Exhibit 10.44

LICENSE, SUPPLY AND MARKETING AGREEMENT

THIS LICENSE, SUPPLY AND MARKETING AGREEMENT (this “Agreement”) is made
effective as of December 28th, 2006 (the “Effective Date”) by and between
Oscient Pharmaceuticals Corporation, a Massachusetts corporation with a
principal place of business at 1000 Winter Street, Suite 2200, Waltham,
Massachusetts (“Oscient”), Menarini International Operation Luxembourg SA, a
Luxembourgian company with a place of business at 1, Avenue de La Gare, L-1611
Luxembourg GD (“MIOL”) Oscient and MIOL are each hereafter referred to
individually as a “Party” and together as the “Parties”.

WHEREAS, Oscient is the owner or licensee of certain patent rights, know-how,
trademark rights and other intellectual property rights relating to the Compound
in the Territory (each as defined below); and

WHEREAS, Oscient wishes to grant MIOL rights under such intellectual property
rights and appoint MIOL as its exclusive distributor of the Finished Product (as
defined below) in the Territory and MIOL wishes to obtain such a license on the
terms and subject to the conditions set forth below; and

WHEREAS, the Active Pharmaceutical Ingredient (as defined below) for the
Finished Product is manufactured by L.G. Life Sciences Ltd and supplied to
Oscient to fulfill Oscient and its sublicensees’ requirements for Active
Pharmaceutical Ingredient; and

WHEREAS, the Parties desire that Oscient supply MIOL with such Active
Pharmaceutical Ingredient under this Agreement on the terms and subject to the
conditions set forth below.

NOW THEREFORE, in consideration of the mutual covenants contained herein, and
for other good and valuable consideration, the receipt and adequacy of which are
hereby acknowledged, the Parties hereby agree as follows:

 

1. DEFINITIONS AND INTERPRETATION

1.1 Definitions. Whenever used in the Agreement with an initial capital letter,
the terms defined in this Section 1.1 shall have the meanings specified.

 

  (a) “ABS” shall mean acute bacterial sinusitis.

 

  (b) “Active Pharmaceutical Ingredient” shall mean the Compound in active bulk
form meeting the Specifications.

 

  (c) “Actual Weighted Average Price Per Tablet” shall mean, subject to
Section 9.2(d)(iii), the product of (i) the quotient equal to (A) the sum of the
Gross Sales in Euros for each country in the Territory for the applicable
Quarter, divided by (B) the total number of Tablets sold by MIOL and its
Affiliates and Sub-Distributors in the Territory in the applicable Quarter (as
determined using verifiable, written data from MIOL), multiplied by (ii) [*]%,
multiplied by (iii) the Calculated Exchange Rate; provided that, Gross Sales and
the total number of Tablets sold by MIOL and its Affiliates and Sub-Distributors
in the Territory for the first whole Quarter after the First Commercial Sale
shall include Gross Sales and Tablets sold by MIOL and its Affiliates and
Sub-Distributor in the prior partial Quarter, if any.

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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  (d) “Additional Products” shall mean any pharmaceutical product that (i) is
not the Finished Product, and (ii) is a formulation of a product containing the
Compound as an active ingredient except any single enantiomer-based product
containing gemifloxacin as an active ingredient.

 

  (e) “Adverse Event” shall have the meaning as set forth in the
Pharmacovigilance Joint Operating Policy to be agreed between the Parties
pursuant to Section 8.3.

 

  (f) “AECB” shall mean acute bacterial exacerbations of chronic bronchitis.

 

  (g) “Affiliate” shall mean in respect of any Party any corporation, firm,
limited liability company, partnership or other entity which controls or is
controlled by or is under common control with such Party. For the purpose of
this definition only, “control” means direct or indirect beneficial ownership of
fifty percent (50%) or more of the shares of stock entitled to vote for the
election of directors, in the case of a corporation, or fifty percent (50%) or
more of the equity interests in the case of any other type of legal entity,
status as a general partner in any partnership, or any other arrangement whereby
a party controls or has the right to control the Board of Directors or
equivalent governing body of a corporation or other entity.

 

  (h) “Annual Exchange Rate” shall mean the quotient determined by dividing
(i) the sum of the conversion rate for Euros to U.S. Dollars existing in the
United States (as reported in The Wall Street Journal) on each Business Day in
the twelve-month period preceding the date upon which the Annual Exchange Rate
is to be calculated, by (ii) the number of Business Days in such twelve-month
period. If The Wall Street Journal ceases to be published, then the rate of
exchange to be used shall be that reported in such other business publication of
national circulation in the United States as the Parties reasonably agree.

 

  (i) “Annual Calculated Exchange Rate” shall be equal to (i) if the Annual
Exchange Rate is greater than [*]% of the Base-Exchange Rate and less than [*]%
of the Base-Exchange Rate, the Annual Exchange Rate, or (ii) if the Annual
Exchange Rate is less than [*]% of the Base-Exchange Rate or greater [*]% of the
Base-Exchange Rate, the number equal to:

 

Base-Exchange Rate – Annual Exchange Rate

   +    Annual Exchange Rate 2      

 

  (j)

“Applicable Law” shall mean all applicable laws, rules and regulations,
including any rules, regulations, guidelines or other requirements of any
Regulatory Authority and industry guidelines or codes of conduct, that may be in
effect from time to time, including relevant provisions of Directive 2001/83/EC,
Regulation (EC) 726/2004, relevant national, International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use (“ICH”), European Commission and

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

 

Committee for Medicinal Products for Human Use (“CHMP”) guidance and, in
particular, those guidelines published by the European Commission in the Rules
Governing Medicinal Products in the European Union, as updated and amended from
time to time and, in each case where relevant, the national implementations of
these rules.

 

  (k) “Assumed Weighted Average Price Per Tablet” shall mean the product of
(i) the weighted average reimbursed ex-factory per tablet price in Euros (as
determined or accepted by the applicable Regulatory Authority (as set forth in
Section 9.5(b) herein) at the time of calculation) for [*], as determined within
thirty (30) days of the date of the first calculation of the Transfer Price,
multiplied by (ii) [*]%, multiplied by (iii) the Calculated Exchange Rate;
provided that, (A) on and after the second anniversary of the First Commercial
Sale, the Assumed Weighted Average Price Per Tablet shall be equal to the last
Actual Weighted Average Price Per Tablet calculated pursuant to Section 9.2(c)
below, and (B) in no event shall the Assumed Weighted Average Price Per Tablet
be less than $[*] per Tablet.

 

  (l) “Base-Exchange Rate” shall be the currency factor for conversion of Euros
to Dollars equal to [*].

 

  (m) “Business Day” shall mean any day other than a Saturday or Sunday on which
banking institutions in both Massachusetts, United States of America and Grand
Duchy of Luxemburg are open for business.

 

  (n) “Calculated Exchange Rate” shall be equal to (i) if the Quarterly Exchange
Rate is greater than [*]% of the Base-Exchange Rate and less than [*]% of the
Base-Exchange Rate, the Quarterly Exchange Rate, or (ii) if the Quarterly
Exchange Rate is less than [*]% of the Base-Exchange Rate or greater [*]% of the
Base-Exchange Rate, the number equal to:

 

Base-Exchange Rate – Quarterly Exchange Rate

   +    Quarterly Exchange Rate 2      

 

  (o) “Call” shall mean a personal visit by a Sales Representative to a member
of the Target Audience in the Territory.

 

  (p) “CAP” shall mean community-acquired pneumonia of mild-to-moderate
severity.

 

  (q) “Centralized Procedure” shall mean the centralized procedure for obtaining
a Marketing Authorization in the European Union as set forth in Regulation (EC)
726/2004.

 

  (r) “Commercialize” and “Commercialization” shall mean (i) all activities
relating to the marketing, promotion, handling, distribution, storage, sale,
shipping, offer for sale and importation for sale of the Finished Product in the
Territory and (ii) all activities relating to the handling, storage, shipping
and importation of the Active Pharmaceutical Ingredient for the Finished
Product.

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

  (s) “Compound” shall mean the form of gemifloxacin mesylate having the
molecular formula [*].

 

  (t) “Confidential Information” shall mean with respect to a Party (the
“Receiving Party”), all information and materials (including compositions of
matter, assays and biological materials (if any)) which are disclosed by another
Party (the “Disclosing Party”) to the Receiving Party hereunder or to any of its
employees, consultants, Affiliates, licensees or, in the case of MIOL,
Third-Party Manufacturers or Sub-Distributors, except to the extent that the
Receiving Party can demonstrate by written record or other suitable physical
evidence that such information, (i) as of the date of disclosure is demonstrably
known to the Receiving Party or its Affiliates other than by virtue of a prior
confidential disclosure to the Receiving Party or its Affiliates by the
Disclosing Party; (ii) as of the date of disclosure is in, or subsequently
enters, the public domain, through no fault or omission of the Receiving Party;
(iii) is obtained from a Third Party having a lawful right to make such
disclosure free from any obligation of confidentiality to the Disclosing Party;
or (iv) is independently developed by or for the Receiving Party without
reference to or reliance upon any Confidential Information of the Disclosing
Party.

 

  (u) “Controlled” shall mean, with respect to any Patent Rights, know how,
Regulatory Documentation, Trademarks, the MIOL Information, the Oscient
Information or other intellectual property right, possession of the right,
whether directly or indirectly, and whether by ownership, license or otherwise
(other than pursuant to this Agreement), to grant access to such information or
Regulatory Documentation or to assign, or grant a license, sublicense or other
right to or under, such Patent Rights, information, Regulatory Documentation,
Trademarks or other intellectual property right as provided for herein, without
violating the terms of any agreement, or other arrangement, with any Third
Party.

 

  (v) “Copyrights” shall mean all copyright works including literary and
artistic works.

 

  (w) “Detail” or “Detailing” shall mean the communication by a Sales
Representative during a Call (i) involving face-to-face contact; (ii) describing
in a fair and balanced manner the approved indicated uses and other relevant
characteristics of the Finished Product; (iii) using marketing, promotional and
educational materials in an effort to increase the Target Audience prescribing
and/or hospital ordering preferences of the Finished Product for its approved
indicated uses; and (iv) made at the Target Audience member’s office, in a
hospital, at marketing meetings sponsored by MIOL or a Sub-Distributor for the
Finished Product or other appropriate venues conducive to pharmaceutical product
informational communication where the principal objective is to place an
emphasis, either primary, secondary or tertiary, on the Finished Product and not
simply to discuss the Finished Product with a member of the Target Audience.

 

  (x)

“Develop” and “Development” shall mean all activities relating to obtaining
advice on, seeking, obtaining and/or maintaining Regulatory Approvals and

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

 

public and private formulary listings, including clinical studies and trials
(subject to Section 6.3 herein), regulatory affairs, statistical analysis and
report writing and the preparation, submission, review and development of data
related thereto and all other pre-approval activities, but excluding
(i) activities relating to synthesis, manufacture or otherwise making or having
made any Active Pharmaceutical Ingredient, or any component or formulation
thereof; or (ii) non-clinical research and drug development activities of the
Finished Product.

 

  (y) “Development Plan” shall mean the plan for the Development of the Finished
Product in the Territory developed and agreed to by the Steering Committee on an
annual basis.

 

  (z) “Diligent Efforts” shall mean using commercially reasonable efforts and
resources, consistent with prudent business judgment, including the carrying out
of obligations or tasks consistent with the standard of practice in the
research-based pharmaceutical industry for the commercialization of a
pharmaceutical product having similar market potential, profit potential or
strategic value as the Finished Product, based on conditions then prevailing,
including the maturity of the Finished Product and the intellectual property
protection surrounding the Finished Product. Diligent Efforts requires that
MIOL, at a minimum, provided that such actions are commercially reasonable:
(i) determine the general industry practices with respect to the applicable
activities; (ii) reasonably promptly assign responsibility for such obligations
to specific employee(s) who are held accountable for progress, and monitor such
progress on an on-going basis; (iii) set and consistently seek to achieve
specific and meaningful objectives for carrying out such obligations; and
(iv) make and implement decisions and allocate resources designed to advance
progress with respect to such objectives; provided that, MIOL will not be found
not to have met its Diligent Effort obligations hereunder to the extent such
failure has been caused by Oscient’s failure to perform its obligations under
this Agreement.

 

  (aa) “EMEA” shall mean the European Medicines Agency and any successor agency
thereto.

 

  (bb) “Exploit” shall mean to Develop, Manufacture or Commercialize and
“Exploitation” means the act of Exploiting.

 

  (cc) “Finished Product” shall mean the pharmaceutical product containing the
Compound in finished tablet form labeled and packaged in accordance with
Applicable Law in the Territory, including the package inserts and other
components reasonably necessary for its sale or distribution in the Territory,
and ready for sale to the market or distribution as professional samples in the
Territory, but specifically excluding any single enantiomer-based product or
non-oral formulations.

 

  (dd) “First Commercial Sale” shall mean the date of the first arm’s length
sale of Finished Product in a country in the Territory after Regulatory Approval
for the Finished Product has been obtained in such country by or on behalf of
MIOL, other than sales by MIOL to Sub-Distributor.

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

  (ee) “Gross Sales” shall mean gross invoiced sales of the Finished Product
sold by MIOL, its Affiliates or a Sub-Distributor to Third Parties throughout
the Territory minus any Government Payments (calculated on a Per Tablet basis)
for the applicable period.

 

  (ff) “Government Payment” shall mean any mandatory rebate imposed by, or any
sum to be paid to, any national, supra-national, regional, state or local
regulatory agency, department, bureau, commission, council or other governmental
entity with respect to, in whole or in part, the Finished Product to the extent
identified on the relevant invoice or through other written, verifiable
evidence.

 

  (gg) “Good Manufacturing Practices” or “GMP” shall mean the then current
standards for good manufacturing practices in the Territory as promulgated under
Applicable Law, including Directive 2001/83/EC, Directive 2003/94/EC and any
applicable guidance on good manufacturing practices adopted pursuant to
Section 47 of Directive 2001/83/EC, in particular relevant guidance on good
manufacturing practices contained in Volume 4 of the Rules Governing Medicinal
Products in the European Union and the national implementations of these rules.

 

  (hh) “ICH Q7A” shall mean the good manufacturing practice guidance for active
pharmaceutical ingredients developed under the auspices of the International
Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use.

 

  (ii) “LG” shall mean L.G. Life Sciences Ltd or its successors or assigns.

 

  (jj) “LG License” shall mean the License and Option Agreement between Oscient
(formerly Genesoft Pharmaceuticals, Inc.) and LG dated October 22, 2002, as
amended from time to time.

 

  (kk) “Licensed Patent Rights” shall mean the Patent Rights set forth in
Schedule 1.1(kk) attached hereto.

 

  (ll) “Major Countries” shall mean each of France, Germany, Italy, Spain and
the United Kingdom.

 

  (mm) “Mandatory Supply Term” shall mean the period commencing on the First
Commercial Sale and continuing, until the later of (i) the expiration of the
last to expire of the Patent Rights granted in the Territory set forth in
Schedule 1.1(mm), or (ii) the expiration of the period of data and market
exclusivity for the Finished Product in the Territory provided for by Directive
2001/83/EC.

 

  (nn)

“Manufacture” shall mean the activities related to the fill-finish manufacturing
of Finished Product in accordance with the written specifications delivered to
MIOL by Oscient, including the conversion of Active Pharmaceutical Ingredient
into Finished Product, manufacturing of supplies of Finished Product for
commercial sale, packaging, labeling, in-process and finished product testing,
release of product or any component or ingredient thereof, quality assurance
activities related to manufacturing and

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

 

release of product, ongoing stability tests and regulatory activities related to
any of the foregoing; but excluding activities relating to synthesis,
manufacture or otherwise making or having made any Active Pharmaceutical
Ingredient, or any component or formulation thereof.

 

  (oo) “Marketing Authorization” shall mean an authorization issued by the
relevant Regulatory Authority to market Finished Product in the Territory or in
a country in the Territory as the case may be.

 

  (pp) “MIOL Information” shall mean all information, know-how, materials, data,
documents and plans relating to the Active Pharmaceutical Ingredient and/or
Finished Product, excluding Oscient Information, but including Regulatory
Documentation and data resulting from clinical trials, Controlled by MIOL and/or
its Third-Party Manufacturer and/or Sub-Distributors from time to time during
the Term.

 

  (qq) “Minimum Labeling Requirements” shall mean the approved label for
Finished Product in a particular country in the Territory which contains
(i) [*]; and (ii) is otherwise substantially consistent with the minimum
criteria set forth on Schedule 1.1(qq).

 

  (rr) “Net Sales” shall mean the gross invoiced sales price for all Finished
Products sold by MIOL, its Affiliates or a Sub-Distributor to Third Parties
throughout the Territory during each Quarter, less the following amounts
incurred or paid by MIOL or Sub-Distributor during such Quarter with respect to
sales of Finished Products regardless of the Quarter in which such sales were
made:

 

  (i) trade, cash and quantity discounts or rebates actually allowed or taken,
where permitted by law;

 

  (ii) credits or allowances actually given or made for rejection of, and for
uncollectible amounts on, or return of previously sold Finished Products;

 

  (iii) reasonable transportation and insurance charges directly related to the
sale of the Finished Products to a Third Party in the Territory, each to the
extent separately invoiced and paid by MIOL; and

 

  (iv) any tax, tariff, duty, Government Payment and governmental charge levied
on the sales, transfer, transportation or delivery of the Finished Products to a
Third Party, other than franchise or income tax of any kind whatsoever.

Provided that, any amount deducted from gross invoiced sales in item “(iv)”
above which is later paid back to MIOL shall be deemed to be Net Sales upon
receipt by MIOL.

Deductions due to (i), (ii) and (iii) above shall not exceed a total of [*]
percent ([*]%) of the gross invoiced sales. “Net Sales” shall not include sales
or transfers of Finished Products between MIOL and its Affiliates or
Sub-Distributors, unless the Finished Product is consumed by such Affiliate or

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

Sub-Distributor. For the purpose of this definition and the definition of Gross
Sales, Finished Product shall be deemed to have been sold by MIOL or a
Sub-Distributor at the earliest of (A) such Finished Product being shipped to
the Third Party purchaser by MIOL or a Sub-Distributor as the case may be,
(B) such Third Party being invoiced by MIOL or a Sub-Distributor, or (C) such
Finished Product being paid for, by or on behalf of MIOL’s or Sub-Distributor’s
customer.

 

  (ss) “Oscient Information” shall mean all information and know-how relating to
the Oscient Product Controlled by Oscient that is necessary or reasonably
required by MIOL to enable MIOL to obtain advice on, apply for or maintain
Regulatory Approvals in accordance with this Agreement, including information
relating to toxicology, pharmacology, pharmacokinetics, metabolism, general
chemistry and pharmacy of the Oscient Product and any information provided to
MIOL pursuant to Section 6.3(a); provided that Oscient Information shall not
include any information relating to the bulk chemical manufacture or the
formulation of the Compound or Active Pharmaceutical Ingredient, other than
information that is included in the Applicant’s Part of the Active Substance
Master File submitted to EMEA or any other relevant Regulatory Authority.

 

  (tt) “Oscient Intellectual Property” shall mean the Licensed Patent Rights,
Trademarks and any Copyrights or other intellectual property rights in the
Oscient Information.

 

  (uu) “Oscient Product” shall mean gemifloxacin mesylate 320 mg tablets for
oral administration sold in the United States of America under the trade name
Factive® Tablets.

 

  (vv) “Patent Rights” shall mean any and all (i) patents, (ii) pending patent
applications, including all provisional applications, continuations,
continuations-in-part, divisions, reissues, renewals, and all patents granted on
such pending patent applications, (iii) all patents-of-addition, reissue
patents, re-examinations and extensions or restorations by existing or future
extension or restoration mechanisms, supplementary protection certificates or
the equivalent thereof, and (iv) any equivalent of any of the foregoing in any
jurisdiction.

 

  (ww) “Person” shall mean any individual, firm, corporation, partnership,
limited liability company, trust, joint venture, governmental entity, or other
entity or organization.

 

  (xx) “Printed Materials” shall mean product labels, printed packaging
materials or packaging inserts relating to the Finished Product.

 

  (yy) “Quarter” shall mean each successive period of three (3) months
commencing January 1, April 1, June 1 or September 1 and “Quarterly” shall have
a corresponding meaning.

 

  (zz)

“Quarterly Exchange Rate” shall mean the quotient determined by dividing (i) the
sum of the conversion rate for Euros to U.S. Dollars existing in the

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

 

United States (as reported in The Wall Street Journal) on the first Business Day
and the last Business Day of the applicable Quarter immediately preceding the
date upon which the Assumed Weighted Average Price Per Tablet or Actual Weighted
Average Price Per Tablet, as the case may be, is to be calculated, by (ii) two.
If The Wall Street Journal ceases to be published, then the rate of exchange to
be used shall be that reported in such other business publication of national
circulation in the United States as the Parties reasonably agree.

 

  (aaa) “Regulatory Approval” shall mean any and all approvals (including any
applicable supplements, amendments, variations, pre- and post-approvals,
governmental price and reimbursement approvals and approvals of applications for
regulatory exclusivity), product and establishment licenses, registrations or
authorizations of any kind of any Regulatory Authority necessary for the
Exploitation of the Finished Product in the Territory, including, for the
avoidance of doubt, all registrations, licenses and authorizations required to
permit the Active Pharmaceutical Ingredient of the Finished Product to be
imported into the Territory.

 

  (bbb) “Regulatory Authority” shall mean the EMEA or any other national,
supra-national, regional, state or local regulatory agency, department, bureau,
commission, council or other governmental entity with authority with respect to
the Development, Manufacture or Commercialization of the Finished Product in the
Territory.

 

  (ccc) “Regulatory Documentation” shall mean all applications, registrations,
governmental licenses, authorizations and approvals (including all Regulatory
Approvals), all correspondence submitted to or received from Regulatory
Authorities and all supporting documents and all results of pre-clinical and
clinical studies and tests, relating to the Finished Product, and all data
contained in any of the foregoing.

 

  (ddd) “Reimbursement Price” shall mean, for each country within the Territory,
the price per Tablet, expressed in Euros, at which the Finished Product is or
will be reimbursed, in whole or in part, by the national health system or any
broadly equivalent scheme in that country at the time of calculation.

 

  (eee) “Sales Representative” shall mean a professional pharmaceutical sales
representative engaged or employed by MIOL or any of its Affiliates or
Sub-Distributors to conduct, among other sales responsibilities, Detailing and
other promotional efforts with respect to the Finished Product.

 

  (fff) “Serious Adverse Event” shall have the meaning as set forth in the
Pharmacovigilance Joint Operating Policy to be agreed between the Parties
pursuant to Section 8.3.

 

  (ggg) “Specifications” shall mean, for the Active Pharmaceutical Ingredient
for the Finished Product, such specifications as set forth in Schedule 1.1(ggg),
as such specifications may be supplemented or modified from time to time
hereafter in accordance with the provisions of this Agreement or as provided by
Regulatory Authorities.

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

  (hhh) “Sub-Distributor” shall mean any Affiliate or Third Party (as
hereinafter defined) to whom MIOL has granted the right to promote and
distribute the Finished Product in the Territory (or part of it) in accordance
with the terms of this Agreement.

 

  (iii) “Tablet” shall mean one 320mg tablet of Finished Product.

 

  (jjj) “Target Audience” shall mean, for the Finished Product, general
practitioners and specialists involved in the treatment of upper and lower
respiratory infections who prescribe pharmaceutical products or issue hospital
orders for pharmaceutical products in the Territory as identified in the
applicable Marketing Plan, as may be amended from time to time by the Steering
Committee.

 

  (kkk) “Territory” shall mean 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, Vatican City, Cyprus, Czech Republic, Estonia, Hungary, Latvia,
Lithuania, Malta, Poland, Slovakia, Slovenia, Bulgaria, Romania, Croatia,
Macedonia and Liechtenstein.

 

  (lll) “Third Party” shall mean any Person other than Oscient or MIOL or their
respective Affiliates.

 

  (mmm) “Transfer Price Per Kilo” shall mean the product of: (i) the Assumed
Weighted Average Price Per Tablet, multiplied by (ii) [*].

 

  (nnn) “Trademarks” shall mean the trademarks described in Schedule 1.1(nnn)
attached hereto as may be amended from time to time in accordance with this
Agreement.

1.2 Interpretation.

In this Agreement a reference to:

(i) a particular Article, Section, Schedule or Exhibit shall be a reference to
that article, section, schedule or exhibit in or to this Agreement;

(ii) the singular shall include the plural and vice versa and a reference to any
gender shall include all genders;

(iii) a statutory provision includes a reference to the statutory provision as
modified or re-enacted or both from time to time before or after the date of
this Agreement and any subordinate legislation made under the statutory
provision (as so modified or re-enacted) before or after the date of this
Agreement;

(iv) a document (or section thereof) is a reference to that document as
modified, amended, restated or replaced from time to time;

(v) a “month” is a reference to a calendar month;

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

(vi) “herein”, “hereof”, “hereunder”, “hereafter”, and words of similar import
refer to this Agreement as a whole and not to any particular Article or Section
hereof;

(vii) money herein or “$” are references to United States Dollars unless
otherwise specifically noted; and

(viii) “include”, “includes”, “including” and “in particular” are to be
construed as if they were immediately followed by the words “without
limitation”.

1.3 If any payment is required to be made or other action required to be taken
pursuant to this Agreement, except for any action required to be taken pursuant
to Section 8.3, on a day which is not a Business Day, then such payment or
action shall be made or taken on the next Business Day.

1.4 In calculating interest payable under this Agreement for any period of time,
the first day of such period shall be included and the last day of such period
shall be excluded.

1.5 The table of contents hereto and the headings of any Article, Section or
part thereof are inserted for purposes of convenience only and do not form part
of this Agreement.

 

2. LICENSE RIGHTS

2.1 Appointment and License. Subject to the terms and conditions of this
Agreement, Oscient hereby appoints MIOL as its exclusive distributor of the
Finished Product in the Territory and in connection with such appointment hereby
grants to MIOL subject to Section 2.2:

(a) the exclusive sublicense and right under the Licensed Patent Rights to
import into the Territory Active Pharmaceutical Ingredient supplied by Oscient
in accordance with Articles 3 and 4 (“Oscient API”);

(b) the exclusive, subject as set out below, sublicense and right under the
Licensed Patent Rights to Exploit Finished Product, in which the only Active
Pharmaceutical Ingredient is Oscient API, under the Trademark throughout the
Territory;

(c) subject to Section 6.3, the exclusive right to use the Oscient Information
to Exploit the Finished Product, in which the only Active Pharmaceutical
Ingredient is Oscient API, under the Trademark throughout the Territory; and

(d) the exclusive right to use the Trademarks solely in connection with the
Exploitation of Finished Product in which the only Active Pharmaceutical
Ingredient is Oscient API in the Territory.

2.2 Right to Appoint Third-Party Manufacturer/Sub-Distributor. MIOL may appoint
(A) Sub-Distributors and/or (B) Third Parties to Manufacture Finished Product
pursuant to Section 3.4 herein (each a “Third-Party Manufacturer”); provided,
however, that (i) Oscient shall be notified of and shall have consented to such
appointment, such consent not to be unreasonably withheld; provided however,
that, Oscient confirms its consent to the appointment of any Affiliates of MIOL
as a Sub-Distributor or Third-Party Manufacturer; (ii) the terms of the
agreement with any Sub-Distributor or Third-Party Manufacturer shall be
consistent with the terms and conditions of this Agreement; (iii) a
Sub-Distributor shall have no right to Develop or Manufacture or further appoint
a sub-distributor, nor to assign or

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

delegate all or any part of its rights; (iv) a Third-Party Manufacturer shall
have no right to Develop or further sub-contract its obligations to Manufacture
and shall sell all Finished Products manufactured by it to MIOL or MIOL’s
Affiliates; (v) such appointment shall not relieve MIOL of any of its
obligations under this Agreement and in particular MIOL shall remain obligated
for the payment to Oscient of all of its payment obligations hereunder,
including the payment of any fees described in Article 9 hereof; (vi) to the
maximum extent permitted by Applicable Law, each Sub-Distributor shall be
required to purchase all its requirements of Finished Product from MIOL; and
(vii) except as Oscient may in its discretion agree in writing, any agreement
with any Sub-Distributor or Third-Party Manufacturer shall terminate upon
termination of this Agreement.

2.3 Retained Rights. Subject to the other terms of this Agreement, Oscient
retains the right (a) to use and exploit the Trademarks and the Oscient
Information for (i) uses in the Territory relating to governmental obligations
or requirements and investor promotions (i.e., Oscient exhibit booths or
magazine publications discussing Oscient’s business); and (ii) any and all uses
outside of the Territory and (b) to conduct clinical trials for Oscient Product
in the Territory and fill-finish Oscient Product in the Territory for sale
outside the Territory. All rights not expressly granted under this Agreement to
MIOL are reserved to Oscient. For the avoidance of doubt, MIOL is not granted
any rights to use Oscient Information to seek any approval from EMEA or any
other regulatory authority to market or otherwise exploit any product other than
Finished Product in which the only Active Pharmaceutical Ingredient is Oscient
API.

2.4 Modification of Product. Oscient reserves the right to modify, change,
develop or improve the Active Pharmaceutical Ingredient, including changes in
the manufacturing process or the site at which such manufacture is to occur, (an
“Alteration”) during the Term and shall give prior notice to MIOL of any
Alteration which could give rise to notification requirements to Regulatory
Authorities or the need for any Regulatory Approval under Applicable Law;
provided that any material change to the Specifications shall require MIOL’s
consent, not to be unreasonably withheld. Any reasonable and verifiable costs
associated with any such Alteration shall be borne by Oscient. It is however
understood that if an Alteration requires a Regulatory Approval no Active
Pharmaceutical Ingredient manufactured after implementation of such Alteration
shall be supplied pursuant to this Agreement before the Regulatory Approval is
granted. The Parties agree to pursue diligently any such Regulatory Approvals
following notice of any proposed Alteration from Oscient. Oscient agrees that it
shall not cause an Alteration to be made after MIOL submits an application for
Marketing Authorization and prior to receipt of such Market Authorization.

2.5 Grant of Rights to Oscient. MIOL shall, and shall procure that each
Third-Party Manufacturer and Sub-Distributor shall, during the Term, promptly
make available to Oscient all MIOL Information and MIOL hereby grants to Oscient
a non-exclusive, perpetual, fully paid-up, irrevocable, worldwide (not including
the Territory during the Term) license to use the MIOL Information with the
right to grant sublicenses. In connection with such use, Oscient may disclose
MIOL Information to any Regulatory Authority or equivalent regulatory authority
outside the Territory.

 

3. SUPPLY OF PRODUCT

3.1 Supply Terms. Until expiration of the Mandatory Supply Term, Oscient shall
supply to MIOL, and MIOL will exclusively purchase from Oscient, all of MIOL’s
requirements for Active Pharmaceutical Ingredient for use in Manufacturing
Finished Product in the Territory

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

pursuant to purchase orders delivered from time to time by MIOL to Oscient in
accordance with Section 4.2. During the Mandatory Supply Term, neither Oscient
nor any of its Affiliates shall have the right to manufacture or supply any
Active Pharmaceutical Ingredient for or to any Third Party in the Territory
(except to a Third Party appointed to manufacture Oscient Product for sale
outside the Territory as permitted by Section 2.2). Notwithstanding any other
provision of this Agreement to the contrary, Oscient will not be liable to MIOL
with regard to Finished Product or Active Pharmaceutical Ingredient sold into
the Territory by, or otherwise originating from, customers of Oscient located
outside of the Territory, nor will such sales constitute a breach by Oscient of
this Agreement. Unless otherwise specified herein or expressly consented to in
writing by MIOL and Oscient, MIOL shall have no direct relationship with LG
regarding all activities necessary to supply MIOL with Active Pharmaceutical
Ingredient manufactured by or on behalf of LG as contemplated hereunder. The
relationship with LG shall be maintained by Oscient acting according to
reasonable standard industry practice. All manufacturers of Active
Pharmaceutical Ingredient supplied to MIOL pursuant to this Agreement shall
manufacture Active Pharmaceutical Ingredient for supply pursuant to this
Agreement in compliance with GMP. Unless provided otherwise and only as and if
permitted herein, a Party’s sublicensing, subcontracting or delegating
activities to be performed under this Agreement to an Affiliate or Third Party
shall not release such Party from the performance of any of its responsibilities
hereunder.

After the expiry of the Mandatory Supply Term, MIOL shall have the right to
source Active Pharmaceutical Ingredient, the Compound and the Finished Product
from any Third Party and to continue using the Trademarks and the Regulatory
Approvals subject to the payment obligations set forth in Section 9.4.

3.2 Initial Supply of Finished Product. Oscient agrees to discuss with MIOL its
ability to supply MIOL with Finished Product instead of Active Pharmaceutical
Ingredient until the transfer of technology pursuant to Section 3.4 is
completed. Any such supply shall be on the terms of a supply agreement to be
agreed to by the Parties.

3.3 Miscellaneous Supply of API by Oscient in the Territory. Notwithstanding
anything to the contrary contained herein, Menarini agrees to allow Oscient to
supply certain amounts of Active Pharmaceutical Ingredient to Third Parties in
the Territory solely for academic, non-commercial purposes.

3.4 MIOL Manufacturing and Packaging. MIOL shall Manufacture (or have
Manufactured on its behalf (subject to Section 2.2 above)) Finished Product for
distribution in the Territory in accordance with Applicable Law and the
specifications provided by Oscient. If requested by Oscient, MIOL shall provide
Oscient with all artwork, copy or other material developed or produced by MIOL
or any Sub-Distributor for such Printed Materials. All use of Trademarks shall
be in accordance with Sections 7.6 and 11.8 and unless otherwise specified by
Oscient, the Finished Product shall indicate that the Trademark is a registered
trademark, if applicable. Pursuant to the provisions of Article 6 below, MIOL
shall submit for approval proposed labeling (including package inserts and
primary packages) for Finished Product to the Regulatory Authority, to the
extent approval by the Regulatory Authority is required, at MIOL’s sole cost and
expense. Notwithstanding anything to the contrary herein, MIOL is responsible
for ensuring all Printed Materials comply with Applicable Law.

3.5 Technology Transfer and Support Activities. To the extent not previously
disclosed, Oscient shall, without additional compensation, disclose and make
available to

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

MIOL the Oscient Information promptly after the Effective Date and thereafter
shall reasonably promptly disclose any additional Oscient Information.
Reasonably in advance before Menarini starts to Manufacture the Finished
Product, Oscient shall provide to MIOL (or its Third Party Manufacturer) for a
period not exceeding nine (9) months such assistance as MIOL may reasonably
request in connection with the technology transfer of the Oscient Information.
Such supporting activities shall include the assistance to MIOL’s technical
staff both at Oscient and at the MIOL’s production site, transfer of relevant
chemical and microbiological analyses and technical documentation including all
available stability data forming part of the Oscient Information provided that
if MIOL requests Oscient’s representatives to visit any MIOL facility, Oscient
shall only be required to make up to two (2) appropriate representatives
available for up to ten (10) days each and MIOL shall reimburse Oscient for its
reasonable and verifiable expenses of travel and accommodations for such
representatives.

3.6 Quality Agreement. Oscient and MIOL shall negotiate and agree to, within
ninety (90) days following the Effective Date, a quality agreement with respect
to Oscient’s supply of Active Pharmaceutical Ingredient (the “Quality
Agreement”), which shall (a) be on terms consistent with those standard in the
industry for transactions similar to this Agreement and (b) become effective as
of the Effective Date. Each Party agrees to comply with the Quality Agreement.
To the extent there are any inconsistencies or conflicts between this Agreement
and the Quality Agreement, the terms and conditions of this Agreement shall
control unless otherwise agreed to in writing by Oscient and MIOL in the form of
an amendment to this Agreement. In the event that the Quality Agreement contains
material provisions that differ from Applicable Law, Applicable Law shall
control.

3.7 Documentation, Monitoring and Recordkeeping. Oscient (or its Third Party
licensors), MIOL and all Sub-Distributors and Third-Party Manufacturers shall
maintain complete and accurate documentation of all validation data, stability
testing data, batch records, quality control and laboratory testing, as
applicable, and any other data required under Applicable Law and other
requirements of any relevant Regulatory Authority generated in connection with
the performance of any manufacturing hereunder. Throughout the Term, and for so
long thereafter as is required by Applicable Law, each Party shall monitor and
maintain reasonable records respecting its compliance with GMP for Finished
Product (in the case of MIOL) and ICH Q7A (in the case of Oscient), including
through the establishment and implementation of such operating procedures as are
reasonably necessary to assure such compliance.

 

4. FORECASTING, ORDERING AND SHIPPING

4.1 Rolling Forecasts. Throughout the Term, MIOL shall provide Oscient, by the
15th day of every month of each calendar year, with a rolling forecast
(“Forecast”) prepared in good faith by MIOL projecting MIOL’s requirements of
Active Pharmaceutical Ingredient for the twenty-four (24) month period
commencing on the first day of the next calendar month (i.e. 1 March, 1 June,
1 September or 1 December, as the case may be), specifically indicating such
projected requirements for each month during such twenty-four (24) month period
and forecasted monthly prescription volumes of Tablets for each country in the
Territory.

4.2 Submission of Purchase Orders. MIOL shall issue a purchase order, in
substantially the format attached hereto as Exhibit A, for the Active
Pharmaceutical Ingredient to be manufactured and shipped to it on a date (the
“Required Delivery Date”) not less than [*]

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

days from the date of such purchase order. The quantities of Active
Pharmaceutical Ingredient ordered in each such purchase order shall be firm and
binding on MIOL and shall not be subject to reduction by MIOL. All purchase
orders shall be sent by MIOL to the attention of the employee of Oscient as may
from time to time be designated by Oscient. To the extent the terms of any
purchase order or acknowledgment thereof are inconsistent with, or additional
to, the terms of this Agreement, such terms are of no force and effect.

4.3 Terms of Delivery. Oscient shall execute all accepted purchase orders
consistent with this Agreement and use commercially reasonable efforts to
deliver Active Pharmaceutical Ingredient to MIOL’s designated carrier at
Oscient’s designated facility (determined in Oscient’s reasonable discretion,
currently in South Korea), within +/- seven (7) days of the delivery date
specified in MIOL’s purchase orders in accordance with Section 4.2. MIOL shall
be responsible for arranging, at its expense, all shipping, freight and
insurance, customs clearance and payment of any customs duties and import fees
for its orders of Active Pharmaceutical Ingredient. Title and risk of loss will
pass to MIOL when each order of Active Pharmaceutical Ingredient is delivered to
MIOL’s designated carrier at Oscient’s designated facility. If MIOL does not
timely indicate in writing its selection of a carrier to Oscient, Oscient shall
be entitled to select an appropriate carrier. Oscient shall package each order
of Active Pharmaceutical Ingredient for shipment in accordance with customary
industry practices therefor, unless otherwise reasonably specified in writing by
MIOL.

4.4 Accompanying Documentation. With each shipment of Active Pharmaceutical
Ingredient, Oscient shall provide MIOL with (i) all appropriate documentation
directly related to the Active Pharmaceutical Ingredient necessary to allow MIOL
to export the Active Pharmaceutical Ingredient and (ii) with a certificate of
analysis and certificate of conformity pursuant to the terms of the Quality
Agreement.

4.5 Retention of Samples. Oscient or its Third Party manufacturer shall properly
store and retain appropriate samples of the Active Pharmaceutical Ingredient
that it supplies to MIOL in conditions and for times consistent with Applicable
Law and to permit appropriate or required internal and regulatory checks and
references.

 

5. INSPECTION AND DEFECTIVE PRODUCTS

5.1 Receipt of Active Pharmaceutical Ingredient by MIOL. MIOL shall be entitled
to reject any portion or all of any shipment of Active Pharmaceutical Ingredient
that does not conform to the certificate of analysis and certificate of
conformity or otherwise fails to comply with the warranties set forth in
Section 12.1(e) of this Agreement (unless such nonconformity was attributable to
an act or omission of MIOL, Third-Party Manufacturer, Sub-Distributor or the
common carrier once the Active Pharmaceutical Ingredient was delivered by
Oscient to such common carrier); provided, that MIOL shall notify Oscient within
[*] days after receipt of such shipment if it is rejecting a shipment pursuant
to this Section 5.1. If no notice is provided by MIOL within the relevant time
periods, then MIOL shall be deemed to have accepted the shipment. Any notice of
rejection by MIOL shall be accompanied by a reasonably detailed statement of its
reasons for rejection and a report of any pertinent analysis performed by MIOL
on the allegedly nonconforming product, together with the methods and procedures
used. Oscient shall notify MIOL as promptly as reasonably possible, but in any
event within [*] days after receipt of such notice of rejection, whether it
accepts MIOL’s assertions of nonconformity.

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

5.2 Replacement Active Pharmaceutical Ingredient. Whether or not Oscient accepts
MIOL’s assertion of nonconformity, promptly upon receipt of a notice of
rejection, unless otherwise specified by MIOL, Oscient shall use its
commercially reasonable efforts to provide replacement Active Pharmaceutical
Ingredient for that rejected by MIOL in the original shipment. If the Active
Pharmaceutical Ingredient rejected by MIOL from such original shipment
ultimately is found to be nonconforming (whether pursuant to Section 5.3 or if
Oscient so acknowledges in writing), Oscient shall bear all expenses for such
replacement Active Pharmaceutical Ingredient (including all transportation
and/or disposal charges and cost of manufacture for such nonconforming Active
Pharmaceutical Ingredient) to the extent MIOL previously paid for any
corresponding nonconforming Active Pharmaceutical Ingredient. If it is
determined subsequently that such Active Pharmaceutical Ingredient was in fact
conforming (whether pursuant to Section 5.3 or if MIOL so acknowledges in
writing), then MIOL shall be responsible not only for the purchase price of the
allegedly nonconforming Active Pharmaceutical Ingredient (including all
transportation charges), but also, upon receipt and acceptance by MIOL in
accordance with the procedures (and at the same price charged in the original
shipment) set forth above, the replacement Active Pharmaceutical Ingredient.
Replacement shipments shall also be subject to the procedures contained in
Article 4.

5.3 Independent Laboratory Analysis. If Oscient disagrees with any alleged
nonconformity timely notified to Oscient under Section 5.1, then an independent
laboratory (or other expert) of recognized repute reasonably acceptable to
Oscient and MIOL (the “Independent Laboratory”) shall analyze (i) a sample from
the relevant shipment provided by MIOL and (ii) a Shipment Sample as retained by
Oscient in accordance with Section 4.5, as may be necessary to substantiate
whether the shipment rejected by MIOL conformed in all material respects to the
certificate of analysis and the pertinent Specifications or otherwise failed to
comply with the warranties set forth in Section 12.1(e) of this Agreement at the
time of delivery to the common carrier. At the same time each of Oscient and
MIOL furnishes to the Independent Laboratory its sample, such Party shall also
furnish to the other Party a split sample of such sample. In conducting its
analysis hereunder, the Independent Laboratory shall use the same analytical
methodology used by Oscient. Oscient shall provide a reasonably detailed
description of such analytical methodology to the Independent Laboratory. Both
Oscient and MIOL agree to cooperate with the Independent Laboratory’s reasonable
requests for assistance in connection with its analysis hereunder. The
Independent Laboratory’s results of analysis, absent manifest error, shall be
deemed final as to any dispute over compliance of the Active Pharmaceutical
Ingredient in all material respects with the certificate of analysis and/or the
pertinent Specifications and/or the warranties set forth in Section 12.1(e) of
this Agreement. If the analysis of the Independent Laboratory shows that the
Active Pharmaceutical Ingredient did not at the material time(s) conform in all
material respects to the certificate of analysis or the pertinent Specifications
or the warranties set forth in Section 12.1(e) of this Agreement at the time of
delivery to the common carrier, the costs of such analysis shall be paid by
Oscient. If the analysis of the Independent Laboratory shows that the Active
Pharmaceutical Ingredient did at the material time(s) conform in all material
respects to the certificate of analysis and the pertinent Specifications and the
warranties set forth in Section 12.1(e) of this Agreement at the time of
delivery to the common carrier, the costs of such analysis shall be paid by
MIOL.

5.4 Disposition of Non-Conforming Active Pharmaceutical Ingredient. If Oscient
acknowledges an alleged nonconformity (or if the Independent Laboratory
concludes that the Active Pharmaceutical Ingredient was nonconforming in
accordance with Section 5.3),

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

Oscient promptly (and in any case within thirty (30) days thereafter) shall make
arrangements for the return, reworking or disposal, at Oscient’s option, of the
nonconforming Active Pharmaceutical Ingredient. If Oscient requests that MIOL
dispose of such nonconforming Active Pharmaceutical Ingredient, Oscient shall
give MIOL written instructions as to how MIOL or its agent shall, at Oscient’s
expense, lawfully dispose of any nonconforming Active Pharmaceutical Ingredient,
and MIOL shall provide Oscient with written certification of such destruction.
Oscient shall pay, or reimburse MIOL, for any reasonable return shipping charges
or out-of-pocket costs incurred by MIOL for such return shipment or lawful
disposal of such nonconforming Active Pharmaceutical Ingredient in accordance
with Oscient’s instructions.

 

6. DEVELOPMENT OF PRODUCTS

6.1 Regulatory Approval.

(a) Subject to Steering Committee review as set forth below, MIOL shall use
Diligent Efforts in, and be responsible for, all activities relating to
obtaining and/or maintaining all Regulatory Approvals from Regulatory
Authorities in the Territory for the Commercialization and Manufacture of the
Finished Product in the Territory, including using Diligent Efforts (A) to
obtain Marketing Authorizations for [*], [*] and [*] indications for the
Finished Product consistent with the Minimum Labeling Requirements according to
the Development Plan, (B) to request a scientific advice meeting with the EMEA
on eligibility of the Finished Product for the Centralized Procedure, proposed
risk management plan, scientific data supporting the Marketing Authorization
application; in case of non-eligibility possibility to request further advice
from other national Regulatory Authorities, (C) to submit the letter of intent
to submit a Marketing Authorization application to the EMEA, (D) to prepare the
Common Technical Document for submission to the EMEA or other relevant
Regulatory Authorities, (E) to submit the application for a Marketing
Authorization to the EMEA or other relevant Regulatory Authorities, and (F) to
follow up on all the regulatory applications. MIOL agrees: (i) to keep Oscient
informed as to the status of its draft regulatory applications and to permit
Oscient to review, in advance, any filing, correspondence, communication or
other documentation to be filed with Regulatory Authorities during their
preparation, (ii) to confer with Oscient regarding the preparation of such
filings and communications and the registration process, (iii) to provide
Oscient, upon request, with copies of all written communications with Regulatory
Authorities with respect thereto, and (iv) where practical, to give reasonable
prior notice to Oscient in order to allow Oscient to attend all material
meetings with Regulatory Authorities. MIOL shall conduct all such regulatory
activities in accordance with Applicable Law. Subject to Section 9.7 below,
costs of Development and related Regulatory Approvals shall be borne by MIOL.
Immediately upon obtaining any Regulatory Approval, MIOL shall provide true
copies of the same to Oscient.

(b) Subject to Section 6.1(a), MIOL shall be responsible for communications with
the Regulatory Authorities with respect to the Regulatory Documentation. Oscient
shall provide reasonable assistance to MIOL in preparing documentation to
support pre- and post-authorization meetings and in responding to any queries
from a Regulatory Authority. Oscient will be responsible for the transfer of all
the relevant information on the Active Pharmaceutical Ingredient and the
Finished Product to allow MIOL to prepare the necessary documentation for
Regulatory Applications (both pre- and post-authorization) including electronic
version of the preclinical and clinical documentation to be included in the
Regulatory Documentation. Notwithstanding anything to the contrary herein,
Oscient shall

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

not be required to deliver any information or data not already in its Control or
to perform any development activities; in particular Oscient shall be under no
obligation to provide to MIOL any information relating to the bulk chemical
manufacture or the formulation of the Compound or Active Pharmaceutical
Ingredient, other than information that is included in the Applicant’s Part of
the Active Substance Master File submitted to EMEA or any other relevant
Regulatory Authority. Oscient shall or shall procure that LG shall be
responsible for supplying Active Pharmaceutical Ingredient manufacturing process
information direct to the EMEA or any other relevant Regulatory Authorities and
will respond to relevant queries from Regulatory Authorities regarding the same.
MIOL shall advise Oscient of material developments and events relating to
regulatory issues in writing within three (3) Business Days after notice of such
material developments and events. MIOL shall take the steps necessary to ensure
that all information submitted to Regulatory Authorities is kept confidential.

(c) For the avoidance of doubt, during the Development and subject to the
Steering Committee review and approval pursuant to Sections 6.2 and 6.3 herein,
MIOL shall have the right, but not the obligation, to perform clinical trials
necessary to obtain the Regulatory Approval(s), at MIOL’s sole discretion.

(d) As soon as reasonably possible, Oscient agrees to withdraw the regulatory
application previously submitted to MHRA by Oscient.

6.2 Joint Steering Committee.

(a) Within ninety (90) days of the date of this Agreement, a joint steering
committee, comprised of equal representation by both Parties (up to a maximum of
three (3) representatives per Party (the “Steering Committee”)), shall be
established by both Parties. Except as otherwise provided in this Agreement, the
Steering Committee shall have authority to make all necessary strategic
decisions relating to the Development of Finished Product and the implementation
of any Development Plan. The Steering Committee shall also review and approve
any amendments to the Development Plans and shall review the MIOL Information
and all filings made with any Regulatory Authority as well as to perform such
other functions as appropriate to further the purposes of this Agreement as
determined by the Parties. In addition, MIOL shall keep Oscient informed of the
following matters through the Steering Committee:

 

  (i) Plans and updates relating to the Commercialization of the Finished
Product, including updates on achievement of objectives set forth in the
applicable Marketing Plan (as defined in Section 7.2 below), progress towards
sales goals, and related sales and marketing activities;

 

  (ii) Prices, discounts, rebates and similar policies for the Finished Product
in each country in the Territory;

 

  (iii) Reporting and pricing information to government authorities in
accordance with Applicable Law;

 

  (iv) Manufacturing issues; and

 

  (v) Summary and analysis of any Adverse Event information or other medical
inquires specified in Section 8.3 herein.

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

(b) A Party may change or replace its representatives on the Steering Committee
as it deems appropriate, by notice to the other Party provided that all such
representatives shall be individuals of suitable authority and seniority with
significant experience or expertise in pharmaceutical drug development,
commercialization or marketing. Any member of the Steering Committee may
designate a substitute of equal experience and seniority to attend and perform
the functions of that member at any meeting of the Steering Committee. Each
Party may invite (at its discretion and with the consent of the other Party)
additional employees, or consultants to attend Steering Committee meetings. The
Steering Committee shall hold meetings at such times and places as shall be
determined by the co-chairpersons. The meetings shall be held no less frequently
than (i) once every three (3) months prior to the grant of a Marketing
Authorization obtained through the Centralized Procedure or, if Marketing
Authorizations are sought on a country by country basis (rather than via the
Centralized Procedure), the grant of a Marketing Authorization in each of the
Major Countries and (ii) once every six (6) months thereafter. Steering
Committee meetings may be held in person or by telephone or video conference.

(c) In the event of a dispute within the Steering Committee such that no
decision can be made with respect to a particular issue, the matter may be
referred by either Party to Oscient’s chief executive officer and MIOL’s
Managing Director for attempted resolution by good faith negotiation. If such
individuals are unable to resolve the dispute within thirty (30) days after
referral, subject to Section 6.3 below, then MIOL shall make the final
determination to the extent not inconsistent with the terms and conditions of
this Agreement, provided that any such determination shall be commercially
reasonable and consistent with Applicable Law and MIOL shall not be entitled to
make a unilateral determination: (i) if the proposed Development activities
would be inconsistent with the U.S. label for the Oscient Product or might
reasonably be expected to have an adverse effect on the development, manufacture
or commercialization of Oscient Product or any other product containing the
Compound outside the Territory, or (ii) to apply for Marketing Authorizations on
a country by country basis (rather than via the Centralized Procedure); and any
such determination shall require Oscient’s prior written consent. Prior to
resolving any such dispute unilaterally, MIOL shall consider in good faith
Oscient’s position in reaching any such decision and shall act in good faith and
in the best interests of the Development and Commercialization of the Finished
Product.

(d) The Steering Committee shall only have such powers as are expressly
delegated to it in this Agreement. The Steering Committee is not a substitute
for the rights or obligations of the Parties and shall not have the authority to
amend this Agreement.

(e) Each Party will designate one of its members of the Steering Committee to
act as a co-chairperson to facilitate the performance of its rights and
satisfaction of its obligations hereunder.

6.3 Clinical Development.

(a) Subject to Oscient’s review and agreement, the Parties agree that MIOL may,
but is not obligated to, pursue in the Territory Regulatory Approval for
additional indications beyond the currently approved U.S. indications for the
Oscient Product, CAP and AECB; provided that, the Parties agree that MIOL will
seek to obtain Marketing Authorizations for each of ABS and CAP based on a 5-day
duration of therapy. Any activities relating to additional indications shall
form part of the Development Plan and shall be subject to review and approval by
the Steering Committee. Oscient shall provide to MIOL data from new

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

clinical studies for the Oscient Product conducted or completed by Oscient or
its Affiliates or its licensee after the Effective Date if and to the extent
Controlled by Oscient, to support MIOL if MIOL pursues such additional
indications. Oscient shall promptly provide to MIOL data from post-marketing
clinical trials concerning the Oscient Product before and after the Effective
Date if and to the extent Controlled by Oscient in order to include them in the
Regulatory Documentation.

(b) Upon reasonable notice, Oscient shall have the right to (a) review any raw
data generated in any clinical trial conducted by or on behalf of MIOL or its
Affiliates with respect to the Finished Product, (b) visit clinical
investigators and centers involved in the performance of such clinical trials,
and (c) discuss any such clinical trial and its results in detail with such
clinical investigators. MIOL shall provide Oscient with the data resulting from
all clinical trials conducted by MIOL in accordance with Section 6.3(a). Oscient
shall be free to use the results of any or all such clinical trials in
connection with the marketing, promotion, packaging, handling, distribution,
use, storage, sale and offer for sale and product licensing of Oscient Product
outside the Territory. Except as required by Applicable Law, the results of any
clinical studies shall not be publicized or published in any way without the
prior written consent of Oscient. All patentable inventions conceived,
discovered, developed or otherwise made by or on behalf of MIOL or its
Affiliates which are Developed hereunder shall be jointly owned in accordance
with Section 11.1.

6.4 Inspections, Inquiries and Complaints.

(a) MIOL shall advise Oscient of any visit to, or written or oral inquiry about,
any facilities or procedures relating to the Manufacture and/or
Commercialization of the Finished Product by or from any Regulatory Authority,
promptly (but in no event later than one (1) Business Day) after notice of such
visit or inquiry is received by MIOL or its Affiliates or Third-Party
Manufacturer or Sub-Distributors. MIOL shall, within three (3) Business Days of
receipt or submission, furnish to Oscient any report or correspondence issued by
or provided to the Regulatory Authority in connection with such visit or
inquiry.

(b) Oscient shall advise MIOL of any visit to, or written or oral inquiry about,
any facilities or procedures relating to the manufacture of the Active
Pharmaceutical Ingredient by or from any Regulatory Authority, or comparable
regulatory authority outside the Territory, promptly (but in no event later than
one (1) Business Day) after notice of such visit or inquiry is received by
Oscient.

(c) MIOL shall advise Oscient within twenty four (24) hours of any
investigation, complaint, claim or potential claim, whether from a Regulatory
Authority or not, about the Finished Product relating to a safety issue, and
shall also advise Oscient within two (2) Business Days of any issue that may
give rise to a potential recall.

 

7. COMMERCIALIZATION OF PRODUCT

7.1 Responsibility and Efforts. From and after the Effective Date, MIOL shall
have full control and authority over the Commercialization of Finished Products
in the Territory, and shall exercise Diligent Efforts in Commercializing
Finished Products in the Territory. MIOL shall (i) diligently seek formulary
listings and Reimbursement Prices in each country in the Territory, in order to
maximize the commercial potential for the Finished Product in the Territory, and
(ii) Commercialize the Finished Product in each country in the Territory in
which MIOL receives a Reimbursement Price of at least $[*] (after applying the
Annual

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

Calculated Exchange Rate in effect at such time) (the “Acceptable Country”);
provided that, if the Actual Weighted Average Price Per Tablet at the time of
receipt of a Reimbursement Price is less than $[*], then, MIOL shall not be
obligated to Commercialize the Finished Product in such Acceptable Country. All
activities relating to Commercialization under this Agreement shall be
undertaken at MIOL’s sole cost and expense. MIOL and Oscient shall discuss and
agree in good faith, at least three months before the launch in each of the
Major Countries that have received Marketing Authorization approval, on the
minimum number of Calls to be made by MIOL in each of the Major Countries using
as a reference the projections used to develop the target promotional plan set
forth in Schedule 7.1.

7.2 Annual Marketing Plan. Within sixty (60) days of the First Commercial Sale
and thereafter not later than each anniversary date of the First Commercial
Sale, MIOL shall submit to Oscient a business and marketing plan for the
following year for each country in the Territory (each a “Marketing Plan”). The
Marketing Plan shall be in a form reasonably required by Oscient, and shall
include: (i) a description of the market and marketing, promotional and customer
service programs anticipated for the following year and budgets for each on a
country by country basis; (ii) an outline of training and regulatory activities
expected for the following year, (iii) the number and type of Details to be
performed; (iv) the aggregate amount of Commercializing expenses to be incurred;
(v) a three-year forecast of purchases of Active Pharmaceutical Ingredient from
Oscient and sales of the Finished Product to customers; (vi) an inventory status
report; and (vii) such other information concerning the market, the status of
customers and competitors, the business of MIOL or such other matters related to
the Finished Product as Oscient may reasonably request. MIOL shall consider in
good faith any comments made by Oscient in connection with any Marketing Plan
and in particular any concerns that Oscient may have that execution of any
Marketing Plan in accordance with its terms would not constitute Diligent
Efforts in Commercializing Finished Products in the relevant country.

7.3 Standards and Sales Activities. MIOL shall, at its sole expense,
Commercialize the Finished Product in accordance with good commercial practice
with respect to regulated pharmaceutical products, including Applicable Law.
MIOL shall avoid using any practice that would prejudice Oscient’s name, the
Trademarks, or the quality of the Finished Product. MIOL shall market the
Finished Product in a manner that maximizes the goodwill and the value over the
long term of the Finished Product.

7.4 Training. MIOL shall ensure that each of its and its Sub-Distributors’ sales
force and employees are fully trained with respect to the Finished Product and
reporting of Adverse Event information in accordance with Applicable Law.

7.5 Sales Outside the Territory. MIOL and its Sub-Distributors shall not:
(i) establish any branch, sales offices, warehouse or other facilities outside
of the Territory with respect to the Finished Product, (ii) adopt a policy of
selling the Finished Product outside the Territory nor undertake the sale or
promotion of sales of the Finished Product outside the Territory, (iii) seek
customers or solicit orders from any prospective customer whose principal
address or place of business is located outside the Territory, (iv) provide any
price quotations for the Finished Product to any prospective customer whose
principal address or place of business is located outside the Territory, and/or
(v) directly or indirectly sell to any person (including a pharmacy or
wholesaler) that MIOL knows or has reason to believe, directly or indirectly
sells to any person outside of the Territory. If MIOL or Sub-Distributor
receives an order from a prospective customer located outside the Territory,
MIOL and Sub-Distributor shall immediately refer that order to Oscient. Without
Oscient’s prior consent, MIOL, or

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

Sub-Distributor may not deliver or tender, or cause to be delivered or tendered,
the Finished Product (or any sample of the Product) outside the Territory.
Neither MIOL, nor Sub-Distributor shall sell any Finished Product to any
purchaser if (A) it knows, or has reason to believe, that such purchaser intends
to remove the Finished Product from the Territory, either directly or
indirectly, or if (B) such purchaser is known to remove pharmaceuticals from the
Territory, either directly or indirectly.

7.6 Marketing, Promotional and Educational Materials. Unless otherwise agreed by
Oscient, the Finished Product shall be sold under the trade name Factive ®;
provided, however, that MIOL may propose alternative trade names for specific
countries, and upon Oscient’s prior written consent, not to be unreasonably
withheld, and subject to any necessary Regulatory Approvals, the Finished
Product shall be marketed under such trade name (the “New Trademark”). The New
Trademark shall be the property of Oscient or its designee and shall be
registered by Oscient or its designee. If the New Trademark is initially
registered by MIOL, MIOL shall promptly on request assign all its rights and
interest in any such New Trademark to Oscient or as Oscient may direct. The
definition of “Trademark” hereunder shall include any such New Trademark
registered in Oscient’s name. All marketing, promotional and educational
materials related to the Finished Product and prepared for use in the Territory
by MIOL or a Sub-Distributor (the “Promotional Materials”) shall be prepared in
a manner consistent with Applicable Law and relevant self-regulatory codes of
conduct and guidelines. Oscient shall be presented at least thirty (30) days in
advance of use with samples or proofs of all such Promotional Materials for
review and comments. Notwithstanding this, MIOL shall remain at all times
responsible for ensuring that all Promotional Materials and their use are in
compliance with Applicable Law. All Promotional Materials shall display the
Trademarks in a manner that promotes the Finished Product and each of the
Parties in a manner consistent with good commercial practice in dealing with
regulated pharmaceutical products and shall unless otherwise agreed by Oscient
indicate that any Trademark is a registered trademark, if applicable. Oscient
shall have the right to reproduce, distribute and otherwise use outside the
Territory all Promotional Materials. MIOL shall provide and distribute to
customers and prospective customers marketing, promotional and educational
materials reasonably necessary to promote the Finished Product in the Territory.
MIOL shall be responsible for all expenses relating to the advertising,
promotion or sales of the Finished Product. Oscient shall provide MIOL with
samples of Product-related marketing and promotional materials prepared by
Oscient, including related logos and graphics, for use by MIOL in connection
with the development of Promotional Materials.

 

8. RECORDS AND REPORTS

8.1 Records. MIOL shall maintain complete and accurate records of all
inventories, Finished Product in storage, movements, shipments, sales and
potential problems involving the Finished Product by unit, by batch number and
by customer so that all such matters can be traced quickly and effectively. Upon
request, MIOL shall provide copies of such records to Oscient, and shall provide
Oscient, or its representatives, with access to the place where the Finished
Product is Manufactured, stored and/or shipped and other facilities used by MIOL
in carrying out this Agreement, during normal business hours and upon reasonable
notice, for the purpose of inspecting such facilities for compliance with the
terms of this Agreement. MIOL shall maintain all such records for at least five
(5) years or such longer period as may be required by Applicable Law.

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

8.2 Reports. MIOL shall provide Oscient with written reports regarding the
Development and Commercialization of the Finished Product. MIOL shall provide
such written reports no less frequently than annually during the Term. In
addition, MIOL shall provide Oscient with prompt written notice of the
occurrence of the First Commercial Sale of the Finished Product in each country
in the Territory. All reports, updates, Adverse Event information and other
information provided by one Party to another Party under this Agreement shall be
considered Confidential Information of the Disclosing Party, subject to the
terms of Article 10 hereof.

8.3 Adverse Events. The Parties shall comply with the Pharmacovigilance Joint
Operating Policy, which shall be negotiated and agreed to within ninety
(90) days from the Effective Date, with respect to the investigation and
reporting of Adverse Events and shall regularly review and update the
Pharmacovigilance Joint Operating Policy as may be required to enable both
Parties to comply with Applicable Law relating to pharmacovigilance. The Parties
shall provide each other on a regular basis and in accordance with the
Pharmacovigilance Joint Operating Policy with any information which has become
available to them and which is relevant to the safe use of the Finished Product
or the Oscient Product or which is required by Applicable Law in all countries
where the Finished Product or the Oscient Product is marketed or is in a
clinical study. MIOL, at its sole expense, shall be responsible for conducting
any post-marketing surveillance of the Finished Products sold by MIOL pursuant
to this Agreement and for reporting Serious Adverse Events and Non-Serious
Adverse Events arising in connection with any Finished Product to the
appropriate Regulatory Authorities in the Territory in accordance with
Applicable Law. Oscient, or its Third Party sublicensor and sublicensees shall
be responsible for making all Adverse Event reports outside the Territory. The
Parties shall transmit to each other a copy of any report relating to a Serious
Adverse Event for a Finished Product or an Oscient Product made to any
Regulatory Authority, comparable regulatory authority outside the Territory or
ethics committee within two (2) calendar days following submission to the
relevant regulatory authority or ethics committee made by MIOL, its Affiliates
or its Sub-Distributors (or within two (2) calendar days following notice of
submission to the relevant regulatory authority made by a Third Party (other
than a Sub-Distributor)) by transmitting it in accordance with such procedures
as the Parties may agree in writing from time to time.

8.4 MIOL Information. During the Term MIOL shall promptly provide to Oscient
copies of any and all MIOL Information.

 

9. PAYMENTS AND FEES

9.1 License Fee. In consideration of the license described in Article 2 hereof,
MIOL agrees to pay to Oscient a non-refundable license fee of $[*] within ten
(10) Business Days from the Effective Date.

9.2 Transfer Price.

(a) Oscient shall supply free of any charge up to one (1) kilogram of Active
Pharmaceutical Ingredient ordered by MIOL for the purposes of obtaining
necessary Regulatory Approvals to Commercialize the Finished Product in the
Territory; provided that, any such Active Pharmaceutical Ingredient may not be
used to Manufacture Finished Product to be Commercialized in the Territory.

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

(b) For each kilogram of Active Pharmaceutical Ingredient delivered by Oscient
to MIOL during the Term, MIOL shall pay to Oscient an amount per kilogram of
Active Pharmaceutical Ingredient equal to the Transfer Price Per Kilo. Each
invoice for Active Pharmaceutical Ingredient shall specify the purchase order
number to which it corresponds. All amounts due to Oscient pursuant to Sections
9.2(a) and 9.2(d) shall be paid by MIOL within fifty (50) days following the
date of invoice and otherwise in accordance with this Article 9.

(c) Within twenty (20) days following the end of every Quarter after the First
Commercial Sale, MIOL shall provide to Oscient a report detailing (i) the Gross
Sales (including specifics related to applicable Government Payments) and Net
Sales (including an accounting of deductions taken in the calculation of Net
Sales) for each country in the Territory for the applicable Quarter, (ii) the
total number of Tablets sold by MIOL or its Affiliates or Sub-Distributors in
each such country in that Quarter, and (iii) the reconciliation of the Assumed
Weighted Average Price Per Tablet and the Actual Weighted Average Price Per
Tablet (calculated for the applicable Quarter) pursuant to Section 9.2(d) below
(the “Quarterly Report”). MIOL shall cause its or the applicable Affiliate’s
Managing Director to certify that the information contained in each Quarterly
Report is complete and accurate.

(d)(i) If in any Quarter the Actual Weighted Average Price Per Tablet is greater
than the Assumed Weighted Average Price Per Tablet for the same Quarter, then
MIOL shall owe and pay to Oscient an amount equal to (A) the difference between
the Actual Weighted Average Price Per Tablet and the Assumed Weighted Average
Price Per Tablet, multiplied by (B) the number of Tablets sold (including the
number of professional samples of Tablets given to medical professionals without
cost) by MIOL and its Affiliates and Sub-Distributors (as determined using
verifiable, written data from MIOL) in the applicable Quarter, to be paid to
Oscient pursuant to the provisions of Section 9.8 below).

(ii) If in any Quarter the Assumed Weighted Average Price Per Tablet is greater
than the Actual Weighted Average Price Per Tablet for the same Quarter, then
Oscient shall owe to MIOL an amount equal to (A) the difference between the
Assumed Weighted Average Price Per Tablet and the Actual Weighted Average Price
Per Tablet, multiplied by (B) the number of Tablets sold (including the number
of professional samples of Tablets given to medical professionals without cost)
by MIOL and its Affiliates and Sub-Distributors (as determined using verifiable,
written data from MIOL) in the applicable Quarter, such sum to be paid to MIOL
pursuant to the provisions of Section 9.8 below.

(iii) Notwithstanding anything hereunder to the contrary, when calculating the
Actual Weighted Average Price Per Tablet for any applicable Quarter for purposes
of the reconciliation set forth in this Section 9.2(d), in no event shall the
Actual Weighted Average Price Per Tablet be less than $.[*] per Tablet. In the
event the Actual Weighted Average Price Per Tablet calculated for two
(2) consecutive Quarters would, but for this Section 9.2(d)(iii), be less than
$.[*] per Tablet, MIOL may notify Oscient in writing that it wishes to negotiate
in good faith a new minimum per Tablet price which is mutually acceptable to
both Parties.

(e) During the Mandatory Supply Term, MIOL shall provide to Oscient, on the 75th
day after the end of each Quarter, IMS audit data detailing Gross Sales, the
total number of Tablets sold by MIOL and its Affiliates and Sub-Distributors and
the total number packs of Finished Product sold to pharmacies (pharmacy sell-in)
(including corresponding Tablets per package in each case in the Quarter, in the
Territory. At the end of every Sales Year (as

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

defined below), the Parties shall reconcile such IMS data received by Oscient
against the Quarterly information presented by MIOL and shall make appropriate
payments to each other if use of the IMS data would have resulted in a change of
such payments made pursuant to this Section 9.2 in such Sales Year of greater
than [*] percent ([*]%) of the actual payments made pursuant to this Section 9.2
during such Sales Year.

(f) For purposes of clarification, Schedule 9.2 is attached hereto to provide
hypothetical forecasted examples of the calculation of the Actual Weighted
Average Price Per Tablet.

9.3 Additional Payments. In further consideration of the grant of the license
and rights by Oscient pursuant to Article 2, and subject to the other terms of
this Agreement (including the remainder of this Section 9.3), commencing on the
date of the First Commercial Sale and continuing for the duration of the
Mandatory Supply Term, if Annual Net Sales in any Sales Year are in excess of
$[*] million, MIOL shall make a non-refundable payment to Oscient in an amount
equal to [*] percent ([*]%) of such Annual Net Sales which are in excess of $[*]
million in that Sales Year multiplied by the Annual Calculated Exchange Rate (as
calculated on the last day of the applicable Sales Year) (“Additional Payment”).
Unless otherwise expressly provided, MIOL shall make any Additional Payment owed
to Oscient hereunder in arrears, within twenty (20) days from the end of each
Sales Year in which such Additional Payment accrues. MIOL shall provide to
Oscient, by no later than twenty (20) days after each Sales Year, a report
detailing sales of Finished Products in the preceding Sales Year in the
Territory and specifying: for each month in the relevant Sales Year, on a
country by country basis, the Gross Sales (including specifics related to
applicable Government Payments) and Net Sales in the Territory and aggregate
gross sales and Net Sales; the amounts payable, including an accounting of
deductions taken in the calculation of Net Sales; and the applicable Annual
Calculated Exchange Rate to convert from Euros into United States Dollars under
this Section 9.3.

9.4 Royalties After Mandatory Supply Term. During the Term, following expiration
of the Mandatory Supply Term, MIOL shall make Quarterly royalty payments to
Oscient on Net Sales in each country in the Territory equal to [*] percent
([*]%) of Net Sales in the relevant Quarter multiplied by the Annual Calculated
Exchange Rate (as calculated on the last day of the applicable Quarter) (the
“Quarterly Royalty”) for so long as MIOL or any Affiliate or Sub-Distributor
continues to use the Trademarks, the Regulatory Approvals or otherwise
Commercializes the Finished Product in such country. Unless otherwise expressly
provided, MIOL shall make any Quarterly Royalty owed to Oscient hereunder in
arrears, within twenty (20) days from the end of the Quarter in which such
Quarterly Royalty accrues. Each Quarterly Royalty made pursuant to this
Section 9.4 shall be accompanied by a report detailing for each month in the
relevant Quarter on a country by country basis sales of Finished Products
covered by such statement and specifying: the gross sales and Net Sales, the
amounts payable, including an accounting of deductions taken in the calculation
of Net Sales, and the applicable Annual Calculated Exchange Rate to convert from
Euros into United States Dollars. MIOL shall cause its or the applicable
Affiliate’s Managing Director to certify that the information contained in each
such report is complete and accurate.

9.5 Milestone Payments.

(a) Approval Milestones Payment. In further consideration of the rights granted
hereunder and subject to the other terms and conditions of this Agreement, MIOL
shall: (i) if a Marketing Authorization for the Finished Product is granted via
the Centralized Procedure

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

and MIOL has not elected to terminate the Agreement pursuant to
Section 15.4below, make a non-refundable, non-creditable payment of $[*] million
within thirty (30) days of the grant by the European Commission of such
Marketing Authorization for the Finished Product or (ii) if MIOL has applied for
any Marketing Authorization by a procedure other than the Centralized Procedure,
(A) make a non-refundable, non-creditable payment of $[*] million to Oscient
within thirty (30) days of receipt of Marketing Authorization in at least three
(3) the Major Countries, and (B) make the following non-refundable,
non-creditable payments to Oscient within (30) days of the first occurrence of
each of the following events:

 

Milestone

   Payment  

Upon grant of the first Marketing Authorization in the United Kingdom

   $ [ *]

Upon grant of the first Marketing Authorization in France

   $ [ *]

Upon grant of the first Marketing Authorization in Germany

   $ [ *]

Upon grant of the first Marketing Authorization in Italy

   $ [ *]

Upon grant of the first Marketing Authorization in Spain

   $ [ *]

(b) Reimbursement Milestones Payment. In further consideration of the rights
granted hereunder and subject to the other terms and conditions of this
Agreement, MIOL shall make the following nonrefundable, non-creditable payments
to Oscient within thirty (30) days of the occurrence of each of the following
events or circumstances (“Reimbursement Milestones”):

 

Milestone

   Payment  

Upon inclusion of the Finished Product in Part VIII of the National Health
Service Drug Tariff for England and Wales

   $ [ *]

Upon publication in the Journal Officiel of the price for such Finished Product
agreed with or set by the Comité Économique des Produits de Santé in France

   $ [ *]

If, 60 days after the first Marketing Authorization has been granted in Germany,
the Gemeinsamer Bundesausschuss has not published a determination that the
Finished Product may not be reimbursed

   $ [ *]

Upon publication in the Italian Official Gazette of a Decision of the Agenzia
Italiana del Farmaco to reimburse the Finished Product in Italy

   $ [ *]

Upon resolution of the Ministerio de Sanidad y Consumo to reimburse the Finished
Product in Spain

   $ [ *]

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

In the event that the specific Reimbursement Milestone described above for a
Major Country has not occurred, but the Finished Product is nevertheless
marketed in that Major Country and is in fact reimbursed, in whole or in part,
by the national health system or any broadly equivalent scheme in that Major
Country, the Reimbursement Milestone for that Major Country shall be deemed to
have occurred and MIOL shall pay the relevant Reimbursement Milestone payment
within thirty (30) days of the first such reimbursement.

(c) Sales Milestone Payment. In further consideration of the rights granted
hereunder and subject to the other terms and conditions of this Agreement, MIOL
shall make the following nonrefundable, non-creditable payments to Oscient
within thirty (30) days of the first occurrence of each of the following
milestones (“Sales Milestones”):

 

Milestone

   Payment  

Annual Net Sales exceed $[*] million dollars

   $ [ *]

Annual Net Sales exceed $[*] million dollars

   $ [ *]

Annual Net Sales exceed $[*] million dollars

   $ [ *]

Annual Net Sales exceed $[*] million dollars

   $ [ *]

For the avoidance of doubt, each of the Sales Milestones detailed in this
Section 9.5(c) are payable only once but may fall due for payment in the same
Sales Year. For example, if Annual Net Sales are $105 million in a Sales Year
and no payment has previously been made by MIOL on Annual Net Sales exceeding
$50 million, MIOL shall pay Oscient a non-refundable, non-creditable sum of
$[*].

(d) Determination that Payments are Due. MIOL shall promptly (and in any event
within ten (10) Business Days) provide Oscient with written notice upon its or
its Affiliates’ or Sub-Distributors’ achievement of each of the milestones set
forth in Sections 9.5(a), (b) and (c). In the event that Oscient believes any
milestone payment is due pursuant to Sections 9.5(a), (b) and (c) in spite of
not having received notice from MIOL, it shall so notify MIOL and shall provide
to MIOL the data and information supporting its belief that the conditions for
payment have been achieved. If MIOL does not provide adequate evidence that such
milestone has not been achieved within thirty (30) days of receipt of the data
and information from Oscient, the conditions for payment shall be deemed to have
been achieved.

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

(e) Milestone Payments Terms. Unless otherwise expressly provided, MIOL shall
make any milestone payment owed to Oscient pursuant to this Section 9.5 in
arrears, within thirty (30) days from the achievement of such milestone.

9.6 Calculation of Annual Net Sales. For purposes of Section 9.3 and
Section 9.5, “Annual Net Sales” shall be calculated (i) based on the twelve
(12) month period commencing on the first day of the first full Quarter
following the First Commercial Sale of the Finished Product (the “First Sales
Year”) and each successive twelve (12) month period thereafter (each a “Sales
Year”); provided that, Annual Net Sales in the First Sales Year shall also
include any Net Sales completed in the Quarter in which the First Commercial
Sale occurred; and (ii) using the Annual Calculated Exchange Rate as calculated
at the end of each Quarter.

9.7 Development Expenses. Within thirty (30) day of the end of each Quarter
following the Effective Date, MIOL shall provide Oscient with a statement
setting forth the costs and expenses incurred by MIOL (together with the
relevant invoices and such supporting documentation as Oscient may reasonably
require), and Oscient shall reimburse MIOL within thirty (30) days of receipt of
such statement all reasonable and verifiable expenses incurred by MIOL in such
Quarter in undertaking Development of the Finished Product in accordance with
this Agreement (the “MIOL Development Expenses”); provided that, (i) Oscient
shall not be obligated to pay more than [*] Dollars ($[*]) in any applicable
Quarter and (ii) the aggregate amount to be paid by Oscient for such expenses
shall not exceed [*] Dollars ($[*]). MIOL shall keep complete and accurate books
and financial records pertaining to its costs and expenses of Developing the
Finished Product, which books and financial records shall be retained by MIOL
until two (2) years after the end of the Quarter to which they pertain. Oscient
shall have the right to inspect and audit, during normal business hours and upon
reasonable prior written notice, the books and financial records of MIOL
relating to its costs and expenses of Developing the Finished Product during any
Quarter; provided that Oscient shall not have the right to inspect or audit any
Quarter more than once and will not go back over records more than two (2) years
old unless a discrepancy is found.

9.8 Payment Terms. All sums payable by MIOL pursuant to this Agreement shall be
paid in United States dollars by bank wire transfer in immediately available
funds to the following account unless MIOL is otherwise notified in writing by
Oscient:

 

Bank Account:   

Citizens Bank

28 State Street

Boston, MA 02109

USA

1-877-471-1961

Account Number:    1135568364 Bank ABA Number:    011500120

9.9 Overdue Payments. Subject to the other terms of this Agreement, any payments
not paid within the time period set forth in this Article 9 shall bear interest
at a rate of LIBOR plus [*] percent ([*]%) for the applicable month from the due
date until paid in full, provided that in no event shall said annual rate exceed
the maximum interest rate permitted by law in regard to such payments. Such
payment when made shall be accompanied by all interest so accrued. Said interest
and the payment and acceptance thereof shall not negate or waive the right of
Oscient to any other remedy, legal or equitable, to which it may be entitled
because of the delinquency of the payment.

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

9.10 Tax Withholding; Restrictions on Payment. It is the Parties’ understanding
that no withholding or deduction should be required to be made from any payment
made to Oscient pursuant to this Article 9. Any payments payable by either
Oscient or MIOL (the “Withholding Party”) to the other under this Agreement may
be reduced by the amount required to be withheld or deducted from such payment
pursuant to any applicable law (“Withholding Taxes”); provided however, that
Withholding Party shall withhold taxes at the lowest tax rate allowed in the
applicable tax treaties. The Withholding Party shall submit to the other Party a
copy of an original receipt received by the Withholding Party showing payment
thereof to the relevant governmental authority, or if such receipt is not
available, other reasonable proof of such payment of any Withholding Taxes
withheld or deducted, together with an accounting of the calculations of such
taxes, as promptly as practicable but in no case later than thirty (30) days
after such Withholding Taxes are remitted to the proper governmental authority.
All taxes (“Other Taxes”) other than Withholding Taxes shall be borne by the
Party upon which such Other Tax is imposed. Oscient and MIOL will cooperate
reasonably in completing and filing documents required under the provisions of
any applicable Luxembourg tax law or under any other applicable Luxembourg law
in connection with the making of any required withholding or deduction, or in
connection with the payment of any such withholding or deduction to the proper
governmental authority or in connection with any claim to a refund of or credit
for any such payment.

9.11 Records Retention; Review.

(a) Records. Commencing as of the date of First Commercial Sale of the Finished
Product hereunder, MIOL and Sub-Distributors shall keep for at least five
(5) years from the end of the calendar year to which they pertain complete and
accurate records of sales by MIOL or Sub-Distributor, as the case may be, of the
Finished Product and the reimbursement price from time to time in each country
in the Territory and total units of Finished Products dispensed in each country
by month, in sufficient detail to allow the accuracy of the payments hereunder
to be confirmed.

(b) Review. Subject to the other terms of this Section 9.11, at the request of
Oscient, which shall not be made more frequently than once per calendar year
during the Term, upon at least thirty (30) days’ prior written notice from
Oscient, and at the expense of Oscient (except as otherwise provided herein),
MIOL shall permit independent accountants (who may be certified public
accountants or chartered accountants) reasonably selected by Oscient to inspect
(during regular business hours) the relevant records required to be maintained
by MIOL under this Section 9.11. Results of any such review shall be binding on
the Parties absent manifest error. Each Party agrees to treat the results of any
such accountant’s review of the Party’s records under this Section 9.11 as
Confidential Information of such other Party subject to the terms of Article 10.
If any review reveals a deficiency in the calculation and/or payment of
royalties by MIOL, then (i) MIOL shall promptly pay Oscient the amount remaining
to be paid, and (ii) if such underpayment is by [*] percent ([*]%) or more, MIOL
shall pay the reasonable out-of-pocket costs and expenses incurred by Oscient in
connection with the review.

(c) Sub-Distributors. MIOL shall include in any agreement with the
Sub-Distributor terms requiring such party to retain records as required in this
Section 9.11 and to permit Oscient to inspect such records as required by this
Section 9.11.

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

10. TREATMENT OF CONFIDENTIAL INFORMATION

10.1 Confidential Obligations. Oscient and MIOL each recognize that the other
Party’s Confidential Information constitutes highly valuable and proprietary
confidential information. Oscient and MIOL each agree that during the Term and
for five (5) years thereafter, it will keep confidential, and will cause its
employees, consultants, Affiliates and, in the case of MIOL, Third-Party
Manufacturer, Sub-Distributors and, in the case of Oscient, LG to keep
confidential, all Confidential Information of the Disclosing Party; provided
that, MIOL agrees to keep, and will cause its employees, consultants, Affiliates
and Third-Party Manufacturer and Sub-Distributors to keep, Confidential
Information regarding the manufacturing process for Active Pharmaceutical
Ingredient confidential for a further period of ten (10) years after expiration
or termination of this Agreement. Neither Oscient nor MIOL nor any Third-Party
Manufacturer nor Sub-Distributor, nor any of their respective employees,
consultants or Affiliates shall use the Disclosing Party’s Confidential
Information for any purpose whatsoever other than exercising any rights granted
to it or reserved by it hereunder. Without limiting the foregoing, the Receiving
Party may disclose information to the extent such disclosure is reasonably
necessary to (a) file and prosecute patent applications and/or maintain patents
which are filed or prosecuted in accordance with the provisions of this
Agreement, or (b) file, prosecute or defend litigation in accordance with the
provisions of this Agreement or (c) comply with Applicable Law, court orders or
the rules of any nationally recognized securities exchange, quotation system or
over-the-counter market on which the Receiving Party or its Affiliates or, in
the case of MIOL, the relevant Third-Party Manufacturer or Sub-Distributor is
listed or traded; provided, however, that if the Receiving Party is required to
make any such disclosure of the Disclosing Party’s Confidential Information in
connection with any of the foregoing, it will give reasonable advance notice to
the Disclosing Party of such disclosure requirement and, except to the extent
inappropriate in the case of patent applications, will use reasonable efforts to
assist the Disclosing Party in efforts to secure confidential treatment of such
information required to be disclosed.

10.2 Limited Disclosure and Use. Oscient and MIOL each agree that any disclosure
of the Disclosing Party’s Confidential Information to any officer, employee,
consultant or agent of the Receiving Party or any of its Affiliates, or in the
case of Menarini, any Third-Party Manufacturer or Sub-Distributor, shall be made
only if and to the extent necessary to carry out its rights and responsibilities
under this Agreement, shall be limited to the maximum extent possible consistent
with such rights and responsibilities and shall only be made to the extent any
such persons are bound by written confidentiality obligations to maintain the
confidentiality thereof and not to use such Confidential Information except as
expressly permitted by this Agreement. Oscient and MIOL each further agree not
to disclose or transfer the Disclosing Party’s Confidential Information to any
Third Parties under any circumstance without the prior written approval from the
Disclosing Party (such approval not to be unreasonably withheld), except as
otherwise required by Applicable Law, and except as otherwise expressly
permitted by this Agreement. Oscient shall be permitted to disclose Confidential
Information to LG to the extent required pursuant to the LG License. The
Receiving Party shall take such action, and shall cause its Affiliates to take
such action, to preserve the confidentiality of the Disclosing Party’s
Confidential Information as it would customarily take to preserve the
confidentiality of its own Confidential Information, using, in all such
circumstances, not less than reasonable care. The Receiving Party, upon the
request of the Disclosing Party, will return all the Confidential Information
disclosed or transferred to it by the Disclosing Party pursuant to this
Agreement, including all copies and extracts of documents and all manifestations
in whatever form, within sixty (60) days of such request or,

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

if earlier, the termination or expiration of this Agreement; provided however,
that the Receiving Party may retain (a) any Confidential Information of the
Disclosing Party which is the subject of a continuing license to the Receiving
Party at the time of such request or termination or expiry of this Agreement as
the case may be and (b) one (1) copy of all other Confidential Information in
inactive archives solely for the purpose of establishing the contents thereof.

10.3 Publicity. Neither Oscient nor MIOL may publicly disclose the existence or
terms or any other matter of fact regarding this Agreement without the prior
written consent of the other Party, which consent shall not be unreasonably
withheld or delayed; provided, however, that any Party may make such a
disclosure (a) to the extent required by Applicable Law or by the requirements
of any nationally recognized securities exchange, quotation system or
over-the-counter market on which such Party has its securities listed or traded,
(b) to any investors, prospective investors, lenders and other potential
financing sources who are obligated to keep such information confidential, or
(c) in the case of Oscient, as required under the LG License. In the event that
such disclosure is required as aforesaid, the Party required to make such
disclosure shall make reasonable efforts to provide the other Party with notice
beforehand and to coordinate with the other Party with respect to the wording
and timing of any such disclosure. The Parties, upon the execution of this
Agreement, will mutually agree to a press release with respect to this
transaction for publication. Once such press release or any other written
statement is approved for disclosure by the Parties, either Party may make
subsequent public disclosure of the contents of such statement without the
further approval of the other Party.

10.4 Use of Name. No Party shall employ or use the name of another Party in any
promotional materials or advertising relating to this Agreement without the
prior express written permission of the other Party or as specifically set out
in this Agreement.

10.5 Access to Information. If MIOL, Third-Party Manufacturer or Sub-Distributor
receives an access to information or freedom of information request relating to
Finished Product, it shall notify Oscient within two days of such request, and
provide a copy of its proposed response to such request to Oscient at least five
days before the deadline for responding. If Oscient suggests that the proposed
response should be amended to keep additional information confidential, MIOL,
Third-Party Manufacturer or Sub-Distributor, as applicable, shall amend the
proposed response accordingly.

 

11. INTELLECTUAL PROPERTY RIGHTS

11.1 Ownership of Intellectual Property.

(a) Oscient Intellectual Property. Subject to the license granted by Oscient to
MIOL under this Agreement, as between the Parties, Oscient shall own and retain
all right, title and interest in and to the Oscient Intellectual Property.

(b) Joint Intellectual Property. As between the Parties, each Party shall own an
undivided one-half interest in and to any patentable invention conceived,
discovered developed or otherwise made, by or on behalf of MIOL, its Affiliates
or its Third-Party Manufacturer or Sub-Distributors pursuant to this Agreement
(a “Joint Invention”) regardless of inventorship, provided that Oscient may
designate LG or any Affiliate of LG (a “Designee”) as the joint owner of any
Joint Invention in its place, with full ownership rights in and to any field and
each Party and any Designee shall have the right, subject to the rights

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

and licenses granted under, and the other provisions of, this Agreement, to
freely exploit, transfer, license or encumber its rights in any Joint Invention
(together with all Patent Rights in that subject matter (the “Joint Patent
Rights”)) without the consent of, or payment or accounting to, the other Party,
and each Party waives any right it may have under any Applicable Law to require
such payment, accounting or consent. This Section 11.1 shall survive termination
of this Agreement howsoever caused. During the Term, MIOL shall and shall
procure that each Third-Party Manufacturer and Sub-Distributor shall, promptly
disclose to Oscient in writing, the characterization, conception, development or
making of any Joint Invention and notwithstanding any other provision of this
Agreement, Oscient shall be free to disclose details of such Joint Invention to
LG or any Designee. MIOL shall, and does hereby, assign, and shall cause its
Affiliates, Third-Party Manufacturers and Sub-Distributors to so assign, to
Oscient, or as Oscient may direct, without additional compensation, such right,
title and interest in and to any Joint Inventions as well as any Patent Rights
therein, as is necessary to fully effect the joint ownership provided for in
this Section.

11.2 Patent Filing, Prosecution and Maintenance. As between the Parties, Oscient
shall be responsible for preparing, filing, prosecuting, obtaining and
maintaining, at its sole cost, expense and discretion (but acting reasonably),
all Licensed Patent Rights and Joint Patent Rights in the Territory; provided
however, MIOL shall reimburse Oscient one-half of the costs and expenses
relating to the Joint Patent Rights in the Territory. Oscient will keep MIOL
reasonably informed of the status of such filing, prosecution, obtaining and
maintenance and MIOL, at its cost, shall provide such assistance as Oscient may
reasonably require in connection with such filing, prosecution, obtaining and
maintenance.

11.3 Trademarks Filing, Prosecution and Maintenance. Oscient may seek and
maintain such registrations as it deems advisable in respect of the Trademarks
in the Territory, and will keep MIOL reasonably informed of the status of such
registrations and applications therefore. Oscient may from time to time add to,
modify or delete any Trademarks.

11.4 Infringement. If, during the Term, any Party learns of any actual, alleged
or threatened infringement by a Third Party of any of the Oscient Intellectual
Property or the Joint Patent Rights, such Party shall promptly notify the other
Party and shall provide the other Party with available evidence of such
infringement and the Parties shall consult in good faith to determine the
appropriate action to be taken in relation to such infringement.

11.5 Violation of Intellectual Property by Third Party(ies). MIOL shall have the
first right (but not the obligation), at its own expense and with legal counsel
of its own choice, to bring suit (or take other appropriate legal action)
against any actual, alleged or threatened infringement or other violation of the
Oscient Intellectual Property or the Joint Patent Rights in the Territory.
Oscient and LG shall have the right, at their own expense, to be independently
represented in any such action by MIOL by counsel of Oscient’s own choice;
provided, however, that under no circumstances shall the foregoing affect the
right of MIOL to control the suit as described in the first sentence of this
Section 11.5. If MIOL does not notify Oscient of its decision as to whether it
intends to file an action or proceeding against a material infringement or other
violation (the “Notice”) within thirty (30) days after the later of (i) MIOL’s
notice to Oscient under Section 11.4 above, or (ii) a written request from
Oscient to take action with respect to such infringement (the “Notice Date”) or,
having given notice of its intention to file an action or proceeding, MIOL fails
to initiate such action or proceeding or having done so fails to diligently
prosecute such action or proceeding then Oscient (or LG) shall have the right
(but not the obligation), at its own expense, to bring suit

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

(or take other appropriate legal action) against such actual, alleged or
threatened infringement, with legal counsel of its own choice. MIOL acknowledges
that LG, as the person licensing certain of the Oscient Intellectual Property to
Oscient, is entitled to be represented in suits or actions involving the Oscient
Intellectual Property in the Territory, and to have its costs and expenses
incurred in respect of such litigation reimbursed, pro rata with Oscient, from
any damages, monetary awards, costs or other amounts recovered through such
suits or actions, or settlement thereof; subject to any deductions required to
be made in order to reimburse LG as aforesaid. Any damages, monetary awards,
costs or other amounts recovered, whether by judgment or settlement, pursuant to
any suit, proceeding or other legal action taken under this Section 11.5, shall
applied as follows:

(a) First, to reimburse Oscient, LG and MIOL for their respective costs and
expenses (including reasonable legal fees, expert fees and other disbursements)
incurred in prosecuting such enforcement action;

(b) Second, to reimburse MIOL for MIOL’s profits on lost sales associated with
Finished Products and to reimburse Oscient for Oscient’s profits on lost sales
of Active Pharmaceutical Ingredient to MIOL and Additional Payments, Quarterly
Royalties and milestone payments owing hereunder based on such lost sales;

(c) Third, any amounts remaining shall be allocated as follows: (A) if Oscient
is the Party bringing such suit or proceeding or taking such other legal action,
[*] percent ([*]%) to Oscient, (B) if MIOL is the Party bringing such suit or
proceeding or taking such other legal action, [*] percent ([*]%) to MIOL, and
(C) if the suit is brought jointly, [*] percent ([*]%) to each of Oscient and
MIOL.

If either of Oscient or MIOL brings any such action or proceeding hereunder, the
other agrees to be joined as party plaintiff if necessary to prosecute such
action or proceeding, and to give the Party bringing such action or proceeding
reasonable assistance and authority to file and prosecute the suit; provided,
however, that neither Oscient nor MIOL shall be required to transfer any right,
title or interest in or to any property to the other, to any Sub-Distributor or
any Third Party to confer standing on a Party hereunder.

The Party that controls the prosecution of any such action or proceeding shall
also have the right to control settlement of such action; provided, however,
that no settlement shall be entered into without the written consent of the
other Party if such settlement would materially adversely affect the interests
of such other Party.

11.6 Infringement of Third Party Patents.

If MIOL receives notice from a Third Party claiming that the importation of
Active Pharmaceutical Ingredient into the Territory or the Exploitation of the
Finished Product in the Territory by MIOL or its Affiliates or Sub-Distributors
infringes or misappropriates any Patent Rights of such Third Party in any
country in the Territory, MIOL shall promptly notify Oscient and the Parties
shall consult in good faith to determine the appropriate action to be taken in
relation to such alleged infringement or misappropriation. MIOL shall have the
first right, but not the obligation, through counsel of its choosing, to
negotiate and obtain a licence from such Third Party as necessary for MIOL and
its Affiliates to import Active Pharmaceutical Ingredient into the relevant
country and/or MIOL and its Affiliates, Sub-Distributors and Third-Party
Manufacturers to Exploit the Finished Products in the Territory or the relevant
country (a “Third Party License”). Oscient shall have the right, but not

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

obligation, at its own expense, to participate in any such negotiations and to
be independently represented by counsel of Oscient’s own choice. MIOL shall
conduct any negotiations with such Third Party in co-operation with Oscient, and
shall not conclude any Third Party License without the prior written consent of
Oscient, such consent not to be unreasonably withheld or delayed.

In the event that MIOL is required to pay a royalty based on Net Sales of the
Finished Product pursuant to a Third Party License (a “Third Party Royalty”),
Oscient shall during the Mandatory Supply Term, reimburse MIOL (or, if the
Parties agree, pay to the Third Party directly), Quarterly in arrears an amount
equal to [*] percent ([*]%) of the Third Party Royalty payable by MIOL with
respect to the preceding Quarter; provided that the amount to be paid by Oscient
with respect to any Quarter shall not exceed the lower of:

(i) [*] percent ([*]%) of Net Sales in that Quarter; and

(ii) an amount equal to the product of (A) the Actual Weighted Average Price Per
Tablet in that Quarter minus $[*], multiplied by (B) the number of Tablets sold
by MIOL or its Affiliates or Sub-Distributors in that Quarter (as determined in
accordance with Section 9.2).

If, with respect to one or more countries in the Territory, MIOL reasonably
determines that it requires, but is unable to obtain a Third Party License on
commercially reasonable terms, MIOL shall have the right to cease
Commercialization in such country upon not less than ninety (90) days written
notice to Oscient; provided that prior to serving any such notice, MIOL shall
promptly notify Oscient in writing of such determination together will all
relevant information with respect to such determination and the Parties shall
consult in good faith to determine the appropriate action to be taken.

11.7 Right to Use Intellectual Property. MIOL acknowledges that it has no
interest in, and agrees that it will not at any time assert or claim any
interest in, nor register or attempt to register any form of intellectual
property which would infringe or otherwise violate any of the Oscient
Intellectual Property, and will cooperate with Oscient to secure Oscient’s
rights under the Oscient Intellectual Property in the Territory. All benefit and
goodwill arising from MIOL’s or Sub-Distributor’s use of the Trademarks shall,
as among the Parties, inure to the benefit of Oscient.

11.8 Trademarks. No right, title or interest of any kind in or to the Trademarks
is transferred by this Agreement to MIOL, except the rights granted pursuant to
Section 2.1. MIOL agrees that it will not, in the Territory, use, except in
accordance with the terms hereof, or attempt to register, the Trademarks, or any
marks similar thereto, in any language or adopt any trademark that is
confusingly similar to or a colorable imitation of the Trademarks.

11.9 Patent Term Extensions. Oscient shall make all determinations as to whether
to seek patent term extensions, including supplementary protection certificates
and any other extensions that are now or become available in the future
regarding the Licensed Patent Rights with respect to the Finished Product and
MIOL shall not seek any such extensions or any extension of any other Patent
Rights with respect to the Finished Product without Oscient’s prior written
consent. MIOL shall provide Oscient with a copy of any and all Marketing
Authorizations within four (4) weeks of obtaining such Marketing
Authorization(s), shall timely and in writing provide any other data reasonably
required by

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

Oscient to complete any applications for such patent term extensions and agrees
to provide such assistance as Oscient may reasonably require in connection with
such extensions.

11.10 Further Assurance. Each Party undertakes that all employees, consultants
and agents shall be engaged on terms, recorded in writing, that provide that all
discoveries and inventions conceived or reduced to practice by that individual
as a result of or in connection with such engagement shall be promptly reported,
fully disclosed, and assigned to the engaging Party. In the event that a patent
application is filed directed to the subject matter of any such discovery or
invention, any such assignment shall be promptly recorded in the appropriate
patent office(s).

 

12. WARRANTIES

12.1 Oscient Warranties. Oscient warrants to MIOL that:

(a) the execution and delivery of this Agreement and the performance of the
transactions contemplated hereby have been duly authorized by all appropriate
Oscient corporate action;

(b) this Agreement is a legal and valid obligation binding upon Oscient and
enforceable in accordance with its terms, and the execution, delivery and
performance of this Agreement by the Parties does not conflict with any
agreement, instrument or understanding to which Oscient is a party or by which
it is bound;

(c) Oscient has the full right and legal capacity to grant the rights granted to
MIOL hereunder in the Territory without violating the rights of any Third Party;

(d) Oscient is not aware of any Third Party patent, patent application or other
intellectual property rights in the Territory that would be infringed (i) by
using the Trademarks, or (ii) by making, using, distributing, offering for sale
or selling the Finished Product; and

(e) Oscient warrants exclusively to MIOL to manufacture the Active
Pharmaceutical Ingredient in accordance with Applicable Law. Oscient warrants
exclusively to MIOL that all Active Pharmaceutical Ingredient shipped in
accordance with this Agreement: (i) shall meet Oscient’s specifications for the
shelf life of such Product when stored and handled in accordance with Oscient’s
labeled conditions, (ii) shall be manufactured in accordance with ICH Q7A and
Applicable Law in effect at the time of manufacture, and (iii) shall conform
with Oscient’s specifications for the Finished Product. Subject to Section 14.1
(b), Oscient’s sole obligation and MIOL’s sole remedy under this warranty is
replacement of any Active Pharmaceutical Ingredient or a refund of the purchase
price that Oscient reasonably determines to be covered by this warranty.

12.2 MIOL Warranties. MIOL warrants to Oscient that:

(a) the execution and delivery of this Agreement and the performance of the
transactions contemplated hereby have been duly authorized by all appropriate
MIOL corporate action;

(b) this Agreement is a legal and valid obligation binding upon MIOL and
enforceable in accordance with its terms, and the execution, delivery and
performance of this

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

Agreement by the Parties does not conflict with any agreement, instrument or
understanding to which MIOL is a party of or by which it is bound.

(c) MIOL has the capacity to fulfill all its obligations under this Agreement.

(d) MIOL warrants that it shall Manufacture, Commercialize and Develop the
Finished Product in accordance with Applicable Law.

12.3 No Warranties.

(a) Nothing in this Agreement is or shall be construed as:

 

  (i) a warranty or representation by any Party as to the validity or scope of
any patent application or patent licensed hereunder; or

 

  (ii) a warranty or representation that anything made, used, sold or otherwise
disposed of under any license granted pursuant to this Agreement is or will be
free from infringement of patents, copyrights, and other rights of Third
Parties.

(b) Except as expressly set forth in this Agreement, NO PARTY MAKES ANY
REPRESENTATION OR EXTENDS ANY WARRANTIES OR CONDITIONS OF ANY KIND, EITHER
EXPRESS OR IMPLIED. ALL OTHER WARRANTIES, CONDITIONS AND TERMS, EXPRESS OR
IMPLIED BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, WHETHER OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE, OR OF NON-INFRINGEMENT OF ANY PATENT,
COPYRIGHT, TRADEMARK, OR OTHER RIGHTS OF THIRD PARTIES, OR ANY OTHER EXPRESS OR
IMPLIED WARRANTIES ARE HEREBY EXPRESSLY EXCLUDED TO THE MAXIMUM EXTENT PERMITTED
BY APPLICABLE LAW.

 

13. PRODUCT RECALL

In the event that: (i) a Regulatory Authority or any other governmental agency
or authority issues a request or orders that the Finished Product be recalled;
(ii) a court of competent jurisdiction in the Territory orders that the Finished
Product be recalled; or (iii) Oscient reasonably determines, after consultation
with MIOL, that the Finished Product should be recalled or a notice is required
relating to restrictions on use of the Finished Product, MIOL and
Sub-Distributor shall attend to the same, as determined by the mutual agreement
of Oscient and MIOL, and the Parties shall co-operate in a manner which is
appropriate and take all appropriate corrective action. In the event such action
results from: (a) Oscient’s negligence or willful misconduct, Oscient shall be
responsible for the expenses thereof or, if applicable, a proportionate share of
such recall costs according to the extent to which Oscient is responsible,
(b) MIOL’s, its Affiliate’s and/or Third-Party Manufacturer’s and/or
Sub-Distributor’s negligence or willful misconduct, MIOL shall be responsible
for the expenses thereof or, if applicable, a proportionate share of such recall
costs according to the extent to which they are responsible; and (c) otherwise,
Oscient and MIOL shall share equally the expenses of the action. For purposes of
this Agreement, the expenses of the action shall be the expenses of notification
and return or destruction (if authorized by Oscient) of the Finished Product,
the cost of replacement of the Finished Product, and any costs directly
associated with the distribution of replacement Finished Product. Oscient, MIOL,
Third-Party Manufacturer and Sub-Distributor shall cooperate fully with one
another in carrying out such action.

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

14. INDEMNIFICATION

14.1 Indemnification.

(a) MIOL Indemnity. MIOL shall indemnify, defend and hold harmless Oscient, its
Affiliates and their respective directors, officers, employees, stockholders and
agents and their respective successors, heirs and assigns (the “Oscient
Indemnitees”) from and against any liability, damage, loss or expense (including
reasonable legal fees and expenses of litigation) incurred by or imposed upon
such Oscient Indemnitees, or any of them, in connection with any Third Party
claims, suits, actions, demands or judgments, including personal injury and
product liability matters, to the extent arising out of (i) handling of the
Active Pharmaceutical Product, or the Manufacture, Development or
Commercialization of the Finished Product, by MIOL, its Affiliates, Third-Party
Manufacturers or Sub-Distributors, or (ii) any material breach of this Agreement
by MIOL, all except to the extent of Oscient’s responsibility therefor under
Section (b) below.

(b) Oscient Indemnity. Subject to Section 14.1(a) above, Oscient shall
indemnify, defend and hold harmless MIOL, its Affiliates and their respective
directors, officers, employees, and agents, and their respective successors,
heirs and assigns (the “MIOL Indemnitees”), from and against any liability,
damage, loss or expense (including reasonable legal fees and expenses of
litigation) incurred by or imposed upon such MIOL Indemnitees, or any of them,
in connection with any Third Party claims, suits, actions, demands or judgments,
including personal injury and product liability matters, to the extent arising
out of (i) any material breach of this Agreement by Oscient, or (ii) any supply
of Active Pharmaceutical Ingredient in violation of warranties set forth in
Section 12.1(e).

14.2 Indemnification Procedures. In the event that any Indemnitee is seeking
indemnification under Section 14.1 above from a Party (the “Indemnifying
Party”), the other Party shall notify the Indemnifying Party of such claim with
respect to such Indemnitee as soon as reasonably practicable after the
Indemnitee receives notice of the claim, and the Party (on behalf of itself and
such Indemnitee) shall permit the Indemnifying Party (or if the Indemnifying
Party is Oscient, LG) to assume direction and control of the defense of the
claim (including the right to settle the claim solely for monetary
consideration) and shall cooperate as requested (at the expense of the
Indemnifying Party) in the defense of the claim. The indemnification obligations
under Section 14.1 shall not apply to any harm suffered as a direct result of
any delay in notice to the Indemnifying Party hereunder or to amounts paid in
settlement of any claim, demand, action or other proceeding if such settlement
is effected without the consent of the Indemnifying Party, which consent shall
not be withheld or delayed unreasonably. The Indemnitee, its employees and
agents, shall reasonably cooperate with the Indemnifying Party and its legal
representatives in the investigation of any claim, demand, action or other
proceeding covered by Section 14.1.

14.3 Insurance Covenant. From the Effective Date and for a period of five years
after the 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 (with
respect to Oscient) and the Territory (with respect to Menarini) for companies
of comparable size and activities. Such product liability insurance shall insure
against all liability arising as a result of administration of Finished Product
to humans (including liability for personal injury, physical injury, and
property damage). The Parties expressly agree that, for the period commencing as
of the Effective Date and ending as of the fifth anniversary of the Effective
Date, the reasonable and customary amount of

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

product liability insurance shall be construed to be as follows: Primary
coverage in the amount of at least [*] dollars ($[*]) per occurrence and [*]
dollars ($[*]) in the annual aggregate. Each Party shall provide written proof
of the existence of such insurance to the other Party promptly upon request.
MIOL may self insure any or a portion of the above required insurance if
(i) such self-insurance is effected through a captive insurance company duly
authorized by an appropriate authority in a favorably recognized domicile; or
(ii) MIOL can demonstrate to have proceeded with adequate accruals in its
balance sheet destined only for product liability self-insurance.

 

15. TERM AND TERMINATION

15.1 Termination Rights for Breach. Subject to the other terms of this
Agreement, this Agreement and the rights and options granted herein may be
terminated (i) by Oscient upon any material breach by MIOL, or (ii) by MIOL upon
any material breach by Oscient, of any material obligation or condition,
effective thirty (30) days after giving written notice to the breaching Party of
such termination, which notice shall describe such breach in reasonable detail.
The foregoing notwithstanding, if such default or breach is cured or remedied or
shown to be non-existent within the aforesaid thirty (30) day period, the notice
shall be automatically withdrawn and of no effect.

15.2 Termination for Bankruptcy. In the event that either Oscient or MIOL files
for protection under bankruptcy laws, makes an assignment for the benefit of
creditors, appoints or suffers appointment of a receiver or trustee over its
property, files a petition under any bankruptcy or insolvency act or has any
such petition filed against it which is not discharged within sixty (60) days of
the filing thereof, or any other analogous event occurs in any jurisdiction,
then the other may terminate this Agreement effective immediately upon written
notice to such Party.

15.3 Oscient Right to Terminate. Upon thirty (30) days’ written notice to MIOL,
Oscient shall have the right to terminate this Agreement if: (i) MIOL challenges
the validity of any of the Oscient Intellectual Property, (ii) in the event that
aggregate Net Sales in the Sales Year commencing on or after the third
anniversary of the date of First Commercial Sale are less than $50 million
(calculated pursuant to Section 9.6); provided that MIOL has prior to the end of
that Sales Year launched the Finished Product in at least three (3) Major
Countries, (iii) if MIOL has applied for a Marketing Authorization by a
Centralized Procedure, MIOL has not received Marketing Authorization on or
before the third anniversary of the Effective Date, (iv) if MIOL has applied for
any Marketing Authorization by a procedure other than the Centralized Procedure,
MIOL has not received Marketing Authorization in at least two (2) of the Major
Countries on or before the third anniversary of the Effective Date, (v) MIOL
manufactures or has manufactured Active Pharmaceutical Ingredient, or purchases
Active Pharmaceutical Ingredient from any Third Party, for Exploitation in the
Territory, or (vi) MIOL has not secured a Reimbursement Price of at least $[*]
(after applying the Annual Calculated Exchange Rate in effect at such time) in
at least one (1) of the Major Countries on or before the third anniversary of
the Effective Date.

15.4 MIOL Right to Terminate. Upon thirty (30) days’ written notice to Oscient,
MIOL shall have the right to terminate this Agreement: (i) if, prior to MIOL
submitting an application for a Marketing Authorization via the Centralized
Procedure, the EMEA confirms to MIOL in writing before or after the scientific
advice Procedure that (A) the Finished Product is not eligible for approval via
the Centralized Procedure and/or (B) that the risk-

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

benefit ratio for more than one of the proposed indications is not favorable,
subject to the Minimum Labeling Requirements; (ii) in the event that MIOL has
submitted an application for a Marketing Authorization via the Centralized
Procedure, if (a) at any time following MIOL’s response to the list of questions
from the EMEA’s Committee for Medicinal Products for Human Use (“CHMP”),
customarily provided on day 120 of the Centralized Procedure, the CHMP or the
CHMP’s Rapporteurs for the Marketing Authorization application inform MIOL that
the CHMP will adopt a negative opinion, recommending that the Commission do not
grant a Marketing Authorization in accordance with the Minimum Labeling
Requirements, or (b) if the CHMP in fact adopts any such negative opinion; or
(c) the Commission has granted a Marketing Authorization not in compliance with
the Minimum Labeling Requirements; (iii) in the event that MIOL has applied for
any Marketing Authorization by a procedure other than the Centralized Procedure,
if the Regulatory Authorities in at least three (3) Major Countries have refused
to grant a Marketing Authorization in accordance with the Minimum Labeling
Requirements; or (iv) if, within three (3) months of the date on which MIOL
serves notice on Oscient pursuant to Section 9.2(d)(iii) above, the Parties are
unable to establish a new minimum per Tablet price for the Actual Weighted
Average Price Per Tablet; provided that in each case notice of such termination
shall be served within thirty (30) days of the occurrence of the relevant
trigger event and shall include reasonably satisfactory evidence of such event.

15.5 Term. The term of the agreement shall commence on the Effective Date and
continue, until the [*] ([*]) anniversary after the expiry of the Mandatory
Supply Term (the “Initial Term”); provided that, MIOL may, prior to the expiry
of the Initial Term, extend the term for an additional [*] ([*]) years following
the Initial Term upon not less than six (6) month written notice to Oscient (the
“Extended Term” and together with the Initial Term, the “Term”); provided
however, that, Oscient shall have no obligations under this Agreement during the
Extended Term other than the granting of the Trademark and the Oscient
Information license set forth in Sections 2.1(c). and 2.1(d).

15.6 Termination of LG License. This Agreement shall automatically terminate on
the termination of the LG License. Provided that MIOL is not in breach of this
Agreement on such termination or has committed willful misconduct with respect
to this Agreement, Oscient hereby has furnished MIOL with a letter dated the
date hereof from LG (the LG Warranty Letter”) under which, if requested by MIOL
in writing within thirty (30) days of such termination, LG shall have a direct
relationship with MIOL concerning the subject matter of this Agreement at terms
and conditions set forth in such LG Warranty Letter.

15.7 Effects of Termination.

(a) Upon termination of this Agreement for any reason, as of the effective date
of such termination, all relevant licenses and sublicenses granted by Oscient to
MIOL hereunder shall terminate automatically and MIOL shall and shall procure
that and any Third-Party Manufacturer and Sub-Distributor shall cease
Manufacturing, Commercializing or Developing the Finished Product or using the
Oscient Intellectual Property.

(b) Upon termination of this Agreement for any reason (other than where LG and
MIOL enter into the LG/MIOL Agreement pursuant to Section 15.6 herein), MIOL
shall transfer, assign and fully release to Oscient, or its designee, at
Oscient’s expense, any and all Regulatory Approvals obtained by MIOL pursuant to
this Agreement. For purposes of the foregoing, MIOL shall, on or before the
expiry of ten (10) Business Days after such expiration or termination, transfer
the Regulatory Documentation to Oscient and take all

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

measures and execute such documents as Oscient considers necessary or reasonably
useful to perfect the transfer of all Regulatory Approvals to Oscient or its
designee. For the avoidance of doubt, no compensation shall be payable to MIOL
for such transfer of Regulatory Approvals.

(c) Upon termination of this Agreement, MIOL shall co-operate with Oscient in
the cancellation of all or any licenses registered pursuant to this Agreement
and shall execute such documents and do all acts and things as may be necessary
to effect such cancellation.

(d) Upon termination of this Agreement, MIOL shall immediately deliver to
Oscient, or such other person as it may designate, all promotional material,
including catalogues, Finished Product price lists, and any other documents or
material (including any material delivered in electronic form and Confidential
Information) provided by Oscient to MIOL or prepared or developed by MIOL with
respect to the Finished Product or its Commercialization in the Territory.

(e) For a period of one (1) year from termination of this Agreement, MIOL shall
cooperate with Oscient, its representatives and agents, including any new
distributor designated by Oscient in place of MIOL, in taking over the importing
into the Territory of the Active Pharmaceutical Ingredient and the
Commercialization of the Finished Product in place of MIOL.

(f) From and after the termination of this Agreement, MIOL shall have a period
of four (4) months to sell its remaining inventory of the Finished Product (with
royalties and other fees to be paid to Oscient on all Net Sales of such Finished
Products as provided for in Sections 9.3, 9.4 and 9.5, if applicable), provided
it shall do so at a price not less than its market price in effect immediately
prior to the termination.

(g) From and after the termination of this Agreement, the Oscient license of
MIOL Information set forth in Section 2.4 shall be expanded to allow Oscient to
use and sublicense such information and data in the Territory.

(h) MIOL agrees, upon Oscient request, to provide services for the continued
Development of the Finished Product in the Territory in consideration for
reasonable industry standard fees related to such regulatory Development
services for a maximum period of two (2) years from termination of this
Agreement,

(i) If MIOL terminates the Agreement pursuant to Sections 15.4(i), or 15.4(ii),
or 15.4(iii) herein, Oscient shall pay to MIOL all MIOL Development Expenses
incurred by MIOL through such date of termination; provided that, the aggregate
amount to be paid by Oscient for such MIOL Development Expenses at such date of
termination shall not exceed [*] Dollars ($[*]) minus all amounts previously
paid by Oscient pursuant to Section 9.7 above.

15.8 Remedies. Except as otherwise expressly set forth in this Agreement, the
termination provisions of this Article 15 are in addition to any other relief
and remedies available to the Parties at law.

15.9 Surviving Provisions. Notwithstanding any provision herein to the contrary,
the rights and obligations of the Parties set forth in Sections 1.1 (to the
extent applicable to other surviving provisions), 1.2, 2.5 (only for purposes of
the perpetual license granted therein),

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

4.5, 8.1, 9.11, 10, 11.1, 11.7, 11.8, 14, 15.7, 15.8, 15.9, 16 and 18 (other
than 18.21) as well as any rights or obligations otherwise accrued hereunder
(including any accrued payment obligations), shall survive the expiration or
termination of the Term. Without limiting the generality of the foregoing, MIOL
shall have no obligation to make any milestone or royalty payment to Oscient
that has not accrued prior to the effective date of any termination of this
Agreement, but shall remain liable for all such payment obligations accruing
prior to the effective date of such termination.

 

16. DISPUTES

16.1 Negotiation. The Parties recognize that a bona fide dispute as to certain
matters may from time to time arise during the Term which relates to any Party’s
rights and/or obligations hereunder. In the event of the occurrence of such a
dispute, any Party may, by written notice to the other Party, have such dispute
referred to their respective senior officials designated below or their
successors or designees, for attempted resolution by good faith negotiations
within thirty (30) days after such notice is received. Said designated senior
officials are as follows:

For MIOL: Managing Director

For Oscient: Chief Executive Officer

In the event the designated senior officials are not able to resolve such
dispute within the thirty (30) day period, any Party may invoke the provisions
of Section 16.2.

16.2 Arbitration. Subject to Section 16.1, any dispute, controversy or claim
initiated by any Party arising out of, or in connection with this Agreement, or
the performance by another Party of its obligations under this Agreement (other
than bona fide third party actions or proceedings filed or instituted in an
action or proceeding by a Third Party against a Party), whether before or after
termination of this Agreement, including any question regarding its existence,
validity or termination, shall be finally settled under the Rules of Arbitration
of the International Chamber of Commerce of Paris by a panel of three
arbitrators appointed in accordance with such Rules. Any such arbitration shall
be held in London (UK) and the language of the arbitration shall be English. The
arbitrators shall have the power to grant injunctions and/or specific
performance and to allocate amongst the Parties the costs of arbitration in such
equitable manner as they determine. Judgment upon any award rendered by the
arbitration panel may be entered in any court having jurisdiction or application
may be made to such court for judicial acceptance of any award and for an order
of enforcement, as the case may be. In no event shall a demand for arbitration
be made after the date when institution of a legal or equitable proceeding based
upon such claim, dispute or other matter in question would be barred by the
applicable statute of limitations. Notwithstanding the foregoing, any Party
shall have the right, without waiving any right or remedy available to such
Party under this Agreement or otherwise, to seek and obtain from any court of
competent jurisdiction any interim or provisional relief that is necessary or
desirable to protect the rights or property of such Party, pending the selection
of the arbitrators hereunder or pending the arbitrators’ determination of any
dispute, controversy or claim hereunder.

 

17. NON-COMPETITION

17.1 MIOL shall not and shall procure that its Affiliates and Sub-Distributors
shall not directly or indirectly for a period of [*] ([*]) years from the date
of the first Marketing

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

Authorization, develop, import, market, promote, distribute, sell, offer for
sale or otherwise exploit in such country of the Territory any (i) [*]
(“Competitive Products”). The Parties hereby agree that the foregoing provisions
of this Article 17 shall not apply to the products listed in Schedule 17.1 that
are sold and/or marketed by MIOL or any MIOL’s Affiliates in the Territory on
the Effective Date.

In addition, MIOL shall not and shall procure that its Affiliates and their
respective directors, officers and employees shall not directly or indirectly
during the Term and for [*] ([*]) year thereafter, solicit any of Oscient’s
employees or take any action to cause or that might reasonably be expected to
cause Oscient to lose any of its employees, agents, distributors, customers,
customer contacts or other elements of its goodwill.

17.2 During the period beginning on the fifth anniversary of the date of the
first Marketing Authorization, until the expiry of the Mandatory Supply Term,
MIOL shall and shall procure that its Affiliates shall purchase from Oscient at
least [*]% of the Active Pharmaceutical Ingredient required by MIOL in
connection with the supply of the Finished Product or Competitive Products in
the Territory.

 

18. MISCELLANEOUS

18.1 Notification. All notices, requests and other communications hereunder
shall be in writing, shall be addressed to the receiving Party’s address set
forth below or to such other address as a Party may designate by notice
hereunder, and shall be either (i) delivered by hand, (ii) made by facsimile
transmission (to be followed with written fax confirmation), (iii) sent by
international courier service providing evidence of receipt, or (iv) sent by
airmail. The addresses and other contact information for the Parties are as
follows:

 

If to Oscient:   

Oscient Pharmaceutical Corporation

1000 Winter Street, Suite 2200

Waltham, MA 02451

Attention: Chief Executive Officer

With a copy to:   

Oscient Pharmaceutical Corporation

1000 Winter Street, Suite 2200

Waltham, MA 02451

Attention: Legal

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

If to MIOL:   

Menarini International Operations Luxembourg SA

1, Avenue de la Gare, L-1611 Luxembourg

Attention: Menaring Director

With a copy to:   

A. Menarini Industrie Farmaceutiche Riunite Srl

3, Via Sette Santi

50131 Florence – Italy

Attention: Legal Affairs

All notices, requests and other communications hereunder shall be deemed to have
been given either (i) if by hand, at the time of the delivery thereof to the
receiving Party at the address of such Party set forth above, (ii) if made by
telecopy or facsimile transmission, at the time that receipt thereof has been
acknowledged by the recipient, (iii) if sent by international courier, on the
day such notice is delivered to the recipient, or (iv) if sent by airmail, on
the fifth (5th) Business Day following the day such mailing is made.

18.2 Language. This Agreement has been prepared in the English language and the
English language shall control its interpretation.

18.3 Governing Law. This Agreement will be construed, interpreted and applied in
accordance with the laws of England (excluding its body of law controlling
conflicts of law).

18.4 Entire Agreement. This is the entire Agreement between the Parties with
respect to the subject matter hereof and supersedes all prior representations,
understandings and agreements whether written or oral between the Parties with
respect to the subject matter hereof. Each Party confirms that, in agreeing to
enter into this Agreement, it has not relied on any representation, warranty,
collateral contract or other assurance except those set out in this Agreement
(and in respect of which the only remedy shall be for breach of contract) and to
the extent any other representation, warranty, collateral contract or assurance
was made to a Party, such Party waives all rights and remedies with respect
thereto. Nothing in this Agreement will operate or limit to exclude a Party’s
liability for fraud. No modification of this Agreement shall be effective unless
in writing with specific reference to this Agreement and signed by the Parties.

18.5 Waiver. The terms or conditions of this Agreement may be waived only by a
written instrument executed by the Party waiving compliance. The failure of any
Party at any time or times to require performance of any provision hereof shall
in no manner affect its rights at a later time to enforce the same. No waiver by
any Party of any condition or term shall be deemed as a continuing waiver of
such condition or term or of another condition or term.

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

18.6 Headings. Article, Section and subsection headings are inserted for
convenience of reference only and do not form part of this Agreement.

18.7 Assignment. Neither this Agreement nor any right or obligation hereunder
may be assigned, delegated or otherwise transferred, in whole or part, by any
Party without the prior express written consent of the others; provided,
however, that Oscient may without the written consent of MIOL, assign this
Agreement and its rights and delegate its obligations hereunder to its
Affiliates, or in connection with the transfer or sale of all or substantially
all of its assets or business, or in the event of its merger, consolidation,
change in control or similar transaction. Any permitted assignee shall assume
all obligations of its assignor under this Agreement. Any purported assignment
in violation of this Section 18.7 shall be void. The terms and conditions of
this Agreement shall be binding upon and inure to the benefit of the permitted
successors and assigns of the Parties.

18.8 Force Majeure. No Party shall be liable for failure of or delay in
performing obligations set forth in this Agreement (excluding any payment
obligation under this Agreement), and no Party shall be deemed in breach of its
obligations, if such failure or delay is due to natural disasters, labor strikes
or any other form of industrial action, trade embargo, fire explosion, flood,
act of God, civil disturbance, terrorism, pandemic, epidemic or any other cause
beyond the reasonable control of such Party. In event of such force majeure, the
Party affected thereby shall given prompt notice to the other Parties and use
reasonable efforts to cure or overcome the same and resume performance of its
obligations hereunder.

18.9 Construction. The Parties hereto acknowledge and agree that: (i) each Party
and its counsel reviewed and negotiated the terms and provisions of this
Agreement and have contributed to its revision; (ii) the rule of construction to
the effect that any ambiguities are resolved against the drafting Party shall
not be employed in the interpretation of this Agreement; and (iii) the terms and
provisions of this Agreement shall be construed fairly as to all Parties hereto
and not in favor of or against any Party, regardless of which Party was
generally responsible for the preparation of this Agreement.

18.10 Severability. If any provision(s) of this Agreement are or become invalid,
are ruled illegal by any court of competent jurisdiction or are deemed
unenforceable under then current applicable law from time to time in effect
during the Term hereof, it is the intention of the Parties that the remainder of
this Agreement shall not be affected thereby. The Parties hereto covenant and
agree to renegotiate any such term, covenant or application thereof in good
faith in order to provide a reasonably acceptable alternative to the term,
covenant or condition of this Agreement or the application thereof that is
invalid, illegal or unenforceable, it being the intent of the Parties that the
basic purposes of this Agreement are to be effectuated.

18.11 Status. Nothing in this Agreement is intended or shall be deemed to create
a relationship of co-venturers, partners, associates, principal and agent,
master and servant, employer and employee, or any similar relationship between
the Parties. MIOL shall perform its duties under the terms of this Agreement as
an independent contractor acting as a principal for its own account. MIOL is not
the representative of Oscient for any purpose and shall not have the power or
authority as agent or in any other capacity to represent, act for, bind, or
otherwise create or assume any obligation on behalf of Oscient for any purpose
whatsoever. Neither MIOL nor Oscient has or shall represent or hold itself out
to a Third Party as having power or authority to bind the other in any way.

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

18.12 Limitation of Liability. EXCEPT FOR ANY BREACH OF ANY CONFIDENTIALITY
OBLIGATIONS OR THE PROVISIONS OF SECTION 7.5 HEREUNDER OR TO THE EXTENT CAUSED
BY RECKLESSNESS OR WILFUL MISCONDUCT BY A PARTY, IN NO EVENT SHALL ANY PARTY BE
LIABLE TO THE OTHER OR ANY OF THEIR AFFILIATES FOR LOSS OF REVENUE, LOSS OF
ACTUAL OR ANTICIPATED PROFITS, LOSS OF BUSINESS OR LOSS OF GOOD WILL (WHETHER
SUCH LOSSES WERE DIRECT OR INDIRECT OR FORESEEN OR FORESEEABLE) NOR FOR ANY
CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES
SUFFERED OR INCURRED BY SUCH OTHER PARTY OR ITS AFFILIATES IN CONNECTION WITH A
BREACH OR ALLEGED BREACH OF THIS AGREEMENT, WHETHER IN CONTRACT, WARRANTY, TORT,
STRICT LIABILITY OR OTHERWISE.

18.13 Export Compliance.

(a) MIOL shall be responsible for the importation of the Active Pharmaceutical
Ingredient for the Finished Product into the Territory, in its name as importer
of record, and shall obtain at its expense, all permits and authorizations, and
shall comply with all customs laws, regulations and official standards
applicable to such importation into the Territory and shall pay any customs
duties and import fees associated therewith.

(b) MIOL shall comply with all European and United States laws and regulations
controlling the export of certain commodities and technical data, including all
Export Administration Regulations of the United States Department of Commerce
(collectively, “Export Control Laws”). Among other things, these Export Control
Laws prohibit or require a license for the export of certain types of
commodities and technical data to specified countries. MIOL hereby gives written
assurance that it will comply with, and will cause its Affiliates, Third-Party
Manufacturers and Sub-Distributors to comply with, all Export Control Laws, that
it bears sole responsibility for any violation thereof by itself or its
Affiliates Third-Party Manufacturers or Sub-Distributors, and that it will
indemnify, defend, and hold Oscient harmless (in accordance with Article 14) for
the consequences of any such violation.

18.14 Anti-Corruption. MIOL shall not and shall procure that none of its
Affiliates, Third-Party Manufacturers or Sub-Distributors, or any of their
respective employees, consultants or representatives make any payment,
contribution or gift (including any payoff, bribe, rebate or kickback) to any
official or employee of any government, Regulatory Authority or other agency or
instrumentality of any government, or to any prescriber or potential prescriber
of the Finished Products for the purpose of obtaining Regulatory Approvals,
medical reimbursement coverage, favorable treatment in securing or maintaining
business, influencing prescribing decisions or influencing in any other way any
act or decision of such person.

18.15 Further Assurances. Each Party agrees to execute, acknowledge and deliver
such further instructions, 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. In
particular, by way of security, MIOL shall on the date of notice of termination
of the Agreement pursuant to Section 15 herein execute, or have executed by any
Affiliate, a perpetual irrevocable power of attorney in favor of Oscient in the
form set out in Exhibit B (the “Power of Attorney”) to enable Oscient to effect
the transfer, assignment and release of any and all Regulatory Approvals on
termination of this Agreement for any reason. If requested by Oscient upon
termination,

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

MIOL shall, and shall procure that any Affiliate at that time holding a
Marketing Authorization shall, execute such further documents as Oscient
considers necessary or reasonably useful to enable Oscient or its designee, as
the case may be, to effect the transfer, assignment and release of any and all
Regulatory Approvals on termination of this Agreement for any reason.

18.16 Counterparts. This Agreement may be executed simultaneously in one or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.

18.17 Third Party Beneficiaries. None of the provisions of this Agreement shall
be for the benefit of or enforceable by any Third Party, including any creditor
of any Party whether pursuant to The Contracts (Rights of Third Parties) Act
1999 or otherwise. No such Third Party shall obtain any right under any
provision of this Agreement or shall by reasons of any such provision make any
claim in respect of any debt, liability or obligation (or otherwise) against any
Party.

18.18 LG. MIOL acknowledges that certain rights granted pursuant to this
Agreement are designed to enable Oscient to comply with its obligations to LG
under the LG License. Without creating any direct relationship between MIOL and
LG, MIOL shall permit Oscient to exercise its rights under this Agreement for
the benefit of LG; provided that, OSCIENT represents and warrants that any
Confidential Information of MIOL shall be treated by LG as per the terms of this
Agreement.

18.19 Non-Solicitation. Until the [*] ([*]) year anniversary of the termination
or expiration of this Agreement, no Party nor its respective Affiliates shall,
and shall cause each of its Affiliates not to, directly or indirectly, without
the other Parties’ prior written consent, solicit the employment of any employee
(or former employee bound by a non-competition obligation know to that Party) of
the other Parties or their respective Affiliates with whom it has come in
contact in conducting activities under this Agreement; provided, however, that
the foregoing provisions shall not apply to a general advertisement or
solicitation program that is not specifically targeted at such persons.

18.20 United Nations Convention on Sale of Goods. The United Nations Convention
on Sale of Goods is hereby expressly excluded from application to this
Agreement.

18.21 Additional Product Option.

(a) Oscient hereby grants MIOL for the Mandatory Supply Term an exclusive option
(the “Option”) to acquire an exclusive sublicense for the Territory under the
Licensed Patents Rights (and any other relevant patents to which Oscient has
Control), to develop and commercialize Additional Products. Oscient shall notify
MIOL in the event that it is planning to commercialize an Additional Product in
the Territory (the “Notice”), and the Notice shall contain all relevant
information available in connection therewith (provided that, any such
information shall be deemed to be Confidential Information of Oscient for the
purposes of Section 10.1 herein). MIOL will have thirty (30) days from the date
of receipt of such Notice from Oscient to give written notice to Oscient of
MIOL’s election to exercise the Option, failing which the Option shall expire
and be of no further force or effect. In the event that MIOL elects to exercise
the Option, the Parties shall enter into good faith negotiations regarding the
terms and conditions of such sublicense and further agree to negotiate economic
terms that are fair and reasonable to both Parties.

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

(b) In the event that the Parties fail to reach an agreement regarding the
economic terms of such sublicense within ninety (90) days after MIOL’s exercise
of the Option (the “Negotiation Period”), then Oscient may offer any and all
rights to such Additional Products to one or more Third Parties; provided,
however, that, prior to consummating a transaction with a Third Party, Oscient
shall offer to MIOL a right to acquire the sublicense on the same economic terms
and conditions as agreed upon with the Third Party, if the economic terms for
rights to the Additional Product are, in the aggregate, more favorable to such
Third Party than the terms and pricing last offered to MIOL by Oscient. MIOL
shall thereupon have thirty (30) days to accept such terms and conditions in
which case, Oscient shall grant such sublicense to Menarini on such terms and
conditions.

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representative in two (2) originals.

 

Menarini International Operation

Luxembourg SA

   

OSCIENT PHARMACEUTICALS

CORPORATION

By:          By:      Title:          Title:     

 

[*]

   =   Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

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

Schedule 1.1(kk)

[*]

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

Schedule 1.1(mm)

[*]

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Schedule 1.1(qq)

[*]

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Schedule 1.1(ggg)

[*]

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Schedule 1.1(nnn)

[*]

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Schedule 7.1

[*]

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

Schedule 9.2

[*]

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Schedule 17.1

[*]

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

EXHIBIT A

[*]

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EXHIBIT B

[*]