Exhibit 10.3

NOTE: C ERTAIN C ONFIDENTIAL I NFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT AND REPLACED BY “[*]”. A COMPLETE COPY OF THIS DOCUMENT INCLUDING THE C ONFIDENTIAL I NFORMATION HAS BEEN FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION .

DISTRIBUTION AND LICENSE AGREEMENT

BY AND BETWEEN

NPS ALLELIX CORP.

NPS PHARMACEUTICALS, INC.

AND

NYCOMED GmbH

DATED

SEPTEMBER 24, 2007

 

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Table of Contents

 

				Page
ARTICLE 1		DEFINITIONS		1
ARTICLE 2		MANAGEMENT OF COLLABORATIVE ACTIVITIES		11
2.1		Management Committee		11
2.2		Joint Development Committee		13
2.3		Additional Committees		14
2.4		Minutes of Committee Meetings		15
2.5		Independent Action		15
2.6		Compliance with Law		15
ARTICLE 3		LICENSE GRANTS AND ASSIGNMENTS		15
3.1		NPS Grants and Assignments		15
3.2		Sublicenses		16
3.3		Nycomed Grants		16
3.4		NPS Retained Rights; Transfer of Rights		16
3.5		Nycomed Right of First Negotiation		16
3.6		Licenses under Existing Third Party Agreements		17
ARTICLE 4		DEVELOPMENT		18
4.1		Development Rights		18
4.2		Development Responsibilities		18
4.3		Development Efforts; Manner of Performance; Reports		20
4.4		Right to Audit		21
4.5		Regulatory Submissions and Regulatory Approvals		21
ARTICLE 5		COMMERCIALIZATION		23
5.1		Commercialization in the Territory		23
5.2		Advertising and Promotional Materials		24
5.3		Sales and Distribution		24
5.4		Complaints		24
5.5		Adverse Event Reporting Procedures		24
5.6		Recalls, Market Withdrawals or Corrective Actions		25
ARTICLE 6		MANUFACTURE AND SUPPLY		25
6.1		General		25
6.2		Manufacture and Supply for the Territory		25
6.3		Transfer of Responsibility and Technology		26

 

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Table of Contents

 

				Page
6.4		Subsequent Information		26
6.5		[*] Process		26
6.6		Master Cell Bank and Working Cell Banks		27
6.7		Other Ongoing Rights and Responsibilities		27
ARTICLE 7		FINANCIAL PROVISIONS		27
7.1		Signing Fee		27
7.2		First Milestone Payment		27
7.3		Milestone Payments		28
7.4		Payment of Royalties on Net Sales		29
7.5		Existing Third Party Agreement Payments		30
7.6		Audits		30
7.7		Tax Matters		30
7.8		United States Dollars		31
7.9		Currency Exchange		31
7.10		Blocked Payments		31
7.11		Late Payments		31
7.12		Shared Development Costs		31
ARTICLE 8		INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS		32
8.1		Ownership of Inventions		32
8.2		Prosecution and Maintenance of Patent Rights		32
8.3		Third Party Infringement		34
8.4		Patent Invalidity Claim		35
8.5		Claimed Infringement		36
8.6		Patent Term Extensions		36
8.7		Patent Marking		36
8.8		Trademarks		36
ARTICLE 9		CONFIDENTIALITY AND PUBLICITY		38
9.1		Confidential Information		38
9.2		Employee, Consultant and Advisor Obligations		39
9.3		Publicity		39
9.4		Publications		39

 

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Table of Contents

 

				Page
ARTICLE 10		REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS; INDEMNIFICATION		40
10.1		Exclusivity Covenant		40
10.2		Mutual Representations and Warranties		40
10.3		Additional NPS Representations and Warranties		41
10.4		Existing Third Party Agreements		42
10.5		Disclaimer of Warranties		42
10.6		Indemnification		42
10.7		Procedure for Indemnification		43
10.8		Assumption of Defense		44
ARTICLE 11		TERM AND TERMINATION		44
11.1		Term		44
11.2		Termination		44
11.3		Effects of Termination		45
11.4		Continuation of Agreement if NPS Becomes Insolvent		49
11.5		License Grant Effective Upon Expiration of Term		50
11.6		Survival		50
ARTICLE 12		FINAL DECISION-MAKING; DISPUTE RESOLUTION		50
12.1		Arbitration		50
ARTICLE 13		MISCELLANEOUS		51
13.1		Choice of Law		51
13.2		Notices		51
13.3		Severability		52
13.4		Captions		52
13.5		Integration		52
13.6		Independent Contractors; No Agency		52
13.7		Assignment; Successors		53
13.8		Expenses		53
13.9		Execution in Counterparts; Facsimile Signatures		53
13.10		No Consequential or Punitive Damages		53
13.11		Non-Solicitation		53
13.12		Transfer of NPS Intellectual Property; NPS Allelix No Longer a Party		53

 

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DISTRIBUTION AND LICENSE AGREEMENT

This Distribution and License Agreement (this “Agreement” ) is made and effective as of the 24th day of September, 2007 (the “Effective Date” ) by and between NPS Allelix Corp., a Canadian corporation ( “NPS Allelix” ), having offices at MaRS Centre, 101 College Street, South Tower, Suite 800, Toronto, ON MSG 1L8 Canada, NPS Pharmaceuticals, Inc., a Delaware corporation ( “NPS US” , and, together with NPS Allelix, collectively, “NPS” ), having offices at Morris Corporate Center 1, 4th Floor, Building B, 300 Interpace Parkway, Parsippany, NJ 07054, and Nycomed GmbH, a German corporation with company registration number Hrb Nr 701257 ( “Nycomed” ), having offices at Byk Gulden Str. 2, 78467 Konstanz.

INTRODUCTION

1. NPS Controls certain patents, know-how and other rights related to the Product;

2. Nycomed has considerable knowledge and experience in developing, promoting and marketing pharmaceutical products throughout the Territory;

3. NPS and Nycomed believe that a distribution and license arrangement regarding the Product in the Territory would be desirable; and

4. On the terms and subject to the conditions set forth herein, NPS and Nycomed therefore desire to provide for the development, manufacture and commercialization of Product as described herein.

NOW, THEREFORE, for and in consideration of the mutual covenants contained herein, NPS and Nycomed, intending to be legally bound, hereby agree as follows:

ARTICLE 1

DEFINITIONS

As used in this Agreement, the following terms, whether used in the singular or plural, shall have the meanings set forth below:

1.1 “ Additional Indication ” shall mean any indication for Product other than the Primary Indication.

1.2 “ Affiliate ” shall mean with respect to any Party, any Person controlling, controlled by or under common control with such Party. For purposes of this Section 1.2, “control” shall mean (a) in the case of a Person that is a corporate entity, direct or indirect ownership of fifty percent (50%) or more of the stock or shares having the right to vote (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) for the election of directors of such Person and (b) in the case of a Person that is an entity, but is not a corporate entity, the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such Person, whether through the ownership of voting securities, by contract or otherwise.

 

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1.3 “ API ” shall mean the drug substance/active pharmaceutical ingredient of the Compound.

1.4 “ Calendar Quarter ” shall mean for each Calendar Year, each of the three (3) month periods ending March 31, June 30, September 30 and December 31; provided, however, that the first calendar quarter for the first Calendar Year shall extend from the Effective Date to the end of the first complete calendar quarter thereafter.

1.5 “ Calendar Year ” shall mean, for the first calendar year, the period commencing on the Effective Date and ending on December 31 of the calendar year during which the Effective Date occurs, and each successive period beginning on January 1 and ending twelve (12) consecutive calendar months later on December 31.

1.6 “ CIGIM ” shall mean chemotherapy-induced gastrointestinal mucositis.

1.7 “ Claims ” shall mean all charges, complaints, actions, suits, proceedings, hearings, investigations, claims and demands.

1.8 “ CMO ” shall mean a contract manufacturing organization.

1.9 “ Commercialization ” or “ Commercialize ” shall mean any and all activities directed to obtaining marketing, pricing and reimbursement approvals, marketing, promoting, Detailing, distributing, importing, exporting, offering for sale or selling a product. Commercialization shall not include any activities related to Development or Manufacturing.

1.10 “ Compound ” shall mean the compound known as teduglutide, as further described in Schedule 1.10 , and any analogues, fragments, derivatives, receptors and compositions thereof.

1.11 “ Control ” or “ Controlled ” shall mean, with respect to any intellectual property right or other intangible property, the possession (whether by license or ownership, or by control over an Affiliate having possession by license or ownership) by a Party of the ability to grant to the other Party access and/or a license or sublicense as provided herein without violating the terms of any agreement with any Third Party.

1.12 “ Co-Owned Patent Rights ” shall mean the NPS Patent Rights, to the extent that such NPS Patent Rights were solely owned by NPS prior to the assignment in Section 3.1(b) hereof.

1.13 “ Country ” shall mean any generally recognized sovereign entity.

1.14 “ Cover ”, “ Covering ” or “ Covered ” shall mean, with respect to Product or Compound, or with respect to technology, that, in the absence of a license granted under a Valid Claim, the Manufacture, use, Commercialization, Development or importation of Product or the practice of such technology would infringe such Valid Claim.

 

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1.15 “ CPI ” shall mean the Consumer Price Index – Urban Wage Earners Clerical Workers, U.S. City Average, All Items, 1982-84 = 100, published by the United States Department of Labor, Bureau of Statistics (or its successor equivalent index).

1.16 “ Development ” or “ Develop ” shall mean non-clinical and clinical research and drug development activities associated with development of Product for Regulatory Approval as a drug product, including without limitation toxicology, test method development and stability testing, process development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, clinical studies (including pre- and post-approval studies and Investigator Sponsored Clinical Studies), regulatory affairs, and product approval and clinical study regulatory activities (excluding regulatory activities directed to obtaining pricing and reimbursement approvals).

1.17 “ Development Costs ” shall mean costs incurred by the Parties after the Effective Date and specifically attributable to Developing the Compound or a Product, and may include without limitation:

(a) the out-of-pocket costs and expenses incurred to the extent not covered by (b) through (d);

(b) the costs of internal scientific, medical, technical or managerial personnel engaged in such efforts, which costs shall be determined based on the applicable FTE Rate, unless another basis is otherwise agreed by the Parties in writing;

(c) the costs and expenses of clinical supplies for such efforts, including without limitation, (i) direct costs and expenses incurred to purchase and/or package comparator or combination drugs or devices, and (ii) direct costs and expenses of disposal of clinical samples; and

(d) the direct costs and expenses incurred in connection with manufacturing process development and validation, manufacturing scale-up and improvements, stability testing and quality assurance/quality control development, and qualification and validation of Third Party contract manufacturers.

1.18 “ Development Plan ” shall mean the plan for the Development of the Compound or a Product for any Indication including, without limitation, the budget and nature, number and schedule of Development activities.

1.19 “ Device ” shall mean the drug delivery device described in Schedule 1.19 hereto and any future Improvements or replacements thereof.

1.20 “ Diligent Efforts ” shall mean, with respect to Product, the carrying out of obligations in a diligent and sustained manner using efforts not less than the efforts a Party devotes to a product of similar market potential, profit potential or strategic value resulting from its own research efforts, but excluding consideration of any obligation to the other Party under this Agreement.

 

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1.21 “ Drucker License Agreement ” shall mean the License Agreement, dated September 28, 1995, by and among 1149336 Ontario Inc., Daniel J. Drucker, M.D. and Allelix Biopharmaceuticals Inc.

1.22 “ EMEA ” shall mean the European Medicines Agency or any successor agency thereto.

1.23 “ Equivalent Product ” shall mean any pharmaceutical product (other than any branded non-generic versions but Equivalent Product specifically includes any added-value generic versions) containing a glucagon-like peptide-2 (GLP-2) or any analog, homologue (including, but not limited to, teduglutide), or derivative or fragment thereof, including compositions thereof.

1.24 “ European Union ” or “ EU ” shall mean the Countries of the European Union, as it is constituted as of the Effective Date and as it may be expanded from time to time.

1.25 “ Executive Officers ” shall mean the Chief Executive Officer of NPS (or a senior executive officer of NPS designated by NPS’ Chief Executive Officer) and Nycomed’s Chief Executive Officer (or a senior executive officer of Nycomed designated by Nycomed’s Chief Executive Officer).

1.26 “ Existing Third Party Agreements ” shall mean the Drucker License Agreement, [*], the UTAUS License Agreement and the Restoragen License Agreement.

1.27 “ FDA ” shall mean the United States Food and Drug Administration or any successor agency thereto.

1.28 “ Field ” shall mean the treatment and diagnosis of all Indications in humans and animals.

1.29 “ First Commercial Sale ” shall mean, with respect to Product in a Country, the first commercial sale of Product in such Country.

1.30 “ FTE ” shall mean a full-time equivalent person year (consisting of a total of 1,750 hours) of work.

1.31 “ FTE Rate ” shall mean [*], increased or decreased by the percentage increase or decrease in the CPI as of the then most recent December 31 over the level of the CPI on December 31, 2006.

1.32 “ Future Partner ” shall mean a Third Party to whom NPS grants rights to Commercialize or distribute Product in North America.

1.33 “ GAAP ” shall mean United States generally accepted accounting principles.

1.34 “ Governmental Authority ” shall mean any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of (a) any government of any Country, (b) a federal, state, province, county, city or other political subdivision thereof or (c) any supranational body.

 

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1.35 “ [*] Process ” shall mean the process for manufacturing Compound currently being Developed by NPS which, for the avoidance of doubt, is a different process than the secreted process.

1.36 “ Indications ” shall mean the Primary Indication and the Additional Indications.

1.37 “ Investigator Sponsored Clinical Study ” shall mean a human clinical study of Product that is sponsored and conducted by a Third Party under an agreement with a Party pursuant to which such Party provides clinical supplies of Product and/or funding for such clinical study.

1.38 “ Joint Intellectual Property ” shall mean Joint Know-How and Joint Patent Rights, collectively.

1.39 “ Joint Know-How ” shall mean any Know-How that is developed or acquired jointly by the Parties or their Affiliates or sublicensees in connection with their collaborative activities pursuant to this Agreement during the Term including Joint Inventions.

1.40 “ Joint Patent Rights ” shall mean Patent Rights that Cover Joint Inventions or Joint Know-How.

1.41 “ Know-How ” shall mean any information and materials, whether proprietary or not and whether patentable or not, including without limitation ideas, concepts, formulas, methods, procedures, designs, compositions, plans, documents, data, inventions, discoveries, trade secrets, works of authorship, compounds and biological materials, solely to the extent such know-how is directly related to the research, Development, Manufacture or Commercialization of Compound or Product in the Field.

1.42 “ Losses ” shall mean any and all damages (including all incidental, consequential, statutory and treble damages), awards, deficiencies, settlement amounts, defaults, assessments, fines, dues, penalties, costs, fees, liabilities, obligations, taxes, liens, losses, lost profits and expenses (including without limitation court costs, interest and reasonable fees of attorneys, accountants and other experts) incurred by or awarded to Third Parties and required to be paid to Third Parties with respect to a Claim by reason of any judgment, order, decree, stipulation or injunction, or any settlement entered into in accordance with the provisions of this Agreement, together with all documented out-of-pocket costs and expenses incurred in complying with any judgments, orders, decrees, stipulations and injunctions that arise from or relate to a Claim of a Third Party.

1.43 “ Major EU Country ” shall mean the United Kingdom, Germany, France, Italy and Spain.

1.44 “ Manufacturing ” or “ Manufacture ” shall mean activities directed to producing, manufacturing and processing Product.

 

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1.45 “ Master Cell Bank ” means NPS’ master cell banks containing the host cells (with the plasmid incorporated therein) used in the fermentation process for the production of recombinant glycine2-human glucagon-like peptide-2(ALX-600(Teduglutide)) as a secreted material in the fermentation culture broth and as a fusion peptide for the inclusion bodies in the host cell. The Master Cell Bank for the secreted process is designated [*] and is used to generate the Working Cell Bank for such process. The Master Cell Bank for the [*] Process is designated [ * ] and is used to generate the Working Cell Bank designated [ * ].

1.46 “ NDA ” shall mean a new drug application or supplemental new drug application or any amendments thereto submitted to the FDA in the United States.

1.47 “ NEC ” means necrotizing enterocolitis.

1.48 “ Net Sales ” shall mean, with respect to Product, the gross invoiced commercial sales of Product by Nycomed, its Affiliates and sublicensees to Third Parties in the Territory (and for the purposes of Section 4.5 only, sales of Product by NPS, its Affiliates or Future Partners, in Canada and/or Mexico, as applicable), less the following deductions to the extent included in the gross invoiced sales price for Product or otherwise directly paid, allowed, accrued, or incurred by Nycomed, its Affiliates or sublicensees with respect to the sale of Product:

(a) quantity or cash discounts, credits, retroactive price reductions, rebates, allowances and adjustments granted, to the extent usual and customary in the pharmaceutical industry and consistent with Nycomed’s usual course of dealing for its products other than Product (including, without limitation, government mandated and managed healthcare negotiated rebates);

(b) amounts repaid, credited or written off by reason of rejections, recalls, billing errors and returns;

(c) sales, excise, turnover, inventory, value-added, and similar taxes assessed on the sale of Product (other than income taxes of Nycomed, its Affiliates or sublicensees), and import and customs duties; and

(d) transportation, importation, shipping insurance and other handling expenses.

Notwithstanding the foregoing, in any case where Product is sold or otherwise disposed of in a transaction that is not an arm’s length sale of Product exclusively for cash that is separate from any sale or disposition of other products or of services, Net Sales shall mean the greatest of:

(x) the Net Sales amount for Product sold in such transaction determined as provided above, with any non-cash consideration attributable to such transaction valued at fair market value;

(y) if there has been any arm’s length sale of Product separate from any sale or disposition of other products or of services to a non-sublicensee Third Party, the Net Sales amount, determined as provided above, for the most contemporaneous such sale; or

 

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(z) if there has been no such arm’s length sale, the fraction of the overall value of such transaction reasonably attributed to Product sold in such transaction, with any non-cash consideration attributable to such transaction valued at fair market value.

For sake of clarity, sales by Nycomed, its Affiliates or sublicensees to distributors and wholesalers shall be considered sales to Third Parties.

1.49 “ North America ” shall mean the United States, Mexico and Canada.

1.50 [*].

1.51 “ NPS Intellectual Property ” shall mean NPS Know-How and NPS Patent Rights.

1.52 “ NPS Know-How ” shall mean any Know-How that is Controlled by NPS on the Effective Date, but shall not include Joint Know-How.

1.53 “ NPS Patent Rights ” shall mean Patent Rights, to the extent that they (a) Cover NPS Know-How or are directly related to the Manufacture, use, Commercialization or Development of Compound or Product in the Field, and (b) are Controlled by NPS, but shall not include Joint Patent Rights.

1.54 “ NPS Royalty Term ” shall mean the NPS Initial Royalty Term and the NPS Secondary Royalty Term.

1.55 “ NPS Initial Royalty Term ” shall mean the period commencing on the Effective Date and ending on the later of, on a Country-by-Country and Product-by-Product basis, (a) ten (10) years from First Commercial Sale of Product in such Country and (b) the expiration or termination of the last to expire Valid Claim of a Patent Right listed on Schedule 1.55 Covering such Product in such Country.

1.56 “ NPS Secondary Royalty Term ” shall mean the period commencing at the end of the NPS Initial Royalty Term, on a Country-by-Country and Product-by-Product basis, and ending twenty (20) years from First Commercial Sale of Product, on a Country-by-Country and Product-by-Product basis.

1.57 “ Nycomed Intellectual Property ” shall mean Nycomed Know-How and Nycomed Patent Rights.

1.58 “ Nycomed Know-How ” shall mean any Know-How that either (a) is Controlled by Nycomed on the Effective Date or (b) comes within Nycomed’s Control during the Term, including Nycomed Sole Inventions, but shall not include Joint Know-How.

1.59 “ Nycomed Patent Rights ” shall mean Patent Rights, to the extent that they (a) Cover Nycomed Know-How or are directly related to the Manufacture, use, Commercialization or Development of Compound or Product in the Field, and (b) are Controlled by Nycomed, but shall not include Joint Patent Rights.

 

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1.60 “ Nycomed Royalty Term ” shall mean the Nycomed Initial Royalty Term and the Nycomed Secondary Royalty Term.

1.61 “ Nycomed Initial Royalty Term ” shall mean the period commencing on the Effective Date and ending, on the later of, on a Country-by-Country and Product-by-Product basis, (a) ten (10) years from First Commercial Sale of such Product in such Country on a Country-by-Country and Product-by-Product basis and (b) the expiration or termination of the last to expire Valid Claim of a Patent Right Covering such Product in such Country.

1.62 “ Nycomed Secondary Royalty Term ” shall mean the period commencing at the end of the Nycomed Initial Royalty Term, on a Country-by-Country and Product-by-Product basis, and ending twenty (20) years from First Commercial Sale of Product, on a Country-by-Country and Product-by-Product basis.

1.63 “ Ongoing Studies ” shall mean the following clinical studies: (a) CL0600-004 entitled “A Study of the Efficacy of Teduglutide in Subjects with Parenteral Nutrition-Dependent Short Bowel Syndrome”, (b) CL0600-005 entitled “A Study of the Efficacy of Teduglutide in Subjects with Parenteral Nutrition-Dependent Short Bowel Syndrome Who Completed Protocol CL0600-004”, and (c) CL0600-017 entitled “Pharmacokinetics of 20mg Teduglutide in Subjects with Moderately Impaired Hepatic Function Compared to Healthy Subjects with Normal Hepatic Function”.

1.64 “ Parties ” shall mean NPS and Nycomed.

1.65 “ Party ” shall mean either NPS or Nycomed.

1.66 “ Patent Rights ” shall mean patents and patent applications and all substitutions, divisions, continuations, continuations-in-part, any patent issued with respect to any such patent applications, any reissue, reexamination, renewal or extension (including any supplemental protection certificate) of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent, and all counterparts thereof in any Country.

1.67 “ Person ” shall mean any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government, or any agency or political subdivisions thereof.

1.68 “ Phase III Clinical Study ” shall mean a clinical study of Product in human subjects to confirm with statistical significance the efficacy and safety of Product performed to obtain Regulatory Approval for Product in any Country, which shall be deemed commenced when the first patient in such study has received his or her initial dose of Product.

1.69 “ Phase IV Clinical Study ” shall mean a clinical study initiated after Product has been granted Regulatory Approval in any Country, and which is aimed at strengthening the clinical evidence for Product to be used in the Commercialization of Product.

1.70 “ Primary Indication ” shall mean SBS.

 

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1.71 “ Product ” shall mean any pharmaceutical formulation, dosing and administration form containing the Compound as an active ingredient.

1.72 “ Regulatory Approval ” shall mean, with respect to a particular Indication for Product, any approval (including price approvals), registration, license or authorization from any Governmental Authority required for the Manufacture, Development, Commercialization, distribution, sale, storage or transport of Product for such Indication in any Country of the Territory, and shall include, without limitation, an approval, registration, license or authorization granted in connection with any Regulatory Approval Application.

1.73 “ Regulatory Approval Application ” shall mean, with respect to a particular Indication for Product, the submission to the relevant Governmental Authority of an appropriate application seeking any Regulatory Approval, and shall include, without limitation, a marketing authorization application, supplementary application or variation thereof, NDA or any equivalent applications in any Country of the Territory.

1.74 “ Regulatory Authority ” shall mean any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the marketing and sale of a pharmaceutical product in a Country, including without limitation FDA in the United States and EMEA in the EU.

1.75 “ Restoragen License Agreement ” shall mean the Exclusive License Agreement, dated November 21, 2002, by and between Restoragen, Inc. and NPS Pharmaceuticals, Inc.

1.76 “ SBS ” shall mean short bowel syndrome.

1.77 “ SBS Clinical Supply Cost ” shall mean, with respect to Product or the Device, as applicable, for Development for the Primary Indication, [*].

1.78 “ Successful Proof of Concept Study ” shall mean proof of efficacy in a particular Indication in the form of a clinical study that generates, confirms or otherwise provides an adequate benefit-risk for Product through statistically meaningful endpoints, which may be derived from one or more doses in accordance with the statistical analysis plan described in a Development Plan and which is used as the basis for a decision to move forward with a Regulatory Approval strategy for an Indication or a label change for a previous Indication for Product.

1.79 “ Territory ” shall mean the entire world and all Countries, territories and possessions therein, except for North America.

1.80 “ Third Party ” shall mean any Person other than a Party or any of its Affiliates.

1.81 “ United States ” shall mean the United States of America and its territories and possessions.

1.82 “ UTAUS License Agreement ” shall mean the Non-Exclusive Patent License Agreement, UTAUS Agreement No. 02-073, dated May 15, 2004, by and between the Board of Regents of the University of Texas System and NPS Allelix Corp.

 

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1.83 “ Validation Batch ” shall mean any one of each of three (3) consecutive batches of API or dosage form which conform to the critical parameters described in the process and which are Manufactured according to the Manufacturing process.

1.84 “ Valid Claim ” shall mean, with respect to any Country, a Claim of an issued and unexpired patent or a Claim included in a pending patent application within the NPS Intellectual Property, Nycomed Intellectual Property or Joint Intellectual Property in such Country Covering the Compound or Product which has not been held unenforceable, unpatentable or invalid by a decision of a court or other Governmental Authority of a competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise.

1.85 “ Working Cell Banks ” means NPS’ working cell banks containing the host cells (with the plasmid incorporated therein) used in the fermentation process for the production of recombinant glycine2-human glucagon-like peptide-2(ALX-0600(Teduglutide)) as a secreted material in the fermentation culture broth and as a fusion peptide for the inclusion bodies in the host cell. The Working Cell Banks for the secreted process are designated [*] and are generated from the Master Cell Bank for such process. The Working Cell Bank for the [*] Process is designated [*] and is generated from the Master Cell Bank designated [ * ].

1.86 Additional Definitions . Each of the following definitions is set forth in the Section of this Agreement indicated below:

 

Definition		Section
1974 Convention		13.1
Active Party		4.2(g)
Additional Committees		2.3
Agreement		Preamble
ATCC		6.6
Breaching Party		11.2(c)
[*]		6.6
CIGIM Proposal		4.2(e)
Code		11.3(c)
Competing Product		10.1
Confidential Information		9.1
Controlling Party		6.4
Developing Party		6.5(b)
Effective Date		Preamble
Improvement		8.1(c)
IND		4.2(e)
Indemnified Party		10.7(a)
Indemnifying Party		10.7(a)
Initial Development Plan		4.2(c)
Initial Enforcement Rights Party		8.3(c)
Invalidity Claim		8.4

 

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Definition		Section
Joint Development Committee		2.2(a)