DEVELOPMENT AND LICENSE AGREEMENT

1.

Definitions

1.1

“Affiliates” means a corporation or non-corporate business entity that controls, is controlled by, or is under common control with a Party to this Agreement. An entity will be deemed to control another entity if (a) it owns, directly or indirectly, at least 50% of the voting securities of the other entity (or possesses the right to vote at least 50% of the voting securities of the other 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 or policies of the corporation

1.2

“BII Commercialization Period” means a period of time equivalent in length to the actual amount of time that Inspire commercialized the Product in the United States during the Inspire Commercialization Period.

1.3

“BII Documents” means the documents listed or referred to in Annex 1 and containing information and data relating to the Compound.

1.4

“BII IP” means collectively BII Patents, BII Know-How and Trademark A.

1.5

“BII Know-How” means:

(i)

Know-How owned by or licensed to BII or an Affiliate as of the Effective Date that is contained in the BII Documents, and

(ii)

any additional Know-How (other than Inspire Know-How) which during the Term of this Agreement becomes owned by or licensed to BII or an Affiliate and which is accessible to BII pursuant to Clause 4.2(b) and which BII in its reasonable assessment deems necessary for the Development of the Product and obtaining the Product Registration(s), and which BII is free to disclose to a third party.

1.6

“BII Patent Rights” means the Patent Rights (i) owned by or licensed to BII or an Affiliate (other than Inspire Patent Rights) as of the Effective Date as set forth in Annex 2, and (ii) any other Patent Rights as far as they relate to the Compound, the use thereof, or a formulation thereof, (but specifically excluding any Patent Rights relating to the manufacture of the Compound), and are owned by or licensed to BII or an Affiliate at any time during the Term of this Agreement, it being understood that in the case of Patent Rights licensed to BII or an Affiliate, BII or such Affiliate must be free to sub-license such rights to a third party.

1.7

“BII Territory” means all countries and territories of the world other than the Inspire Territory.

1.8

“Compound” means epinastine, including but not limited to all pharmaceutically acceptable salts thereof, in particular epinastine HCL.

1.9

“Confidential Information” of a particular Party means any information disclosed by or on behalf of such Party to the other Party relating to the disclosing Party’s Know-How, trade secrets or any other information relating to business affairs, finances or products of the disclosing Party or its Affiliates, which is considered by the disclosing Party as confidential as well as the terms of this Agreement, excluding, however, information (i) which can be demonstrated as being already in the receiving party’s and its Affiliates’ possession prior to the date of execution of this Agreement and the Material Transfer Agreement dated June 7, 2005 and the Confidentiality Agreement dated March 15, 2004 entered into by the Parties; (ii) comes into public domain by publication or otherwise through no breach of this Agreement; (iii)

1.10

“Development Program” means the program of work to be conducted by, or on behalf of, Inspire hereunder for obtaining Product Registration(s) for the Product (including but not limited to all further development work which may be required for Product Registrations, manufacturing and marketing purposes, but excluding Compound manufacturing development work) in the Field, a preliminary outline of which is attached as Annex 3.

1.11

“Effective Date” means the date specified on the first page of this Agreement.

1.12

“Field” means the therapeutic treatment or prevention of allergic and non-allergic rhinitis in humans through nasal administration.

1.13

“First Commercial Sale” means, with respect to any country within either the Inspire Territory or the BII Territory, as the case may be, the date upon which the Product is first sold by the Party having rights to commercialize the Product in such Territory (or its Affiliates or its Recognised Agents) in a commercial transaction, as evidenced by the selling party’s invoice to a third party in such country, after the required Product Registration has been granted by the Regulatory Agency in such country.

1.14

“Generic Equivalent” means a generic version of the Product, which contains the Compound given by intranasal administration, marketed and sold by a third party in any country of the Inspire Territory or BII Territory, as the case may be.

1.15

“Inspire Commercialization Period” means the period beginning on the First Commercial Sale of Product in the United States and ending on December 31, 2022.

1.16

“Inspire IP” means collectively Inspire Know-How and Inspire Patent Rights.

1.17

“Inspire Know-How” means all Know-How generated by or on behalf of Inspire and its Affiliates during the Term, to the extent that it relates to Inspire’s and its Affiliates’ (i) development, manufacturing and marketing of the Product, and (ii) the Compound, the use thereof or a formulation thereof.

1.18

“Inspire Patent Rights” means all Patent Rights owned by or licensed to Inspire and its Affiliates (other than the BII Patents) during the Term, relating to inventions made by or on behalf of Inspire and its Affiliates (in particular under the Development Program) to the extent that they relate to (i) the development and manufacturing of the Product, and (ii) the Compound, the use thereof, or a formulation thereof, it being understood that in the case of Patent Rights licensed to Inspire or an Affiliate, Inspire or such Affiliate must be free to sub-license such rights to a third party.

1.19

“Inspire Territory” means the United States of America and Canada and their respective territories and possessions.

1.20

“Know-How” means information which is not known to the public including information comprising or relating to inventions, including patent applications in preparation, concepts, discoveries, data, designs, formulae, ideas, experience; information comprising or relating to material, methods, models, assays, research plans, procedures, designs for experiments and tests and results of experimentation and testing including results of research or development together with processes including manufacturing processes, specifications, techniques, chemical, pharmacological, toxicological, clinical, analytical and quality control data, trial data, case report forms, data analyses, reports or summaries and correspondence no matter whether contained in written documents, tapes, discs, diskettes, CD ROM and any other media on which Know How can be stored. The fact that a specific item is known to the public will not be taken to exclude the possibility that a compilation or combination including such item, and/or a development related to such item, is (or remains) not known to the public.

1.21

“Marketing Year” means with respect to each country in the Inspire Territory and the BI Territory, as the case may be, (i) the period from the First Commercial Sale in such country until December 31 ^st of the same year (“First Marketing Year”), or (ii) each calendar year, subsequent to the First Marketing Year, during the Term of this Agreement.

1.22

“Net Sales” means the actual gross amounts invoiced for sales of Product by a Party and its Affiliates to any third party purchaser (including Recognised Agents) less the following deductions with respect to such sales:

-

any rebates, quantity, trade and cash discounts, and other usual and customary discounts to customers actually paid or deducted;

-

retroactive price reductions, credits or allowances actually granted upon rejections or returns of Products, including for recalls or damaged goods;

-

freight, postage, shipping and insurance charges actually allowed or paid for delivery of Products, to the extent included in the gross sales price;

-

sales taxes, excise taxes, use taxes, import/export duties or other governmental charges actually due or incurred with respect to such sales, including without limitation value-added taxes; and

-

charge-back payments and rebates (or the equivalent thereof) granted to managed health care organisations or to federal, state and local governments, their respective agencies, purchasers or reimbursers;

1.23

“OTC” means ‘over the counter’.

1.24

“OTC Product” means a Product that is sold to consumers OTC without the necessity of a prescription.

1.25

“OTC-Switch” means, with respect to each country of the Inspire Territory, the transfer of the Product from a prescription medicine to an over-the-counter medicine in such country. The Product will be deemed to be transferred, and the OTC-Switch deemed to be finalised, with respect to a given country of the Inspire Territory upon final approval by the Regulatory Agency in such country of the Inspire Territory that has regulatory jurisdiction over such transfer.

1.26

“Party” means a party to this Agreement. The correlative term “Parties” means both of the parties to this Agreement.

1.27

“Patent Rights” means rights in all patent applications and granted patents, patents with post grant amendments, design patents, improvement patents and models and certificates of addition, utility patent applications, utility patents, utility models, utility model applications and all foreign counterparts of them, including any provisional applications, divisional applications and patents, refilings, renewals, continuations, continuations-in-part, patents of addition, extensions, re-examinations, reissues, substitutions, confirmations, registrations, revalidation and additions of or to any of them, as well as any supplementary protection certificates, and equivalent protection rights in respect of any of them.

1.28

“Product” means any nasal dosage form containing the Compound for use in the Field.

1.29

“Product Registration” means a valid pharmaceutical product registration or marketing authorisation for the Product (including pricing approval, if applicable) granted by any Regulatory Agency as well as any other regulatory approval with respect to the Product or which are required for the manufacture, marketing, promotion, pricing, reimbursement and selling of any Product.

1.30

“Reasonable Efforts” means the employment of reasonable efforts of, and appropriate funding by, a Party consistent with the prudent exercise of business judgement which will not be less than those employed for the development, registration, launch and commercialisation than those which a similarly situated pharmaceutical company would employ for its own pharmaceutical products with similar commercial potential, at a similar stage in its product life cycle, taking into account the stage of development of a

1.31

“Recognised Agents” means an organisation which is not an Affiliate of either Party which such Party uses in the normal course of its business to market, promote, detail, distribute or sell its products in a particular country of its Territory.

1.32

“Regulatory Agency” means any national or local agency or authority including any regulatory authority, department, inspectorate, minister, ministry official, parliament or public or statutory person (whether autonomous or not) or any government of any country having jurisdiction over either (i) any of the activities contemplated by this Agreement or the Parties including for the avoidance of doubt where the context admits any ethics committee or any equivalent review board, or (ii) the marketing and sale of pharmaceutical products.

1.33

“Relevant Market” means (i) if the context refers to prescription drug products, the market for all prescription drug products containing the Compound given by intranasal administration, or (ii) if the context refers to an OTC product, the market for all OTC products containing the Compound given by intranasal administration.

1.34

“Semi-exclusive” means a grant of rights by one Party to the other Party and its Affiliates and Sublicensees which is exclusive as to any and all third parties, but the grantor of such rights retains for itself and its Affiliates and Sublicensees the rights to use and exploit such rights in addition to the grantee of such rights.

1.35

“Sublicensee” means with respect to either Party any person, company, corporation or other business entity, other than a Recognised Agent and/or an Affiliate of a Party, that is granted a sublicense by such Party under this Agreement to develop, clinically test, make, have made, use, offer for sale and sell Products.

1.36

“Term” is defined in Clause 15.1.

1.37

“Trademark A” means the trademark(s) selected pursuant to Clause 10.3 and agreed upon by BII and Inspire and thereafter attached to this Agreement as Annex 4.

2.

Grant of Rights to Inspire

2.1.

Exclusive and Semi-exclusive Licences

(i)

Development and Commercialization Rights . BII hereby grants to Inspire, and Inspire hereby accepts, with effect from the Effective Date until the end of the Inspire Commercialization Period, an exclusive right and license in the Field under the BII Patents and BII Know-How

(ii)

Manufacturing Rights . Furthermore, BII hereby grants to Inspire, and Inspire hereby accepts, with effect from the Effective Date until the end of the Inspire Commercialization Period, a Semi-exclusive right and license in the Field under the BII Patents and BII Know-How (with the right to sublicense) to manufacture, or have manufactured, the Product in (a) the Inspire Territory, and (b) the BII Territory but solely for the development, marketing, distribution and sale of the Product in the Inspire Territory, it being understood and agreed, however, that the manufacturing rights granted hereunder (including any sublicense thereof) relate only to the manufacture of the Product and not to the manufacture of the Compound.

(iii)

Trademark Rights . BII hereby grants to Inspire, and Inspire hereby accepts, with effect from the Effective Date and continuing for the period referenced in Clause 2.2(ii) below, an exclusive right and license to use Trademark A in connection with the commercialization of the Product in the Field in the Inspire Territory.

2.2

Duration of the Licenses; End of Exclusivity Period

(i)

Upon the expiration of the Inspire Commercialization Period, the exclusive and Semi-exclusive license granted to Inspire under Clauses 2.1(i) and (ii) in respect of the BII Patents and BII Know-How, (but not the rights with respect to Trademark A under Clause 2.1(iii)), will convert (and will thereafter continue beyond the Term of this Agreement as defined in Clause 15.1) into a perpetual, fully paid-up, non-exclusive license under the BII Patents and BII Know-How to develop, manufacture, market, distribute and sell the Product, with the restriction that the manufacturing rights relate only to the manufacture of the Product and not to the manufacture of the Compound.

(ii)

Inspire will retain an exclusive license to Trademark A for the Inspire Territory under this Clause 2.2 (ii), subject to the royalty obligations in respect of such Trademark A set forth in this Agreement, for so long as Inspire is commercializing the Product.

(iii)

Notwithstanding Clauses 2.2(i) and (ii) above, in the event that the Product is switched from a prescription product to an OTC Product and the OTC-Switch has been finalised in a particular country of the Inspire Territory in accordance with Clause 7, the rights granted to Inspire under Clause 2.1 will immediately terminate with respect to such country of the Inspire Territory.

2.3

No Other Rights

2.4

BII’s Right to Manufacture the Compound

2.5

Rights to Subcontract

3.

Grant of Rights to BII

3.1

Exclusive License

(i)

Inspire hereby grants to BII, and BII hereby accepts, with effect from the Effective Date and continuing for the period set forth in Clause 3.4, an exclusive right and license (with the right to sublicense) in the Field under the Inspire IP to develop, market, distribute and sell the Product in the BII Territory.

(ii)

Furthermore, Inspire hereby grants to BII, and BII hereby accepts, with effect from the Effective Date and continuing for the period set forth in Clause 3.4, a Semi-exclusive right and license in the Field under the Inspire IP (with the right to sublicense) to manufacture, or have manufactured, the Product both in (a) the BII Territory, and (b) in the Inspire Territory but solely for the development, marketing, distribution and sale of the Product in the BII Territory.

(iii)

Inspire hereby grants to BII, and BII hereby accepts, on a country-by-country basis, from the time of finalising the OTC-Switch for the Product in a given country of the Inspire Territory subject to all requirements of Clause 7 and continuing for the period set forth in

(iv)

For the avoidance of doubt, BII shall have the right, but not the obligation, to avail itself of the rights granted hereunder. Inspire shall not claim any damages or reimbursement due to the fact that BII does not exercise the rights granted under this Clause 3. For the avoidance of doubt, however, the Parties acknowledge and agree that this Clause 3.1(iv) will not affect the obligations of BII to manufacture and provide Compound to Inspire pursuant to the Supply Agreement.

3.2

License/Sublicense to Third Party Rights and Assignment

(i)

Each of the Parties acknowledges that Inspire will need to acquire third party rights (if not internally developed) to an intranasal administration device in order to be able to commercialize the Product. In any subsequent negotiation with the owner of any intranasal administration device, Inspire will use Reasonable Efforts to acquire access to such device, whether by license agreement, supply agreement, or otherwise, on a worldwide basis, such that Inspire or such third party, as the case may be, would be in a position to grant access to such intranasal administration device to BII. Prior to entering into such negotiations with the owner of any intranasal administration device, Inspire shall notify BII hereof and BII shall notify Inspire whether BII is interested in obtaining such third party rights. It is understood and agreed, however, that it is BII’s responsibility to bear all costs of obtaining access to the rights to such intranasal administration device for the Product in the BII Territory, and also in the event that BII is commercializing an OTC Product in the Inspire Territory. Inspire shall not act on behalf of BII or create any obligation for BII.

(ii)

In addition, in the event that BII exercises its OTC Switch Rights, Inspire will assign or otherwise transfer to BII, and BI will assume from Inspire, any and all rights and obligations with respect to agreements relating the intranasal administration device for the Product, if any, under conditions not less favourable as those applicable to Inspire in respect to each country where BII has exercised its OTC Switch Rights. In connection therewith, BII will use Reasonable Efforts to cause Inspire to be released from its obligations contained in such agreements.

3.3

Sublicense Rights

3.4

Duration of the License

4.

Development, Registration, and Access to Know-How

4.1

Responsibility for Development Program

(a)

Subject to the provisions of Clause 4.5, and with effect from the Effective Date, Inspire shall be responsible, at its own expense, for and shall employ Reasonable Efforts for the development of the Product, including the conduct of the Development Program.

(b)

Inspire shall prepare, based on the outline in Annex 3, a detailed outline of the Development Program for the Product (the “DP Summary”) within 6 (six) weeks following the pre-IND (Investigational New Drug) meeting and forward promptly thereafter such DP Summary to BII. The DP Summary will describe in detail the work activities and planned clinical trials and non-clinical studies to be carried out by, or on behalf of, Inspire in order to be able to seek Product Registrations in the Inspire Territory including associated preliminary timeline estimates. Inspire shall update the DP Summary on an annual basis and shall promptly provide BII with such updates. BII may, at its option, review and comment on the content of each version of the DP Summary; provided, however, that Inspire will not be required to cease or delay the Development Program while BII is reviewing the DP Summary. If BII has not commented within six (6) weeks of receipt of such DP Summary, it will be presumed that it has no comments to the DP Summary. In the event that BII tenders comments to Inspire on the DP Summary, Inspire shall reasonably consider in good faith BII’s comments, but in the event that the Parties do not agree on the content of the DP Summary, Inspire shall retain the final decision on such matters.

(c)

In the event that it becomes apparent to Inspire that the Development Program will be significantly delayed, Inspire shall promptly notify BII of such fact and such notice will be accompanied by a summary description and explanation as to the reasons, or potential reasons, for such significant delay and potential remedies.

4.2

Regulatory Filings during Development

(a)

Except as otherwise provided herein, in the event that the results of the Development Program so justify, Inspire shall use Reasonable Efforts to seek a Product Registration for the Product, and, at its expense, to submit all regulatory filings and approvals required by any Regulatory Agency with respect to the development and commercialization of the Product with respect to each country in the Inspire Territory (including but not limited to IND filings and NDA filings). Once filed with a Regulatory Agency, Inspire will use Reasonable Efforts to obtain approval of each Product Registration for the Product. In the event that Inspire decides not to pursue the Development Program or not to seek the Product Registration for the Product, it shall notify BII thereof immediately in writing.

(b)

BII undertakes to use Reasonable Efforts to make available to Inspire all information regarding Compound which (i) comes to the attention of employees of BII or its Affiliates, and (ii) BII in its reasonable assessment considers useful for the regulatory filing for the Product. *[CONFIDENTIAL].

4.3

Supply of Study Reports

4.4

Drug Master File

4.5

Preparation, Filing and Maintenance of Product Registration

4.6

Filings by BII

4.7

Notice of Registration, Approval and Launch

(a)

Inspire shall promptly inform BII of the date of filing of a Product Registration, approval of such Product Registration and the First Commercial Sale of the Product in each country of the Inspire Territory.

(b)

BII shall promptly inform Inspire of the date of filing of a Product Registration, approval of such Product Registration and the First Commercial Sale of the Product in each country of the BII Territory.

4.8

Shipment of the BII Documents, No Obligation to Create BII Know-How

4.9

Availability and Transfer of Inspire Know-How

5.

Commercialisation

5.1

Responsibility

5.2

Sales Forecasts

5.3

Commercialisation by BII

5.4

Co-Promotion Rights

6.

Product Safety

6.1

Compliance with Product Registrations

6.2

Recall System

6.3

Information Exchange

(a)

Both Parties shall comply fully with all applicable adverse event reporting requirements in all countries where the Parties intend to carry out clinical trials or commercialize the Product and agree to exchange all such adverse event information as may be necessary to achieve compliance with law and to ensure that both Parties are completely informed regarding the adverse events associated with the Product, including but not limited to single case reports, appropriate medical evaluation, as well as aggregation data.

(b)

Upon execution of this Agreement, BII shall provide to Inspire all available information regarding the safety of, and the adverse events associated with, the Compound including all adverse event reports received in the past, published literature and previous actions taken by BII or by Regulatory Agencies due to safety issues.

(c)

Further provisions regarding safety and adverse events shall be governed by a Pharmacoviligence Agreement to be entered into by the Parties.

7.

OTC-Switch Rights

7.1

OTC-Switch in the Inspire Territory

7.2

Responsibility for OTC-Switch

7.3

OTC-Switch Payment

7.4

Restriction of Competition after OTC-Switch

7.5

Assignment/Assumption of Rights

8.

Obligations

8.1

Inspire’s Obligations

(i)

as long as Inspire has exclusive rights under Clause 2, use Reasonable Efforts to carry out the Development Program in accordance with the provisions of Clause 4.1 and to meet the timelines set forth in the DP Summary and using all reasonable care and skill, and in accordance with all applicable laws, the principles of the current ICH, Good Clinical Practice Guidelines and the provisions of this Agreement;

(ii)

upon request of BII, supply to BII fre