Document:

EXHIBIT
10.2

 

MODIFICATION OF
LOAN AND SECURITY AGREEMENT

 

 

WHEREAS this agreement is
in reference to a loan which is evidenced by an instrument entitled LOAN AND
SECURITY AGREEMENT (“AGREEMENT”), dated February 20, 2001, executed by and
between LEE PHARMACEUTICALS as “BORROWER” AND PREFERRED BUSINESS CREDIT, INC.
(“PBC”), as “LENDER.”

 

NOW THEREFORE, it is
agreed by the undersigned parties that the AGREEMENT shall be amended in the
following respect:

 

In Section 2.8 of the
Agreement, . This Agreement shall become effective upon acceptance by PBC and
shall continue in full force and effect for a term ending one year from the
date of this Agreement (the “Renewal Date”) and shall be automatically renewed
for successive one (1) year periods thereafter, unless sooner terminated
pursuant to terms hereof.  Either party
may terminate this Agreement on the Renewal Date or on any anniversary of the
Renewal date by giving the other party at least ninety (90) days prior written
notice by registered or certified mail, return receipt requested.  Notwithstanding the foregoing, PBC shall
have the right to terminate this Agreement immediately and without notice upon
the occurrence of an Event of Default.

 

Except as noted above,
all the terms, conditions and provisions of said AGREEMENT shall remain
unchanged and in full force and effect.

 

	
  DATE:  May 20, 2004

  
	
   

  	
   

  	
   

  	
   

  
	
  PREFERRED BUSINESS
  CREDIT, INC.

  	
  AGREED AND ACCEPTED:

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  LEE PHARMACEUTICALS

  	
   

  
	
   

  	
   

  	
  a California
  corporation

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  BY:

  	
  FARHAD MOTIA

  	
   

  	
   

  	
   

  
	
   

  	
  Farhad Motia, President

  	
   

  	
   

  
					

 

 

	
   

  	
  By:

  	
  RONALD G. LEE

  	
   

  
	
   

  	
   

  	
  Ronald G. Lee,
  PresidentEXHIBIT
10.3

 

DEMAND PROMISSORY NOTE

 

 

	
  $225,809.49

  	
   

  	
  Due:  June 15, 2004

  

 

For value received, the
undersigned, Lee Pharmaceuticals (the “Borrower”), hereby acknowledges itself
indebted to Henry L. Lee, Jr. (the “Lender”) and promises to pay on demand to
or to the order of the Lender, at South El Monte, California, or as otherwise
directed in writing by the Lender, the principal sum of $225,809.49 with
interest thereon at the rate of 12% per annum, compounded monthly, based on a
365-day year, actual day month.

 

The Lender may assign all
of his right, title and interest in, to and under this demand promissory
note.  All payments required to be made
hereunder shall be made by the Borrower without any right of set off or counterclaim.

 

The Demand Promissory
Note shall be governed by and interpreted in accordance with the laws of the
State of California.  This note is
unsecured.

 

 

	
  JUNE 15, 2004

  	
   

  	
  RONALD G. LEE

  	
   

  
	
   

  	
  Lee Pharmaceuticals by
  Ronald G. Lee

  
	
   

  	
  President

  
	
   

  	
   

  
	
   

  	
   

  
	
  JUNE 15, 2004

  	
   

  	
  MICHAEL L. AGRESTI

  	
   

  
	
   

  	
  Lee Pharmaceuticals by
  Michael L. Agresti

  
	
   

  	
  Vice President -
  FinanceExhibit 10.2

 

CONFIDENTIAL INFORMATION
OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT

 

THIS AGREEMENT is made the April 27, 2004 (the
“Effective Date”) by and between PRAECIS PHARMACEUTICALS INCORPORATED, a
corporation organized and existing under the laws of State of Delaware having
its principal place of business at 830 Winter Street, Waltham, MA 02451, USA
(hereinafter referred to as “Praecis”) and SCHERING AG, a corporation organized
and existing under the laws of Germany having its principal place of business
at 13442 Berlin, Germany (hereinafter referred to as “Schering”).  Praecis and Schering are sometimes referred
to herein individually as a “Party” and collectively as the “Parties”.

 

WITNESSETH:

 

WHEREAS, Praecis is engaged, among other things, in
the business of research, development, manufacturing and commercialization of
pharmaceutical products, including its proprietary drug PlenaxisTM;

 

WHEREAS, Schering is engaged, among other things,
in the business of developing, marketing and selling pharmaceutical products in
the Territory;

 

WHEREAS, subject to the terms and conditions set
forth in this Agreement, Praecis and Schering wish to collaborate in the
development and commercialization of the Product in the Territory;

 

WHEREAS, subject to the terms and conditions set
forth in this Agreement, Praecis wishes to license to Schering and Schering
wishes to license from Praecis certain rights relating to the Product in the
Territory;

 

WHEREAS, Praecis and Schering signed a
Confidentiality Agreement on November 21, 2001, as amended, in order to govern
the protection of confidential information made available by the Parties in
connection with the discussions concerning this transaction;

 

NOW, THEREFORE, in consideration of the foregoing
recitals and the mutual covenants and agreements contained herein, the Parties
hereto, intending to be legally bound, do hereby agree as follows:

 

ARTICLE
I

 

DEFINITIONS

 

1.1           Definitions.  The following terms, when capitalized, shall
have the following meanings (such meanings to be equally applicable to both the
singular and plural forms of the terms defined), when used in this Agreement.

 

“Affiliate” means any person, corporation,
partnership, firm, joint venture, or other entity which, directly or
indirectly, by itself or through one or more intermediaries, controls,

 

 

is controlled by, or is under common control with,
Praecis or Schering, as the case may be. As used in this definition, the term
“control” means the possession of the power to direct or cause the direction of
the management and policies of an entity, whether through the ownership of the
outstanding voting securities or by contract or otherwise.

 

“Agreement” means this License, Supply and
Distribution Agreement.

 

“Approved Label” shall mean the therapeutic
indication as defined in section 4.1 of the SmPC of the Marketing Authorization
for the Current Product in the MRP-Countries.

 

“Average Net Sales Price” means, with respect to
any country in the Territory in any specified time period, the total Net Sales
of the Product in that country during such time period, divided by the number
of Product units sold in such time period.

 

“Bankruptcy Event” shall have the meaning set forth
in Section 16.2(d).

 

“Bulk Product” means the Product in bulk form, in
unlabeled vials.  For the Current
Product, “Bulk Product” means, as of the Effective Date, the Product in
irradiated powder form, in 100mg unlabeled vials, in accordance with the
Specifications for the Current Product.

 

“Business Day” means a day which is not a Saturday,
a Sunday or other day on which banks are required or authorized by law to be
closed in Boston, Massachusetts, USA or Berlin, Germany.

 

“CFR” means the US Code of Federal Regulations, as
amended from time to time.

 

“Clinical Development” means all activities relating
to planning and execution of clinical studies in humans directed towards
obtaining Regulatory Approvals, including Marketing Authorizations for the
Product.

 

“Clinical Life Cycle Management” means any Phase IV
or other post-marketing clinical development, studies or other post-Marketing
Approval Development activities that may be required or advisable for the
Current Product in the Territory.

 

“CMC/Process Development” means the development of
one or more processes for the manufacture and packaging of the Bulk Product for
Clinical Development and Commercialization, and shall include, without
limitation, formulation, production, fill/finish, sourcing of components, raw
materials, and packaging supplies for the Bulk Product, development of methods
and controls appropriate for Regulatory Approval, including assays, quality
control and quality assurance methodology and stability protocols.

 

“Commercialization” and “Commercialize” mean all
activities relating to the pre-marketing, importing for sale, marketing,
distribution and sale, of the Product. 
“Commercialization” does not include Development or manufacture of the
Product.

 

“Competing Product” means [*].

 

“Confidential Information” shall have the meaning
set forth in Section 12.1.

 

“Control” or “Controlled” means the right to grant
an exclusive or non-exclusive license or sublicense, as applicable, of patent
rights, know-how, Information or other intangible rights as provided for herein
without violating the terms of any agreement or other arrangement with any
Third Party.

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

2

 

“Current Product” means the Product for the treatment
of the Indication of hormonally responsive advanced prostate cancer, as such
Indication may be limited or otherwise modified in each country in the
Territory pursuant to the Marketing Authorization in such country.

 

“Development” and “Develop” mean all activities and
obligations relating to Existing Trials, Clinical Development, CMC/Process
Development, Clinical Life Cycle Management and pharmacovigilance, and any
other activities customarily undertaken or reasonably required to obtain and
maintain all Regulatory Approvals, including Marketing Authorizations, for the
Product.

 

“Domain Names” mean all Domain Names identical or
similar with the Praecis and/ or Schering Trademarks, as set forth in
Attachment [tbd], which may be supplemented from time to time in accordance
with Article XIV, to be used for the promotion of the Product.

 

“EMEA” means the European Medicines Evaluation
Agency, or any successor agency with substantially the same responsibility for
regulating the development, manufacture and sale of human pharmaceutical
products.

 

“End User Kit” means a kit for use of the Product
by end users, as specified as of the Effective Date by Praecis, and as such kit
may be modified either (a) to comply with Regulatory Requirements or other
applicable law or (b) as mutually agreed to by the Parties.  For the Current Product, the End User Kit
consists, as of the Effective Date, of the components and specifications set
forth on Schedule 2.

 

“EU” means the countries listed under Item 1 of
Schedule 1.

 

“EU cGMP” means the current Good Manufacturing
Practices as set out in Directive 2003/94 as effective of Nov. 2003, of the
Commission of the European Communities and further elaborated in The Rules
Governing Medicinal Products in the European Community, Volume IV - Guide to
Good Manufacturing Practice for Medicinal Products, Contract Manufacture and
Analysis, as such may be amended from time to time.

 

“Existing Development” means the Existing Trials
set out in Schedule 3 to this Agreement.

 

“Existing Trials” means the ongoing (as of the
Effective Date) clinical studies of the Product.

 

“FDA” means the United States Food and Drug
Administration, or any successor agency.

 

“Field” means [*].

 

“Finished Product” shall mean the Product in a
finally packaged form for distribution to end users, including the End User
Kit, with all legally required and appropriate warnings, labeling and
packaging, and all outer distribution and transport packaging for the
foregoing.

 

“Firm Order” shall have the meaning set forth in
Section 10.3.1(a).

 

“First Commercial Sale” means the date Schering or
an Affiliate or a sublicensee of Schering first sells commercially, pursuant to
a Regulatory Approval, the Product in any country of the Territory; provided,
however, that where such sale has occurred in a country for which pricing or
reimbursement approval is necessary for widespread sale, then such sale shall

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

3

 

not be deemed a First Commercial Sale until such
pricing or reimbursement approval has been obtained.

 

“First Forecast” shall have the meaning set forth
in Section 10.3.1(b).

 

“Floor Price” shall have the meaning set forth in
Section 11.1.

 

“GAAP” means the then-current applicable Generally
Accepted Accounting Principles in the United States, consistently applied.

 

“GCP” shall mean the Tripartite Guideline on Good
Clinical Practice (ICH-GCP) established by the International Conference on
Harmonization in June 1996 as amended from time to time, and implemented and
published by the EMEA and the FDA.

 

“GLP” means the Good Laboratory Practices
regulations promulgated by FDA and/or the GLP regulations required by the local
authorities of the countries where the studies will be performed or resultant
data submitted, as they may be amended from time to time.

 

“GMP” means EU cGMP and US cGMP.

 

“Gross Margin” means, for any country in the
Territory, the quotient expressed as a percentage, of (a) the positive
difference between (i) the Average Net Sales Price for the Finished Product in
such country minus (ii) the sum of Floor Price plus any government-mandated
price reductions, divided by (b) the positive difference between (i) the
Average Net Sales Price for the Finished Product in such country minus (ii) any
government-mandated price reductions.

 

“Health Regulatory Authority” means EMEA, the
national competent authorities of the EU member states, FDA and any other
government entity that has jurisdiction to grant Regulatory Approvals,
including, but not limited to, Marketing Authorizations, for the Product in the
Territory.

 

“Improvement” means with respect to the Product,
any of the following: (i) any change to the formulation, dosage, mode of
administration or packaging thereof that is not either (a) expressly included
in or reflective of the Product as initially approved by the BfArM of Germany
and in the initial round of Mutual Recognition Process by Concerned Member
States, or (b) expressly set forth in the IND for a Product for any other
Indication in the Field when Clinical Development is initiated for such
Product, or (ii) a method, process or apparatus for manufacture thereof, which
results in an enhancement or alteration of any component of the Product with
respect to, without limitation, efficacy, safety, drug delivery profiles,
stability, shelf-life, dosage, cost, ease of use, or styling.  Notwithstanding the foregoing, for purposes
of Section 2.6, “Improvement” shall have the meaning set forth in Section 1.6
of the IUF License Agreement.  For the
avoidance of doubt, “Improvement” does not include any Indication.

 

“IND” means an Investigational New Drug Application
filed with the FDA pursuant to 21 CFR 312.1 et seq.

 

“IND Equivalent” means an application submitted in
a country other than the United States for approval to conduct Clinical
Development of a drug compound or drug composition.

 

“Indication” means any human medical indication in
the Field.

 

“Information” means: (i) techniques, data and
information reasonably related to the Licensed Activities, including, but not
limited to, inventions, practices, methods, manufacturing

 

4

 

processes, knowledge, know-how, skill, trade
secrets, experience, test data (including pharmacological, toxicological,
preclinical and clinical test data); data, records and information derived from
Development, regulatory submissions, adverse reactions, analytical and quality
control data, and manufacturing data (to the extent related to Schering
Manufacturing from and after such time as such activities are undertaken by
Schering pursuant to this Agreement),
but excluding raw and source patient data as required to comply with the applicable
law and excluding any data and information specific to the marketing, pricing,
cost, sales and distribution information for the Product outside the Territory
or inside the Territory but outside of the Field.

 

“IU” means Indiana University.

 

“IUF” means shall mean Advanced Research Technology
Institute, as successor-in-interest to Indiana University Foundation. “IUF
License Agreement” means that certain License Agreement dated as of October 17,
1996 between IUF and Praecis, as amended.

 

“Licensed Activities” means Development (to the
extent Schering may undertake such activities pursuant to this Agreement,
including Sections 4.6 or Article V), regulatory prosecution pursuant to
Articles IV and V, and Commercialization of the Product in the Territory, as
well as Schering Manufacturing and all obligations of Schering under this
Agreement.

 

“Losses” shall have the meaning set forth in
Section 17.1.

 

“Marketing Authorization Application” means an
application for Regulatory Approval which is required before commercial sale,
use or placing on the market the Product as a proprietary medicinal product in
a country in the Territory. This includes, for the purposes of Regulatory
Approval in the European Union, applications pursuant to the current version of
Directive 2001/83/EC or Council Regulation ECC/2309/81 as applicable.  Any successor legislation has to be followed
accordingly.

 

“Marketing Authorization” means the right to place
a (proprietary) medicinal product on a market in the Territory for commercial
exploitation.

 

“MRP Country” means any country in the EU or the
European Economic Area as set forth in Schedule 1 that participates in the
Mutual Recognition Procedure for Marketing Authorizations for the Current
Product.

 

“Net Sales” [*]

 

[*]

 

[*]  

 

[*]

 

[*]

 

[*]

 

[*]

 

“Other Praecis Products” shall mean at any given
point in time, any pharmaceutical compounds or products containing PPI-149 as
an active pharmaceutical ingredient, other than the Product within the
Territory.

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

5

 

“Patents” means all existing patents and patent
applications and all patent applications hereinafter filed, including any
continuation, continuation-in-part, division, provisional or any substitute
applications, any patent issued with respect to any such patent applications,
any reissue, reexamination, renewal or extension (including any supplemental patent
certificate) of any such patent, and any confirmation patent or registration
patent or patent of addition based on any such patent, and all foreign
counterparts of any of the foregoing. 
“Patents” also includes a Supplementary Certificate of Protection of a
member state of the European Union and any other similar protective rights in
any other country.

 

“Patent Expenses” means the fees, expenses and
disbursements and outside counsel and agent fees incurred in connection with
the preparation, filing, prosecution and maintenance of Praecis Patents,
including costs of patent interference and opposition proceedings.

 

“PPI-149” shall mean the compound set forth on
Schedule 4 of this Agreement.

 

“PPI Licensed Rights” shall mean the Patents and
Information licensed to Praecis pursuant to the IUF License Agreement.

 

“Praecis Improvement” means an Improvement
Controlled by Praecis.

 

“Praecis Information” means Information within the
Control of Praecis as of the Effective Date or which comes within the Control
of Praecis during the term of this Agreement and reasonably relates to the
Licensed Activities in the Territory. 
“Praecis Information” includes Information Controlled by Praecis that
constitute or are reasonably related to Praecis Improvements, subject to Section
2.3.  Notwithstanding anything herein to
the contrary, Praecis Information shall exclude Praecis Patents.

 

“Praecis Name” means the “PRAECIS PHARMACEUTICALS
INCORPORATED” trade name, or any successor name of Praecis, or the name of any
successor or acquiring entity of Praecis.

 

“Praecis Trademark” means the Trademark PLENAXIS
owned by Praecis.

 

“Praecis Patents” means any Patents owned or
Controlled by Praecis or its Affiliates as of the Effective Date or which come
within the Control of Praecis or any of its Affiliates during the term of this
Agreement covering the manufacture, use, importation, sale or offer for sale of
the Product in the Territory.  “Praecis
Patents” includes Patents Controlled by Praecis that claim Improvements,
subject to Section 2.3.

 

“Praecis Trademark” means “PLENAXIS.”

 

“Pricing and Reimbursement Authorization” means, in
respect of any country in the Territory, the Regulatory Approvals necessary for
pricing and reimbursement of the Product in such country, but excluding any
Marketing Authorizations.

 

“Product” means a pharmaceutical product containing
PPI-149 as an active ingredient: (i) for the Indication, formulation, dosage
and mode of administration constituting the Current Product, (ii) for any
additional Indications, in the formulations, dosages and modes of
administration specified therefor, and (iii) in any other formulation, dosage
and mode of administration licensed hereunder as a Praecis Improvement for any
Indication in accordance with Section 2.3.

 

“QAA” shall mean a Quality Assurance Agreement
which will be in a form mutually agreed by the Parties and will be entered
within 90 days after execution of this

 

6

 

Agreement, it being acknowledged by the Parties
that the form of Quality Assurance Agreement attached hereto as Schedule 6 will
form the basis for finalizing the Quality Assurance Agreement.

 

“Quality Specifications” are those specifications
for release of the Finished Product as set forth in Appendix 2 of the QAA as
amended from time to time.

 

“Registration Dossier” means any and all
information, processes, techniques and data owned and prepared by Praecis or
Schering relating to the Product and submitted to Health Regulatory Authorities
in the format required by the regulations applicable in the particular
jurisdiction to obtain Regulatory Approvals, including, but not limited to
Marketing Authorizations.

 

“Regulatory Approval” means all approvals, product
and establishment licenses, registrations or authorizations of any federal,
state or local authority, department, bureau or other governmental entity,
necessary for the manufacture, use, storage, importation, export, transport,
sale, placing on the market, pricing or reimbursement of the Product in a
jurisdiction.  “Regulatory Approval”
includes Marketing Authorizations and Pricing and Reimbursement Authorizations.

 

“Regulatory Requirements” means, for the Product,
(i) the Specifications, (ii) GMP, (iii) requirements under laws and regulations
of Health Regulatory Authorities in each jurisdiction that are applicable to
the manufacturing activities undertaken in that jurisdiction with respect to
the manufacture of Product and (iv) requirements under laws and regulations of
Health Regulatory Authorities, and requirements in Marketing Authorizations for
the Territory, incorporated as Changes pursuant to the change management
process of Article VI.

 

“Risk Management Program” means a program for the
monitoring of the use of the Product (as such phrase is used by the FDA), in
accordance with requirements of any Health Regulatory Authority.

 

“Schering Information” means Information generated
or obtained by Schering and reasonably related to the Licensed Activities
(other than Information provided to Schering by Praecis) during the term of
this Agreement and Controlled by Schering.

 

“Schering Manufacturing” means production of the
Finished Product from the Bulk Product and, if and to the extent Schering
obtains and exercises its right to do so pursuant to Section 10.7, the manufacture
of the Bulk Product.

 

“Schering Trademark” means any trademark to be used for the promotion, marketing
and selling of the Product, other than the Praecis Trademark.

 

“Shipment Date” shall have the meaning set forth in
Section 10.5.2.

 

“Second Forecast” shall have the meaning set forth
in Section 10.3.1.c.

 

“Specifications” means (i) with respect to the
Current Product, the specifications in the Marketing Authorization therefor in
Germany, (ii) with respect to any other Indication and any other formulation,
dosage or mode of application for the Product (other than the Current Product),
the specifications in the Marketing Authorization therefor in the Reference
Member State, in the case of (i) or (ii), as amended pursuant to the change
management process set forth in Article VI.

 

“Steering Committee” or “SC” means the coordinating
committee established by the Parties in Section 7.1.

 

7

 

“Sublicensee” means (i) Schering Affiliates and
customary members of Schering’s distribution chain for prostate cancer
products, and (ii) any other Third Parties, if such other Third Parties are
approved in advance by Praecis in writing, in each case (i) and (ii) to which
Schering grants a sublicense, provided that Schering remains primarily liable
for the acts and omissions of such sublicensees.

 

“Supply Price” shall mean the price for Bulk
Product, determined as set forth in Section 11.1.

 

“Territory” means the countries listed in Schedule
1, except to the extent this Agreement is terminated with respect to any such
country pursuant to Sections 16.2(b) or 16.2(f).

 

“Third Party” means any entity other than Praecis
or Schering and their respective Affiliates and, with respect to Schering for
purposes of the Net Sales definition, Sublicensees in their capacity as
Sublicensees.

 

“Trademark” means, with respect to each country in
the Territory, the trademark actually used for the promotion, marketing and
selling of the Product in such country in the Territory.

 

“US cGMP” means the FDA’s current Good
Manufacturing Practice regulations as promulgated under the Act at 21 CFR
(chapters 210, 211, 600 and 610), and as further defined by FDA guidance
documents, as such may be amended from time to time.

 

“Valid Claim” shall mean a claim in any unexpired
and issued Praecis Patent that has not been disclaimed, revoked or held invalid
or unenforceable by a final unappealable decision of a court or government
agency of competent jurisdiction.

 

ARTICLE
II

 

LICENSES AND TRANSFER OF INFORMATION

 

2.1                                 Exclusive Patent
and Information License to Schering

 

(a)                                  Praecis hereby
grants to Schering a license, with a right to sublicense to Sublicensees in
accordance with Section 2.2, under the claims contained in the Praecis Patents
and under the Praecis Information, to use manufacture, have manufactured,
market, sell, import for sale and distribute the Product in the Territory to
the extent the foregoing are within the scope of the Licensed Activities,
subject to the terms and conditions hereof. 
The foregoing license grant is (i) exclusive with respect to
Commercialization in the Territory and (ii) non-exclusive with respect to all
other Licensed Activities.

 

(b)                                 Notwithstanding
any of the foregoing in Section 2.1(a), Schering acknowledges that Praecis may
hold, sponsor and participate in conferences and symposia in the Territory
related to the Product subject to Schering’s prior written consent which shall
not be unreasonably withheld. Schering acknowledges that Praecis has undertaken
various conference and symposia sponsorships and other premarketing activities
relating to the Product, and will reasonably cooperate with Praecis in
transitioning responsibilities and costs for such activities to Schering.

 

(c)                                  A list of the
Praecis Patents identified as of the Effective Date is attached hereto as
Schedule 5.  If at any time during the
term of this Agreement any additional Patents come under the Control of Praecis
as Praecis Patents, such shall be added periodically, at least quarterly,  to the list attached hereto as Schedule 5.

 

8

 

(d)                                 Each Party shall
disclose and provide to the other Party all Praecis Information or Schering
Information, as applicable, including but not limited to all Praecis
Information regarding the Existing Trials. If at any time during the term of
this Agreement any additional Praecis Information is acquired by Praecis,
Praecis shall periodically, at least quarterly, disclose and provide to
Schering all such additional Praecis Information.  If at any time during the term of this
Agreement any additional Schering Information is acquired by Schering, Schering
shall periodically, at least quarterly, disclose and provide to Praecis all
such additional Schering Information. 
Praecis may use such Schering Information in connection with the
development, manufacture and commercialization of Other Praecis Products.

 

(e)                                  Schering
acknowledges and agrees that Praecis may disclose Schering Information
(including Development-related Information) to Praecis’ other licensees and
contractors upon Schering’s prior written consent, such consent not to be
unreasonably withheld.  Praecis shall use
commercially reasonable efforts to make available to Schering for use with the
Product in the Territory the Information of such other licensees and
contractors (“Additional Partner Data”). 
Schering shall use and disclose to Sublicensees and Regulatory
Authorities Praecis Information, including such Information of other Praecis licensees
and contractors, only as required to obtain and maintain Regulatory Approvals
for the Product in the Territory, or as otherwise reasonably necessary to
exercise its rights and perform its obligations under this Agreement, subject
to Article XII.  In all agreements
entered into after the Effective Date with Third Parties or Affiliates
involving Information, Schering and Praecis, respectively, shall use reasonable
efforts to include in such agreements a provision requiring that such Third
Parties and Affiliates provide the other Party with access to all such
Information, to the extent reasonably necessary to exercise the rights and
fulfill the obligations of the other Party under this Agreement.

 

2.2                                 Sublicensing.  Schering shall have the right to sublicense
reasonable subportions of the licenses granted pursuant to Section 2.1 to any
Sublicensee; provided that Schering may not sublicense substantially all
supervisory control over any of the Licensed Activities in any part of the
Territory (other than to a wholly-owned Affiliate of Schering, or to customary
members of the Schering distribution channel) without the prior written consent
of Praecis, such consent not to be unreasonably withheld with respect to any
country representing less than five percent (5%) of total Net Sales for the
Territory.

 

2.3                                 Improvements.  The license grant of Section 2.1(a) includes
all Praecis Improvements, subject to Section 5.2.1.

 

2.4                                 Right of First
Negotiation for Indications Outside the Field.

 

2.4.1                        Praecis hereby
grants to Schering a right of first negotiation (the “Schering Right of First
Negotiation”) for the development and commercialization in the Territory of
PPI-149 for any indication outside of the Field (each, an “Additional
Indication”), upon the terms and subject to the conditions set forth in this Section
2.4.

 

2.4.2                        [*]

 

2.4.3                        Schering may, [*]
make a written proposal of key terms to Praecis for the development and/or
commercialization in the Territory of such Additional Indication (a “Schering
Proposal”).  Praecis and Schering shall
then negotiate in good faith for up to [*] in an effort to reach a definitive
agreement for the development and commercialization in the Territory of such
Additional Indication (the “ROFN Negotiation Period”).

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

9

 

2.4.4                        [*]

 

2.5                                 Third Party Terms
and Conditions.  The provisions of this
Agreement are expressly subject to the terms and conditions of the IUF License
Agreement with respect to Praecis Patents and Praecis Information that is
licensed by Praecis under the IUF License Agreement.  The license grants under this Agreement with
respect to any Third Party intellectual property Controlled by Praecis (other
than the PPI Licensed Rights) is expressly subject to any additional terms and
conditions of applicable third party agreements.  To the extent that any fees or royalties are
payable to any such Third Party with respect to such Third Party intellectual
property (other than the PPI Licensed Rights), Schering, as the sublicensee
under this Agreement shall be responsible for such fees or royalties reasonably
allocable to Schering’s license grant under this Agreement, [*] Praecis
represents and warrants to Schering that, as of the Effective Date, there are
no royalties or other payments that Schering is obligated to pay to third
parties under the license grant of Section 2.1.

 

2.6                                 License Back of
IUF Improvements.  Schering hereby grants
to Praecis a perpetual, irrevocable license under any Improvements made by
Schering, solely for purposes of and to the extent necessary for Praecis to
grant to IUF and IU a royalty-free, non-exclusive license to use the Schering
Improvements for research and educational purposes only, and without the right
to sublicense.

 

2.7                                 Savings
Clause.  Except as expressly set forth
herein or in Article XIV, no rights or licenses are granted to Praecis Patents,
Praecis Information or Praecis Trademarks.

 

ARTICLE
III

 

DEVELOPMENT OF THE CURRENT PRODUCT

 

3.1                                 Development and
Clinical Life Cycle Management

 

(a)                                  Praecis shall
solely be responsible for and control all Development of the Current Product
relevant for obtaining Marketing Authorizations for the Current Product [*]

 

(b)                                 Development of the
Current Product to obtain Marketing Authorizations in any country in the
Territory other than [*]  

 

(c)                                  [*]

 

3.2                                 [*]

 

3.3                                 [*]

 

ARTICLE
IV

 

REGISTRATION, PHARMACOVIGILANCE

 

4.1                                 Praecis shall be
solely responsible for the preparation of Marketing Authorization Applications,
including the corresponding Registration Dossiers, to seek Marketing
Authorizations for the Current Product in the MRP Countries.  For avoidance of doubt, the foregoing shall
apply in the event the Mutual Recognition Procedure is repeated.

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

10

 

4.2                                 A copy of each
such Marketing Authorization Application and the respective Registration
Dossier shall be promptly provided to Schering. 
In connection with all such Marketing Authorization Applications being
prosecuted by Praecis, Praecis agrees to provide Schering with a copy (which
may be wholly or partly in electronic form) of all filings to Health Regulatory
Authorities that it makes in connection with Section 4.1, such copy to be
provided at substantially the same time as Praecis files with the Health
Regulatory Authority.

 

[*]

 

4.3                                 Registration in
the MRP Countries

 

4.3.1                        Praecis shall
conduct and be solely responsible for the Marketing Authorization Application
for the Current Product in the MRP Countries until Mutual Recognition of the
Current Product is achieved.  All such
Marketing Authorization Applications shall be filed in the name of Praecis or
its Affiliates and Schering shall be named as the distributor of the Current
Product.

 

4.3.2                        [*]

 

4.3.3                        [*]

 

4.3.4                        [*]

 

4.3.5                        [*]

 

4.4                                 Registration in
all other Countries of the Territory

 

4.4.1                        [*]

 

[*]

 

4.4.2                        [*]

 

[*] 

 

4.5                                 [*]

 

4.6                                 [*]

 

4.7                                 [*]

 

4.8                                 Mutual Exchange
Product Safety related Information. Praecis and Schering will regularly inform
each other of any material information relating to the safety of the Product,
including any serious unexpected and expected side effects of which the Parties
shall inform each other expeditiously and in accordance with the relevant and
current legislation of the countries of the Territory.  This information exchange also includes
material information and serious adverse reactions acquired from Third Parties,
as set forth in the Pharmacovigilance Agreement.

 

4.9                                 Within 90 days
after the execution of the Agreement, and before the First Commercial Sale in
one of the countries of the Territory and before enrollment of the first
patient in a Schering sponsored study, the Parties agree to enter into a
customary and reasonable

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

11

 

Pharmacovigilance Agreement which should be set up
by both Parties to govern safety information exchange including but not limited
to collection, investigation and reporting to Regulatory Authorities of
Product-related adverse drug experience reports, such that each of the Parties
can comply with its legal obligations worldwide.  The standard operating procedure will
encompass individual case safety reports from all sources as well as periodic
reporting (e.g. periodic safety update reports). The standard operating
procedure will be promptly amended as changes in international legal
obligations require. Both Parties acknowledge that the form of
Pharmacovigilance Agreement attached hereto as Schedule 7 will form the basis
for finalizing the Pharmacovigilance Agreement.

 

4.10                           Any capitalized
term in this Article or elsewhere in this Agreement relating to the Mutual
Recognition Process which is not defined in this Agreement shall have the
meaning accorded that term in EU directive 2001/83/EC or its succeeding
legislation.

 

ARTICLE
V

 

ADDITIONAL DEVELOPMENT AND REGULATORY
MATTERS

 

5.1                                 Development of
Other Indications Within the Field.  In the event that either Party
wishes to initiate Development directed toward Marketing Authorization in any
country in the Territory of either (i) any Product referred to in clause (ii)
of the definition of Product for use in the Field, or (ii)  expansion of the Indication for the Current
Product, the Parties will negotiate in good faith the allocation of
responsibilities and costs for Development and registration of such Product
(including any such expansion) within the Field.  Schering would have the exclusive
Commercialization rights in the Territory for any such Product (including any
such expansion) within the Field.

 

5.2                                 Development and
Regulatory Prosecution of Improvements.

 

5.2.1                        [*]

 

5.2.2                        Record-Keeping and
Reporting.

 

(a)                                  Record
keeping.  Schering and Praecis shall
maintain records of Development and regulatory activities with respect to the
Product (or cause such records to be maintained) in sufficient detail and in
good scientific manner as will properly reflect all Development and regulatory
work done and results achieved.

 

(b)                                 Reports.  Each Party shall periodically provide the SC
with a written report summarizing the progress of Development and regulatory
activities performed by or under authority of such Party with respect to the
Product in the Territory during the preceding calendar half-year.  Unless otherwise agreed, such reports shall
be due semi-annually, by March 1 and September 1 of each calendar year for so
long as the Party is undertaking such activities.

 

5.3                                 Compliance. To the
extent a Party engages in additional Development activities with respect to the
Product in the Territory, such Party will comply in all material respects with
applicable laws and Regulatory Requirements of the European Commission
applicable to such Development activities.

 

ARTICLE
VI

 

CHANGE MANAGEMENT PROCESS

 

6.1                                 [*]

 

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ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

12

 

6.2                                 [*]

 

[*]

 

6.3                                 [*]

 

6.4                                 Other Changes.

 

6.4.1                        [*]

 

6.4.2                        [*]  

 

6.5                                 [*]

 

6.6                                 [*]

 

6.7                                 [*]

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

13

 

ARTICLE
VII

 

STEERING COMMITTEE / WORKING TEAM

 

7.1                                 Establishment. The
Parties hereby agree that promptly after execution of this Agreement, they will
form a Steering Committee composed of four (4) members (the “SC Members”) with
functions more fully described in Section 7.2 below. Each Party shall have the right
to appoint two (2) SC Members to serve on the Steering Committee each of whom
shall be (i) a member of the respective Party’s senior management and (ii) duly
authorized by such Party to transact the business of the Steering Committee.
Upon written notice to the other, each Party shall be entitled to appoint
substitute SC Member(s), provided that, such substitute(s) belong to the senior
management of its respective Party. SC Members shall be allowed to be
represented by someone who has the appropriate mandate by that Party. The
Parties hereby agree that the Steering Committee shall meet at least
semi-annually at mutually agreeable dates and places (provided, that, alternate
meetings of the SC shall be held at Praecis’ headquarters in the United States
or such other location reasonably agreed to by the Parties) and that, upon
invitation of either Party, other representatives of Schering, Praecis, or
both, shall be allowed to attend such meetings (provided such representatives
are subject to reasonable confidentiality restrictions). The Parties further
agree that each shall bear all expenses of its respective SC Members and
representatives with respect to their participation in the Steering Committee.

 

7.2                                 General Functions
of the Steering Committee. The Parties agree that the functions of the Steering
Committee shall be to exchange information and to jointly plan activities with
respect to the Product in the Territory. The Steering Committee shall also
appoint a Working Team, as more fully described in Section 7.4 below and a
Manufacturing and Supply Team, as more fully described in Section 10.2 below.

 

7.3                                 Decision-Making.
The Parties hereby agree that all decisions and/or actions taken by the
Steering Committee shall be taken exclusively by the unanimous express consent
of all the SC Members. In the event the Steering Committee is unable to reach
an agreement on any matter, then such matter shall be referred to the Chief
Executive Officer of Praecis and to the Chief Executive Officer of Schering’s
Region Europe for their consideration and resolution.  The Parties however agree that, in the event
of any issue arising in connection with the marketing of the Product,
Schering’s decision shall constitute the final decision, and that this decision
shall be binding upon both Parties, provided such decision is not inconsistent
with the express obligations of Schering under this Agreement.

 

7.4                                 The Parties hereby
agree that the Steering Committee shall meet at least semi-annually at mutually
agreeable dates and places (provided, that, alternate meetings of the SC shall
be held at Praecis’ headquarters in the United States or such other location
reasonably agreed to by the Parties) and that, upon invitation of either Party,
other representatives of Schering, Praecis, or both, shall be allowed to attend
such meetings (provided such representatives are subject to reasonable
confidentiality restrictions).

 

7.5                                 General Functions
of the Working Team. The Parties agree that the Working Team’s functions shall
be to set up a Life Cycle Management Plan and submit it for the approval of the
Steering Committee. Without limitation of Section 3.1(b), the Working Team
shall be responsible for overseeing and guiding the implementation of the Life
Cycle Management Plan and co-ordination of each Party’s respective activities.
The Parties agree that the Working Team shall meet at least once every four (4)
months at mutually agreeable dates and places, and that, upon invitation of
either Party, other representatives of Schering, Praecis, or both, shall be
allowed to attend such meetings (provided such representatives are subject to
reasonable confidentiality restrictions). The

 

14

 

Parties further agree that each Party shall bear
all expenses of its WT Members and representatives with respect to their
participation in the Working Team.

 

7.6                                 Retention of
Powers. The Parties hereby agree that, notwithstanding the creation of the
Steering Committee and/or the Working Team and/or Manufacturing and Supply
Team, each Party to this Agreement shall (i) at all times retain the rights and
powers granted to it pursuant to the terms and conditions of this Agreement,
and that (ii) except as otherwise expressly provided in this Agreement or
expressly agreed to by the Parties in writing to that effect, neither the
Steering Committee nor the Working Team nor the Manufacturing and Supply Team
thereof shall be delegated or vested with any such rights or powers. Neither
the Steering Committee nor the Working Team nor the Manufacturing and Supply
Team shall have at any time the power to amend or modify this Agreement in any
way, as such may only be amended or modified as provided in Section 18.15 of
this Agreement.

 

7.7                                 Global Steering
Committee.  The Parties will establish a
global steering committee (“Global Steering Committee”) for the purpose of
enabling Praecis, Schering and such additional Praecis licensees as may
designate representatives to the Global Steering Committee as contemplated by
this Section 7.7, to consider, and as appropriate and subject to any
contractual restrictions or restrictions of Applicable Law, to inform one
another, discuss and if appropriate, coordinate, global Development or
Commercialization strategies for the Product. 
The Global Steering Committee shall consist of an equal number of
representatives from each Party (but in no event less than two (2)).  Praecis may also invite to become members an
equal number of representatives from each of Praecis’ additional
licensees.  The respective individual
representatives of Praecis and Schering to the Global Steering Committee may be
removed and replaced from time to time at the discretion of such Party by
sending written notice of such action to the other parties which have
designated a representative on the Global Steering Committee. Unless otherwise
unanimously agreed by the parties which have designated a representative on the
Global Steering Committee, the Global Steering Committee shall meet at least
once each calendar year.  The Parties agree
and acknowledge that the recommendations and determinations of the Global
Steering Committee shall in no way be binding upon Praecis, Schering or
Praecis’ other licensees.  No party which
has designated a representative on Global Steering Committee shall be
personally liable to any other party which has designated a representative on
the Global Steering Committee by reason of the actions of any such
representative in the conduct of the business of the Global Steering Committee.  If no other licensees are participating in
the Global Steering Committee, the Global Steering Committee’s function will
instead be carried out by the SC.

 

ARTICLE
VIII

 

MILESTONE PAYMENTS

 

8.1                                 Milestone
Payments.  Schering shall make the
following payments (“Milestone Payments”) to Praecis within thirty (30)
Business Days after the first achievement of each of the following milestones,
except that payment of the Signing Milestone Payment shall be paid by Schering
within ten (10) Business Days after signature of this Agreement.  Each of these Milestone Payments shall be
paid only once regardless of the number of times the milestones are achieved by
the Product.  Each Milestone Payment is
nonrefundable, except to the extent expressly set forth in Schedule 8.1.

 

15

 

 

	
  MILESTONES

  	
   

  	
  PAYMENT

  	
   

  
	
  Signature of this Agreement (“Signing
  Milestone Payment”).

  	
   

  	
  US$

  	
  2,000,000.00

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
					

 

ARTICLE
IX

 

COMMERCIALIZATION

 

9.1                                 Schering as Sole
Marketing Party.  Subject to the terms
and conditions of this Agreement (including, but not limited to, Article II),
Schering shall have the exclusive right to Commercialize the Product, either by
itself or through its Sublicensees, in the Territory.

 

9.2                                 Commercialization
Efforts.  Subject to Section 9.2.1,
Schering agrees to use commercially reasonable efforts with respect to the
Commercialization of the Product in the Territory as provided hereunder.  Such commercially reasonable efforts will be
consistent with the efforts used by Schering in preparing commercialization
plans and commercializing its own pharmaceutical products, and may include
sub-licensing to the extent permitted hereunder.  [*]

 

9.2.1                        [*]

 

9.3                                 [*]

 

9.4                                 Schering shall
conduct (or cause to be conducted) all of its Commercialization activities with
respect to the Product in accordance with all requirements of applicable law,
and all other requirements of any applicable Health Regulatory Authorities.

 

9.5                                 [*]

 

9.6           Non-Compete
Obligations.

 

9.6.1                        Schering
Non-Compete.

 

(a)                                  [*]  

 

(b)                                 Without limitation
of Section 9.6.1(a), if at any time during the term of this Agreement Schering
or its Affiliates:

 

[*]  

 

[*]

 

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ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

16

 

then Schering will immediately provide written
notice thereof to Praecis and will provide Praecis with sufficient information
for Praecis to evaluate the strategic and commercial implications of such
activities.  Schering will provide
updates to such information on a quarterly basis.  [*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]  

 

[*]

 

9.6.2                        Praecis
Non-Compete.

 

[*]

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

17

 

ARTICLE
X

 

MANUFACTURE AND SUPPLY

 

10.1                           Manufacture and
Supply

 

10.1.1                  Subject to the
following terms and conditions, Praecis will manufacture the Product and shall
supply Schering with all of Schering’s requirements of the Product for sale in
the Territory and Schering shall purchase its requirements of the Product
exclusively from Praecis. Product shall be supplied by Praecis as Bulk Product
released for the EU subject to Section 10.5.1.

 

10.1.2                  Praecis will
manufacture the Bulk Product pursuant to the processes described in the
relevant documents provided for in the Regulatory Requirements and as laid out
in the QAA, which, upon execution thereof, will form an integral part of this
Agreement. Praecis will adhere strictly to these processes and instructions to
the extent legally required, and will otherwise materially comply therewith.

 

10.1.3                  Praecis represents
and warrants that, prior to first delivery of the Bulk Product to Schering for
the sale in any country of the Territory, it will have obtained all material
approvals of Regulatory Authorities necessary for the manufacture of the
Product to the extent set forth in the Regulatory Requirements.  Praecis covenants that during the term of
this Agreement, it shall comply with the Regulatory Requirements in carrying
out its obligations pursuant to this Agreement. Each Party will inform the
other Party about any notification from the responsible Health Regulatory
Authorities to such Party of any non compliance with applicable laws and
regulations.

 

10.2                           Manufacturing and
Supply Team

 

10.2.1                  The Steering
Committee shall form as a sub-committee, the Manufacturing and Supply Team, to
act as a forum for effectively addressing issues brought to the attention of
the Steering Committee by either Party relating to the manufacture and supply
of the Product, the failure to supply Product in a timely manner, quality
issues or other logistical issues.

 

10.2.2                  The Manufacturing
and Supply Team shall consist of 2 (two) representatives from each Party.
Substitutes may be appointed at any time upon written notice. The Manufacturing
and Supply Team shall meet at mutually agreed dates and places. Additional
representatives of Schering and Praecis or both, in addition to members of the
Manufacturing and Supply Team, may attend such meetings at the invitation of
either Party. Schering and Praecis shall bear all expenses of their respective
members related to the participation in meetings of the Manufacturing and
Supply Team.

 

10.2.3                  The Manufacturing
and Supply Team shall serve as an advisor to the Steering Committee with
respect to issues described in Section 10.2.1 and shall have no right to
exercise the rights of the Parties under this Agreement. The Manufacturing and
Supply Team shall not have the power to amend or modify this Agreement, which
may be amended or modified only as provided in Section 18.15.

 

10.2.4                  Advice given by
the Manufacturing and Supply Team to the Steering Committee shall only be given
following unanimous agreement of the members of the Manufacturing and Supply
Team. Should it prove impossible to obtain such agreement then the disputed
matter will be referred to the Steering Committee for resolution in accordance
with Section 7.3.

 

18

 

10.3                           Ordering and
Forecast

 

10.3.1                  [*]

 

(a)                                  [*]

 

(b)                                 [*]

 

(c)                                  [*]

 

[*]

 

10.3.2                  The operation of
the foregoing provisions is illustrated in the following example:

 

[*]

 

10.3.3                  Within two (2)
weeks upon receipt of the First Forecast Praecis will submit to Schering a
written confirmation of whether Praecis expects to be able to supply Schering
with its requirements according to the First Forecast, such confirmation not to
be unreasonably withheld and is subject to Section 10.6. If no such
confirmation is given by Praecis within the two (2) week period,  Praecis shall be deemed to have confirmed
that it expects to be able to supply Schering with its requirements according
to the First Forecast.

 

10.3.4                  [*]

 

10.3.5                  The Firm Orders
shall specify the Shipment Dates for each month of the Firm Order. The Shipment
Dates and quantities specified in Firm Orders will be confirmed by Praecis in
writing within two (2) weeks of receipt. 
If no confirmation is given by Praecis within the two (2) weeks period,
the Firm Orders shall be deemed to have been accepted.  Praecis shall use commercially reasonable
efforts to use the Schering item number and the purchase order system for all
deliveries.  All invoices, delivery
documentation and delivery notes have to contain the corresponding purchase
order number and P.O. position.  All
purchase orders will be pursuant to a mutually agreeable, standard order
form.  In the event of any conflict
between any such purchase order and this Agreement, this Agreement will govern.

 

10.3.6                  If Schering
desires to alter any quantities set forth in a Firm Order or to accelerate the
Shipment Dates, then Praecis shall undertake reasonable efforts to comply with
any changes of ordered quantities or acceleration of Shipment Dates, especially
with regard to changes to prevent the interruption of market supply or to cuts
in ordered quantities or cancellations where the non-fulfillment of changes
would require to destroy the Product, but Praecis will have no liability for
failing to meet such altered quantity requests or accelerated Shipment Dates
(including, without limitation, no liability for late shipments under Section
10.5.3), and no such failure will constitute or contribute to a failure of
supply for purposes of Section 10.7.

 

10.3.7                  [*]

 

10.3.8                  [*]

 

10.3.9                  [*]

 

10.4                           Packaging

 

The packaging of the Bulk Product shall be
consistent with the Specifications.

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
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ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

19

 

10.5                           Shipment

 

10.5.1                  [*]

 

10.5.2                  [*]

 

10.5.3                  [*]

 

(a)                                  [*]

 

(b)                                 [*]

 

10.5.4                  [*]

 

10.5.5                  Praecis represents
and warrants to manufacture the Product in accordance with the Specifications
and will comply in all material respects with the QAA. Bulk Product which is
finally determined not to be manufactured materially in accordance with the
Specifications will not satisfy the obligations of Praecis as set forth in this
Agreement.

 

10.5.6                  Should any
quantities of Bulk Product supplied by Praecis, as demonstrated by Schering’s
quality control testing, not conform with the Specifications, Schering will
notify Praecis in writing within thirty (30) days from the date of delivery of
the Bulk Product from Praecis to Schering. Schering will supply Praecis with
details of the alleged non-conforming Bulk Product including samples thereof
and will cooperate in any investigation Praecis should wish to carry out. Even
if such determination is disputed by Praecis, Praecis shall as soon as possible
and not later than thirty (30) days replace such non-conforming Bulk Product
free of charge pending analysis of the asserted nonconformance.

 

10.5.7                  Notwithstanding
the above, if a dispute arises between Praecis and Schering concerning the
non-conformity of the Bulk Product to the Specifications, and said dispute is
not resolved within thirty (30) days from the receipt by Praecis of the
notification mentioned in Section 10.5.5, the matter shall be submitted to an
independent laboratory chosen in common agreement between the Parties or,
failing such agreement within ten (10) Business Days after the receipt of such
notification by Praecis, by the SC, whose decision will be final. The costs for
the nonconforming Product and the expenses incurred for said determination
shall be paid by the Party whose position is found erroneous by the said
decision.

 

10.5.8                  In the event
rejected Bulk Product can not be reworked and must be destroyed, all
destruction shall be performed by Praecis or, if mutually agreeable, by
Schering.  The Party, which has caused
the defective or otherwise nonconforming Bulk Product will pay the costs of
such rework and destruction.  Following
destruction, the applicable Party will send to the other a certificate of
destruction indicating the following: 
name of the Bulk Product, batch number, quantity, and name of the
company that destroyed the Bulk Product.

 

10.6                           Shortage of Supply

 

[*]

 

10.7.                        Supply Failure
Remedies

 

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ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

20

 

10.7.1                  Should Praecis be
unable to supply (i) [*] in accordance with the terms of this Agreement, the
Parties shall discuss said inability and develop and implement commercially
reasonable measures to minimize the risk of further supply disruptions.  Praecis will be responsible for implementing,
at its sole cost, any such reasonable measures intended to address causes of
the inability to supply within Praecis’ control.  If such measures do not resolve such issues
within a reasonable period of time, then upon Schering’s written request,
Praecis shall authorize Schering to manufacture or have manufactured quantities
of the Product and shall provide Schering free of charge with all necessary
know-how, technology, information and assistance for such manufacturing that is
available to and Controlled by Praecis and will assist and cooperate with
Schering in negotiating contracts (but will not assign any of Praecis’
contracts) with Praecis’ contract manufacturers.  Schering will be responsible for its expenses
in connection with the establishment of such supply chain.  Schering acknowledges that Praecis outsources
substantially all of its manufacturing process to several contract
manufacturers, and that Praecis does not Control those manufacturers’
intellectual property.

 

10.7.2                  If Schering
assumes the manufacturing of the Bulk Product for the Territory in accordance
with the terms of Section 10.7.1 hereof, Schering shall as a subcontractor
invoice Praecis the subcontracted manufacturing at the cost of goods [*]

 

10.7.3                  In the event that
Praecis encounters capacity constraints with respect to Schering’s non-binding
long-term requirement plan for the Bulk Product, Praecis shall develop a
contingency plan to satisfy Schering’s long-term requirements.  If both Parties can not agree on such plan,
[*]

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
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ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

21

 

1.1                                 10.8         Finished Product.

 

10.8.1                  [*]

 

10.8.2                  Subject to
applicable law, Schering will identify Praecis as the supplier of the Product
in a fair and reasonable manner, reasonably acceptable to Praecis, including by
clearly and reasonably prominently identifying Praecis as the manufacturer/developer
of the Product on all Finished Product packaging and packaging insert.  Schering may use the Praecis Name in
promoting, marketing and selling the Finished Product in the Territory.  All use of the Praecis Trademark and Praecis
Name under this Agreement shall be subject to the quality control provisions
set forth in Section 14.3.2 of the Agreement. 
All samples shall be clearly marked “for sample use only” or some
similar phrasing suggested by Schering and approved by Praecis.

 

10.9                           Inspections.
Praecis shall, upon reasonable advance notice, permit any inspection, during
normal working hours, of premises and facilities where Praecis manufactures
and/or analyses or has manufactured and/or analyzed Bulk Product and/or its
intermediates, and of premises where it stores raw materials, auxiliary
materials, intermediates, packing materials, and Bulk Product, and of
manufacturing records pertaining to production of Bulk Product, by Regulatory
Authorities in the Territory or by Schering, if called for by such Regulatory
Authorities or by Schering.  Praecis
shall be entitled to have its representatives present as part of any such
inspection.  Schering shall write a
report after any such inspection by Schering and make this available to
Praecis, who shall, in conjunction with the relevant contract manufacturer if
appropriate, respond in writing to any recommendations made by Schering.

 

10.10                     GMP Compliance.
Any costs and expenses which need to be incurred by Praecis or its contract
manufacturers and suppliers to ensure compliance with GMP and other Regulatory
Requirements applicable in the Territory shall be borne solely by Praecis and
its respective contract manufacturers and suppliers. Following any inspections
by Schering, as described in Section 10.9, Schering may prepare a report
detailing any deficiencies identified in Praecis’ or its contract
manufacturers’ progress towards achieving, or maintaining, GMP standards.
Praecis will discuss with Schering any recommendations made by Schering and
will implement those with which it agrees. For the avoidance of doubt, any
official advice received from a relevant Health Regulatory Authority regarding
the requirements of GMP will be conclusive, unless Praecis can reasonably
demonstrate that such advice is erroneous, and, unless Praecis so demonstrates,
Praecis will implement any such requirements. 
However, and for the further avoidance of doubt, Praecis shall not be
obligated to implement official advice which is in the form of suggestions that
are not necessary for compliance with GMP. 
The Parties agree that Praecis shall ensure that Sterigenics shall
comply with the Regulatory Requirements in the Territory, including but not
limited to monitoring and storage conditions. 
Nothing contained in this Section 10.10 is intended to limit or
otherwise affect the provisions of Article VI, and, to the extent such
provisions are applicable in accordance with their terms, such provisions, and
not this Section 10.10, shall control.

 

ARTICLE
XI

 

SUPPLY PRICE, PAYMENTS

 

11.1                           Supply Price.
Praecis shall supply all of Schering’s Product requirements as Bulk Product on
a country-by country basis at the price set forth in the table immediately
below, [*]  

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

22

 

	
  Average Net Sales Price

  	
   

  	
  Supply Price in%

  	
   

  	
  Supply Price

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
   

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
   

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  	
   

  	
   

  

 

11.2                           [*]

 

11.3                           [*]

 

11.4                           [*]

 

11.5                           Invoice; Payments.
Praecis shall invoice to Schering upon shipment of the Product [*]

 

11.6                           [*]

 

11.7                           Payments;
Interest. Payments due under this Agreement shall be due on such date as
specified in this Agreement and, in the event such date is not a Business Day,
then the next succeeding Business Day, and shall be made by wire transfer of
immediately available funds to a bank account designated by the receiving
Party, at least ten (10) days before payment is due.  Any failure by a Party to make a payment
within ten (10) Business Days after the date when due shall obligate such Party
to pay computed interest to the receiving Party, the interest period commencing
on the due date and ending on the payment day, to the other Party, at a rate
per annum equal to the one month EURIBOR as quoted on the due date on REUTERS
screen EURIBOR01. The interest calculation shall be based on
the act/360 computation method.  The
interest rate shall be adjusted and interest shall be compounded monthly in
arrears.  Such interest shall be due and
payable on the tender of the underlying overdue payment.

 

11.8                           Taxes. Praecis
shall pay any and all taxes levied on account of all payments it receives under
this Agreement.  If laws or regulations
require that taxes be withheld, Schering will (i) deduct those taxes from all
remittable payments, (ii) timely pay the taxes to the proper taxing authority,
and (iii) send proof of payment to Praecis within thirty (30) days of receipt
of confirmation of payment from the relevant taxing authority.  Schering agrees to make all lawful and
reasonable efforts to minimize such taxes to Praecis.

 

11.9                           Payment Currency.
Payments by Schering under this Agreement shall be paid to Praecis in Euro
(except for the signing fee, which is in United States dollars) by wire
transfer of immediately available funds.

 

11.10                     Conversion.

 

11.10.1            For purposes of
paying the first installment or in any other circumstance where prices under this Agreement are expressed in US$, the amount of US$ shall be
converted into Euro at the Euro Foreign Exchange Reference Rates published by
the European Central Bank in Frankfurt / Main, Germany two (2) Business Days
prior to the date the payment is made.

 

11.10.2            Where payments are
based on Net Sales in countries other than member states of the European
Monetary Union, the amount of such Net Sales expressed in the currency of each
country shall be converted into Euro at the Euro Foreign Exchange Reference
Rates published by the European Central Bank in Frankfurt / Main, Germany on
the last Business Day of the applicable calendar quarter.

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

23

 

11.10.3            The Euro Foreign
Exchange Reference Rates are, as of the Effective Date, published on Reuters
screen <ECB37>. If no Euro Foreign Exchange Reference Rate is determined
for United States dollars or such other relevant currency, the Parties shall
agree upon another reference rate.

 

11.11                     Records of
Revenues and Expenses.

 

(a)                                  Schering will
maintain complete and accurate records relevant to the calculation of revenues
under this Agreement at its principle place of business, or such other readily
accessible single location as Schering may designate.  Not more often than once each year, Schering
shall make the said records available for inspection during normal business
hours for the period required by applicable laws, but not less than three (3)
years from creation of individual records by a certified public accountant or
chartered accountant selected by Praecis (subject to the consent of Schering
not to be unreasonably withheld or delayed) or Praecis’ internal accountants,
for the sole purpose of verifying for Praecis the correctness of calculations
and classifications of such revenues under this Agreement.  Praecis shall bear its own costs related to
such audit; provided that, for any underpayments greater than five (5) percent
by Schering, Schering shall pay Praecis the amount of underpayment, interest as
provided for in Section 11.6 from the time the amount was due and Praecis’
out-of-pocket expenses.  For any
underpayments of less than five (5) percent by Schering, Schering shall pay
Praecis the amount of underpayment.  Any
overpayments by Schering will be refunded to Schering or credited to future
amounts payable hereunder by Praecis to Schering, at Schering’s discretion.  Any records or accounting information
received from Schering shall be Confidential Information for the purposes of
Article XII.  Results of any such audit
shall be provided to both Parties and shall also constitute Confidential
Information for the purposes of Article XII.

 

(b)                                 If there is a
dispute between the Parties following any audit performed pursuant to Section
11.11(a), either Party may refer the issue (an “Audit Disagreement”) to an
independent certified public accountant or chartered accountant for
resolution.  In the event an Audit
Disagreement is submitted for resolution by either Party, the Parties shall
comply with the following procedures: (i) the Party submitting the Audit
Disagreement for resolution shall provide written notice to the other Party
that it is invoking the procedures of this Section 11.11(b);  (ii) within thirty (30) Business Days of the
giving of such notice, the Parties shall jointly select a recognized
international accounting firm to act as an independent expert to resolve such
Audit Disagreement; (iii) The Audit Disagreement submitted for resolution shall
be described by the Parties to the independent expert, which description may be
in written or oral form, within ten (10) Business Days of the selection of such
independent expert; (iv) The independent expert shall render a decision on the matter
as soon as practicable; (v) The decision of the independent expert shall be
final and binding unless such Audit Disagreement involves alleged fraud, breach
of this Agreement or construction or interpretation of any of the terms and
conditions thereof; (vi) All fees and expenses of the independent expert,
including any Third Party support staff or other costs incurred with respect to
carrying out the procedures specified at the direction of the independent
expert in connection with such Audit Disagreement, shall be borne by each Party
in inverse proportion to the disputed amounts awarded to the Party by the
independent expert through such decision (e.g. Praecis disputes $100, the
independent expert awards Praecis $60, then Praecis pays forty (40%) percent
and Schering pays sixty (60%) of the independent expert’s costs).

 

24

 

ARTICLE XII

 

CONFIDENTIALITY

 

12.1                           Confidentiality;
Exceptions.  Except to the extent
expressly authorized by this Agreement or otherwise agreed in writing, the
Parties agree that the receiving Party shall keep confidential and shall not
publish or otherwise disclose or use for any purpose other than as provided for
in this Agreement any Information and other information and materials furnished
to it by the other Party pursuant to this Agreement or any Information
developed during the course of the collaboration hereunder, or any provisions
of this Agreement that are the subject of an effective order of the Securities
Exchange Commission granting confidential treatment pursuant to the Securities
Act of 1934 as amended (collectively “Confidential Information”), except to the
extent that it can be established by the receiving Party that such Confidential
Information:

 

(a)                                  was already known
to the receiving Party, other than under an obligation of confidentiality, at
the time of disclosure by the other Party; or

 

(b)                                 was generally
available to the public or otherwise part of the public domain at the time of
its disclosure to the receiving Party; or

 

(c)                                  became generally
available to the public or otherwise part of the public domain after its
disclosure and other than through any act or omission of the receiving Party in
breach of this Agreement.

 

(d)                                 was disclosed to
the receiving Party, other than under an obligation of confidentiality, by a
Third Party who had no obligation to the disclosing Party not to disclose such
information to others; or

 

(e)                                  was independently
discovered or developed by the receiving Party as documented in its corporate
records.

 

12.2                           Authorized
Disclosure.  Each Party may disclose
Confidential Information hereunder to the extent such disclosure is reasonably
necessary (a) in filing or prosecuting patent applications, prosecuting or
defending litigation, or conducting Development, in each case to the extent
within the scope of the Licensed Activities, provided that the receiving Party
receives the prior written consent of the disclosing Party, such consent not to
be unreasonably withheld or delayed, and (b) for filing or updating any
Marketing Authorization Application under this Agreement, or complying with
applicable governmental laws, rules and regulations, provided that, if a Party
is required by law or regulation to make any such disclosures under (a) or (b)
of the other Party’s Confidential Information it will, except where
impracticable for necessary disclosures (for example in the event of medical
emergency or where, in the good faith judgment of a Party after consultation
with outside securities law counsel, prompt disclosure is required under
applicable securities laws, regulations or under the rules of a trading market
applicable to such Party and it is impracticable to provide the other Party
with such advanced notice of such disclosure), give reasonable advance notice
to the other Party of such disclosure requirement and, except to the extent
impracticable as described above, will use its reasonable efforts to secure
confidential treatment of such Confidential Information required to be
disclosed.  In addition, and with prior
written notice to the other Party of each Third Party with whom a confidential
disclosure agreement is being entered into, each Party shall be entitled to
disclose, under a binder of confidentiality, Confidential Information to any
Third Party for the purpose of carrying out the purposes of this
Agreement.  Nothing in this Article XII
shall restrict any Party from using for any purpose any Confidential
Information independently developed by it during the course of the
collaboration hereunder, or from using Confidential Information that is
specifically derived

 

 

25

 

from pre-clinical or clinical trials to carry out
Regulatory Approval marketing, sales or professional services support functions
as is customary in the pharmaceutical industry. 
Where materiality of disclosure requires a press release or other disclosure
pertaining to this Agreement by one Party, the disclosing Party shall give at
least three (3) Business Days’ advance notice to the other Party, except in
cases where, in the good faith judgment of a Party after consultation with
counsel outside securities law counsel, prompt disclosure is required and it is
impracticable to provide such advance notice of such disclosure.

 

12.3                           Nondisclosure of
Terms.  Each of the Parties hereto agrees
not to disclose the terms of this Agreement to any Third Party without the
prior written consent of the other Party hereto, which consent shall not be
unreasonably withheld, except to such Party’s attorneys, advisors and others on
a need to know basis under circumstances that reasonably ensure the
confidentiality thereof, or to the extent a Party determines, after
consultation with outside counsel, that such disclosure is or may be required
by law or regulation.

 

12.4                           Publications.  A Party (the “Publishing Party”) may publish
in accordance with scientific standards any such result or study generated or
Developed under this Agreement after providing the other Party at least thirty
(30) days prior to submission of an abstract or manuscript (a “Publication”),
in English, a copy of such proposed Publication to determine whether such
proposed Publication contains subject matter for which Patent protection should
be sought prior to publication or to determine whether it should be modified or
deleted to avoid disclosure of Proprietary Information or to avoid regulatory
issues.  If such other Party informs the
Publishing Party, within such thirty (30) day period, that such Publication, in
its judgment, contains subject matter for which Patent protection should be
sought prior to publication or would disclose Confidential Information or
possibly result in regulatory issues, the Publishing Party shall delay or
prevent such Publication as proposed.  In
the case of any proposed Publication containing subject matter as to which such
other Party has advised the Publishing Party that Patent protection should be
sought prior to such publication, the delay shall be sufficiently long to
permit the timely preparation and filing of a Patent application with respect
to such subject matter.  It is understood
that with respect to proposed Publications consisting of abstracts that timing
is often critical; accordingly and without limiting the foregoing, with respect
to abstracts submitted by a Party to the other for review pursuant to this
Section 12.4, the reviewing Party shall use good faith efforts to complete its
review and notify the other Party of any issues as soon as practicable after
receipt thereof.  Authorship for all
publications under this Section 12.4 shall be credited appropriately and in
accordance with standard scientific practice. 
Notwithstanding any of the foregoing, neither Party may file or
prosecute a Patent application that contains or would disclose Confidential
Information of the other Party, without the prior written consent of the other
Party, such consent not to be unreasonably withheld or delayed.

 

12.5                           Survival. This
Article XII shall survive the termination or expiration of this Agreement.

 

ARTICLE
XIII

 

OWNERSHIP OF INTELLECTUAL PROPERTY, PATENT
RIGHTS AND USE OF NAME

 

13.1                           Ownership. Each
Party shall solely own, and it alone shall have the right to apply for, Patents
within and outside of the Territory for any inventions made solely by that
Party’s employees or consultants in the course of performing work under this
Agreement.  This Section 13.1 shall
survive the termination or expiration of this Agreement.

 

 

26

 

13.2                           Third Party Patent
Rights. Each Party agrees to bring to the attention of the other Party any
Third Party Patent it discovers, or has discovered, and which relates to the
subject matter of this Agreement.

 

13.3                           Enforcement
Rights.

 

(a)                                  Notification of
Infringement. If either Party learns of any infringement or threatened
infringement by a Third Party of the Praecis Patents such Party shall promptly
notify the other Party and shall provide such other Party with all available
evidence of such infringement.

 

(b)                                 Enforcement in the
Territory. Subject to the next sentence, Praecis shall have the right, at its
own expense, to enforce Praecis Patents in the Territory. Schering shall have
the right, but not the obligation, to institute, prosecute and control at its
own expense any action or proceeding with respect to infringement of any
Praecis Patents covering solely the manufacture, use, importation, sale or
offer for sale of the Product being developed or marketed in the Territory that
is within the scope of the Licensed Activities, by counsel of its own choice,
subject to Praecis’ consent to the bringing of such action or proceeding, such
consent not to be unreasonably withheld. 
Praecis shall have the right, at its own expense, to be represented in
any such action by counsel of its own choice. 
If Schering fails to bring an action or proceeding or otherwise take
appropriate action to abate such infringement within a period of one hundred
eighty (180) days of notice by Praecis to Schering requesting action, or such
shorter time period if material rights otherwise would be waived or lost,
Praecis will have the right to bring and control any such action or proceeding
relating to Praecis Patents by counsel of its own choice and Schering will have
the right to be represented in any such action by counsel of its own choice and
at its own expense.  If one Party brings
any such action or proceeding, the other Party agrees to be joined as a party
plaintiff if necessary to prosecute the action or proceeding and to give the
first Party commercially reasonable assistance and authority to file and
prosecute the suit.  Any damages or other
monetary awards recovered pursuant to this Section 13.3(b) shall be allocated
first to the costs and expenses of the Party bringing suit, then to the costs
and expenses, if any, of the other Party. 
[*]

 

(c)                                  Settlement with a
Third Party. The Party that controls the prosecution of a given action shall also
have the right to control settlement of such action, provided however, that if
one Party controls, no settlement shall be entered into without the written
consent of the other Party (which consent shall not be unreasonably withheld or
delayed) if such settlement would materially and adversely affect the interests
of such other Party.

 

13.4                           Defense and
Settlement of Third Party Claims. If a Third Party asserts that a patent, trade
secret or copyright owned by it is infringed by any Product in the Territory,
Praecis will be solely responsible for defending against any such assertions at
its cost and expense (subject to the provisions of Section 13.3(b)).  Praecis will consult with Schering prior to
entering into any settlement with any such defendant, but will have the sole
right to make the final determination regarding any such settlement.  The costs of any such settlement (including,
without limitation, damages, expense reimbursements, compliance, future
royalties or other amounts) shall be paid by Praecis.  If any Third Party is successful in any such
claim and Schering is ordered to make any payments to such Third Party in
connection therewith, any such payments may be offset or deducted from the
payment obligations of Schering under the Agreement.

 

13.5                           Licenses under
Third Party Patents.

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

 

27

 

13.5.1                  Determination.  Upon mutual agreement, the Parties may seek
to obtain a license or right under one or more Third Party Patents covering any
Product in the Territory in order to avoid infringement.  In the event that either Party determines
that it is beneficial for the Parties to obtain a license or right under one or
more Third Party Patents covering any Product in the Territory and the other
Party objects to such determination within thirty (30) days after such
determination is made, the Parties shall suspend action for a period of one (1)
month (the “Deferral Period”) to allow the objecting Party to present its
position to and discuss its position with the other Party.  Such discussion shall involve senior
management of each Party.

 

13.5.2                  Each Party may
present such facts, findings, conclusions and other information as it deems
necessary during the Deferral Period. 
Upon the earlier of the end of the Deferral Period or both Parties’
presentation of all of their information, Praecis shall evaluate such
information and make a final determination, in its reasonable judgment, as to
the desirability of obtaining a license or right under such Third Party
Patents.  The decision reached by Praecis
shall thereafter be final and binding on the Parties.

 

13.5.3                  Licensing.  In the event that the Parties agree to seek
to obtain a license or right under any Third Party Patents or in the event of
final determination by Praecis of the desirability to obtain a license or right
under any Third Party Patents, Schering and Praecis will make reasonable
efforts to obtain such license or right.

 

13.5.4                  Royalties.  Any royalties and fees to be paid to the
Third Party in consideration of the license or right under the Third Party
Patents with respect to the Product sold by Schering, its Affiliates or its
sublicensees shall be borne by Praecis.

 

13.6                           Patent Prosecution
and Expenses. Praecis shall have the right, at its expense, to control the
preparing, filing, prosecuting and maintaining of the Praecis Patents in the
Territory, and the conducting of any interferences, re-examinations, reissues,
oppositions or requests for Patent term extensions relating to the Praecis
Patents.  If Praecis determines in its
sole discretion to abandon or not maintain any Praecis Patents in the
Territory, then Praecis, to the extent it may do so, shall use commercially
reasonable efforts to provide Schering with at least sixty (60) days’ prior
written notice of such determination.  In
such event, Schering shall have the right, at its option (except with respect
to unpublished Patent applications, in which case such right is only upon the
prior written consent of Praecis, granted at Praecis’ sole discretion) to
control the filing, prosecution and/or maintenance of any such Patent at its
own expense, in Praecis’ name.  Notwithstanding
the foregoing, if the SC agrees that failure to obtain or maintain such Patent
protection would have a material adverse impact on the Development or
Commercialization of the Product in the Territory, Schering shall have the
right to credit against amounts due to Praecis hereunder all out-of-pocket
costs incurred by Schering in connection with the such filing, prosecution and
maintenance of the Praecis Patents pursuant to this Section 13.6. All Patent
Expenses with respect to Praecis Patents incurred by Praecis, and by Schering
to the extent provided in this Section 13.6, shall be borne by Praecis.

 

13.7                           Praecis will have
no obligation whatsoever with respect to any claim that arises from, or license
that is required due to (i) any Change requested by Schering, (ii) Schering’s
failure to use replacement Product that does not violate such third party
rights or (iii) the combination of the Product with any other non-Praecis
intellectual property, hardware or processes.

 

13.8                           For avoidance of
doubt, Schering acknowledges that Praecis Patents include Third Party Patents,
and that Praecis may not have the right to control the bringing of claims to
enforce such Patents or to defend such Patents, and that, in accordance with
Section 2.5,

 

 

28

 

the provisions of this Article XIII are subject to
any limiting terms and conditions in the applicable third party licenses.

 

13.9                           Except as
expressly set forth otherwise in this Article XIII, each Party will be solely
responsible for any intellectual property-related litigation in which it may
become involved in connection with the Development or Commercialization of the
Product, or its exploitation of the Praecis Patents, Praecis Information and
Praecis Trademarks, including any such litigation arising from (i) the
combination of any such intellectual property with any other intellectual
property, hardware, processes or combination thereof, or (ii) any intellectual
property other than the licensor Party’s intellectual property or (iii) any
claim relating to the other Party’s intellectual property that could be avoided
by the use of a reasonable alternative provided by the other Party.

 

13.10                     Use of Names.
Except as provided in Article XIV, neither Party shall use the name of the
other Party in relation to this transaction in any public announcement, press
release or other public document without the written consent of such other
Party (unless such use is required by law or regulation), which consent shall
not be unreasonably withheld or delayed; provided however, that either Party
may use the name of the other Party in any document filed with any Health
Regulatory Authority, including the FDA, or with the Securities and Exchange
Commission, in which case Schering shall be referred to as “Schering AG,
Germany”.

 

ARTICLE
XIV

 

TRADE MARK RIGHTS AND INFRINGEMENT

 

14.1.1                  Each party
recognizes the exclusive ownership by the other Party of any proprietary name,
logotype or Trademark furnished by such Party (including Affiliates) for use in
connection with the marketing, sale or distribution of the Product.  Neither Party shall, either while this
Agreement is in effect, or at any time thereafter, register, use or challenge
or assist others to challenge the Trademarks of the other Party or attempt to
obtain any right in or to any such name, logotype or trademark or in and to any
name, logotype or trademarks confusingly similar to the Product or any other
goods and products, notwithstanding that such goods or products have a
different use or are dissimilar to the Product.

 

14.1.2                  Schering may use
the Praecis Trademark or any other Schering Trademark in connection with the
marketing, sale or distribution of the Product in the Territory.

 

14.2         Schering
Trademarks

 

14.2.1                  Schering shall be
responsible for the selection, registration, maintenance and defense of all
Schering Trademarks, which are employed in
connection with the marketing and selling of the Product in the Territory, and shall own
and control such Schering Trademarks and pay any costs in connection therewith.

 

14.2.2                  Schering shall be
responsible for the selection and the registration, hosting, maintenance and
defense of the Schering Trademarks as Domain Names which are used in connection with the Product under all country code Top
Level Domains (ccTLD) and all current and future generic Top Level Domains
(gTLD). For the avoidance of doubt Schering shall be allowed to register in its
own name, to host on its own servers, maintain and defend such Domain Names and
use them for websites.

 

14.3                           Praecis Trademark

 

 

29

 

14.3.1                  In the case that
Schering decides to use the Praecis Trademark, Praecis hereby grants to
Schering, subject to the terms and conditions herein, the exclusive right to use
the Praecis Trademark and the Praecis Name in the Territory for the term of
this Agreement free of charge. Such license shall be exclusive for the Praecis
Trademark and non-exclusive for the Praecis Name.

 

14.3.2                  Schering shall, at
its costs and expenses, and whenever necessary for the performance of the terms
of this Agreement, (i) file and undertake in good faith to obtain and then
maintain the Praecis Trademarks’ registrations in the Territory, and (ii)
inform Praecis of the status of such Praecis Trademarks.  A list on the legal status of the Trademarks
for all countries of the Territory is attached as of Effective Date as Schedule
14.3.2.

 

(a)                                  In the case that
Schering decides to use the Praecis Trademark, Praecis shall transfer to
Schering all Domain Names similar to the Praecis Trademark; provided, however,
if Praecis is using, or plans to use, the Praecis Trademark outside of the
Territory, the Domain Names shall not be transferred to Schering.  Schering shall be responsible for the
registration, hosting, maintenance and defense of the Praecis Trademark as
Domain Names in the Territory. For the avoidance of doubt, Schering is allowed
to register in its own name, to host on its own servers, maintain and defend
such Domain Names in the Territory and use them for websites. A list on the
legal status of the Domain Names for all countries of the Territory as of
Effective Date will be provided by Praecis by May 15, 2004. Schering agrees
that (i) any use of the Praecis Marks will be only in a proper trademark sense,
shall identify the Praecis Marks as a trademark by including the appropriate
trademark symbol in association with the Praecis Marks and (ii) all goodwill
resulting from its use of the Praecis Marks shall inure to the exclusive
benefit of Praecis.  Schering
acknowledges that Praecis makes no representation or warranty that trademark
registrations can be obtained or maintained for the Praecis Trademark.  Schering recognizes Praecis’ exclusive
ownership of and title in and to the Praecis Marks, and, notwithstanding any
other provision of this Agreement, shall not at any time do or authorize to be
done any act or thing which is likely to materially impair the rights of
Praecis in and to the Praecis Marks or in any trademark registration or
application therefor, and Schering shall not at any time claim any right of
interest in or to the Praecis Marks or the aforesaid trademark registrations or
applications therefor.The Parties acknowledge the importance of exercising
quality control over use of the Praecis Marks in order to preserve the
continued integrity and validity of the Praecis Marks and to protect the
goodwill associated therewith.  Schering
agrees that the Product offered or sold under the Praecis Marks pursuant to
this Agreement must be of a standard and quality at least equal to or better
than that required by Praecis for its own use thereof.  If no standard is expressly required by
Praecis, then the Product offered or sold under the Praecis Marks will be of a
standard at least reasonably comparable to that prevailing with respect to
Other Praecis Products offered by Praecis that also use the Praecis Marks.  As required in each country in the Territory
to preserve proprietary rights in the Praecis Marks, or as otherwise requested
by Schering, Praecis shall provide Schering with reasonable usage guidelines
for the Praecis Marks.

 

14.4                           Trademark
infringement:

 

Each Party shall promptly notify the other of any
actual alleged or threatened infringement of the Trademark or of any unfair
trade practices, trade dress limitation, passing off of counterfeit goods, or
similar offences of which it becomes aware. 
Except to the extent otherwise required by law or protect proprietary
rights in and to the Praecis Trademark, only Schering will be authorized to initiate
at its own discretion legal proceedings against any infringement or threatened
infringement of a Trademark

 

 

30

 

applicable to the Product as defined in this
Agreement. Schering shall be responsible for all costs in connection with such
legal proceedings.  Praecis shall
co-operate reasonably in connection with Schering’s actions for the protection
of the Trademarks.

 

14.5                           In the event that
this Agreement is terminated in accordance with Article XVI Schering shall,
upon Praecis’ request, transfer the Praecis Trademark, and all applications and
registrations therefor, to Praecis, and for such transfer, other than in the
case of termination by Praecis for material breach by Schering, the Parties
will further negotiate in good faith a reasonable consideration, reflecting the
value of the Trademark created by Schering, which shall be paid by Praecis to
Schering. The value will be determined at that time of the assignment.

 

ARTICLE
XV

 

REPRESENTATIONS AND WARRANTIES

 

15.1         Representations
and Warranties

 

(a)                                  Each of the
Parties represents and warrants to the other Party, as of the Effective Date,
as follows:

 

(i)                                     The Agreement is a
legal and valid obligation binding upon such Party and enforceable in
accordance with its terms.  The
execution, delivery and performance of the Agreement by such Party does not
conflict with any agreement, instrument or understanding, oral or written, to
which it is a party or by which it is bound, nor to such party’s knowledge,
violate any law or regulation of any court, governmental body or administrative
or other agency having jurisdiction over it.

 

(ii)                                  Neither Party has
granted, and during the term of this Agreement neither Party will grant, any
right to any Third Party relating to the Praecis Patents and/or Praecis
Information, or Schering Information, which would conflict with the rights
granted to the other Party hereunder.

 

(iii)                               There are no
actions, suits, proceedings or unsatisfied judgments outstanding, pending or,
to the knowledge of such Party threatened, against or affecting such Party,
which may impair the ability of such Party to perform its obligations under
this Agreement, and with respect to Praecis subject to the disclosure refered
to in Section 15.1 (b) (iii) such Party is not aware of any existing ground on
which any such action, suit or proceeding might be commenced with any
reasonable likelihood of success.

 

(b)                                 Praecis hereby
represents and warrants to Schering, as of the Effective Date, that Praecis:

 

(i)                                     Has provided
Schering with reasonable access to all material information in its possession
or control or of which it is aware as of the Effective Date, concerning
efficacy, side effects, injury, toxicity, or sensitivity, reaction and
incidents or severity thereof, associated with any clinical use, studies,
investigations or tests with the Product (animal or human), whether or not
determined to be attributable to the Product.

 

(ii)                                  To the best of its
knowledge, Praecis has not employed, or used a contractor or consultant that
employs, any individual or entity debarred

 

 

31

 

by the FDA (or subject to a similar sanction of
EMEA), or, to the best knowledge of Praecis, any individual who or entity which
is the subject of an FDA debarment investigation or proceeding (or similar
proceeding of EMEA), in the conduct of the preclinical or clinical studies of
Products.

 

(iii)                               As of the
Effective Date, except as it may have previously disclosed to Schering in
writing, has not received any notices of infringement or any written
communications asserting a possible infringement with respect to the Product,
and that it is not aware that the manufacture, use or sale of the Product
infringes any Third Party patent rights.

 

(iv)                              As of the
Effective Date, Praecis is not aware of any prior act or any fact which causes
it to conclude that any Praecis Patent owned by Praecis or licensed under the
PPI Licensed Rights is invalid or unenforceable.

 

(v)                                 Praecis has
obtained all right, title and interest in and to all rights to the Praecis
Patents and Praecis Information, free and clear of any liens, encumbrances or
rights to repurchase; and

 

(vi)                              During the term
hereof, Praecis will not take enter into any agreements with any Third Party
which would adversely Schering’s rights under this Agreement.

 

(vii)                           Praecis has
conducted, or has caused its contractors or consultants to conduct, the
preclinical and clinical studies for the Product in the US, in all material
respects in accordance with applicable laws and published standards of the FDA,  and regulatory standards applicable to the
conduct of studies in the United States, including without limitation, GMPs,
GLPs and GCPs.

 

(viii)                        Notwithstanding
any term or condition to the contrary in this Agreement, Praecis makes no
representation, warranty or covenant (i) as to the validity or scope of any of
the Praecis Patents (except as set forth in Section 15.1(b)(iv) above), (ii)
that the Praecis Patents or Praecis Information or the performance of any of the
License Activities will not infringe any Third Parties’ intellectual property,
except as expressly represented and warranted in Section 15.1(b)(iii) (and
without limiting Praecis’ indemnification obligation pursuant to Article XVII),
(iii) that the Praecis Patents include composition-of-matter claims that cover
PPI-149 in any country in the Territory other than those listed in Schedule
15.1(b), or (iv) that the PLENAXIS trademark is or can be registered in any
country in the Territory other than those listed in Schedule 15.1(b) as having
been registered as of the Effective Date.

 

(c)                                  Schering hereby
represents and warrants to Praecis, as of the Effective Date, that Schering:

 

(i)                                     During the term
hereof, Schering will not enter into any agreements with any Third Party which
would adversely affect Praecis’ rights under this Agreement.

 

 

32

 

ARTICLE
XVI

 

TERM AND TERMINATION

 

16.1                           Term. This
Agreement shall commence as of the Effective Date and, unless sooner terminated
as provided herein, shall continue in effect until (i) the last Praecis Patent
licensed to Schering pursuant Section 2.1 expires or (ii) ten (10) years after
the First Commercial Sale of the Product in the first of one of the following
countries: Germany, United Kingdom, France, Spain or Italy, whichever of (i)
and (ii) is longer. Schering will notify Praecis about the First Commercial
Sale of the Product. This Agreement will automatically extend for renewal
periods of one (1) year unless either Party gives written notice to the other
Party of its intention not to renew at least one (1) year prior to the expiry
date.

 

16.2                           Termination

 

(a)                                  [*]

 

(b)                                 [*]

 

(c)                                  Failure of
Schering or Praecis to materially comply with any of their respective material
obligations and conditions contained in this Agreement shall entitle the other
Party to give the Party in default notice requiring it to cure such
default.  If such default is not
substantially cured (or fully cured, in the case of a payment default) within
[*] after receipt of such notice, the notifying Party shall be entitled
(without prejudice to any of its other rights conferred on it by this
Agreement) to terminate this Agreement in its entirety only. Notwithstanding
the foregoing, in the event of a non-monetary default, if the default is not
reasonably capable of being cured [*] by the defaulting Party and such
defaulting Party is making a good faith effort to cure such default, the
notifying Party may not terminate this Agreement, provided however, that the
notifying Party may terminate this Agreement if such default is not cured
[*]  The right of either Party to
terminate this Agreement as hereinabove provided shall not be affected in any
way by its waiver of, or failure to take action with respect to any previous
default.

 

(d)                                 In the event that
one of the Parties hereto shall go into liquidation, a receiver or a trustee be
appointed for the property or estate of that Party and said receiver or trustee
is not removed within thirty (30) days, or the Party makes an assignment for
the benefit of creditors (collectively, a “Bankruptcy Event”), and whether any
of the aforesaid Bankruptcy Events be the outcome of the voluntary act of that
Party, or otherwise, the other Party shall be entitled to terminate this
Agreement in its entirety only by written notice to the Party that is subject
to a Bankruptcy Event.

 

(i)                                     If Praecis enters
into an arrangement for creditors and/or bankruptcy, one week prior to such
arrangement for creditors and/or bankruptcy, Schering shall have the right to
be notified by Praecis of such arrangement and/or bankruptcy, and any and all
license fees owed directly to IUF by Praecis pursuant to this Agreement shall
thereafter, upon notice to Schering, be paid by Schering directly to IUF, and
Schering may offset such payments against amounts otherwise to be paid by
Schering to Praecis under this Agreement.

 

(e)                                  Should Schering or
Praecis consider the distribution of the Product dangerous or harmful, either
Party shall immediately notify the other Party and provide in

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

 

33

 

writing any and all reason and information which
prompted such decision. If both Parties consider that such decision is
well-founded, or a Health Regulatory Authority requires the cessation of
marketing and sales of the Product, each Party will be entitled to terminate
this Agreement in its entirety only  by
sending a termination notice to the other Party. Any Firm Orders issued by
Schering for the term after the termination will be deemed to be cancelled with
the notification of termination according to this Section 16.2(e). For the
avoidance of doubt, Praecis and Schering will each bear its own costs incurred.

 

(f)                                    [*]

 

(g)           [*]

 

[*]

 

[*]

 

[*]

 

[*]

 

(h)                                 Effect of
Termination

 

(a)                                  In the event that
this Agreement is terminated in its entirety or in one or more countries by
Schering in accordance with Section 16.2 (b) above, by Praecis in accordance
with Section 16.2 (f), by either Party in its entirety in accordance with this
Article XVI or pursuant to any other provision of this Agreement entitling a
Party to terminate this Agreement, Schering will, with respect to each country
for which the termination applies (or all countries in the Territory in the
case of termination of this Agreement in its entirety): (i) not use the Praecis
Information as long as it has to be kept confidential pursuant to Article XII
hereof in such country; (ii) not infringe any of the Praecis Patents in such
country; (iii) make all payments accrued under this Agreement with respect to
such country prior to the effective termination date; (vi) transfer all
regulatory filings and approvals related to the applicable Product in such
country to Praecis, on Praecis’ written request for same; and (vii) sell to
Praecis, at any time within ninety (90) days of such termination, at Praecis’
election, all or any portion of the inventory of the Product owned by Schering
or its Affiliates which are intended for sale in such country at a price equal
to Schering’s or its Affiliate’s fully burdened costs for such inventory.  Such election shall be made by Praecis in
writing and within thirty (30) days of such termination.  If Praecis elects to purchase such Schering
inventory, then Schering shall ship at Praecis’ cost and direction such
inventory to Praecis.  Praecis shall pay
for such inventory upon receipt of such inventory.

 

(b)                                 Notwithstanding
the provisions of subparagraph (a) of this Section 16.2(h) or any other
provision of this Agreement, unless this Agreement has been validly terminated
in its entirety (in which event Praecis shall be entitled to Commercialize the
Product in any and all countries in the Territory), Praecis shall not be
permitted to Commercialize the Product in any country in the EU.

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

 

34

 

(i)                                     Upon termination,
the right and obligations of the Parties cease, and all licenses terminate,
except where expressly provided for otherwise in this Agreement, and provided
that termination of this Agreement shall not relieve the Parties hereto of any
liability, including any obligation to make payments hereunder, which accrued
hereunder prior to the effective date of such termination, nor preclude either
Party from pursuing all rights and remedies it may have hereunder or at law or
in equity with respect to any breach of this Agreement nor prejudice any
Party’s right to obtain performance of any obligation which arose prior to the
effective date of such termination.

 

16.3                           Surviving
Rights.  The rights and obligations set
forth in this Agreement shall extend beyond the termination of the Agreement
only to the extent expressly provided in this Article XVI or expressly provided
for elsewhere in this Agreement.

 

ARTICLE
XVII

 

INDEMNIFICATION

 

17.1                           Indemnification.
Schering hereby agrees to save, defend and hold Praecis and its officers,
directors, consultants, agents and employees harmless from and against any and
all Third Party suits, claims, actions, demands, liabilities, expenses or
losses, including reasonable legal expenses and attorneys’ fees (collectively
“Losses”) resulting from or arising out of the Commercialization of the Product
except to the extent such Losses result from or arise out of breach by Praecis
of this Agreement, including without limitation the inaccuracy of any
representation of Praecis set forth in this Agreement or breach of any of
Praecis’ warranties set forth in Article XV, or resulting from Praecis’
manufacture of the Product or the negligence or willful misconduct of Praecis, in
which case Praecis hereby agrees to save, defend and hold Schering and its
directors, officers, agents and employees harmless from any and all such
Losses.

 

17.2                           Except as provided
in Section 17.1, Schering and Praecis, (as applicable, the “First Party”) hereby
agree to save, defend and hold the other Party and its directors, officers,
agents and employees harmless from and against any and all Losses resulting
from or arising out of the Development of any Product to the extent such
Development was performed by or on behalf of the First Party, except to the
extent such Losses result from or arise out of the negligence or willful
misconduct of the other Party, in which case such other Party hereby agrees to
save, defend and hold the First Party and its directors, officers, agents and
employees harmless from any and all such Losses, provided that, for purposes
hereof Development performed by Schering hereunder is deemed not to be on
behalf of Praecis.

 

17.3                           Each indemnified
Party agrees to give the indemnifying Party prompt written notice of any Loss
or discovery of fact upon which such indemnified Party intends to base a
request for indemnification under Sections 17.1 or 17.2.  Each Party shall furnish promptly to the other
copies of all papers and official documents received in respect of any
Loss.  With respect to any indemnifiable
claim hereunder that does not relate solely to the indemnified Party becoming
subject to injunctive or other equitable relief, and as to which the
indemnifying Party shall have acknowledged in writing the obligation to
indemnify the indemnified Party hereunder, the indemnifying Party shall have
the sole right to defend, settle or otherwise dispose of such Loss, on such
terms as the indemnifying Party, in its sole discretion, shall deem
appropriate.  The indemnified Party will
have the right to control indemnifiable claims hereunder that relate solely to
injunctive or equitable relief brought solely against the indemnified Party.  The Party not controlling the litigation may
participate in the litigation, with counsel of its own choosing, at its own
expense.   The indemnifying Party shall obtain the
written consent of the indemnified Party, which shall 

 

 

35

 

not be unreasonably withheld or delayed, prior to
ceasing to defend, settling or otherwise disposing of any Loss if as a result
thereof the indemnified Party would become subject to injunctive or other
equitable relief, or any remedy other than the payment of money which is the
responsibility of the indemnifying Party. 
The indemnifying Party shall not be liable for any settlement or other
disposition of a Loss by the indemnified Party which is reached without the
consent of the indemnifying Party.  If
and to the extent that any litigation relating to a Loss is conducted by the
indemnified Party as provided above, the reasonable costs and expenses,
including reasonable fees and disbursements of counsel incurred by any
indemnified Party in connection with any such litigation, shall be reimbursed,
once it is at least preliminarily determined that such Party is entitled to
indemnification under this Article XVII, on a quarterly basis by the
indemnifying Party, without prejudice to the indemnifying Party’s right to
contest the indemnified Party’s right to indemnification and subject to refund
in the event the indemnifying Party is ultimately held not to be obligated to
indemnify the indemnified Party.

 

17.4                           In the event any
Party becomes liable to pay any damages to a Third Party with respect to any
matter related to the Product not otherwise provided for in Section 17.1 or
Section 17.2,, the Parties hereby agree that any such damages shall be borne by
the Party in whose sphere of responsibility lays the responsibility for the
damage, and, to that effect, the Parties further agree to define sphere of
responsibilities with respect to the manufacture and quality control as laid
out in Appendix 7 to the QAA from and after the time the QAA is executed and
delivered by the Parties. In the event either Party fails to fulfill its
obligations pursuant to this Article XVII, the other Party shall be entitled to
notify it and such failure shall, if material, be deemed a default as more
fully described in Section 16.2(c) of this Agreement.

 

17.5                           Insurance. Praecis
agrees and warrants that, during the term of this Agreement and for a period of
five (5) years thereafter, it shall obtain and maintain at its own expenses,
product liability insurance from a recognized insurance carrier providing
liability coverage in the aggregate, per occurrence and per year, with coverage
limits of not less than fifteen million U.S. dollars ($15,000,000). Praecis
will prove this insurance cover by furnishing Schering with copies of the
relevant insurance documentation.

 

17.6                           This Article XVII
shall survive the termination or expiration of this Agreement.

 

ARTICLE
XVIII

 

MISCELLANEOUS

 

18.1                           Assignment.

 

(a)                                  Each Party may
assign this Agreement or any of its rights or obligations under this Agreement
to any of its Affiliates; provided, however, that such assignment shall not
relieve the Party of its responsibilities for performance of its obligations
under this Agreement.

 

(b)                                 The Parties may
not assign this Agreement to any Third Party without the prior written consent
of the other Party, such consent not to be unreasonably withheld or unduly
delayed, except that no prior written consent shall be required in the event
that a Third Party acquires all or substantially all of the assets or
outstanding shares of, or merges with, Schering or Praecis, as the case may be;
provided, that, the assignee shall agree in writing to assume all of the
assignor’s rights and responsibilities hereunder, the assignee shall provide
notice of such assignment to the other Party to this Agreement as soon as
practicable following such assignment, and such assignment shall not relieve
the Party of its responsibilities for performance of its obligations under this
Agreement.

 

 

36

 

(c)                                  This Agreement
shall be binding upon and inure to the benefit of the permitted assigns of the
Parties.  Any purported assignment not in
accordance with this Agreement shall be null and void.

 

18.2                           Force
Majeure.  Neither Party shall lose any
rights hereunder or be liable to the other Party for damages or losses on
account of failure of performance by the defaulting Party, other than for
payment obligations, if the failure is occasioned by government action
(including, without limitation, laws, regulations or orders), war, fire, terrorism,  explosion, flood or other weather event,
strike, lockout, embargo, act of God or any other cause beyond the control of
the defaulting Party, provided that the Party claiming force majeure has
extended reasonable efforts normally followed in its industry to avoid or
remedy any such force majeure, continues to employ such efforts and promptly
notifies the other Party of such force majeure event.

 

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

 

18.4                           Survival of
Representations; Disclaimer.  EACH PARTY
AGREES AND ACKNOWLEDGES THAT, EXCEPT AS SET FORTH IN ARTICLE XV, NEITHER PARTY
MAKES ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND WHATSOEVER, EXPRESS,
IMPLIED OR STATUTORY, AND EACH PARTY HEREBY EXPRESSLY DISCLAIMS ALL
REPRESENTATIONS AND WARRANTIES, EXPRESS, IMPLIED OR STATUTORY, INCLUDING
WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, AGAINST NON-INFRINGEMENT OR THE LIKE, OR ARISING FROM
COURSE OF PERFORMANCE, COURSE OF DEALING OR FROM TRADE PRACTICES, OR REGARDING
THE VALUE, ADEQUACY, QUALITY, EFFICIENCY, STABILITY, CHARACTERISTICS OR
USEFULNESS OF ANY PRODUCTS.

 

18.5                           Exclusion of
Liability.  EXCEPT AS EXPRESSLY AGREED IN
THIS AGREEMENT, TO THE MAXIMUM EXTENT PERMITTED BY LAW, NEITHER PARTY, ITS
AFFILIATES NOR ANY OF THEIR LICENSEES OR REPRESENTATIVES SHALL BE LIABLE TO THE
OTHER PARTY, ITS AFFILIATES OR ANY OF THEIR LICENSEES OR REPRESENTATIVES FOR
ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, RELIANCE OR PUNITIVE DAMAGES
OR LOST OR IMPUTED PROFITS OR ROYALTIES, LOST DATA OR COST OF PROCUREMENT OF
SUBSTITUTE GOODS OR SERVICES, WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT
(INCLUDING, WITHOUT LIMITATION, NEGLIGENCE AND STRICT PRODUCT LIABILITY),
INDEMNITY OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY
REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE
ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE.

 

18.6                           No Third-Party
Rights.  No provision of this Agreement
shall be deemed or construed in any way to result in the creation of any rights
or obligation in any person not a Party to this Agreement.  To the extent that either Party’s directors,
officers, employees, or Affiliates is entitled to indemnification under this
Agreement, Schering and Praecis, respectively will have the sole right to seek
such indemnification on behalf of such indemnitee.

 

18.7                           No Trademark
Rights.  Except as otherwise provided
herein, no right, express or implied, is granted by this Agreement to use in
any manner the names “Schering” or “Praecis” or any other trade name or
trademark of the other Party or its Affiliates in connection with the
performance of this Agreement.

 

 

37

 

18.8                           Notices.  All notices hereunder shall be in writing,
effective upon receipt, and shall be delivered personally, hand-delivered, mailed
by registered or certified mail (return receipt requested, postage prepaid), or
sent by express courier service, to the other Party at the following addresses
(or at such other address for a Party as shall be specified by like notice):

 

(a)                                  If to Schering

 

Schering Aktiengesellschaft

D-13342 Berlin, Germany

Legal Department

 

(b)                                 If to Praecis

 

Praecis Pharmaceutical Inc.

830 Winter Street,

Waltham, MA 02451, USA

 

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

 

18.10                     Severability.  Each Party hereby agrees that it does not
intend, by its execution hereof, to violate any public policies, statutory or
common laws, rules, regulations, treaties or decisions of any government agency
or executive body thereof of any country or community or association of
countries.  Should one or more provisions
of this Agreement be or become invalid, the Parties hereto shall substitute, by
mutual consent, valid provisions for such invalid provisions, which valid provisions
in their economic and other effects are sufficiently similar to the invalid
provisions that it can be reasonably assumed that the Parties would have
entered into this Agreement with such valid provisions.  In case such valid provisions cannot be agreed
upon, the invalidity of one or several provisions of this Agreement shall not
affect the validity of this Agreement as a whole or the validity of any
portions hereof, unless the invalid provisions are of such essential importance
to this Agreement that it is to be reasonably assumed that the Parties would
not have entered into this Agreement without the invalid provision.

 

18.11                     Ambiguities.  The Parties acknowledge and agree that: (a)
each Party and its counsel reviewed and negotiated the terms and provisions of
this Agreement and have contributed to its revision; (b) 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 (c) the terms and provisions of this Agreement shall be construed fairly as
to the Parties hereto and not in favor of or against any Party, regardless of
which Party was generally responsible for the preparation of this Agreement.

 

18.12                     Governing Law;
Jurisdiction. This Agreement shall be governed by and interpreted in accordance
with the laws of New York, without regard to conflict of laws principles of
such state. Each Party hereby irrevocably and unconditionally submits, for
itself and its property, to the exclusive jurisdiction of any New York state or
U.S. federal court located in the Southern District of New York and any
appellate court from such court, in any suit, action or proceeding arising out
of this Agreement, and agrees that all claims in respect of any such suit,
action or proceeding may be heard and determined in such court; 

 

 

38

 

provided, that, each Party shall be entitled to
enforce any judgment in any court having jurisdiction over the matter.

 

18.13                     Headings.  The section and paragraph headings contained
herein are for the purposes of convenience only and are not intended to define
or limit the contents of said sections or paragraphs.

 

18.14                     Counterparts.  This Agreement may be executed by the Parties
in one or more counterparts.  Such
counterparts may be exchanged by facsimile (provided that each executed
counterpart is transmitted in one complete transmission).  Where there is an exchange of executed
counterparts, each Party shall be bound by this Agreement notwithstanding that
original copies of this Agreement may not be exchanged immediately.  The Parties shall cooperate after execution
of this Agreement and exchange by facsimile to ensure that each Party obtains
an original, executed copy of this Agreement.

 

18.15                     Entire Agreement;
Amendments.  This Agreement, including
all Schedules attached hereto, all documents and things incorporated herein by
reference and all of the documents delivered concurrently herewith set forth
all the covenants, promises, agreements, warranties, representations, conditions
and understandings between the Parties hereto and supersede and terminate all
prior agreements and understandings between the Parties.   No subsequent alteration, amendment, change
or addition to this Agreement shall be binding upon the Parties hereto unless
reduced to writing and signed by the respective authorized officers of the
Parties.

 

18.16                     Expenses.  Except as otherwise specified in this
Agreement, all costs and expenses, including, without limitation, fees and
disbursements of counsel, financial advisers and accountants, incurred in
connection with this Agreement and the transactions contemplated hereby shall
be paid by the Party incurring such costs and expenses.

 

18.17                     Independent
Contractors.  The status of the Parties
under this Agreement shall be that of independent contractors.  Neither Party shall have the right to enter
into any agreements on behalf of the other Party, nor shall it represent to any
person that it has any such right or authority. 
Nothing in this Agreement shall be construed as establishing a
partnership or joint venture relationship between the Parties.

 

18.18                     Schering
Standstill.  Without the express prior
written consent of Praecis, for a period of [*] after the Effective Date,
neither Schering nor any of its Affiliates will, directly or indirectly, (i)
purchase or otherwise acquire any securities, or rights or options to acquire
any securities, of Praecis such that, after giving effect to such purchase or
other acquisition, Schering, alone or together with its Affiliates, would
“beneficially own” (determined as provided in Rule 13d-3 under the Securities
Exchange Act of 1934, as amended) more than [*] of Praecis’ outstanding common
stock, (ii) make any “solicitation” of “proxies” (as such terms are used in the
proxy rules of the United States Securities and Exchange Commission) or (iii)
make any written offer or proposal, or any public announcement, concerning any
business combination, merger or consolidation, tender or exchange offer or
equity investment involving, or sale of all or a significant portion of the
assets of, Praecis, or (iv) instigate, join, act in concern with or assist
(including but not limited to providing, or assisting in any way in obtaining,
financing for, or acting as a joint or co-bidder with) any Third Party to take
any action referred to in clauses (i) through (iii) above.

 

IN WITNESS WHEREOF, Schering and Praecis have
caused this Agreement to be executed as of the Effective Date by their
respective duly authorized representatives.

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

 

39

 

	
  Berlin, April 27, 2004

  	
  Waltham, April 27, 2004

  
	
  SCHERING AKTIENGESELLSCHAFT

  	
  PRAECIS PHARMACEUTICALS INC.

  
	
   

  	
   

  	
   

  
	
  /s/ Christian Nowak

  	
   

  	
  /s/ Daniel Horn

  	
   

  	
  /s/ Kevin F. McLaughlin

  	
   

  
	
  Christian Nowak

  	
  Dr. Daniel Horn

  	
   

  
						

 

 

40

 

Schedule 1 - Countries of Territory

 

1.                                      European Union

 

Austria

Belgium

Czech Republic

Cyprus

Denmark

Estonia

Finland

France

Germany

Great Britain

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxemburg

Malta

Netherlands

Poland

Portugal

Slovakia

Slovenia

Spain

Sweden

 

2.             European
Union and European Economic Area

 

European Union

Iceland

Liechtenstein

Norway

Switzerland

 

3.             Eastern
Europe and Middle East

 

Albania

Armenien

Azerbaijan

Belarus

Bosnia-Herzog.

Bulgaria

Croatia

Georgia

Kazakhstan

Kirghizia

Macedonia

Mongolia

Moldavia

Montenegro

Romania

Russia

Serbia

Tadzhikistan

Turkey

Turkmenistan

Ukraine

Uzbekistan

Afghanistan

Bahrain

Bangladesh

Egypt

India

Iran

Iraq

Israel

Jordan

Kuwait

Lebanon

Libya

Oman

Qatar

Pakistan

Saudi Arabia

South Africa

Sri Lanka

Syria

United Arab
Emirates

Yemen

 

4.             Region
Asia/Pacific

 

Australia

New Zealand

 

 

41

 

Schedule 2 - End User Kit Contents and
Specifications

 

Kit
Components as Designated in MAA section 3.2 P.7 Submitted to BfArM in June 2003
and

Current as of Effective Date

 

	
  Component

  	
   

  	
  Supplier Name and Address

  	
   

  
	
  Abarelix 100 mg powder for suspension for
  injection vial

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
  [*]

  	
   

  
	
  0.9% Sodium
  Chloride Injection, 5 mL ampoule

  	
   

  	
  [*]

  	
   

  
	
  3 cc Luer-LockTM syringe with 18 gauge
  1-1/2” needle, CE certified

  	
   

  	
  [*]

  	
   

  
	
  22 gauge 1-1/2” Safety Glide Needle,  CE certified

  	
   

  	
  [*]

  	
   

  
	
  Drug Product Label

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Technical Instructions

  	
   

  	
  [*]

  	
   

  

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

 

42

 

Specifications for Injection Vial, Stopper
and Seal Components

 

As Designated in MAA Submitted to BfArM in
June 2003 and Current as of Effective Date

 

	
  Component

  	
   

  	
  Supplier

  	
   

  	
  Material

  	
   

  	
  Description

  	
   

  
	
  Vial

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Stopper

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Seal, Flip-off

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  [*]

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  360 Medical Fluid

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  

 

(a)           [*]

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

 

43

 

Schedule 3 - Existing
Development

 

Existing Clinical
Trials

 

1.                                       Praecis is
currently undertaking a dosing study (Praecis number 149-04-01) for Plenaxis in
androgen independent prostate cancer patients. 
That study will start to accrue patients in the United States beginning
in April 2004.  As of the Effective Date,
the clinical protocol has been commented upon by the FDA and resubmitted with
further changes.

 

2.                                       There are also
on-going evaluations of improved delivery devices and formulations for the
Current Product.

 

 

44

 

Schedule 4 - PPI-149

 

“PPI-149” shall mean a compound having the
following structure, as described in US Patents 5,843,901, 6,423,686, and
6,455,499:

 

 

 

45

 

Schedule 5 - Praecis Patents in the
Territory

 

Granted Patents(1)

 

AT 0794961

BE 0794961

CH 0794961

DE 0794961

DK 0794961

ES 0794961

FI 0794961

FR 0794961

GB 0794961

GR 0794961

IE 0794961

IT 0794961

LU 0794961

MC 0794961

NL 0794961

PT 0794961

SE 0794961

 

AU 715,399

AU 735,174

AU 782,801

AU 730,948

 

JR 1998

 

NZ 336269

 

RU 2202371

 

ZA 97/10994

 

(1) Indicated status reflects communications
received by PRAECIS from foreign patent agents as of April 14, 2004.

 

 

Pending Applications

 

AU 31301/00

AU 54008/01

AU 39667/99

AU 37642/99

AU 41883/01

 

EP 01204149.7

EP 97953188.6

EP 96942812.7

EP 02078871.7

EP 99922735.8

EP 99920059.5

EP 01913197.8

 

CZ PV 2066-99

 

DZ 970221

 

HR P970674A

 

HU 22857/99

 

IL 130,309

 

NZ 511431

NZ 507498

NZ 507504

 

PL P-334076

 

SK PV0793-99

 

TR 1382

 

UA 99073900

 

 

46

 

Schedule 8.1 - Approval Milestone Payment

 

[*]

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

 

47

 

Schedule 14.3.2 Plenaxis Trademark
Registrations and

Pending Applications in the Territory

 

 

I.                                         Registrations/applications
owned by PRAECIS

 

	
  Country

  	
   

  	
  Filing date

  	
   

  	
  Application

  number

  	
   

  	
  Reg. date

  	
   

  	
  Reg.

  number

  	
   

  	
  Status

  	
   

  
	
  COMMUNITY TRADE MARK

  	
   

  	
  15/7/02

  	
   

  	
  2775674

  	
   

  	
  14/10/03

  	
   

  	
  2775674

  	
   

  	
  REGISTRATION

  	
   

  
	
  EGYPT

  	
   

  	
  26/4/00

  	
   

  	
  132426

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  LEBANON

  	
   

  	
  14/4/00

  	
   

  	
  768863

  	
   

  	
  14/4/00

  	
   

  	
  83292

  	
   

  	
  REGISTRATION

  	
   

  

 

II.                                     Registrations/applications
to be assigned to PRAECIS by Sanofi-Synthelabo (information below as provided
by Sanofi-Synthelabo)

 

	
  Country

  	
   

  	
  Filing date

  	
   

  	
  Application

  number

  	
   

  	
  Reg. date

  	
   

  	
  Reg.

  number

  	
   

  	
  Status

  	
   

  
	
  ALBANIA

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  ARMENIA

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  AUSTRIA

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  AZERBAIJAN

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  BAHRAIN

  	
   

  	
  16/05/01

  	
   

  	
  2708/2000

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PUBLICATION

  	
   

  
	
  BELARUS

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  BENELUX

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  BOSNIA-HERZEGOVINA

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  BULGARIA

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  CROATIA

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  CYPRUS

  	
   

  	
  07/11/00

  	
   

  	
  58326

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  CZECH REPUBLIC

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  DENMARK

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  ESTONIA

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  FRANCE

  	
   

  	
  06/08/99

  	
   

  	
  99807338

  	
   

  	
  06/08/99

  	
   

  	
  99807338

  	
   

  	
  REGISTRATION

  	
   

  
	
  GEORGIA

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
  REGISTRATION

  	
   

  
	
  GERMANY

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  HUNGARY

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  ICELAND

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  IRAN

  	
   

  	
  16/12/00

  	
   

  	
  7909861

  	
   

  	
  28/04/01

  	
   

  	
  93430

  	
   

  	
  REGISTRATION

  	
   

  
	
  ISRAEL

  	
   

  	
  09/11/00

  	
   

  	
  143751

  	
   

  	
  04/12/01

  	
   

  	
  143751

  	
   

  	
  REGISTRATION

  	
   

  
	
  ITALY

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  JORDAN

  	
   

  	
  13/11/00

  	
   

  	
  59905

  	
   

  	
  10/07/02

  	
   

  	
  59905

  	
   

  	
  REGISTRATION

  	
   

  
	
  KAZAKHSTAN

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  KUWAIT

  	
   

  	
  13/05/01

  	
   

  	
  50028

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PUBLICATION

  	
   

  

 

 

48

 

	
  KYRGYZSTAN

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
  REGISTRATION

  	
   

  
	
  LATVIA

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  LEBANON

  	
   

  	
  09/11/00

  	
   

  	
  09/11/00

  	
   

  	
   

  	
   

  	
  85380

  	
   

  	
  REGISTRATION

  	
   

  
	
  LITHUANIA

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  MACEDONIA

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  MALTA

  	
   

  	
  06/11/00

  	
   

  	
  32525

  	
   

  	
  10/11/00

  	
   

  	
  32525

  	
   

  	
  REGISTRATION

  	
   

  
	
  MOLDOVA (REP)

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  NORWAY

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
  REGISTRATION

  	
   

  
	
  OMAN

  	
   

  	
  12/11/00

  	
   

  	
  23971

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  POLAND

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  PORTUGAL

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  QATAR

  	
   

  	
  26/11/00

  	
   

  	
  24290

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  ROMANIA

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  RUSSIAN FEDERATION

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  SAUDI ARABIA

  	
   

  	
  28/11/00

  	
   

  	
  68200

  	
   

  	
  28/11/00

  	
   

  	
  617/70

  	
   

  	
  REGISTRATION

  	
   

  
	
  SERBIA and MONTENEGRO

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  SLOVAKIA

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  SLOVENIA

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  SWITZERLAND

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  SYRIA

  	
   

  	
  13/01/01

  	
   

  	
  361890

  	
   

  	
  05/02/01

  	
   

  	
  75259

  	
   

  	
  REGISTRATION

  	
   

  
	
  TAJIKISTAN

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  TURKEY

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
  REGISTRATION

  	
   

  
	
  TURKMENISTAN

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  UKRAINE

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
  REGISTRATION

  	
   

  
	
  UNITED ARAB EMIRATES

  	
   

  	
  17/12/00

  	
   

  	
  39911

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PUBLICATION

  	
   

  
	
  UZBEKISTAN

  	
   

  	
  10/10/00

  	
   

  	
  743725

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  APPLICATION

  	
   

  
	
  YEMEN (REPUBLIC OF)

  	
   

  	
  26/11/00

  	
   

  	
  19327

  	
   

  	
  09/09/01

  	
   

  	
  14046

  	
   

  	
  REGISTRATION

  	
   

  

 

 

49

 

Draft

 

Quality Assurance Agreement

 

 

Schedule 6 to the Licence, Supply and
Distribution Agreement between

 

 

Schering AG

 

(„Schering”)

 

and

 

 

Praecis Pharmaceuticals Inc.

 

(“Praecis”)

 

 

50

 

[*]

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

 

51

 

DRAFT

 

Schedule
7

 

Pharmacovigilance
Agreement between Schering AG and Praecis for Plenaxis

 

[*]

 

CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

52

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00070-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00070-of-00352.parquet"}], [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00070-of-00352.parquet"}]]