**Exhibit 10.22**

 

EXECUTION COPY

 

**LICENSE**

 

**AND**

 

**RESEARCHAGREEMENT**

 

**BY ANDAMONG**

 

**BRISTOL-MYERSSQUIBB COMPANY,**

 

**AMRTECHNOLOGY, INC.,**

 

**AND**

 

**ALBANYMOLECULAR RESEARCH, INC.**

 

**EXECUTED: OCTOBER 20,2005**

** **

**LICENSE AND RESEARCH AGREEMENT**

 

 

**CONFIDENTIALTREATMENT REQUESTED**

 

----

 

**LICENSEAND RESEARCH AGREEMENT**

 

This License and Research Agreement (this “Agreement”)is made by AMR Technology, Inc., a corporation organized and existingunder the laws of Vermont and having a principle place of business at 5429 MainStreet, Manchester, Vermont, Albany Molecular Research, Inc., acorporation organized and existing under the laws of the State of Delaware andhaving a principle place of business at 21 Corporate Circle, Albany, New York12203 (with “**AMRI**” meaning individually andcollectively AMR Technology, Inc. and Albany Molecular Research, Inc.)and Bristol-Myers Squibb Company, a corporation organized and existing underthe laws of the State of Delaware and headquartered at 345 Park Avenue, NewYork, New York 10154 USA (“**BMS**”).

 

**Recitals**

 

A. Bristol-Myers Squibb Pharma Company (an Affiliate (as defined below)of BMS and formerly called “DuPont Pharmaceuticals Company”) assigned certainpatent applications and patents to Albany Molecular Research, Inc. (the “AssignedPatent Rights”) under the Existing License Agreement (as defined below);

 

B. Under the Existing License Agreement, Albany Molecular Research, Inc.retained the rights under the Assigned Patent Rights in the CNS Field (as thatterm is defined in the Existing License Agreement) and granted BMS an exclusivelicense under the Assigned Patent Rights so that BMS could make, have made,import, use, offer to sell and sell compounds covered by the Assigned PatentRights and products containing those compounds in the Non-CNS Field (as thatterm is defined in the Existing License Agreement).

 

C. Under the Existing License Agreement, Bristol-Myers Squibb PharmaCompany licensed certain then unpatented compounds (the “Attachment A Compounds”)to Albany Molecular Research, Inc. in 

 

Confidential TreatmentRequested

 

1

----

 

the CNS Field and retained all rights in the Non-CNS Field (as thatterm is defined in the Existing License Agreement);

 

D. Albany Molecular Research, Inc. and BMS entered into theWarrant Issue Agreement (as defined below) on the same date as they enteredinto the Existing License Agreement;

 

E. Albany Molecular Research, Inc. issued warrants to BMS underthe Warrant Issue Agreement and, on September 11, 2003, BMS and AlbanyMolecular Research, Inc. entered into an amendment to amend the WarrantIssue Agreement so that the period for BMS to exercise the warrants under theWarrant Issue Agreement was extended, and they entered into the First Amendment(as defined below)  in which the ExistingLicense Agreement was amended to be consistent with the amendment to theWarrant Issue Agreement;

 

F. BMS is willing to have the warrants cancelled as part of thisAgreement;

 

G. On January 7, 2004, BMS, Bristol-Myers Squibb Pharma Companyand Albany Molecular Research, Inc. entered into the Second Amendment (asdefined below) under which the Existing License Agreement was amended so thatAlbany Molecular Research, Inc. was given the right to file patentapplications and to obtain patents on the Attachment A Compounds as well as oncertain other compounds, including but not limited to derivatives of theAttachment A Compounds and derivatives of compounds claimed in the AssignedPatent Rights;

 

H. Albany Molecular Research, Inc. has generated AmineNeurotransmitter Reuptake-Inhibitors (as defined below) after it entered intothe Existing License Agreement, some of which are analogs and derivatives ofthe compounds covered by the Assigned Patent Rights or of the Attachment ACompounds, and Albany Molecular Research, Inc. has filed patentapplications on some of these Amine Neurotransmitter Reuptake-Inhibitors it hasgenerated;

 

Confidential TreatmentRequested

 

2

----

 

I. Albany Molecular Research, Inc. would like to obtain ownershiprights in all Attachment A Compounds, to have Bristol-Myers Squibb PharmaCompany assign to AMR Technology, Inc. its entire right, title andinterest in and to those Attachment A Patent Rights (as defined in the ExistingLicense Agreement) in which Bristol-Myers Squibb Pharma Company has anyownership interest, and to terminate certain other intellectual property rightswhich it conveyed to BMS in the Existing License Agreement, while BMS wouldlike to obtain an exclusive license from AMRI under those rights and theAssigned Patent Rights and the Attachment A Patent Rights to Develop (asdefined below) and Commercialize (as defined below) in the Field (as definedbelow) Licensed Compounds (as defined below) and Licensed Products (as definedbelow);

 

J. BMS, Bristol-Myers Squibb Pharma Company and Albany MolecularResearch, Inc. will enter into an agreement to terminate the ExistingLicense Agreement (the“License Termination Agreement”) on the same date as BMS, AMRI Technology, Inc.and Albany Molecular Research, Inc. enter into this Agreement. Inthe License Termination Agreement, Bristol-Myers Squibb Pharma Company willassign to Albany Molecular Research, Inc. its entire right, title andinterest in and to the Attachment A Compounds and will agree to assign to AMRTechnology, Inc. its entire right, title and interest in and to the BMSAttachment A Patent Rights (as defined in the Existing License Agreement). As part of the upfront payment underthis Agreement, BMS and Albany Molecular Research, Inc. will cancel allexisting warrants issued by Albany Molecular Research, Inc. under theWarrant Issue Agreement by entering into an agreement to terminate the WarrantIssue Agreement (the “Warrant Termination Agreement”) on the same date as theyenter into this 

Agreement.** **This Agreement, the License TerminationAgreement and the Warrant Termination Agreement will not be effective unlessall of them are entered into on the same date.

 

Confidential TreatmentRequested

 

3

----

 

K. The Parties would like to undertake aResearch Program (as defined below) for the research, discovery andidentification of Amine Neurotransmitter Reuptake-Inhibitors for BMS to Developand Commercialize;

 

L. AMRI and BMS desire to manage suchResearch Program through a Joint Research Committee (as defined below); and

 

M. This Agreement sets forth the particular terms and conditionsgoverning the Research Program to be undertaken by AMRI and BMS concerningAmine Neurotransmitter Reuptake-Inhibitors and the Development (as definedbelow) and Commercialization (as defined below) of Licensed Compounds andLicensed Products by BMS under this Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants containedherein and other good and valuable consideration, the receipt and sufficiencyof which is hereby acknowledged, the Parties hereto agree as follows:

 

**1.****                          DEFINITIONS.**

 

1.1                                 **Definitions**. Capitalized terms used, shall have the meaningascribed to them in this Agreement. Words defined importing the singular alsoinclude the plural and vice versa, unless the text requires otherwise. As usedin this Agreement, the following terms have the following meanings:

 

“**Acceptance**” or “**Accepted**”, asit applies to a Drug Approval Application, means that the filing has beenaccepted by the applicable Regulatory Authority for consideration of the filingon its merits.

 

Confidential TreatmentRequested

 

4

----

 

**“Action”**means individually or collectively (a) anylawsuit(s) or request(s) for preliminary discovery initiated by BMS or AMRI ora Third Party on behalf of AMRI or BMS under Section 3.2(h) in theUnited States or in a foreign country or jurisdiction against a Third Party orThird Parties for infringement of AMRI Patent Rights, AMRI Third Party Rights,BMS Licensed Patent Rights or BMS Third Party Rights and/or (b) anycounterclaim(s) or lawsuit(s) instituted by a Third Party against BMS or AMRIor a Third Party that initiates a lawsuit on behalf of BMS or AMRI in theUnited States or in a foreign country or jurisdiction, in relation to AMRIPatent Rights, AMRI Third Party Rights, BMS Licensed Patent Rights or BMS ThirdParty Rights.

 

**“Advanced Lead Candidate Compound”**meansa compound identified in Exhibit 1.1C, which shall be a writtenlist agreed upon and signed by the Parties within thirty (30) days of theEffective Date identifying up to ten (10) compounds that are AMRICompounds as of the Effective Date. Such list shall be attached to thisAgreement and be part of this Agreement.

 

“**Affiliate**” means any company or organization that, eitherdirectly or indirectly, through one or more intermediaries, controls, iscontrolled by, or is under common control with a Party. For the purpose of thisAgreement “control” means the power to, directly or indirectly, appoint amajority of the managing directors, or otherwise direct or cause the directionof the management or policies of such person, whether through share ownershipof at least fifty per cent (50%) of the stock entitled to vote for the electionof directors or, in case of non-stock company, by contract or otherwise.

 

“**Agreement**”****means thisAgreement and all Exhibits attached hereto and incorporated herein byreference, as the same may be amended or supplemented from time to timehereafter.

 

****“Amine Neurotransmitter Reuptake-Inhibitor” and/or “AmineNeurotransmitter Reuptake-Inhibitor Compound”****means a compound that exhibits an inhibitory equilibrium binding

 

Confidential Treatment Requested

 

5

----

 

constant (K**i**)of less than one (1) micromolar in a competition binding assay for atleast two of the three biogenic amine transporters (norepinephrine, dopamineand serotonin).

 

**“AMRICompounds**” means (i) theAttachment A Compounds,

 

(ii) the Amine NeurotransmitterReuptake-Inhibitor Compounds that are listed in Part II of Exhibit 1.1E,

 

(iii) all compounds first synthesizedpursuant to the Research Program and owned solely or jointly by AMRI or any ofits Affiliates (including but not limited to any such compound that is jointlyowned by AMRI and BMS),

 

(iv) all compounds Covered at the time offiling and/or at the time of grant by a compound claim of Patent Rights thatare filed on any of the compounds included in items (i)-(iii), (whether or notsuch compounds in such claim are those of items (i) – (iii)) and suchPatent Rights are owned solely or jointly by AMRI or any of its Affiliates, andin each case such compounds are owned solely or jointly by AMRI or any of itsAffiliates (including but not limited to any such compound that isjointly owned by AMRI and BMS),

 

(v) all isomers, enantiomers, hydrates,conjugates, esters, racemates, polymorphs, and metabolites of any of theforegoing compounds,

 

(vi) all salt forms of any of the foregoingcompounds; and

 

(vii) all prodrugs of any of the foregoingcompounds.

 

Confidential TreatmentRequested

 

6

----

 

For the avoidance of doubt, a compound claim of item(iv) excludes any formulation, process, method of use, or combinationclaim and is limited to a claim that claims a compound *per se*.

 

“**AMRIKnow-How**” means (a) AMRI Compounds; (b) any Know-Howdirectly related to (i) AMRI Compounds and/or BMS Compounds and/or (ii) compositionsthat contain any AMRI Compound and/or any BMS Compound, and (c) Know-Howreasonably required and/or useful for the research, discovery, identification,Development, manufacture and/or use of any Licensed Compound and/orcompositions containing any Licensed Compound, in each case, which Know-How isowned solely or jointly by AMRI or any of its Affiliates as of the EffectiveDate and/or during the Combined Period. For the avoidance of doubt, AMRIKnow-How may include research tools and targets.

 

“**AMRI PatentRights**” means all of the Patent Rights that are owned solely orjointly by AMRI or any of its Affiliates which (i) claim an inventionconceived or reduced to practice prior to the Effective Date or during theCombined Period relating to any Amine Neurotransmitter Reuptake-InhibitorCompound and/or a composition containing such a compound and/or the research,discovery, identification, Development, manufacture, Commercialization and/oruse of such a compound and/or composition, or (ii) to the extent notincluded in (i) claim an invention conceived or reduced to practicepursuant to work performed under the Research Program relating to a compound, acomposition and/or the research, discovery, identification, Development,manufacture, Commercialization and/or use of a compound and/or composition, or (iii) tothe extent not included in (i) and (ii), are directed to an AMRI Compoundand/or BMS Compound and/or a composition containing such a compound and/or theresearch, discovery, identification, Development, manufacture,Commercialization and/or use of such a compound and/or composition. For theavoidance of doubt AMRI Patent Rights include the Attachment A Patent Rightsand the Assigned Patent Rights. All of the Assigned Patent Rights as of theEffective Date are listed in Part I of Exhibit 1.1A, all ofthe Attachment A Patent Rights as of the Effective Date are listed in Part IIof Exhibit 1.1A, and all other AMRI Patent Rights as of theEffective Date are listed in Part III of Exhibit 1.1A.

 

Confidential Treatment Requested

 

7

----

 

For the further avoidance ofdoubt, all Patent Rights that are owned solely or jointly by AMRI or any of itsAffiliates and that are reasonably required and/or useful to use the AMRIKnow-How licensed to BMS under this Agreement for the research, discovery,identification, Development, manufacture and/or use of any AMRI Compound and/orany BMS Compound and/or compositions containing any AMRI Compound and/or anyBMS Compound are included in the AMRI Patent Rights, a Patent Right is an AMRIPatent Right even if such Patent Right includes or claims an invention inaddition to those of items (i) – (iii) above, and AMRI Patent Rights may includePatent Rights covering targets and/or research tools.

 

“**AMRI Technology**” means AMRI Patent Rights and AMRI Know-How.

 

“**API**” means an active pharmaceutical ingredient.

 

“**Approvals**” means and includes all licenses, permits,authorizations, and approvals, including, but not limited to reimbursementdecisions and price approvals, of, and all registrations, filings, and othernotifications to, any governmental agency or department within the Territory,including, without limitation, the FDA, the EMEA in Europe and the Koseisho inJapan and equivalent foreign agencies, necessary or appropriate for themanufacture, production, distribution, marketing, sale, and/or use of aLicensed Product for commercial purposes anywhere within the Territory.

 

**“AssignedPatent Rights”**has the meaning assigned in theRecitals.

 

**“AttachmentA Patent Rights”**has the meaning assigned in theSecond Amendment to the Existing License Agreement.

 

**“BMSCompounds”**means (i) the Amine NeurotransmitterReuptake-Inhibitor Compounds that are listed in Exhibit 1.1G andthose compounds that exist as of the Effective Date that (a) are 

 

Confidential TreatmentRequested

 

8

----

 

owned solely or jointly by BMS or any of itsAffiliates, (b) are known by BMS or any of its Affiliates to be AmineNeurotransmitter Reuptake-Inhibitor Compounds as of the Effective Date, and (c) BMSelects in writing to include them as BMS Compounds under this Agreement,

 

(ii) all compounds first synthesizedpursuant to the Research Program and owned solely or jointly by BMS or any ofits Affiliates,

 

(iii) all compounds Covered at the time offiling and/or at the time of grant by a compound claim of Patent Rights thatare filed on any of the compounds included in item (ii), (whether or not suchcompounds in such claim are those of item (ii)) and such Patent Rights areowned solely or jointly by BMS or any of its Affiliates, and in each case suchcompounds are owned solely or jointly by BMS or any of its Affiliates,

 

(iv) those compounds that (a) are Coveredat the time of filing and/or at the time of grant by a compound claim of PatentRights that are filed on any of the compounds included in item (i), (whether ornot such compounds in such claim are those of item (i)), and in each case suchPatent Rights are owned solely by BMS or any of its Affiliates, and (b) BMS elects to include as BMS Compounds under this Agreement,

 

(v) all isomers, enantiomers, hydrates,conjugates, esters, racemates, polymorphs, and metabolites of any of theforegoing compounds,

 

(vi) all salt forms of any of the foregoingcompounds; and

 

(vii) all prodrugs of any of the foregoingcompounds.

 

Confidential TreatmentRequested

 

9

----

 

BMS Compounds do not include compounds thatare AMRI Compounds. Forthe avoidance of doubt, a compound claim of item (iii) or (iv) excludesany formulation, process, method of use, or combination claim and is limited toa claim that claims a compound *per se*.

 

“**BMS Know-How**” means (a) BMS Compounds-, (b) Know-Howdirectly related to (i) BMS Compounds and/or AMRI Compounds and/or (ii) compositionsthat include any BMS Compound and/or any AMRI Compound, and (c) Know-Howreasonably required for the manufacture or use of any Licensed Compound and/orcompositions that include any Licensed Compound, in each of the foregoing caseswhich Know-How is owned by BMS or any of its Affiliates as of the EffectiveDate and/or during the Combined Period. For the avoidance of doubt, BMSKnow-How excludes research tools and targets.

 

**“BMS LicensedPatent Rights”**means all of the Patent Rights that areowned solely or jointly by BMS or its Affiliates which (i) claim an invention conceived or reduced to practice pursuantto work performed under the Research Program with respect to a compound, a compositionand/or the manufacture and/or use of a compound and/or composition, or (ii) tothe extent not included in (i), claim an Amine Neurotransmitter ReuptakeInhibitor Compound included in item (i) of the definition of BMS Compoundsand/or a composition containing such a compound and/or the manufacture and/oruse of such a compound or composition, or (iii) to the extent not includedin (i) or (ii) is directed to an AMRI Compound and/or BMS Compound ora composition containing such a compound and/or the manufacture and/or use ofsuch a compound and/or composition or (iv) to the extent not included in (i) or(ii) claims an invention conceived or reduced to practice during theCombined Period pursuant toactivities directed to researching, Developing and/or improving LicensedCompounds as Amine Neurotransmitter Reuptake-Inhibitors.  For the avoidance of doubt, BMS LicensedPatent Rights do not include Patent Rights Covering targets and/or researchtools. For the further avoidance of doubt, a Patent Right is a BMS LicensedPatent Right even if such Patent Right includes or claims an invention inaddition to those of items (i) – (iii) above.

 

Confidential TreatmentRequested

 

10

----

 

“**BMS Patent Rights**” means Patent Rights that are Controlledby BMS or its Affiliates prior to or during the term of this Agreement and thatBMS or its Affiliates have the right to enforce.

 

“**BMS Technology**” means BMS Licensed Patent Rights and BMSKnow-How.

 

**“BusinessDay”** or **“business day”**means a day other than Saturday, Sunday or any day on which commercial bankslocated in New York, New York are authorized or obligated by law to close.

 

“**Calendar Quarter**” means a three-month period ending on thelast day of March, June, September or December in any year.

 

**“Calendar****Year**” means the period from January 1through December 31.

 

**“Combination Product”** means a Licensed Product that includes atleast one API other than a Licensed Compound. Drug delivery vehicles,adjuvants, and excipients shall not be deemed to be “APIs”, except in the casewhere such delivery vehicle, adjuvant, or excipient is recognized by the FDA asan API in accordance with 21 CFR 210.3(b)(7).

 

“**CombinedPeriod**” means the period beginning on the Effective Date and endingat the end of the Extended Period.

 

“**Commercialize**” means to promote, market, distribute, selland provide product support (including manufacturing) for a product, and “**Commercializing**” and “**Commercialization**”shall be interpreted accordingly.

 

“**Commercially Reasonable Efforts**” means, with respect to theefforts to be expended by a Party with respect to an activity, such reasonable,diligent, good faith efforts to accomplish such

 

Confidential TreatmentRequested

 

11

----

 

activity as such Party would normally use toaccomplish a similar activity.  Withrespect to the Development of at least one Licensed Product in the UnitedStates and Major Market Countries, Commercially Reasonable Efforts means thereasonable, diligent good-faith effort (and funding thereof) that BMS would usefor a product at a similar stage of development as to which the LicensedProduct is being Developed, taking into account the safety and efficacy profileof the Licensed Product and the regulatory requirements for Approval thereof inthe applicable country. With respect to Commercialization of at least oneLicensed Product in the United States and Major Market Countries, CommerciallyReasonable Efforts means the reasonable, diligent good-faith efforts (andfunding thereof) that would be used by BMS for a product of similar commercialpotential that BMS would continue to Commercialize in the United States and/orthe applicable Major Market Countries.

 

Such effortsalso require that the applicable Party shall (i) on a timely basis assignresponsibility for such activities to specifically identified and sufficientlyqualified and experienced employees who are held accountable for progress andmonitor such progress on an ongoing basis, (ii) set and consistently seekto achieve specific and meaningful objectives for carrying out such activities,and (iii) consistently implement decisions and allocate human, financial,and organizational resources designed to advance progress toward each of theseobjectives. The Parties shall regularly, clearly, and in reasonable detailrecord evidence of compliance with each of items (i) through (iii) abovein research and development plans, laboratory and other logbooks, reports, andother normally used documentation in the pharmaceutical business all inaccordance with standard scientific procedures.

 

**“ConfidentialInformation”**has the meaning assigned in Section 9.1.

 

“**Control**” or “**Controlled**”means, with respect to any intellectual property right or other intangible property,the possession (whether by license or ownership, or by control over anAffiliate having possession by license or ownership) by a Party, of the abilityto grant to the other Party access

 

Confidential TreatmentRequested

 

12

----

 

and/or a license or sublicense as providedherein without violating the terms of any agreement with any Third Party.

 

“**Cover**,” “**Covered**” or “**Covering**” means, with respect to Patent Rights, that themaking, using, importation, offer for sale or sale of an invention claimed insuch Patent Rights or the conducting of an activity, in the absence of alicense under such Patent Rights, would infringe at least one claim of suchPatent Rights whether present in an issued patent or in a patent application ifit issued as a patent containing such claim.

 

**“Development**”means non-clinical and clinical drug development activities reasonably relatedto the development and submission of information to a Regulatory Authority,including, without limitation, toxicology, pharmacology and other discovery andpre-clinical efforts, test method development and stability testing, processdevelopment, formulation development, delivery system development, qualityassurance and quality control development, statistical analysis, clinicalstudies (including, without limitation, pre- and post-approval studies andspecifically excluding regulatory activities directed to obtaining pricing andreimbursement approvals) and manufacturing of clinical materials. When used asa verb, **“Develop”**means to engage inDevelopment. **“Developing”** means engaging in Development.

 

“**Dollars**” or “**$**” means the legal tender of the United States of America.

 

“**Drug Approval Application**”means an application for Approval required for commercial sale or marketing ofa Licensed Product in a regulatory jurisdiction, including without limitationan NDA, an MAA or a JNDA.

 

**“ECN Approval”**meansthe approval, by BMS, of a Licensed Compound to proceed to studies leading toan IND filing and clinical Development.

 

Confidential TreatmentRequested

 

13

----

 

“**ECN Compound**” means a Licensed Compound that has achievedECN Approval prior to the end of the Combined Period.

 

**“EffectiveDate**” means the date on which this Agreement shallhave been executed by all Parties.

 

**“EMEA”**means the European Agency for the Evaluation of Medicinal Products, or anysuccessor agency thereto.

 

**“Excluded Compounds”**means the compounds included in items (i) and (iv), of the definition ofBMS Compounds and the corresponding compounds included in items (v) through(vii) of the definition of BMS Compounds that are not ECN Compounds orReleased Compounds at the time any right or this Agreement is terminated under Section 13.2.1,13.2.2 or 13.3.1, and (b) Licensed Compounds, the Development orCommercialization of which was terminated by BMS or an Affiliate or sublicenseeof BMS for Safety Reasons.

 

“**Excluded Products”**means (a) compositions, including products, containing any ExcludedCompound, and (b) Licensed Products, the Development or Commercializationof which was terminated by BMS for Safety Reasons.

 

**“ExistingLicense Agreement**” means the License Agreement enteredinto by Albany Molecular Research Inc., BMS and Bristol-Myers Squibb PharmaCompany (formerly called “DuPont Pharmaceuticals Company”) on March 15,2002, as amended by the First Amendmentto License Agreement, dated September 11, 2003, and by the SecondAmendment to License Agreement, dated January 7, 2004.

 

“**Extended Period**” means the period beginning at the end ofthe Research Term and ending four (4) years after the end of the ResearchTerm.

 

Confidential TreatmentRequested

 

14

----

 

“**FDA**” means the United States Food and Drug Administration orany successor agency having comparable jurisdiction.

 

“**Field**” means all uses for the treatment, palliation,prevention or control of any human or animal diseases, disorders or conditions.

 

“**Finished Product**” means a Licensed Product that is labeled,packaged and released in a form suitable for use by the end user.

 

“**First Commercial Sale**” means, in any particular country ofthe Territory, the first sale of a Royalty Bearing Product in that country foruse by the general public after Approval has been granted by the RegulatoryAuthority of that country for such Royalty Bearing Product.

 

“**FTE**” means the equivalent of the work of one (1) employeefull time for one (1) year of work directly related to the research,discovery, identification, Development or manufacture of Licensed Compounds andLicensed Products, or any other activities contemplated under this Agreement.

 

“**FTE Rate**”means the FTE rate applicable to AMRI’s FTEs, which rate, as of the EffectiveDate, is set forth in Exhibit 1.1D. Beginning in the third year ofthe Research Program, the FTE Rate will be increased by three (3) percentper year.

 

**“GAAP**”means United States generally accepted accounting principles.

 

Confidential TreatmentRequested

 

15

----

 

**“Good Manufacturing Practices”**or**“cGMPs”** means current goodmanufacturing practices for pharmaceuticals as described in regulationspromulgated by the FDA, or an equivalent regulatory agency.

 

**“IncludedCompounds”** means (a) all isomers, enantiomers, hydrates, conjugates, esters, racemates,polymorphs, and metabolites of a particular compound, (b) all salt formsof such particular compound and of the compounds included in (a), and (c) allprodrugs of such particular compound and of the compounds included in (a) and(b).

 

“**IND**” means an Investigational New Drug Application filedwith the FDA in the United States with respect to a Licensed Product.

 

**“INDEquivalent”** means any similar application filed withthe Regulatory Authority in any other country in the Territory with respect toa Licensed Product.

 

“**Indication**” means a disease entity, disorder, condition,symptom or syndrome, for which a product may be approved for treatment,palliation, prevention or control by the FDA or equivalent RegulatoryAuthority, or for which such Approval may be sought from the FDA orequivalent Regulatory Authority. Examples of Indications are listed in themajor bullet points of Exhibit 1.1F, and each such Indication isfurther exemplified by sub-indications listed below the Indication. For thepurposes of this Agreement, an Indication includes the Indication and all ofits respective sub-indications as exemplified in Exhibit 1.1F.

 

“**Joint Research Committee**” or “**JRC**”means the committee comprised of representatives of both Parties establishedpursuant to Section 2.3.1, having the responsibilities set forth inSections 2.3 2 and 2.3.3, and having the membership set forth in Section 2.4.1.

 

Confidential TreatmentRequested

 

16

----

 

**“JNDA”**means a Drug Approval Application filed with the Koseisho required formarketing approval for the applicable Licensed Product in Japan.

 

**“JNDAApproval”** means Approval of a JNDA by the Koseisho forthe applicable Licensed Product in Japan.

 

“**Know-How**” means any information and/or invention and/ormaterial, whether or not proprietary or patentable and whether stored ortransmitted in oral, documentary, electronic or other form. Know-How includes,without limitation, ideas, concepts, formulas, methods, procedures, designs,compounds, compositions, plans, documents, data, discoveries, developments,works of authorship, biological materials, and any information relating toresearch and development plans, experiments, results, compounds, therapeutic leads,candidates and products, clinical and preclinical data, trade secrets andmanufacturing, marketing, financial, regulatory, personnel and other businessinformation and plans, and any scientific, clinical, regulatory, marketing,financial and commercial information or data. Notwithstanding anything hereinto the contrary, Know-How shall exclude Patent Rights.

 

**“Koseisho”**means the Japanese Ministry of Health and Welfare, or any successor agencythereto.

 

**“Lead Party”**refers to that Party having pursuant to Section 3.2(e) or Section 3.2(f) thepatent enforcement and extension rights set forth in Article 14 of thisAgreement.

 

**“Lead Party Patent Rights”** means those Patent Rights for which a Party is the Lead Party.

 

**“Lead Product”** means a Licensed Product underDevelopment for which there is at least one back-up Licensed Product underDevelopment.

 

**“License”**means a grant and/or transfer of rights, other than ownership, with respect tothe Development and/or Commercialization of any Licensed Compound and/orLicensed Product.

 

Confidential Treatment Requested

 

17

----

 

“License” alsorefers to the corresponding grant and/or transfer by AMRI of rights back to BMSwith respect to one or more Licensed Compound(s) and/or Licensed Product(s)pursuant to Article 5.

 

**“LicensedCompound(s)”** means (i) BMS Compounds, (ii) AMRICompounds, (iii) compounds which at the time of filing and/or at the timeof grant are Covered by a compound claim of an AMRI Patent Right and/or a BMSLicensed Patent Right, (iv) Retained Compounds, (v) ReleasedCompounds, and (vi) compounds that (a) are conceived or reduced topractice during the Combined Period or * thereafter, (b) are AmineNeurotransmitter Reuptake Inhibitors, and (c) are based on and/or derivedfrom a compound of any of items (i) – (v) above. For the avoidance of doubt, a compound claimof item (iii) excludes any formulation, process, method of use, orcombination claim and is limited to a claim that claims a compound *per se*.

 

**“LicensedProduct”** means any pharmaceutical product containing aLicensed Compound (alone or with other APIs), in all forms, presentations,formulations and dosage forms. For the avoidance of doubt, a Retained Productis a Licensed Product, and a Released Product is a Licensed Product.

 

**“MAAApproval”** means Approval by the EMEA of a marketingauthorization application (“MAA”) filed with the EMEA for the applicableLicensed Product under the centralized European procedure and the subsequentobtainment of any reimbursement decisions and price approvals necessary and/orappropriate for the manufacture, production, distribution, marketing, sale,and/or use of the Licensed Product for commercial purposes in any one of thefollowing countries:  France, Germany,Italy, Spain and the United Kingdom. If the centralized EMEA filing procedureis not used, MAA Approval shall be achieved upon the first Approval for theapplicable Licensed Product in one of the following countries:  France, Germany, Italy, Spain and the United Kingdom.

 

Confidential TreatmentRequested

 

18

----

 

“**Major Market Countries**” means the United States, Japan,United Kingdom, France, Germany, Italy and Spain, and “Major Market Country”means one of these countries.

 

**“NDA**”means a New Drug Application filed with the FDA in the United States withrespect to a Licensed Product in conformance with applicable laws andregulations, and includes any supplemental NDA, and supporting documents forApproval in the United States.

 

“**Net Sales**”shall mean the amount invoiced in a given country by BMS or any Affiliate ofBMS or any (sub)licensee of BMS or any Affiliate of a sub(licensee) for salesof a Royalty Bearing Product to a Third Party, and less the following to theextent accrued or credited and not paid or reimbursed by the Third Party:

 

(a)          discounts (includingcash discounts and quantity discounts), retroactive price reductions,charge-back payments and rebates granted to managed health care organizationsor to federal, state and local governments, their agencies, and purchasers andreimbursers or to trade customers;

 

(b)         credits or allowancesaccrued upon claims, damaged goods, rejections or returns of such RoyaltyBearing Product, including Royalty Bearing Product returned in connection withrecalls or withdrawals;

 

(c)          shipping and insurancecharges relating to the delivery of a Royalty Bearing Product;

 

(d)         taxes or duties leviedon, absorbed or otherwise imposed on the sale of such Royalty Bearing Product,including without limitation value-added taxes, or other governmental chargesotherwise imposed upon the invoiced amount, as adjusted for rebates andrefunds; and

 

(e)          amounts repaid, creditedor written off by reason of uncollectible debt and amounts written off onaccount of factoring of receivables, to the extent consistent with BMS’

 

Confidential TreatmentRequested

 

19

----

 

business practices for the majority of itspharmaceutical products, as determined on a country-by-country basis.

 

If aRoyalty Bearing Product is sold in the form of a Combination Product(which may be either combined in a single formulation or packaged withseparate formulations but sold as one product), Net Sales for such CombinationProduct will be calculated by multiplying actual Net Sales of such CombinationProduct by the fraction A/(A+B) where A is the invoice price of the LicensedProduct containing the Licensed Compound if sold separately (for the samedosage strength), and B is the total invoice price of the other activeingredient or ingredients in the Combination Product, if sold separately. If,on a country-by-country basis, the other active ingredient or ingredients inthe Combination Product are not sold separately in said country, Net Sales forthe purpose of determining royalties of the Combination Product shall bedetermined in good faith by the Parties and in a manner consistent with theintent of this Agreement.

 

Net Sales shall be determined by BMS in amanner consistent with GAAP and consistently applied to all products of BMS. Forclarity, sales to a distributor (other than a distributor in a country whereBMS and its Affiliates do not normally sell through a distributor), wholesaler,group purchasing organization, PBM, or retail chain customer (none of whichshall be considered a (sub)licensee or an Affiliate of a (sub)licensee for thepurposes of calculating Net Sales) are considered sales to a Third Party;provided, that Net Sales by BMS or an Affiliate of BMS to a Third Party consigneeor to a distributor in a country where BMS and its Affiliates do not normallysell through a distributor are not recognized as Net Sales by BMS until theThird Party consignee or such distributor sells the Royalty Bearing Product.

 

In the case ofany sale or other disposal of a Royalty Bearing Product between or among BMSand its Affiliates or their (sub)licensees and their Affiliates or distributorsin countries where BMS and its Affiliates do not normally sell through adistributor for resale, Net Sales shall be calculated as above on the resale toan independent Third Party. Subject to the preceding paragraph, for thepurposes of Net Sales, a (sub)licensee is a person or entity that obtains a(sub)license from BMS or its

 

Confidential Treatment Requested

 

20

----

 

Affiliates or a person or entity that obtainssuch rights through a person or entity that has been granted such a(sub)license.

 

Only oneroyalty shall be paid on the sale of each unit of a Royalty Bearing Product.

 

**“Non-AdvancedLead Candidate Compound”** means a Licensed Compoundthat is not identified in Exhibit 1.1C.

 

**“PatentRights”** means (a) patents and patent applicationsCovering the research, discovery, identification, Development, manufacture,use, exportation, importation, offer for sale and/or Commercialization of anycompound and/or product, (b) all foreign counterparts thereof, (c) alldivisionals, continuations, continuations-in-part thereof or any otherpatent application claiming priority directly or indirectly to (i) any ofthe patents orpatent applications in (a)  or (b) or (ii) any patent or patentapplication from which the patents or patent applications in (a) or (b) claimdirect or indirect priority, and (d) all patents issuing onany of the foregoing, and any foreign counterparts thereof, together with allregistrations, reissues, re-examinations, supplemental protection certificates,or extensions thereof, and any foreign counterparts thereof.

 

“**Patented Royalty Bearing Product**” means a Licensed Compoundor Licensed Product that is Covered by a Valid Claim of an AMRI Patent Rightand/or BMS Licensed Patent Right.

 

“**Party**” means AMRI or BMS; “**Parties**”means BMS and AMRI.

 

**“Phase IClinical Trial”** means a human clinical trial of aLicensed Product, the principal purpose of which is a preliminary determinationof safety in healthy individuals or patients.

 

Confidential TreatmentRequested

 

21

----

 

“**Phase IIa Clinical Trial**” means a human clinical trial inpatients with the disease or indication under study of a Licensed Product, theprincipal purpose of which is to provide an indication of the efficacy ofthe Licensed Product for its intended use. A Phase IIa Clinical Trial shall be deemed to have commencedwhen the first patient in such trial has been dosed.

 

**“Phase IIbClinical Trial”** means a controlled clinical trialwhich utilizes the pharmacokinetic and pharmacodynamic information obtainedfrom one or more previous Phase I Clinical Trial(s) and/or Phase IIa ClinicalTrial(s) to confirm the optimal manner of use of the Licensed Product (dose anddose regimen) prior to initiation of the pivotal Phase III Clinical Trials. Theperiod of dosing in Phase IIb Clinical Trials will typically be more than two (2) weeks(the duration of dosing in Phase IIaClinical Trials) and less than twenty-six (26) weeks (the minimumduration of dosing typically expected in the Phase III Clinical Trials). APhase IIb Clinical Trial shall be deemed to have commenced when the firstpatient in such trial has been dosed.

 

“**Phase III Clinical Trial**” means a pivotal human clinicaltrial of a Licensed Product on a sufficient number of subjects that is designedto establish that a pharmaceutical product is safe and efficacious for itsintended use, and to define warnings, precautions, and adverse reactions thatare associated with such pharmaceutical product in the dosage range to beprescribed, and to support approval by a Regulatory Authority of suchpharmaceutical product or label expansion of such pharmaceutical product. APhase III Clinical Trial shall be deemed to have commenced when the firstpatient in such trial has been dosed.

 

**“PrimaryScreening Program”**has the meaning assigned in Section 3.8.

 

“**Registration Dossier**” means (i) any Drug ApprovalApplication or (ii) any registration or other filing made with aRegulatory Authority to initiate or receive approval to initiate clinicaltesting in a country (e.g., an IND).

 

Confidential TreatmentRequested

 

22

----

 

“**Regulatory Authority**” means, any governmental authority,including without limitation FDA, EMEA or Koseisho, with responsibility (i) forgranting any licenses or approvals or granting pricing and/or reimbursementapprovals necessary for the marketing and sale of a Licensed Product in anycountry or (ii) for allowing the conduct of clinical trials in a givencountry.

 

“**Related Compounds”** has the meaning assigned in Section 3.2(b).

 

**“ReleasedCompound”** means a compound that becomes a ReleasedCompound pursuant to Section 3.2(b), 3.2(c) or 3.2(d).

 

**“ReleasedProduct(s)”** means any pharmaceutical productcontaining a Released Compound (alone or with other APIs), in all forms,presentations, formulations and dosage forms.

 

**“ResearchPlan”**means the research activities and timelines setforth in Exhibit 1.1B, and as may be amended from time to timeby the JRC.

 

“**Research Program**” means a research program directed toresearching, discovering and identifying Amine NeurotransmitterReuptake-Inhibitors for human therapeutic uses to be performed by the Partiespursuant to this Agreement. For the avoidance of doubt, the Research Programdoes not include any activities with respect to any Licensed Compound aftersuch Licensed Compound achieves ECN Approval or becomes a Released Compound. Adescription of the Research Program and the responsibilities of the Partiesunder the Research Program is contained in the Research Plan, which is attachedhereto as Exhibit 1.1B.

 

“**Research Term**” has the meaning assigned in Section 2.9.

 

Confidential TreatmentRequested

 

23

----

 

“**Reserved Indications**” has the meaningassigned in Section 4.2.1.

 

“**Retained Compound**” means (i) an ECNCompound and/or (ii) a compound that becomes a Retained Compound pursuant toSection 3.2(b), 3.2(c) or 3.2(d).

 

**“Retained Product”**means any pharmaceutical product containing a Retained Compound (alone or withother APIs), in all forms, presentations, formulations and dosage forms.

 

“**Royalty Bearing Product**” meansindividually and collectively Unpatented Royalty Bearing Product and PatentedRoyalty Bearing Product.

 

**“Safety Reasons”**means it is BMS’ or one of its Affiliates’ or sublicensee’s reasonable beliefthat there is an unacceptable risk for harm in humans based upon pre-clinicaldata, including but not limited to data from toxicology studies, or based uponthe observation of adverse effects in humans after a Licensed Compound orLicensed Product has been administered to or taken by humans, such as during aclinical trial or after the launch of a Licensed Product.

 

“**Synthesized Compound**” means a LicensedCompound that has been synthesized by or on behalf of BMS and/or AMRI or any oftheir Affiliates prior to the end of the Combined Period.

 

 “**Territory**”means the world.

 

 “**Third Party**”means any person other than a Party or an Affiliate of a Party.

 

“**Unpatented Royalty Bearing Product**”means a Licensed Compound or Licensed Product that is not a Patented RoyaltyBearing Product.

 

Confidential Treatment Requested

 

24

----

 

**“Unrestricted Indications”**hasthe meaning assigned in Section 4.2.1.

 

 “**U.S**.”or “**United States**” means the fifty statesof the United States, the District of Columbia, Puerto Rico, and allterritories and possessions of the United States.

 

“**Valid Claim**” means a claim of anyissued, unexpired patent that has not been revoked or held unenforceable orinvalid by a decision of a court or governmental agency of competentjurisdiction from which no appeal can be taken, or with respect to which anappeal is not taken within the time allowed for appeal, and that has not beendisclaimed or admitted to be invalid or unenforceable through reissue,disclaimer or otherwise.

 

**“Warrant Issue Agreement”**meansthe Warrant Issue Agreement entered into by AMRI and BMS on March 15, 2002, asamended by the First Amendment to theWarrant Issue Agreement, dated September 11, 2003, and by the Second Amendmentto the Warrant Issue Agreement, dated April 30, 2004.

 

**1.2****          Additional Defined Terms**.The following additional defined terms shall have the meanings set forth belowor in the sections of this Agreement listed below:

 

**“Additional Compound”**hasthe meaning assigned in Section 3.2(c).

 

**“AMRI Third Party Rights”**has the meaning assigned in Section 3.7.

 

**“Attachment A Patent Rights”**has the meaning assigned in the Second Amendment.

 

**“BMS Third Party Rights”**has the meaning assigned in Section 4.3.

 

Confidential Treatment Requested

 

25

----

 

**“First Amendment”**meansthe First Amendment to the Existing License Agreement entered into by AMRI andBMS on September 11, 2003.

 

**“Second Amendment”**meansthe Second Amendment to the Existing License Agreement entered into by AMRI andBMS on January 7, 2004.

 

**2.****             OBJECTIVEOF RESEARCH PROGRAM; MANAGEMENT OF RESEARCH PROGRAM**

 

**2.1****          Objectiveof Research Program**. The objective of the Research Program is: (i) todiscover Amine Neurotransmitter Reuptake-Inhibitors for human therapeutic uses,and (ii) to conduct IND-enabling testing on Licensed Compounds to the pointwhere BMS may identify those Licensed Compounds that BMS wants to take intoclinical development.

 

2.1.1        BMSwill be solely responsible for the following activities that are necessary forthe Research Program:  performing primaryand advanced biological testing, including, but not limited to screeningcompounds for biological and therapeutic activities, performing secondarypharmacodynamic testing, performing testing related to pre-clinicaloptimization of compounds (including but not limited to safety studies),performing pharmacokinetic and ADME studies, studying pharmaceuticalformulations, and performing toxicology testing. BMS, and any Third Partiesemployed by BMS in its sole discretion to carry out any such activities, shallperform such activities in accordance with the Research Plan, and in the caseof any such Third Parties, BMS shall be responsible for their compliance withthe Research Plan. AMRI shall have no right or option to supply or perform suchactivities for BMS.

 

Confidential Treatment Requested

 

26

----

 

2.1.2        AMRIwill be responsible for performing all necessary medicinal chemistry andanalytical chemistry research included in the Research Program related to thediscovery of Amine Neurotransmitter Reuptake-Inhibitors for human therapeuticuses, including but not limited to designing new molecules, synthesizingcompounds for biological testing, and providing bulk samples of compounds, ifappropriate, in such quantities as may be required for preliminary compoundoptimization studies. BMS agrees to pay AMRI for all such costs pursuant toSections 2.7 and 2.8 and Exhibit 1.1D. AMRI may not outsource to any ThirdParty any chemistry research included in the Research Program for which it isresponsible without the prior written consent of BMS, which shall not beunreasonably withheld. AMRI, and any Third Parties employed by AMRI with thewritten consent of BMS, shall perform the activities for which AMRI isresponsible under the Research Program, in accordance with the Research Plan, andin the case of any such Third Parties, AMRI shall be responsible for theircompliance with the Research Plan and the applicable provisions of thisAgreement, including but not limited to Article 9 and Section 14.1.

 

2.1.3        AMRIand BMS recognize that each Party will have knowledge and experience in theother Party’s areas of responsibility. With this in mind, and for the purposeof maximizing the productivity and probability of success of the ResearchProgram, AMRI and BMS will each be receptive to the advice and suggestions ofthe other, in the conduct of the Research Program.

 

2.1.4        TheResearch Program and the responsibilities of the Parties under the ResearchProgram are described in more detail in the Research Plan attached hereto as Exhibit1.1B.

 

Confidential Treatment Requested

 

27

----

 

2.2**           AdditionalAgreements.**The Parties may implement certain matters of this Agreementthrough a number of separate agreements, as and when required, concludedbetween them or at the level of their Affiliates as the case may be. Theprovisions of such agreements will be determined in reasonable and fairnegotiations along the lines of, and respecting the principles set forth inthis Agreement. AMRI and BMS guarantee that their respective Affiliates will inall respects adhere to the terms and provisions of this Agreement and allagreements concluded pursuant thereto.

 

2.3**  JointResearch Committee.**

 

2.3.1        Formationand Purpose. Within thirty (30) days after the Effective Date, AMRI and BMSshall establish the Joint Research Committee, which shall oversee andcoordinate the activities of the Parties under the Research Program andexpedite the synthesis of new compounds, and the selection, testing andDevelopment to pre-ECN Approval of Licensed Compounds. The JRC shall have themembership and shall operate by the procedures set forth in Section 2.4. TheJRC shall be dissolved at the end of the Combined Period unless otherwiseagreed to by the Parties.

 

2.3.2        SpecificResponsibilities of the JRC During the Term of the Research Program. Inaddition to its overall responsibility for the Research Program, the JRC shall,in particular, during the Research Term:

 

(i)            resolveany disputes or disagreements relating to the Research Program that aresubmitted to it;

 

(ii)           monitorthe progress of pre-ECN Approval studies of each Licensed Compound in theTerritory;

 

Confidential Treatment Requested

 

28

----

 

(iii)          facilitatethe exchange of data relating to all tests and studies performed as part of theResearch Program for each Licensed Compound;

 

(iv)          modifythe Research Plan as necessary, but in no event shall such modificationincrease the chemistry resource requirements for AMRI to greater than * FTEswithout the consent of AMRI or be contrary to the intent and purpose of thisAgreement, including but not limited to the requirements of Section 2.7;

 

(v)           controlall chemical process development and manufacturing of Licensed Products for GLPtoxicity studies and clinical trials (including, without limitation,manufacture of API (other than API that is manufactured by the commercialprocess for such API), but not formulation, packaging and finishing ofsupplies); and

 

(vi)          facilitateexchange of information with respect to work being performed by BMS on ECNCompounds.

 

2.3.3        SpecificResponsibilities of the JRC Following the Term of the Research Program.Following the expiration of the Research Term, the JRC shall continue to havethe responsibilities enumerated in Sections 2.3.2(ii) and (vi) during theExtended Period. During the Extended Period, the JRC shall meet once perCalendar Quarter, or less frequently, as the Parties may decide, and at eachsuch meeting, BMS will update the JRC on what Licensed Compounds are beingDeveloped by BMS at that time, and provide AMRI with any information it mightreasonably request in order for it to assess progress of any Licensed Compound.The JRC will also be responsible for

 

Confidential Treatment Requested

 

29

----

 

determining the disposition of theSynthesized Compounds, as described in Section 3.2(b).

 

2.3.4        Decisionsof the JRC. The JRC shall make its decision on matters within its purviewonly after the JRC discusses such matters and only after reasonably consideringeach Party’s comments (through its JRC members) on such matters. All decisionsby the JRC must be consistent with the terms of this Agreement, and may notmodify the terms and conditions of this Agreement or the rights and obligationsof a Party under this Agreement.

 

2.4**           JRC Membership andProcedures**.

 

2.4.1        Membership.For the JRC, each of AMRI and BMS shall designate four (4) representatives withappropriate expertise to serve as members of such Committee. Each Party mayreplace any of its JRC representatives at any time upon written notice to theother Party. The JRC shall have co-chairpersons. BMS and AMRI shall each selectfrom their representatives a co-chairperson for the JRC. The co-chairpersons ofthe JRC shall be responsible for calling meetings, preparing and circulating anagenda in advance of each meeting of the JRC, and preparing and issuing minutesof each meeting within thirty (30) days thereafter; *provided*that a JRC co-chairperson shall call a meeting of the JRC promptly upon thewritten request of the other co-chairperson to convene such a meeting. Suchminutes will not be finalized until both chairpersons review and confirm theaccuracy of such minutes in writing.

 

2.4.2        Meetings.Except as provided in Section 2.3.3, the JRC shall hold meetings at such timesas it elects to do so, but in no event shall such meetings be held lessfrequently than once every Calendar Quarter. The JRC shall meet alternately atAMRI’s

 

ConfidentialTreatment Requested

 

30

----

 

facilities inNew York and BMS’ facilities in Connecticut or at such locations as the Partiesmay otherwise agree. Other employees of each Party involved in the Developmentand/or Commercialization of a Licensed Compound and/or Licensed Product mayattend meetings of the JRC as nonvoting participants, and, with the consent ofeach Party, consultants, representatives, or advisors involved in theDevelopment of a Licensed Compound and/or Licensed Product may attend meetingsof the JRC as nonvoting observers; provided that each such Third Partyrepresentative is under obligations of confidentiality and non-use applicableto the Confidential Information of each Party that are at least as stringent asthose set forth in Article 9 and each such Third Party representative isobligated under a written agreement to assign to a Party its entire right,title and interest in any invention conceived by it in the course of itsactivities related to this Agreement, including during its attendance at ameeting of the JRC. Each Party shall be responsible for all of its own expensesof participating in the JRC (including without limitation in the Working Groupand any sub-committee of the JRC). Meetings of the JRC may be held by audio orvideo teleconference with the consent of each Party; *provided*that at least one (1) meeting of the JRC per Calendar Year shall be heldin person. A quorum for a meeting of the JRC requires the presence of at leastone designee of each Party.

 

2.4.3        Decision-Making.Each Party’s designees on the JRC shall, collectively, have one vote (the “***Party Vote***”) on all matters broughtbefore the JRC, which Party Vote shall be determined by majority vote (the “***Designee Vote***”) of such designees presentat the meeting. Except as otherwise expressly provided in this Agreement, theJRC shall operate as to matters within its jurisdiction by unanimous Party Vote(although the votes of the designees underlying such Party Votes need not beunanimous); *provided*, that the JRC shall not havethe authority to amend or modify, or waive compliance with, this Agreementother than to modify the Research Plan, but only as

 

Confidential Treatment Requested

 

31

----

 

permitted by this Agreement. Notwithstanding any other provision ofthis Agreement, BMS shall have final decision-making authority and tie-breakingvote on the JRC with respect to all matters delegated to the JRC that are setforth in Section 2.3, which shall be made in good faith including aconsideration of the interests of both Parties to this Agreement; *provided*, that no such decision shall violate or breach anyprovision of this Agreement, and no such authority or tie-breaking vote shallextend to disputes concerning the validity, interpretation or construction of,or the compliance with or breach of, this Agreement. No such decision by BMS inthe exercise of its final decision-making authority shall be subject to anydispute resolution mechanism or procedure, including without limitation anydispute resolution mechanism provided for in Article 17.

 

2.4.4        MeetingAgendas. Each Party will disclose to the other proposed agenda items alongwith appropriate information at least five (5) Business Days in advance of eachmeeting of the JRC; provided that under exigent circumstances requiring JRCinput, a Party may provide its agenda items to the other Party within a lesserperiod of time in advance of the meeting, or may propose that there not be aspecific agenda for a particular meeting, so long as such other Party consentsto such later addition of such agenda items or the absence of a specific agendafor such JRC meeting.

 

2.4.5        WorkingGroups. A working group will beestablished immediately after the formation of the JRC (the **“Working Group”**). The Working Group will have threechairpersons:  a chemistry chairpersonfrom AMRI, a chemistry chairperson from BMS and a biology chairperson from BMS.The key responsibility of the Working Group will be the day-to-day execution ofthe Research Plan. The Working Group will report directly to the JRC and willpresent its progress against the Research Plan to the JRC once per CalendarQuarter during the term of the Research Program. The

 

Confidential Treatment Requested

 

32

----

 

chairpersonsof the Working Group will designate employees from BMS and AMRI to be membersof the Working Group as needed to get proper representation on the WorkingGroup for all expertise needed to execute the Research Plan. Inaddition, from time to time, the JRC may establish and delegate duties tosub-committees on an “as-needed” basis to oversee particular projects oractivities. Each such sub-committee shall be constituted and shall operate asthe JRC determines. Sub-committees may be established on an ad hoc basis forpurposes of a specific project or on such other basis as the JRC may determine.The Working Group and each sub-committee and their activities shall be subjectto the oversight, review and approval of, and shall report to, the JRC. Decisionsof the Working Group and each sub-committee shall be reached by consensusbetween the Parties, and in no case shall either Party have a casting vote indecisions of the Working Group, or any sub-committee of the JRC. In the case ofa non-concurrence in the Working Group, or in a sub-committee, the issue shallbe referred for a decision to the JRC. In no event shall the authority of theWorking Group exceed that specified for the JRC in this Article 2.

 

2.4.6        InteractionsBetween the JRC and the Working Group, and Internal Teams. The Partiesrecognize that while they will establish the JRC, the Working Group, andsub-committees of the JRC for the purpose of the Research Program, each Partypossesses an internal structure (including without limitation variouscommittees, teams and review boards) that will be involved in administeringsuch Party’s activities under this Agreement. The JRC and the chairpersons ofthe Working Group shall establish procedures to facilitate communicationsbetween the JRC and the Working Group and any relevant internal committee, teamor board in order to maximize the efficiency of the Research Program, includingwithout limitation by requiring appropriate members of the JRC, the WorkingGroup, or any sub-committee

 

Confidential Treatment Requested

 

33

----

 

of the JRC to be available at reasonable times and places and uponreasonable prior notice for making appropriate oral reports to, and respondingto reasonable inquiries from, the relevant internal committee, team or board. Furthermore,the JRC and the Working Group will establish the necessary working levelcontacts between the two Parties to ensure that necessary day-to-dayinteractions will occur in implementing the Research Plan.

 

2.5           **Research Program Guidelines.**It is the intent of theParties, in working together in the Research Program to assign responsibilitiesfor the various operational aspects of the Research Program to those portionsof their respective organizations which have the appropriate resources,expertise and responsibility for such functions. In all matters related to theResearch Program, the Parties shall strive to balance as best they can thelegitimate interests and concerns of the Parties and to realize the economicpotential of the Licensed Compounds and Licensed Products (taking into accountthe risks and costs of further Development and Commercialization).

 

2.6           **Compliance with Law**. Each Party hereby covenants and agreesto comply with all laws and regulations applicable to its activities connectedwith the Development, manufacture and Commercialization (as applicable) ofLicensed Compounds and Licensed Products, including without limitation allapplicable laws in carrying out such research and development activities,including, where applicable, Good Laboratory Practice Rules, Good ClinicalPractice Rules, Good Manufacturing Practice Rules, and Good InformationPractice Rules that are generally accepted in the pharmaceutical industry.

 

2.7           **FTEs.**BMS will fund * (*) FTE’s per year for each year ofthe Research Term at the FTE Rate. All of such FTEs shall be deployed on theResearch Program to perform medicinal chemistry and analytical chemistryrelated to the Research Program. If at any time after the

 

ConfidentialTreatment Requested

 

34

----

 

second anniversary of the Effective Date ofthe Agreement any of the * (*) FTEs are not required to work on the ResearchProgram, BMS shall have the right to have such funded FTEs redeployed to workon other medicinal chemistry research for BMS.

 

2.8           In addition to the FTE Rate, BMS shall reimburse AMRI for all of itsResearch Program-specific out-of-pocket costs, including but not limited to,chemicals, reagents, materials, supplies, chromatography columns, and equipmentpurchased directly for use in the Research Program. At the end of each month,AMRI shall invoice BMS for such out-of-pocket costs incurred during such month;provided, however, the Parties agree that any such out-of-pocket costs inexcess of $1,000.00 require the written approval of BMS, prior to beingincurred, and that BMS shall not be liable for items purchased for the ResearchProgram in excess of $1,000.00 per item without BMS’ prior written consent. BMSshall pay any such invoices within fifty (50) days after receipt thereof. BMSretains ownership of any such Research Program-specific items, including butnot limited to, chemicals, reagents, materials, supplies, chromatographycolumns, and equipment, and at BMS’ option, AMRI agrees to deliver, at BMS’expense, or to dispose of such Research Program-specific items followingcompletion of the Research Term or earlier termination of this Agreement. TheParties agree that if AMRI wishes to retain any such Research Program-specificitems, BMS will consider reasonable offers from AMRI to purchase such ResearchProgram-specific items from BMS. AMRI shall afford BMS a reasonableopportunity, from time to time, to verify the direct costs paid by AMRI for anysuch Research Program-specific items.

 

2.9           **Research Term**. The Research Program shall commence on theEffective Date and have an initial term of three (3) years (such initial termtogether with any extensions thereof is referred to as the **“ResearchTerm.”**). BMS shall have theoption of extending the term of the Research Program on a year-by-year basisthereafter. To extend the initial term of the Research Program by a year, BMSmust provide AMRI with at least ninety (90) days written

 

ConfidentialTreatment Requested

 

35

----

 

notice prior to the end of the initial term of the Research Programthat BMS wants to extend the term of the Research Program by a year, whereuponthe term of the Research Program will be extended for a year. Thereafter, BMSmust provide AMRI with at least ninety (90) days written notice prior to theend of the extended term of the Research Program that BMS wants to extend theterm of the Research Program by another year, whereupon the term of theResearch Program will be extended for another year. Should BMS fail to providesuch written notice, as described above, and ask to extend the term of theResearch Program less than ninety (90) days prior to the end of the initialterm of the Research Program or the extended term of the Research Program, asthe case may be, then AMRI shall have no obligation to extend the term of theResearch Program. At that time the Parties may agree to extend the ResearchProgram upon financial terms to be negotiated, but in no case shall the FTERate be less than the then prevailing FTE Rate.

 

2.10         **Records.**Each Party shall maintain complete and accuraterecords of all work conducted in furtherance of the Research Program and allresults, data and developments made in furtherance thereof. Such records shallbe in sufficient detail and in good scientific manner appropriate for patentand regulatory purposes.

 

2.11         **Reports.**During the Combined Period, the Parties shallprovide each other with quarterly written reports during the Research Term ofthe work performed under the Research Program and the results they achieve andwith quarterly written reports during the Extended Period of any work performedin connection with the Development and Commercialization of Licensed Compoundsand Licensed Products. Each Parties’ quarterly written report shall be providedto the other Party within approximately thirty (30) days of the end of aCalendar Quarter and describe the work performed and the results achievedduring the just ended Calendar Quarter. After the Combined Period, and untilBMS has satisfied its diligence obligations under Section 8.2 with regard toobtaining Approval of at least one Retained Product for at least one

 

ConfidentialTreatment Requested

 

36

----

 

Reserved Indication in each Major MarketCountry, unless Commercialization of such Product in any such Major MarketCountry is not warranted because of Approval and/or Commercialization issues insuch country that are not caused by BMS or a product being marketed or to bemarketed by BMS in such country, BMS shall provide AMRI with written reportswith respect to each Retained Product under Development within sixty (60) daysafter June 30 and December 31 of each calendar year, which shall describe thework performed and results achieved during the applicable one-half year periodand key steps to be taken in the next calendar half-year. BMS shall cooperatewith AMRI to answer questions of AMRI with respect to any such report providedafter the Combined Period.

 

3.             **AMRI LICENSE GRANTS TO BMS**; **EXCLUSIVITY;TRANSFER OF AMRI KNOW-HOW**

 

3.1           (a)           Subjectto the terms, conditions and limitations of this Agreement, including Sections3.1(f) and 3.6, and the rights retained under Section 3.1(b), AMRI herebygrants to BMS an exclusive license under the AMRI Technology, with the right tosublicense as permitted by and consistent with this Agreement, to research,discover, identify, Develop, make, have made, use, export, import, offer tosell, sell, and Commercialize Licensed Compounds, and Licensed Products in theField in the Territory, which license after the Combined Period shall excludeReleased Compounds and Released Products and which license after the CombinedPeriod shall be co-exclusive with AMRI with respect to Licensed Compounds andLicensed Products that are not Released Compounds and/or Released Productsand/or Retained Compounds and/or Retained Products. Any sublicense shall besubject to the terms and conditions of Article 9, Sections 3.1(d) and3.2(b)-(h), the first sentence of Section 3.6, and Sections 4.3, 4.4, 6.1-6.4and 11.7 of this Agreement and BMS shall be liable for any breach of Article 9,or the first sentence of Section 3.6, or Section 11.7  of this Agreement by a sublicensee.

 

ConfidentialTreatment Requested

 

37

----

 

(b)           Duringthe Research Term, AMRI retains a license under the AMRI Technology, to performits obligations under Section 2.1.2 of this Agreement.

 

(c)           Afterthe Combined Period, BMS covenants and agrees that it will not grant anysub-licenses with respect to Licensed Products and/or Licensed Compounds thatare not Retained Products and/or Retained Compounds, and AMRI covenants and agreesthat it will not grant any sub-licenses with respect to Licensed Compoundsand/or Licensed Products that are not Released Compounds and/or ReleasedProducts.

 

(d)           Afterthe Combined Period, BMS agrees that BMS will use the co-exclusive license ofSection 3.1(a) only for the purpose of synthesizing and testing LicensedCompounds for the purpose of designating such Licensed Compounds as RetainedCompounds and AMRI agrees that AMRI will use the co-exclusive license ofSection 3.1(a) only for the purpose of synthesizing and testing LicensedCompounds for the purpose of designating such Licensed Compounds as ReleasedCompounds.

 

(e)           Forthe avoidance of doubt nothing in this Section 3.1 shall be construed as aright or license to any compound that is not a Licensed Compound, including butnot limited to any such compound that is not a Licensed Compound that now is orin the future is under Development or being Commercialized by AMRI or any ofits Affiliates or any of their licensees or that is contained in a product thatnow or in the future is under Development or being Commercialized by AMRI orany of its Affiliates or any of their licensees.

 

(f)            Notwithstanding any provision of thisAgreement to the contrary, after the Combined Period (or in the event thisAgreement is terminated prior to the end of the Combined Period), BMS and itsAffiliates shall have the right and license under the AMRI Technology and the

 

ConfidentialTreatment Requested

 

38

----

 

BMS Technology to make, have made, import and use all LicensedCompounds for internal research purposes, and such internal research purposesshall include the generation of derivatives and analogs of Licensed Compounds.

 

3.2           (a)           Duringthe Combined Period, BMS shall have exclusive rights to all Licensed Compoundsand all Licensed Products in the Field in the Territory so long as BMS isDeveloping (pre-clinically or clinically) or Commercializing at least oneLicensed Compound or Licensed Product. For the avoidance of doubt, during theResearch Term, where BMS is paying for at least * (*) FTE’s of AMRI that areworking on the Research Program and/or Licensed Compounds, BMS shall be deemedto be Developing or Commercializing at least one Licensed Compound or LicensedProduct.

 

(b)           Atleast six (6) months prior to the end of the Extended Period, the JRC shallinitiate the selection and distribution of Synthesized Compounds as RetainedCompounds and Released Compounds in accordance with this Section 3.2(b), whichselection and distribution shall be completed by the end of the Extended Period.It is the intention of the Parties that with respect to the selection anddistribution of Synthesized Compounds as Released Compounds and RetainedCompounds, a Party that selects a Synthesized Compound (e.g., under Section3.2(b)(v) below) or has a Synthesized Compound distributed to it (e.g., underSection 3.2(b)(i) or Section 3.2(b)(iii) below) that the Party is thencurrently Developing or that the Party states in writing to the other Partythat it intends to Develop****will haveadditional compounds that are closely related structurally to such SynthesizedCompound and that may have the desirable properties of such SynthesizedCompound (“Related Compounds”) designated as Retained Compounds (where suchSynthesized Compound is selected or distributed to BMS as a Retained Compound)or Released Compounds (where such Synthesized Compound is selected ordistributed to AMRI as a Released Compound), and such Related Compounds shallin any event at least include the Included Compounds for such

 

ConfidentialTreatment Requested

 

39

----

 

Synthesized Compound. Where the Partyselecting or being distributed a Synthesized Compound as a Retained Compound ora Released Compound is not then Developing or does not state in writing to theother Party that it intends to Develop such Synthesized Compound, no RelatedCompounds for such Synthesized Compound, including but not limited to IncludedCompounds for such Synthesized Compound, shall be designated as RetainedCompounds or Released Compounds as a result of such Synthesized Compound beingselected or distributed as a Retained Compound or a Released Compound, as thecase may be. In the event the Parties are unable to agree on the RelatedCompounds that will be designated as Retained Compounds or Released Compoundsfor a Synthesized Compound that is eligible to have Related Compoundsdesignated as Retained Compounds or Released Compounds, then such dispute shallbe subject to the dispute resolution procedure of Article 17. In the case ofsuch a dispute, the Included Compounds for that particular Synthesized Compoundshall nevertheless be designated as Retained Compounds or Released Compounds,as the case may be, prior to the initiation of the dispute resolution procedureof Article 17. The procedure for selecting and distributing SynthesizedCompounds as Retained Compounds and Released Compounds shall proceed in thefollowing order:

 

(i) All ECN Compounds shall be distributed to BMS as Retained Compounds, andall Included Compounds for each ECN Compound shall be Retained Compounds.

 

(ii)  The Related Compounds other than the IncludedCompounds for each ECN Compound shall be determined by the Parties and shall beRetained Compounds.

 

(iii) All Synthesized Compounds that are not included in (i) and (ii) and thatare not Amine Neurotransmitter Reuptake Inhibitor Compounds shall bedistributed to AMRI as Released Compounds.

 

ConfidentialTreatment Requested

 

40

----

 

(iv) Only with respect to each Synthesized Compound that is distributed toAMRI as a Released Compound pursuant to (iii) above and that AMRI has stated inwriting to BMS that AMRI intends to Develop such Synthesized Compound shall theParties determine the Related Compounds, and the Related Compounds determinedby the Parties for each such Synthesized Compound shall be Released Compounds. TheRelated Compounds for each such Synthesized Compound shall at a minimum includethe Included Compounds for such Synthesized Compound. For the avoidance ofdoubt, the Related Compounds for each such Synthesized Compound may not includeany ECN Compound or any Related Compound of an ECN Compound. With respect toeach Synthesized Compound that is distributed to AMRI as a Released Compoundpursuant to (iii) above and that AMRI does not state in writing to BMS that itintends to Develop such Synthesized Compound, there shall be no RelatedCompounds for each such Synthesized Compound that will become ReleasedCompounds.

 

(v) With respect to Synthesized Compounds that are not Retained Compounds orReleased Compounds pursuant to (i) through (iv) above, BMS shall have the firstright to select one such Synthesized Compound as a Retained Compound. If BMS isthen currently Developing or states in writing to AMRI that it intends toDevelop such selected Synthesized Compound, the Parties shall determine theRelated Compounds for such selected Synthesized Compound, and such selectedSynthesized Compound and its Related Compounds that are not Released Compoundsshall be Retained Compounds. If BMS is not then currently Developing or doesnot state in writing to AMRI that it intends to Develop such selectedSynthesized Compound, there shall be no Related Compounds for such selectedSynthesized Compound that will become Retained Compounds. AMRI shall have thesecond right to select one such Synthesized Compound that is not a RetainedCompound as a Released Compound. If AMRI states in writing to BMS that itintends to Develop such selected Synthesized Compound, the Parties shalldetermine the Related Compounds for such selected Synthesized Compound, andsuch selected Synthesized Compound and each of its Related Compounds that isnot a

 

ConfidentialTreatment Requested

 

41

----

 

Retained Compound shall be ReleasedCompounds. If AMRI does not state in writing to BMS that it intends to Developsuch selected Synthesized Compound, there shall be no Related Compounds forsuch selected Synthesized Compound that will become Released Compounds. Suchprocedure shall continue until all the Synthesized Compounds have become aRetained Compound or a Released Compound.

 

(vi) For the avoidance of doubt, the RelatedCompounds of Synthesized Compounds do not have to be Synthesized Compounds, andif there is any overlap between the Related Compounds of a Retained Compoundthat is a Synthesized Compound and the Related Compounds of a Released Compoundthat is a Synthesized Compound, the Party that is distributed or selects suchRetained Compound or such Released Compound first under the procedure set forthin this Section 3.2(b) shall have the right to have the overlapping RelatedCompounds included as Retained Compounds or Released Compounds, as the case maybe.

 

(c)           Afterthe Combined Period, if a Party or an Affiliate of such Party first synthesizesa Licensed Compound that is not a Retained Compound or a Released Compound (**“Additional Compound”**) and demonstrates, in the case of BMS,that such Additional Compound has activity potentially usable for a ReservedIndication or Unrestricted Indication or, in the case of AMRI, such AdditionalCompound has activity potentially usable for an Unrestricted Indication, thensuch Additional Compound shall be a Retained Compound or a Released Compound,as the case may be. If the relevant Party states in writing to the other Partythat it intends to Develop such Additional Compound, the Parties shalldetermine the Related Compounds for such Additional Compound, and the RelatedCompounds that are not Released Compounds if such Additional Compound is firstsynthesized and demonstrated to have activity potentially usable for a ReservedIndication or Unrestricted Indication by BMS or one of its Affiliates and thatare not Retained Compounds if such Additional Compound is first synthesized byAMRI or one of its Affiliates and demonstrated to have activity

 

ConfidentialTreatment Requested

 

42

----

 

potentially usable for an UnrestrictedIndication shall become Retained Compounds if BMS is such Party and ReleasedCompounds if AMRI is such Party, subject to the overlap rules of Section3.2(b)(vi). If the relevant Party does not state in writing to the other Partythat it intends to Develop such Additional Compound, there shall be no RelatedCompounds for such Additional Compound that will become Retained Compounds orReleased Compounds, as the case may be. If a Party disputes that the otherParty has met the criteria of this Section 3.2(c), then such dispute shall besubject to the dispute resolution procedure of Article 17.

 

(d)           Afterthe Combined Period, in the event a Party selected or was distributed aSynthesized Compound as a Retained Compound or a Released Compound underSection 3.2(b)(iii), (iv) or (v) above, as the case may be, and no RelatedCompounds for such Synthesized Compound were determined at the time suchSynthesized Compound was selected or distributed as a Retained Compound or aReleased Compound, as the case may be, and such Party notifies the other Partyin writing that it intends to Develop such Synthesized Compound or has begunDeveloping such Synthesized Compound, the Parties shall determine the RelatedCompounds for such Synthesized Compound, and such Related Compounds shall beRetained or Released Compounds, as the case may be, subject to the overlaprules of Section 3.2(b)(vi).

 

(e)           Oncethe selection process under Section 3.2(b) is completed, as of the end of theExtended Period, (i) BMS shall be the Lead Party for all AMRI Patent Rights andall BMS Licensed Patent Rights that Cover a compound that is an ECN Compound asof the end of the Extended Period or is a Retained Compound that is a RelatedCompound of any such ECN Compound, or a composition containing any suchcompound, or a method of use or manufacture of any such compound or any suchcomposition, regardless of whether any such Patent Right also Covers anycompound that is a Released Compound as of the end of the Extended Period, or acomposition containing any such compound, or a method of use or 

 

ConfidentialTreatment Requested

 

43

----

 

manufacture of any such compound or any suchcomposition, (ii) BMS shall be the Lead Party for all AMRI Patent Rights andall BMS Licensed Patent Rights not included in (i) above that Cover a compoundthat is a Retained Compound as of the end of the Extended Period, or acomposition containing any such compound, or a method of use or manufacture ofany such compound or any such composition and do not Cover any compound that isa Released Compound as of the end of the Extended Period, or a compositioncontaining any such compound, or a method of use or manufacture of any suchcompound or any such composition, and (iii) AMRI shall be the Lead Party for (a) all AMRI Patent Rights that are notincluded in (i) above and that Cover a compound that is a Released Compound asof the end of the Extended Period, or a composition containing any suchcompound, or a method of use or manufacture of any such compound or any suchcomposition and do not Cover any compound that is a Retained Compound as of theend of the Extended Period, or a composition containing any such compound, or amethod of use or manufacture of any such compound or any such composition, and(b) all BMS Licensed Patent Rights that are not included in (i) above, that arelicensed to AMRI under Section 4.2.2 of this Agreement, and that do not Coverany compound that is a Retained Compound as of the end of the Extended Period,or a composition containing any such compound, or a method of use ormanufacture of any such compound or any such composition.

 

(f)            Withrespect to any AMRI Patent Right or BMS Licensed Patent Right for which thereis no Lead Party pursuant to Section 3.2(e), the first Party to initiate dosingof a patient in a Phase IIb Clinical Trial of a Released Product (in the caseof AMRI) or a Retained Product (in the case of BMS) that is Covered, or themanufacture or use of which is Covered, by such Patent Right or that contains aReleased Compound (in the case of AMRI) or a Retained Compound (in the case ofBMS) that is Covered, or the manufacture or use of which is Covered, by suchPatent Right, shall be the Lead Party for such Patent Right as of such dosingdate.

 

ConfidentialTreatment Requested

 

44

----

 

(g)           Withrespect to any AMRI Patent Right or BMS Licensed Patent Right for which thereis no Lead Party pursuant to Section 3.2(e) or Section 3.2(f) at the time aParty becomes aware of a suspectedinfringement of such Patent Right, such Party shall notify the otherParty of such suspected infringement and the Parties will consult and conferwith one another and decide whether an infringement Action should be broughtunder such Patent Right and which Party should control any such Action that isbrought. Neither Party shall have the right to prevent the other Party frominitiating an infringement Action if the Parties do not reach agreementpursuant to this Section 3.2(g).

 

(h)           Withrespect to any Patent Right of a Third Party licensed to AMRI or BMS andsublicensed to the other Party pursuant to Section 3.7 or 4.3, if either Partybecomes aware of a suspectedinfringement of such Patent Right, such Party shall notify the otherParty of such suspected infringement and the Parties will consult and conferwith one another and decide whether an infringement Action should be broughtunder such Patent Right. If the Parties decide that an infringement Action shouldbe brought under such Patent Right, to the extent that only one of the Partiesis permitted by such Third Party to bring such Action, such Party shall bringand control such Action, to the extent that either Party is permitted by suchThird Party to bring such Action, the Parties will decide which Party willbring and control such Action, and to the extent that neither Party ispermitted by such Third Party to bring such Action, such Third Party will berequested to bring such Action pursuant to the terms of the license agreementbetween such Third Party and the Party licensed by such Third Party. The rightto bring and pursue such an Action shall be controlled by the applicablelicense agreement with such Third Party.

 

3.3           **AMRI Covenants Regarding Licensed Compounds.**During theCombined Period, AMRI and its Affiliates will not Develop and/or Commercializethemselves, or license any AMRI

 

ConfidentialTreatment Requested

 

45

----

 

Technology to a Third Party to Develop and/orCommercialize, or collaborate with a Third Party to Develop and/orCommercialize, any Licensed Compound and/or any Licensed Product in theTerritory, for any use in the Field. During the Combined Period, AMRI and itsAffiliates will not outside of this Agreement (i) research, discover, identify,Develop, make, have made, use, export, import, offer to sell, sell and/orCommercialize themselves, or for or on behalf of or in collaboration with aThird Party any Amine Neurotransmitter Reuptake-Inhibitor that is or has beenidentified as an Amine Neurotransmitter Reuptake-Inhibitor through a PrimaryScreening Program and/or (ii) license any AMRI Technology to any Third Party toresearch, discover, identify, Develop, make, have made, use, export, import,offer to sell, sell and/or Commercialize any Amine NeurotransmitterReuptake-Inhibitor that is or has been identified as an Amine NeurotransmitterReuptake-Inhibitor through a Primary Screening Program. Nothing in this Section3.3 shall be construed to limit AMRI’s fee for services business, provided thatAMRI does not knowingly employ itself, or share with a Third Party, AMRITechnology, for the purpose of, researching, discovering, identifying, making,using, exporting, importing, Developing, offering to sell, selling and/orCommercializing any Amine Neurotransmitter Reuptake Inhibitor.

 

3.4           Documentation.During the ninety (90) day period following the Effective Date, AMRI shallprovide BMS as soon as reasonably possible with one (1) electronic or papercopy of all material documents, data or other information Controlled by AMRI orany of its Affiliates as of the Effective Date to the extent that suchdocuments, data and information contain or comprise AMRI Know-How licensedunder Article 3. AMRI shall be responsible for the cost of providing to BMS one(1) set of copies only.

 

3.5           TechnicalAssistance. Without charge to BMS, during the three (3) month periodfollowing the Effective Date, AMRI shall reasonably cooperate with BMS toassist BMS with understanding and using the AMRI Know-How provided to BMS underSection 3.4. Such cooperation shall include, without limitation, providing BMSwith reasonable access by

 

Confidential Treatment Requested

 

46

----

 

teleconference or in-person at AMRI’s facilities (subject to AMRI’scustomary rules and restrictions with respect to site visits by non-AMRIpersonnel) to AMRI personnel directly involved in the research, discovery,identification and Development of Licensed Compounds and Licensed Products toprovide technical assistance and consultation in connection with the AMRIKnow-How transferred under Section 3.4.

 

3.6           BMS agrees that BMS will not use AMRI Technology, except with respectto Licensed Compounds and Licensed Products during the Combined Period andthereafter only with respect to Retained Compounds and Retained Products as towhich BMS is licensed under this Agreement and with respect to the synthesisand testing of Licensed Compounds that are not Retained Compounds in order toidentify Licensed Compounds that BMS may want to select as Retained Compoundsunder Section 3.2(c). Except as provided in Article 13, AMRI agrees that AMRIwill only use BMS Technology during the Research Term as permitted underSection 4.1, will not use BMS Technology during the Extended Period except asexpressly permitted in a separate agreement, such as an agreement to provideclinical supplies of a Licensed Product, and will only use BMS Technology afterthe Extended Period as permitted under Section 4.2.2 with respect to ReleasedCompounds and Released Products and with respect to the synthesis and testingof Licensed Compounds that are not Released Compounds in order to identifyLicensed Compounds that AMRI may want to select as Released Compounds underSection 3.2(c).

 

3.7           In the event that prior to the end of theCombined Period, AMRI is licensed under AMRI Third Party Rights that are usefulfor the research, discovery, identification, Development, manufacture, use,exportation, importation, offer for sale and/or Commercialization of anyLicensed Compound and/or Licensed Product and AMRI has the right to grant asublicense to BMS, AMRI shall promptly notify BMS after obtaining any such AMRIThird Party Rights, and then at the request of BMS during or after the CombinedPeriod, AMRI shall grant to BMS such a sublicense to the fullest extentpermitted under the license under which the

 

Confidential Treatment Requested

 

47

----

 

sublicenseis granted and subject to the terms, conditions and requirements thereof toresearch, discover, identify, Develop, manufacture, use, export, import, offerfor sale and/or Commercialize Licensed Compounds and Licensed Products to thesame extent and subject to the same restrictions as set forth in Section 3.1(a)to (e). Such sublicense shall be granted by an amendment to this Agreement, andwithout additional consideration to AMRI and provided that BMS agrees to payany and all amounts due to such Third Party as a direct result of the grantingof the sublicense and any other payments (royalties, milestones, etc.) duethereunder as a direct result of BMS being a sublicensee and/or its activitiesas a sublicensee, which payments shall not be creditable against any royaltiesand/or payments due to AMRI under this Agreement.

 

3.8           Duringthe Combined Period, AMRI and its Affiliates will not conduct any screeningprogram specifically directed to identifying compounds as AmineNeurotransmitter Reuptake-Inhibitor Compounds that are not Licensed Compounds(and for the avoidance of doubt, such excluded screening program is limited toa screening program that uses equilibrium binding assays for at least two ofthe three biogenic amine transporters, norepinephrine, serotonin and dopamine,as primary screens to identify compounds as Amine Neurotransmitter ReuptakeInhibitor Compounds (i.e., the purpose of the screens is to identify compoundswhose intended activity is that of an Amine Neurotransmitter Reuptake InhibitorCompound)) (a “**Primary Screening Program**”)themselves, or for or on behalf of or in collaboration with a Third Party.

 

**4****.****             GRANT OFLICENSES BY BMS TO AMRI**

 

4.1           **Grant to AMRI During the Research Program.**Subject to theterms and conditions of this Agreement, BMS hereby grants to AMRI a limited,non-exclusive license in the Territory, without the right to sublicense, underBMS Technology solely to the extent necessary for AMRI to perform AMRI’sobligations under the Research Program.

 

Confidential Treatment Requested

 

48

----

 

4.2           **Grant to AMRI for Released Compounds.**

 

4.2.1        TheUnrestricted Indications. At the end of the Extended Period, if there isonly one ECN Compound that is still under Development or being Commercializedby BMS as of such date, BMS may notify AMRI of * Indications for which BMS maywant to Develop or Commercialize such ECN Compound, and if there is more thanone such ECN Compound as of such date, BMS may notify AMRI for each such ECNCompound of * Indications for which BMS may want to Develop or Commercializeeach such ECN Compound, and if there isno such ECN Compound as of such date but BMS has an active discovery programfor at least one Licensed Compound as of such date, BMS may notify AMRI of *Indications for which BMS may want to Develop such Licensed Compound. Forthe avoidance of doubt, an ECN Compound that is a back-up for a Lead Productand for which milestones are not to be paid under Section 10.4, shall not becounted as an ECN Compound for determining the number of Reserved Indicationsto which BMS is entitled. For example, if there are * ECN Compounds at the endof the Extended Period that are still under Development or being Commercializedby BMS as of such date, BMS may notify AMRI of * Indications (i.e., *Indications per ECN Compound). All such Indications for which AMRI receivessuch written notification shall collectively be called the **“ReservedIndications.”**  The **“Unrestricted Indications”** shall be all Indications otherthan the Reserved Indications. After the end of the Combined Period, BMS, bywritten notice to AMRI, may, with respect to an ECN Compound, change anexisting Reserved Indication(s) therefor to an existing Reserved Indication(s)for another ECN Compound as long as an ECN Compound does not have more than *Reserved Indications when there is only one ECN Compound and each ECN Compounddoes not have more than * Reserved Indications when there is more than one ECNCompound.

 

ConfidentialTreatment Requested

 

49

----

 

4.2.2                        License Grant in the Unrestricted Field. After the end of the Extended Period, subjectto the terms, conditions and limitations of this Agreement, BMS agrees to grant and hereby grants toAMRI (i) a royalty-free, exclusive license (with the right to sublicenseas permitted by and consistent with this Agreement,) in the Territory under that BMS Technology that is reasonablyrequired by AMRI to research, make, have made, use, sell, Develop and/orCommercialize one or more Released Compounds and/or Released Products for oneor more Unrestricted Indications, to research, Develop, make, have made, use,sell, offer to sell, export, import and Commercialize the Released Compoundsand Released Products for the Unrestricted Indications and (ii) anon-exclusive, royalty-free license (with no right to sublicense) in theTerritory to synthesize and test Licensed Compounds that are not RetainedCompounds in order to identify Licensed Compounds that AMRI may want toselect as Released Compounds under Section 3.2(c) under that BMSTechnology that is reasonably required by AMRI to so synthesize and test suchLicensed Compounds. Any sublicense shall be subject to the terms and conditionsof Article 9,  Sections 3.1(d) and3.2(c)-(h), the second sentence of Section 3.6, and Section 3.8 ofthis Agreement and AMRI shall be liable for any breach of Article 9, thesecond sentence of Section 3.6, or Section 3.8 of this Agreement by asublicensee. For the avoidance of doubt, AMRI shall have no right to Develop orCommercialize any Released Compound or Released Product outside theUnrestricted Indications, and BMS shall have no right to Develop orCommercialize any Released Compounds or Released Products for any Indication,and BMS shall have the right to Develop and Commercialize any Retained Compoundand any Retained Product for any Indication. For the further avoidance ofdoubt, nothing in this Section 4.2.2 or this Agreement shall be construedas a right or license to (a) any Know-How or Patent Right that isControlled by BMS or any Affiliate of BMS that may be useful but is notreasonably required by AMRI to

 

Confidential Treatment Requested

 

50

----

 

research, make, have made, use, sell, offer to sell,export, import, Develop and/or Commercialize Released Compounds and/or ReleasedProducts for the Unrestricted Indications or reasonably required by AMRI tosynthesize and test Licensed Compounds that are not Retained Compounds in orderto identify Licensed Compounds that AMRI may want to select as ReleasedCompounds under Section 3.2(c), (b) any compound that is not aLicensed Compound, including but not limited to any such compound that is not aLicensed Compound that now is or in the future is under Development or beingCommercialized by BMS or any of its Affiliates or any of their licensees orthat is contained in a product that now is or in the future is underDevelopment or being Commercialized by BMS or any of its Affiliates or any oftheir licensees, or (c) any Know-How or Patent Right Controlled by BMS orany Affiliate of BMS relating to any such compound covered by (b) that isnot a Licensed Compound or any product containing any such compound covered by (b) thatis not a Licensed Compound. Inthe event that AMRI wants to license the Development and/or Commercializationof any Released Compound and/or a Released Product for the UnrestrictedIndications to a Third Party, BMS shall have a right of first refusal for suchReleased Compound and/or Released Product as set forth in Article 5.

 

4.3                                 In the event that prior to the end of theCombined Period, BMS is licensed under Patent Rights and/or Know How of a ThirdParty that are reasonably required by AMRI for the research,  Development, manufacture, use, exportation,importation, offer for sale and/or Commercialization of any Released Compound,and/or Released Product ( “BMS Third Party Rights”) and BMS has the right togrant a sublicense thereunder to AMRI, BMS shall promptly notify AMRI afterobtaining any such BMS Third Party Rights, and then at the request of AMRIduring or after the Combined Period, BMS shall grant to AMRI such a sublicenseto the fullest extent permitted under the license under which the sublicense isgranted and subject to the terms, conditions and requirements thereof toresearch, Develop, manufacture, have manufactured, use, export, import, offerfor sale, sell and/or

 

Confidential Treatment Requested

 

51

----

 

Commercialize Released Compounds, andReleased Products for the Unrestricted Indications to the same extent andsubject to the same restrictions as set forth in Section 4.2.2. Suchsublicense shall be granted by an amendment to this Agreement, and withoutadditional consideration to BMS and provided that AMRI agrees to pay any andall amounts due to such Third Party as a direct result of the granting of thesublicense and any other payments (royalties, milestones, etc.) due thereunderas a direct result of AMRI being a sublicensee and/or its activities as a sublicensee.

 

4.4                              During the CombinedPeriod, BMS and its Affiliates will not conduct any Primary Screening Programwith respect to any compound that is not a Licensed Compound themselves or onbehalf of or in collaboration with a Third Party. During the Combined Period,BMS and its Affiliates will also not conduct any Development and/orCommercialization activities themselves, or for or on behalf of or incollaboration with a Third Party, relating to any Amine NeurotransmitterReuptake-Inhibitor Compounds that are or have been identified as AmineNeurotransmitter Reuptake-Inhibitor Compounds through a Primary ScreeningProgram and that are not Licensed Compounds.

 

4.5                                 Notwithstanding any provision of thisAgreement to the contrary, after the Combined Period, AMRI and its Affiliatesshall have the right and license under the AMRI Technology and the BMSTechnology to make, have made, import and use all Licensed Compounds forinternal research purposes, and such internal research purposes shall includethe generation of derivatives and analogs of Licensed Compounds.

 

**5.****                                      BMSRIGHT OF FIRST REFUSAL**

 

5.1                                 **BMS Right of First Refusal**. BMS shall have a right of firstrefusal with respect to Released Compounds and Released Products as follows.

 

Confidential Treatment Requested

 

52

----

 

5.1.1                        In the event that AMRI desires at any time to enter into a Licensearrangement with respect to a Released Compound and/or a Released Product,before entering into an agreement with any Third Party with respect to suchLicense, AMRI will notify BMS in writing of its desire, including informationas to the scope and type of License and the Released Compounds and ReleasedProducts that are to be part of such License and a comprehensive,confidential package of information with respect thereto that is in thepossession of AMRI (a **“License Notice”**).During the thirty (30) day period after AMRI so notifies BMS, AMRI shallpromptly provide BMS with any additional information in the possession of AMRIthat BMS reasonably requests from AMRI relating to the Released Compounds andReleased Products that will be the subject of such License.  If BMS notifies AMRI in writing of itselection to pursue a License for such Released Compound(s) and/or Released Product(s)within * (*) days after BMS’ receipt of such License Notice, AMRI and BMS shallenter into good faith negotiations with respect to such License for a period of* (*) days following AMRI’s receipt of such election from BMS (the **“Negotiation Period”**). During the Negotiation Period, AMRIwill provide BMS with an opportunity to make a proposal of terms and conditionswith respect to such License and AMRI will either accept the proposal, refusethe proposal or provide a counter offer to BMS. During the NegotiationPeriod, each Party may revise the terms and conditions of its proposal tothe other Party and the last such term sheet that BMS delivers to AMRI shall bedeemed the term sheet that BMS delivers to AMRI for purposes of Section 5.2below. Such * day Negotiation Period shall be extended by an additional * (*)days if AMRI and BMS reach agreement in principle with respect to a term sheetwith respect to such License during such * day Negotiation Period.

 

5.1.2                        If AMRIand BMS do not conclude an agreement or an agreement in principle with respectto such License during the * day Negotiation Period or an agreement in the * (*)day extended period, AMRI will then be free to enter into an agreement

 

Confidential Treatment Requested

 

53

----

 

with any ThirdParty regarding such a License for such Released Compound(s) and/or ReleasedProduct(s)  that were the subject of theLicense Notice delivered to BMS under Section 5.1.1, and free to enterinto any such License, subject to the provisions set forth in Section 5.2 and provided that such License has the sameterritory, the same scope of Released Compound(s) and/or Released Product(s),the same scope of Indications, and the same field of use as offered to BMS inthe License Notice delivered to BMS under Section 5.1.1.

 

5.2                                 Tothe extent that BMS’ rights under this Article 5 have not terminated orexpired, AMRI shall not enter into any agreement with any Third Party withrespect to a License under terms and conditions which are Less Favorable toAMRI than the terms and conditions set forth in the term sheet last offered byBMS to AMRI, unless BMS is unwilling to enter into a license agreement for theLess Favorable to AMRI terms. AMRI shall have the option, exercisable in itssole discretion, of having an Independent Evaluator render a decision bindingupon AMRI and BMS as to whether a Third Party Term Sheet is Less Favorable toAMRI than the terms and conditions set forth in the term sheet last offered byBMS to AMRI.

 

5.2.1                        If AMRI intends to enter into a Licenseagreement with a Third Party and wants to exercise its option to have anIndependent Evaluator determine whether the Third Party Term Sheet with suchThird Party is Less Favorable to AMRI than the terms and conditions setforth in the term sheet last offered by BMS to AMRI, AMRI shall so notify BMS and this Section 5.2.1 and Sections5.2.2, 5.2.3 and 5.2.4 shall apply. AMRI shall bear the costs of engaging theIndependent Evaluator. AMRI shall provide the Independent Evaluator with a copyof the Third Party Term Sheet with such Third Party, without revealing theidentity of such Third Party, and shall also provide the Independent Evaluatorwith a copy of the last term sheet offered by BMS to AMRI.

 

Confidential Treatment Requested

 

54

----

 

5.2.2                        The Independent Evaluator shall promptly makea determination of whether the terms and conditions of the Third Party TermSheet are Less Favorable to AMRI than the terms and conditions of the last termsheet offered by BMS to AMRI in accordance with Section 5.4.1 below. TheIndependent Evaluator shall be required to make a definite determination basedon the information provided to it as to whether or not the Third Party TermSheet is Less Favorable to AMRI than the last term sheet offered by BMS to AMRI.The Independent Evaluator shall not have the authority to render any otherdetermination or to respond without a decision, and the Parties agree (i) thatthe Independent Evaluator shall have no liability in any way by reason of itsdecision, and (ii) to be bound by and not to challenge such determination,except in the case where a Party alleges that the Independent Evaluator did notact in good faith, breached a fiduciary duty or engaged in willful misconduct.

 

5.2.3                        If the Independent Evaluator determines thatthe Third Party Term Sheet was not Less Favorable to AMRI than the last TermSheet offered by BMS to AMRI, AMRI will be free to enter into an agreement withsuch Third Party having the terms and conditions set forth in the Third PartyTerm Sheet (or terms and conditions more favorable to AMRI than the terms andconditions set forth in the Third Party Term Sheet) and such other terms andconditions as AMRI and the Third Party agree, *providedhowever*, that AMRI shall not have the right to enter into anagreement with respect to such License with a Third Party having terms andconditions that are Less Favorable to AMRI than the terms and conditions setforth in the Third Party Term Sheet presented to the Independent Evaluator.

 

5.2.4                        If the Independent Evaluator determines thatthe terms and conditions set forth in the Third Party Term Sheet are LessFavorable to AMRI than the terms and conditions last offered by BMS to AMRI,AMRI may at its discretion continue its negotiation with the Third Party,with the objective of obtaining financial terms and conditions

 

Confidential Treatment Requested

 

55

----

 

that are not Less Favorableto AMRI than the financial terms and conditions last offered by BMS to AMRI. Alternatively,AMRI may offer such financial terms and conditions set out in the ThirdParty Term Sheet to BMS (or AMRI may offer BMS terms and conditionsfinancially less favorable to AMRI than those set out in the Third Party TermSheet). In the event that AMRI makes such offer to BMS, AMRI shall also offerto BMS the same terms with respect to governance and decision-making as set outin the Third Party Term Sheet (or otherwise proposed by AMRI to the ThirdParty). If AMRI offers such terms and conditions for a License to BMS inaccordance with this Section 5.2.4, BMS will have an additional fifteen(15) business days to provide AMRI with notice that BMS desires to enter intoan agreement with AMRI on substantially the same financial terms and conditionsas set out in such term sheet (an “Acceptance Notice”). If an Acceptance Noticeis provided by BMS, the Parties will work diligently to expeditiously completesuch an agreement. If an Acceptance Notice is not provided by BMS within suchfifteen (15) business day period, or if AMRI and BMS do not execute a bindingLicense agreement within ninety (90) days after receipt of the AcceptanceNotice, AMRI will be free to enter into an agreement with such Third Partyhaving the terms and conditions not financially Less Favorable to AMRI thanthose set forth in the Third Party Term Sheet. Such ninety (90) day periodshall be extended for the period of any delays in completing the Licenseagreement caused by reasons beyond the reasonable control of BMS.

 

5.3                                 AnyLicense agreement entered into by AMRI in accordance with Section 5.2shall be consistent with the terms and conditions of this Agreement and shallfully enable AMRI to fully perform all of its obligations under thisAgreement which will continue in effect.

 

5.4                                 **Certain Definitions**. For the purposes of this Article 5,the following capitalized terms shall have the following meanings:

 

Confidential Treatment Requested

 

56

----

 

5.4.1                        “LessFavorable to AMRI” means, with respect to a Third Party Term Sheet comparedto the most recent term sheet offered by BMS to AMRI, that the Third Party TermSheet contains financial terms which, taken as a whole, are materially lessfavorable to AMRI than financial terms set forth in the last term sheet for aLicense offered to AMRI by BMS. The determination as to whether the financial terms are materially lessfavorable to AMRI than the financial terms set forth in the last term sheet fora License offered to AMRI by BMS shall be based upon the present value of thetotal payments, adjusting for the risk of pharmaceutical compound development(i.e., risk adjusted net present value (NPV) analysis), with the same assumptionsapplied in the same manner to both the Third Party Term Sheet and the last termsheet offered to AMRI by BMS. In such evaluation, payments of equity shallbe given less value than corresponding payments in cash. The assumedprobability of Approval for the risk assessment shall be based on industrystandards for compounds at the same stage of development.

 

5.4.2                        “ThirdParty Term Sheet” means a term sheet summarizing the key terms andconditions on which AMRI would be willing to enter into a potential Licensearrangement with a Third Party, and sucha Third Party term sheet shall contain a level of detail comparable to the termsheet last provided by BMS under Section 5.1.1.

 

5.4.3                            “Independent Evaluator” means an individual with relevantexpertise in the Commercialization of pharmaceutical products employed by anindependent certified public accounting firm or investment bank of nationallyrecognized standing that,  at the time ofthe evaluation set forth in Section 5.2 is not providing, and during thetwelve (12) months prior to such evaluation has not provided, auditing orconsulting services to either Party, and that is selected by AMRI andreasonably acceptable to BMS, or such other qualified person as the Parties may mutuallyagree to.

 

Confidential Treatment Requested

 

57

----

 

**6.****                                      OUTSOURCING**

 

6.1                                 **Subcontracting**. Except for those activities for which AMRIis responsible for performing for the Research Program, and subject to Section 6.2,the JRC or BMS may perform any activities in support of the research,discovery, identification, Development, exportation, importation, manufacture,offering for sale or Commercialization of Licensed Compounds and LicensedProducts through subcontracting to a Third Party contractor or contract serviceorganization.

 

6.2                                 **AMRI Option**. AMRI shall have a first option to be thesupplier of any outsourcing of chemistry research by the JRC or BMS that is notincluded in the chemistry research to be carried out by AMRI pursuant to the ResearchPlan and that directly relates to the Research Program or directly relates tothe Development of Licensed Compounds, including new chemical synthesis, andanalytical development. (For the avoidance of doubt, this option shall notapply to the outsourcing of chemistry process development, the manufacture ofany API or the manufacture of any clinical or commercial supplies of anyLicensed Products, and such outsourcing is dealt with below in Sections 6.3, 6.4 and 6.5.)  In the event the JRC or BMS wants tooutsource any such chemistry research, it shall notify AMRI in writing that itwants to do so (such notice the **“Chemistry OutsourcingNotice”**). If AMRI is both willing and able to provide such chemistryresearch at the then current FTE Rate, AMRI shall so notify the JRC or BMSwithin ten (10) business days of the receipt of the Chemistry OutsourcingNotice, whereupon the JRC or BMS will not outsource such chemistry research toa Third Party and will outsource such chemistry research to AMRI. If, however,AMRI fails to notify the JRC or BMS within (10) business days of thereceipt of the Chemistry Outsourcing Notice that AMRI is both willing and ableto provide such chemistry research at the then current FTE Rate or AMRInotifies the

 

Confidential Treatment Requested

 

58

----

 

JRC or BMS within (10) business days ofthe receipt of the Chemistry Outsourcing Notice that AMRI is not interested inproviding such chemistry research at the then current FTE Rate, then the JRC orBMS shall be free to outsource such chemistry research to any Third Party.

 

6.3                                 **Chemical Process Development and Non-Commercial Manufacture of API andLicensed Products**. During its existence, the JRC will control allchemical process development and manufacturing of Licensed Products for GLPtoxicity studies and clinical trials (including, without limitation,manufacture of API (other than API that is manufactured by the commercialprocess for such API), but not formulation, packaging and finishing ofsupplies), and after the expiration of the Extended Period, BMS will controlall such activities. During the Extended Period, AMRI shall notify the BMSco-chairperson of the JRC on each anniversary of the Effective Date, and afterthe Extended Period, AMRI shall notify BMS, pursuant to Section 18.5, onthe anniversary of the Effective Date, whether AMRI has an interest inperforming such activities for BMS in the event that BMS seeks to outsource anyof the foregoing activities. AMRI acknowledges that where BMS seeks tooutsource any of the foregoing activities, BMS must have the flexibility tohave dual sources for each such activity, and in some cases, additional sources.As a result, in the event that BMS desires to use an entity other than BMS toperform such activities, BMS will give AMRI written notice of such desireand will solicit bids from AMRI and Third Parties and will select AMRI to perform suchactivities, alone or in addition to one or more Third Parties, provided that (a) AMRIsubmits a bid to perform such activities, (b) AMRI can meet thequality targets for such activities, (c) AMRI can meet the qualityperformance criteria for such activities, (d) AMRI can meet the deliverytimelines for such activities, (e) AMRI’s bid is competitive with theother bids from Third Parties for such activities, and (f) AMRI entersinto a quality agreement for such activities containing standard BMS terms. Indetermining whether AMRI can

 

Confidential Treatment Requested

 

59

----

 

meet the quality targets, quality performancecriteria and the timelines for an activity, BMS may rely upon its priorexperiences with AMRI for the provision of process development work.  As long as AMRI can meet these criteria, itshall receive a portion of the outsourcing work.

 

6.4                                 **Commercial Manufacture of API and Licensed Products**. Withrespect to the manufacture of API (to be manufactured by the commercial processfor such API) and/or the formulation, packaging and/or finishing of LicensedProduct (as the case may be) for Development purposes or commercial sale,in the event that BMS elects not to manufacture all of its requirements of suchAPI or to formulate, package and/or finish all of its requirements of suchLicensed Product (as the case may be) BMS will select AMRI to manufactureat least * percent of BMS’ outsourced requirements of such API or to formulate,package and/or finish at least * percent of BMS’ outsourced requirements ofsuch Licensed Product (as the case may be) provided that (a) AMRIsubmits a bid to manufacture such API and/or formulate, package and/or finishsuch Licensed Product (as the case may be), (b) AMRI has thecapabilities to manufacture such API and/or formulate, package and/or finishsuch Licensed Product (as the case may be), (c) AMRI’s bid iscompetitive with the other bids from Third Parties for the manufacture of suchAPI and/or the formulation, packaging and/or finishing of such Licensed Product(as the case may be), and (d) AMRI meets the following criteria:

 

(i)  AMRI must have a manufacturingplant in existence at the time it submits its bid with all necessary regulatorypermits and certifications that meet all applicable laws and regulations.

 

(ii)  Such plant must be suitable forthe production of products regulated by the FDA.

 

Confidential Treatment Requested

 

60

----

 

(iii)  Such plant must have existingcapacity at the time AMRI’s bid is submitted to meet the first three years ofAMRI’s potential allocation of BMS’ forecasted requirements (as of the time ofthe bid).

 

(iv) AMRI may subcontract anyportion, but not all, of the manufacture of any such API and/or theformulation, packaging and/or finishing of any such Licensed Product (as thecase may be) with the written consent of BMS, which consent shall not bewithheld unreasonably.

 

(v)  AMRI must not have any open FDA Form 483observations from the FDA or any unaddressed written document from a regulatorybody equivalent to the FDA indicating non-compliance with cGMPs.

 

(vi) AMRI must enter into a qualityagreement containing standard BMS terms.

 

6.5                                 TheJRC or BMS shall be free to use any Third Party to perform any of theactivities described under Sections 6.2, 6.3 and 6.4 provided the applicableprocess set forth above in Section 6.2, 6.3 or 6.4 is followed. Any breachby the JRC or BMS of Sections 6.2, 6.3or 6.4 shall not be a material breach of this Agreement and AMRI may notterminate this Agreement for any such breach.

 

**7.**                      **CLINICAL DEVELOPMENT;  REGULATORYFILINGS;  COMMERCIALIZATION**

 

7.1                                 **Non-clinical Development Outside the Research Program.**Asbetween the Parties, BMS shall have sole responsibility for, and shall bear thecost of conducting all non-clinical Development that is not included in theResearch Program, and shall bear the cost of its

 

Confidential TreatmentRequested

 

61

----

 

activities in carrying out itsresponsibilities under the Research Program and the costs incurred inaccordance with Sections 2.7 and 2.8.

 

7.2**                                 ClinicalDevelopment Responsibilities and Costs.**As between the Parties, BMS shallhave sole responsibility for, and shall bear the cost of conducting allclinical trials with respect to the Licensed Compounds, and Licensed Productsbeing Developed by BMS during the Combined Period and with respect to theRetained Compounds and Retained Products being Developed by BMS after theCombined Period. At the cost and expense of BMS, AMRI will cooperate with andsupport BMS, as may be reasonably necessary, in obtaining Approvals forany Retained Product, in the Territory, including providing necessarydocuments, or other materials required by law to file Registration Dossiers orobtain Approvals.

 

7.3**                                 RegulatoryResponsibilities and Costs.**As between the Parties, BMS shall have soleresponsibility for, and shall bear the cost of preparing, all regulatoryfilings and related submissions with respect to the Licensed Compounds andLicensed Products being Developed by BMS during the Combined Period and withrespect to the Retained Compounds and Retained Products being Developed by BMSafter the Combined Period, and BMS shall own all such regulatory filings,including all Registration Dossiers.

 

7.4**                                ****Commercialization.**Asbetween the Parties, BMS shall have sole responsibility for, and shall bear thecost of Commercializing Retained Products in the Territory.

 

**8.****                                      COMMITMENTUNDERTAKINGS OF AMRI AND BMS**

 

8.1                                 **Undertakings of AMRI and BMS. **During the Research Term,each Party will promptly communicate to the other Party all Know-How which, inthe case of BMS, is BMS Know-How and which, in the case of AMRI, is AMRIKnow-How.

 

Confidential TreatmentRequested

 

62

----

 

8.2**                                 DiligentPerformance**. Each Partyshall use Commercially Reasonable Efforts during the Research Term to perform thatpart of the Research Program for which such Party is responsible pursuantto the terms and conditions of this Agreement, and to complete such tasks incompliance with the Research Plan. BMS shall use Commercially ReasonableEfforts to Develop or Commercialize at least one Licensed Compound or LicensedProduct. During the Combined Period, such Commercially Reasonable Efforts shallbe satisfied if BMS uses Commercially Reasonable Efforts to conduct theDevelopment of at least one Licensed Compound to obtain ECN Approval thereof. Duringthe period that BMS is funding at least * (*) FTEs of AMRI that are working onthe Research Program, BMS shall be deemed to be using such Commercially ReasonableEfforts and to have satisfied its obligation under this Agreement to useCommercially Reasonable Efforts to Develop or Commercialize at least oneLicensed Compound or LicensedProduct. After the Combined Period, BMS shall use Commercially ReasonableEfforts to conduct the Development, manufacturing, and obtain Approval of atleast one Retained Product for at least one Reserved Indication in the UnitedStates. After Approval in the United States of a Retained Product for anIndication, BMS shall use Commercially Reasonable Efforts to Commercialize eachsuch Retained Product for each such Indication in the United States. Withrespect to countries outside the United States, after the Combined Period BMSshall use Commercially Reasonable Efforts to obtain Approval of at least oneRetained Product for at least one Reserved Indication in each Major MarketCountry other than the United States unless Commercialization of such Productin any such Major Market Country is not warranted because of Approval and/orCommercialization issues in such country that are not caused by BMS or aproduct being marketed or to be marketed by BMS in such country. As reasonablyrequested by AMRI, BMS shall provide AMRI with information as to whyCommercialization is not warranted. Inthe event that BMS is complying with BMS’ obligations under this Section 8.2with respect to one Retained Product, then all Reserved Indications shallremain Reserved Indications. In

 

Confidential Treatment Requested

 

63

----

 

addition, if BMS is meeting its obligations underthis Section 8.2 with respect to one Retained Product, then BMS shall notbe obligated to Develop or Commercialize any other Retained Product.

 

8.3                                 In the event that there is a ReservedIndication that is not a Reserved Indication for a Retained Compound that isbeing Developed pursuant to Section 8.2, AMRI and BMS shall discuss ingood faith changing such Reserved Indication to an Unrestricted Indication.

 

8.4                                 In the event that within three (3) yearsafter the end of the Combined Period BMS has not initiated a Phase I ClinicalTrial with respect to an ECN Compound that was an ECN Compound at the end ofthe Combined Period and there is a Reserved Indication for such ECN Compoundthat is not a Reserved Indication for an ECN Compound that is being Developedpursuant to Section 8.2, BMS agrees to change such Reserved Indication toan Unrestricted Indication unless BMS can reasonably demonstrate a good faithintent to initiate Development without an unreasonable delay and to continue toDevelop for Approval in the United States a Retained Product as to which suchReserved Indication is a Reserved Indication. For the avoidance of doubt, inthe event BMS does demonstrate a good faith intent to initiate Developmentwithout an unreasonable delay and to continue to Develop for Approval in theUnited States a Retained Product for such Reserved Indication, all otherReserved Indications associated with such Retained Product shall also remainReserved Indications.

 

8.5                                 In the event that BMS terminates Developmentof an ECN Compound after initiation of a clinical trial with respect theretoand BMS does not pursue in good faith a program to identify a Licensed Compoundthat is licensed to BMS under this Agreement to replace such ECN Compound ordoes not identify another ECN Compound licensed to BMS under this Agreementthat is such a replacement within two (2) years after the termination ofsuch

 

Confidential TreatmentRequested

 

64

----

 

clinical trials and there is a Reserved Indicationfor such ECN Compound that is not a Reserved Indication for an ECN Compoundthat is being Developed pursuant to Section 8.2, then BMS agrees to changesuch Reserved Indication to an Unrestricted Indication unless BMS canreasonably demonstrate a good faith intent to initiate Development without anunreasonable delay and to continue to Develop for Approval in the United Statesa Retained Product for such Reserved Indication. For the avoidance of doubt, inthe event BMS does demonstrate a good faith intent to initiate Developmentwithout an unreasonable delay and to continue to Develop for Approval in theUnited States a Retained Product for such Reserved Indication, all other ReservedIndications associated with such Retained Product shall also remain ReservedIndications.

 

8.6                                 In the event that BMS or any of itsAffiliates decides that BMS will discontinue and/or suspend Development and/orCommercialization of a Licensed Product and/or such Development and/orCommercialization is discontinued or suspended, BMS shall provide AMRI promptlywith written notice thereof.

 

Confidential TreatmentRequested

 

65

----

 

**9.****                                     ****CONFIDENTIAL INFORMATION.**

 

9.1                                 **In General.**During the term of this Agreement, and for aperiod of ten (10) years after this Agreement expires or terminates, eachParty will maintain all Confidential Information received by it under suchAgreement in trust and confidence and will not disclose any such ConfidentialInformation to any Third Party or use any such Confidential Information for anypurposes in each case other than those permitted by this Agreement. ConfidentialInformation shall not be used for any purpose or in any manner that wouldconstitute a violation of any laws or regulations, including without limitationthe export control laws of the United States. Confidential Information shallnot be reproduced in any form except as required to accomplish the intentof this Agreement. No Confidential Information shall be disclosed to anyAffiliate or any employee, agent, consultant, contractor, clinicalinvestigator, or sublicensee of such Party or its Affiliates who does not havea need for such information. To the extent that disclosure is authorized bythis Agreement, the disclosing Party will obtain prior agreement from itsemployees, agents, consultants, contractors, Affiliates, sublicensees, andclinical investigators to whom disclosure is to be made to hold in confidenceand not make use of such information for any purpose other than those permittedby this Agreement. Each Party will use at least the same standard of care as ituses to protect its own Confidential Information of a similar nature to ensurethat such employees, agents, consultants, contractors, Affiliates, sublicenseesand clinical investigators do not disclose or make any unauthorized use of suchConfidential Information, but no less than reasonable care. Each Party willpromptly notify the other upon discovery of any unauthorized use or disclosureof the Confidential Information.

 

                                                As usedin this Agreement, “***Confidential******Information***” shall mean allinformation, data and tangible materials, received by either Party from theother Party pursuant to this Agreement and all information, data and tangiblematerials developed during the course of the Research Program that relates toLicensed Compounds and/or Licensed Products shall be the

 

Confidential TreatmentRequested

 

66

----

 

Confidential Information of each Party (andeach Party shall be deemed to have received such information, data and tangiblematerials from the other Party; provided that neither Party will be deemed adisclosing Party with respect to such information, data and tangible materialsfor the purposes of Section 9.2.1), including without limitation Know-How,scientific information, clinical data, efficacy and safety data, adverse eventinformation, formulas, methods and processes, specifications, pricing information(including discounts, rebates and other price adjustments) and other terms andconditions of sales, customer information, business plans, and all otherintellectual property.

 

9.2                                 **Exceptions.**Confidential Information shall not include anyinformation that the receiving Party can demonstrate, by competent proof:

 

                                                9.2.1                       is publiclydisclosed by the disclosing Party, either before or after it becomes known tothe receiving Party or is already in or hereafter enters the public domainthrough no fault of the receiving Party or its Affiliates;

 

                                                9.2.2                       was knownto the receiving Party or any of its Affiliates, without obligation to keep itconfidential, prior to when it was received from the disclosing Party or priorto being developed in the case of information, data and tangible materialsdeveloped during the course of the Research Program;

 

                                                9.2.3                       ishereafter lawfully furnished to the receiving Party or any of its Affiliates bya Third Party without restriction on disclosure and where such Third Party doesnot violate any contractual, legal or fiduciary obligation to the disclosingParty (or the other Party in the case of information, data and tangiblematerials developed during the course of the Research Program) by providingsuch Confidential Information to the receiving Party; or

 

Confidential TreatmentRequested

 

67

----

 

                                                9.2.4.                    is the subjectof a written permission to disclose provided by the disclosing Party (or theother Party in the case of information, data and tangible materials developedduring the course of the Research Program), or

 

                                                9.2.5                       isindependently developed by employees of the receiving Party, who did not useConfidential Information of the disclosing Party or information, data andtangible materials developed during the course of the Research Program byeither Party and without breach of this Agreement.

 

9.3                                 **Financial Terms Confidential.**The Parties agree that thefinancial terms of this Agreement will be considered Confidential Information ofboth Parties. Notwithstanding the foregoing, either Party may disclosesuch terms to sublicensees, its attorneys and financial advisers, bona fidepotential acquirors and/or merger/acquisition candidates and/or copromotionpartners, financial underwriters, potential investors, lenders, and permittedsubcontractors and sub-distributors, and other parties with a need to know suchinformation. All such disclosures shall be made only to parties under anobligation of confidentiality. In addition, such financial terms may bedisclosed where required by an applicable rule, law and/or regulation, providedthat the disclosing Party provides prior notice to the other Party and attemptsto seek confidential treatment thereof to the extent available. With respect toany filing relating to this Agreement required by the Securities and ExchangeCommission of the United States or any equivalent body, the Party making suchfiling with the Securities and Exchange Commission of the United States or anyequivalent body shall provide the non-filing Party with a reasonableopportunity to review and comment upon any such proposed filing prior to thesubmission of such filing and shall make every effort to accommodate anyrequests of the non-filing Party with respect to such proposed filing.

 

Confidential TreatmentRequested

 

68

----

 

9.4                                 **Authorized Disclosure.**Notwithstanding any other provisionof this Agreement, each Party may disclose Confidential Information if andto the extent such disclosure:

 

                                                9.4.1                       is inresponse to a valid order of a court or other governmental body of the UnitedStates or a foreign country, or any political subdivision thereof; *provided*, however, that the responding Party shall firsthave given notice to the other Party and shall have made a reasonable effort toobtain a protective order requiring that the Confidential Information sodisclosed be used only for the purposes for which the order was issued;

 

                                                9.4.2                       isotherwise required by law or regulation; or

 

                                                9.4.3                       isotherwise necessary to file or prosecute patent applications included in theAMRI Patent Rights or BMS Licensed Patent Rights, to prosecute or defendlitigation, to comply with applicable governmental regulations, or to establishor exercise rights or enforce obligations under this Agreement, but only to theextent that any such disclosure is necessary;

and providedthat with respect to Sections 9.4.2 and 9.4.3, the other Party is notified inadvance (where possible) or shortly thereafter (where it is not possible toprovide advance notice) of such disclosure.

 

9.5         **Equitable Remedies.**The Parties acknowledge and agree thatmoney damages may not be a sufficient remedy for any breach or threatenedbreach of this Article 9 and that the Parties shall be entitled, withoutthe requirement of posting a bond or other security, to seek specificperformance and injunctive or other equitable relief as a remedy for any suchbreach or threatened breach. Such remedies shall not be deemed to be theexclusive remedies for a breach or threatened breach

 

Confidential TreatmentRequested

 

69

----

 

of this Article 9but shall be in addition to all other remedies available to the Parties at lawor in equity.

 

9.6         **Other Terms**. Nothing in this Article 9 shall beconstrued to create or imply any right or license under any patent rights,trademarks, copyrights or other intellectual property rights owned orcontrolled by a Party or its Affiliates except as may be expressly setforth in the other Articles of this Agreement. The confidentiality obligationsset forth in this Article 9 shall supersede the confidentialityobligations set forth in the confidentiality agreement dated as of April 7,2004 between BMS and AMRI, as amended, and the June 8, 2005, MaterialTransfer Letter Agreement between BMS and AMRI, and shall govern any and allinformation disclosed by either Party to the other pursuant thereto and shallbe retroactively effective to the date of such confidentiality agreement. Nothingin this Article 9 shall be construed to preclude AMRI from Developingand/or Commercializing a Released Compound and/or Released Product and/orlicensing a Released Compound and/or Released Product to a Third Party anddisclosing and using Confidential Information of BMS with respect theretoconsistent with the rights and obligations of AMRI under this Agreement;  provided however, Confidential Information ofBMS must be disclosed to any such Third Party on the same terms and conditionsas contained in this Article 9. Nothing in this Article 9 shall beconstrued to preclude BMS from Developing and/or Commercializing a RetainedCompound and/or a Retained Product and/or licensing a Retained Compound and/orRetained Product to a Third Party and disclosing and using ConfidentialInformation of AMRI with respect thereto consistent with the rights andobligations of BMS under this Agreement; provided however, Confidential Information of AMRI must be disclosed toany such Third Party on the same terms and conditions as contained in this Article 9.

 

9.7         **Procedurefor Public Announcements.**Neither Party will issue any press releaseor make any public announcement concerning this Agreement without obtaining theprior consent of the other Party to the content of the press release orannouncement, which consent shall not be

 

Confidential TreatmentRequested

 

70

----

 

unreasonablywithheld. This Section does not limit either Party’s right to makedisclosures to the extent required by applicable law.

 

9.8         **Publications.**Neither Party shall publish or otherwise present any AMRI Know-How,BMS Know-How or other Confidential Information (including, without limitation,inventions arising under this Agreement) (collectively, the “***Reviewable Publications***”), withoutthe opportunity for prior review by the other Party and without the priorwritten consent of the other Party, except where otherwise expressly providedfor under this Agreement. Each Party agrees to provide the other Party’s patentcounsel the opportunity to review any such proposed publication or presentation(including, without limitation, abstracts, manuscripts or verbal presentations)at least thirty (30) days prior to their intended submission for publication orpresentation and agrees, upon request, not to submit any such proposedpublication or make such proposed presentation for such additional reasonableperiod of time (but not to exceed an additional 90 days) to enable the otherParty to secure patent protection for any material therein which it believes tobe patentable or to discuss the implications of publication or presentation oneventual commercialization and competitors.   Neither Party shall have the right to publishor present Confidential Information of the other Party. Notwithstanding theforegoing, the Parties recognize that independent investigators will be engagedin the future, to conduct clinical trials of Licensed Products. The Partiesrecognize that such investigators operate in an academic environment and may releaseinformation regarding such studies in a manner consistent with academicstandards; provided, that each Party will use reasonable efforts to filerelevant patent applications priorto publication or presentation of such studies. Notwithstanding anything to thecontrary, BMS shall have the right to disclose the chemical structure of aLicensed Compound after filing an IND therefor.

 

**10.****                                                                              UPFRONTPAYMENT AND MILESTONE PAYMENTS.**

 

10.1                           **Initial Payment and Cancellation of Warrants**. Within ten (10) businessdays of the Effective Date, BMS shall pay to AMR Technology, Inc. anon-refundable, non-creditable

 

Confidential Treatment Requested

 

71

----

 

payment ofeight million Dollars ($8,000,000) by electronic funds transfer into an accountdesignated in writing by AMRI, and BMS and Albany Molecular Research, Inc.shall cancel the warrants issued to BMS pursuant to the Warrant IssueAgreement.

 

10.2                           **Milestone Payments.**Subject to the terms of this Agreement,and in particular Sections 10.4 and 10.5, BMS shall make the followingnoncreditable, nonrefundable milestone payments to AMR Technology, Inc.within twenty (20) business days following the occurrence of each of thefollowing milestone events for the first two (2) Licensed Products toachieve each milestone event. The milestone payment to be made will depend uponwhether the Licensed Product contains an Advanced Lead Candidate Compound or aNon-Advanced Lead Candidate Compound. By way of illustration, if the first twoproducts that are Licensed Products that achieve a milestone event contain acompound that is not an Advanced Lead Candidate Compound, the milestone paymentwill be the corresponding Non-Advanced Lead Candidate Compound milestonepayment set forth in this Section 10.2 in the table below and the thirdproduct that is Licensed Product to achieve that milestone event contains anAdvanced Lead Candidate Compound, the milestone payment for such third productachieving that milestone event would be the milestone payment set forth in thetable in Section 10.3, not the Advanced Lead Candidate Compound milestonepayment set forth in this Section 10.2 in the table below.

 
| **EVENT**                                   | ** ** | **Non-  Advanced  Lead  Candidate  Compound** | ** ** | **Advanced  Lead  Candidate  Compound** | ** ** |
|---------------------------------------------|------------|-----------------------------------------------|------------|-----------------------------------------|------------|
|                                        |       |                                          |       |                                    |       |
| ECN Approval                                |       | *                                             |       | *                                       |       |
| IND Filing  (or IND Equivalent)             |       | *                                             |       | *                                       |       |
| Commencement  of a Phase IIa Clinical Trial |       | *                                             |       | *                                       |       |

 

Confidential TreatmentRequested

 

72

----

 
| Commencement  of a Phase III Clinical Trial |   | * |   | * |   |
|---------------------------------------------|--------|---|--------|---|--------|
| Acceptance  of NDA filing in the US         |   | * |   | * |   |
| NDA Approval                                |   | * |   | * |   |
| Acceptance  of MAA filing                   |   | * |   | * |   |
| MAA Approval                                |   | * |   | * |   |
| Acceptance  of JNDA filing in Japan         |   | * |   | * |   |
| JNDA  Approval                              |   | * |   | * |   |

 

10.3                           Subjectto the terms of this Agreement, and in particular Sections 10.4 and 10.5, BMSshall make the following noncreditable, nonrefundable milestone payments to AMRTechnology, Inc. within twenty (20) business days following the occurrenceof each of the following milestone events for the * products that are LicensedProducts to achieve each milestone event (regardless of whether such LicensedProduct contains an Advanced Lead Candidate Compound or a Non-Advanced LeadCandidate Compound):

 
| **EVENT**                                  | ** ** | ** ** | ** ** |
|--------------------------------------------|------------|------------|------------|
|                                       |       |       |       |
| ECN Approval                               |       | *          |       |
| IND Filing (or IND Equivalent)             |       | *          |       |
| Commencement of a Phase IIa Clinical Trial |       | *          |       |
| Commencement of a Phase III Clinical Trial |       | *          |       |
| Acceptance of NDA filing in the US         |       | *          |       |
| NDA Approval                               |       | *          |       |
| Acceptance of MAA filing                   |       | *          |       |
| MAA Approval                               |       | *          |       |

 

Confidential TreatmentRequested

 

73

----

 
| Acceptance of JNDA filing in Japan |   | * |   |
|------------------------------------|--------|---|--------|
| JNDA Approval                      |   | * |   |

 

10.4                           Inthe event that the Development or Commercialization of a Lead Product isterminated, milestone payments will be due for those milestone events that areachieved by a backup Licensed Product and that were not achieved by the LeadProduct. For the avoidance of doubt, if a particular milestone payment has beenpaid for one Licensed Product and another Licensed Product is substituted forthat Licensed Product which is no longer being developed where the substituteLicensed Product is being developed for the same Indication as the earlierLicensed Product and the substitute Licensed Product achieves the samemilestone, no payment will be due for the substitute Licensed Product achievingthat earlier milestone event, provided, however, that future milestones for thesubstitute Licensed Product shall be paid under Section 10.2 or 10.3dependent upon whether it contains an Advanced or Non-Advanced Lead CandidateCompound. No milestone payments shall be due or payable for a Licensed Product(after the end of the Combined Period) that is a backup to a Lead Product(i.e., is being Developed for the same Indication as a Lead Product) and forwhich BMS has not received Reserved Indications under Section 4.2.1(during the Combined Period), until either the backup has replaced a LeadProduct and achieves a later milestone event, as described above, or until anNDA for the Lead Product obtains Approval, for which it is a backup. In thelatter case, if the backup is continued in Development, after an NDA obtainsApproval for its respective Lead Product, then payment for all milestone eventsachieved by that backup will be due and payable. Subject to the foregoing, forthe purposes of paying a milestone payment for more than one Licensed Productthat achieves the corresponding milestone event, each Licensed Product thatachieves that milestone event must have a different API than any other LicensedProduct that has previously achieved that milestone

 

Confidential Treatment Requested

 

74

----

 

event. Nomilestone payment will be paid for a different Indication for a LicensedProduct that has already achieved the corresponding milestone event for anyother Indication.

 

10.5                           Ifa milestone event is achieved for a Licensed Product and an earlier milestoneevent(s) has not been achieved for such Licensed Product, then the milestonepayment for such earlier milestone event(s) shall also become due and payablefor such Licensed Product at such time. By way of illustration, if a Phase IIaClinical Trial is not conducted for a Licensed Product and a Phase III ClinicalTrial is commenced for such Licensed Product, then the milestone payment forthe commencement of a Phase IIa Clinical Trial for such Licensed Product andthe milestone payment for the commencement of a Phase III Clinical Trial wouldboth be due and payable.

 

10.6                           The fact that a payment under this Agreementis indicated to be non-refundable shall not affect the calculation of anydamages that a Party may be entitled to under this Agreement.

 

**11.****                               ROYALTYPAYMENTS**

 

11.1**                           Royalties.**BMS will pay the following royalties to AMR Technology, Inc. based oncombined, worldwide annual Net Sales of all Royalty Bearing Products containingNon-Advanced Lead Candidate Compounds:

 
| ** **                                                  | ** ** | **Royalty Rate** | ** ** |
|-------------------------------------------------------------|------------|------------------|------------|
|                                                        |       |             |       |
| **Annual Net Sales under $1.0 billion**                     |       | *                | %          |
| **Annual Net Sales between $1.0 billion and  $2.0 billion** |       | *                | %          |
| **Annual Net Sales greater than $2.0 billion**              |       | *                | %          |

 

Confidential Treatment Requested

 

75

----

 

By way of illustration, if the annual worldwide Net Sales of RoyaltyBearing Products containing Non-Advanced Lead Candidate Compounds as APIs are$2.2 billion, the royalties due would be $* million (i.e., (*% x $* billion) +(*% x $* billion) + (*% x $* million) = $* million + $* million + $* million =$* million).

 

BMS will pay the following royalties to AMR Technology, Inc. based oncombined, worldwide annual Net Sales of all Royalty Bearing Products containingAdvanced Lead Candidate Compounds:

 

| ** **                                                  | ** ** | **Royalty Rate** | ** ** |
|-------------------------------------------------------------|------------|------------------|------------|
|                                                        |       |             |       |
| **Annual  Net Sales under $1.0 billion**                    |       |             | *%         |
| **Annual  Net Sales between $1.0 billion and $2.0 billion** |       |             | *%         |
| **Annual  Net Sales greater than $2.0 billion**             |       |             | *%         |

 

By way of illustration, if the annual worldwide Net Sales of RoyaltyBearing Products containing Advanced Lead Candidate Compounds as APIs are $2.2billion, the royalties due would be $* million (i.e., (*% x $* billion) + (*% x$* billion) + (*% x $* million) = $* million + $* million + $* million = $*million).

 

11.2**         RoyaltyTerm.**  ** **Royalties will be paid by BMS on aRoyalty Bearing Product by Royalty Bearing Product and country-by-country basisfor each Royalty Bearing Product in each country for each year until ten (10)years after First Commercial Sale in such country of such Royalty BearingProduct; provided, however, that royalties shall continue in such country foreach Calendar Quarter that such Royalty Bearing Product sold in such country isa Patented Royalty Bearing Product in such country (i.e., the actual commercialmanufacture of such Royalty Bearing Product in such

 

Confidential Treatment Requested

 

76

----

 

country, the sale of such Royalty Bearing Product in such country, orthe use for which such Royalty Bearing Product is sold in such country by BMS,its Affiliates or (sub)licensees is Covered by a Valid Claim of an AMRI PatentRight in such country and/or a Valid Claim of a BMS Licensed Patent Right insuch country) or *(the **“Royalty Term”**), and if in such case such Patented RoyaltyBearing Product is a Patented Royalty Bearing Product in such country, theroyalty in such country shall not be reduced, and if in such case such PatentedRoyalty Bearing Product is not a Patented Royalty Bearing Product in suchcountry but is * the royalty in such country shall be reduced by * percent, and further provided if there areno Valid Claims in the AMRI Patent Rights and/or the BMS Patent Rights in suchcountry that are able, by filing of an infringement Action, to prevent a ThirdParty or Third Parties from marketing a product or products containing the sameLicensed Compound as that contained in such Royalty Bearing Product (or any salt, solvate, crystalline ornoncrystalline form of such Licensed Compound), whether filed under an NDA or ANDA(Abbreviated New Drug Application) or otherwise and such Third Party or ThirdParties are not authorized by BMS, its Affiliates or its (sub)licensees to sellsuch product or products (each such product a “***GenericProduct***”), royalties shall be reduced in such country in aCalendar Quarter by: (a) * percent(*%) if sales of such GenericProducts in such country in such Calendar Quarter exceed * percent (*%) of the sum of all prescriptions for such form of such RoyaltyBearing Product sold by BMS, its Affiliatesand (sub)licensees and by the Third Party seller(s) of such Generic Product(s)(based on unit-equivalent data for all dosage strengths of such form) in suchcountry during such Calendar Quarter, (b) by * percent (*%) if suchsales of such Generic Product(s) in such country in such Calendar Quarterexceed * percent (*%) of the sum of all prescriptions for such form of such RoyaltyBearing Product sold by BMS, itsAffiliates and (sub)licensees and by the Third Party seller(s) of such GenericProduct(s) (based on unit-equivalent data for all

 

Confidential Treatment Requested

 

77

----

 

dosagestrengths of such form) in such country during such Calendar Quarter, and (c)by * percent (*%) if sales of such Generic Product(s) in such country in suchCalendar Quarter exceed * percent (*%) of the sum of all prescriptions for suchform of such Royalty Bearing Product sold by BMS, its Affiliates and (sub)licensees and by the Third Partyseller(s) of such Generic Product(s) (based on unit-equivalent data for alldosage strengths of such form) in such country in such Calendar Quarter.  If the prescriptions are not reportable in agiven country, then the Parties will use another mutually agreed upon methodfor such country.  Such adjustments shallbe retroactive to the beginning of the applicable Calendar Quarter

 

11.3     If BMS, in its reasonable judgment, isrequired to obtain a license from any Third Party under any patent or patentapplication in order to import, export, manufacture, use, offer to sell and/orCommercialize any Licensed Compound, and if BMS is required to pay to suchThird Party a royalty under such license calculated on sales of a RoyaltyBearing Product in a particular country, or if BMS is required by a court ofcompetent jurisdiction to pay such a royalty to such a Third Party, then theamount of BMS’ royalty obligations under Section 11.1 hereof with respect tosuch Royalty Bearing Product sold in such country in a Calendar Quarter shallbe reduced by * percent (*%) of the amount of the royalty paid to such ThirdParty for such Royalty Bearing Product sold in such country in such CalendarQuarter, *provided however*, that the royaltiespayable under Section 11.1 hereof shall not be reduced in any such event below*% of the amounts set forth in Section 11.1 with respect to such RoyaltyBearing Product in such country in such Calendar Quarter.

 

11.4     **Reports; PaymentProcedures, Taxes**.

 

11.4.1**             **Withintwenty (20) days of the end of each Calendar Quarter, BMS shall provide to AMRTechnology, Inc. a written report, in the English language, showing (a) the NetSales (and how calculated)  of each formof Royalty Bearing Product sold by BMS, its Affiliates and its (sub) licensees(if applicable) in each country of the

 

Confidential Treatment Requested

 

78

----

 

Territory during the reporting period; (b) the calculation of anyroyalty amounts due AMR Technology, Inc., (c) withholding taxes, if any,required by law to be deducted in respect of such Net Sales; and (d) theexchange rates used in determining the amount of Dollars. With respect to salesof a Licensed Product invoiced in Dollars, the Net Sales shall be expressed inDollars. With respect to sales of a Licensed Product invoiced in a currencyother than Dollars, the Net Sales hereunder shall be expressed in the domesticcurrency of the entity making the sale, together with the Dollar equivalents ofsame, calculated using the procedure set forth in Section 11.6.  If any permitted (sub)licensee makes anysales invoiced in a currency other than its domestic currency, the Net Salesshall be converted to its domestic currency in accordance with the permitted(sub) licensee’s normal accounting practices.

 

## 11.4.2.             Any tax, duty orother levy paid or required to be withheld by BMS or its sublicensees on behalfof AMR Technology, Inc. on account of any payments payable to AMR Technology,Inc. by BMS, under this Agreement shall be deducted from the amount of paymentsotherwise due, *provided* that BMS shall usediligent efforts to make such deductions only to the minimum practical extentrequired by the relevant jurisdiction. Upon request, BMS shall secure and send to AMR Technology, Inc. proof ofany such taxes, duties or other levies withheld and paid by BMS or itssublicensees for the benefit of AMR Technology, Inc.,****andcooperate at AMR Technology, Inc.’s reasonable request to ensure that amountswithheld are reduced to the fullest extent permitted by the relevantjurisdiction, and to permit AMR Technology, Inc. to obtain tax credits andother benefits.

##  

## Confidential Treatment Requested

##  

## 79

## 

##  

## 11.4.3              Anything to thecontrary notwithstanding, neither Party shall have any obligation to pay anyincome, revenue or profit tax imposed on the other Party or any of itsAffiliates that may arise from the transactions contemplated by this Agreement.

##  

## 11.4.4              All payments to bemade by BMS under this Article 11 shall be payable within forty five (45) daysof the end of each Calendar Quarter in Dollars and shall be paid by BMS on itsaccount and on account of its Affiliates and (sub) licensees by electronicfunds transfer to AMR Technology, Inc.’s bank account in accordance with theTransfer Instructions set forth in Exhibit 11.4.4 or to any other bankaccount that may be indicated by AMR Technology, Inc. in writing by any officerholding the title equivalent of Vice President (or higher) in AMR Technology,Inc.    AMR Technology, Inc. shall provideBMS in writing with such other information as BMS may require to make thetransfer.  If at any time legalrestrictions prevent the prompt remittance of part or all of any such paymentdue under this Article 11 with respect to any country where the Licensed Productis sold, BMS shall have the right and option to make such payments bydepositing the amount thereof in local currency to AMR Technology, Inc.’saccount in a bank or other depository in such country.

 

11.5         **Late Payments. **In theevent that any payment due hereunder is not made when due, the payment shallaccrue interest from the date due at the rate of two percent (2%) per annumabove the Prime Rate then prevailing at Citibank, N.A., New York, New York, providedthat in no event shall such rate exceed the maximum legal annual interest ratein New York, New York, USA.  The paymentof such interest shall not limit AMR Technology, Inc. from exercising any otherlegal rights it may have as a consequence of the lateness of any payment.

 

11.6         **CurrencyConversion**.   Any amountsrequired to be converted into U.S. dollars under this Article 11 shall beconverted into U.S. Dollars on a monthly basis using the applicable

 

Confidential Treatment Requested

 

80

----

 

exchange ratesthen used by BMS for converting local currency into the United States Dollar inproducing its financial accounts for its annual report to its shareholders, itbeing understood that BMS currently calculates the rate for an applicable monthbased on the average of the New York Federal Reserve daily foreign exchangerates as of 12 Noon EST from the 21st to the 20th of thetwo (2) months prior to the month of calculation (e.g., the March monthlycalculation would be set based on January 21 to February 20th).

 

11.7         **Records, Audits.**  BMSagrees to maintain and shall require its Affiliates, and (sub) licensees tomaintain accurate books and records in accordance with all applicableaccounting standards and law and regulations and consistent with the books andrecords of BMS generally, that accurately reflect all costs, expenses, andrevenues relevant to the determination of any royalty payment obligationspursuant to this Agreement.   AMRTechnology, Inc., together with its independent representatives and accountantsreasonably acceptable to BMS (and subject to the execution of an appropriatewritten agreement of confidentiality), shall be entitled to audit such booksand records of BMS and its Affiliates and (sub) licensees, at reasonable timesand upon reasonable notice, solely for the purposes of verifying thecorrectness and/or completeness of any royalty report and the calculation ofroyalty payments with respect to one or more of the three (3) Calendar Yearspreceding the Calendar Year in which the request is made. The foregoing rightof review may be exercised only once per Calendar Year and only once withrespect to any such royalty report and/or royalty payment.  Results of any such examination shall be (a)limited to information relating to the royalty reports and royalty paymentsbeing audited, (b) made available to both AMR Technology, Inc. and BMS and (c)subject to Article 9 (Confidential Information).   AMR Technology, Inc. shall bear the fullcost of the performance of any such audit, unless such audit discloses avariance to the detriment of AMR Technology, Inc. of more than five percent(5%) from the amount of aggregate royalties payable for the Calendar Years thatare audited.  In such case, BMS shall bearthe full cost of the performance of such audit. BMS shall, within ten (10)

 

Confidential Treatment Requested

 

81

----

 

Business Days of receipt of the report of theauditor, make a correcting payment to AMR Technology, Inc. in an amountsufficient to correct the underpayment determined by the audit and to payinterest on the amount of the underpayment equal to two (2) percentagepoints over the Prime Rate as published from time to time by Citibank N.A., NewYork, New York, compounded annually, from the date the underlying payments wereoriginally due to the date of the correcting payment.  Any overpayment shall be promptly refunded byAMR Technology, Inc. to BMS without interest.

 

**12.****              INDEMNIFICATIONAND INDEMNIFICATION PROCEDURE.**

 

12.1         **Indemnification.**

 

12.1.1      Indemnificationby BMS. Subject to Section 12.2, BMS agrees to defend AMRI, its Affiliates andtheir respective directors, officers, employees and agents (collectively, the “***AMRI Indemnitees***”) against (at BMS’cost and expense), and shall indemnify and hold harmless the AMRI Indemniteesfrom and against any liabilities, losses, costs, damages, fees and/or expenses(including reasonable legal expenses and attorneys’ fees) (such liabilities,losses, costs, damages, fees and/or expenses, collectively, “***Losses***”) payable to a Third Partyarising out of, any claim, action, lawsuit, or other proceeding (collectively, “***Claims***”) brought against any AMRIIndemnitee by a Third Party resulting directly or indirectly from (i) theresearch, discovery, identification, Development, use, handling, storage,Commercialization and/or other disposition of Licensed Compounds, and/orLicensed Products in the Territory by or on behalf of BMS, its Affiliates,and/or their respective directors, officers,

 

Confidential Treatment Requested

 

82

----

 

employees,agents, contractors and/or (sub)licensees, and/or (ii) the manufacture ofLicensed Products and/or Licensed Compounds for use and/or sale by or on behalfof BMS, its Affiliates, and/or their respective directors, officers, employees,agents, contractors and/or (sub)licensees, (iii) the use of Licensed Productsand/or Licensed Compounds obtained directly or indirectly from BMS, itsAffiliates and/or their (sub)licensees, and/or (iv) the negligence, unlawfulacts or willful misconduct of BMS and/or its Affiliates and/or their respective(sub)licensees, directors, officers, agents, directors and/or contractors incarrying out activities pursuant to this Agreement and/or in connection withLicensed Compounds prior to the Effective Date of this Agreement, except (1) tothe extent that it is established that such Losses result from (a) the grossnegligence, willful misconduct or unlawful act of any AMRI Indemnitee; (b) anybreach by AMRI of any of its representations and warranties under Article 16 ofthis Agreement or any breach by AMRI of any of its covenants and obligationsunder this Agreement; (c) trade secret misappropriation liability by an AMRIIndemnitee resulting from the research, discovery, identification, Developmentand/or manufacture by or on behalf of any AMRI Indemnitee of any LicensedCompound and/or Licensed Product prior to the Effective Date, and/or (2) to theextent that it is established that AMRI is obligated to indemnify a portion ofsuch Losses pursuant to Section 12.1.2. Except as provided in Section 12.2.2, with respect to reasonable legalexpenses and attorneys’ fees incurred by the AMRI Indemnitees in connectionwith a Claim, only such expenses and fees that are incurred until such time asBMS has acknowledged and assumed its indemnification obligation hereunder withrespect to such Claim shall be included in Losses.

 

12.1.2      Indemnificationby AMRI.  Subject to Section 12.2, AMRI agrees to defendBMS, its Affiliates and their respective directors, officers, employees andagents (collectively, the “***BMS Indemnitees***”)against (at AMRI’s cost and expense), and shall indemnify and hold harmless theBMS Indemnitees from and against any and all Losses arising out of, any Claimbrought against any BMS Indemnitee by a Third Party resulting directly orindirectly from (a) the research, discovery, identification, Development,

 

Confidential Treatment Requested

 

83

----

 

use,handling, storage, Commercialization and/or other disposition of LicensedCompounds and/or Licensed Products in the Territory by and/or on behalf ofAMRI, its Affiliates, and/or any of their respective directors, officers,employees, agents, contractors and/or (sub)licensees, (b) the manufacture ofLicensed Products and/or Licensed Compounds for use and/or sale by or on behalfof AMRI, its Affiliates, and/or their respective directors, officers,employees, agents, contractors and/or (sub)licensees, (c) the use of LicensedProducts and/or Licensed Compounds obtained directly or indirectly from AMRI,its Affiliates and/or their (sub)licensees, and/or (d) the negligence orwillful misconduct or unlawful acts of AMRI and/or its Affiliates and/or theirrespective (sub)licensees, directors, officers, agents, directors and/orcontractors in carrying out activities pursuant to this Agreement and/or inconnection with Licensed Compounds prior to the Effective Date of thisAgreement, except (1) to the extent that it is established that such Lossesresult from; (i) the gross negligence, unlawful act or willful misconduct ofany BMS Indemnitee; or (ii) any breach by BMS of any of its representations andwarranties under Section 16.1 of this Agreement and/or any breach by BMS of anyof its covenants and obligations under this Agreement; and/or (2)  to the extent that it is established that BMSis obligated to indemnify a portion of such Losses pursuant to Section 12.1.1.  Except as provided in Section 12.2.2, withrespect to reasonable legal expenses and attorneys’ fees incurred by the BMSIndemnitees in connection with a Claim, only such expenses and fees that areincurred until such time as AMRI has acknowledged and assumed itsindemnification obligation hereunder with respect to such Claim shall beincluded in Losses.

 

Confidential Treatment Requested

 

84

----

 

12.2         **Procedure.**

 

12.2.1      A Party believing that it isentitled to indemnification under Section 12.1.1 or 12.1.2 (an “***Indemnified Party***”) shall giveprompt written notification to the other Party (the “***IndemnifyingParty***”) of the commencement of any Claim for whichindemnification may be sought or, if earlier, upon the assertion of any suchClaim by a Third Party (it being understood and agreed, however, that thefailure by an Indemnified Party to give notice of a Third Party Claim asprovided in this Section 12.2 shall not relieve the Indemnifying Party of itsindemnification obligation under this Agreement except and only to the extentthat such Indemnifying Party is actually prejudiced as a result of such failureto give notice).  Within thirty (30) daysafter delivery of such notification, the Indemnifying Party shall, upon writtennotice thereof to the Indemnified Party, assume control of the defense of suchClaim with counsel reasonably satisfactory to the Indemnified Party.  If a Party believes that a Claim presented toit for indemnification is one as to which the Party seeking indemnification isnot entitled to indemnification, it shall so notify the Party seekingindemnification.

 

12.2.2      The Indemnified Party mayparticipate in such defense at its own expense; provided that if theIndemnified Party reasonably concludes, based on advice from counsel, that theIndemnifying Party and the Indemnified Party have conflicting interests withrespect to such Claim, the Indemnifying Party shall be responsible for thereasonable fees and expenses of counsel to the Indemnified Party solely inconnection therewith.

 

12.2.3      The Indemnifying Party shallkeep the other Party advised of the status of such Claim and the defensethereof and shall consider recommendations made by the Indemnified Party withrespect thereto.

 

Confidential Treatment Requested

 

85

----

 

12.2.4      The Indemnified Party shallnot agree to any settlement of such Claim without the prior written consent ofthe Indemnifying Party.  The IndemnifyingParty shall not agree to any settlement of such Claim and/or consent to anyjudgment in respect thereof that does not include a complete and unconditionalrelease of the Indemnified Party from all liability with respect thereto and/orthat imposes any liability and/or obligation on the Indemnified Party and/oradversely affects the Indemnified Party and/or any intellectual property of theIndemnified Party without the prior written consent of the Indemnified Party.

 

12.3    **Insurance**.  EachParty shall maintain at its sole cost and expense, an adequate liabilityinsurance policy or a self-insurance program (including contractual liabilityand product liability insurance) to protect against potential liabilities andrisk arising out of activities to be performed under this Agreement and anyagreement related hereto and upon such terms (including coverages, deductiblelimits and self-insured retentions) as are customary in the pharmaceuticalindustry for the activities to be conducted by such Parties under thisAgreement and are appropriate to cover the Parties’ respective indemnificationobligations hereunder (the “***Coverage***”).  Such liability insurance or self-insuranceprogram shall insure against all liability, including without limitationpersonal injury, physical injury or property damage arising out of theresearch, discovery, identification, Development, manufacture, use, orCommercialization of the Licensed Compounds and Licensed Products.  In the case of BMS, as of the date a LicensedProduct is first administered to a human by or on behalf of BMS, and in thecase of AMRI, as of the earlier of the date a Released Product is firstadministered to a human or the date any Licensed Product for which AMRI wasinvolved with the manufacture, formulation, packaging or finishing of suchLicensed Product or the API in such Licensed Product is first administered to ahuman by or on behalf of BMS, the required minimum amount of Coverage by theapplicable Party shall be not less than twenty-five million Dollars($25,000,000) per claim and fifty million Dollars ($50,000,000) in theaggregate.  Each Party shall furnish tothe other evidence of such insurance and/or self insurance, upon request.  Such

 

Confidential Treatment Requested

 

86

----

 

insuranceinformation shall be kept in confidence in the same manner as any otherConfidential Information disclosed by one Party to the other hereunder.  The coverage limits set forth herein shallnot create any limitation on a Party’s liability to the other under thisAgreement.

 

**13.****          TERMAND TERMINATION.**

 

13.1         Term**.**  The term of thisAgreement shall commence upon the Effective Date and, unless earlier terminatedpursuant to another subsection of this Article 13, shall continue thereafteruntil neither Party shall have any obligation to the other under this Agreement(other than under Article 9 (Confidential Information) and Article 12(Indemnification) or until both Parties agree in writing to terminate thisAgreement, in whole or in part.

 

13.2         Terminationby AMRI.  AMRI shall have the rightto terminate this Agreement, at AMRI’s sole discretion, as follows:

 

13.2.1      Breach.  Subject to Section 13.2.3, AMRI shall havethe right to terminate this Agreement, at AMRI’s sole discretion, upon deliveryof written notice to BMS in the event of any material breach by BMS of thisAgreement (except, the failure to use Commercially Reasonable Efforts toDevelop or Commercialize at least one Licensed Compound or Licensed Product,which is covered under Section 13.2.2), *provided* thatsuch breach has not been cured within sixty (60) days after written noticethereof is given by AMRI to BMS; *provided, however*,that if such breach relates to the failure to make a payment when due, suchbreach must be cured within thirty (30) days after written notice thereof isgiven by AMRI.  If BMS disputes the amountof a payment, BMS shall pay to AMRI any amount that is not in dispute.

 

13.2.2      Terminationfor Failure to Develop or Commercialize. Subject to Section 13.2.3 below,AMRI shall have the right to terminate this Agreement on a country-by-countrybasis or in all countries as the case may be, (except as otherwise set forth inthis Section 13.2.2), at AMRI’s sole discretion, in the event that BMS fails touse

 

ConfidentialTreatment Requested

 

87

----

 

Commercially Reasonable Efforts to Develop or Commercialize at least oneLicensed Compound or Licensed Product in the Territory.  Terminationunder this Section 13.2.2 shall apply to all Licensed Compounds and LicensedProducts, but only for the affected country or countries, *providedhowever*, that (i) if the applicable termination event relates to theUnited States, then the termination shall apply to all countries in theTerritory, and (ii) if the applicable termination event relates to any countryother than the United States, then the termination shall apply only to thatcountry.   For clarity, it is understoodand acknowledged that to the extent BMS uses CommerciallyReasonable Efforts (by itself or through its Affiliates or sublicensees) toDevelop at least one Licensed Compound or Licensed Product through a centralized filing with the EMEA,BMS shall be deemed to be using Commercially Reasonable Efforts to Develop atleast one Licensed Compound or Licensed Product with respect to all countriesin Europe.

 

13.2.3      Disputed Breach.  If BMS disputes the existence or materialityof a breach specified in a notice provided by AMRI pursuant to Section 13.2.1within the applicable thirty (30) day or sixty (60) day period or a failure to use Commercially ReasonableEfforts specified in a notice provided by BMS pursuant to Section 13.2.2within thirty (30) days of receipt of such notice, and BMS provides notice toAMRI of such dispute and the reasons therefor within the applicable period andinitiates arbitration pursuant to Section 17.2 during such applicable period,(BMS in such arbitration may request that the arbitratior determine whether ornot BMS shall have the right to cure and if so the cure), AMRI shall not havethe right to terminate this Agreement unless and until there is a determinationin such arbitration that there is a material breach or such failure and BMSfails to make a payment within thirty (30) days thereafter if the materialbreach or such failure was for non-payment of an amount due to AMRI under thisAgreement, and if the arbitration determines a cure for such material

 

Confidential Treatment Requested

 

88

----

 

breach or suchfailure that is not a non-payment of an amount due to AMRI under thisAgreement, BMS fails to cure as determined in the arbitration.  It is understood and acknowledged that duringthe pendency of such a dispute, all of the terms and conditions of thisAgreement shall remain in effect and the Parties shall continue to perform allof their respective obligations hereunder. If BMS does not dispute the existence or materiality of a breachspecified in a notice provided by AMRI pursuant to Section 13.2.1 or a failure to use Commercially ReasonableEfforts specified in a notice provided by BMS pursuant to Section 13.2.2and initiate arbitration pursuant to this Section 13.2.3, then BMS shall bedeemed to have agreed to termination of this Agreement pursuant to Section13.2.1 or 13.2.2, as the case may be.

 

13.3         Termination by BMS.  BMS shall have the right to terminate thisAgreement, at BMS’ sole discretion, as follows:

 

13.3.1      Following expiry of theResearch Term, on a country-by-country and Licensed Product-by-Licensed Productbasis, effective upon three (3) months prior written notice, or upon six (6)months prior written notice in the case where Approval has been obtained forthe applicable Licensed Product in the United States of America, BMS mayterminate its rights under this Agreement for any reason.

 

13.3.2      Subjectto Sections 13.3.3 and 13.3.4, BMS shall have the right to terminate thisAgreement at BMS’ sole discretion, upon delivery of written notice to AMRI inthe event of any material breach by AMRI of this Agreement, *provided* that such breach has not been cured within sixty(60) days after written notice thereof is given by BMS to AMRI; *provided, however*, that if such breach relates to thefailure of AMRI to make a payment when due, such breach must be cured withinthirty (30) days after written notice thereof is given by BMS.   If AMRIdisputes the amount of a payment, AMRI shall pay to BMS any amount that is notin dispute.

 

Confidential Treatment Requested

 

89

----

 

13.3.3      (a) Subject to Section13.3.4, in lieu of termination under Section 13.3.2, in the event of anymaterial breach of this Agreement by AMRI during the Combined Period, at BMS’sole discretion, BMS may deliver written notice of such breach and if suchbreach has not been cured within sixty (60) days after written notice thereofis given by BMS to AMRI under this Agreement, then (i) the ability of AMRI toselect and/or have distributed compounds under Section 3.2 as ReleasedCompounds shall be limited to the compounds of items (i) and (ii) in thedefinition of AMRI Compounds and the corresponding compounds of items(iv)-(vii) in the definition of AMRI Compounds, (ii) all licenses granted underSection 4.2.2 shall be terminated and no further licenses shall be grantedunder Section 4.2.2, (iii) the rights granted to AMRI under Sections 6.2, 6.3and 6.4 shall be terminated and (iv) except for Licensed Compounds of item (i)of this Section 13.3.3(a) that become Released Compounds, all other LicensedCompounds shall be Retained Compounds.

 

(b) Subject toSection 13.3.4, in lieu of termination under Section 13.3.2, in the event thatAMRI or an Affiliate of AMRI materially breaches this Agreement after theCombined Term by Developing and/or Commercializing itself or in activecollaboration with a Third Party a Released Compound and/or a Released Productfor a Reserved Indication, BMS shall have the right to terminate the licensesgranted under Section 4.2.2 at BMS’ sole discretion by written notice to AMRIprovided that such breach has not been cured within sixty (60) days afterwritten notice thereof is given by BMS. Upon such termination of AMRI’slicenses granted under Section 4.2.2, (i) AMRI and its Affiliates shallterminate Development and Commercialization of all Released Compounds andReleased Products subject to the licenses granted under Section 4.2.2, and allRelated Compounds of such Released Compounds and of the Released Compoundscontained in such Released Products, and AMRI and its Affiliates shallthereafter have no right to Develop and/or Commercialize such Released Compounds,such Released Products and such Related

 

Confidential Treatment Requested

 

90

----

 

Compounds,(ii) in the event that any Released Compound and/or Released Product that isDeveloped and/or Commercialized for a Reserved Indication by AMRI or anyAffiliate of AMRI is not subject to the licenses granted under Section 4.2.2(e.g., it is an AMRI Compound Covered by an AMRI Patent Right solely owned byAMRI), AMRI and its Affiliates shall terminate Development and Commercializationof such Released Compound and/or Released Product, and thereafter AMRI and itsAffiliates shall have no right to Develop and/or Commercialize such ReleasedCompound and/or its Related Compounds and/or such Released Product and/or theRelated Compounds of the Released Compound contained in such Released Product,themselves or in active collaboration with a Third Party, or to license theDevelopment and/or Commercialization of such Released Compound, such RelatedCompounds and/or such Released Product to any Third Party, and (iii) the rightsgranted to AMRI under Sections 6.2, 6.3 and 6.4 shall be terminated.

 

13.3.4      If AMRI disputes theexistence or materiality of a breach specified in a notice provided by BMSpursuant to Section 13.3.2 or 13.3.3  andAMRI provides notice to BMS of such dispute and the reasons therefor within theapplicable thirty (30) day or sixty (60) day period, and initiates arbitrationpursuant to Section 17.2 during such applicable period, (AMRI in sucharbitration may request that the arbitration determine whether or not AMRIshall have the right to cure and if so the cure), BMS shall not have the rightto terminate this Agreement as provided in Section 13.3.2 or AMRI’s rights asprovided in Section 13.3.3, as the case may be, and the provisions of Sections13.3.3(a)(i)-(iv) or 13.3.3(b)(i)-(iii), as applicable, shall not take effect unlessand until there is a determination in such arbitration that there is a materialbreach and AMRI fails to make such payment within thirty (30) days thereafterif the material breach was for non-payment of an amount due to AMRI under thisAgreement, and if the arbitration determines a cure for such material breachthat is

 

Confidential Treatment Requested

 

91

----

 

not anon-payment of an amount due to AMRI under this Agreement, AMRI fails to cureas determined in the arbitration. It is understood and acknowledged that duringthe pendency of such a dispute, all of the terms and conditions of thisAgreement shall remain in effect and the Parties shall continue to perform allof their respective obligations hereunder. If AMRI does not dispute the existence or materiality of a breachspecified in a notice provided by AMRI pursuant to Section 13.3.2 or 13.3.3 andinitiate arbitration pursuant to this Section 13.3.4, AMRI shall be deemed tohave agreed to termination of this Agreement under Section 13.3.2 ortermination of AMRI’s rights pursuant to Section 13.3.3, and the provisions ofSections 13.3.3(a)(i)-(iv) or 13.3.3(b)(i)-(iii), as applicable, shall takeeffect, if the notice was provided under Section 13.3.3.

 

13.4         Effect of Terminationby AMRI under Section 13.2.1.  Upontermination of this Agreement by AMRI under Section 13.2.1:

 

13.4.1      Subject to Section 13.12,all rights and licenses granted to BMS under Article 3 and sublicensesthereunder shall terminate.  AMRI shallhave no rights or licenses with respect to Excluded Compounds and ExcludedProducts except for those rights and licenses under Section 4.5, and no rightto have any marketing authorizations, INDs or other regulatory filings andApprovals for Excluded Compounds or Excluded Products assigned to it under thisSection 13.4, and except as provided below in this Section 13.4.1, shall haveno right to have access to any data or information concerning ExcludedCompounds and Excluded Products under this Section 13.4, and except forExcluded Compounds and Excluded Products, neither BMS nor its Affiliates shallDevelop or Commercialize a Licensed Product and/or Licensed Compound.  Upon such termination, BMS shall notify AMRIin writing as to those Excluded Compounds and Excluded Products the Developmentand/or Commercialization of which was terminated by BMS or one of itsAffiliates or

 

Confidential Treatment Requested

 

92

----

 

sublicenseesfor Safety Reasons and the nature of such Safety Reasons. BMS agrees to makeavailable for AMRI’s inspection, relevant data, materials and reports thatsupport such Safety Reasons, provided that AMRI enters into an agreement withBMS or the relevant Affiliate or sublicensee of BMS to maintain theconfidentiality of such data, materials and reports.

 

13.4.2      Subjectto the terms, conditions and limitations of this Agreement, except for theExcluded Compounds and Excluded Products, BMS agrees to grant and hereby grantsAMRI an exclusive license, with theright to sublicense to, research, Develop, make, have made, use, export,import, offer to sell, sell and Commercialize Licensed Compounds and LicensedProducts in the Field in the Territory under Patent Rights and Know-How that(a) are owned by BMS or its Affiliates as of the date of the termination ofthis Agreement, (b) are Controlled by BMS or its Affiliates as of the date ofthe termination of this Agreement and (c) are reasonably required by AMRI tomake, have made, use, sell, import, export, offer to sell, research, Developand/or Commercialize Licensed Compounds and Licensed Products in the Field and,to the extent not previously transferred, BMS shall transfer to AMRI, at thecost and expense of BMS, the Know-How licensed to AMRI under this Section13.4.2.  For the avoidance of doubt, suchPatent Rights and Know How licensed under this Section 13.4.2 exclude researchtools and targets and Patent Rights Covering research tools and/or targets. Anysublicense shall be subject to the terms and conditions of Article 9 and AMRIshall be liable for any breach of Article 9 by a sublicensee.

 

13.4.3      In the event that prior to such termination of this Agreement, BMS islicensed under Patent Rights and/or Know How of a Third Party that have beenused by BMS or its Affiliates prior to such termination of this Agreement withrespect to Licensed Compounds and/or Licensed Products other than ExcludedCompounds and/or Excluded Products, and such Patent Rights and/or Know-How arereasonably

 

ConfidentialTreatment Requested

 

93

----

 

required by AMRI to make, have made, use, sell, offer to sell, import,export, research, Develop and/or Commercialize Licensed Compounds and/orLicensed Products other than Excluded Compounds and Excluded Products and BMShas the right to grant a sublicense thereunder to AMRI when this Agreement isterminated under Section 13.2.1, BMS shall notify AMRI of such Patent Rightsand Know-How, and then at the request of AMRI, BMS shall grant to AMRI such asublicense to the fullest extent permitted under the license under which thesublicense is granted and subject to the terms, conditions and requirementsthereof to make, have made, use, sell, offer to sell, import, export, research,Develop and/or Commercialize Licensed Compounds and Licensed Products otherthan Excluded Compounds and Excluded Products to the same extent and subject tothe same restrictions as set forth in Section 13.4.2.  Such sublicense shall be granted in aseparate agreement without additional consideration to BMS, provided that AMRIagrees to pay any and all amounts due to such Third Party as a direct result ofthe granting of the sublicense and any other payments (royalties, milestones,etc.) due thereunder as a direct result of AMRI being a sublicensee and/or itsactivities as a sublicensee.

 

13.4.4      All amounts due and/orpayable to AMRI that were accrued, and/or that arise out of acts and/or eventsoccurring, prior to the effective date of termination shall remain due andpayable.

 

13.4.5      Should BMS have anyinventory of any Licensed Product licensed to BMS prior to the date of suchtermination that is Finished Product approved and allocated prior totermination for sale in a terminated country, BMS shall have six (6) monthsthereafter in which to dispose of such inventory (subject to the payment toAMRI of any royalties due hereunder thereon),

 

Confidential Treatment Requested

 

94

----

 

13.4.6      Neither Party shall berelieved of any obligation that accrued prior to the effective date of suchtermination.

 

13.4.7      The licenses granted to AMRIunder this Agreement shall remain in full force and effect, except that suchlicenses shall be for all Indications.

 

13.4.8      Nothing in this Section 13.4shall be deemed to limit any remedy to which AMRI may be entitled by applicablelaw.

 

13.4.9      Except for Excluded Compoundsand Excluded Products, in the event that at the date of such termination BMS orits Affiliate or their supplier is responsible for manufacturing a LicensedProduct and/or Licensed Compounds for the purposes of conducting clinicaltrials and/or for Commercializing a Licensed Product, then until the earlier of(A) the date that AMRI obtains an alternative supply thereof or (B) *, at AMRI’soption, BMS shall supply such Licensed Product and Licensed Compounds to AMRI at * percent (*%) of BMS’ or its Affiliate’scost for such Licensed Product and/or Licensed Compounds (and in the case whereBMS or its Affiliate manufactures such Licensed Product and/or LicensedCompounds, such cost shall be * percent (*%) of BMS’ or its Affiliate’sfully-burdened manufacturing cost for such Licensed Product and/or LicensedCompounds), under terms and conditions mutually agreed between the Parties;provided however, if there are restrictions in an agreement between BMS or an Affiliate of BMS and aThird Party governing the manufacture or supply of such Licensed Product and/orany such Licensed Compound that would limit the amount of such Licensed Productand/or any such Licensed Compound that could be supplied to AMRI or that wouldpreclude the period from being up until *, then the limits in such agreement asto the amount of such Licensed Product and/or any such Licensed Compound thatcould be supplied shall govern and such period shall be up to as long a time aspermitted under such agreement and further provided that if BMS or itsAffiliate is manufacturing the

 

Confidential Treatment Requested

 

95

----

 

Licensed Compound and/orLicensed Product, BMS shall not be obligated to manufacture and supply suchLicensed Compound and/or Licensed Product in amounts that exceed the amounts ofsuch Licensed Compound and/or Licensed Product being manufactured by BMS or itsAffiliate as of the date of termination.

 

13.4.10    Subject to Section 13.12 andexcept for Excluded Compounds and Excluded Products, BMS shall transfer toAMRI, at the cost and expense of BMS, all marketing authorizations, INDs andother regulatory filings and Approvals, on a country-by-country basis, for anyLicensed Product that is being Developed and/or Commercialized by BMS or itsAffiliates or its (sub)licensees at the time of such termination.  In the event that in any country suchtransfer is not legally possible, BMS shall (and shall cause its Affiliates and(sub)licensees to) take all reasonable actions that are permitted by theapplicable Regulatory Authority to permit AMRI to also have the benefit of therelevant marketing authorizations, INDs and other regulatory filings andApprovals that exist at the time of termination for any such Licensed Product,including allowing AMRI to cross-reference data and information on file withany Regulatory Authority, and to this end, BMS (itself and on behalf of itsAffiliates) consents to and shall cause its sublicensees to consent to anyRegulatory Authority cross-referencing to the data and information on file withany Regulatory Authority to the extent that it exists at the time of suchtermination as may be necessary to facilitate the granting of permitted secondmarketing authorizations, INDs, regulatory filings and Approvals to AMRI.

 

13.4.11    The licenses granted under this Section 13.4 shall be royalty freeexcept for any license granted pursuant to Section 13.4.3 and any LicensedProduct that contains an ECN Compound or an Included Compound of an ECNCompound.  With respect to any LicensedProduct that contains an ECN Compound or an Included Compound of an ECNCompound, AMRI shall pay BMS a royalty of * percent (*%) of net sales

 

ConfidentialTreatment Requested

 

96

----

 

(calculated in the same manner as Net Sales) of such Licensed Productfor the same term and with the same reductions specified in Section 11.2 withrespect to Royalty Bearing Product except that there shall be no reduction inroyalties for Generic Products in a country until the sales of Generic Productsin such country in a Calendar Quarter exceed * (*) percent of the sum of allprescriptions for such form of such Royalty Bearing Product sold by AMRI, itsAffiliates and (sub)licensees and by the Third Party Seller(s) of such GenericProduct(s) in such country during such Calendar Quarter, and in such case, theroyalties shall be reduced by * (*) percent for such Calendar Quarter.    The terms and conditions set forth inSections 11.4 through 11.7 shall apply to AMRI with respect to such royaltypayments by AMRI in the same manner as they would apply to BMS prior to suchtermination.

 

13.5         Effect of Terminationby AMRI under Section 13.2.2.  Upontermination of this Agreement by AMRI under Section 13.2.2 or, with respect to all Licensed Compoundsand Licensed Products in each applicable country as to which termination occurspursuant to Section 13.2.2 hereof (the rights and obligations of the Parties asto all Licensed Compounds and Licensed Products in countries of the Territoryin which termination under Section 13.2.2 has not occurred, being unaffected bysuch termination):

 

13.5.1      Subject to Section 13.12, all rightsand licenses granted to BMS under Article 3 and sublicenses thereunder shallterminate in each applicable country and except for Excluded Compounds andExcluded Products, neither BMS nor its Affiliates shall Develop orCommercialize a Licensed Product and/or Licensed Compound.  AMRI shall have no rights or licenses with respectto Excluded Compounds and Excluded Products in each terminated country exceptfor those rights and licenses under Section 4.5, and no right to have anymarketing authorizations, INDs or other regulatory filings and Approvals forExcluded Compounds or Excluded Products in

 

Confidential Treatment Requested

 

97

----

 

any terminatedcountry assigned to it, and except as provided below in this Section 13.5.1,shall have no right to have access to any data or information concerningExcluded Compounds and Excluded Products. Upon such termination, BMS shallnotify AMRI in writing as to those Excluded Compounds and Excluded Products theDevelopment and/or Commercialization of which was terminated by BMS or one ofits Affiliates or sublicensees for Safety Reasons and the nature of such SafetyReasons. BMS agrees to make available for AMRI’s inspection, relevant data,materials and reports that support such Safety Reasons, provided that AMRIenters into an agreement with BMS or the relevant Affiliate or sublicensee ofBMS to maintain the confidentiality of such data, materials and reports.

 

13.5.2      Except for the Excluded Compounds andExcluded Products, BMS agrees to grant and hereby grants AMRI anexclusive license, with the right tosublicense, to research, Develop make, have made, use, export, import, offer tosell, sell and Commercialize Licensed Compounds and Licensed Products in theField in each terminated country under Patent Rights and Know-How that (a) areowned by BMS or its Affiliates as of the date of such termination, (b) areControlled by BMS or its Affiliates as of the date of such termination and (c)are reasonably required by AMRI to make, have made, use, sell, import, export,offer to sell, research, Develop or Commercialize Licensed Compounds and/orLicensed Products in the Field and, to the extent not previously transferred,BMS shall transfer to AMRI, at the cost and expense of BMS, the Know-Howlicensed to AMRI under this Section 13.5.2. For the avoidance of doubt, suchPatent Rights and Know How licensed under this Section 13.5.2 exclude researchtools and targets and Patent Rights Covering research tools and/ortargets.  Any sublicense shall be subjectto the terms and conditions of Article 9 and AMRI shall be liable for anybreach of Article 9 by a sublicensee.

 

ConfidentialTreatment Requested

 

98

----

 

13.5.3      In the event that prior to such termination, BMS is licensed underPatent Rights and/or Know How of a Third Party that have been used in aterminated country by BMS or its Affiliates prior to such termination withrespect to Licensed Compounds and/or Licensed Products other than ExcludedCompounds and/or Excluded Products, and such Patent Rights and/or Know-How arereasonably required by AMRI to make, have made, use, sell, offer to sell,import, export, research, Develop and/or Commercialize Licensed Compoundsand/or Licensed Products other than Excluded Compounds and Excluded Products ina terminated country and BMS has the right to grant a sublicense thereunder toAMRI at the time of such termination under Section 13.2.2, BMS shall notifyAMRI of such Patent Rights and Know-How, and then at the request of AMRI, BMSshall grant to AMRI such a sublicense to the fullest extent permitted under thelicense under which the sublicense is granted and subject to the terms,conditions and requirements thereof to make, have made, use, sell, offer tosell, import, export, research, Develop and/or Commercialize Licensed Compoundsand Licensed Products other than Excluded Compounds and Excluded Products ineach terminated country to the same extent and subject to the same restrictionsas set forth in Section 13.5.2.  Suchsublicense shall be granted in a separate agreement without additionalconsideration to BMS, provided that AMRI agrees to pay any and all amounts dueto such Third Party as a direct result of the granting of the sublicense andany other payments (royalties, milestones, etc.) due thereunder as a directresult of AMRI being a sublicensee and/or its activities as a sublicensee.

 

13.5.4      All amounts due and/orpayable to AMRI that were accrued, or that arise out of acts or eventsoccurring in a terminated country, prior to the effective date of terminationshall remain due and payable.

 

Confidential Treatment Requested

 

99

----

 

13.5.5       Should BMS have anyinventory of any Licensed Product licensed to BMS prior to the date of suchtermination that is Finished Product approved and allocated prior to terminationfor sale in a terminated country, BMS shall have six (6) months thereafter inwhich to dispose of such inventory (subject to the payment to AMRI of anyroyalties due hereunder thereon),

 

13.5.6      Neither Party shall berelieved of any obligation that accrued prior to the effective date of suchtermination.

 

13.5.7      The licenses granted to AMRIunder this Agreement shall remain in full force and effect except that suchlicense shall be for all Indications in each country where the licenses of BMShave been terminated.

 

13.5.8      Nothing in this Section 13.5shall be deemed to limit any remedy to which AMRI may be entitled by applicablelaw.

 

13.5.9      Except for Excluded Compounds and Excluded Products, in theevent that at the date of such termination BMS or its Affiliate or theirsupplier is responsible for manufacturing a Licensed Product and/or LicensedCompounds for the purposes of conducting clinical trials and/or forCommercializing a Licensed Product in or for a terminated country, then untilthe earlier of (A) the date that AMRI obtains an alternative supply thereof or(B) the second anniversary of the date of such termination in a terminatedcountry, at AMRI’s option, BMS shall supply such Licensed Product and LicensedCompounds to AMRI at * percent (*%) ofBMS’ or its Affiliate’s cost for such Licensed Product and/or LicensedCompounds (and in the case where BMS or its Affiliate manufactures suchLicensed Product and/or Licensed Compounds, such cost shall be * percent (*%) ofBMS’ or its Affiliate’s fully-burdened manufacturing cost for such LicensedProduct and/or Licensed Compounds), under terms and conditions mutually agreedbetween the Parties;

 

Confidential Treatment Requested

 

100

----

 

providedhowever, if there are restrictions in an agreement between BMS or an Affiliate of BMS and aThird Party governing the manufacture or supply of such Licensed Product and/orany such Licensed Compound that would limit the amount of such Licensed Productand/or any such Licensed Compound that could be supplied to AMRI or that wouldpreclude the period from being up until the second anniversary of the date ofsuch termination, then the limits in such agreement as to the amount of suchLicensed Product and/or any such Licensed Compound that could be supplied shallgovern and such period shall be up to as long a time as permitted under suchagreement and further provided that if BMS or its Affiliate is manufacturingthe Licensed Compound and/or Licensed Product, BMS shall not be obligated tomanufacture and supply such Licensed Compound and/or Licensed Product inamounts that exceed the amounts of such Licensed Compound and/or LicensedProduct being manufactured by BMS or its Affiliate as of the date oftermination.

 

13.5.10    Subject to Section 13.12 and except for Excluded Compounds and ExcludedProducts, at the cost and expense of BMS, BMS shall transfer to AMRI allmarketing authorizations, INDs and other regulatory filings and Approvals in aterminated country for any Licensed Product that is being Developed and/orCommercialized by BMS or its Affiliates or its (sub)licensees in suchterminated country as of the date of such termination.  In the event that in any terminated countrysuch transfer is not legally possible, BMS shall (and shall cause itsAffiliates and (sub)licensees to) take all reasonable actions that arepermitted by the applicable Regulatory Authority to permit AMRI to also havethe benefit of the relevant marketing authorizations, INDs and other regulatoryfilings and Approvals in such terminated country that exist at the time oftermination for any such Licensed Product in such terminated country, includingallowing AMRI to cross-reference data and information on file with theRegulatory Authority in such terminated country, and to this end, BMS (itselfand on

 

Confidential Treatment Requested

 

101

----

 

behalf of its Affiliates) consents to and shall cause its sublicenseesto consent to such Regulatory Authority cross-referencing to the data andinformation on file with such Regulatory Authority to the extent that it existsat the time of such termination as may be necessary to facilitate the grantingof permitted second marketing authorizations, INDs, regulatory filings andApprovals in such terminated country to AMRI.

 

13.5.11    The licenses granted under this Section 13.5shall be royalty free except for any license granted pursuant to Section 13.5.3and any Licensed Product that contains an ECN Compound or an Included Compoundof an ECN Compound. With respect to Licensed Product that contains an ECNCompound or an Included Compound of an ECN Compound, AMRI shall pay BMS aroyalty of * percent (*%) of net sales (calculated in the same manner as NetSales) of such Licensed Product for the same term and with the same reductionsspecified in Section 11.2 with respect to Royalty Bearing Product except thatthere shall be no reduction in royalties for Generic Products in a countryuntil the sales of Generic Products in such country in a Calendar Quarterexceed * (*) percent of the sum of all prescriptions for such form of suchRoyalty Bearing Product sold by AMRI, its Affiliates and (sub)licensees and bythe Third Party Seller(s) of such Generic Product(s) in such country duringsuch Calendar Quarter, and in such case, the royalties shall be reduced by * (*)percent for such Calendar Quarter. The terms and conditions set forth inSections 11.4 through 11.7 shall apply to AMRI with respect to such royaltypayments by AMRI in the same manner as they would apply to BMS prior to suchtermination.

 

13.6         Effectof Termination by BMS for AMRI Breach. Upon termination of this Agreementby BMS pursuant to Section 13.3.2:

 

13.6.1      Subjectto Section 13.12, all rights and licenses granted to BMS and sublicensesgranted thereunder shall terminate, and except for Excluded Compounds and 

 

Confidential Treatment Requested

 

102

----

 

Excluded Products BMS shall not Develop and/or Commercialize anyLicensed Compound and/or any Licensed Product.

 

13.6.2      Allamounts due and/or payable to AMRI that were accrued, and/or that arise out ofacts and/or events occurring, prior to the effective date of termination shallremain due and payable.

 

13.6.3      NeitherParty shall be relieved of any obligation that accrued prior to the EffectiveDate of such termination or expiration.

 

13.6.4      Nothingin this Section 13.6 shall be deemed to limit any remedy to which BMS may beentitled by applicable Law.

 

13.6.5      Subject to Section 13.12, all rights andlicenses granted to AMRI under this Agreement (except for the rights andlicenses granted under Section 4.5), including but not limited to all rightsand licenses granted under Section 4.2.2, shall terminate, and AMRI shall notDevelop and/or Commercialize any BMS Compound and/or any Licensed Productcontaining a BMS Compound.

 

13.7         Effect of Termination by BMS Under Section13.3.1. Upon termination ofthis Agreement under Section 13.3.1, with respect to each applicable LicensedCompound and/or Licensed Product (such terminated Licensed Compounds andterminated Licensed Products being collectively “Terminated Products”) in eachapplicable country as to which termination occurs pursuant to Section 13.3.1hereof (such countries being collectively “Terminated Countries”) (the rightsand obligations of the Parties as to the remaining Licensed Products andLicensed Compounds and countries of the Territory in which termination underSection 13.3.1 has not occurred, being unaffected by such termination):

 

13.7.1      Subject to Section 13.12, all rights and licenses granted to BMSunder Article 3 and sublicenses thereunder shall terminate for TerminatedProducts in Terminated Countries and except for Excluded Compounds and ExcludedProducts, neither BMS 

 

Confidential Treatment Requested

 

103

----

 

nor its Affiliates shall Develop and/or Commercialize TerminatedProducts in Terminated Countries. AMRI shall have no rights or licenses withrespect to Excluded Compounds and Excluded Products in Terminated Countriesexcept for those rights and licenses under Section 4.5, and no right to haveany marketing authorizations, INDs or other regulatory filings and Approvalsfor Excluded Compounds or Excluded Products in Terminated Countries assigned toit under this Section 13.7, and except as provided below in this Section13.7.1, shall have no right to have access to any data or informationconcerning Excluded Compounds and Excluded Products under this Section 13.7. Uponsuch termination, BMS shall notify AMRI in writing as to those ExcludedCompounds and Excluded Products the Development and/or Commercialization ofwhich was terminated by BMS or one of its Affiliates or sublicensees for SafetyReasons and the nature of such Safety Reasons. BMS agrees to make available forAMRI’s inspection, relevant data, materials and reports that support such SafetyReasons, provided that AMRI enters into an agreement with BMS or the relevantAffiliate or sublicensee of BMS to maintain the confidentiality of such data,materials and reports.

 

13.7.2      Except for Excluded Compounds and ExcludedProducts, BMS agrees to grant and hereby grants AMRI an exclusive license, with the right to sublicense, toresearch, Develop, make, have made, use, export, import, offer to sell, selland Commercialize Terminated Compounds in the Field in each Terminated Countryunder Patent Rights and Know-How that (a) are owned by BMS or its Affiliates asof the date of such termination, (b) are Controlled by BMS or its Affiliates asof the date of such termination and (c) are reasonably required by AMRI tomake, have made, use, sell, offer to sell, import, export, research, Developand/or Commercialize Terminated Products in the Field and, to the extent notpreviously transferred, BMS shall transfer to AMRI, at the cost and expense ofAMRI, the Know-How licensed to AMRI under this Section 13.7.2. For theavoidance of doubt, AMRI shall be responsible for all 

 

ConfidentialTreatment Requested

 

104

----

 

internal costs (includingcosts of employee time) and out-of pocket expenses incurred by BMS for thetransfer of such Know-How. For the avoidance of doubt, such Patent Rights andKnow How licensed under this Section 13.7.2 exclude research tools and targetsand Patent Rights Covering research tools and/or targets. Any sublicense shallbe subject to the terms and conditions of Article 9 and AMRI shall be liablefor any breach of Article 9 by a sublicensee.

 

13.7.3      In the event that prior to such termination,BMS is licensed under Patent Rights and/or Know How of a Third Party that havebeen used in a Terminated Country by BMS or its Affiliates prior to suchtermination with respect to Terminated Products other than Excluded Compoundsand/or Excluded Products, and such Patent Rights and/or Know-How are reasonablyrequired by AMRI to make, have made, use, sell, offer to sell, import, export,research, Develop and/or Commercialize Terminated Products other than ExcludedCompounds and Excluded Products in a Terminated Country and BMS has the rightto grant a sublicense thereunder to AMRI at the time of such termination underSection 13.3.1, BMS shall notify AMRI of such Patent Rights and Know-How, andthen at the request of AMRI, BMS shall grant to AMRI such a sublicense to thefullest extent permitted under the license under which the sublicense isgranted and subject to the terms, conditions and requirements thereof to make,have made, use, sell, offer to sell, import, export, research, Develop and/orCommercialize Terminated Products other than Excluded Compounds and ExcludedProducts in each Terminated Country to the same extent and subject to the samerestrictions as set forth in Section 13.7.2. Such sublicense shall be grantedin a separate agreement without additional consideration to BMS, provided thatAMRI agrees to pay any and all amounts due to such Third Party as a directresult of the granting of the sublicense and any other payments (royalties,milestones, etc.) due 

 

ConfidentialTreatment Requested

 

105

----

 

thereunder as a directresult of AMRI being a sublicensee and/or its activities as a sublicensee.

 

13.7.4      The licenses granted under this Section 13.7shall be royalty free except for any license granted pursuant to Section 13.7.3and any Terminated Product that contains an ECN Compound or an Included Compoundof an ECN Compound. With respect to any Terminated Product that contains an ECNCompound or an Included Compound of an ECN Compound, AMRI shall pay BMS aroyalty of * percent (*%) of net sales (calculated in the same manner as NetSales) of such Terminated Product for the same term and with the samereductions specified in Section 11.2 with respect to Royalty Bearing Product,except that there shall be no reduction in royalties for Generic Products in acountry until the sales of Generic Products in such country in a CalendarQuarter exceed * (*) percent of the sum of all prescriptions for such form ofsuch Royalty Bearing Product sold by AMRI, its Affiliates and (sub)licenseesand by the Third Party Seller(s) of such Generic Product(s) in such countryduring such Calendar Quarter, and in such case, the royalties shall be reducedby * (*) percent for such Calendar Quarter. The terms and conditions set forthin Sections 11.4 through 11.7 shall apply to AMRI with respect to such royaltypayments by AMRI in the same manner as they would apply to BMS prior to suchtermination.

 

13.7.5All amounts due and/or payable to AMRI that were accrued, or that arise out ofacts or events occurring, prior to the effective date of termination shallremain due and payable.

 

13.7.6 Should BMS have any inventory of any Licensed Product licensedto BMS prior to the date of such termination that is Finished Product approvedand allocated prior to termination for sale in a terminated country, BMS shallhave six (6) months thereafter in which to dispose of such inventory (subjectto the payment to AMRI of any royalties due hereunder thereon),

 

Confidential Treatment Requested

 

106

----

 

13.7.7  Neither Party shall be relieved of any obligationthat accrued with respect to a Terminated Product in a Terminated Country priorto the effective date of such termination.

 

13.7.8 The licenses granted to AMRI under this Agreement shall remainin full force and effect, except that the licenses shall be for all Indicationsthat are not Reserved Indications in the Terminated Countries.

 

13.7.9Nothing in this Section 13.7 shall be deemed to limit any remedy to which BMSmay be entitled by applicable law.

 

13.7.10Except for Excluded Compounds and Excluded Products, in the event thatat the date of such termination BMS or its Affiliate or their supplier isresponsible for manufacturing a Terminated Product for the purposes ofconducting clinical trials and/or for Commercializing a Terminated Product fora Terminated Country, then until the earlier of (A) the date that AMRI obtainsan alternative supply thereof or (B) the second anniversary of the date of suchtermination, at AMRI’s option, BMS shall supply such Terminated Product to AMRIat * percent (*%) of BMS’ or itsAffiliate’s cost for such Terminated Product (and in the case where BMS or itsAffiliate manufactures such Terminated Product, such cost shall be * percent (*%)of BMS’ or its Affiliate’s fully-burdened manufacturing cost for such TerminatedProduct), under terms and conditions mutually agreed between the Parties;provided however, if there are restrictions in an agreement between BMS or an Affiliate of BMS and aThird Party governing the manufacture or supply of such Terminated Product thatwould limit the amount of such Terminated Product that could be supplied toAMRI or that would preclude the period from being up until the secondanniversary of the date of such termination, then the limits in such agreementas to the amount of such Terminated Product that could be supplied shall governand such period shall be up to as long a time as permitted under such agreementand further provided that if BMS or its Affiliate is manufacturing theTerminated Product, BMS shall not be obligated to manufacture and supply suchTerminated 

 

Confidential Treatment Requested

 

107

----

 

Productin amounts that exceed the amounts of such Terminated Product beingmanufactured by BMS or its Affiliate as of the date of termination.

 

13.7.11 Subject to Section13.12 and except for Excluded Compounds and Excluded Products, at the cost andexpense of AMRI, BMS shall transfer to AMRI all marketing authorizations, INDsand other regulatory filings and Approvals, on a country-by-country basis, forany Terminated Product in a Terminated Country that is being Developed and/orCommercialized by BMS or its Affiliates or its (sub)licensees at the time ofsuch termination. For the avoidance of doubt, AMRI shall be responsible for allinternal costs (including costs of employee time) and out-of pocket expensesincurred by BMS for the transfer of such regulatory filings and Approvals. Inthe event that in any Terminated Country such transfer is not legally possible,BMS shall (and shall cause its Affiliates and (sub)licensees to) take allreasonable actions that are permitted by the applicable Regulatory Authority topermit AMRI to also have the benefit of the relevant marketing authorizations,INDs and other regulatory filings and Approvals that exist at the time oftermination for any such Terminated Product, including allowing AMRI tocross-reference data and information on file with any Regulatory Authority, andto this end, BMS (itself and on behalf of its Affiliates) consents to and shallcause its sublicensees to consent to any Regulatory Authority cross-referencingto the data and information on file with any Regulatory Authority to the extentthat it exists at the time of such termination as may be necessary tofacilitate the granting of permitted second marketing authorizations, INDs,regulatory filings and Approvals to AMRI.

 

13.8                 Effectof Expiration of this Agreement. Upon expiration of this Agreement:

 

Confidential Treatment Requested

 

108

----

 

13.8.1      Allamounts due and/or payable to BMS or AMRI that were accrued, and/or that ariseout of acts and/or events occurring, prior to the effective date of expirationshall remain due and payable.

 

13.8.2      NeitherParty shall be relieved of any obligation that accrued prior to the effectivedate of such expiration.

 

13.8.3      Thelicense with respect to AMRI Technology granted under Section 3.1 shall remainin effect and shall be fully paid up, subject to the terms of this Agreement.

 

13.8.4      Thelicenses granted under Sections 4.2.2 and 4.5 shall remain in effect and shallbe fully paid up.

 

13.9         Scopeof Termination. Except as otherwise expressly provided herein, terminationof this Agreement shall be as to all countries in the Territory and allLicensed Compounds and Licensed Products.

 

13.10       Survival.The following provisions shall survive termination or expiration of thisAgreement, as well as any other provisions which by their nature are intendedto survive termination or expiration: Articles 9, 12, 13, 16, 17 and 18 andSections 3.1(f), 3.6, 4.5, 11.4-11.7 (with respect to royalties and paymentsthat accrued prior to expiration or termination), 14.1 and 14.4 (with respectto any infringement or suspected infringement by a Third Party occurring priorto the termination or expiration of this Agreement).

 

13.11       Order of Divestment.

 

13.11.1    In the event that BMS or its Affiliate isordered by a government agency to divest all or any portion of the businessrelating to its efforts to Develop and/or Commercialize Licensed Compoundsand/or Licensed Products, subject to Section 13.11.2, BMS shall have the rightto divest all or such portion of such business (as the case may be), whichright shall include, but not be limited to, the right to assign to one or moreThird Parties, without the consent of AMRI, all of BMS’ rights and obligationsunder 

 

Confidential Treatment Requested

 

109

----

 

thisAgreement with respect to all or such portion of such business. AMRI shallfully cooperate with BMS and take any actions that BMS reasonably requests,including amending this Agreement, in order to effect any such divestitureduring the time period set by such government agency to divest all or any suchportion of such business. During such time period, BMS shall provide AMRI withthe opportunity to bid on all or such portion of such business and shallconsider any bid by AMRI in good faith.

 

13.11.2    In the event that BMS or its Affiliate isordered by a government agency to divest all or portion of the businessrelating to its efforts to Develop and/or Commercialize Licensed Compoundsand/or Licensed Products during the Research Term and no Licensed Product is ina clinical trial or is being Commercialized, then BMS and its Affiliates shallassign such business to AMRI * to AMRI, except that AMRI shall be responsiblefor the costs and expenses incurred by BMS to transfer any Know-How and anyregulatory filings associated with such business. For the avoidance of doubt,AMRI shall be responsible for all internal costs (including costs of employeetime) and out-of pocket expenses incurred by BMS for the transfer of suchKnow-How and regulatory filings.

 

13.12       Sublicense Survival. In the event that any license granted to aParty under this Agreement is terminated (a “Terminated Party”) and theTerminated Party has granted a sublicense thereunder to a Third Partysublicensee, then the other Party (the “Non-Terminated Party”) shall grant adirect license to such sublicensee under the terms and conditions of thisAgreement to the extent of such sublicense, provided that such sublicenseeagrees to be bound to the Non-Terminated Party under the terms and conditionsof this Agreement and such sublicensee is not in material breach of itsagreement for such sublicense with the Terminated Party (or if it is inmaterial breach, such sublicensee does not cure such breach within sixty 

 

Confidential Treatment Requested

 

110

----

 

(60)days of the termination of the license from the Non-Terminated Party to theTerminated Party with respect to such sublicensed rights). In the event that theNon-Terminated Party is AMRI and AMRI grants a direct license to suchsublicensee, such sublicensee shall not be required to transfer to AMRI uponthe termination of such license granted to BMS under this Agreement anymarketing authorizations, INDs and/or other regulatory filings and Approvalsfor any Licensed Product being Developed and/or Commercialized by such sublicensee.Any such direct license between the Non-Terminated Party and such sublicenseeshall not prejudice any remedy a Party may have against another Party inconnection with such termination of the license to the Terminated Party underthis Agreement (in whole or in part), the Terminated Party shall no longer beobligated under this Agreement to pay amounts set forth in this Agreement, tothe extent such amounts are payable based on the activities of suchsublicensee, its Affiliates and its sublicensees from and after the effectivedate of such termination, under such direct license, and such direct licenseshall not modify the rights and obligations of the Parties following anytermination of the license to the Terminated Party under this Agreement or thetermination of this Agreement in whole or in part.

 

**14.****          INTELLECTUALPROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS**

 

14.1         **Program Inventions.**Inventorship of inventions conceivedand/or reduced to practice in the course of conducting activities under thisAgreement shall be determined by application of United States patent lawspertaining to inventorship. If such inventions are jointly invented in thecourse of such activities by one or more employees or consultants orcontractors of both Parties, such inventions shall be jointly owned by theParties (a **“Joint Invention”)**, and ifone or more claims included in an issued patent or pending patent applicationwhich is filed in a patent office in the Territory claim such Joint Invention,such patent or patent application, respectively, shall be jointly owned by theParties. If such an invention is solely invented in the course of suchactivities by one or more employees or consultants or contractors of a 

 

Confidential Treatment Requested

 

111

----

 

Party, such invention shall be solely owned by such Party (a **‘Sole Invention”**), and any patent application filed and anypatent issuing therefrom claiming such solely owned invention (and no JointInvention) shall also be solely owned by such Party. This Agreement shall beunderstood to be a joint research agreement in accordance with 35 U.S.C.§ 103I(3) to develop the Licensed Compounds and Licensed Products. EachParty shall enter into binding agreements obligating all employees andconsultants performing activities under or contemplated by this Agreement,including but not limited to activities related to the AMRI Patent Rights,Licensed Compounds and/or Licensed Products, to assign his/her interest in anyinvention conceived and/or reduced to practice in the course of such activitiesto the Party for which such employee or consultant is providing its services. Withrespect to contractors, each Party shall use good faith and diligent efforts tosecure an agreement from such contractor to assign or license (with the rightto sublicense) to such Party inventions (and patent rights Covering suchinventions) made by such contractor in performing such services for such Party.

 

14.2         **Filing, Prosecution and Maintenance of Patent Rights**.

 

14.2.1      AMRIshall be responsible, using outside patent counsel free of ethical conflictsand mutually agreed upon by AMRI and BMS, for the preparation, filing,prosecution (including, without limitation, any interferences, reissueproceedings and reexaminations) and maintenance of the AMRI Patent Rights,including AMRI Patent Rights claiming Joint Inventions.

 

14.2.2      Subjectto Section 14.2.8, starting on the Effective Date and during the CombinedPeriod BMS shall be responsible for the costs and expenses incurred by AMRIwith respect to the preparation, filing, prosecuting and maintenance of AMRIPatent Rights and thereafter the Parties shall equally share such costs andexpenses of AMRI Patent Rights, except for AMRI Patent Rights that are solelydirected to Retained 

 

Confidential Treatment Requested

 

112

----

 

Products and/or solely directed to Released Products for which suchcosts and expenses shall be paid only by BMS and only by AMRI, respectively. BMSmay, at its option and with prior written notice to AMRI, discontinue itspayment obligations for costs incurred in connection with the filing,prosecution and maintenance of one or more particular patent(s) or patentapplication(s) within the AMRI Patent Rights in one or more countries. It isunderstood that BMS’ rights in accordance with this Agreement, under suchpatent or patent application in such country, would terminate (such patent orpatent application hereinafter, a “Cost-terminated” patent or patentapplication), but that all remaining rights and licenses under all otherpatent(s) and patent application(s) of the AMRI Patent Rights would remain ineffect. It is also understood that BMS will be offered the opportunity toassume all costs for the filing, prosecution, and maintenance of any patent orpatent application claiming priority directly or indirectly from suchCost-terminated patent or patent application, and that where all such costs areassumed by BMS, BMS will be afforded all rights and licenses contemplated bythis Agreement for the AMRI Patent Rights (other than Cost-terminated patentsor patent applications) in connection with such patent or patent application.

 

14.2.3      AMRIshall provide BMS with quarterly updates of the filing, prosecution andmaintenance status for each of the AMRI Patent Rights.

 

14.2.4      TheParties shall cooperate fully in the preparation, filing, prosecution andmaintenance of the AMRI Patent Rights. TheParties agree to confer, and meet as necessary, through their respectivein-house patent counsels or other in-house legal representatives, together withoutside counsel selected in accordance with Section 14.2.1 in order to maximizethe potential for different patents to separately Cover, respectively, RetainedCompounds (or compounds likely to be Retained Compounds) 

 

Confidential Treatment Requested

 

113

----

 

andReleased Compounds (or compounds likely to be Released Compounds), such as by,without limitation, the filing of appropriate divisional or continuationapplications, or original applications, Covering particular subject matter.

 

14.2.5      AMRIshall reasonably consult with and cooperate with BMS with respect to thepreparation, filing, prosecution and maintenance of the AMRI Patent Rights. Suchconsultation and cooperation shall include, but not be limited to, AMRIproviding BMS with a copy of each patent application included in the AMRIPatent Rights that AMRI intends to file in sufficient time for BMS to provide itscomments with respect to such patent application before such patent applicationis filed by AMRI, and providing BMS with a copy of all material officialcorrespondence to or from patent offices in sufficient time for BMS to provideits comments with respect to such correspondence before a response to any suchcorrespondence is filed by AMRI.

 

14.2.6      BMSmay file a notice with governmental patent offices of the exclusive license tothe AMRI Patent Rights granted to BMS hereunder.

 

14.2.7      BMSshall be responsible for the preparation, filing, prosecution (includingwithout limitation, any interferences, reissue proceedings and reexaminations)and maintenance of the BMS Licensed Patent Rights, except for those claimingJoint Inventions (which are handled pursuant to Sections 14.2.1 and 14.2.2) andcosts associated in connection therewith.

 

14.2.8      *

 

14.3         **Patent Abandonment**. In no event shall AMRI permit any of theAMRI Patent Rights to be abandoned, or elect not to file a new patent 

 

Confidential Treatment Requested

 

114

----

 

application claiming priority to a patent application within the AMRIPatent Rights either before such patent application’s issuance or within thetime period required for the filing of an international (i.e., PatentCooperation Treaty), regional (including European Patent Office) or nationalapplication, without BMS first being given an opportunity to assume fullresponsibility for the continued prosecution and maintenance of such AMRIPatent Rights, or the filing of such new patent application. AMRI shall provideBMS with notice of the allowance and expected issuance date of any such patentwithin the AMRI Patent Rights, or any of the aforementioned filing deadlines. Inthe event that AMRI decides either (i) not to continue the prosecution ormaintenance of a patent application or patent within the AMRI Patent Rights inany country as permitted in this Section 14.3 or (ii) not to file such newpatent application requested to be filed by BMS, AMRI shall provide BMS with****notice of this decision at least thirty (30) days prior toany pending lapse or abandonment thereof. In such event, AMRI shall provide BMSwith an opportunity to assume responsibility for the filing and/or furtherprosecution and maintenance of such patent application and any patent issuingthereon (such filing to occur prior to the issuance of the patent to which theapplication claims priority or expiration of the applicable filing deadline, asset forth above). In the event that BMS assumes such responsibility for suchfiling, prosecution and maintenance costs, AMRI shall transfer at BMS’ soleoption the responsibility for such filing, prosecution and maintenance of suchpatent applications and patents to patent counsel selected by BMS andreasonably acceptable to AMRI. In such case, BMS shall provide AMRI with anupdate of the filing, prosecution and maintenance status for each of suchpatent applications and patents, including copies of any material officialcorrespondence to or from patent offices. BMS shall reasonably consult with andcooperate with AMRI with respect to the preparation, prosecution andmaintenance of such patent applications and patents. Such patent applicationsand patents shall otherwise continue to be subject to all of the terms andconditions of the Agreement in the same way as the other AMRI Patent Rights.

 

Confidential Treatment Requested

 

115

----

 

14.4         **Enforcement of AMRI Patent Rights Against Infringers**.

 

14.4.1      (a) In the event that BMS or AMRI becomes aware of a suspectedinfringement of any AMRI Patent Right or BMS Licensed Patent Right in theField, such Party shall notify the other Party promptly, and following suchnotification, the Parties shall confer. The Lead Party shall have the right,but shall not be obligated, to bring an infringement action for suspectedinfringement of its Lead Party Patent Rights in the Field at its own expense,in its own name and entirely under its own direction and control, subject tothe following. The Party which is not the Lead Party (“**Non-LeadParty**”) shall reasonably assist the Lead Party (at the Lead Party’sexpense) in any action or proceeding being prosecuted for such suspectedinfringement if so requested, including by being named or joined as a plaintiffto such actions or proceedings if requested by the Lead Party or required bylaw. The Non-Lead Party if not requested to participate shall have the right tovoluntarily participate and be represented in any such suit by its own counselat its own expense.

 

(b)  No settlement of any such action orproceeding which restricts the scope, or adversely affects the enforceabilityor validity, of a Lead Party Patent Right in the Field may be entered into bythe Lead Party without the prior written consent of the Non-Lead Party, whichconsent shall not be unreasonably withheld, delayed or conditioned. Further, nosettlement of any such action or proceeding which pertains to the infringementof the Lead Party Patent Rights by virtue of the Development orCommercialization of a Licensed Compound in the Field by a Third Party that isnot a sublicensee may be entered into by the Lead Party without the priorwritten consent of the Non-Lead Party, which consent shall not be unreasonably withheld,delayed or conditioned except no consent shall be required with respect to thegranting of a sublicense to the extent that the Lead Party has the right underthis Agreement to grant such a sublicense. Consent under this Section 14.4.1(b)is not required where 

 

Confidential Treatment Requested

 

116

----

 

BMSis the Lead Party enforcing a BMS Licensed Patent Right not claiming a JointInvention, and that is not licensed to AMRI under this Agreement with respectto a Released Compound and/or Released Product. Consent under this Section14.4.1 (b) is not required after the Combined Period, where AMRI is the LeadParty enforcing an AMRI Patent Right not claiming a Joint Invention that is notlicensed to BMS for a Retained Product and/or Retained Compound.

 

I   Notwithstanding anything else to thecontrary in this Agreement, in the event that AMRI grants a (sub)license underAMRI Technology and/or BMS Technology with respect to one or more ReleasedCompounds and/or Released Products and such (sub)licensee (or its (sub)licensee)Develops and/or Commercializes such a Released Compound and/or Released Productfor a Reserved Indication, BMS shall have the right to enforce the AMRI PatentRights and/or BMS Licensed Patent Rights by bringing an infringement actionwith respect to such Development and/or Commercialization by such (sub)licensee(or its (sub)licensee) of such Released Compound and/or Released Product forsuch Reserved Indication. The provisions of Section 14.4.1(a) shall beapplicable to any infringement action brought by BMS pursuant to this Section14.4.1(c), and BMS shall be considered the Lead Party, AMRI shall be consideredthe Non-Lead Party, and the applicable AMRI Patent Rights and/or BMS Licensed PatentRights shall be considered Lead Party Patent Rights of BMS for the purposes ofso applying Section 14.4.1(a). No settlement of any such infringement actionbrought pursuant to this Section 14.4.1(c) which restricts the scope oradversely affects the enforceability or validity of an AMRI Patent Right may beentered into by BMS without the prior consent of AMRI, which consent shall notbe unreasonably withheld, delayed or conditioned.

 

14.4.2      Enforcement by Non-Lead Party. If the Lead Party elects not to bring any action for infringementdescribed in Section 14.4.1 and so notifies the Non-Lead Party, then the 

 

Confidential Treatment Requested

 

117

----

 

Non-LeadParty may bring such action at its own expense, in its own name and entirelyunder its own direction and control, subject to the following, and to thewritten consent of the Lead Party, such consent to not be unreasonably withheld.The Non-Lead Party shall include in any such action a claim agreed upon by theParties for reasonable damages suffered by the Lead Party as a result of suchinfringement in an amount to be agreed upon by the Parties (**“Lead Party Infringement Damages”**). The Lead Party shallreasonably assist the Non-Lead Party (at the Non-Lead Party’s expense) in anyaction or proceeding being prosecuted if so requested, including by being namedor joined as a plaintiff to such actions or proceedings if requested by theNon-Lead Party or required by law. The Lead Party shall have the right to participateand be represented in any such suit by its own counsel at its own expense. Nosettlement of any such action or proceeding which restricts the scope, oradversely affects the validity or enforceability, of any Lead Party PatentRight may be entered into by the Non-Lead Party without the prior writtenconsent of the Lead Party, which consent shall not be unreasonably withheld,delayed or conditioned. This Section 14.4.2 is not applicable where AMRI is theNon-Lead Party and the Patent Right is a BMS Licensed Patent Right not claiminga Joint Invention, unless such Patent Right is licensed to AMRI under thisAgreement with respect to a Released Compound and/or Released Product.

 

14.4.3      Withdrawal. Ifeither Party brings an action or proceeding under this Section 14.4 andsubsequently ceases to pursue or withdraws from such action or proceeding, itshall promptly notify the other Party and the other Party may substitute itselffor the withdrawing Party under the terms of this Section 14.4.

 

14.4.4      EachParty authorizes both its in-house attorneys and outside counsel that are ormay be involved in the Actions to consult and cooperate with the attorneys forthe other 

 

Confidential Treatment Requested

 

118

----

 

Party in preparing for, defending, or pursuing claims against ThirdParties in the Actions.

 

14.4.5      Toensure the protection of the mental impressions, conclusions, opinions, legaltheories, and other work product of counsel, as well as to ensure the protectionof client confidences and other attorney-client privileged and work productimmune information, and all information, documents, and other materialsdirectly or indirectly derived therefrom (hereinafter referred to collectivelyas “Privileged Information”), each Party agrees that any such PrivilegedInformation it or its counsel receives from the other Party or its counsel inconnection with joint efforts in the preparation for, defense, or pursuit ofclaims in the Actions shall be deemed subject to the terms of this Agreement (“AgreementPrivileged Information”).

 

14.4.6      EitherParty may designate any information, documents, or materials as “PrivilegedInformation” by so stating in connection with any oral or telephoniccommunication, and/or by so marking or labeling any documents or materials. Sucha designation is not required for protection under this Agreement.

 

14.4.7      Subjectto Section 14.4.9, each Party shall honor the other Party’s claim that anyAgreement Privileged Information is subject to applicable attorney/clientprivilege, work product protection, joint defense privilege, or other privilegeor protection until such claim is withdrawn by the Party making it or isfinally determined by a court to be invalid. Such claims of privilege orprotection may not be waived by any Party to this Agreement without the priorwritten consent of the Party that produced or disclosed such AgreementPrivileged Information.

 

Confidential Treatment Requested

 

119

----

 

14.4.8      Ifany person or entity requests or demands access to Agreement PrivilegedInformation provided pursuant to this Agreement, by subpoena or otherwise, theParty receiving the demand or subpoena shall immediately notify the Party whosupplied that Agreement Privileged Information. The Party receiving the demandor subpoena shall take all steps necessary or appropriate to permit theassertion of all applicable rights and privileges with regard to said AgreementPrivileged Information in the appropriate forums, including providing anopportunity for the Party from whom the Agreement Privileged Informationoriginated to assert all applicable rights and privileges, and shall cooperatefully in any proceedings relating to the disclosure sought.

 

14.4.9      Otherthan the disclosures authorized by this Agreement to be made among the Partiesand their attorneys, the Parties shall not disclose any Agreement PrivilegedInformation to any other person or body without the written consent of theother Party that produced or disclosed such Agreement Privileged Information,or an order of a court, or the receiving Party’s determination that, it itsopinion, the Agreement Privileged Information is not entitled to remainprivileged. In the latter case (that is, where the receiving Party has madesuch determination), the receiving Party shall provide an opportunity, to theextent it will not be prejudiced in doing so, for the disclosing Party topresent its arguments in support of privilege to a court for consideration. NeitherParty shall use Agreement Privileged Information for any purpose other than forpreparing, instituting, prosecuting and/or defending the Actions.

 

14.4.10    TheParties may, pursuant to this Agreement, exchange confidential proprietarybusiness or trade information or documents (“Confidential Documents”). EachParty agrees to maintain the confidentiality of any documents so designated bythe other 

 

Confidential Treatment Requested

 

120

----

 

Party. If any person or entity requests or demands access toConfidential Documents provided to one Party by the other Party pursuant tothis Agreement, by subpoena or otherwise, counsel for the Party receiving thedemand or subpoena shall immediately notify counsel for the Party who suppliedthose Confidential Documents. Counsel receiving the demand or subpoena shallcooperate with counsel for the other Party by taking all steps necessary orappropriate to permit the assertion of all applicable rights and privilegeswith regard to Confidential Documents in the appropriate forums and shallcooperate fully in any proceeding relating to the disclosure sought.

 

14.4.11    Inthe event that a Party to this Agreement ultimately becomes an adverse party tothe other Party in an Action or in any other litigation arising out of thesubject matter of an Action, it is expressly agreed that any AgreementPrivileged Information obtained exclusively pursuant to this Agreement shallnot be admissible as evidence at trial in such litigation unless it isdetermined by a court that the Agreement Privileged information is not entitledto remain privileged.

 

14.4.12    Damages In the event that either Party exercises the rights conferred in thisSection 14.4 and recovers any damages or other sums in such action, suit orproceeding or in settlement thereof, such damages or other sums recovered shallfirst be applied to all out-of-pocket costs and expenses incurred by theParties in connection therewith, including, without limitation, attorneys fees.If such recovery is insufficient to cover all such costs and expenses of bothParties, it shall be shared in proportion to the total of such costs andexpenses incurred by each Party. If after such reimbursement any funds shallremain from such damages or other sums recovered, such funds shall (i) belongto AMRI to the extent that they result from damages with respect to a ReleasedCompound and/or Released Product and (ii) belong to BMS to the extent that theyresult from a Licensed Product and/or Licensed Compound that is not a ReleasedCompound and/or Released Product and BMS shall pay to AMRI out of 

 

Confidential Treatment Requested

 

121

----

 

 

suchamounts an amount equal to the lost royalties that AMRI would have received ifBMS had sold such Licensed Products and/or Licensed Compounds.

 

14.4.13    In the event that a Party joins an Actionunder this Article 14 at the request of the other Party or is required to joinan action under this Article 14, and in each such case such Party joins suchAction, then the other Party shall indemnify and hold harmless such Party fromand against any judgment, damages or liabilities incurred by such Party inconnection with or as a result of such Action provided that such judgment,damages or liabilities does not result from a claim that such Party hasindemnification obligations to the other Party pursuant to Article 12 of thisAgreement.

 

14.5         PatentExtensions. BMS and AMRI shall each cooperate with one another and shalluse Commercially Reasonable Efforts in obtaining patent term extension(including without limitation, any pediatric exclusivity extensions as may beavailable) or supplemental protection certificates or their equivalents in anycountry with respect to AMRI Patent Rights or BMS Licensed Patent RightsCovering the Licensed Products. If elections with respect to obtaining suchpatent term extensions are to be made for a particular Lead Party Patent Right,the Lead Party for that Lead Party Patent Right shall have the right to makethe election to seek patent term extension or supplemental protection, *provided* that such election shall be made so as to maximizethe period of marketing exclusivity for the Licensed Product.

 

14.6         DataExclusivity and Orange Book Listings.

 

14.6.1      Withrespect to data exclusivity periods (such as those periods listed in the FDA’sOrange Book (including without limitation any available pediatric extensions)or periods under national implementations of Article 10.1(a)(iii) of Directive2001/EC/83, and all international equivalents), BMS and AMRI, as appropriateshall use Commercially Reasonable Efforts consistent with its obligations underapplicable law to seek, maintain and enforce all such data exclusivity periodsavailable for the 

 

Confidential Treatment Requested

 

122

----

 

Licensed Products. With respect to filings in the FDA Orange Book (andforeign equivalents) for issued patents for a Licensed Product, the appropriateParty shall, consistent with its obligations under applicable law, list in atimely manner and maintain all applicable AMRI Patent Rights or BMS LicensedPatent Rights required to be filed by it, or that it is permitted to file,under applicable law in connection with such Licensed Product. At least sixty(60) days prior to an anticipated deadline for the filing of patent listinginformation for AMRI Patent Rights or BMS Licensed Patent Rights, the Partymaking such filing shall notify in writing and consult with the other Partyregarding the content of such filing. In the event of a dispute between theParties as to whether an AMRI Patent Right or BMS Licensed Patent Right can belisted and/or the content of the filing for such listing, the Parties shalltake expedited steps to resolve the dispute as promptly as possible, includingseeking advice of an independent legal counsel to guide their decision. Theother Party shall provide, consistent with its obligations under applicablelaw, reasonable cooperation to the Party making such listing in filing andmaintaining such Orange Book (and foreign equivalent) listings.

 

14.6.2      Patent Analysis. A Party agrees to provide reasonablecooperation to the other Party and its selected outside counsel, when the otherParty, at its sole option and expense, elects to obtain patent analyses andopinions to assist it in decisions in connection with the other Party’s rightsunder this Agreement to obtain patent term extensions, Orange Book listings(and any foreign equivalents thereof) and/or enforcement.

 

14.6.3      Lead Party Patent Rights. AMRI and BMS agree that during the term ofthis Agreement it will not relinquish to a Third Party (a) its ownership rightsin, or (b) its right to, at its sole option, extend the term of, list in theOrange Book (or its equivalents outside the United States) or enforce, anypatent as to which the other Party has a Lead Party Patent Right.

 

Confidential Treatment Requested

 

123

----

 

14.7         Notification of Patent Certification. A Party receiving any allegation of patentinvalidity, unenforceability or non-infringement of an AMRI Patent Right or aBMS Licensed Patent Right pursuant to a Paragraph IV Patent Certification by aThird Party filing an Abbreviated New Drug Application, an application under§505(b)(2) or other similar patent certification by a Third Party, and/or anyforeign equivalent thereof in connection with a Licensed Compound or LicensedProduct shall notify the other Party and shall provide the other Party withcopies of all such allegations. Such notification and copies shall be providedto the other Party within five (5) days after receipt of such certification. TheLead Party shall have the right, but not the obligation, to contest such patentcertification and initiate and control Actions with respect thereto. Inaddition, upon request by the Lead Party having such right, the other Partyshall provide reasonable assistance and cooperation (including, withoutlimitation, making available to such Lead Party documents possessed by theother Party that are reasonably required by such Lead Party and makingavailable personnel for interviews and testimony) in any actions undertaken bysuch Lead Party to contest any such patent certification.

 

14.8         NeitherBMS nor AMRI shall be required to take any action pursuant to this Article 14that it reasonably determines in its sole judgment and discretion conflictswith or violates any court or government order or decree that it is thensubject to or otherwise may create legal liability on the part of it.

 

**15**.          **BANKRUPTCY.**

 

All rights and licenses granted under or pursuant to this Agreement,including amendments hereto, by each Party to the other Party are, for allpurposes of Section 365(n) of Title 11 of the U.S. Code  (“***Title 11***”),licenses of rights to intellectual property as defined in Title 11. Each Partyagrees during the term of this Agreement to create and maintain current copiesor, if not amenable to copying, detailed descriptions or other appropriateembodiments, to the 

 

Confidential Treatment Requested

 

124

----

 

extent feasible, of all such intellectual property. If a case iscommenced by or against either Party (the “***Bankrupt Party***”)under Title 11, then, unless and until this Agreement is rejected as providedin Title 11, the Bankrupt Party (in any capacity, includingdebtor-in-possession) and its successors and assigns (including, withoutlimitation, a Title 11 Trustee) shall, at the election of the Bankrupt Partymade within 60 days after the commencement of the case (or, if no such electionis made, immediately upon the request of the non-Bankrupt Party) either (i)perform all of the obligations provided in this Agreement to be performed bythe Bankrupt Party including, where applicable and without limitation,providing to the non-Bankrupt Party portions of such intellectual property(including embodiments thereof) held by the Bankrupt Party and such successorsand assigns or otherwise available to them or (ii) provide access or a licenseto the non-Bankrupt Party to all such intellectual property (including allembodiments thereof) held by the Bankrupt Party and such successors and assignsor otherwise available to them. If a Title 11 case is commenced by or againstthe Bankrupt Party and this Agreement is rejected as provided in Title 11 andthe non-Bankrupt Party elects to retain its rights hereunder as provided inTitle 11, then the Bankrupt Party (in any capacity, includingdebtor-in-possession) and its successors and assigns (including, withoutlimitations, a Title 11 Trustee) shall provide access or a license to thenon-Bankrupt Party to all such intellectual property (including all embodimentsthereof) held by the Bankrupt Party and such successors and assigns orotherwise available to them immediately upon the non-Bankrupt Party’s writtenrequest therefor. Whenever the Bankrupt Party or any of its successors orassigns provides access or a license to the non-Bankrupt Party to any of theintellectual property licensed hereunder (or any embodiment thereof) pursuantto this Article 15, the non-Bankrupt Party shall have the right to perform theobligations of the Bankrupt Party hereunder with respect to such intellectualproperty, but neither such provision nor such performance by the non-BankruptParty shall release the Bankrupt Party from any such obligation or liabilityfor failing to perform it. All rights, powers and remedies of the non-BankruptParty provided herein are in addition to and not in substitution for any andall other 

 

Confidential Treatment Requested

 

125

----

 

rights, powers and remedies now or hereafter existing at law or inequity (including, without limitation, Title 11) in the event of thecommencement of a Title 11 case by or against the Bankrupt Party. Thenon-Bankrupt Party, in addition to the rights, power and remedies expresslyprovided herein, shall be entitled to exercise all other such rights and powersand resort to all other such remedies as may now or hereafter exist at law orin equity (including, without limitation, under Title 11) in such event. TheParties agree that they intend the foregoing non-Bankrupt Party rights toextend to the maximum extent permitted by law and any provisions of applicablecontracts with Third Parties, including without limitation for purposes ofTitle 11, (i) the right of access or a license to any intellectual property(including all embodiments thereof) of the Bankrupt Party or any Third Partywith whom the Bankrupt Party contracts to perform an obligation of the BankruptParty under this Agreement, and, in the case of the Third Party, which isnecessary for the Development, registration and manufacture of LicensedProducts and (ii) the right to contract directly with any Third Party describedin (i) in this sentence to complete the contracted work. Any intellectualproperty provided pursuant to the provisions of this Article 15 shall besubject to the licenses set forth elsewhere in this Agreement and the paymentobligations of this Agreement, which shall be deemed to be royalties forpurposes of Title 11.

 

**16.****          REPRESENTATIONS ANDWARRANTIES.**

 

16.1         **Mutual Representations and Warranties**. Each Party representsand warrants to the other as of the Effective Date that:

 

16.1.1      itis duly organized and validly existing under the laws of its jurisdiction ofincorporation or formation, has full corporate or other power and authority toenter into this Agreement and to carry out the provisions hereof, is dulyauthorized to execute and deliver this Agreement and to perform its obligationshereunder, and the 

 

Confidential Treatment Requested

 

126

----

 

person or persons executing this Agreement on its behalf has been dulyauthorized to do so by all requisite corporate action.

 

16.1.2      thisAgreement is legally binding upon it, enforceable in accordance with its terms.The execution, delivery and performance of this Agreement by it does notconflict with any agreement, instrument or understanding, oral or written, towhich it is a party or by which it may be bound, nor violate any material lawor regulation of any court, governmental body or administrative or other agencyhaving jurisdiction over it.

 

16.1.3      ithas not granted any right to any Third Party that would conflict with therights granted to the other Party hereunder. It has (or will have at the time performance is due) maintained andwill maintain and keep in full force and effect all agreements (includinglicense agreements) and filings (including patent filings) necessary to performits obligations hereunder.

 

16.1.4      (i)subject to Section 16.4 to its knowledge, and after making reasonable inquiryof its internal and external attorneys, it has sufficient legal and/orbeneficial title under its intellectual property rights to grant the licensescontained in this Agreement; and (ii) has not received any material writtencommunications alleging that the conduct of the Parties’ responsibilities ascurrently proposed under this Agreement would violate any of the intellectualproperty rights of a Third Party.

 

16.2         **Representations and Warranties of AMRI.**AMRI represents andwarrants that, as of the Effective Date:

 

Confidential Treatment Requested

 

127

----

 

16.2.1      subjectto Section 16.4 the Patent Rights listed on Exhibit 1.1A are all owned solelyor jointly by AMRI, and as of the Effective Date are the only Patent RightsControlled by AMRI relating to the Development, manufacture, use, exportation,importation, offer for sale or Commercialization of Licensed Compounds orLicensed Products.

 

16.2.2      subjectto Section 16.4 to the knowledge of AMRI, and after making reasonable inquiryof its internal and external attorneys, there are no claims, pending suits, judgmentsor settlements against AMRI, pending or threatened, seeking to invalidate orenjoin the use of any AMRI Technology or any rights therein;

 

16.2.3      tothe knowledge of AMRI after making reasonable inquiry of its internal andexternal attorneys, its scientists and its regulatory employees andconsultants, there are no investigations, inquiries or other proceedings inrespect of any AMRI Technology or the Licensed Compounds pending or threatenedby any Regulatory Authority;

 

16.2.4      tothe knowledge of AMRI after making reasonable inquiry of its internal andexternal attorneys and its scientists, AMRI has made available to BMS allmaterial information in AMRI or its Affiliates’ possession regarding safety andtoxicity of the Licensed Compounds that are in existence as of the EffectiveDate;

 

16.2.5      AMRIhas not granted any lien, security interest or other encumbrance (including anylicenses, except those granted to BMS under the Existing License Agreement)with respect to any AMRI Technology, or permitted such a lien, securityinterest or other encumbrance (including any licenses, except those granted toBMS under the

 

Confidential Treatment Requested

 

128

----

 

Existing License Agreement) to attach to the AMRI Technology in eachcase that are inconsistent with the rights and licenses granted to BMS underthis Agreement;

 

16.2.6      tothe knowledge of AMRI after reasonable inquiry of its internal and externalattorneys and its scientists, the AMRI Technology does not include any tradesecrets that have been misappropriated from any Third Party or obtained inbreach of any contractual obligation of AMRI to a Third Party (it beingunderstood that this Section 16.2.6 is not applicable to Assigned PatentRights);

 

16.2.7      tothe knowledge of AMRI after reasonable inquiry of its internal and externalattorneys, its scientists and its business personnel, AMRI has no knowledge ofany infringement by any Third Party of any of the AMRI Technology;

 

16.2.8      Tothe knowledge of AMRI after reasonable inquiry of its internal and externalattorneys and its scientists, there are no Third Party patents or Know-Howrights included in the AMRI Technology licensed to BMS under Article 3 as ofthe Effective Date;

 

16.2.9      tothe knowledge of AMRI after reasonable inquiry of its internal and externalattorneys and its scientists, the development through the Effective Date of theLicensed Compounds has been conducted by AMRI and its Affiliates and itsindependent contractors in compliance in all material respects with allapplicable laws, rules and regulations, including any permits, governmentallicenses, registrations, approvals, orders, injunctions and decrees;

 

16.2.10    ithas not entered into any written agreements or other arrangements with anyThird Parties for the manufacture and/or supply of any clinical or commercialquantities of

 

Confidential Treatment Requested

 

129

----

 

any AMRI Compound or any Licensed Product containing same;

 

16.2.11    tothe knowledge of AMRI, Schedule 1.1E includes all of the Attachment A Compoundsand all Amine Neurotransmitter Reuptake-Inhibitors Controlled by AMRI and anyof its Affiliates as of the Effective Date.

 

16.2.12    as of the Effective Date, AMRI has not receivedany statement or assertion that any claim in any of the granted AMRI PatentRights is, or may be or become rendered, invalid or unenforceable;

 

16.2.13    AMRTechnology, Inc. is wholly owned by Albany Molecular Research, Inc.: and

 

16.2.14    AMRI acknowledges and understands that BMS isoperating under the FTC Consent Order dated April 14, 2003 and the DeferredProsecution Agreement dated June 15, 2005.

 

16.2.15       (i) all named inventors of anyinventions included within the Patent Rights that are part of the AMRI PatentRights, as of the Effective Date, have assigned their entire right, title andinterest in and to such inventions and the corresponding Patent Rights to AMRIor its Affiliates, and (ii) to AMRI’s knowledge, no person other thanthose persons named as inventors on any of the patents that are part of theAMRI Patent Rights, as of the Effective Date, is or alleges being an inventorof the inventions claimed in such Patent (it being understood that this Section16.2.15 is not applicable to Assigned Patent Rights).

 

For purposes of this Article 16, (i) “knowledge,” with respect to aParty, means the actual knowledge of its president, chief executive officer orsenior vice presidents.

 

Confidential Treatment Requested

 

130

----

 

16.3         **NO OTHER REPRESENTATIONS**. THE EXPRESS REPRESENTATIONS ANDWARRANTIES STATED IN THIS AGREEMENT ARE IN LIEU OF ALL OTHERREPRESENTATIONS AND WARRANTIES, EXPRESS, OR IMPLIED, BY EITHER PARTY, INCLUDINGWITHOUT LIMITATION, THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR APARTICULAR PURPOSE.

 

16.4         Therepresentations and warranties made by AMRI pursuant to Sections  16.1.3, 16.1.4, 16.2.1, 16.2.2 and 16.2.15are subject to the effect of any of * has on the AMRI Patent Rights.

 

# **17.****         DISPUTERESOLUTION.**

 

17.1**         Disputes.**TheParties recognize that disputes as to certain matters may from time to timearise during the term of this Agreement that relate to either Party’s rightsand/or obligations hereunder. It is the desire of the Parties to establishprocedures to facilitate the resolution of disputes arising under thisAgreement in an expedient manner by mutual cooperation and without resort toarbitration or litigation. To accomplish this objective, the Parties agree tofollow the procedures set forth in this Article 17 if and when a dispute arisesunder this Agreement. If the dispute involves a matter for which the Agreementdoes not provide a casting vote (e.g. for BMS at the JRC), then either Partymay, by written notice to the other Party, have such dispute referred to theirrespective executive officers designated below or their successors, forattempted resolution by good faith negotiations within thirty (30) days aftersuch notice is received. Such designated officers are as follows:

 

**For BMS:**              CEOor his/her direct report

 

**For AMRI:****           **CEO

 

Confidential Treatment Requested

 

131

----

 

In the event the designated officers are not able to resolve suchdispute within such thirty (30) day period after receipt of such writtennotice, then each Party may request, within five (5) Business Days thereafter,that the Parties attempt non-binding mediation of any such matter for a periodnot to exceed thirty (30) days. If the dispute remains unresolved after such30-day period, or if neither Party so requests such non-binding mediation, thenany such dispute, to the extent it relates to the validity, interpretation orconstruction of, or the compliance with or breach of, this Agreement, shall, atthe election of either Party, be decided in accordance with the provisions ofSection 17.2 below.

 

17.2**         Arbitration**.Any dispute between the Parties relating to or arising out of the validity,interpretation or construction of, or the compliance with or breach of, thisAgreement that cannot be resolved in accordance with Section 17.1 above,or that is submitted to arbitration pursuant to Section 13.2.3 or Section13.3.3, shall be resolved through binding arbitration as follows:

 

(a)           AParty may submit such dispute to arbitration by notifying the other Party, inwriting, of such dispute. Within thirty (30) days after receipt of such notice,the Parties shall designate in writing a single arbitrator to resolve thedispute; *provided, however*, that if the Partiescannot agree on an arbitrator within such thirty (30) day period, thearbitrator shall be selected by the New York, NY office of the AmericanArbitration Association (the “AAA”) or, if such office does not exist oris unable to make a selection, by the office of the AAA nearest to New YorkCity. The arbitrator shall be an expert knowledgeable and experienced in thelaw concerning the subject matter of the dispute and the subject matter of thedispute, and shall not be an Affiliate, employee, consultant, officer, directoror stockholder of either Party, or otherwise have any current or previousrelationship with either Party or its respective Affiliates. The governing lawin Section 18.1 shall govern any such proceedings.

 

Confidential Treatment Requested

 

132

----

 

(b)           Disputesregarding the validity, scope or enforceability of intellectual property rightsor to confidentiality obligations shall not be subject to arbitration pursuantto this Section 17.2.

 

I               Withinthirty (30) days after the designation of the arbitrator, the arbitrator andthe Parties shall meet, and each Party shall provide to the arbitrator awritten summary of all disputed issues, such Party’s position on such disputedissues and such Party’s proposed ruling on the merits of each such issue.

 

(d)           Thearbitrator shall set a date for a hearing, which shall be no later than thirty(30) days after the submission of written proposals pursuant to this Section17.2I, for the presentation of evidence and legal argument concerning each ofthe issues identified by the Parties. The Parties shall have the right to berepresented by counsel. All arbitration shall be conducted in the Englishlanguage. Except as provided herein, the arbitration shall be governed by theCommercial Arbitration Rules of the AAA applicable at the time of the notice ofarbitration pursuant to Section 17.2(a); *provided, however*,that the Federal Rules of Evidence shall apply with regard to the admissibilityof evidence in such hearing. The arbitrator shall permit discovery inaccordance with the discovery provisions of the Federal Rules of CivilProcedure.

 

(e)           Thearbitrator shall use his or her best efforts to rule on each disputed issuewithin thirty (30) days after completion of the hearing described in Section17.2(d). In the case of an arbitration directed to a breach of this Agreement,the arbitration shall also determine whether the breach is curable, and thecure for such breach. The determination of the arbitrator as to the resolutionof any dispute shall be binding and conclusive upon all Parties. All rulings ofthe arbitrator shall be in writing and shall be delivered to the Parties exceptto the extent that the Commercial Arbitration Rules of the AAA provideotherwise. Nothing contained herein shall be construed to permit the arbitratorto award punitive, exemplary or any similar damages.

 

ConfidentialTreatment Requested

 

133

----

 

(f)            The(i) attorneys’ fees of the Parties in any arbitration, (ii) fees of engagingthe arbitrator and (iii) costs and expenses of the arbitration shall be borneby the Parties in a proportion determined by the arbitrator.

 

(g)           Anyarbitration pursuant to this Section 17.2 shall be conducted in New York,New York. Any arbitration award may be entered in and enforced by a court inaccordance with Section 17.3.

 

(h)           Notwithstandinganything in Sections 17.1 or 17.2, each Party shall have the right to seekinjunctive or other equitable relief from a court of competent jurisdictionpursuant to Section 17.3 that may be necessary to avoid irreparable harm,maintain the status quo or preserve the subject matter of the arbitration.

 

17.3         Jurisdiction.Any suit, action or other proceeding relating to a dispute regarding the validity,scope or enforceability of intellectual property rights or to confidentialityobligations shall not be subject to the provisions of this Section 17.3 andSection 17.4. Unless the Parties otherwise agree in writing, each Party, forthe purpose of enforcing an award under Section 17.2 or for seeking injunctiveor other equitable relief as permitted under Section 17.2(h), herebyirrevocably submits to the exclusive jurisdiction of (i) the Supreme Court ofthe State of New York, New York County (the “State Court”) and (ii) the UnitedStates District Court for the Southern District of New York (the “DistrictCourt”), for the purposes of any suit, action or other proceeding arising outof this Agreement or out of any transaction contemplated hereby. Each partyagrees to first commence any such action, suit or proceeding in the DistrictCourt or if such suit, action or other proceeding may not be brought in suchcourt for jurisdictional reasons, in the State Court.

 

17.4         Eachparty further agrees that service of any process, summons, notice or documentby personal delivery, by registered mail, or by a recognized internationalexpress delivery service 

 

Confidential Treatment Requested

 

134

----

 

to such Party’s respective address set forth above shall be effectiveservice of process for any action, suit or proceeding in the District Court orthe State Court with respect to any matters to which it has submitted tojurisdiction in this Section. Each party irrevocably and unconditionally waivesany objection to the laying of venue of any action, suit or proceeding arisingout of this Agreement or the transactions contemplated hereby in the applicableDistrict Court or State Court, and hereby and thereby further irrevocably andunconditionally waives and agrees not to plead or claim in any such court thatany such action, suit or proceeding brought in any such court has been broughtin an inconvenient forum and further irrevocably waives the right to object,with respect to such action, suit or other proceeding, that such Court does nothave any jurisdiction over such Party.

 

**18.****          MISCELLANEOUS.**

 

18.1         **Governing Law.**This Agreement shall be governed by,enforced, and shall be construed in accordance with the laws of the State ofNew York without regard to its conflicts of law provisions (other than section5-1401 of the New York General Obligations Law).

 

18.2         **Amendment.**No amendment or modification hereof shall bevalid or binding upon the Parties unless made in writing and signed by bothParties.

 

18.3         **Assignment.**This Agreement will not be assignable in part orin whole by any Party without the prior written consent of the other Party tothe Agreement being assigned; except that any Party may assign this Agreementto one or more of its Affiliates, provided the assigning Party remains liablefor all of the duties and obligations of the assigning Party notwithstandingthe assignment. In addition, any Party may assign this Agreement to anysuccessor by merger, consolidation, or sale of substantially all of itsbusiness to which this Agreement relates provided the assigning Party remainsliable for all of the duties and obligations of the assigning Partynotwithstanding the assignment (except where the assigning Party is not a 

 

Confidential Treatment Requested

 

135

----

 

surviving entity), and the assignee agrees to be bound by theobligations under this Agreement. The Agreement will be binding upon thesuccessors and permitted assigns of the Parties. Any assignment that is not inaccordance with this section will be null and void *ab initio*.

 

18.4         **Independent Contractors; No Agency.**Neither Party shall haveany responsibility for the hiring, firing or compensation of, or for theprovision of any employee benefits to, the other Party’s employees. NeitherParty is, nor will be deemed to be, an employee, agent, or legal representativeof the other Party for any purpose. Neither Party will be entitled to enterinto any contracts in the name of, or on behalf of the other Party, nor will aParty be entitled to pledge the credit of the other Party in any way or holditself out as having authority to do so. This Agreement is negotiated on an arm’s-lengthbasis between the Parties and shall not constitute or be construed as a jointventure or partnership in any of Territories. For all purposes, andnotwithstanding any other provision of this Agreement to the contrary, eachParty’s legal relationship under this Agreement to the other Party shall bethat of independent contractor.

 

18.5**         Notices.**Anynotice or other communication required or permitted to be given to either Partyhereto shall be in writing and shall be delivered in person, by expressdelivery service, or by facsimile, provided that any notice by facsimile shallbe promptly followed by delivery in person or by express delivery service. Noticesdelivered in person will be deemed effective when so delivered; noticesdelivered by express delivery service will be deemed to be effective whendelivered as indicated by the records of the express delivery service or, ifreceipt is refused for any reason, the date on which delivery was firstattempted; notices sent by facsimile (and appropriately followed by personal orexpress delivery) will be deemed effective when delivery is confirmed by thesending fax machine. All notices shall be sent to the Parties at the followingrespective addresses:

 

Confidential Treatment Requested

 

136

----

 

In the case of AMRI:

 

Albany Molecular Research, Inc.

 

21 Corporate Circle

 

Albany, New York 12212-5098

 

Attn:  Chief Executive OfficerFacsimile No.:  518 867 4375

 

With a required copy to:

 

Albany Molecular Research, Inc.

 

21 Corporate Circle

 

Albany, New York 12212-5098

 

Attn: Director, Legal AffairsFacsimile No.:  518 867 4375

 

In the case of BMS:

 

Bristol-Myers Squibb CompanyRoute 206 and Province Line RoadPrinceton, New Jersey 08543-4000Attn:  Senior Vice President, Corporateand Business DevelopmentFacsimile No.:  609-252-7128

 

With a required copy to:

 

Bristol-Myers Squibb CompanyRoute 206 and Province Line RoadPrinceton, New Jersey 08543-4000Attn:  Senior Counsel, BusinessDevelopment and LicensingFacsimile No.:  609-252-4232

 

Either Party may change its address for communications by a notice tothe other Party in accordance with this section.

 

18.6         **Waivers.**No failure on the part of BMS or AMRI to exerciseand no delay in exercising any right, power, remedy or privilege under thisAgreement, or provided by statute or at law or in equity or otherwise, shallimpair, prejudice or constitute a waiver of any such right, power, remedy orprivilege or be construed as a waiver of any breach of this Agreement or as an 

 

Confidential Treatment Requested

 

137

----

 

acquiescence therein, nor shall any single or partial exercise of anysuch right, power, remedy or privilege preclude any other or further exercisethereof or the exercise of any other right, power, remedy or privilege.

 

18.7         **Cumulative Rights.**Except as otherwise expressly provided inany of this Agreement, (a) the rights, powers and remedies under this Agreementshall be in addition to, and not in limitation of, all rights, powers, andremedies provided at law or in equity, or under any other agreement between theParties, and (b) all of such rights, powers, and remedies shall be cumulative,and may be exercised successively or cumulatively.

 

18.8         **Severability.**If any term, condition, or provision of thisAgreement is held to be unenforceable for any reason, it shall, if possible, beinterpreted, to achieve the intent of the Parties to this Agreement to theextent possible rather than voided. In any event, all other terms, conditions,and provision of this Agreement shall be deemed valid and enforceable to thefull extent unless enforcement of this Agreement without the term, condition,or provision held to be unenforceable would materially alter the economicconsequences of this Agreement to either Party, in which event the Partiesshall negotiate in good faith an appropriate resolution.

 

18.9         **Force Majeure**. Except for payment obligations, each Partyshall be excused from the performance of their obligations under this Agreementto the extent that such performance is prevented by force majeure and thenonperforming Party promptly provides notice of the prevention to the otherParty. Such excuse shall be continued so long as the condition constitutingforce majeure continues and the nonperforming Party takes Commercially ReasonableEfforts to remove the condition. For purposes of this Agreement, force majeureshall be limited to the conditions beyond the control of the Parties, includingwithout limitation, an act of God, war, acts of terrorism, civil commotion,intervention of any 

 

Confidential Treatment Requested

 

138

----

 

governmental authority, labor strike or lock-out, epidemic, failure ornegligence of a Third Party supplier, failure or default of public utilities orcommon carriers, destruction of production facilities or materials by fire,earthquake, flood, storm or similar catastrophe.

 

18.10       **Headings, Captions.**All headings and captions in thisAgreement are for convenience only and shall not be interpreted as having any substantivemeaning.

 

18.11       **Entire Agreement.**This Agreement and any and all Exhibitsreferred to in this Agreement, the Warrant Termination Agreement, and theLicense Termination Agreement embody the entire understanding of the Partieswith respect to the subject matter of this Agreement and shall supersede allprevious communications, representations, or understandings, either oral orwritten, between the Parties relating to the subject matter of this Agreement. The confidentiality agreement entered into byBMS and Albany Molecular Research, Inc. on April 7, 2004, as amended, (the “ConfidentialityAgreement”) is hereby terminated and all Confidential Information (as that termis defined in the Confidentiality Agreement), including Highly ConfidentialInformation (as that term is defined in the Confidentiality Agrement) disclosedto BMS by Albany Molecular Research Inc. under the Confidentiality Agreementshall be considered Confidential Information (as that term is defined in thisAgreement) of AMRI disclosed under this Agreement and shall be subject to theterms and conditions of this Agreement. The letter agreement entered into byBMS and Albany Molecular Research, Inc. on or about June 8, 2005 (the “LetterAgreement”), is hereby terminated, and all data and results generated by BMSunder the Agreement and all information included in the Report (as defined inthe Letter Agreement) shall be considered Confidential Information (as thatterm is defined in this Agreement) of BMS disclosed under this Agreement andshall be subject to the terms and conditions of this Agreement.

 

Confidential Treatment Requested

 

139

----

 

18.12       **Execution in Counterparts; Facsimile Signatures.**ThisAgreement may be executed in counterparts, each of which counterparts, when soexecuted and delivered, shall be deemed to be an original, and all of whichcounterparts, taken together, shall constitute, with respect to this Agreement,one and the same instrument, even if both Parties have not executed the samecounterpart. Signatures provided by facsimile transmission shall be deemed tobe original signatures.

 

18.13       **Nonsolicitation of Employees**. During the Combined Period,each Party agrees that neither it nor any of its Affiliates that participatesin or is responsible for the research, discovery, identification, Development,manufacture, or Commercialization of any Licensed Compound or Licensed Productpursuant to this Agreement shall recruit, solicit or induce any employee of theother Party directly involved in the activities conducted pursuant to thisAgreement to terminate his or her employment with such other Party and becomeemployed by or consult for such other Party, whether or not such employee is afull-time employee of such other Party, and whether or not such employment ispursuant to a written agreement or is at-will. For purposes of the foregoing, “recruit”,“solicit” or “induce” shall not be deemed to mean (a) circumstances where anemployee of one Party initiates contact with the other Party or any of itsAffiliates with regard to possible employment, or (b) general solicitations ofemployment not specifically targeted at employees of a Party or any of itsAffiliates, including responses to general advertisements.

 

18.14       **No Debarment.**In the course of the Development of LicensedProduct pursuant to this Agreement, such Party has not used, and during theterm of this Agreement will not use, any employee or consultant that isdebarred by any Regulatory Authority or, to the best of such Party’s knowledge,is the subject of debarment proceedings by any Regulatory Authority. If eitherParty learns that its employee or consultant performing on its behalf underthis Agreement has been debarred by any Regulatory Authority, or has become thesubject of debarment proceedings by any Regulatory Authority, such Party shallso promptly notify the 

 

ConfidentialTreatment Requested

 

140

----

 

other Partyand shall prohibit such employee or consultant from performing on its behalfunder this Agreement.

 

18.15       **Further Assurance**. Each Party will duly execute anddeliver, or cause to be duly executed and delivered, such further instrumentsand do and cause to be done such further acts and things, including the filingof such assignments, agreements, documents and instruments, as may be necessaryor as the other Party may reasonably request in connection with this Agreementor to carry out more effectively the provisions and purposes, or to betterassure and confirm unto such other Party its rights and remedies under thisAgreement.

 

18.16       **Affiliates**. Inthe event an Affiliate of a Party performs an act (or fails to act), whichperformance or failure, if committed by such Party, would be a breach of thisAgreement, then such Party shall cause such Affiliate to cure such breach andsuch Party shall be liable for any such breach.

 

18.17       **Construction**. Except where the context otherwiserequires, the use of any gender will be applicable to all genders andthe singular includes the plural and vice versa. The captions of this Agreementare for convenience of reference only and in no way define, describe, extend orlimit the scope or intent of this Agreement or the intent of any provisioncontained in this Agreement. The term “including” as used herein meansincluding, without limiting the generality of any description preceding suchterm. References to “Section” or “Sections” are references to the numberedsections of this Agreement, unless expressly stated otherwise. All dollars areUnited States Dollars.

 

18.18       This Agreement shall only be effective ifthis Agreement, the License Termination Agreement and the Warrant TerminationAgreement are entered into on the same date. In the event all of theseagreements are entered into on the same date, the License Termination Agreementshall be deemed to have been entered into first, this Agreement shall be deemedto have been entered into second, and the Warrant Termination Agreement shallbe deemed to have been entered into last.

 

Confidential Treatment Requested

 

141

----

 

**[The next page is the signature page]**

 

 

Confidential Treatment Requested

 

142

----

 

In witness whereof, duly authorized representatives of the Parties haveduly executed this Agreement on the Effective Date.

 

 
| BRISTOL-MYERS SQUIBB COMPANY                         | ALBANY MOLECULAR RESEARCH, INC.      |
|------------------------------------------------------|--------------------------------------|
|                                                 |                                 |
|                                                 |                                 |
| By                                                   | /s/ Elliott Sigal                    |   | By | /s/ Thomas E. D’Ambra |   |
| Name: Elliott Sigal, M.D., Ph.D.                     | Name: Thomas E.  D’Ambra, Ph.D. |
| Title: Chief Scientific Officer & President, PRI | Title: Chairman, President & CEO |
| Date:                                                | October 20, 2005                     |   | Date: | October 20, 2005 |   |
|                                                      |                                      |  |  |  |  |  |  |

 

 
| AMR TECHNOLOGY, INC.                |
|-------------------------------------|
|                                |
|                                |
| By                                  | /s/ Thomas E. D’Ambra |   |
| Name: Thomas E. D’Ambra, Ph.D. |
| Title: President                    |
| Date:                               | October 20,  2005 |   |
|                                     |  |  |  |  |

 

Confidential Treatment Requested

 

143

----

 

**EXHIBIT 1.1A****AMRI PATENT RIGHTS**

 

 

**PART I**

**THE ASSIGNED PATENTRIGHTS**

 

Title:  ARYL AND HETEROARYL SUBSTITUTEDTETRAHYDROISOQUINOLINES AND USE THEREOF TO BLOCK REUPTAKE OF NOREPINEPHRINE,DOPAMINE AND SEROTONIN

 
| Country            |   | Patent or Patent Application Number |
|--------------------|--------|-------------------------------------|
|               |   |                                |
| Japan              |   | 2001-534777                         |
| South Korea        |   | 10-2002-7005744                     |
| Mexico             |   | PA/a/2002/004330                    |
| Canada             |   | 2,389,306                           |
| EPC                |   | 00976885.4                          |
| Australia          |   | 14597/01                            |
| New Zealand        |   | 519145                              |
| Russian Federation |   | 2002114338                          |
| Brazil             |   | PI 0015320-6                        |
| China P.R.         |   | 00818078.4                          |
| India              |   | IN/PCT/2002/00631CHE                |
| United States      |   | 6,579,885                           |
| United States      |   | 10/426,097                          |
| United States      |   | 10/917,801                          |

 

Title:  4-PHENYL SUBSTITUTED TETRAHYDROISOQUINOLINESAND USE THEREOF TO BLOCK REUPTAKE OF NOREPINEPHRINE, DOPAMINE AND SEROTONIN

 
| Country            |   | Patent or Patent Application Number |
|--------------------|--------|-------------------------------------|
|               |   |                                |
| United States      |   | *                                   |
| Japan              |   | 2001-534776                         |
| South Korea        |   | 10-2002-7005740                     |
| Mexico             |   | PA/a/2002/004329                    |
| Canada             |   | 2,389,300                           |
| EPC                |   | 00976884.7                          |
| Australia          |   | 14596/01                            |
| New Zealand        |   | 519146                              |
| Russian Federation |   | 2002114337                          |
| Brazil             |   | PI 0015307-9                        |
| China P.R.         |   | 00817789.9                          |
| India              |   | IN/PCT/2002/00630CHE                |

 

Confidential Treatment Requested

 

144

----

 

Title:  NOVEL 4-PHENYL SUBSTITUTEDTETRAHYDROISOQUINOLINES THERAPEUTIC USE THEREOF

 
| Country            |   | Patent or Patent Application Number                        |
|--------------------|--------|------------------------------------------------------------|
|               |   |                                                       |
| United States      |   | 09/902,845                                                 |
| Japan              |   | 2002-509320                                                |
| South Korea        |   | 10-2003-7000364                                            |
| Mexico             |   | PA/a/2003/000275                                           |
| China P.R.         |   | 01815157.4                                                 |
| Brazil             |   | PI 0112350-5                                               |
| Russian Federation |   | 2003103849                                                 |
| Canada             |   | 2,415,532                                                  |
| India              |   | 40/CHENP/2003                                              |
| EPC                |   | 01952616.9                                                 |
| Australia          |   | 2001273349                                                 |
| New Zealand        |   | 523456                                                     |
| United States      |   | Filed 9/21/05 as a continuation application  of 09/902,845 |

 

 

**PART II**

**THE ATTACHMENT APATENT RIGHTS**

 

Title: ARYL- AND HETEROARYL-SUBSTITUTEDTETRAHYDROISOQUINOLINES AND USE THEREOF TO BLOCK REUPTAKE OF NOREPINEPHRINE,DOPAMINE AND SEROTONIN

 
| Country        |   | Patent Application Number |
|----------------|--------|---------------------------|
|           |   |                      |
| United  States |   | *                         |
| PCT            |   | PCT/US2005/025193         |
| United  States |   | *                         |

 

Confidential Treatment Requested

 

145

----

 

**PART III**

**OTHER AMRI PATENT RIGHTS**

 

Title:  NOVEL 4-PHENYL SUBSTITUTEDTETRAHYDROISOQUINOLINES AND THERAPEUTIC USE THEREOF

 
| Country        |   | Patent Application Number |
|----------------|--------|---------------------------|
|           |   |                      |
| United  States |   | 10/994,706                |

 

Title:  ARYL- AND HETEROARYL-SUBSTITUTEDTETRAHYDROISOQUINOLINES AND USE THEREOF TO BLOCK REUPTAKE OF NOREPINEPHRINE,DOPAMINE AND SEROTONIN

 
| Country        |   | Patent Application Number |
|----------------|--------|---------------------------|
|           |   |                      |
| United  States |   | 10/994,956                |

 

Title:  4-PHENYL SUBSTITUTED TETRAHYDROISOQUINOLINESAND USE THEREOF TO BLOCK REUPTAKE OF NOREPINEPHRINE, DOPAMINE AND SEROTONIN

 
| Country        |   | Patent Application Number |
|----------------|--------|---------------------------|
|           |   |                      |
| United  States |   | 10/994,688                |

 

 

Title:  ARYL- AND HETEREROARYL-SUBSTITUTEDTETRAHYDROBENZAZEPINES AND USE THEREOF TO BLOCK REUPTAKE OF NOREPINEPHRINE,DOPAMINE AND SEROTONIN

 
| Country        |   | Patent Application Number |
|----------------|--------|---------------------------|
|           |   |                      |
| United  States |   | *                         |

 

Confidential Treatment Requested

 

146

----

 

**EXHIBIT 1.1B****RESEARCH PLAN**

 

*

 

 

**CONFIDENTIAL TREATMENT REQUESTED**

 

147

----

 

**EXHIBIT 1.1C****ADVANCED LEAD CANDIDATE COMPOUNDS**

 

The list of Advanced Lead Candidate Compounds will identify up to ten (10)compounds that are AMRI Compounds as of the Effective Date and will be agreedupon and signed by the Parties within thirty (30) days of the Effective Date.

 

 

**CONFIDENTIAL TREATMENT REQUESTED**

 

 

148

----

 

**EXHIBIT 1.1D**

**FTE RATE**

 

The FTE Rate for the first two years of theResearch Program shall be $* per FTE. Beginning in the third year of theResearch Program, the FTE Rate will be increased by * (*) percent per Year.

 

 

**CONFIDENTIAL TREATMENT REQUESTED**

 

149

----

 

**EXHIBIT 1.1.E**

 

**PART I**

 

**ATTACHMENT A COMPOUNDS**

 

**Compound Code in the Existing LicenseAgreement**

 

*****

 

**PART II**

 

**AMINE NEUROTRANSMITTER REUPTAKE-INHIBITORSNOT**

**INCLUDED IN PART I ABOVE**

 

**AMRI Compound Code**

 

*

 

 

**CONFIDENTIAL TREATMENT REQUESTED**

 

150

----

 

**EXHIBIT 1.1.F**

**INDICATIONS**

 

*

 

**CONFIDENTIAL TREATMENT REQUESTED**

 

151

----

 

**EXHIBIT 1.1.G**

**BMS AMINE NEUROTRANSMITTER REUPTAKEINHIBITORS**

 

BMS Compound Code

 

*****

 

 

**CONFIDENTIAL TREATMENT REQUESTED**

 

152

----

 

**EXHIBIT 11.4.4**

**TRANSFER INSTRUCTIONS**

 

**AMRI Transfer Instructions:**

 

AMR Technology, Inc.

Bank Name:  TD Banknorth, N.A.

Account Name:  AMR TechnologyInc.

Acct number:  *

ABA number:  *

 

#263232 v20 - License Agt - Bristol Myers & albanyMolecular

 

 

**CONFIDENTIAL TREATMENT REQUESTED**

 

153

----