AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT

Collaboration Agreement

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FOXHOLLOW TECHNOLOGIES, INC | MERCK & CO, INC

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Title: AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT
Governing Law: New York Date: 11/9/2006
Industry: Medical Equipment and Supplies Law Firm: Cooley Godward Sector: Healthcare

AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT, Parties: foxhollow technologies inc , merck & co inc

EXECUTION VERSION

[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24 B -2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

E XHIBIT 10.22

AMENDED AND RESTATED

COLLABORATION AND LICENSE AGREEMENT

by and between

MERCK & CO., INC.

and

FOXHOLLOW TECHNOLOGIES, INC.

EXECUTION VERSION

AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT

This Amended and Restated Collaboration and License Agreement (as may be amended from time to time, this “Agreement”) dated as of September 26, 2006, (the “Restatement Date”) is entered into by and between Merck & Co., Inc., a New Jersey corporation, having offices at One Merck Drive, Whitehouse Station, New Jersey (“Merck”), and FoxHollow Technologies, Inc., a Delaware corporation, having offices at 740 Bay Road, Redwood City, California (“FHT”), and amends and restates in its entirety that certain Collaboration and License Agreement, effective as of September 15, 2005 (the “Original Effective Date”), between Merck and FHT (the “Original Agreement”).

Background:

FHT and Merck desire to amend and restate the Original Agreement on the terms and subject to conditions set out in this Agreement. In connection with the execution of this Agreement, Merck also shall purchase common stock of FHT on the terms and conditions set forth in that certain Stock Purchase Agreement executed as of the Restatement Date (the “Stock Purchase Agreement”).

NOW, THEREFORE, Merck and FHT agree as follows:

ARTICLE 1 DEFINITIONS. Unless specifically set forth to the contrary in this Agreement, the following terms, whether used in the singular or plural, shall have the respective meanings set forth below.

1.1

“Affiliate” means (a) any corporation or business entity of which fifty percent (50%) or more of the securities or other ownership interests representing the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by Merck or FHT; or (b) any corporation or business entity which, directly or indirectly, owns, controls or holds fifty percent (50%) (or the maximum ownership interest permitted by law) or more of the securities or other ownership interests representing the equity, the voting stock or, if applicable, the general partnership interest, of Merck or FHT; or (c) any corporation or business entity of which fifty percent (50%) or more of the securities or other ownership interests representing the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by a corporation or business entity described in (a) or (b).

1.2	“Alignment Committee” is defined in Section 2.2.3.

1.3	“Background Package” means the background package submitted to the FDA for the end-of-Phase II meeting between Merck (or its Affiliate) and the FDA to prepare for implementation of a Phase III Clinical Trial.

1.4	“Biological Samples and Data” means:

(a)

biological material (“Material”) directly obtained from human or animals, or derivatives of such materials, and collected or tested under the Collaboration Program, including during the period from September 15, 2006 until the Effective Date.

Examples of Material include [ * ] and [ * ] contained in the [ * ], and all [ * ] that meets [ * ], and all [ * ], as well as any [ * ] from [ * ] or [ * ]; and

(b)

information generated from the testing or use of Material, or information concerning the source of such Material (“Data”).

Examples of such Data include [ * ] concerning or resulting from the [ * ] of any Material. This includes [ * ] found in [ * ] at different [ * ], and all [ * ], as well as any [ * ].

1.5	“Calendar Quarter ” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.

1.6	“Calendar Year ” means each successive period of twelve (12) months starting on January 1 and ending on December 31.

1.7	“Cardiovascular Device” means a Device for the treatment or diagnosis of a disease of the blood vessels or heart.

1.8	“ Change of Control” as the meaning assigned thereto under the Stock Purchase Agreement.

1.9	“Collaboration Program” means the activities undertaken by the Parties under this Agreement during the Collaboration Program Term. All work to be conducted by FHT under the Collaboration Program shall be conducted at the request or approval of Merck, as further described in Section 2.1.

1.10	“Collaboration Program Budget” means the budget for activities to be undertaken by FHT under the Collaboration Program, as described in Section 5.3.

1.11	“Collaboration Program Clinical Study” or “CPCS” means a clinical study conducted under the Collaboration Program in accordance with a protocol that has been approved by Merck.

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1.12	“Collaboration Program Inventions and Results ” means:

(a)

all Biological Samples and Data;

(b)

all Inventions, protocols, results, data, discoveries, formulas, know-how and trade secrets, including any biomarkers or surrogate markers, assays, tests, clinical trial methodologies, or procedures (in each case whether patentable or otherwise) that were generated in the course of or arise from the performance of the Collaboration Program, including during the period from September 15, 2006 until the Effective Date, or resulting from the analysis of Biological Samples and Data during the Collaboration Program Term or Tail Period, including during the period from September 15, 2006 until the Effective Date; and

(c)

any improvements or enhancements to, or subsequent inventions resulting from, any of the items described in clauses (a) and (b) to the extent such improvements, enhancements or inventions are generated during the Collaboration Program Term or Tail Period or during the period from September 15, 2006 until the Effective Date; provided , however the term “Collaboration Program Inventions and Results” shall not apply to, and shall exclude, FHT Independent Inventions and Improvements, Excluded Merck Compound Rights, and Merck Independent Inventions and Improvements.

1.13

“Collaboration Program Patent Rights” means any and all patents and patent applications (which for the purposes of this Agreement shall be deemed to include certificates of invention, provisional applications, and applications for certificates of invention) claiming any Collaboration Program Invention and Results.

1.14	“Collaboration Program Term” means the duration of the Collaboration Program, as described more fully in Section 2.8.

1.15	“Combination Product” means a product containing both a Therapeutic Product as well as one or more active ingredients that are other than a Profiled Compound. All references to Product in this Agreement shall be deemed to include Combination Products.

1.16	“Contract Year” means a year of 365 days (or 366 days in a leap year) beginning on the Effective Date and ending one year thereafter and so on, year-by-year.

1.17

“Control” with respect to intellectual property or tangible property rights (e.g., compounds or information), means the legal authority (whether by ownership or license, other than pursuant to this Agreement) of a Party to grant access to, or a license or sublicense of such intellectual property rights or tangible property.

1.18	“CPCS Samples and Data” is defined in Section 2.4.8(c).

1.19	“CRO” means a contract research organization.

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1.20	“Data” is defined in Section 1.3.

1.21	“DDMAC ” means the FDA’s Division of Drug Marketing, Advertising, and Communications.

1.22	“Device” means a mechanical device that FHT owns or controls.

1.23	“Dose Ranging Product ” means a Therapeutic Product that achieved Therapeutic Product Development Milestone [ * ] described in Section 5.4[ * ], and Therapeutic Product Development Milestone [ * ] described in Section 5.4[ * ].

1.24	“ Effective Date” means the Closing Date, as defined in the Stock Purchase Agreement.

1.25	“ EMEA ” means the European Medicines Agency.

1.26	“Enhanced Label Product” means a Therapeutic Product with respect to which any Collaboration Inventions and Results are contained in both: (i) [ * ]; and (ii) [ * ] used by Merck or its Affiliates in the United States for such Therapeutic Product.

1.27	“Exceptions to the Exclusive Field” are set out in Attachment B.

1.28	“Excluded Claim” is defined in Section 9.7.6.

1.29	“Excluded Merck Compound Rights” means all Merck NCEs (and any uses, formulations or enhancements to the same), and all data on Merck NCEs.

1.30	“Exclusive Field” means the conduct of any Exclusive Field Activity, but excluding all Exceptions to the Exclusive Field.

1.31	“Exclusive Field Activity” means each of those activities set out in Attachment A.

1.32	“Exclusivity Maintenance Payment” is defined in Section 5.2.2.

1.33	“ FDA” means the United States Food and Drug Administration.

1.34	“FHT Collaboration Program Inventions and Results” means all Collaboration Program Inventions and Results discovered, developed or invented solely by employees of FHT, or other persons not employed by Merck acting on behalf of FHT.

1.35	“FHT Collaboration Program Patents” means all Collaboration Program Patent Rights that claim FHT Collaboration Program Inventions and Results.

1.36	“FHT Exclusivity Period ” is defined in Section 2.9.

1.37

“FHT Independent Inventions and Improvements ” means: (a) FHT-Controlled technology, methods, devices, and systems for the excision of plaque; (b) the TALON Registry (excluding any Material contained therein that meets the Sample Criteria); (c) any improvements to the items listed in (a) created under the Collaboration Program or

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independent of the Collaboration Program but after the Original Effective Date; and (d) FHT patents, patent applications and know-how covering any of the foregoing.

1.38	“Filing” means the acceptance by the first Regulatory Authority of an NDA for filing.

1.39	“First Commercial Sale” means, with respect to any Product or Test, the first sale for end use or consumption of such Product or Test in a country, excluding, however, any sale or other distribution for use in clinical trials.

1.40

“FTE” means the equivalent of a full-time FHT or Merck employee’s work time in full working days over a 12-month period (including normal vacations, sick days and holidays, but excluding weekends), provided that one person can only account for a single FTE, regardless of the number of hours such person works on Collaboration Program activities, or non-Collaboration Program activities. The portion of an FTE year devoted by a FHT or Merck employee to the Collaboration Program shall be determined by dividing the number of full working days during any 12-month period devoted by such employee to the Collaboration Program by the total number of working days of such employee during any such 12-month period.

1.41	“FTE Rate” means the amount that Merck will pay FHT in a Contract Year to support one FTE assigned to the Collaboration Program during such Contract Year. The FTE Rate will be [ * ] per FTE for each of the first two Contract Years. [ * ]

1.42

“Image-Enhancing Agent” means a combination of: (i) a vector (the source of specificity, including but not limited to, small molecules, peptides, polymers, proteins, antibody fragments, antibodies); and (ii) a reporter (the source of physical detection; including, but not limited to, radionuclides, optical chromophores, gadolinium complexes, iron oxide particles, iodine or tungsten containing compounds, ultrasound bubbles).

1.43

“ Indication ” means a separate and distinct disease or medical condition in humans (a) which a Therapeutic Product is intended to treat, and/or prevent, where the Therapeutic Product is either in Phase III Clinical Trials, or is the subject of an NDA; and/or (b) for which a Therapeutic Product has received Marketing Authorization (meaning that such Indication is contained in the Therapeutic Product’s labeling approved by a Regulatory Authority as part of the Marketing Authorization for such Product).

1.44	“Information” means all information and data, whether communicated in writing or orally or by any other method, which is provided by one Party to the other Party under this Agreement.

1.45	“Initial FHT Exclusivity Period” is defined in Section 2.9.

1.46	“Initial Term” is defined in Section 2.8.

1.47	“Initiation” means, with respect to a Phase III Clinical Trial, the administration of the first dose to the first patient in such Phase III Clinical Trial.

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1.48	“Invention” means any process, method, composition of matter, article of manufacture, discovery or finding that is conceived and/or reduced to practice in the course of the activities of the Collaboration Program, including during the period from September 15, 2006 until the Effective Date.

1.49	“Joint Collaboration Program Inventions and Results” means all Collaboration Program Inventions and Results discovered, developed or invented jointly by employees of Merck and FHT, or others acting on behalf of Merck and FHT.

1.50	“Joint Patent Rights ” means all Collaboration Program Patent Rights that claim Joint Collaboration Program Inventions and Results.

1.51	“Labeled Product” means any Therapeutic Product with respect to which any Collaboration Inventions and Results are contained in the [ * ], but are not contained in [ * ] used by Merck or its Affiliates in the United States for such Therapeutic Product.

1.52	“Major Indication” means any of the following Indications: [ * ].

1.53

“ Major Market” means any the following: United States of America, Japan, and either (i) the European Union, in the case of EMEA centralized procedure for drug approval, or (ii) France, Germany, Italy, the United Kingdom, or Spain, in the case where Merck or its Affiliates does not make use of the EMEA centralized procedure for drug approval.

1.54

“Marketing Authorization” means all approvals necessary from the relevant Regulatory Authority to market and sell a Therapeutic Product or Test (including without limitation all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product or Test in a country).

1.55	“Material” is defined in Section 1.4.

1.56	“Merck Collaboration Program Inventions and Results” means all Collaboration Program Inventions and Results discovered, developed or invented solely by employees of Merck, or other persons not employed by FHT acting on behalf of Merck.

1.57	“Merck Collaboration Program Patents” means all Collaboration Program Patent Rights that claim Merck Collaboration Program Inventions and Results.

1.58

“Merck Independent Inventions and Improvements” means (a) Merck-Controlled compounds (including Merck NCEs), methods of treatment, analysis technology, clinical specimens (other than Biological Samples and Data), biomarkers, and assays; (b) any improvements on the same created under the Collaboration Program or independent of the Collaboration Program but after the Original Effective Date; and (c) Merck (including Affiliate) patents, patent applications, and know how covering any of the foregoing.

1.59	“Merck NCE” means any Merck-Controlled Profiled Compound that has not received FDA approval for sale as a human use product at the time it is studied in the Collaboration Program.

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1.60

“NDA” means a New Drug Application, Biologics License Application, or Marketing Application Authorization, or similar application or submission for Marketing Authorization filed with a Regulatory Authority to obtain marketing approval for a biological, pharmaceutical or diagnostic product in country or in group of countries within the jurisdiction of the Regulatory Authority.

1.61	“Non-Cardiovascular Device” means a Device other than a Cardiovascular Device.

1.62	“Original Agreement” is defined in the preamble.

1.63	“Original Effective Date” is defined in the preamble.

1.64	“Original Agreement Period” means the period between the Original Effective Date and the Effective Date.

1.65	“Party” means Merck or FHT, and “Parties” shall mean Merck and FHT.

1.66	“Patent Rights” means both the FHT Collaboration Program Patent Rights and FHT’s interest in the Joint Collaboration Program Patent Rights.

1.67	“Permitted Cardiovascular Applications or Indications” is defined on Attachment B, but expressly excludes de novo atherosclerosis and acute coronary syndrome.

1.68	“ Person ” means any individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, or joint stock company.

1.69	“Phase III Clinical Trial” means a human clinical trial that is pivotal to Filing and satisfies the requirements of 21 CFR 312.21(c).

1.70	“Phase III Ready” means that a drug has completed [ * ].

1.71	“Product” means each of the Dose Ranging Product, Labeled Product and Enhanced Labeled Product, and each “Products” means all such products, collectively. “Product” also includes any Combination Product.

1.72	“Product Net Sales” means the gross invoice price of Product sold by Merck, its Affiliates and their respective sublicensees to the first Third Party after deducting, if not previously deducted, from the amount invoiced or received:

1.72.1

trade and quantity discounts other than early pay cash discounts;

1.72.2

returns, rebates, chargebacks and other allowances;

1.72.3

the standard inventory cost of devices or delivery systems used for dispensing or administering Product (such as syringes or inhalation devices, but not packaging);

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1.72.4

sales commissions paid to Third Party distributors and/or selling agents, in amounts customary to the trade and to the extent allocable to the Product;

1.72.5

retroactive price reductions that are actually allowed or granted; and

1.72.6

a fixed amount equal to [ * ] to cover bad debt, sales or excise taxes, early payment cash discounts, transportation and insurance, custom duties, and other governmental charges.

With respect to sales of Combination Products, Net Sales shall be calculated on the basis of the gross invoice price of Product(s) containing the same strength of Profiled Compound sold, without other active ingredients. If the Therapeutic Product contained within any Product is not sold separately, Net Sales shall be calculated on the basis of the gross invoice price of the Combination Product multiplied by a fraction, the numerator of which shall be the [ * ] and the denominator of which shall be the [ * ] in the Combination Product. Inventory cost shall be determined in accordance with Merck’s regular accounting methods, consistently applied. The deductions set out in Sections 1.72.1 through 1.72.6 will be applied in calculating Net Sales for a Combination Product. If Product is sold only as a Combination Product and either Party reasonably believes that the calculation set forth in this paragraph does not fairly reflect the value of the Product relative to the other active ingredients in the Combination Product, the Parties shall negotiate, in good faith, other means of calculating Net Sales with respect to Combination Products

1.73

“Profiled Compound” means any chemical compound (including but not limited to small molecules, proteins, antibodies and therapeutic nucleic acids): (a) for which Biological Samples and Data is generated concerning such compound’s effectiveness; or (b) the discovery, identification or development of which utilizes or is based upon Collaboration Program Inventions and Results.

1.74	“ Project Leader” is defined in Section 2.2.1.

1.75	“Project Manager” is described in Section 2.2.2.

1.76

“Promotional Material” means any material for promotion of a Therapeutic Product in the United States that Merck prepares and that it is required to submit to DDMAC on FDA transmittal Form 2253 (pursuant to 21 CFR 314.81) for a Therapeutic Product, including brochures, booklets, detailing pieces, advertisements published in journals, magazines, other periodicals and newspapers, or broadcast through media such as radio, television, and telephone communications systems, to the extent Merck (or its Affiliate) has approved and obtains FDA approval for same for use in the United States.

1.77	“Prospective Registry” means the tissue and data collection registry created under the Collaboration Program, as more fully described in Section 2.4.2.

1.78	“Regulatory Authority” means the FDA, EMEA, and, with respect to Japan, the Japanese governmental regulatory authority involved in granting approvals for the

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manufacturing, marketing, reimbursement and/or pricing of a Product or Test in the Japan, and any successor governmental authority having substantially the same function.

1.79	“Restatement Date” is defined in the preamble.

1.80	“Restenosis Drug” means a [ * ] therapy directed to [ * ].

1.81	“Sample Criteria” is defined in Section 2.4.4.

1.82	“Securities Act” has the meaning given such term in the Stock Purchase Agreement.

1.83	“Significant Event” is described in Section 8.2.1 (c).

1.84	“Stock Purchase Agreement” is defined in the Preamble.

1.85	“Tail Period” means the [ * ] month period immediately following the end of the Collaboration Program Term.

1.86

“ TALON Registry ” means: (a) FHT’s multi-center registry designed to capture and archive patient outcomes data, as well as all biological material, such as excised plaque using FHT technology, and (b) any and all de-identified patient-related clinical and demographic data corresponding to such biological material, as well as any genetic, and genomic data associated with such collections. TALON Registry is further described in Attachment C.

1.87	“Territory” means all of the countries in the world, and their territories and possessions.

1.88

“Test” means (a) a prognostic test [ * ], to the extent such test was developed, discovered or identified by Merck using, or incorporates, Collaboration Program Inventions and Results; and/or (b) a diagnostic test [ * ]; and/or (ii) [ * ]; to the extent such test was developed, discovered or identified by Merck using, or incorporates, Collaboration Program Inventions and Results.

1.89	“ Test Net Sales ” mean the gross invoice price of Tests sold by Merck, its Affiliates and their respective sublicensees to the first Third Party after deducting, if not previously deducted, from the amount invoiced or received:

1.89.1

trade and quantity discounts other than early pay cash discounts;

1.89.2

allowances actually credited to such Third Party for spoiled, damaged, outdated or returned Tests; and

1.89.3

a fixed amount equal to [ * ] of the amount invoiced to cover bad debt, sales or excise taxes, early payment cash discounts, transportation and insurance, custom duties, and other governmental charges.

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If Merck sells a Test in the form of kit containing items developed, discovered or identified by Merck using Collaboration Inventions and Results, together with other diagnostic or prognostic items that were developed, discovered or identified without the use of Collaboration Invention and Results, the Parties shall negotiate, in good faith, other means of calculating Net Sales with respect to such Test kits to fairly reflect the value of the Collaboration Inventions and Results relative to the other items in the Test kit.

1.90	“Therapeutic Product” means any pharmaceutical or biological preparation in final form containing a Profiled Compound for: (a) sale by prescription, over-the-counter or any other method; or (b) administration to human patients in a Phase III Clinical Trial.

1.91	“Third Party” shall mean an entity other than Merck and its Affiliates, and FHT.

1.92

“Valid Product Patent Claim” means a claim of an issued and unexpired Merck-Controlled patent claiming the composition of matter of a Product which claim has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, and which decision is not appealable or has not been appealed within the time allowed for appeal, and which claim has not been disclaimed, denied or admitted by Merck to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise.

1.93

“Valid Test Patent Claim” means a claim of an issued and unexpired claim within the Collaboration Program Patents Right which claim has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, and which decision is not appealable or has not been appealed within the time allowed for appeal, and which claim has not been disclaimed, denied or admitted by Merck to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise.

ARTICLE 2 COLLABORATION PROGRAM.

2.1

General. FHT and Merck shall engage in and conduct the Collaboration Program on the terms and subject to the conditions set out in this Agreement. Merck shall be responsible for providing the overall direction of the Collaboration Program, and all Collaboration Program activities shall require the prior approval of Merck. In the event of disputes between the FHT and Merck with respect to the implementation of Collaboration Program activities, FHT will have final decision-making authority with respect to the methods and procedures for harvesting and collecting of tissue, and Merck shall have the final decision-making authority with respect to all other matters, subject to any and all provisions in this Agreement that explicitly require FHT’s consent or approval of particular decisions.

2.2	Collaboration Program Oversight and Management.

2.2.1

Project Leaders. The project leaders (“Project Leaders”) for the Collaboration

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Program are [ * ] for FHT, and [ * ] for Merck. The Project Leaders shall have responsibility for providing day-to-day direction and oversight of the Collaboration Program, documenting Collaboration Program assignments and results, and presenting each of the Parties with periodic progress reports (but no less than once per Calendar Quarter) describing the work performed and the results achieved to date on the Collaboration Program. Each Party is entitled to designate a replacement Project Leader reasonably acceptable to the other Party, but shall notify the other Party in writing as soon as practicable upon the changing of its Project Leader.

2.2.2

Project Manager . Following the Effective Date, Merck shall have the right to designate a Merck employee to serve as the project manager (the “Project Manager”) of the Collaboration Program. The Project Manager shall coordinate day-to-day Collaboration Program activities, track expenses incurred in the performance of Collaboration Program activities against the established Collaboration Program Budget for such activities, provide the Project Leaders with reports on such expenses on a quarterly basis, or more frequently as the Parties may agree, and make recommendations to the Project Leaders with respect to the operation of the Collaboration Program.

2.2.3

Alignment Committee . Promptly following the Effective Date, the Parties will establish a joint committee (the “Alignment Committee”) with equal representation from FHT and Merck of no less than two representatives each (who may be substituted or replaced by alternates at any time). The Alignment Committee will act as a non-decision making forum for periodic review, assessment and discussions concerning the progress of the Collaboration Program, and is intended to provide the Parties with an opportunity to draw on each other’s experience and knowledge relevant to the Collaboration Program. The Alignment Committee will meet in accordance with schedule established by mutual agreement of the Parties, but at least twice per Contract Year during the Collaboration Program Term, with the location for such meetings alternating between Merck and FHT facilities (or such other location as may be determined by the Alignment Committee. Alternatively, the Alignment Committee may meet by means of teleconference, videoconference or other communication equipment.

2.3	General Collaboration Program Responsibilities.

2.3.1

FHT will have the obligation to conduct all Collaboration Program activities reasonably requested by Merck, and to use commercially reasonable efforts to conduct such activities within the timeframes reasonably requested by Merck, provided that Merck complies with its funding obligations in accordance with Section 5.3. Notwithstanding the foregoing, any request by Merck that FHT perform Collaboration Program activities shall be subject to FHT’s consent, not to be unreasonably withheld, only to the extent FHT in good faith determines that performing such activities within the requested timeframe would not be practicable due to availability of appropriate FTEs. It is understood and agreed

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that FHT in no way guarantees the scientific results of any activities conducted under the Collaboration Program. FHT and Merck each shall conduct its Collaboration Program obligations and activities in good scientific manner, and in compliance in all material respects with all requirements of applicable laws, rules and regulations and attempt to achieve their respective objectives efficiently and expeditiously. FHT and Merck shall each proceed diligently with the work under the Collaboration Program by using its respective good faith efforts to allocate sufficient time, effort, equipment and facilities to the activities assigned to each Party under the Collaboration Program. Merck and FHT shall each use personnel with sufficient skills and experience as are required to accomplish the Collaboration Program in accordance with the terms of this Agreement.

2.3.2

Merck is entitled to utilize the services of its Affiliates and Third Parties to perform its Collaboration Program activities; provided that Merck shall notify in writing FHT periodically as to the identify of any such Merck Affiliates and Third Parties to the extent not previously disclosed to FHT. FHT shall be entitled to utilize the services of Third Parties to perform its Collaboration Program activities only upon Merck’s prior written consent. Notwithstanding any such consent or pre-approval, both Parties shall remain at all times fully liable for its respective responsibilities under the Collaboration Program. Each Party certifies that it has not, and will not, employ or otherwise use in any capacity the services of any person debarred under United States law, including but not limited to Section 21 USC 335a, in performing any portion of its Collaboration Program responsibilities.

2.4	Specific Collaboration Program Responsibilities. Without limiting the generality of the foregoing Section 2.3, the following Collaboration Program tasks are examples of the Parties’ responsibilities under the Collaboration Program.

2.4.1

TALON Registry Biological Samples and Data . FHT shall own the TALON Registry. During the Collaboration Program Term FHT shall be responsible for maintaining the TALON Registry, and shall be responsible for providing access to Merck to the Biological Samples and Data resulting from the TALON Registry.

2.4.2

Prospective Registry Components. FHT shall be responsible for collecting the components of the Prospective Registry. Merck agrees and acknowledges that FHT has performed tasks and deliverables required of it pursuant to the Original Agreement with respect to the deliverables owed with respect to the Prospective Registry during the Initial Term of the Original Agreement. Following the Effective Date, with respect to any additional Prospective Registry, FHT shall be responsible for collecting the components of the Prospective Registry. The Parties anticipate that the Prospective Registry will be made up of Biological Samples and Data collected from the following sources:

(a)

CPCS subjects who were not provided with any drug compounds,

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including any Merck NCEs;

(b)

TALON Registry Materials and Data that meet the Sample Criteria;

(c)

Peripheral arterial disease and coronary disease plaque excision procedures conducted by or on behalf of FHT after the Original Effective Date that do not involve the study of Profiled Compounds. This category will be made up of Biological Samples and Data collected by physicians using FHT’s excision devices; and

(d)

Carotid endarterectomy plaque excision procedures or excisions of any other tissue excised by or on behalf of FHT after the Original Effective Date that do not involve the study of Profiled Compounds. This category will be made up of Biological Samples and Data collected by physicians using FHT’s excision devices.

2.4.3

Ownership and Delivery of Prospective Registry Material and CPCS Samples and Data . Notwithstanding anything to the contrary in this Agreement, Merck shall solely own the Material contained in the Prospective Registry and the CPCS Samples and Data. From time to time during the Collaboration Program Term as reasonably requested by Merck and in accordance with Merck’s reasonable instructions, FHT shall transfer to Merck the Prospective Registry Material and the CPCS Samples and Data, along with a complete set of Data associated with such Material.

2.4.4

Sample Criteria . As part of the Prospective Registry protocol, Merck and FHT shall establish criteria (“Sample Criteria”) that Biological Samples and Data comprising the Prospective Registry are intended to meet. Any TALON Registry Biological Samples and Data meeting the Sample Criteria shall be included in the Prospective Registry.

2.4.5

Compounds and Biological Sample Analysis .

(a)

Compounds . Merck shall be responsible for, and shall bear the cost of, providing compounds to be profiled in the Collaboration Program or used in any CPCS.

(b)

Collaboration Program Plaque Analysis . Merck, itself or through its Affiliates, shall be responsible for analyzing Biological Samples and Data in an effort to establish plaque biomarkers of atherosclerotic disease activity. Merck’s Collaboration Program plaque analysis responsibilities, include, but are not limited to, histology, all forms of protein and gene expression analysis, and all forms of lipid content analysis.

(c)

Non-Collaboration Program Plaque Analysis . Merck will provide up to [ * ] for plaque analysis for the sole purpose of supporting FHT Device innovation as permitted by Section 2.4.12 and 2.4.13. Merck shall provide

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such plaque analysis services [ * ]. If [ * ], Merck shall [ * ]. Merck will own the data results of any plaque analysis Merck performs under this Section 2.4.5(c), provided that FHT shall have the right to use the results of such analysis solely for FHT Device innovation, regulatory filings in support of such Device approval, and promotion of such Devices. FHT shall retain ownership of any plaque samples analyzed by Merck under this Section 2.4.5(c).

2.4.6

Regulatory Matters.

(a)

During the Collaboration Program Term and thereafter, Merck shall be solely responsible for, and shall bear the cost of, preparing and submitting registration dossiers for Therapeutic Products, Products and Tests in the Territory; provided , that Merck shall provide FHT with the regulatory reports as described in Section 2.6.1.

(b)

Merck shall, by way of the Project Leaders, keep FHT periodically and reasonably informed of Merck meetings with the FDA involving discussions of Collaboration Program Inventions and Results in connection with milestone events set out in Sections 5.4 and 5.5. [ * ]

(c)

Merck shall have sole discretion as to the regulatory strategy and decision making for any Therapeutic Product, Product or Test; provided however, that during the Collaboration Program Term, Merck shall consider in good faith any and all FHT recommendations regarding regulatory strategy with respect to the use of Collaboration Program Inventions and Results.

(d)

All Marketing Authorizations shall be held by and in the name of Merck (or its Affiliates), and Merck (or its Affiliates) shall solely own all regulatory submissions in connection therewith.

2.4.7

Clinical Trial Methodology . The Parties shall collaborate on efforts to:

(i)

study and collect Biological Samples and Data, and optimize Biological Samples and Data handling and processing; and

(ii)

develop methodologies for designing and conducting clinical trials involving [ * ]

The results of such efforts shall be deemed Collaboration Program Inventions and Results.

2.4.8

Collaboration Program Clinical Studies. FHT is responsible for conducting Collaboration Program Clinical Studies. All CPCSs must be performed under the direction and control of Merck, in accordance with the terms of the applicable Merck-approved study protocol. Each CPCS involving a Merck NCE shall be performed under a separate Clinical Study Agreement based on the form of

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agreement attached as Attachment D to this Agreement and executed by the appropriate parties. FHT shall conduct each CPCS in compliance with all FDA regulations relating to Good Clinical Practice and Clinical Trials, and other applicable regulations.

(a)

CPCS Protocols . Merck shall be responsible for writing all protocols for CPCSs involving Merck NCEs and other Merck-Controlled compounds. Merck and FHT shall determine which Party shall be responsible for writing non-Merck NCE CPCS protocols on a case-by case basis. FHT shall be responsible for obtaining all necessary approvals and appropriate informed consents, in writing, for the collection of Biological Samples and Data for each CPCS. All protocols authored by FHT shall be in writing and reviewed and approved by Merck. In addition, Merck has the right to approve informed consents for each CPCS involving Merck NCEs and other Merck-Controlled compounds.

(b)

Responsibility for CPCS Resources . Once Merck has approved a CPCS protocol, FHT shall make available scientific and managerial personnel with sufficient expertise and experience necessary to coordinate and conduct the CPCS. FHT shall have the right to use a CRO to conduct a Collaboration Program Clinical Study, provided that: (i) Merck consents in advance; (ii) the CRO agrees to use only facilities approved in advance by Merck; (iii) the CRO is retained by FHT pursuant to a written agreement; and (iv) the terms of such agreement are approved by Merck (not to be unreasonably withheld). During a given Contract Year, to the extent Merck approves the use by FHT of the services of a CRO in the conduct of any CPCS, the Collaboration Program Budget shall be revised in accordance with Section 5.3.1.

(c)

CPCS Samples and Data . FHT shall use commercially diligent efforts to collect, pursuant to one or more CPCS, and deliver to Merck Biological Samples and Data meeting Merck-specified quality control criteria (the “CPCS Samples and Data”).

2.4.9

Agreements with Third Parties. If during the Collaboration Program Term FHT believes that one or more Third Parties may possess skills, technology or intellectual property of use to the Parties in the conduct of the Collaboration Program, it shall identify such Third Party to the Merck, and Merck shall determine in good faith whether or not it should enter into discussions with such Third Party to collaborate with, or license intellectual property from, such Third Party (a “Third Party Collaboration Agreement”). Without limiting the generality of the foregoing, Merck agrees that, in the event that FHT presents to Merck a Test business opportunity, Merck will consider such opportunity in good faith.

2.4.10

Image-Enhancing Agents. Notwithstanding Section 8 of Attachment A and

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Section 2.9.1, if FHT, or Merck, determines that the use of Collaboration Program Inventions and Results would be useful in the development of Image-Enhancing Agents (non-OCT Agents), it shall so inform the other Party, and where the Parties agree in writing, they will collaborate on the development of such Image-Enhancing Agents. If as a result of such collaboration, Merck and FHT develop Image-Enhancing Agents suitable for commercialization as stand-alone products, or for sale to Third Parties to be sold into the market in combination with other services or products of such Third Parties, all revenue generated from the sale of such Image-Enhancing Agents would be shared on a [ * ] basis as between Merck and FHT, and where a Third Party also contributes to such product, as further agreed by the Parties, taking into consideration the contribution of such Third Party. In such event, the direct costs associated with the development of such Image-Enhancing Product would also be shared on a [ * ] basis as between Merck and FHT, and to the extent one Party had expended funds in excess of [ * ], the other Party would reimburse such overage costs. Merck shall further have the right to count any amounts reimbursed to FHT for its expenses associated with such development towards its funding requirements set forth in Section 5.3.3. The terms of this Section 2.4.10 shall only apply to Image-Enhancing Agents not covered by Section 2.4.11.

2.4.11

OCT Image-Enhancing Agents; Catheters.

(a)

Notwithstanding Section 8 of Attachment A and Section 2.9.1, if FHT or Merck determines that the use of Collaboration Program Inventions and Results would be useful in the development of Image-Enhancing Agents comprised of a reporter, with or without a vector, for use with optical coherence tomography (“OCT”), it shall so inform the other Party and [ * ]. Where the Parties so agree, they will then collaborate pursuant to a separate agreement or work plan on the development and commercialization of such Image-Enhancing Agents (“OCT Agents”).

(b)

If the Parties do agree to so collaborate, and Merck and FHT develop OCT Agents suitable for commercialization as stand-alone products, or for sale to Third Parties to be sold into the market in combination with other services or products of such Third Parties, all [ * ] generated from the sale of such OCT Agents would [ * ] as between Merck and FHT. In such event, the [ * ] as between Merck and FHT, and to the extent one Party had [ * ], the other Party would [ * ]. Merck shall further have the right to count any amounts reimbursed to FHT for its expenses associated with such development towards its funding requirements set forth in Section 5.3.3.

(c)

If the Parties do agree to so collaborate , FHT shall also have the right to work with a Third Party on behalf of the Collaboration Program with the sole purpose of developing the [ * ]; provided that (i) FHT shall not have the right to disclose Collaboration Program Inventions and Results or

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Merck Information to such Third Party; (ii) all plaque analysis done as part of the FHT work with such a Third Party will [ * ]; and (iii) any such [ * ] developed as a result of FHT’s work with such Third Party would be considered Collaboration Program Inventions and Results arising as part of the Collaboration Program, and [ * ] according to the negotiated agreement referred to in Section 2.4.11(a), subject to such payments as are required to be paid to such Third Party for its contribution to such [ * ]. [ * ] associated with such development of the [ * ] would be [ * ] in the manner set forth above.

(d)

If Merck declines to so participate in the collaborative development and commercialization of such OCT Agents with FHT, FHT would nonetheless have the right to independently develop and commercialize such OCT Agents, either by itself or with one or more Third Parties, subject to Section 2.4.11(e) and to the remainder of this Section 2.4.11(d). FHT shall not have the right to use Collaboration Inventions and Results in connection with the development and/or commercialization of such OCT Agent, without the express written approval of Merck. Any such approval would only be for [ * ], and in no event shall FHT have the right to disclose Collaboration Program Inventions and Results to any Third Party. If FHT obtains Merck’s approval for the proposed use of Collaboration Inventions and Results, and FHT develops an OCT Agent suitable for commercialization, Merck would be entitled to [ * ] arising from the sale of such OCT Agents if the development and/or commercialization of such OCT Agents made use of any Collaboration Program Inventions and Results. Taking into consideration the contribution of such Collaboration Program Inventions and Results in the development and/or commercialization of the resulting OCT Agent, Merck and FHT would negotiate in good faith the exact [ * ] Merck would have the right to receive under this Section 2.4.11(d).

(e)

If, after Merck declines to so participate in the collaborative development and commercialization of such OCT Agents with FHT, FHT independently develops and commercializes such OCT Agents, either by itself or with one or more Third Parties, without the use of Collaboration Program Inventions and Results, Merck shall [ * ] arising from the sale of such OCT Agents.

(f)

It is expressly understood that [ * ] on the development of OCT Agents, but that [ * ]. In addition, during such time as Merck and FHT have an active program ongoing with respect to the development and commercialization of an OCT Agent, [ * ]. For clarity, the foregoing sentence [ * ]. Merck shall also [ * ], provided Merck [ * ], and [ * ] in such work. If [ * ] (meaning that [ * ]), FHT will notify Merck accordingly and Merck would no longer be subject to the obligations set forth in this Section 2.4.11(e).

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(g)

In addition if Merck desires to use an OCT catheter in connection with the testing, development or use of a Merck drug, and FHT owns or controls at such time an FDA-approved, and commercially available diagnostic OCT catheter, then [ * ] any Third Party with respect to the use of such Third Party’s OCT catheter.

2.4.12

Delivery of Non-Oral Drugs by Device to Improve Clinical Performance of Non-Cardiovascular Devices . As set forth in Section 2.9.2, FHT shall have the right to identify and use non-orally delivered drugs for local, non-systemic delivery by a Device in order to improve the clinical performance of any Non-Cardiovascular Device (“Non-Cardiovascular Device Drugs”) and to develop such combination product of a Non-Cardiovascular Device and Non-Cardiovascular Device Drug, subject at all times to the terms of this Section 2.4.12. If FHT desires to work with one or more Third Parties to identify and/or develop such Non-Cardiovascular Device Drugs (each such effort, a “Drug Delivery Opportunity”), FHT shall not have the right to so proceed with such Third Party without the consent of Merck, such consent not to be unreasonably withheld. Merck shall consider such Drug Delivery Opportunity in good faith. Examples of scenarios where it would be [ * ], would include, but not be limited to, the following:

(a)

the drug which is the subject of such Drug Delivery Opportunity [ * ].

(b)

The non-oral drug which is the subject of such Drug Delivery Opportunity [ * ].

(c)

The Third Party proposed by FHT for such Drug Delivery Opportunity is [ * ].

(d)

FHT’s work on such Drug Delivery Opportunity would [ * ] under the Collaboration Program, as determined by [ * ].

2.4.13

Delivery of Non-Oral Drug via Cardiovascular Device to Improve Clinical Performance of Cardiovascular Device. As set forth in Section 2.9.2, FHT shall have the right to identify and use non-orally delivered drugs for local, non-systemic delivery by a Device in order to improve the clinical performance of any Cardiovascular Device for use in a Permitted Cardiovascular Application or Indication (“Cardiovascular Device Drugs”) and to develop the combination product of a Cardiovascular Device and Cardiovascular Device Drugs, subject at all times to the terms of this Section 2.4.13. If FHT desires to work with one or more Third Parties to identify and develop Cardiovascular Device Drugs, FHT first shall so inform Merck, and the following will apply:

(a)

If Merck at such time Controls a drug [ * ], which drug either (i) has been [ * ] or (ii) is [ * ] but either is [ * ], then, should Merck desire to [ * ], FHT will [ * ], on [ * ], prior to [ * ].

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(b)

If (i) Merck at such time Controls no drug which meets the criteria set forth in Subsection 2.4.12(a) above, or (ii) if Merck and FHT proceed with respect to a Merck-Controlled drug as provided under Section 2.4.12(a), [ * ], then in either case, FHT shall have the right to proceed with a Third Party with respect to the development and commercialization of a Cardiovascular Device Drug if such Third Party owns or controls either:

(i)

a drug in the same class as the proposed [ * ], or

(ii)

an unapproved drug in the same class that is [ * ].

2.4.14

De Novo Atherosclerosis Drugs . FHT is not entitled to work with Third Parties to develop drugs for the treatment of de novo atherosclerosis, including the treatment of acute coronary syndrome, unless and until agreed to by Merck.

2.5	FHT Representations Regarding Use of Biological Samples and Data.

With respect to any Biological Samples and Data that have been or are to be collected by FHT and provided by FHT for use in the Collaboration Program, FHT represents, warrants and covenants (i) that it has complied, or shall comply, with all applicable laws, guidelines and regulations relating to the collection and/or use of the Biological Samples and Data and (ii) that it has obtained, or shall obtain, all necessary approvals and appropriate informed consents, in writing, for the collection and/or use of such Biological Samples and Data in the manner contemplated under this Agreement. FHT shall provide documentation of such approvals and consents upon Merck’s request. FHT further agrees that such Biological Samples and Data may be used as contemplated in this Agreement without any obligations to the individuals or entities (“Providers”) who contributed the Biological Samples and Data, including, without limitation, any obligations of compensation to such Providers or any other Third Party for the intellectual property associated with, or commercial use of, the Biological Samples and Data.

2.6	Records and Reports.

2.6.1

Records. FHT and Merck shall maintain records, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall fully and properly reflect all work done and results achieved in the performance of the Collaboration Program by FHT and Merck, respectively, provided , however, Merck is entitled to mask or de-identify all Merck Excluded Merck Compound Rights. FHT will transfer all CPCS data to Merck’s clinical trial data base, in accordance with procedures to be established by the Parties. In addition, during and after the Collaboration Program Term, Merck shall provide FHT with periodic reports fully and properly reflecting the use of Collaboration Program Inventions and Results in connection with milestone events set out in Sections 5.4 and 5.5.

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2.6.2

Copies and Inspection of Records . Merck shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all such records of FHT referred to in Section 2.6.1, and shall maintain such records and the information disclosed therein in confidence in accordance with Section 4.1. Each Party shall have the right to arrange for its employees and/or consultants involved in the activities contemplated hereunder to visit the offices and laboratories of the other Party during normal business hours and upon reasonable notice, and to discuss the Collaboration Program work and its results in detail with the appropriate technical personnel.

2.7	Rights to Collaboration Program Inventions and Results. The entire right, title and interest in:

2.7.1

FHT Independent Inventions and Improvements shall be owned solely by FHT;

2.7.2

Merck Independent Inventions and Improvements and Excluded Merck Compound Rights shall be owned solely by Merck;

2.7.3

FHT Collaboration Program Inventions and Results shall be owned solely by FHT, and are subject to Merck’s exclusive license rights under Section 3.1.3;

2.7.4

Merck Collaboration Program Inventions and Results shall be owned solely by Merck, and are subject to FHT’s non-exclusive license rights under Section 3.2; and

2.7.5

Joint Collaboration Program Inventions and Results shall be owned jointly by FHT and Merck, and together with FHT’s joint interest in such Joint Collaboration Program Inventions and Results, are subject to Merck’s exclusive license rights under Section 3.1.3.

Inventorship will be determined in accordance with the United States laws of inventorship.

2.8

Collaboration Program Term. The initial term of the Collaboration Program (the “Initial Term”) means the period starting on the Original Effective Date and ending on the fourth anniversary of the Effective Date, subject to early termination as provided in Article 8. Merck shall have the right, in its sole discretion, to extend the term of the Collaboration Program for additional 12-month periods by notifying FHT in writing of its decision to extend at least thirty (30) days before the end of the then current term . The Initial Term and subsequent extension terms (if exercised by Merck) are collectively referred to as the “Collaboration Program Term.” Notwithstanding the foregoing, no extension of the Collaboration Program Term pursuant to this Section 2.8 shall be permitted to the extent it would extend the end of the Collaboration Program Term beyond the fifteenth (15th) anniversary of the Effective Date.

2.9	Exclusive Efforts and Exceptions.

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2.9.1

Exclusive Field Activities; FHT Exclusivity Period.

(a)

During the FHT Exclusivity Period (as defined below), neither FHT nor its Down-Stream Affiliates will conduct, either itself or themselves, or with or through any Third Party, any Exclusive Field Activity other than pursuant to the Collaboration Program; provided , however, that to the extent FHT acquires a Person who becomes a Down-Stream Affiliate and at the time of such acquisition, such Person was conducting one or more Exclusive Field Activities, FHT shall not be in breach of this Section 2.9.1(a) provided that it [ * ], or [ * ] of such acquisition transaction.

(b)

The “FHT Exclusivity Period” shall mean the period starting on the Original Effective Date and ending on the fourth anniversary of the Effective Date, provided , however, that if Merck elects to extend the term of the Collaboration Program beyond the Initial Term as provided in Section 2.8, for such extension year, and only in such event, Merck is also entitled, in its sole discretion, to extend the FHT Exclusivity Period, on a Contract Year-by-Contract Year basis, for each year so extended, up to eleven (11) additional Contract Years, by notifying FHT in writing of its decision to so as part of the notification to FHT to extend the Collaboration Program due under Section 2.8, and making the annual Exclusivity Maintenance Payment described in Section 5.2.3 for each such extension year. The initial FHT Exclusivity Period and subsequent renewal terms (if and to the extent able to be exercised by Merck) are collectively referred to as the “FHT Exclusivity Period.” Where Merck fails to so notify FHT of its desire to extend, or fails to pay the annual Exclusivity Maintenance Payment as provided in Section 5.3.3, FHT’s obligations under Section 2.9.1(a) shall terminate. For clarity, extensions of the FHT Exclusivity Period pursuant to this Section 2.9.1(b) are entirely dependent upon Merck’s extension of the term of the Collaboration Program Term pursuant to Section 2.8.

(c)

In any event, following the fifteenth (15 ^th ) anniversary of the Effective Date, FHT will no longer be obligated under the restrictions set forth in Section 2.9.1(a).

(d)

As used in this Section 2.9.1, “Down-Stream Affiliate” means any Person that FHT controls (as term is used in and construed under Rule 144 under the Securities Act) directly, or indirectly through one or more intermediaries; provided in no event shall a Down-Stream Affiliate be deemed to include any Person that acquires all or substantially all of the voting stock or securities, or assets of FHT.

2.9.2

Exceptions to the Exclusive Field.

(a)

Notwithstanding Section 2.9.1, FHT shall have the right, either itself or

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with any Third Party but subject to Sections 2.4.10, 2.4.12, and 2.4.13, to conduct any and all of the activities set forth in Attachment B – Exceptions to the Exclusive Field, at any time.

2.10

No Encumbrances . FHT shall not encumber or convey any rights to Collaboration Program Inventions and Results or Patent Rights.

ARTICLE 3 LICENSES; EXCHANGE OF INFORMATION; DEVELOPMENT AND COMMERCIALIZATION.

3.1	FHT License Grants to Merck.

3.1.1

License to Conduct the Collaboration Program . FHT hereby grants Merck a non-exclusive license under FHT Independent Inventions and Improvements, for the sole purposes of enabling Merck to conduct the Collaboration Program activities assigned to Merck or its Affiliates under this Agreement. The foregoing license may be sublicensed to Merck Affiliates and to Third Parties acting on behalf of Merck.

3.1.2

Exclusive Access to and Use of Biological Samples and Data. In consideration of the fees received under the Original Agreement, FHT hereby grants Merck and its Affiliates an exclusive, perpetual right to access, test, profile, analyze and use all Biological Samples and Data within the TALON Registry as Merck deems scientifically appropriate.

3.1.3

Exclusive License Grant under FHT Collaboration Program Inventions and Results .

FHT hereby grants to Merck an exclusive (even as to FHT and its Affiliates, but subject to FHT retaining such rights as are necessary to conduct its activities under the Collaboration Program), sublicensable license in the Territory under the Patent Rights, the FHT Collaboration Program Inventions and Results and the Joint Collaboration Program Inventions and Results, for any and all uses, subject to the milestones and royalties described in Sections 5.4 and 5.5

3.1.4

Non-Exclusive License Grants. If the making, having made, use, offer for sale, sale or import by Merck, its Affiliates and sublicensees of Therapeutic Products or Tests would infringe during the term of this Agreement a claim of issued letters patent either in existence as of the Original Effective Date, or claiming priority to an application in existence as of the Original Effective Date and Controlled by FHT and which patents are not otherwise covered by the license grant in this Article 3, FHT hereby grants to Merck, to the extent FHT is legally able to do so, a non-exclusive, royalty-free license in the Territory under such issued letters patent for Merck, to develop, make, have made, use, sell, offer for sale or import Therapeutic Products, Products and Tests in the Territory. Such non-exclusive

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license is sublicensable, but only to the extent the sublicensee is acting on behalf of Merck or a Merck Affiliate.

3.2	Merck License Grant to FHT to Conduct the Collaboration Program. M

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