LICENSE AGREEMENT

License Agreement

You are currently viewing:

This License Agreement involves

FAES FARMA, SA | INSPIRE PHARMACEUTICALS, INC

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.

Title: LICENSE AGREEMENT
Governing Law: New York Date: 3/16/2007

LICENSE AGREEMENT, Parties: faes farma sa , inspire pharmaceuticals inc

*[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT CONFIDENTIAL INFORMATION HAS BEEN OMITTED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR THIS CONFIDENTIAL INFORMATION. THE CONFIDENTIAL PORTIONS HAVE BEEN PROVIDED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION.]

Exhibit 10.44

LICENSE AGREEMENT

by and between

INSPIRE PHARMACEUTICALS, INC.

and

FAES FARMA, S.A.

Dated as of October 31, 2006

TABLE OF CONTENTS


ARTICLE 1 DEFINITIONS		1
ARTICLE 2 LICENSES, EXCLUSIVITY AND RELATED RIGHTS		12
2.1	License Grants	12
2.2	Use of Affiliates and Third Party Contractors	14
2.3	No Implied Licenses	15
2.4	Marks	15
2.5	Limitation on Sublicenses in Inspire Principal Territory	15
2.6	Faes Right of First Negotiation	15
2.7	Supply of Compound	16
ARTICLE 3 DEVELOPMENT AND COMMERCIALIZATION		16
3.1	Data and Materials Transfer and Right of Reference	16
3.2	Development	18
3.3	Commercialization	21
3.4	Records and Reports	22
3.5	Inspire Regulatory Matters; Faes Assistance	23
3.6	Faes Regulatory Matters; Inspire Assistance	24
3.7	Adverse Event Reporting	25
ARTICLE 4 INITIAL PAYMENT AND MILESTONE PAYMENTS		25
4.1	Initial Payment	25
4.2	Milestone Payments	25
ARTICLE 5 ROYALTIES		27
5.1	Inspire Royalty Payments	27
5.2	Faes Royalty Payments	28
5.3	Royalty Terms	28
5.4	Minimum Royalties	29
5.5	Reports and Payments	30
5.6	Taxes and Withholding	30
5.7	Currency Exchange; Manner and Place of Payment	31
5.8	Maintenance of Records; Audit	31
5.9	Interest on Late Payments	32
5.10	Reductions	32
ARTICLE 6 REPRESENTATIONS, WARRANTIES AND COVENANTS		34
6.1	Mutual Representations and Warranties	34
6.2	Additional Faes Representations and Warranties	35
6.3	Additional Inspire Representations, Warranties and Covenants	37
6.4	Additional Covenants	37
6.5	No Debarment	37
ARTICLE 7		38
7.1	Confidentiality	38
7.2	Authorized Disclosure	38
7.3	Scientific Publications	38
7.4	Public Announcements	39
7.5	Unauthorized Use	39
7.6	Return of Confidential Information	39
ARTICLE 8 INDEMNIFICATION		40
8.1	Inspire	40
8.2	Faes	40
8.3	Indemnification Procedures	40
8.4	Insurance Proceeds	42
8.5	Insurance	42
ARTICLE 9		42
9.1	Term	42
9.2	Voluntary Termination by Inspire	42
9.3	Material Breach	42


9.4	Bankruptcy or Insolvency	43
9.5	Continuing Rights of Sublicensees	43
9.6	Effect of Expiration or Termination of Agreement	44
9.7	Effect of Partial Termination	44
9.8	Consequences if QT Study Milestone Payment not Made	45
9.9	Change of Control	46
ARTICLE 10		46
10.1	Ownership of Inventions	46
10.2	Obligation to Inform	47
10.3	Prosecution of Faes Licensed Patents	47
10.4	Right to Consult	47
10.5	Abandonment of Prosecution of Faes Licensed Patent	48
10.6	Patent Term Extensions	48
10.7	Third Party Infringement	48
10.8	Infringement of Third Party Rights	50
ARTICLE 11		50
11.1	Assignment	50
11.2	Further Actions	51
11.3	Force Majeure	51
11.4	Notices	51
11.5	Amendment	51
11.6	Waiver	52
11.7	Counterparts; Facsimile Signatures	52
11.8	Descriptive Headings	52
11.9	Governing Law; Dispute Resolution	52
11.10	Severability	52
11.11	Entire Agreement of the Parties	53
11.12	Independent Contractors	53
11.13	Accrued Rights; Surviving Obligations	53
11.14	Expenses	53
11.15	No Third Party Beneficiaries	53
11.16	No Strict Construction	53
11.17	English Language	53
11.18	Rights and Remedies Cumulative, Certain Remedies, etc	53

LICENSE AGREEMENT

This LICENSE AGREEMENT (this " Agreement "), dated as of October 31, 2006 (the " Effective Date "), is made by and between I NSPIRE P HARMACEUTICALS , I NC . , a Delaware corporation having its principal office at 4222 Emperor Blvd., Suite 200, Durham, NC 27703-8466, USA (" Inspire "), and F AES F ARMA , S.A. , a Spanish corporation having its principal office at Máximo Aguirre, 14, 48940 Leioa, Vizcaya, Spain (" Faes "). Inspire and Faes are each sometimes referred to individually as a " Party " and together as the " Parties ."

RECITALS

WHEREAS, Faes owns certain patents and know-how relating to the compound known as bilastine;

WHEREAS, Inspire is engaged in the research, development and commercialization of proprietary pharmaceutical products for the treatment of respiratory, ophthalmic and other indications;

WHEREAS, Inspire desires to obtain from Faes, and Faes desires to grant to Inspire, the exclusive rights in the Inspire Territory to certain patents and know-how for the development and commercialization of Inspire Licensed Products (each as defined below); and

WHEREAS, Faes desires to obtain from Inspire, and Inspire desires to grant to Faes, the exclusive rights in the Faes Territory to certain know-how and other intellectual property controlled by Inspire for the development and commercialization of Faes Licensed Ophthalmic Products and Faes Non-Ophthalmic Products (each as defined below);

NOW, THEREFORE, in consideration of the foregoing premises and the mutual representations, covenants and agreements contained herein, Inspire and Faes, intending to be legally bound, hereby agree as follows:

ARTICLE 1

DEFINITIONS

When used in this Agreement, whether in the singular or plural, each of the following capitalized terms shall have the meanings set forth in this Article 1.

1.1 " Acceptable Primary Label " means, for a particular Principal Product in a particular market, approved labeling for the relief of the nasal and non-nasal symptoms of allergic rhinitis, [C.I.] antihistamines existing as of the Effective Date in a manner that makes such Principal Product essentially unable to obtain significant sales in the applicable market for antihistamine products to treat the nasal and non-nasal symptoms of allergic rhinitis.

1.2 " Affiliate " means a corporation or non-corporate business entity that, directly or indirectly, controls, is controlled by, or is under common control with the Person specified. An entity will be regarded as in control of another entity if: (a) it owns, directly or indirectly, at least 50% of the voting securities or capital stock of such entity, or has other comparable ownership interest with respect to any entity other than a corporation; or (b) it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of the corporation or non-corporate business entity, as applicable, whether through the ownership or control of voting securities, by contract or otherwise.

1.3 " Breach Notice " has the meaning set forth in Section 9.3.

1.4 " Breaching Party " has the meaning set forth in Section 9.3.

1.5 " Business Day " means any day, except Saturday and Sunday, on which commercial banking institutions in New York are open for business. Any reference in this Agreement to "day" whether or not capitalized shall refer to a calendar day, not a Business Day.

1.6 " Combination Licensed Product " means an Inspire Licensed Product that: (a) consists of at least one active ingredient causing such product to be an Inspire Licensed Product in combination with one or more other therapeutically active compounds, or (b) is sold together with one or more other products that do not contain the Compound for a single invoiced price.

1.7 " Commercially Reasonable Efforts " means, with respect to the efforts of a particular Party to complete specific tasks or obligations under this Agreement, the efforts and resources that would be used, consistent with prevailing pharmaceutical industry standards, by a company of similar size and scope to such Party with respect to a product or potential product at a similar stage in its development or product life and of similar market potential taking into account efficacy, safety, the anticipated Regulatory Authority approved labeling, the competitiveness of alternative products in the marketplace or under development, the profitability of the product including the royalties payable to Third Party licensors, the patent and other proprietary position of the product, the likelihood of Regulatory Approval, the commercial value of the product and other relevant factors. Commercially Reasonable Efforts shall be determined on a market-by-market basis for a particular product, and it is anticipated that the level of effort will change over time, reflecting changes in the status of the product and the market involved.

1.8 " Compound " means the chemical compound known as bilastine, whose more specific chemical name is (F-96211-BM; 2-[4-(2-(1-2(-ethoxylethyl) benzimidazole-2-yl) piperidine-1-yl) ethyl) phenyl]-2-methylpropanoic acid, and any salts, esters, or hydrates of such compound.

1.9 " Confidential Information " of a Party means all secret, confidential or proprietary information or data, whether provided in written, oral, graphic, video, computer or other form, provided by such Party (the " Disclosing Party ") to the other Party (the " Receiving Party ") pursuant to this Agreement (including information generated by or on behalf of such Party pursuant to this Agreement and disclosed to the other Party), which may include without limitation information relating to the Disclosing Party’s existing or proposed research, development efforts, patent applications, business or products and any other materials that have not been made available by the Disclosing Party to the general public. The terms of this Agreement shall also be deemed Confidential Information of each Party, except to the extent disclosed pursuant to Section 7.4 herein. Notwithstanding the foregoing sentences, the term "Confidential Information" shall not include any information or materials that the Receiving Party can demonstrate:

(a) were already known to the Receiving Party (other than under an obligation of confidentiality), at the time of disclosure by the Disclosing Party to the extent such Receiving Party has documentary evidence to that effect;

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

(c) became generally available to the public or otherwise part of the public domain after its disclosure or development, as the case may be, and other than through any act or omission of the Receiving Party in breach of its confidentiality obligations under this Agreement;

(d) were subsequently lawfully disclosed to the Receiving Party by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others;

(e) were independently discovered or developed by or on behalf of the Receiving Party without the use of the Confidential Information belonging to the other Party and the Receiving Party has documentary evidence to that effect; or

(f) is approved for release by the Disclosing Party in writing.

1.10 " Control ," " Controls ," or " Controlled " means, with respect to specific materials, Know-How or Patent Rights, that the applicable Party owns or has a license under such materials, Know-How or Patent Rights and has the ability to grant to the other Party licenses or sublicenses thereto as contemplated under this Agreement without violating the terms of any agreement or other arrangement with, or the rights of, any Third Party existing as of the date on which such license or sublicense is granted.

1.11 " Definitive QT Study " means the currently ongoing definitive cardiovascular (QTc prolongation) study relating to the Compound being conducted on behalf of Faes under the Protocol No. BILA 459-09, entitled "A phase I, randomized, multiple-dose, double-blind, 5-way crossover study of the electrocardiographic effects of Bilastine in healthy adult subjects".

1.12 " Development Plan " means the plan describing the development of Subject Products in the Territory as described in Section 3.2.

1.13 " Development Program " means the activities undertaken by each of Inspire and Faes to develop Subject Products in the Territory in accordance with the Development Plan.

1.14 " Development Timeline " has the meaning set forth in Section 3.2(a)(i).

1.15 " Disclosing Party " has the meaning set forth in Section 1.9.

1.16 " Drug Master File " means the Drug Master File, as defined in the U.S. Federal Food, Drug, and Cosmetic Act, pursuant to 21 C.F.R. § 312.420 as amended, and the regulations promulgated thereunder (or the equivalent thereto as specified in any succeeding legislation), or any foreign equivalent thereto, with respect to manufacture of the Compound or an Inspire Licensed Product.

1.17 " Faes Development Activities " has the meaning set forth in Section 3.2(a)(i).

1.18 " Faes Know-How " means all Know-How related to the Compound (including information not covered by the Faes Licensed Patents) and any Inventions, in each case that are Controlled by Faes or its Affiliate as of the Effective Date and at any time during the Term and are necessary or useful to develop, manufacture or commercialize Inspire Licensed Products in the Inspire Territory.

1.19 " Faes Licensed Ophthalmic Product " means any product of Faes or its Affiliate or licensee (other than Inspire) incorporating the Compound and formulated and intended to be used in an Ophthalmic Indication by application to the eye, including any prescription or over-the-counter version of such product, in any dosage strength or size.

1.20 " Faes Licensed Patents " means all Patent Rights in the Inspire Territory that cover or claim the Compound or its manufacture or use or any Inventions, in each case that are Controlled by Faes or its Affiliate as of the Effective Date and at any time during the Term, and are necessary or useful to develop, manufacture or commercialize Inspire Licensed Products in the Inspire Territory. The Faes Licensed Patents owned by Faes as of the Effective Date, and the Faes Licensed Patents Controlled but not owned by Faes as of the Effective Date, are each set forth and identified as such in Schedule 1.20 .

1.21 " Faes Non-Ophthalmic Product " means any product of Faes or its Affiliate or licensee (other than Inspire) incorporating the Compound and formulated to be used in an indication other than an Ophthalmic Indication, including any prescription or over-the-counter version of such product, in any dosage strength or size and for any mode of administration.

1.22 " Faes Ophthalmic OTC Product " means a Faes Licensed Ophthalmic Product that is sold to consumers without a prescription.

1.23 " Faes Ophthalmic Rx Product " means a Faes Licensed Ophthalmic Product that is sold to consumers under a prescription.

1.24 " Faes Ophthalmic Territory " means Spain, Portugal, Guatemala, Belize, El Salvador, Honduras, Nicaragua, Costa Rica, Panama, and all the countries of South America, and their respective territories and possessions.

1.25 " Faes Royalties " has the meaning set forth in Section 5.2.

1.26 " Faes Royalty Term " has the meaning set forth in Section 5.3(b).

1.27 " Faes Technology " means, collectively, the Faes Licensed Patents and the Faes Know-How.

1.28 " Faes Territory " means, with respect to Faes Non-Ophthalmic Products, the entire world, excluding the Inspire Principal Territory, and with respect to Faes Licensed Ophthalmic Products, the Faes Ophthalmic Territory.

1.29 " FDA " means the United States Food and Drug Administration, or any successor agency thereof.

1.30 " Field " means the prevention, palliation or treatment of any condition, indication or disease in humans.

1.31 " First Commercial Sale " means (a) with regard to a particular Inspire Licensed Product in a country in the Inspire Territory, the first commercial sale by Inspire or its Affiliate or sublicensee of such Inspire Licensed Product to a Third Party for end use or consumption in the country after Inspire’s (or its Affiliate’s or sublicensee’s) receipt of Regulatory Approval for such Subject Product in such country, or (b) with regard to a Faes Licensed Ophthalmic Product in a country in the Faes Ophthalmic Territory, the first commercial sale by Faes or its Affiliate or sublicensee of such Faes Licensed Ophthalmic Product to a Third Party for end use or consumption in the country after Faes’ (or its Affiliate’s or sublicensee’s) receipt of Regulatory Approval for such Subject Product in such country. Use of Subject Products for promotional, sampling or compassionate use purposes or for use in clinical trials contemplated by this Agreement (but excluding post-approval clinical trials for which compensation is received by the selling party) shall not be considered a commercial sale hereunder.

1.32 " GAAP " means: (a) as to Inspire, United States generally accepted accounting principles as interpreted and accepted by the Financial Accounting Standards Board and the Securities and Exchange Commission, and (b) as to Faes, the generally accepted accounting principles applicable to Faes and consistently applied through its organization.

1.33 " Generic Competition " means, with respect to a particular Inspire Licensed Product or Faes Licensed Ophthalmic Product (as applicable), that one or more Third Parties is selling, for use in human beings, a Generic Equivalent of such Inspire Licensed Product or Faes Licensed Ophthalmic Product (as applicable) in the applicable country within the Inspire Territory or the Faes Ophthalmic Territory (as applicable).

1.34 " Generic Equivalent " means a Third Party generic version of an Inspire Licensed Product being sold by Inspire in a particular country in the Inspire Territory, or Faes Licensed Ophthalmic Product being sold by Faes in a particular country in the Faes Ophthalmic Territory (as applicable), which generic version contains the Compound, has been approved by the FDA or by any foreign Regulatory Authority, and is being sold under such approval in such country.

1.35 " IND " means an Investigational New Drug Application, as defined in the U.S. Federal Food, Drug, and Cosmetic Act, pursuant to 21 C.F.R. § 312.3 as amended, and the regulations promulgated thereunder, or the equivalent thereto as specified in any succeeding legislation.

1.36 " Indemnitee " has the meaning set forth in Section 8.3(a).

1.37 " Indemnitor " has the meaning set forth in Section 8.3(a).

1.38 " Independent Sublicensees " has the meaning set forth in Section 9.5.

1.39 " Infringement Notice " has the meaning set forth in Section 10.7(a).

1.40 " Inspire Development Activities " has the meaning set forth in Section 3.2(a)(i).

1.41 " Inspire Know-How " means all Know-How related to the Compound (including information not covered by the Inspire Licensed Patents) and any Inventions, in each case that are Controlled by Inspire or its Affiliate at any time during the Term.

1.42 " Inspire Licensed Patents " means all Patent Rights in the Faes Territory that cover or claim the Compound or its manufacture or use or any Inventions, in each case that are Controlled by Inspire or its Affiliate at any time during the Term.

1.43 " Inspire Licensed Product " means any product of Inspire or its Affiliate or sublicensee (other than Faes or its Affiliates and other licensees) that contains the Compound, including any prescription or over-the-counter product, in any dosage strength or size and for any mode of administration, and whose development, manufacture, use, sale, distribution, importation or commercialization (a) is covered by a Valid Claim in a Faes Licensed Patent, and/or (b) materially uses or incorporates, or is materially based upon, Faes Know-How.

1.44 " Inspire Marks " has the meaning set forth in Section 2.4.

1.45 " Inspire Non-Ophthalmic Technology " means, collectively, the Inspire Licensed Patents and the Inspire Know-How that are necessary or useful to develop, manufacture or commercialize Faes Non-Ophthalmic Products outside the Inspire Principal Territory.

1.46 " Inspire Ophthalmic OTC Product " means an Inspire Licensed Product that is formulated and intended to be used in an Ophthalmic Indication by application to the eye, in any dosage strength or size, that is sold to consumers without a prescription.

1.47 " Inspire Ophthalmic Product " means an Inspire Ophthalmic OTC Product or an Inspire Ophthalmic Rx Product.

1.48 " Inspire Ophthalmic Rx Product " means an Inspire Licensed Product that is formulated and intended to be used in an Ophthalmic Indication by application to the eye, in any dosage strength or size, that is sold to consumers under a prescription.

1.49 " Inspire Ophthalmic Technology " means, collectively, the Inspire Licensed Patents and the Inspire Know-How that are necessary or useful to develop, manufacture or commercialize Faes Licensed Ophthalmic Products in the Faes Ophthalmic Territory.

1.50 " Inspire Ophthalmic Territory " means the entire world, excluding the Faes Ophthalmic Territory.

1.51 " Inspire OTC Product " means a Principal OTC Product or an Inspire Ophthalmic OTC Product.

1.52 " Inspire Principal Territory " means the United States and Canada and their respective territories and possessions.

1.53 " Inspire Royalties " has the meaning set forth in Section 5.1.

1.54 " Inspire Royalty Term " has the meaning set forth in Section 5.3(a).

1.55 " Inspire Technology " means, collectively, the Inspire Ophthalmic Technology and the Inspire Non-Ophthalmic Technology.

1.56 " Inspire Territory " means with respect to Principal Products, the Inspire Principal Territory, and with respect to Inspire Ophthalmic Products, the Inspire Ophthalmic Territory.

1.57 " Inventions " means any and all Know-How, developments, inventions or discoveries conceived, reduced to practice, made or developed by or on behalf of a Party or its Affiliate or licensee during the Term.

1.58 " Joint Inventions " has the meaning set forth in Section 10.1(d).

1.59 " Joint Project Team " has the meaning set forth in Section 3.2(c).

1.60 " Know-How " means all non-public information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, whether or not patentable, including databases, practices, methods, techniques, specifications, formulations, formulae, knowledge, skill, experience, data (including pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological and clinical study data), analytical and quality control data, stability data, studies and procedures, and manufacturing process and development information, results and data.

1.61 " Knowledge " means, with respect to the applicable Party, the actual knowledge of such Party as of the given time (without any duty of investigation).

1.62 " Losses " has the meaning set forth in Section 8.1.

1.63 " Marks " means any trademarks, and goodwill associated therewith, for use in connection with the marketing and sale of Inspire Licensed Products, alone or accompanied by any logo or design and any foreign language equivalents in figure, sound or meaning, whether registered or not.

1.64 " Material Amendment " has the meaning set forth in Section 3.2(a)(ii).

1.65 " Milestone Payments " has the meaning set forth in Section 4.2.

1.66 " Minimum Royalty Date " means the first Quarter Start Date that is at least one year (365 days) after the date that Inspire (or its Affiliate or sublicensee) receives the first Regulatory Approval in the United States of a Principal Product comprising an oral tablet formulation for the Primary Indication.

1.67 " Minimum Royalty Period " means the one year period commencing on the Minimum Royalty Date or each yearly anniversary thereof.

1.68 " NDA " means a New Drug Application pursuant to 21 U.S.C. § 505(b)(1) or § 505(b)(2) submitted to the FDA or any successor application or procedure required for Regulatory Approval to commence sale of an Inspire Licensed Product.

1.69 " Net Sales " means the gross amounts invoiced by (i) Inspire, any of its Affiliates or any of its sublicensees for sales of Inspire Licensed Products to Third Parties or (ii) Faes, any of its Affiliates or any of its sublicensees for sales of Faes Licensed Ophthalmic Products to Third Parties, less the total of the following deductions to the extent actually allowed or incurred in connection with such sales:

(a) reasonable and customary trade, cash and quantity discounts off the invoiced price;

(b) excise, sales and other consumption taxes and custom duties to the extent included in the invoice price;

(c) freight, insurance and other transportation charges to the extent included in the invoice price;

(d) amounts repaid, credited or accrued, or allowances or adjustments made, by reason of returns, rejections, or recalls, or because of chargebacks, retroactive price reductions, or billing errors;

(e) reasonable and customary rebates and chargebacks to pharmacy benefit managers, federal, state, or local governments (or their agencies or purchasers), and managed health organizations (including without limitation Medicaid rebates); and

(f) any amounts actually written off or specifically identified as uncollectible in accordance with GAAP;

solely to the extent the above deductions are taken in accordance with GAAP applicable to the particular Party.

Use of Subject Products for promotional, sampling or compassionate use purposes or for use in clinical trials contemplated under this Agreement (but excluding post-approval clinical trials for which compensation is received by the selling party) shall not be considered in determining Net Sales. In the case of any sale of a Subject Product between a Party and its Affiliates or sublicensees for resale, Net Sales shall be calculated as above only on the first arm’s length sale thereafter to a Third Party.

1.70 " Non-Breaching Party " has the meaning set forth in Section 9.3.

1.71 " Ophthalmic Indication " means the prevention or treatment of allergic conjunctivitis in the eye.

1.72 " OTC " means "over-the-counter," as such term is typically understood in the pharmaceutical industry with reference to sales of drug products without a prescription.

1.73 " OTC Switch " means, with respect to a particular country of the Inspire Territory, the transfer of an Inspire Licensed Product from a prescription medicine to an OTC medicine in such country. An Inspire Licensed Product will be deemed to be transferred, and the OTC Switch deemed to be finalized, with respect to a given country of the Inspire Territory upon final approval of the sale of such Inspire Licensed Product as an OTC medicine by the Regulatory Authority in such country that has regulatory jurisdiction over such transfer.

1.74 " Partial Termination " means the termination of this Agreement solely with respect to particular Subject Product(s) and/or one or more countries, as provided in Section 9.2 or 9.3.

1.75 " Patent Rights " means the rights and interests in and to all issued patents and pending patent applications, including without limitation, all provisional applications, substitutions, continuations, continuations-in-part, divisions, and renewals, all letters patent granted thereon, and all patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms (including regulatory extensions), and all supplementary protection certificates, together with any foreign counterparts thereof anywhere in the Territory.

1.76 " Pediatric Indication " means the Primary Indication specifically for use in children as young as six (6) years of age and no older than twelve (12) years of age.

1.77 " Person " or " person " means any individual, firm, corporation, partnership, limited liability company, trust, unincorporated organization or other entity or a government agency or political subdivision thereto, and shall include any successor (by merger or otherwise) of such Person.

1.78 " Phase 3 Clinical Trial " means a controlled clinical trial to confirm with statistical significance the efficacy and safety of a product in larger, targeted populations, performed to obtain Regulatory Approval, as more fully described in 21 C.F.R. § 312.21(c).

1.79 " Primary Indication " means the treatment of allergic rhinitis.

1.80 " Principal OTC Product " means an Inspire Licensed Product for any indication in the Field other than the Ophthalmic Indication that is sold to consumers without a prescription.

1.81 " Principal Product " means a Principal OTC Product or a Principal Rx Product.

1.82 " Principal Rx Product " means an Inspire Licensed Product for any indication in the Field other than the Ophthalmic Indication that is sold to consumers under a prescription.

1.83 " Prosecution" or "Prosecute " means the preparation, filing, prosecution, issuance and maintenance (including, without limitation, interference, opposition and similar third party proceedings before the relevant patent office) of any patent applications or patents.

1.84 " Publishing Party " has the meaning set forth in Section 7.3.

1.85 " Quarter Start Date " means January 1, April 1, July 1, and October 1 of any applicable year.

1.86 " Rate of Interest " means the interest rate equal to [C.I.] percentage points above the prime rate of interest published as of the applicable time in the Wall Street Journal as the prime rate; provided, however that if the Wall Street Journal does not publish such prime rate, then the term "Rate of Interest" shall mean [C.I.] percentage points above the rate of interest publicly announced as of the applicable time by Bank of America, N.A., as its Prime Rate, Base Rate, Reference Rate or the equivalent of such rate, whether or not such bank makes loans to customers at, above, or below said rate.

1.87 " Receiving Party " has the meaning set forth in Section 1.9.

1.88 " Regulatory Amendment " has the meaning set forth in Section 3.2(a)(ii).

1.89 " Regulatory Approval " means the issuance by the appropriate Regulatory Authority of an action letter indicating that an NDA or foreign equivalent, as applicable, is approved. For avoidance of doubt, Regulatory Approval does not mean that the Regulatory Authority issues an action letter indicating that an NDA or foreign equivalent is approvable.

1.90 " Regulatory Authority " means any national ( e.g. , the FDA), state, provincial or local regulatory agency, department, bureau, commission, council or other governmental entity

involved in or responsible for regulation of medicinal products intended for human use in any country.

1.91 " Regulatory Dossier " means the technical, medical and scientific registrations, authorizations and approvals (including, without limitation, approvals of NDAs or foreign equivalents, supplements and amendments, pre- and post- approvals, pricing and Third Party reimbursement approvals, and labeling approvals) of any Regulatory Authority necessary for the development (including the conduct of clinical trials), manufacture, distribution, marketing, promotion, offer for sale, use, import, reimbursement, export or sale of a Subject Product in a regulatory jurisdiction, together with all related correspondence to or from any Regulatory Authority and all documents referenced in the complete regulatory chronology for each NDA or foreign equivalent, including the Drug Master File (if any), IND, NDA and supplemental new drug applications (sNDAs), or foreign equivalents.

1.92 " Reviewing Party " has the meaning set forth in Section 7.3.

1.93 " Rx Product " means a Principal Rx Product or an Inspire Ophthalmic Rx Product.

1.94 " Scientific Publication " has the meaning set forth in Section 7.3.

1.95 " Serious Adverse Drug Experience " means any of an "adverse drug experience," a "life-threatening adverse drug experience," a "serious adverse drug experience," or an "unexpected adverse drug experience," as those terms are defined at either 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80 or relevant foreign regulation within the Territory.

1.96 " Subject Product " means any Faes Licensed Ophthalmic Product, any Faes Non-Ophthalmic Product, or any Inspire Licensed Product.

1.97 " Term " has the meaning set forth in Section 9.1.

1.98 " Territory " means, collectively, the Inspire Territory and the Faes Territory.

1.99 " Third Party(ies) " means any Person other than Faes, Inspire and their respective Affiliates.

1.100 " Third Party Claim " has the meaning set forth in Section 8.1.

1.101 " Third Party License " has the meaning set forth in Section 5.10(a).

1.102 " Urticaria Indication " means the treatment of chronic idiopathic urticaria.

1.103 " Valid Claim " means a claim of an issued and unexpired patent, or a claim of a pending patent application, within the Faes Licensed Patents, which claim has not been held invalid, unpatentable or unenforceable by a court or other government agency of competent jurisdiction from which no appeal can be further taken, and has not been held or admitted to be invalid, unpatentable or unenforceable through abandonment, re-examination or disclaimer, opposition

procedure, nullity suit or otherwise, which claim covers or claims an Inspire Licensed Product or its manufacture or use; provided, however, that if a claim of a pending patent application shall not have issued within [CONFIDENTIAL] after the filing date from which such claim takes priority such claim shall not constitute a Valid Claim for the purposes of this Agreement unless and until such claim shall issue.

1.104 " Withholding Taxes " has the meaning set forth in Section 5.6.

ARTICLE 2

LICENSES, EXCLUSIVITY AND RELATED RIGHTS

2.1 License Grants .

(a) To Inspire .
- - (i) Faes hereby grants to Inspire a royalty-bearing, exclusive (even as to Faes and its Affiliates, except as otherwise provided in subsection (a)(iv) below) right and license, with the right to grant sublicenses (subject to Section 2.5), under the Faes Technology solely (i) to research, develop, make, have made, use, market, offer for sale, sell, and import Principal Products in the Field in the Inspire Principal Territory, and (ii) to research, develop, make, have made, and use Principal Products anywhere in the world solely for the purpose of marketing, commercialization and sale of Principal Products in the Field in the Inspire Principal Territory.
    
    (ii) Faes hereby grants to Inspire a royalty-bearing, exclusive (even as to Faes and its Affiliates, except as otherwise provided in subsection (a)(iv) below) right and license, with the right to grant sublicenses, under the Faes Technology solely (i) to research, develop, make, have made, use, market, offer for sale, sell, and import Inspire Ophthalmic Products in the Ophthalmic Indication in the Inspire Ophthalmic Territory, and (ii) to research, develop, make, have made, and use Inspire Ophthalmic Products anywhere in the world solely for the purpose of marketing, commercialization and sale of Inspire Ophthalmic Products in the Ophthalmic Indication in the Inspire Ophthalmic Territory.
    
    (iii) For the avoidance of doubt, the licenses and rights granted to Inspire under this Agreement shall not include a right to offer for sale, sell or have sold Principal Products, and Inspire expressly covenants that it and its Affiliates and sublicensees shall not sell any Principal Products, in the Inspire Principal Territory in circumstances in which Inspire knows or reasonably should know such Principal Products will be distributed or sold outside the Inspire Principal Territory. Further, the licenses and rights granted to Inspire under this Agreement shall not include a right to offer for sale, sell or have sold Inspire Ophthalmic Products, and Inspire expressly covenants that it and its Affiliates and sublicensees shall not sell any Inspire Ophthalmic Products, in the Inspire Ophthalmic Territory in circumstances

- - in which Inspire knows or reasonably should know such Inspire Ophthalmic Products will be distributed or sold outside the Inspire Ophthalmic Territory or for any uses outside the Ophthalmic Indication.
    
    (iv) Notwithstanding anything in this Agreement to the contrary, and for the avoidance of doubt, (1) Faes (and its Affiliates and other licensees) shall retain the rights under the Faes Technology to research, develop, make, have made, and use Faes Non-Ophthalmic Products in the Inspire Principal Territory solely for the purpose of sale of such products in the Field outside the Inspire Principal Territory; and (2) Faes (and its Affiliates and other licensees) shall retain the rights under the Faes Technology to research, develop, make, have made, and use Faes Licensed Ophthalmic Products in the Inspire Ophthalmic Territory solely for the purpose of sale of Faes Licensed Ophthalmic Products outside the Inspire Ophthalmic Territory; and (3) Faes (and its Affiliates and other licensees) shall retain the exclusive rights to research, develop, make, have made, use, offer for sale, sell, and import all Faes Non-Ophthalmic Products in the Field in all countries, territories and jurisdictions other than the Inspire Principal Territory; and (4) Faes (and its Affiliates and other licensees) shall retain the exclusive rights to research, develop, make, have made, use, market, offer for sale, sell, and import Faes Licensed Ophthalmic Products in the Ophthalmic Indication in the Faes Ophthalmic Territory.
(b) To Faes .
- - (i) Inspire hereby grants to Faes an exclusive (even as to Inspire and its Affiliates, except as otherwise provided in subsection (b)(iv) below) right and license, with the right to grant sublicenses, under the Inspire Non-Ophthalmic Technology solely to research, develop, make, have made, use, market, offer for sale, sell, and import Faes Non-Ophthalmic Products in the Field in all countries, territories and jurisdictions outside the Inspire Principal Territory.
    
    (ii) Inspire hereby grants to Faes a royalty-bearing, exclusive (even as to Inspire and its Affiliates, except as otherwise provided in subsection (b)(iv) below) right and license, with the right to grant sublicenses, under the Inspire Ophthalmic Technology solely to research, develop, make, have made, use, market, offer for sale, sell, and import Faes Licensed Ophthalmic Products in the Ophthalmic Indication in the Faes Ophthalmic Territory.
    
    (iii) For the avoidance of doubt, the licenses and rights granted to Faes under this Agreement shall not include a right to offer for sale, sell or have sold Faes Licensed Ophthalmic Products, and Faes expressly covenants that it and its Affiliates and sublicensees shall not sell any Faes Licensed Ophthalmic Products, in the Faes Ophthalmic Territory in circumstances in which Faes knows or reasonably should know such Faes Licensed Ophthalmic Products will be distributed or sold outside the Faes Ophthalmic Territory or for any uses outside the Ophthalmic Indication. Further, the licenses and rights granted to Faes under this

- - Agreement shall not include a right to offer for sale, sell or have sold Faes Non-Ophthalmic Products, and Faes expressly covenants that it and its Affiliates and sublicensees shall not sell any Faes Non-Ophthalmic Products, in any country outside the Inspire Principal Territory in circumstances in which Faes knows or reasonably should know such Faes Non-Ophthalmic Products will be distributed or sold in the Inspire Principal Territory.
    
    (iv) Notwithstanding anything in this Agreement to the contrary, and for the avoidance of doubt, (1) Inspire (and its Affiliates and other licensees) shall retain the rights under the Inspire Non-Ophthalmic Technology to research, develop, make, have made, and use Principal Products outside the Inspire Principal Territory solely for the purpose of sale of such products in the Field solely in the Inspire Principal Territory; and (2) Inspire (and its Affiliates and other licensees) shall retain the rights under the Inspire Ophthalmic Technology to research, develop, make, have made, and use Inspire Ophthalmic Products outside the Inspire Ophthalmic Territory solely for the purpose of sale of Inspire Ophthalmic Products in the Ophthalmic Indication solely in the Inspire Ophthalmic Territory; and (3) Inspire (and its Affiliates and other licensees) shall retain the exclusive rights to research, develop, make, have made, use, offer for sale, sell, and import Principal Products in the Field in the Inspire Principal Territory; and (4) Inspire (and its Affiliates and other licensees) shall retain the exclusive rights to research, have researched, develop, have developed, make, have made, use, market, have marketed, commercialize, have commercialized, offer for sale, sell, import and have imported Inspire Ophthalmic Products in the Ophthalmic Indication in the Inspire Ophthalmic Territory.
(c) With respect to each particular Inspire Licensed Product, on a country-by-country basis, upon the expiration of the Inspire Royalty Term applicable to such Inspire Licensed Product in a specific country, the licenses and rights granted to Inspire under Section 2.1(a) shall become fully paid up, royalty-free, perpetual and irrevocable solely with regards to such Inspire Licensed Product in such country. With respect to each particular Faes Licensed Ophthalmic Product, on a country-by-country basis, upon the expiration of the Faes Royalty Term applicable to such Faes Licensed Ophthalmic Product in a specific country, the licenses and rights granted to Faes under Section 2.1(b) shall become fully paid up, royalty-free, perpetual and irrevocable solely with regards to such Faes Licensed Ophthalmic Product in such country.

2.2 Use of Affiliates and Third Party Contractors . Without limiting the licenses and rights granted under Section 2.1, Inspire and Faes shall each have the right to engage their Affiliates and Third Party contractors (including but not limited to contract research organizations, clinical trial sites, contract manufacturers and distributors) to perform services to assist the respective Party in exercising its rights and in carrying out its respective activities or obligations under this Agreement, including for the purpose of development and commercialization of Principal Products in the Inspire Principal Territory and Inspire Ophthalmic Products in the Inspire Ophthalmic Territory on behalf of Inspire, or of Faes Licensed Ophthalmic Products in the Faes

Ophthalmic Territory and Faes Non-Ophthalmic Products in all countries and jurisdictions outside the Inspire Principal Territory on behalf of Faes.

2.3 No Implied Licenses . Only the licenses expressly granted herein shall be of legal force and effect. No license rights shall be created hereunder by implication, estoppel or otherwise.

2.4 Marks . Inspire may market Principal Products in the Field in the Inspire Principal Territory, and Inspire Ophthalmic Products in the Ophthalmic Indication in the Inspire Ophthalmic Territory, under such Marks as Inspire shall select in its sole discretion (the " Inspire Marks "). Inspire shall own and control all such Inspire Marks. Inspire shall be responsible for filing, registering and maintaining the Inspire Marks in the Inspire Territory. Faes shall retain the exclusive rights to market Faes Non-Ophthalmic Products in the Field in all countries and jurisdictions outside the Inspire Principal Territory, and Faes Licensed Ophthalmic Products in the Ophthalmic Indication in the Faes Ophthalmic Territory, under such Marks as Faes (or its Affiliate or other licensee) shall select in its sole discretion (the " Faes Marks "). Faes (or its Affiliate or licensee, as applicable) shall own and control all such Faes Marks. Faes (or its Affiliate or licensee, as applicable) shall be responsible for filing, registering and maintaining the Faes Marks in all applicable countries.

2.5 Limitation on Sublicenses in Inspire Principal Territory . Faes shall have the right to approve, such approval not to be unreasonably withheld or delayed, the grant by Inspire of any sublicense to a proposed sublicensee of rights in the Inspire Principal Territory as to any Principal Product; such sublicensed rights would not be further sublicenseable by such sublicensee without Faes’ written approval, such approval not to be unreasonably withheld or delayed.

2.6 Faes Right of First Negotiation . Inspire hereby grants to Faes the right of first negotiation, as set forth below in this Section 2.6, in regards to the Inspire cystic fibrosis development product known as denufosol tetrasodium (the " CF Product "). If Inspire determines to undertake an initiative to out-license on an exclusive basis all or substantially of its intellectual property rights in the CF Product on a regional basis in Spain and Portugal (a " Business Opportunity "), then Inspire will notify Faes in writing of its intent to pursue such Business Opportunity. At the request of Faes, Inspire will afford Faes a reasonable opportunity to review scientific information relevant to the Business Opportunity and available to Inspire, and which has been approved by the Board of Directors of Inspire. Within fifteen (15) days of Faes’ receipt of the written notice, Faes will respond to Inspire in writing regarding Faes’ interest in the Business Opportunity. If Faes indicates interest in pursuing the Business Opportunity, the Parties will negotiate in good faith for a period of at least sixty (60) days to enter into a definitive agreement regarding such Business Opportunity. If, (i) Faes indicates no interest in the Business Opportunity or does not respond to Inspire’s notice of the Business Opportunity within such fifteen (15) day period, or (ii) Faes and Inspire do not enter into a definitive agreement within such sixty (60) day period, then Inspire will be free to pursue the Business Opportunity and will be deemed to have discharged its obligations under this Section 2.6 in full; provided, however, that if at the end of such sixty (60) day period the Parties are actively negotiating the terms of a definitive agreement, then such sixty (60) day period may be extended to a mutually acceptable time by the Parties in writing. For the avoidance of doubt, any Inspire initiative with respect to the CF Product that includes any country other than Spain and Portugal will not be deemed a Business Opportunity, and Inspire will have no obligation with respect to such an initiative, under this Section 2.6.

2.7 Supply of Compound . The Parties acknowledge that it is the Parties’ intention, notwithstanding the license rights granted by Faes in Section 2.1(a), for Faes to supply to Inspire bulk Compound (as API) for Inspire’s use in manufacturing, developing and commercializing Inspire Licensed Products in final form. The Parties agree to initiate negotiation of a supply agreement in good faith promptly after the Effective Date, and to enter into a supply agreement as soon as practicable, which agreement shall contain commercially reasonable, mutually acceptable supply terms and provisions typical of similar supply arrangements, including forecasting and ordering provisions, delivery terms, transfer pricing, and back-up manufacturing rights. Inspire acknowledges that Faes’ right to supply to Inspire the Compound is a fundamental aspect of this Agreement for Faes, and thus Inspire agrees that Inspire shall not negotiate with any third party regarding any manufacturing relationship under which Faes would obtain supplies of Compound, so long as Faes is continuing to negotiate the terms of the supply agreement in good faith as above (and provided that Faes supplies to Inspire its interim requirements for Compound (for use in clinical development under the terms of this Agreement) as set forth in reasonable forecasts provided to Faes). It is understood that Inspire shall have sole responsibility for conducting (or having conducted on its behalf) all product formulation and packaging as needed to use the Compound supplied by Faes to make Inspire Licensed Products in final form.

ARTICLE 3

DEVELOPMENT AND COMMERCIALIZATION

3.1 Data and Materials Transfer and Right of Reference .

(a) In furtherance of the licenses granted by Faes to Inspire under this Agreement and the activities contemplated by this Article 3, Faes shall, or shall cause its Affiliates or Third Party contractors to, transfer promptly (but in all events within thirty (30) days following the Effective Date) to Inspire (i) the physical embodiments, to the extent available, of the Faes Technology that are needed or reasonably useful to Inspire in the development or commercialization of Inspire Licensed Products in the applicable countries of the Inspire Territory as contemplated by this Agreement, and (ii) a copy of the entire Regulatory Dossier in existence as of the Effective Date. Without limiting the foregoing, Faes shall provide to Inspire copies of all final audited study reports, prepared in accordance with applicable FDA guidelines, for all studies relating to the Compound.

(b) Faes shall make reasonably available to Inspire at no cost to Inspire, during business hours and for reasonable amounts of time during the twelve (12) month period following the Effective Date, such of Faes’ employees as are appropriate (including key manufacturing and development personnel) for purposes of consulting with Inspire regarding the development, testing and manufacturing of Inspire Licensed Products, procuring of Regulatory Approval of Inspire Licensed Products, and to enable Inspire to use the Faes Know-How in connection with Inspire Licensed Products.

(c) Faes hereby grants to Inspire a "Right of Reference or Use" as that term is defined in 21 C.F.R. § 314.3(b), and any foreign equivalents, to any and all regulatory filings, data and information within the Faes Know-How relating to the Compound or Subject Products, including without limitation that related to pharmacology, toxicology, preclinical testing,

clinical testing, chemistry, manufacturing and controls data, batch records, trials and studies, safety and efficacy, manufacturing information, analytical and quality control, and agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by Inspire in order to effect such grant, solely for the purposes of developing and seeking regulatory approval in the Inspire Principal Territory of Inspire Principal Products and in the Inspire Ophthalmic Territory of Inspire Ophthalmic Products and conducting such other activities as are contemplated by this Agreement. In addition, Faes hereby grants to Inspire the full right to use and refer to any Drug Master File for the Compound and will provide a copy thereof to Inspire upon Inspire’s request solely for the purposes of developing and seeking regulatory approval in the Inspire Principal Territory of Inspire Principal Products and in the Inspire Ophthalmic Territory of Inspire Ophthalmic Products and conducting such other activities as are contemplated by this Agreement.

(d) Faes hereby agrees to assign and hereby does assign to Inspire the regulatory documents in the Regulatory Dossier relating directly to the Compound in the Inspire Principal Territory. Within thirty (30) days after the Effective Date, Faes shall provide to Inspire a list of all of the documents in the Regulatory Dossier as of the Effective Date relating directly to the Compound in the Inspire Principal Territory. Within thirty (30) days after the Effective Date, the Parties shall execute and deliver to the FDA such documents as are required to notify the FDA of the transfer of the IND number 70,302 to Inspire. In addition, Faes promptly shall execute any and all other instruments, forms of assignment or other documents and take such further actions as Inspire may reasonably request in order to give effect to or evidence the foregoing assignment. Faes shall retain the full rights to use any and all information in the aspects of the Regulatory Dossier assigned to Inspire as above, and the right of reference to all such regulatory documents, solely for purposes relating to development and commercialization of Faes Non-Ophthalmic Products outside the Inspire Principal Territory and Faes Licensed Ophthalmic Products in the Faes Ophthalmic Territory.

(e) In furtherance of the licenses granted by Inspire to Faes under this Agreement and the activities contemplated by this Article 3, Inspire shall, or shall cause its Affiliates or Third Party contractors to, transfer to Faes upon Faes’s reasonable request made from time to time, to the extent available: (i) the physical embodiments of the Inspire Technology that are needed or reasonably useful to Faes in the development or commercialization of Faes Non-Ophthalmic Products in all applicable countries outside the Inspire Principal Territory or of the Faes Licensed Ophthalmic Products in the applicable countries of the Faes Ophthalmic Territory as contemplated by this Agreement, and (ii) a copy of the entire Regulatory Dossier with respect to the Inspire Licensed Products. In addition, Inspire hereby grants to Faes the foreign equivalents, in any country or jurisdiction outside the Inspire Principal Territory, to a "Right of Reference or Use" as that term is defined in 21 C.F.R. § 314.3(b) to any and all regulatory filings, data and information within the Inspire Technology relating to the Compound or Subject Products, including without limitation that related to pharmacology, toxicology, preclinical testing, clinical testing, chemistry, manufacturing and controls data, batch records, trials and studies, safety and efficacy, manufacturing information, analytical and quality control, and agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by Faes in order to effect such

grant, solely for the purposes of developing and seeking regulatory approval outside the Inspire Principal Territory of Faes Non-Ophthalmic Products and/or of the Faes Licensed Ophthalmic Products in the applicable countries of the Faes Ophthalmic Territory as contemplated by this Agreement, and of conducting such other activities as are contemplated by this Agreement.

3.2 Development .

(a) Development Program and Plan .
- - (i) Inspire and Faes will perform the Development Program in accordance with the Development Plan. The Parties acknowledge and agree that the Development Plan sets forth the development activities to be performed by Inspire during the Term (the " Inspire Development Activities ") together with certain of the development activities to be performed by Faes during the Term (the " Faes Development Activities "). The Development Plan includes an overall timeline of the estimated target dates for completing the various development tasks described within the Development Plan (the " Development Timeline "). The initial Development Plan as agreed to by the Parties as of the Effective Date has been signed and acknowledged by each Party and copies of such signed document have been exchanged between the Parties.
    
    (ii) The Parties will work together, through their participation on the Joint Project Team, to evaluate from time to time in light of then-current circumstances the status of the Development Program and progress compared to the Development Timeline. Either Inspire or Faes may propose modifications to the Development Plan, which will be discussed in good faith by the Joint Project Team. Any modification to the Development Plan proposed by either Party (except for Regulatory Amendments (defined below)) that will extend the Development Timeline for more than sixty (60) days or materially increase the costs associated with the development of a Principal Product for the Primary Indication (each, a " Material Amendment ") will require the requesting Party to demonstrate that the potential benefits (economic, commercial, or otherwise) to both Parties that may result from the proposed Material Amendment materially outweigh the potential adverse impact (economic, commercial, or otherwise) on both Parties (including without limitation the impact caused by a delay in launch and any increased development costs) associated with such proposed Material Amendment. Each Material Amendment will require the unanimous approval of the Joint Project Team prior to implementation and any dispute regarding a Material Amendment will be subject to the dispute resolution procedures set forth in Section 11.9; provided, however, that Inspire shall have final decision-making authority with respect to the development and commercialization of Principal Products in the Inspire Principal Territory and of Inspire Ophthalmic Products in the Inspire Ophthalmic Territory, and Faes shall have final decision-making authority with respect to the development and commercialization of Faes Non-Ophthalmic Products outside the Inspire Principal Territory and of Faes Licensed Ophthalmic Products in the Faes Ophthalmic Territory, and compliance with the dispute

- - resolution procedures set forth in Section 11.9 will not be required with respect to such matters. The Joint Project Team also will review and consider any modifications to the Development Plan suggested or required by any Regulatory Authority (each, a " Regulatory Amendment "), and the Parties will amend the Development Plan as necessary to incorporate feedback from any Regulatory authority on the Development Program and to comply with any legal requirement or formal action imposed by any Regulatory Authority.
(b) Development Activities .
- - (i) Inspire will be responsible for undertaking the Inspire Development Activities and will use Commercially Reasonable Efforts to perform the Inspire Development Activities in accordance with the Development Timeline. Faes will be responsible for undertaking the Faes Development Activities and will use Commercially Reasonable Efforts to perform the Faes Development Activities in accordance with the Development Timeline. The Joint Project Team will monitor each Party’s respective obligations and progress towards achieving the goals set forth in the Development Plan. Each Party acknowledges and agrees that the drug development process is a process of scientific discovery and as such is inherently unpredictable and delays to the Development Timeline may occur for reasons beyond a Party’s control as Subject Products are developed, and that the drug development process is subject to a high level of governmental regulation and the requirements of the regulatory process of seeking drug approval may result in delays beyond a Party’s control and that such delays or other similar delays beyond a Party’s control, without evidence of some other lack of Commercially Reasonable Efforts, are not a breach of this Section 3.2(b)(i).
    
    (ii) Without limiting Section 3.2(b)(i), Inspire shall be responsible, at Inspire’s sole cost and expense, for conducting all Phase 3 Clinical Trials in the United States on the Compound as necessary to obtain Regulatory Approval in the United States of a Principal Product for the Primary Indication.
    
    (iii) Without limiting Section 3.2(b)(i), Faes shall be responsible, at Faes’s sole cost and expense, for continuing and completing the Definitive QT Study in accordance with current good clinical practices and any comments received from the FDA. Promptly upon completion of the Definitive QT Study, Faes shall report the results thereof to Inspire. Faes shall prepare or cause to be prepared, at its sole cost and expense, a final, audited study report with respect to the Definitive QT Study in compliance with applicable guidelines and suitable for submission to the FDA, and Faes shall provide such report to Inspire within sixty (60) days after completion of such study. Inspire shall have the right to use and refer to the Definitive QT Study solely in connection with Inspire’s permitted activities under this Agreement.

(c) Joint Project Team .
- - (i) Within ten (10) days after the Effective Date, the Parties will establish a project team to oversee the Development Program (the " Joint Project Team "). The Joint Project Team will be comprised of equal numbers of representatives of each Party, with each Party appointing four (4) representatives as members of the Joint Project Team. The Joint Project Team may change its size from time to time by mutual consent of its members; provided that each of Inspire and Faes at all times will have one (1) vote on any matter requiring the approval of the Joint Project Team. Each Party may replace its Joint Project Team representatives at any time upon written notice to the other Party. Each Party may, in its reasonable discretion, invite non-member representatives of such Party to attend meetings of the Joint Project Team as appropriate to provide input with respect to matters on the agenda; provided that such non-member representatives agree to comply with the non-use and non-disclosure obligations of Article 7 with respect to all information disclosed or exchanged in such meeting. Non-member representatives will not have the power to vote on matters before the Joint Project Team.
    
    (ii) The Joint Project Team will perform the following functions:
    - (A) oversee and coordinate the Parties’ activities conducted in connection with the Development Program;
      
      (B) review and approve the Development Plan and any updates and modifications thereto in accordance with Section 3.2(a)(ii);
      
      (C) monitor progress towards achieving goals set forth in the Development Plan;
      
      (D) address and attempt to resolve conflicts or disputes between the Parties that may arise during the course of performing the Development Plan; and
      
      (E) serve as a forum for communication between the Parties for the activities performed pursuant to the Development Plan.
    (iii) The Joint Project Team will meet in person (or by having certain representatives of the Parties participate by telephone where necessary) no less frequently than once every six (6) months, unless otherwise agreed by the Parties. The members of the Joint Project Team may also convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate. Meetings of the Joint Project Team that are held in person will alternate between the offices of the Parties, or such other place as the Parties may agree. The members of the Joint Project Team will designate one (1) representative at each meeting to serve as secretary for such meeting, who will promptly prepare and distribute to the Parties

- - written minutes summarizing the matters discussed and actions taken, if any, at such meeting. The meeting minutes will be approved by each of Inspire and Faes promptly following the applicable Joint Project Team meeting and will reflect any agreement or disagreement of the Parties with regard to the matters therein. The first meeting of the Joint Project Team will take place at the offices of one of the Parties within thirty (30) days of the Effective Date.
    
    (iv) The Joint Project Team will strive to reach consensus on matters over which it has authority; provided that any proposed amendments or modifications to the Development Plan will be made in accordance with Section 3.2(a)(ii). Subject to the foregoing and except as otherwise provided herein, if, at a meeting of the Joint Project Team, the Joint Project Team is unable to reach consensus on a particular issue, the members of the Joint Project Team will make good faith efforts to resolve such issue over the next thirty (30) days. If after thirty (30) days such effort is unsuccessful, either Party may proceed with the dispute resolution procedures set forth in Section 11.9; provided, however, that Inspire shall have final decision-making authority with respect to the development and commercialization of Principal Products in the Inspire Principal Territory and of Inspire Ophthalmic Products in the Inspire Ophthalmic Territory, and Faes shall have final decision-making authority with respect to the development and commercialization of Faes Non-Ophthalmic Products outside the Inspire Principal Territory and of Faes Licensed Ophthalmic Products in the Faes Ophthalmic Territory, and compliance with the dispute resolution procedures set forth in Section 11.9 will not be required with respect to such matters.
    
    (v) The Joint Project Team will have only such powers as are specifically delegated to it in this Agreement, and will have no power to amend this Agreement or waive a Party’s rights or obligations under this Agreement.

3.3 Commercialization .

(a) Inspire shall be solely responsible, using the efforts required in subsection (b) below, for commercialization of Principal Products in the Inspire Principal Territory and of Inspire Ophthalmic Products in the Inspire Ophthalmic Territory, including without limitation with respect to:
- - (i) Regulatory Approval;
    
    (ii) sales and marketing;
    
    (iii) advertising, marketing and promotional materials;
    
    (iv) sales representatives and sales force matters;
    
    (v) distribution;

- - (vi) regulatory compliance and communications;
    
    (vii) additional required or appropriate clinical studies, such as Phase 4 trials; and
    
    (viii) product inquiries and complaints.
(b) Inspire shall use Commercially Reasonable Efforts to commercialize a Principal Product in the Field in each country in the Inspire Principal Territory and an Inspire Ophthalmic Product in each country in the Inspire Ophthalmic Territory, promptly after obtaining Regulatory Approval for, and such other approvals (including without limitation reimbursement approvals) as are necessary for the marketing of, such Inspire Licensed Product in the applicable country.

(c) Faes shall have the right to recommend to Inspire specific companies that Faes believes would be appropriate as co-promotion or distribution partners for particular Inspire Licensed Products in applicable countries in the Inspire Territory. Inspire shall consider any such recommendations in good faith, and if requested by Faes will discuss such recommendations reasonably with Faes. If Faes and Inspire determine that it would be beneficial to the Parties to seek and enter into an agreement with one or more appropriate, capable co-promotion or distribution partners, such determination to be made reasonably and in good faith, then the Parties shall use Commercially Reasonable Efforts to enter into such agreements. Co-promotion proposals made by Faes or Inspire will not be rejected by the other Party unless such other Party shall have provided a written summary of the reasons that such other Party believes should justify not proceeding with such proposed arrangement, and such reasons are objective and clearly support not proceeding with such arrangement.

3.4 Records and Reports .

(a) Each Party shall maintain records, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall accurately reflect all work done and results achieved in the performance of the Development Program by such Party. All reports and other information provided or made available by a Party under this Section 3.4 shall constitute the Confidential Information of such Party and shall be subject to the provisions of Article 7.

(b) By Inspire . Every six (6) months following the Effective Date, Inspire shall provide Faes a written report summarizing the efforts and accomplishments of Inspire, its Affiliates and its sublicensees during the preceding six (6) month period in developing and commercializing Inspire Licensed Products. Such reports shall include, without limitation, summaries of scientific and clinical data obtained in furtherance of or based on Inspire’s (or its Affiliate’s or sublicensee’s) efforts to develop or commercialize Inspire Licensed Products.

(c) By Faes . Every six (6) months following the Effective Date, Faes shall provide Inspire a written report summarizing the efforts and accomplishments of Faes, its Affiliates and sublicensees during the preceding six (6) month period in developing and commercializing Faes Licensed Ophthalmic Products. Such reports shall include, without limitation, summaries of scientific and clinical data obtained in furtherance of or based on Faes’s (or its Affiliate’s or sublicensee’s) attempts to develop or commercialize Faes Licensed Ophthalmic Products.

(d) Each Party shall have the right, during normal business hours and upon reasonable prior written notice, to inspect all such records of the other Party referred to in Section 3.4(a), and to obtain copies of such records to the extent reasonably needed by such Party in exercising its rights under this Agreement. Each Party shall maintain such records and the information disclosed therein in confidence in accordance with Article 7. Each Party shall have the right to arrange for its employees involved in the activities contemplated hereunder to visit the offices and laboratories of the other Party and any of its Affiliates, twice per calendar year during normal business hours and upon reasonable prior written notice, to discuss the Development Program work and its results in detail with the technical personnel and consultants of the other Party.

3.5 Inspire Regulatory Matters; Faes Assistance . From and after the Effective Date, the aspects of the Regulatory Dossier with respect to Principal Products in the Field in the Inspire Principal Territory and Inspire Ophthalmic Products in the Ophthalmic Indication in the Inspire Ophthalmic Territory, including without limitation any applicable NDA or foreign equivalents covering such products, shall be owned by Inspire and in Inspire’s name. Without limiting Inspire’s obligations set forth in Section 3.3, Inspire shall have exclusive control over, and authority and responsibility for, the regulatory strategies relating to the development and commercialization of all Principal Products in the Field in the Inspire Principal Territory and Inspire Ophthalmic Products in the Ophthalmic Indication in the Inspire Ophthalmic Territory including, without limitation: (a) the preparation of all documents submitted to Regulatory Authorities and the filing of all submissions relating to Regulatory Approval of Inspire Licensed Products in the applicable countries in the Inspire Territory; and (b) all regulatory actions, communications and meetings with any applicable Regulatory Authority with respect to any Inspire Licensed Product in the applicable countries in the Inspire Territory. Upon the request of Inspire, Faes shall use reasonable efforts to provide to Inspire on a timely basis such inf

SITE SEARCH

AGREEMENTS / CONTRACTS

CLAUSES

Search Contract Clauses >>

Browse Contract Clause Library>>

Get Email Updates