticipate receipt of final FDA approval of the Product for the
Initial Indication(s). All deliveries of Product shall be made ***** as such
term is

 

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defined in the INCOTERMS 2000. Title to the Product and all risks of loss or
damage to Product shall *****. LGLS agrees, in accordance with GS’s reasonable
written instructions, to arrange for shipping and insurance, to be paid by GS
from the ***** point to such locations as are requested by GS.

 

5.7 Inspection and Rejection.

 

5.7.1 GS shall, ***** upon receipt of a shipment of Product from LGLS, inspect
such shipment for defects that cause the Product to deviate from the Final
Product Specifications (other than those resulting subsequent to delivery of
Product to GS). If GS discovers such a defect, GS may reject such defective
Product, and shall promptly notify LGLS in writing of the rejection and the
reason therefor.

 

5.7.2 Any rejection of defective or non-conforming Product by GS must occur
within ***** from delivery, failing which GS shall be deemed to have accepted
such shipment and to have irrevocably waived any claims it may have with respect
to such shipment failing to meet the Final Product Specifications.

 

5.7.3 At the request of LGLS, GS shall either allow a representative of LGLS to
inspect the rejected Product and to make a determination as to the cause of the
defect, or return a sample of the defective Product to LGLS for such inspection.
If LGLS disagrees with GS’s determination, it shall notify GS within ***** after
inspection by LGLS as provided in this Section 5.7.3, whereupon the Parties
shall select an independent laboratory to draw a sample and determine whether
such Product in fact conformed to the Final Product Specifications at the time
of delivery to GS. The determination of such independent laboratory shall be
final. The Party whose determination was not accurate shall bear the cost of the
independent analysis.

 

5.7.4 At the request and expense of LGLS, Product under the control of GS found
to be defective shall be returned to LGLS (if by permitted by law) or disposed
of in accordance with LGLS’s lawful instructions. With respect to payments
previously made by GS with respect to defective Product, GS shall be entitled,
at its discretion, either to a refund or a credit against amounts otherwise due
to LGLS for supply hereunder.

 

5.8 Remedies.

 

5.8.1 If GS asserts that a shipment of Product was defective or non-conforming
at the time of delivery to GS, LGLS shall as soon as practical replace the
rejected or disputed Product, pending resolution of the question of whether such
original shipment was or was not defective.

 

5.8.2 The remedies set forth in this Article 5 are GS’s ***** for claims by GS
against LGLS based on Product supplied by LGLS pursuant to this Agreement not
conforming to the Final Product Specifications.

 

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5.9 Supply Price and Payment Mechanism.

 

5.9.1 *****

 

5.9.2 *****

 

5.9.3 Payment for API and Final Product supplied by LGLS hereunder shall be due
***** after delivery to GS’s premises pursuant to Section 5.6, above; provided,
however, that payment for the ***** ordered by GS pursuant to Section 5.5,
above, shall be due in two equal installments. The first such installment shall
be due ***** after delivery to GS’s premises pursuant to Section 5.6, above, and
the second such installment shall be due ***** after the first installment is
due.

 

5.9.4 Notwithstanding the foregoing, in the event that any of the Product
ordered by and delivered to GS pursuant to this Article 5 is unused by GS
because of: (i) the expiration of FDA- or EMEA- approved Product dating, or (ii)
commercial considerations which make such Product unusable (including, without
limitation, because the Product is not approved by the FDA or the EMEA), GS
shall return such unused Product to LGLS (or at LGLS’s request and expense
lawfully dispose of such Product). LGLS shall be responsible for the ***** of
such returned Product and, if GS has previously paid for such Product, shall
give GS a credit or prompt reimbursement for such amount. GS shall be
responsible for the ***** associated with such returned Product.

 

5.10 Release Certificate. LGLS shall provide to GS with each delivery of Final
Product a Release Certificate, a Certificate of Analysis and a Certificate of
Compliance signed by a responsible person duly authorized by LGLS to certify the
quality of the API delivered, each in a form reasonably acceptable to GS. The
Release Certificate shall, inter alia, state that the results of the agreed upon
testing procedures are in compliance with the Final Product Specifications as
well as any additional applicable requirements of Regulatory Authorities.
Without limiting the foregoing, unless expressly agreed by the Parties all Final
Products supplied hereunder shall meet all release criteria established by the
FDA or EMEA with respect to such Final Product.

 

5.11 Production Records. LGLS shall maintain records related to its manufacture
and handling of Final Product in accordance with the applicable rules and
regulations and conditions of its licensure (including applicable rules of the
FDA and EMEA and any other applicable regulatory requirements for record
retention), for the longer of: (i) ***** years after the date of manufacture of
each batch of API, and (ii) the period required by applicable law. LGLS shall
notify GS of any intent to destroy or dispose of records related to the
manufacture or handling of API and allow GS an opportunity to secure said
records for additional storage periods in accordance with the written procedures
of GS or its designee. Upon GS’s request with no fewer than five days’ prior
notice, and at GS’s sole expense, LGLS shall send to GS copies of the relevant
documents or permit GS or an independent auditor selected by GS to have access
to such records from time to time during ordinary business hours to verify
compliance by LGLS

 

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with such rules and regulations. The provisions set forth in this section shall
survive termination of the Agreement for a period of 10 years.

 

5.12 Post Expiration Supply. The Parties recognize that following the expiration
of the term of this Agreement GS may (or may not) continue to sell Product under
the Trademark as contemplated by Sections 10.4 and 11.4. In the event that GS
does so and in the further event that LGLS or any Affiliate of LGLS is at such
time producing API in commercial quantities, LGLS shall offer to supply API to
GS on a *****.

 

ARTICLE 6

CONFIDENTIALITY

 

6.1 Confidentiality; Exceptions. The receiving Party shall keep confidential and
shall not publish or otherwise disclose or use for any purpose other than as
provided for in this Agreement any Information and other information and
materials furnished to it by the other Party pursuant to this Agreement, or any
provision of this Agreement that is the subject of an effective order of the
Securities Exchange Commission granting confidential treatment pursuant to the
Securities Act of 1934, as amended (collectively, “Confidential Information”),
except to the extent that it can be established by the receiving Party that such
Confidential Information:

 

  (i) was already known to the receiving 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 receiving Party;

 

  (iii) became generally available to the public or otherwise part of the public
domain after its disclosure by the disclosing Party and 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 disclosing Party
not to disclose such information to others; or

 

  (v) was developed by the receiving Party’s employees without the use of or
access to confidential information of the disclosing Party, as demonstrated by
contemporaneous written records of the receiving Party.

 

6.2 Authorized Disclosure. A Party may disclose Confidential Information of the
other Party to the extent such disclosure is reasonably necessary in filing or
prosecuting patent applications, prosecuting or defending litigation, complying
with applicable governmental regulations or conducting pre-clinical or clinical
trials, provided that if a Party is required by law to make any such disclosure
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, use reasonable efforts to secure confidential
treatment of such Confidential Information required to be disclosed. In
addition, each Party shall be entitled to

 

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disclose Confidential Information, under a binder of confidentiality containing
provisions as protective as those of this Article 6, to a Third Party for the
purpose of carrying out activities authorized under this Agreement, including
disclosures to authorized or potential sub-licensees. Nothing in this Article 6
shall restrict any Party from using for any purpose outside the Field any
Information developed by it during the course of the collaboration hereunder.

 

6.3 Survival. This Article 6 shall survive the expiration or termination of this
Agreement for a period of five years; provided, however, that Confidential
Information regarding LGLS’s manufacturing process for API shall be kept
confidential by GS during the term of this Agreement and for a further period of
10 years after the expiration or termination of this Agreement, subject to the
exceptions in Section 6.1, above.

 

ARTICLE 7

INFORMATION AND REPORTS

 

7.1 Information and Reports During Development and Commercialization.

 

7.1.1 To the extent permitted by law, GS and LGLS will each regularly disclose
and make available to the other without charge all Information (including,
without limitation, copies of all pre-clinical and clinical reports and
training, marketing and promotional materials) known to them. Without limiting
the foregoing, promptly following the Effective Date, and at reasonable
intervals thereafter, LGLS shall disclose and transfer to GS all LGLS Know-how
and GLAXO Know-how and GS shall disclose and transfer to LGLS all GS Know-how.

 

7.1.2 Upon reasonable prior notice, each Party shall have the right to: (i)
review the raw data generated in any clinical trial conducted by the other Party
with respect to Product, (ii) visit clinical investigators and centers involved
in performance of such clinical trials, and (iii) discuss any such clinical
trial and its results in detail with such clinical investigators.

 

7.2 Publicity Review.

 

7.2.1 Neither Party shall originate any publicity, news release, or other
announcement disclosing any non-public terms of this Agreement (collectively,
“Disclosure”), without the prior prompt review and written approval of the
other, which approval shall not be unreasonably withheld. Once specific
information has been approved for disclosure, that information may be reiterated
in any subsequent Disclosure without further approval; provided, however, that
the Parties shall, to the extent lawful, maintain the confidentiality of
financial information contained in this Agreement and resulting from the
activities contemplated hereunder.

 

7.2.2 Notwithstanding Section 7.2.1, a Party may make any Disclosure it believes
in good faith based upon the advice of its counsel or its auditors is required
by applicable law and without the prior approval of the other Party may make
such disclosures as are required by the rules or regulations of the U.S.
Securities and Exchange Commission or its relevant foreign counterpart. With
respect to disclosures other than those required under such rules or
regulations, prior to making such Disclosure, the disclosing Party shall provide
the other

 

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Party with a written copy or rendition of the materials proposed to be disclosed
and provide the receiving Party with an opportunity to promptly review the
proposed Disclosure.

 

7.3 Use of Names. Except as required by law or in furtherance of the exercise of
its rights hereunder, neither Party shall use the name of the other in any
public announcement, press release or other public document related to this
Agreement or the understanding reflected herein without the written consent of
such other Party, which consent shall not be unreasonably withheld or delayed.
No such approval shall be required to republish a disclosure previously made or
otherwise in the public domain.

 

7.4 Adverse Drug Events. Each Party shall promptly report to the other Party any
adverse event observed during any use of a Product. Prior to the first
commercial sale of a Product in the Territory, the Parties shall in good faith
enter into a data safety exchange agreement consistent with applicable law and
regulatory requirements and practices in the United States and European Union.

 

7.5 Recall

 

7.5.1 Any necessary recall of Product or any batch of Product from the market in
the Territory shall be effected by GS at GS’s reasonable discretion following,
to the extent practicable, consultation with LGLS. Upon any Product recall, any
then-pending orders of Product pursuant to Article 5, above, shall be suspended
until the reinstatement of the Product or revocation of the recall.

 

7.5.2 If any Product is recalled either: *****, then GS shall bear all costs and
expenses of such recall including, without limitation, expenses or obligations
to Third Parties, the cost of notifying end users and costs associated with
shipment of any recalled Products from end users and destruction of such
Products.

 

7.5.3 If any Product is recalled as a result of *****, then LGLS shall bear all
costs and expenses of such recall including, without limitation, refund of the
supply price of the recalled Products, expenses or obligations to Third Parties,
the cost of notifying end users and costs associated with shipment of any
recalled Products from end users and destruction of such Products.

 

7.5.4 If a recall of Products is necessary for reasons attributable in part to
each of the Parties, then LGLS and GS shall be responsible for a proportionate
share of such recall costs on the basis of their respective responsibilities
with respect to the event justifying the recall.

 

7.5.5 In the event of a recall of Products, each Party shall immediately notify
the other Party and cooperate in a manner which is appropriate and reasonable
under the circumstances.

 

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7.6 Except as may be expressly provided herein and without prejudice to either
Party’s responsibility for Third Party damages as provided for in Article 14,
below, no claim for compensation, losses or damages (including, without
limitation, punitive, exemplary, incidental or consequential damages) may be
made by one Party against the other as a result of any Product recall or any
other act or omission of a Party pursuant to this Agreement (including, without
limitation, the termination of this Agreement by either Party).

 

ARTICLE 8

PATENT RIGHTS

 

8.1 LGLS Patents and GLAXO Patents. (a) During the term of this Agreement, LGLS
shall ***** maintain the LGLS Patents and the GLAXO Patents in the Territory and
shall use ***** to convert any currently pending or future filed patent
applications into granted patents without ***** delay. LGLS shall use patent
counsel selected by LGLS and reasonably approved by GS for such prosecution and
maintenance and LGLS shall bear all related Patent Expenses. GS shall cooperate
fully with LGLS in all such matters, at GS’s expense.

 

(b) LGLS shall promptly disclose to GS the text of all LGLS Patents filed after
the Effective Date as well as all information received after the Effective Date
concerning the institution or possible institution of any interference,
opposition, re-examination, reissue, revocation, nullification or any official
proceeding involving an LGLS Patent or GLAXO Patent any where in the Territory.
GS shall have the right to review all such pending applications and other
proceedings and make recommendations to LGLS with respect thereto. LGLS shall
keep GS promptly and fully informed of the course of patent prosecution and
other proceedings and shall provide GS with copies of all substantive
communications, search reports and Third Party observations submitted to or
received from patent offices throughout the Territory. All such disclosures
shall be considered “Confidential Information” subject to Article 6, above.

 

8.2 Abandonment. LGLS shall be free, on at least 30 days’ prior notice to GS, to
abandon and stop funding Patent Expenses related to any of the LGLS Patents in
any country in the Territory. In such event, GS may, at its sole option, assume
and continue prosecution or maintenance of the LGLS Patents and GLAXO Patents in
question, and shall thereafter bear all related Patent Expenses. Following such
abandonment of a LGLS Patent by LGLS, LGLS shall have no further rights
hereunder with respect to the LGLS Patent in question to the extent of such
abandonment, and the term “LGLS Patents” shall be deemed to have been modified
accordingly. LGLS shall not abandon any GLAXO Patent nor stop funding Patent
Expenses related thereto without the prior consent of GS, which consent shall
not be unreasonably withheld.

 

8.3 Infringement. If either Party learns of an infringement or threatened
infringement of the LGLS Patents or GLAXO Patents in the Territory in the Field
it shall promptly notify the other Party and shall provide the latter Party with
all information reasonably available to the notifying Party evidencing such
infringement or threatened infringement.

 

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Thereafter, the Parties shall in good faith consult and cooperate in abating
such infringement or threatened infringement.

 

GS shall have the right, but not the obligation, to bring, defend and maintain
any appropriate suit or action for abatement of the infringement or threatened
infringement of the LGLS or GLAXO Patents in the Territory and in the Field, at
GS’s sole expense. If GS requests LGLS to join GS as a party in such suit or
action, LGLS shall execute all papers and perform such other acts as may be
reasonably requested by GS, at GS’s expense. LGLS shall have the right to
participate in any such suit or action using independent counsel, at its sole
expense. Any amount recovered by GS as a result of such suit or action shall
first be applied to reimburse each of the Parties, pro rata, for any costs or
expenses incurred in bringing, defending and maintaining any such action. The
balance (the “Net Recovery”) shall be for the sole benefit of GS. The Net
Recovery shall be considered “Net Sales” with respect to the calendar quarter in
which payment to GS was received, and royalties shall accordingly be paid on the
amount of the Net Recovery exclusively at the rate(s) specified in Section 10.3,
below. The Net Recovery shall be considered “Net Sales” for purposes of
calculating annual Net Sales in accordance with Milestone 3 and in Section 10.2,
below.

 

If GS fails to initiate suit or action within 90 days after first notice of
infringement or threatened infringement of the LGLS Patents or the GLAXO
Patents, or if having initiated such suit or action it thereafter diligently
fails to prosecute such suit or action, LGLS shall have the right, but not the
obligation, to bring, defend and maintain any appropriate suit or action for
abatement of the infringement or threatened infringement, at LGLS’s sole
expense. If LGLS requests GS to join LGLS as a party in such suit or action, GS
shall execute all papers and perform such other acts as may be reasonably
requested by LGLS, at LGLS’s expense. GS shall have the right to participate in
any such suit or action using independent counsel, at its sole expense. Any
amount recovered by LGLS as a result of such suit or action shall first be
applied to reimburse each of the Parties, pro rata, for any costs or expenses
incurred in bringing, defending and maintaining any such action. The balance
shall be divided equally between the Parties. The amount of any recovery, net of
the amounts necessary to reimburse the Parties as provided above shall be
considered “Net Sales” for purposes of calculating annual Net Sales in
accordance with Milestones 3 and in Section 10.2, below. If such recovery is
apportioned by the court such that portions thereof are attributed to infringing
activity in different calendar years, or if such apportionment of the recovery
can otherwise be readily ascertained, then such apportionment shall govern as to
the calendar year(s) in which Net Sales shall be deemed to have occurred for
purposes of such Milestones. Otherwise, the amount of such recovery shall be
apportioned equally over the number of calendar years in which infringement was
found to have occurred (or in the event of a settlement, over the number of
calendar years in which it was alleged to have occurred).

 

8.4 Third Party Claims. If a Third Party asserts that a patent or other right
owned by it is infringed by the development, manufacture, import, use, sale or
offer for sale of a Product by GS or its Affiliates or sub-licensees in the
Territory in the Field, the Party first obtaining knowledge of such claim shall
immediately provide the other Party notice of such claim and the related facts
in reasonable detail. In such event, the Parties shall determine how best to
control

 

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the defense of any such claim. In the event the Parties cannot agree on the
defense of such claim, such defense shall be controlled by GS with respect to
sales of Product in the Territory and by LGLS with respect to Product sales
outside of the Territory. In each such case, the other Party shall have the
right, at its own expense, to participate in such defense and to be represented
in any such action by counsel of its choice at its sole discretion. With respect
to any such claim, the Party entitled to control defense shall also have the
right to control settlement of such claim; provided, however, that no settlement
shall be entered into without the written consent of the other Party, which
consent shall not be withheld unreasonably.

 

8.5 Ownership. Subject to Section 9.2, below, each Party shall have and retain
sole and exclusive title to all inventions, discoveries and know-how which are
made, conceived, reduced to practice or generated solely by its employees or
agents in the course of or as a result of this Agreement. Each Party shall own
an equal undivided interest in all such inventions, discoveries and know-how
made, conceived, reduced to practice or generated jointly by the employees or
agents of one Party and the employees or agents of the other Party.

 

ARTICLE 9

LICENSES and OPTIONS

 

9.1 License Grant by LGLS. Subject to the terms and conditions of this
Agreement, LGLS hereby grants to GS and GS hereby accepts from LGLS a sole and
exclusive license under the LGLS Patents, LGLS Know-How, GLAXO Patents, GLAXO
Know-how to use, import, package, sell and offer for sale Products within the
Field in the Territory, as well as the exclusive right to use the Trademarks in
the Territory in conjunction with the use or sale of Products.

 

9.2 License Grant by GS. Subject to the terms and conditions of this Agreement,
GS hereby grants to LGLS and LGLS hereby accepts from GS a ***** license under
the GS Know-How to develop, use, import, formulate, package, sell and offer for
sale Products outside of the Territory. Without limiting the foregoing, the
Parties agree that any patent application filed by or on behalf of GS prior to
January 1, 2010 which covers or claims any novel use or formulation or means of
administration of Product shall be jointly owned by the Parties regardless of
inventorship, and to the extent of LGLS’s ownership interest shall be considered
an “LGLS Patent” for purposes of this Agreement. At LGLS’s request GS shall take
all steps reasonably required to assign to LGLS its joint ownership interest.

 

9.3 Sub-licensing. GS may sub-license the license granted to it hereunder on
prior notice to LGLS. LGLS may sub-license the license granted to it with
respect to GS Know-how *****.

 

9.4 Use of Licenses. Neither Party shall use or disseminate the Know-how of the
other Party other than as expressly provided under this Agreement. In addition,
GS warrants that it shall not adapt the GLAXO databases included in the GLAXO
Knowhow or software operating on such databases for uses unrelated to the uses
of Product authorized herein.

 

9.5 *****. During the period commencing ***** (the “Negotiating Period”), the
Parties shall in good faith negotiate the terms and conditions on which LGLS
would grant to GS

 

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*****. During the Negotiating Period LGLS shall not solicit or otherwise
participate in any communications with any Third Party regarding *****.

 

9.6 DNA Nanobinder Compounds. Schedule 9.6 hereto describes GS’s DNA nanobinder
compounds being developed for use in the fields of *****(each, a “GS Option
Field”). Promptly following the completion of the first Phase II clinical trial
for a DNA nanobinder compound in each of the GS Option Fields, GS shall notify
LGLS and disclose to LGLS all available preclinical and clinical data regarding
the use of such DNA nanobinder compound in the GS Option Field in question.
During the ***** period following such closure the Parties shall in good faith
negotiate the terms and conditions on which GS would grant to LGLS the exclusive
right to develop and commercialize such DNA nanobinder compound in the GS Option
Field in question in East Asia, including Japan. If the Parties are unable to
reach agreement by the end of such ***** period, GS shall be free to develop and
commercialize such DNA nanobinder compound in the GS Option Field in question as
it sees fit.

 

9.7 *****. In the event that LGLS proposes to grant commercial rights in the
Territory with respect to ***** to a Third Party, it shall first offer such
rights to GS on definitive terms. GS shall have ***** after receipt of such
offer to accept, failing which LGLS shall be free to offer such rights to a
Third Party on overall terms and conditions no more favorable to such Third
Party than those offered to GS. In the event that LGLS proposes to develop and
commercialize ***** in the Territory directly or in a collaboration with a Third
Party, it shall notify GS. Upon request by GS within ***** following such
notice, the Parties shall in good faith negotiate commercially reasonable terms
and conditions on which GS would receive from LGLS an exclusive license with
respect to such proposed development and commercialization. If the Parties are
unable to reach such agreement within ***** after GS’s notice, at GS’s request
the terms of such an exclusive license shall be set by *****, and the Parties
shall promptly execute a license agreement consistent with *****.

 

ARTICLE 10

PAYMENTS TO LGLS

 

10.1 License Fee. Within 45 days following the Effective Date GS shall: (i) pay
to LGLS a non-refundable license fee of $5.5 million, and (ii) deliver to LGLS
4,749,659 fully-paid up and non-assessable shares of GS common stock (the
“Shares”). GS represents and warrants that the Shares represent 14.0 percent of
the total equity of GS on October 22, 2002, calculated on a fully diluted basis.
The rights and further characteristics of the Shares (including, without
limitation, certain anti-dilution rights) are as set forth in the Stock Purchase
Agreement and related documents attached hereto as Schedule 10.1.

 

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10.2 Milestone Payments. Within ***** after the achievement of each milestone
set forth below, GS shall owe to LGLS a non-refundable milestone payment to LGLS
in the amount set forth below. Each milestone payment shall be due only once,
notwithstanding the number of Products actually developed or commercialized by
GS hereunder. Milestone payments 3 and 4, when earned by LGLS, shall be payable
*****. All other milestone payments shall be due ***** after the relevant
milestone event.

 

Milestone Event

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   Payment

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1. Upon FDA approval of the Product for the Initial Indication. If at the time
of such approval GS has not received and accepted the first shipment of Product
required pursuant to Section 5.8, one half of this milestone shall be deemed to
have been earned, with the second half earned upon receipt and acceptance by GS
of such shipment    $5.0 million 2. Upon an initial public offering (“IPO”) by
GS of its shares or a sale of GS if, at the time of such IPO or sale, Product
has been approved for an Initial Indication    $8.0 million

 

*****.

 

10.3 Royalty Payments. In addition to the foregoing license fee and milestone
payments, GS shall, subject to Sections 4.3 and 10.4, pay to LGLS royalties
*****The Parties acknowledge that LGLS has incurred a royalty obligation to
GLAXO at a rate of ***** percent of Net Sales for the use of the GLAXO Patents,
the GLAXO Know-how and the Trademarks (the “GLAXO Royalty”). During the first
two years following first commercial sale of a Product in the Territory, GS
shall be solely responsible for payment of the GLAXO Royalty and shall pay all
amounts so due to LGLS in accordance with Sections 10.7 through 10.11, below.
Thereafter, LGLS shall be responsible for payment of the GLAXO Royalty and shall
indemnify GS and hold GS harmless from and against any claims by GLAXO as a
result of such use.

 

10.4 Term of Royalty Obligations. GS’s obligation to make royalty payments
pursuant to Section 10.3 with respect to a Product shall commence on the date of
the first commercial sale of such Product in a given country in the Territory
and shall continue until the later of: *****. Following the expiration of GS’s
royalty obligations, GS shall retain a non-exclusive, royalty-free right to use,
sell and offer for sale Product in the Territory, using LGLS Know-how and GLAXO
Know-how licensed to GS as of the Effective Date and the exclusive right to use
the Trademarks for such purposes. GS shall continue to pay to LGLS a royalty in
return for such right to use the Trademark, as provided in Section 11.4, below.

 

10.5 Royalty Reductions. If GS is required to pay royalties to Third Parties in
order to exercise the license granted to GS in Section 9.1, above, with respect
to any Product in any country in the Territory, GS will be entitled to deduct
***** percent of the amount due to such

 

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Third Parties from the amounts due to LGLS pursuant to Section 10.3, above, with
respect to Net Sales of such Product in such country. In no event shall any such
royalty reductions in any calendar quarter be more than ***** percent of the
royalty payment due to LGLS with respect to such calendar quarter in a given
country. Any royalty reduction to which GS would otherwise be entitled may be
carried forward by GS and used by GS in a future period (subject to the maximum
reductions specified in this Section 10.5).

 

10.6 Royalties Payable Only Once; Sales to Affiliates and Sub-Licensees. The
obligation to pay royalties is imposed only once with respect to the same unit
of each Product. Sales of Products between GS and its Affiliates or
sub-licensees, or among such Affiliates and sub-licensees, shall not be subject
to royalties under Sections 10.3 but in such cases the royalties shall be
calculated on ***** by such Affiliates or sub-licensees to Third Parties.

 

10.7 Reports. GS shall deliver to LGLS, within ***** after the end of each
*****, reasonably detailed written accountings of Net Sales that are subject to
royalty payments due to LGLS for such *****. Such ***** reports shall indicate
gross sales on a country-by-country and Product-by-Product basis. When GS
delivers such reports to LGLS, GS shall also deliver all royalty payments due to
LGLS hereunder for such *****.

 

10.8 Accounting and Audits.

 

(a) GS shall keep, and shall require its Affiliates and sub-licensees to keep,
complete and accurate records of the latest five years of sales of Products on
which royalties are due hereunder. For the purpose of verifying royalties due to
LGLS hereunder, LGLS shall have the right annually, at LGLS’s expense, to retain
an independent certified public accountant selected by LGLS and reasonably
acceptable to GS, to review such records in the location(s) where such records
are maintained by GS, its Affiliates or its sub-licensees upon reasonable notice
and during regular business hours and under obligations of confidence. Results
of such review shall be made available to both LGLS and GS. If the review
reflects an underpayment of royalties to LGLS such underpayment shall be
promptly remitted to LGLS, together with*****. If the underpayment of royalties
is equal to or greater than *****, then GS pay all of the costs of such review.

 

(b) LGLS shall keep complete and accurate records of the latest five years of
supply hereunder sufficient to enable GS to confirm LGLS’s cost of goods. For
the purpose of verifying cost of goods, GS shall have the right annually, at
GS’s expense, to retain an independent certified public accountant selected by
GS and reasonably acceptable to LGLS, to review such records in the location(s)
where such records are maintained, upon reasonable notice and during regular
business hours and under obligations of confidentiality. Results of such review
shall be made available to both LGLS and GS. If the review reflects an
overcharge by LGLS, such overcharge shall be promptly remitted to GS, together
with interest calculated in the manner provided in Section 10.9, below. If the
amount of such overcharge is equal to or greater than*****, then LGLS pay all of
the costs of such review. If the review reflects an undercharge by LGLS, GS
shall promptly refund the amount of the overpayment to LGLS, together with
*****.

 

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10.9 Currency and Method of Payment. All payments due or payable hereunder shall
be made in US Dollars, delivered by wire transfer to such account as LGLS may
identify from time to time on notice to GS. Royalty payments due hereunder with
respect to sales not denominated in US Dollars shall be converted using the
applicable conversion rates quoted in the Wall Street Journal for buying US
Dollars in accordance with U.S. generally accepted accounting principles,
consistently applied. GS shall pay interest to LGLS on the amount of any
payments that are not paid on or before the date such payments are due under
this Agreement at a rate of ***** for the applicable period, calculated on the
number of days such payment is delinquent.

 

10.10 Tax Withholding. The Parties shall use all reasonable and legal efforts to
reduce tax withholding on payments made to LGLS hereunder. Notwithstanding such
efforts, if GS concludes that tax withholdings under the laws of any country are
required with respect to payments due to LGLS, GS shall withhold the required
amount and pay it to the appropriate governmental authority. In such a case, GS
will promptly provide LGLS with original receipts or other evidence reasonably
desirable and sufficient to allow LGLS to document such tax withholdings
adequately for purposes of claiming foreign tax credits and similar benefits. No
withholding deduction shall be made if LGLS furnishes lawful documentation
demonstrating that the payment due is exempt from withholding according to the
applicable convention for the avoidance of double taxation between the United
States and the Republic of Korea or other applicable law or treaty.

 

10.11 Blocked Payments. If, by reason of applicable laws or regulations in any
country, it becomes impossible or illegal for GS or its Affiliates or
sub-licensees to transfer, or have transferred on its behalf, royalties or other
payments due hereunder to LGLS, such royalties or other payments shall be
deposited in local currency in the relevant country to the credit of LGLS in a
recognized banking institution designated by LGLS or, if none is designated by
LGLS within a period of 30 days after inquiry from GS, in a recognized banking
institution selected by GS and identified by notice to LGLS.

 

ARTICLE 11

TRADEMARKS

 

11.1 Responsible Party. GS, in consultation with LGLS, shall be responsible for
maintaining the trademark Factive® in all countries in the Territory in which
such mark is registered as of the Effective Date and for establishing and
maintaining such trademark in other countries in the Territory in which GS
intends to Commercialize the Products, all at GS’s expense.

 

11.2 Infringement and Third Party Claims. Each party shall afford the other full
cooperation in the defense and assertion of the Trademarks against Third
Parties. Absent agreement by the Parties, the provisions of Sections 8.2 and 8.3
shall apply by analogy with respect to infringement of or Third Party challenges
to the Trademarks.

 

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11.3 Termination of the Agreement. Following termination of this Agreement for
any reason (but not expiration of its term) GS will refrain from all further use
of the Trademarks in the Territory.

 

11.4 Expiration of the Agreement. Following expiration of GS’s royalty
obligations as provided in Section 10.4, above, and for so long as GS continues
to use the Trademark in the use or sale of Product, GS shall pay to LGLS a
royalty equal to *****. Such royalty shall be calculated and payable as provided
in Sections 10.7 through 10.11, above.

 

ARTICLE 12

REPRESENTATIONS, WARRANTIES AND COVENANTS

 

12.1 Joint Representations and Warranties. Each of the Parties hereby represents
and warrants to the other Party that this Agreement is a legal and valid
obligation binding upon such Party and enforceable in accordance with its terms.
The execution, delivery and performance of the 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 is bound, nor violate any law or regulation
of any court, governmental body or administrative or other agency having
jurisdiction over it.

 

12.2 Representations and Warranties by LGLS. LGLS represents and warrants to GS
that, as of the Effective Date, to the actual knowledge of the executive
officers and directors of LGLS:

 

(a) The information disclosed to GS during the course of its “due diligence”
review of materials related to the Product was true and correct and, through the
Effective Date, no material information has been omitted from the “due
diligence” disclosures made to GS by LGLS.

 

(b) No litigation exists or is threatened which would, if successful, adversely
affect the rights granted to GS hereunder.

 

(c) All material safety issues related to the Product and to its manufacture
have been disclosed to GS.

 

(d) All renewal fees related to the LGLS Patents, the GLAXO Patents and the
Trademarks have been paid in full.

 

(e) LGLS has good title to the LGLS Patents, the GLAXO Patents, the LGLS
Know-how and the GLAXO Know-how and to the Trademarks (to the extent that
filings thereof exist as of the Effective Date), free and clear of any liens or
encumbrances.

 

(f) As of the Effective Date LGLS has not been served with notice of any
interference proceedings with respect to the LGLS Patents or the GLAXO Patents
and to the actual knowledge of LGLS, no such proceedings have been instituted.
To the actual knowledge

 

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of LGLS, as of the Effective Date there is no existing Third Party infringement
of the LGLS Patents, the GLAXO Patents or the Trademarks.

 

(g) The information submitted to the Regulatory Authorities with respect to the
Product is true and correct.

 

(h) It has disclosed to GS the complete texts of all of the LGLS Patents and the
GLAXO Patents existing as of the Effective Date as well as all information known
to LGLS as of the Effective Date concerning the institution or possible
institution of any interference, opposition, re-examination, reissue,
revocation, nullification or any official proceeding involving any of the LGLS
Patents or GLAXO Patents any where in the Territory.

 

12.3 Covenants by LGLS. LGLS hereby covenants that: (i) the Transition Plan
contemplated by Section 2.1 of the GLAXO Agreement shall be completed in full
not later than December 31, 2002, (ii) LGLS shall use its best efforts to
finalize the Technology Transfer Agreement contemplated by Section 3.4 of the
GLAXO Agreement not later than January 31, 2003, and (iii) LGLS shall use its
best efforts to finalize the Supply Agreement contemplated by Section 8.1 of the
GLAXO Agreement, on terms and conditions consistent with this Agreement, not
later than January 31, 2003. LGLS shall indemnify GS and hold GS harmless from
and against any and all losses resulting from the failure by LGLS to complete
the Transition Plan or to finalize the Technology Transfer Agreement or the
Supply Agreement by the dates specified in this Section 12.3.

 

*****

 

12.4 Performance by Affiliates and Sub-licensees. The Parties recognize that
each may perform some or all of its obligations under this Agreement through
Affiliates or, to the extent permitted, by sub-licensees. Nonetheless, each
Party shall remain responsible and shall be the guarantor of the performance by
its Affiliates and sub-licensees and shall cause its Affiliates and
sub-licensees to comply with the provisions of this Agreement in connection with
such performance. In the event of a dispute arising out of the actions of an
Affiliate or sub-licensee under this Agreement, each of GS and LGLS may proceed
directly against the other Party, without any obligation to first proceed
against the Affiliate or sub-licensee.

 

ARTICLE 13

TERM AND TERMINATION

 

13.1 Term. The term of this Agreement shall commence on the Effective Date and
shall expire upon the termination or expiration in all of the countries of the
Territory of the royalty obligations as set forth in Section 10.4, above.

 

13.2 Termination for Material Breach. If either Party materially breaches this
Agreement at any time, which breach is not cured within ***** of notice thereof
from the non-breaching Party, the non-breaching Party shall have the right to
terminate this Agreement on notice to the Party in breach following the
expiration of such cure period; provided, however, that if the Party alleged to
be in breach shall have invoked the dispute resolution mechanism of Article 15
prior to the expiration of such cure period then termination shall not be
effective until the sooner of abandonment of such proceedings by the Party
alleged to be in breach or

 

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* Confidential Treatment has been requested for the marked portions.

 

22

--------------------------------------------------------------------------------

completion of the dispute resolution proceedings and a non-appealable finding in
arbitration in favor of the non-breaching Party.

 

13.3 Termination for Challenge to Patent Rights. If either Party challenges the
validity and/or enforceability of any of the other Party’s patent rights to
which a license is granted hereunder, the latter Party shall have the right, to
the extent lawful, to terminate the license granted pursuant to this Agreement
with respect to the challenged patents.

 

13.4 Unilateral Termination by GS. GS may, at any time by delivery of 30 days’
prior notice to LGLS, elect to abandon its rights and obligations with respect
to any country in the Territory, or to terminate this Agreement in its entirety.
GS shall be entitled to suspend or discontinue its Development, distribution
and/or sale of any Product immediately upon notice to LGLS if *****. Upon notice
by GS pursuant to this Section 13.4, this Agreement and all obligations of LGLS
and GS hereunder with respect to the country or countries in question shall
terminate and GS shall promptly transfer to LGLS all Marketing Authorization
Applications and Regulatory Approvals and the Trademarks with respect to the
country or countries in question, as well as all other Information and know-how
related to such country or countries. In the event that GS terminates its rights
with respect to one or more countries but not the entire Territory, then this
Agreement shall remain in effect with respect to the countries not subject to
such termination which countries shall, thereafter, be considered the
“Territory.”

 

13.5 Bankruptcy. All rights granted hereunder are, and shall otherwise be deemed
to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code (the “Code”)
licenses of rights to “intellectual property” as defined in Section 101(52) of
the Code. The licensee Party under this Agreement shall retain and may fully
exercise all of its rights and elections under the Code, subject to performance
by such Party of its obligations under this Agreement. In the event of the
commencement of a bankruptcy proceeding by or against a Party under the Code,
the licensee Party shall, to the extent permitted by law, be entitled to a
complete duplicate of (or complete access to, as appropriate) any such
intellectual property and all embodiments thereof, which shall promptly be
delivered to the licensee Party, at its sole expense: (i) upon written request
following commencement of a bankruptcy proceeding, or (ii) if not delivered
pursuant to subsection (i), above, upon written request following the rejection
in bankruptcy of this Agreement by or on behalf of the bankrupt Party. In the
event of a filing for bankruptcy or insolvency by a Party, such Party shall, to
the extent permitted by law, confirm to the receiver, trustee or liquidator that
the intellectual property rights licensed hereunder are, notwithstanding such
license, the sole property of the licensor Party and may not be disposed of by
licensee except as expressly provided herein.

 

13.6 Minimum Sales. LGLS shall have the right to terminate this Agreement on
notice to GS in the event that GS’s aggregate gross sales of Products in the
Territory in the *****; provided, however, that such right to terminate shall
not apply in the event that GS sales of Product were at any time materially
impeded by either force majeure or failure of supply outside of GS’s control.

 

--------------------------------------------------------------------------------

* Confidential Treatment has been requested for the marked portions.

 

23

--------------------------------------------------------------------------------

13.7 Effect of Termination

 

13.7.1 Termination of this Agreement shall not relieve the Parties of any
liability, including any obligation to make payments hereunder, which accrued
hereunder prior to the effective date of such termination, nor preclude a Party
from pursuing all rights and remedies it may have hereunder or at law or in
equity with respect to any breach of this Agreement nor prejudice a Party’s
right to obtain performance of any obligation which accrued hereunder prior to
the effective date of such termination. Upon termination (but not expiration of
the term of this Agreement), all licenses and rights to Patents and Know-How
granted hereunder shall terminate.

 

13.7.2 Upon termination of this Agreement (but not expiration of its term), all
Confidential Information supplied by one Party shall be returned by the other
Party except for one copy of such information retained solely for legal archival
or regulatory purposes.

 

13.7.3 Upon termination of this Agreement (but not expiration of its term), GS
shall cooperate in the prompt transfer to LGLS of all Marketing Authorization
Applications and Regulatory Approvals related to the Products in the Territory,
and shall diligently take such other actions and execute such other instruments,
assignments and documents as may be necessary to effect the transfer or
reconveyance of rights hereunder to LGLS and the relinquishment of such rights
by GS.

 

13.7.4 Following termination of this Agreement, GS shall have 120 days to sell
any Product in its possession as of the effective date of termination, subject
to its obligation to pay royalties to LGLS as provided hereinabove with respect
to such sales.

 

13.8 Memorandum of Understanding. The Memorandum of Understanding shall
terminate effective as of the Effective Date.

 

13.9 Surviving Rights. The rights and obligations set forth in this Agreement
shall extend beyond the term or termination of the Agreement only to the extent
expressly provided for herein, or the extent that the survival of such rights or
obligations are necessary to permit their complete fulfillment or discharge.
Without limiting the foregoing, the following shall survive the expiration or
termination of this Agreement: Sections 5.11, 6.1, 6.2, 6.3, 7.4, 7.5, 7.7, 8.3,
8.4,, 10.7, 10.8, 11.2, 11.3, 11.4, and 13.7 and Articles 14, 15 and 16.

 

ARTICLE 14

INDEMNIFICATION

 

14.1 Indemnification by GS. GS shall defend and hold LGLS and its agents,
directors and employees harmless from and against any and all suits, claims,
actions, demands, damages, obligations, settlements, penalties, fines, costs,
liabilities, expenses and/or loss claimed by a Third Party, including reasonable
attorneys’ fees and expenses (collectively, “Losses”), resulting from *****,
except to the extent such Losses result from *****.

 

14.2 Indemnification by LGLS. LGLS shall defend and hold GS and its agents,
directors and employees harmless from and against any and all Losses resulting
from: *****, except to the extent such Losses result from *****.

 

--------------------------------------------------------------------------------

* Confidential Treatment has been requested for the marked portions.

 

24

--------------------------------------------------------------------------------

14.3 Procedure. A Party seeking indemnification under Section 14.1 or Section
14.2, shall inform the other Party of a claim as soon as reasonably practicable
after it receives notice of the Third Party claim, permit the indemnifying Party
to assume direction and control of the defense of the Third Party claim
(including the right to settle the claim solely for monetary consideration), and
cooperate as requested (at the expense of the indemnifying Party) in the defense
of the Third Party claim.

 

14.4 Insurance. Promptly following the Effective Date and for a period of *****
after the expiration or termination of this Agreement, each Party shall obtain
and thereafter maintain, at its sole cost and expense, product liability
insurance in amounts which are reasonable and customary in the U.S.
pharmaceutical industry for companies of comparable size and activities at the
respective place of business of each Party. Such product liability insurance
shall insure against all liability arising as a result of activities completed
or permitted under this Agreement (including, without limitation, liability for
personal injury, physical injury and property damage). Each Party shall provide
written proof of the existence of such insurance to the other Party promptly
upon request.

 

ARTICLE 15

DISPUTE RESOLUTION

 

15.1 Disputes. All disputes arising between the Parties hereunder or with
respect to this Agreement shall be resolved solely as provided in this Article
15. Any such dispute that the Parties are unable to resolve directly may be
referred by either Party to the Steering Committee for resolution. If the
Steering Committee is unable to resolve such dispute within 30 days after
referral, either Party may, on notice to the other, have such dispute referred
to the CEOs of LGLS and GS for attempted resolution by good faith negotiation.
If such individuals are unable to resolve such dispute within 30 days after
referral, then either Party may thereafter seek to resolve the dispute through
arbitration in accordance with the Rules of Arbitration of the International
Chamber of Commerce by one or more arbitrators appointed in accordance with such
rules, in English. The place of arbitration shall be London, England.

 

15.2 Applicable Law. This Agreement shall be governed by and construed under the
substantive laws of the State of California, without regard to conflicts of law
principles.

 

ARTICLE 16

MISCELLANEOUS

 

16.1 Assignment.

 

16.1.1 Either Party may assign all of its rights and obligations under this
Agreement to an Affiliate with the consent of the other Party, such consent not
to be unreasonably withheld or delayed.

 

16.1.2 A Party may assign its rights or obligations under this Agreement to a
non-Affiliate without the approval of the other Party only in connection with a
merger of that Party with a Third Party, acquisition of that Party by a Third
Party, a similar reorganization affecting that Party, or in connection with the
sale by that Party to a Third Party of all or substantially all of the assets to
which this Agreement relates. This Agreement shall survive any

 

--------------------------------------------------------------------------------

* Confidential Treatment has been requested for the marked portions.

 

25

--------------------------------------------------------------------------------

such merger, acquisition or reorganization of a Party with or into, or such sale
of assets to, another party and no consent for such merger, acquisition,
reorganization or sale shall be required hereunder; provided, however, that in
the event of such merger, acquisition, reorganization or sale, no intellectual
property rights of the other merging or acquiring corporation shall be included
in the intellectual property licensed hereunder. This Agreement shall be binding
upon and inure to the benefit of the successors and permitted assigns of the
Parties. Any assignment not in accordance with this Agreement shall be void.

 

16.1.3 In the event of an assignment resulting from a merger or acquisition
permitted pursuant to Section 16.1.2, above, LGLS and its successor entity shall
endeavor to assure that GS confidential information provided under this
Agreement is kept confidential and distributed within the successor entity
solely to the limited extent necessary in order to satisfy such entity’s
obligations, and exercise such entity’s rights, with respect to Gemifloxacin
hereunder.

 

16.2 Force Majeure. Except as otherwise expressly provided herein, neither Party
shall lose any rights hereunder or be liable to the other Party for damages or
losses on account of failure of performance by the defaulting Party if the
failure is occasioned by government action, war, acts of gods, or any other
similar or dissimilar cause beyond the control of the defaulting Party, provided
that the Party claiming force majeure has exerted all reasonable efforts to
avoid or remedy such force majeure.

 

16.3 Further Actions. Each Party agrees to execute, acknowledge and deliver such
further instruments, and to do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement.

 

16.4 Notices. All notices hereunder shall be in writing and shall be deemed
given if delivered personally or by facsimile transmission with confirmed
answer-back, mailed by registered mail (return receipt requested), postage
prepaid, or sent by internationally recognized express courier service, to the
Parties at the addresses first set forth above (or at such other address for a
Party as shall be specified by like notice; provided, that notices of a change
of address shall be effective only upon receipt thereof). Notice by personal
delivery shall be deemed effective upon receipt. Notice by courier or registered
mail shall be deemed effective three business dates after the date sent. Notice
by fax shall be deemed effective upon receipt by the sending Party of
confirmation of receipt of the fax by the receiving Party.

 

16.5 Waiver. The waiver from time to time by either of the Parties of any of
their rights or their failure to exercise any remedy shall not operate or be
construed as a continuing waiver of same or of any other of such Party’s rights
or remedies provided in this Agreement.

 

16.6 Severability. If any term, covenant or condition of this Agreement or the
application thereof to any Party or circumstance shall, to any extent, be held
to be invalid or unenforceable, then the remainder of this Agreement, or the
application of such term, covenant or condition to Parties or circumstances
other than those as to which it is held invalid or unenforceable, shall not be
affected thereby and each term, covenant or condition of this

 

26

--------------------------------------------------------------------------------

Agreement shall be valid and be enforced to the fullest extent permitted by law.
In such event the Parties shall in good faith attempt to reform this Agreement
to reflect the intent and anticipated consequences of the invalidated or
unenforceable provision, to the extent possible in a way that is lawful.

 

16.7 Ambiguities. Ambiguities, if any, in this Agreement shall not be construed
against either Party, irrespective of which Party may be deemed to have authored
the ambiguous provision.

 

16.8 Headings. The section and article heading contained herein are for the
purposes of convenience only and are not intended to define or limit the
contents of said sections or articles.

 

16.9 Counterparts. This Agreement may be executed in two counterparts, each of
which shall be deemed an original, but which together shall constitute one and
the same instrument.

 

16.10 Entire Agreement. This Agreement (including all Schedules hereto) sets
forth all the covenants, promises, agreements, warranties, representations,
conditions and understanding between the Parties hereto and supersedes and
terminates all prior agreements and understanding between the Parties.

 

16.11 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE
OTHER HEREUNDER FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES,
WHETHER IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE.

 

IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate
originals by their proper officers as of the Effective Date.

 

GENESOFT PHARMACEUTICALS, INC.       LG LIFE SCIENCES, LTD. By:   /s/    David
B. Singer               By   /s/    Heung Joon Yang            

--------------------------------------------------------------------------------

         

--------------------------------------------------------------------------------

Its:

  Chairman and CEO      

Its:

  President and CEO    

--------------------------------------------------------------------------------

         

--------------------------------------------------------------------------------

 

27

--------------------------------------------------------------------------------

Schedule 1.4

API Specification

 

*****

--------------------------------------------------------------------------------

* Confidential Treatment has been requested for the marked portions.

--------------------------------------------------------------------------------

Schedule 1.12

Final Product Specification

 

*****

--------------------------------------------------------------------------------

* Confidential Treatment has been requested for the marked portions.

--------------------------------------------------------------------------------

Schedule 1.14

Gemifloxacin

 

*****

--------------------------------------------------------------------------------

* Confidential Treatment has been requested for the marked portions.

--------------------------------------------------------------------------------

Schedule 1.17

GLAXO Knowhow

 

“GLAXO Knowhow” shall mean the following inventions and discoveries, to the
extent that they were conceived, devised and/or reduced to practice by GSK as of
the September 30, 2002, and which are not yet the subject of patent
applications:

 

*****

--------------------------------------------------------------------------------

* Confidential Treatment has been requested for the marked portions.

--------------------------------------------------------------------------------

Schedule 1.18

GLAXO Patents

 

*****

--------------------------------------------------------------------------------

* Confidential Treatment has been requested for the marked portions.

--------------------------------------------------------------------------------

Schedule 1.24

 

*****

--------------------------------------------------------------------------------

* Confidential Treatment has been requested for the marked portions.

--------------------------------------------------------------------------------

Schedule 1.27

LGLS Patents

 

*****

--------------------------------------------------------------------------------

* Confidential Treatment has been requested for the marked portions.

--------------------------------------------------------------------------------

Schedule 1.38

Trademark

 

FACTIVE

 

Country

--------------------------------------------------------------------------------

  

Class(es)

--------------------------------------------------------------------------------

  

Status

--------------------------------------------------------------------------------

  

App. No.

--------------------------------------------------------------------------------

  

App. Date

--------------------------------------------------------------------------------

  

Reg. No.

--------------------------------------------------------------------------------

  

Reg. Date

--------------------------------------------------------------------------------

Andorra    5    Registered    12191    19/11/1998    11723    19/11/1998 5)
MEDICINES FOR HUMAN USE; PHARMACEUTICAL PRODUCTS; REMEDIES FOR HUMAN USE

--------------------------------------------------------------------------------

Austria    5    Registered    AM2218/96    12/04/1996    166024    30/08/1996 5)
PHARMACEUTICAL AND MEDICAL PREPARATIONS AND SUBSTANCES FOR HUMAN USE

--------------------------------------------------------------------------------

Canada         Filed    79870600    01/12/1995           ) ANTI-VIRAL
PREPARATIONS AND SUBSTANCES FOR HUMAN USE

--------------------------------------------------------------------------------

Denmark    5    Registered    VA199600283    16/01/1996    VR199600791   
02/02/1996 5) PREPARATIONS AND SUBSTANCES FOR THE TREATMENT OF RESPIRATORY
DISORDERS

--------------------------------------------------------------------------------

European Union    5    Registered    000950352    08/10/1998    000950352   
31/01/2000 5) PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES

--------------------------------------------------------------------------------

Finland    5    Registered    T199802485    21/07/1998    214152    14/05/1999
5) PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES FOR HUMAN USE;
SPECIFICALLY AN ANTI-BACTERIAL

--------------------------------------------------------------------------------

France    5    Registered    95600030    07/12/1995    95600030    07/12/1995 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES FOR HUMAN USE

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

Greece   5   Registered   128137   31/01/1996   128137   17/03/1998 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES FOR HUMAN USE

--------------------------------------------------------------------------------

Iceland   5   Registered   351/1996   12/03/1996   1216/1996   25/11/1996 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES FOR HUMAN USE,
INCLUDING AN ANTI-VIRAL

--------------------------------------------------------------------------------

Ireland   5   Registered   95/8291   05/12/1995   171292   05/12/1995 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES FOR HUMAN USE

--------------------------------------------------------------------------------

Italy   5   Registered   MI95CO12228   06/12/1995   00733838   14/11/1997 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES FOR HUMAN USE

--------------------------------------------------------------------------------

Mexico   5   Registered   260065   17/04/1996   542746   27/02/1997 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES FOR HUMAN USE

--------------------------------------------------------------------------------

Monaco   5   Registered   020534   17/02/1999   99.20373   17/02/1999 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES

--------------------------------------------------------------------------------

Netherlands Antilles   5   Registered   D-900   24/12/1998   21301   09/02/1999
5) PHARMACEUTICAL, VETERINARY AND SANITARY PREPARATIONS; DIETETIC SUBSTANCES
ADAPTED FOR MEDICAL USE, FOOD FOR BABIES; PLASTERS, MATERIALS FOR DRESSINGS;
MATERIAL FOR STOPPING TEETH, DENTAL WAX; DISINFECTANTS; PREPARATIONS FOR
DESTROYING VERMIN; FUNGICIDES, HERBICIDES

--------------------------------------------------------------------------------

Norway   5   Filed   200112664   25/10/2001         5) ANTI-INFECTIVE
PREPARATIONS FOR HUMAN USE

--------------------------------------------------------------------------------

Norway   5   Registered   19961885   19/03/1996   182042   15/05/1997 5)
PHARMACEUTICAL PREPARATIONS FOR THE TREATMENT OF RESPIRATORY DISORDERS

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

Portugal   5   Registered   314842   15/01/1996   314842   14/10/1996 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES FOR HUMAN USE

--------------------------------------------------------------------------------

Spain   5   Registered   2184599   18/09/1998   2184599   05/10/1999 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES FOR HUMAN USE

--------------------------------------------------------------------------------

Sweden   5   Registered   95-14489   13/12/1995   315811   09/08/1996 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES FOR HUMAN USE

--------------------------------------------------------------------------------

Switzerland   5   Registered   00225/1996   16/01/1996   433454   30/12/1996 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES FOR HUMAN USE, EXCEPT
FOR DISINFECTANT OR STERILIZATION PURPOSES

--------------------------------------------------------------------------------

United Kingdom   5   Registered   2041126   13/10/1995   2041126   13/10/1995 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES FOR HUMAN USE, BUT NOT
INCLUDING ANY SUCH GOODS BEING DISINFECTANTS OR STERILIZING PREPARATIONS

--------------------------------------------------------------------------------

USA   5   Registered   75045500   19/01/1996   2281877   28/09/1999 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES FOR HUMAN USE, NAMELY,
ANTI-VIRALS AND ANTI-INFECTIVES

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

FACTIVE DEV.

 

Country

--------------------------------------------------------------------------------

 

Class(es)

--------------------------------------------------------------------------------

 

Status

--------------------------------------------------------------------------------

 

App. No.

--------------------------------------------------------------------------------

 

App. Date

--------------------------------------------------------------------------------

 

Reg. No.

--------------------------------------------------------------------------------

 

Reg. Date

--------------------------------------------------------------------------------

Andorra   5   Registered           14905   14/07/2000 5) PHARMACEUTICAL AND
MEDICINAL PREPARATIONS AND SUBSTANCES

--------------------------------------------------------------------------------

Austria   5   Registered   AM4560/2000   21/06/2000   195230   04/04/2001 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES

--------------------------------------------------------------------------------

Canada       Filed   1066283   06/07/2000         ) PHARMACEUTICAL AND MEDICINAL
PREPARATIONS AND SUBSTANCES, NAMELY ANTI-VIRALS AND ANTI-INFECTIVES

--------------------------------------------------------------------------------

European Union   5   Registered   001721273   23/06/2000   001721273  
29/05/2001 5) PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES

--------------------------------------------------------------------------------

Iceland   5   Registered   2304/2000   29/06/2000   1149/2000   01/09/2000 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES

--------------------------------------------------------------------------------

Mexico   5   Registered   444544   28/08/2000   688725   28/02/2001 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES

--------------------------------------------------------------------------------

Monaco   5   Registered   022925   06/07/2001   01.22636   06/07/2001 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES

--------------------------------------------------------------------------------

Netherlands Antilles   5   Registered   D-395   10/07/2000   22486   01/11/2000
5) PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES

--------------------------------------------------------------------------------

Norway   5   Registered   200007413   27/06/2000   205945   07/12/2000 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES

--------------------------------------------------------------------------------

Switzerland   5   Registered   07922/2000   03/07/2000   480382   18/01/2001 5)
PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES FOR HUMAN USE, EXCEPT
FOR DISINFECTANT OR STERILISATION

--------------------------------------------------------------------------------

United Kingdom   5   Registered   2236543   20/06/2000   2236543   20/06/2000

--------------------------------------------------------------------------------

5) PHARMACEUTICAL AND MEDICINAL PREPARATIONS AND SUBSTANCES FOR HUMAN USE; BUT
NOT INCLUDING ANY SUCH GOODS BEING DISINFECTANTS OR STERILISING PREPARATIONS

--------------------------------------------------------------------------------

USA

  16   Filed   76054224   23/05/2000         16) PRINTED EDUCATIONAL MATERIALS,
NAMELY, BROCHURES AND PAMPHLETS CONCERNING HEALTHCARE RELATED ISSUES AND
PHARMACEUTICAL TREATMENTS FOR INFECTION

--------------------------------------------------------------------------------

USA

  42   Filed   76052305   18/05/2000         42) PROVIDING INFORMATION, VIA
GLOBAL COMPUTER NETWORKS, CONCERNING INFECTIOUS DISEASES, INCLUDING RESPIRATORY
TRACT INFECTIONS AND TREATMENTS THEREFORE

--------------------------------------------------------------------------------

USA

  5   Filed   76054223   23/05/2000         5) PHARMACEUTICALS, NAMELY,
ANTIBIOTICS

--------------------------------------------------------------------------------

FACPAC3 DAY

Country

--------------------------------------------------------------------------------

 

Class(es)

--------------------------------------------------------------------------------

 

Status

--------------------------------------------------------------------------------

 

App. No.

--------------------------------------------------------------------------------

 

App. Date

--------------------------------------------------------------------------------

 

Reg. No.

--------------------------------------------------------------------------------

 

Reg. Date

--------------------------------------------------------------------------------

USA

  5   Filed   78086704   03/10/2001         5) PHARMACEUTICALS, NAMELY,
ANTIBIOTICS IN TABLET FORM PACKAGED IN CONVENIENCE CARTONS TO ENSURE PATIENT
COMPLIANCE WITH RESPECT TO COMPLETE COURSE OF MEDICATION FACPAC3 (STYLIZED)

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

Country

--------------------------------------------------------------------------------

 

Class(es)

--------------------------------------------------------------------------------

 

Status

--------------------------------------------------------------------------------

 

App. No.

--------------------------------------------------------------------------------

 

App. Date

--------------------------------------------------------------------------------

 

Reg. No.

--------------------------------------------------------------------------------

 

Reg. Date

--------------------------------------------------------------------------------

USA

  5   Filed   78034657   10/11/2000         5) PHARMACEUTICALS, NAMELY,
ANTIBIOTICS IN TABLET FORM PACKAGED IN CONVENIENCE CARTONS TO ENSURE PATIENT
COMPLIANCE WITH RESPECT TO COMPLETE COURSE OF MEDICATION

--------------------------------------------------------------------------------

FACPAC5 AND DEV.

Country

--------------------------------------------------------------------------------

 

Class(es)

--------------------------------------------------------------------------------

 

Status

--------------------------------------------------------------------------------

 

App. No.

--------------------------------------------------------------------------------

 

App. Date

--------------------------------------------------------------------------------

 

Reg. No.

--------------------------------------------------------------------------------

 

Reg. Date

--------------------------------------------------------------------------------

USA

  5   Filed   78028793   03/10/2000         5) PHARMACEUTICALS, NAMELY,
ANTIBIOTICS IN TABLET FORM PACKAGED IN CONVENIENCE CARTONS TO ENSURE PATIENT
COMPLIANCE WITH RESPECT TO COMPLETE COURSE OF MEDICATION

--------------------------------------------------------------------------------

FACPAC5 DAY

Country

--------------------------------------------------------------------------------

 

Class(es)

--------------------------------------------------------------------------------

 

Status

--------------------------------------------------------------------------------

 

App. No.

--------------------------------------------------------------------------------

 

App. Date

--------------------------------------------------------------------------------

 

Reg. No.

--------------------------------------------------------------------------------

 

Reg. Date

--------------------------------------------------------------------------------

USA

  5   Filed   78086709   03/10/2001         5) PHARMACEUTICALS, NAMELY,
ANTIBIOTICS IN TABLET FORM PACKAGED IN CONVENIENCE CARTONS TO ENSURE PATENT
COMPLIANCE WITH RESPECT TO COMPLETE COURSE OF MEDICATION

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

FACPAC5 (STYLIZED)

Country

--------------------------------------------------------------------------------

 

Class(es)

--------------------------------------------------------------------------------

 

Status

--------------------------------------------------------------------------------

 

App. No.

--------------------------------------------------------------------------------

 

App. Date

--------------------------------------------------------------------------------

 

Reg. No.

--------------------------------------------------------------------------------

 

Reg. Date

--------------------------------------------------------------------------------

USA

  5   Filed   78032521   26/10/200         5) PHARMACEUTICALS, NAMELY,
ANTIBIOTICS IN TABLET FORM PACKAGED IN CONVENIENCE CARTONS TO ENSURE PATIENT
COMPLIANCE WITH RESPECT TO COMPLETE COURSE OF MEDICATION

--------------------------------------------------------------------------------

FACPAC7 AND DEV.

Country

--------------------------------------------------------------------------------

 

Class(es)

--------------------------------------------------------------------------------

 

Status

--------------------------------------------------------------------------------

 

App. No.

--------------------------------------------------------------------------------

 

App. Date

--------------------------------------------------------------------------------

 

Reg. No.

--------------------------------------------------------------------------------

 

Reg. Date

--------------------------------------------------------------------------------

USA

  5   Filed   78028794   03/10/2000         5) PHARMACEUTICALS, NAMELY,
ANTIBIOTICS IN TABLET FORM PACKAGED IN CONVENIENCE CARTONS TO ENSURE PATIENT
COMPLIANCE WITH RESPECT TO COMPLETE COURSE OF MEDICATION

--------------------------------------------------------------------------------

FACPAC7 DAY

Country

--------------------------------------------------------------------------------

 

Class(es)

--------------------------------------------------------------------------------

 

Status

--------------------------------------------------------------------------------

 

App. No.

--------------------------------------------------------------------------------

 

App. Date

--------------------------------------------------------------------------------

 

Reg. No.

--------------------------------------------------------------------------------

 

Reg. Date

--------------------------------------------------------------------------------

USA

  5   Filed   78086707   03/10/2001         5) PHARMACEUTICALS, NAMELY,
ANTIBIOTICS IN TABLET FORM PACKAGED IN CONVENIENCE CARTONS TO ENSURE PATIENT
COMPLIANCE WITH RESPECT TO COMPLETE COURSE OF MEDICATION

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

FACPAC7 (STYLIZED)

Country

--------------------------------------------------------------------------------

 

Class(es)

--------------------------------------------------------------------------------

 

Status

--------------------------------------------------------------------------------

 

App. No.

--------------------------------------------------------------------------------

 

App. Date

--------------------------------------------------------------------------------

 

Reg. No.

--------------------------------------------------------------------------------

 

Reg. Date

--------------------------------------------------------------------------------

USA

  5   Filed   78032520   26/10/2000         5) PHARMACEUTICALS, NAMELY,
ANTIBIOTICS IN TABLET FORM PACKAGED IN CONVENIENCE CARTONS TO ENSURE PATIENT
COMPLIANCE WITH RESPECT TO COMPLETE COURSE OF MEDICATION FAST.ACTIVE.FACTIVE

Country

--------------------------------------------------------------------------------

 

Class(es)

--------------------------------------------------------------------------------

 

Status

--------------------------------------------------------------------------------

 

App. No.

--------------------------------------------------------------------------------

 

App. Date

--------------------------------------------------------------------------------

 

Reg. No.

--------------------------------------------------------------------------------

 

Reg. Date

--------------------------------------------------------------------------------

USA

  16   Filed   76092242   19/07/2000         16) PRINTED EDUCATIONAL MATERIALS,
NAMELY BROCHURES, PAMPHLETS, AND BOOKLETS CONCERNING RESPIRATORY TRACT
INFECTIONS AND TREATMENTS THEREOF

--------------------------------------------------------------------------------

USA

  5   Filed   76092240   19/07/2000        

--------------------------------------------------------------------------------

5) PHARMACEUTICALS, NAMELY ANTIBIOTICS

 

FACTIVE.COM

FACTIVE.ORG

FACTIVE.NET

FACTIVE.BIZ

FACTIVE.INFO

--------------------------------------------------------------------------------

Schedule 9.6

DNA Nanobinder Compounds

 

*****

 

--------------------------------------------------------------------------------

* Confidential Treatment has been requested for the marked portions.