AMENDED & RESTATED LICENSE AND DEVELOPMENT AGREEMENT

Portions herein identified by ** have

been omitted pursuant to a request for

confidential treatment and have been

filed separately with the Commission

pursuant to Rule 24b-2 of the Exchange

Act of 1934, as amended.

 

AMENDED & RESTATED LICENSE AND DEVELOPMENT AGREEMENT\

By

and

Between

OMNIPHARM LIMITED and

FIDOPHARM, INC.

 

TABLE OF CONTENTS

(continued)

AMENDED & RESTATED LICENSE AND DEVELOPMENT AGREEMENT

THIS AMENDED & RESTATED LICENSE AND DEVELOPMENT AGREEMENT (“ Agreement ”) is made as of this 22nd day of April 2008 ( “Effective Date” ), by and between: Omnipharm Limited, a company having offices at Century House, 15 / 17 Musters road, West Bridgford, Nottingham, NG2 7PP England, UK ( “Omnipharm” ), and   Fidopharm, Inc., a company having offices 777 Township Line Road, Suite 170, Yardley, Pennsylvania 19067 ( “Fidopharm” ).  Fidopharm and Omnipharmare together referred to as “Parties” and individually as a “Party” .

RECITALS

WHEREAS , Omnipharmis developing ACI-based products for manufacture and commercialization for veterinary or animal application uses.

WHEREAS ,   the largest market in the world for ACI-based products for veterinary or animal application uses is the United States.

WHEREAS ,   the Parties agree that Fidopharm has the requisite expertise and infrastructure to register and commercialize veterinary products in the United States.

WHEREAS , Omnipharmdesires to grant Fidopharm an exclusive license to use its know-how and under its patent rights to, use, make, have made, market, offer for sale, import or export and sell ACI-based products for veterinary or animal application use in the United States, and Fidopharm desires to obtain such license.

AND WHEREAS , Omnipharmshall cause the JV to execute a supply agreement contemporaneously with the execution of this Agreement providing for the exclusive supply of Products to Fidopharm for sale and distribution in the Territory.

NOW, THEREFORE , in consideration of the mutual promises set forth herein, the Parties, intending to be legally bound, hereby agree as follows:

1.	DEFINITIONS

As used herein, the following terms shall have the respective meanings set forth below:

1.1             “ACI” means (a) Active A and/or (b) Active B.

1.2             “Active A” shall have the meaning on Schedule 1 .  

1.3             “Active B” shall have the meaning on Schedule 1 .

1.4             “Affiliate” means any individual, corporation, company, partnership, trust, limited liability company, association or other business entity ( “Person” ) which directly or indirectly controls, is controlled by or is under common control with the Party in question.  As used in this definition of “Affiliate,” the term “control” shall mean, as to any Person, (a) direct or indirect ownership of fifty percent (50%) or more of the voting interests or other ownership interests in the Person in question (or such lesser percentage which is the maximum allowed to be owned by such Person in a particular jurisdiction); (b) direct or indirect ownership of fifty percent (50%) or more of the interest in the income of the Person in question; or (c) possession, directly or indirectly, of the power to direct or cause the direction of management or policies of the Person in question (whether through ownership of securities or other ownership interests, by contract or otherwise).  Notwithstanding the foregoing, the owners of preferred stock (or common stock issued upon conversion thereof) of a Party such as financial institutions, venture capital funds and private equity investors will not be its “Affiliates” for purposes of this Agreement.

 

1.5             “Commercial Sale” means sale of Products by Fidopharm or its Affiliates to a Third Party in the Territory, other than distribution in connection with clinical trials of Products conducted by Fidopharm.

1.6             “Confidential Information” means all secret or confidential proprietary information or data of a Party provided in written, oral, graphic, video, computer, electronic or other form to the other Party.

1.7            “ Controlled ” means, with respect to any intellectual property right or other intangible property, the possession by license or ownership by a Party (or by an Affiliate) to grant to the other Party access or a license or sublicense as provided herein without violating the terms of any written contract with any Third Party.

1.8             “Development” means research and chemical development activities, including without limitation toxicology, test method development and stability testing, process development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, efficacy studies, product performance studies, environmental impact studies, manufacturing process development and scale-up, regulatory affairs, and product approval and regulatory activities other than filing for and seeking Product Registrations.

1.9             “Field” means any and all veterinary or animal application uses.

1.10            “ JV ” means ** Limited, which shall be the entity responsible for supplying Products to Fidopharm.

1.11             “Know-How” means any proprietary technical or other information relating to Products and the make, use or sale of Products, including technology, experience, formulae, concepts, discoveries, trade secrets, inventions, modifications, improvements, data (including all chemical, clinical, toxicological, analytical, and quality control data), results, designs, ideas, analyses, methods, techniques, assays, research plans, procedures, tests, processes (including manufacturing processes, specifications and techniques), laboratory records, reports, summaries, and information contained in submissions to, and information received from, regulatory authorities, that are Controlled by Omnipharm, its Affiliates, JV or Manufacturer as of the Effective Date or during the Term.

1.12             “Law” or “Laws” means the laws, statutes, rules, codes, regulations, orders, judgments and/or ordinances of any governmental authority (including without limitation the Regulatory Authority).

1.13             “Manufacturer” shall have the meaning set forth in Schedule 1 , which shall be amended upon the mutual agreement of the Parties.

1.14             “Patents” means (a) the patents and patent applications listed in Schedule 2 , (b) all patents and patent applications related to Products that may be obtained, including the make, use or sale of Products and (c) all patents and patent applications which are divisions, continuations, continuations-in-part, reissues, renewals, re-examinations, foreign counterparts, substitutions or extensions of or to any patent applications or patents described in clauses (a) or (b) of this sentence, that are Controlled by Omnipharm, its Affiliates, JV or Manufacturer as of the Effective Date or during the Term.  The Parties hereby acknowledge that there are no Patents as of the Effective Date; provided, that upon the filing of a Patent application Omnipharm shall create a Schedule 2 which shall be updated as necessary.

1.15             “Products” means any product containing ACI as its active chemical ingredient and which is covered by Patents and/or uses Know-How, including, but not limited to the following Products:

 

(a)            “Product A” means a product Developed by Omnipharm(including by any Affiliate of Omnipharmor by any Third Party (on behalf of Omnipharmor its Affiliates)) meeting the specifications set forth in Schedule 1 ; and

(b)            “Product B” means a product Developed by Omnipharm(including by any Affiliate of Omnipharm or by any Third Party (on behalf of Omnipharm or its Affiliates)) meeting the specifications set forth in Schedule 1 .

1.16             “Product Registration” means, with respect to a Product in a particular country or territory, the registration or regulatory approval granted by the applicable governmental authority in such country or territory allowing for such Product to be marketed, distributed, sold or imported there.

1.17             “Regulatory Authority” means the United State’s agency with jurisdiction over Products.

1.18             “Specifications” means, with respect to a Product, the specifications for such Product set forth in the Product Registration or as otherwise agreed to by the Parties.

1.19             “Supply Agreement” means that Amended & Restated Manufacture and Supply Agreement entered into with the JV contemporaneously with this Agreement.

1.20             “Territory” means the United States and all of its states, territories and protectorates.

1.21             “Third Party” means any entity or person other than Omnipharm or Fidopharm or their respective Affiliates.

1.22             “Unit” means a ** of Product.

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

 

 

2.	LICENSE GRANT AND OTHER RIGHTS

2.1             Exclusive License.

(a)           Subject to the terms and conditions of this Agreement, Omnipharm hereby grants Fidopharm an exclusive license, with a right to sublicense, to use the Know-How and under the Patents to, use, make, have made, market, offer for sale and import or export Products in the Field in the Territory.  For clarity, Fidopharm’s right to export hereunder shall not include the right to export Product to end-users or commercial distributors outside of the Territory.

(b)           Notwithstanding the license grant above, Fidopharm shall not make or have Products made and supplied (other than through the JV) for Commercial Sale in the Territory unless there as been a Failure (as defined in the Supply Agreement).

2.2             Right of Reference. Omnipharm hereby grants Fidopharm the right to access, reference and use all data and regulatory filings (including all Product Registrations Controlled by Omnipharm, its Affiliates, JV and Manufacturer) and regulatory communications associated with any submissions for the Products to the extent permitted under applicable Laws.  Where required in order for Fidopharm to obtain such access, Omnipharm shall or shall cause the appropriate party to, as soon as reasonably possible (and in any event no later than thirty (30) days from the date of Fidopharm’s request), provide the applicable governmental authority with notice of its consent to such access by Fidopharm in the appropriate form.  In the event that Omnipharm grants any Third Party any rights in Products, (i) Omnipharm shall use its best efforts to ensure that any such Third Party will grant Omnipharm a right to access, reference and use any and all data and regulatory filings related to Products and (ii) Omnipharm hereby grants Fidopharm a right to access, reference and use any and all data and regulatory filings related to Products which Omnipharm has such a right to access; provided, that in any event Omnipharm shall ensure that any such Third Party shall be subject to safety and adverse event reporting obligations no less stringent than the terms and conditions contained in Section 8.3 and Fidopharm shall be made aware of any such safety or adverse events within twenty-four (24) hours of Omnipharm being informed of such an event. Omnipharm reserves the right to use such data worldwide in support of any registration held by it or a Third Party partner.

2.3             Copyrighted Materials.   To the extent that Omnipharm develops or has developed any manuals, logos, and other copyrighted works for use with Products (individually and collectively, the “Copyrighted Materials” ), Omnipharm hereby grants Fidopharm a royalty-free, non-exclusive license to use and distribute such Copyrighted Materials in connection with marketing, promoting, selling or importing Products in the Field in the Territory.

2.4             Exclusive Right of First Negotiation.   Prior to Omnipharm granting to a Third Party a license or similar right (including a co-promotion right or an option to acquire such license or right) to market, offer for sale, import or export one (1) or more products containing ACI (other than Products) in the Field in the Territory, it shall so advise Fidopharm in writing (an “ROFN Notice” ).  Upon request by Fidopharm within thirty (30) days after its receipt of the ROFN Notice, Omnipharm and Fidopharm shall discuss the terms and conditions under which Omnipharm would grant to Fidopharm rights to market, offer for sale, import or export such products in the Field in the Territory.  If the Parties agree to grant such rights to Fidopharm, including the terms and conditions of such grant, the Parties shall prepare and execute an amendment to this Agreement incorporating such additional rights and terms.  If Fidopharm does not so request within the thirty (30) day period after its receipt of the ROFN Notice, or if the Parties do not agree in writing on the terms of such additional grant of rights to Fidopharm within ninety (90) days after the date of the ROFN Notice to Fidopharm, Omnipharm shall be free to grant to one or more Third Parties the right to market, offer for sale, import or export such products in the Field in the Territory, on such terms as Omnipharm considers appropriate.

 

 

3.	CONSIDERATION

3.1             Upfront Payment.   In partial consideration of the grant of rights under this Agreement and Omnipharm’s obligations to conduct the Development activities provided hereunder, Fidopharm shall pay Omnipharm an upfront payment of five hundred thousand dollars (US$500,000) within fourteen (14) days of the Effective Date.

3.2             Supply Agreement.   As further consideration of the grant of rights under this Agreement and its obligations to conduct the Development activities provided hereunder, Fidopharm shall contemporaneously with this Agreement enter into the Supply Agreement.

3.3             No Additional Consideration. Omnipharm shall be entitled to no additional consideration for the grant of rights to Fidopharm under this Agreement and Omnipharm’s obligations to conduct the Development activities other than as provided under this Article 3 and Section 4.7 below.

4.	DEVELOPMENT

4.1             Overview.  Omnipharm shall be primarily responsible, at its sole cost except as otherwise specifically provided herein, for designing and conducting all Development activities necessary to receive Product Registrations for the Product A and Product B (together, the “Initial Products” ) in accordance with the Development Plan.  Fidopharm shall be responsible, at its sole cost, for submitting the Product Registrations to the Regulatory Authority.

4.2           Development Plan.

(a)           The Development of the Initial Products shall be governed by a development plan (the “Development Plan” ).  The initial Development Plan shall be attached hereto as Schedule 4.2 .  The Development Plan shall include options for ‘essentially similar’ and complete clinical package registration data routes with costings, timelines, stage payments, ** and other elements to be set forth in the Development Plan.

(b)           The Development Plan, together with any updates thereto, shall be prepared and approved as follows from time to time during the Term, each Party shall have the right to propose amendments to and amend the existing Development Plan; provided, that in any event Omnipharm shall present Fidopharm an updated Development Plan at least once per calendar year for its review and approval, not to be unreasonably withheld or delayed.  Fidopharm shall have a period of twenty-one (21) days from the date that the updated Development Plan is received to provide its approval.  If approval or rejection is not provided to Omnipharm within such twenty-one (21)-day period, then the Development Plan shall be deemed approved.  For purposes of clarity, no change to the Development Plan shall be made without the prior written approval of both Parties.

4.3             Diligence.   Omnipharm shall carry out the Development activities, in strict accordance with the Development Plan and the timelines set forth therein, necessary for obtaining the Product Registrations as set forth in this Agreement, including generating any additional data necessary to obtain Product Registration specifically for the Territory at Fidopharm’s instruction. Fidopharm shall file the Product Registrations in accordance with the Registration and Commercialization Plan based on the data provided by Omnipharm.

4.4           Reporting and Data.

(a)           Upon request, Omnipharm shall promptly, but in no event later than thirty (30) days after such request provide Fidopharm with (i) a summary in reasonable detail of all data generated or obtained from each discrete Development activity performed under the Development Plan, such as any toxicology study, pharmacokinetics study or stability study, (ii) a summary of the Development progress against the projected Development progress set forth in the current Development Plan and (iii) a final report of the results of each Development activity, together with all material supporting data.

 

(b)           Omnipharm shall provide Fidopharm copies of all substantive or material information with respect to the Development of Products, including clinical data compiled with respect to Products and all information and data filed with any governmental authority with respect to Products outside of the Territory, as soon as reasonably practicable after such information, data or results become available to or compiled by Omnipharm, including any drafts and final versions of any study reports (the “Development Data” ).  Subject to the terms and conditions of this Agreement, Fidopharm shall have the right to use the Development Data or any portion thereof for the purpose of obtaining Product Registrations and commercializing Products in the Territory.

4.5             Compliance with Laws. Omnipharm or its agents shall perform its responsibilities under this Article 4, including those set forth in the Development Plan, in accordance with all applicable Laws.

4.6             Access to Records and Facilities.   Omnipharm shall maintain scientific records, in sufficient detail and in good scientific manner appropriate for obtaining Patents and regulatory purposes, which shall fully and properly reflect all work done and results achieved in the performance of Development under this Agreement.  Fidopharm shall be entitled to have access during regular business hours and upon reasonable advance notice, to Omnipharm’s records and facilities relating to the Development of Products for the purpose of monitoring compliance with all applicable Laws and other applicable regulatory requirements.  In all Third Party agreements involving the Development of Products, Omnipharm shall require that the Third Parties thereto provide Omnipharm with access to such Third Party facilities and all such data generated by Third Parties.  Fidopharm shall have the right to inspect such facilities on behalf of Omnipharm in the event that:

(a)           a specific concern is raised regarding Product by any governmental authority (including the Regulatory Authority);

(b)           a routine inspection/audit for Regulatory Authority purposes;

(c)           a routine inspection to confirm compliance with the terms of this Agreement, including without limitation, the progress of Product Development; or

(d)           a routine inspection/audit for a Fidopharm customer.

For clarity, inspection and audits pursuant to Section 4.6(d) shall be limited to two (2) separate visits in any twelve (12) month period for each specific Third Party; provided, that additional reasonable inspections/audits shall be permitted upon Fidopharm obtaining Omnipharm’s prior consent, which shall not be unreasonably withheld, conditioned or delayed.  All inspection/audit costs shall be borne by the Party incurring such costs.

4.7             Territory Specific Development.   To the extent that additional Development is necessary solely to obtain the Product Registration in the Territory ( “Territory Development” ), Omnipharm shall supplement the current Development Plan with a budget setting forth the reasonable costs for conducting the Territory Development specific activities ( “Territory Development Costs” ) and shall submit such supplement to Fidopharm for its consent and upon approval of such Territory Development Costs by Fidopharm, Fidopharm shall reimburse such costs as they are incurred.

5.	PRODUCT REGISTRATION AND COMMERCIALIZATION

5.1             Product Registration.   Fidopharm shall, at its sole expense, use commercially reasonable efforts to obtain and maintain Product Registrations in accordance with the Registration and Commercialization Plan.  Fidopharm shall be the sole owner of all Product Registrations in the Territory.  For clarity, Fidopharm shall have the sole right in determining whether or not to obtain and/or maintain any specific Product Registration in the Territory.

 

 

5.2             Registration and Commercialization Plans.   No less than thirty (30) days prior to first Commercial Sale Fidopharm shall provide an annual development plan for its activities in order to obtain Product Registrations and after first Commercial Sale Fidopharm shall provide an annual commercialization plan for its efforts to commercialize Products (the “Registration and Commercialization Plan” ).  Fidopharm shall update the Registration and Commercialization Plan annually and shall provide such updated plan to Omnipharm not later than thirty (30) days before start of each year.  The Registration and Commercialization Plan description shall be agreed between the Parties.

5.3             Trademarks.   Fidopharm shall have the sole right to determine the trademark(s) or trade name(s) that Fidopharm shall adopt for use with Products (the “ Trademark ”).  All goodwill generated through the use of Trademarks by Fidopharm shall inure to the benefit of Fidopharm.  Fidopharm shall own all Trademarks and shall register and maintain such Trademarks at its sole cost and discretion.

5.4             Cooperation.   Omnipharm shall provide (a) reasonable cooperation and support to Fidopharm in connection with maintenance of the Product Registration and (b) all information (including Confidential Information) that is reasonably required for the Development and/or commercialization of Products.  Subject to Article 9 , Fidopharm may use such Confidential Information solely for the purpose of Developing and commercializing Products.

5.5             Reporting.   Each Party shall keep the other Party informed of developments known by it that would reasonably be expected to have a material adverse effect on any Product or Product Registration, including, but not limited to, the general regulatory strategy for Products in the Territory.

6.	SUPPLY OF PRODUCTS.

6.1             Supply Agreement.   Contemporaneously with the execution of this Agreement Fidopharm shall enter into the Supply Agreement with the JV.  Pursuant to the terms of the Supply Agreement, the JV shall supply Fidopharm’s requirements of Products.  Notwithstanding the foregoing, as between Fidopharm and Omnipharm, in the event of a conflict between the Supply Agreement and this Agreement, Fidopharm’s rights in regards to the licenses (and any other intellectual property related to the Products) and Product Registrations related to the Products shall be governed solely by the terms of this Agreement.

6.2             Technology Transfer.   In the event that there is a Failure (as defined in the Supply Agreement) or if this Agreement is terminated pursuant to Section 11.2(b), 11.3 or 11.4, (a) the restrictions set forth in Section 2.1(b) of this Agreement shall no longer be applicable (which for clarity, means that Fidopharm shall have the right to manufacture, or have manufactured, Product itself or by a Third Party) and (b) Omnipharm shall undertake, and/or, as necessary, cause the JV and Manufacturer to undertake, an immediate transfer to Fidopharm or its designee of all technology and Know-How necessary, useful or used to manufacture Products.  Omnipharm shall also make available, or cause to be made available any individuals who may be useful implementing the manufacturing processes related to Products.

7.

PATENTS

7.1             Prosecution and Maintenance of Patents.   Omnipharm will prosecute and maintain the Patents at its sole cost in the Territory, using counsel of its choice reasonably acceptable to Fidopharm and shall not abandon any Patent without the prior written consent of Fidopharm.  During the Term, Omnipharm pursuant to this Section 7.1 shall copy Fidopharm, or have Fidopharm copied, on all material or substantive documents regarding Patents, which are received from or to be filed in any patent office in the Territory, promptly following receipt from the patent office and within a reasonable time prior to filing with the patent office (but not less than thirty (30) days), as applicable, including copies of each patent application, office action, response to office action, declaration, information disclosure statement, request for terminal disclaimer, request for patent term extension and request for reexamination.  Fidopharm shall have the right to comment on the prosecution of such Patents and provide such comments to Omnipharm’s patent counsel, and Omnipharm shall consider all such comments in good faith.  For the purposes of this Section 7.1, “ prosecute and maintain ” means, with respect to a patent, the preparing, filing, prosecuting and maintenance of such patent, as well as re-examinations, reissues and requests for patent term extensions and the like with respect to such patent, together with the conduct of interferences, the defense of oppositions and other similar proceedings and appeals thereof with respect to a patent, but shall not include enforcement litigation or the defense of