AMENDED AND RESTATED AGREEMENT

1.  

CAMBRIDGE LABORATORIES LIMITED a company incorporated under the laws of England and having its principal place of business at Deltic House, Kingfisher Way, Silverlink Business Park, Wallsend, Tyne and Wear, England (hereinafter “Cambridge”);

2.  

PRESTWICK PHARMACEUTICALS, INC. a company incorporated under the laws of the State of Delaware and having its registered office at 1825 K Street Northwest, Suite 1475, Washington D.C. 20006, USA (hereinafter “Prestwick”).

1.  

Cambridge has the exclusive right to manufacture, develop, market and sell the Product (as defined herein) throughout the world including a right to grant sub-licences.

2.  

Cambridge wishes Prestwick to carry out the [...***...] Developments, promote, sell and distribute the Product in the Territory and to carry out any agreed [...***...] Developments (as such terms are defined herein) and Prestwick has agreed to do so on the terms set forth herein

3.  

In September 2002 Cambridge and Prestwick Scientific Capital Inc entered into an agreement pertaining to the grant by Cambridge to Prestwick Scientific Capital Inc of certain rights in respect of the Product in the Territory.

4.  

In December 2002 the parties agreed to the assignment of the benefit and burden of the obligations of Prestwick Scientific Capital Inc to Prestwick.

5.  

The parties wish to amend and restate the terms of this Agreement in the manner set forth below such amendments to apply from the date hereof.

1.  

DEFINITIONS and INTERPRETATION

1.1  

In this Agreement unless the context requires otherwise the words and phrases set forth in Schedule I shall have the respective adjacent meanings:

1.2  

Reference in this Agreement to a person shall be deemed to include any legal entity whether it be, without limitation, a natural person, partnership, company, corporation, unincorporated organisation, or any Government or agency thereof.

1.3  

Where the context admits, reference in this Agreement to the singular shall include the plural and vice versa and reference to the masculine shall include the feminine and vice versa.

1.4  

The headings in this Agreement are for ease of reference and shall not affect its interpretation.

2.  

GRANT OF RIGHTS

2.1  

Cambridge hereby:

2.1.1  

appoints Prestwick as its exclusive distributor for the resale of the Product in the Territory and Prestwick hereby agrees to act in that capacity.

2.1.2  

grants to Prestwick an exclusive, royalty free licence to use Cambridge’s know-how, Restricted Information and Intellectual Property relating to the Product to carry out the [...***...] Developments in accordance with the [...***...] Development Plan in the Territory.

2.1.3  

grants to Prestwick an exclusive, royalty free licence to use Cambridge’s know-how, Restricted Information and Intellectual Property relating to the Product to carry out the [...***...] Developments in accordance with any [...***...] Development Plan in the Territory and to commercialise any such [...***...] Developments in the Territory.

2.1.4  

grants to Prestwick an exclusive, royalty free licence in the Territory to use Cambridge’s know-how, Restricted Information and Intellectual Property pertaining to the Product for distributing and selling the Product in the Territory.

2.2  

It is specifically agreed that Prestwick is not granted any right to manufacture the Product, the Active Substance or any product resulting from any [...***...] Development or any [...***...] Development. nor has any right to have such manufactured other than by Cambridge or Cambridge’s nominated manufacturer. Prestwick shall not manufacture the Product, the Active Substance or any product resulting from any [...***...] Development or any [...***...] Development or cause, enable or assist others to do so.

2.3  

Cambridge shall ensure that, save as provided for in clause 9.9, no sales of the Product are made through Cambridge’s web site to any person requiring delivery to an address in the Territory.

2.4  

In the event that [...***...] , Prestwick grants to Cambridge [...***...] license to use that technology and the Prestwick Intellectual Property relating to that technology [...***...] , provided that [...***...] .

2.5  

Neither party shall have the right to use the others Intellectual Property or, in the case of Prestwick, Cambridge’s Restricted Information and the [...***...] , other than as expressly authorised hereunder and subject to the restrictions on such use set forth in the terms of this Agreement.

2.6  

Save as expressly provided in any [...***...] Development Plan, Prestwick shall not copy or reproduce the Active Substance or the Product for any reason or cause, assist or enable others to do so.

2.7  

For the duration of this Agreement and for a period of twelve (12) months following the expiration of any post-termination or post-expiration “sell-off” period (if applicable), Prestwick shall not be engaged, or cause enable or assist third parties to be engaged, in the manufacture, marketing, development, distribution or sale of any product, with applications for treating the symptoms of hyperkinetic movements disorders that respond to the Active Substance or containing the Active Substance or any similar active substance other than the Product without the prior written consent of Cambridge. For the sake of clarity “similar active substance” shall have the same definition as is provided for in EC Commission Regulation 847/2000 of 27 April 2000. It is agreed by Cambridge that nothing in this Agreement shall prevent Prestwick from manufacturing, marketing, developing, distributing or selling any product that is indicated as a cure for (but not for treating the symptoms of) hyperkinetic movements disorders.

2.8  

For the duration of this Agreement Cambridge shall not, save as set forth in this clause, be engaged, or cause enable or assist others to be engaged in the Territory in the manufacture, marketing, development, distribution or sale of any product, other than the Product or any product resulting from any [...***...] Development, with applications for treating the symptoms of hyperkinetic movements disorders that respond to the Active Substance or containing the Active Substance or any similar active substance without the prior written consent of Prestwick. For the sake of clarity “similar active substance” shall have the same definition as is provided for in EC Commission Regulation 847/2000 of 27 April 2000. It is

2.9  

Within [...***...] following the Commencement Date, Cambridge shall provide to Prestwick copies of those parts of the Restricted Information that Cambridge, in its reasonable opinion, believes is necessary to enable Prestwick to perform its obligations under this Agreement.

2.10  

If, at any time up to first commercial sale of the first Product commercialized under this Agreement following the grant of the NDA , Prestwick is unwilling or unable to obtain sufficient capital to enable it to perform its obligations pursuant to this Agreement in a timely manner, Cambridge may terminate this Agreement on [...***...] written notice. If, during that [...***...] notice period Prestwick acquires capital funding it shall notify Cambridge of such and if, in Cambridge’s reasonable opinion, such funding is sufficient to allay the short term fears of Cambridge, the notice shall lapse.

2.11  

For the purposes of clause 2.10 the phrase “in a timely manner” shall mean that the [...***...] Development is proceeding in terms of timing substantially in accordance with Schedule 2 with such changes as the parties may subsequently agree to or which may be required by the study results or FDA action and Prestwick is performing in all material respects any other of its obligations hereunder necessary to enable first commercial sale on such Product following [...***...] in such time frames as are either set forth herein or are otherwise prudent and conservative in order to meet the anticipated date of [...***...] , including but not limited to those obligations set forth in clauses 3.13, 9.11, 9.12, 9.13, 9.15.1, 9.15.5, 9.15.6, 10.1, 10.9 and 12.5. If Prestwick is unable to fulfil any of the obligations mentioned in or contemplated by this clause due to a failure of Cambridge to provide Product, information or materials necessary to enable Prestwick to fulfil them, Cambridge shall not be entitled to invoke clause 2.10 or to terminate this Agreement.

2.12  

Prestwick agrees that, subject to the supervision and direction of the Board of Directors of Prestwick, Kathleen Clarence-Smith is the Prestwick employee with principal responsibility for implementing Prestwick’s development obligations under the [...***...] Development Plan and will remain so through the completion of the [...***...] Development Plan unless:

2.1.5  

she resigns or suffers death or disability;

2.1.6  

she elects to take a different role within Prestwick resulting in her not having enough time to take primary responsibility for such implementation; or

2.1.7  

her employment is terminated for violation of Prestwick’s policies or any laws or regulations of the District of Columbia or the United States.

3  

[...***...] DEVELOPMENT, INDs, NDAs and [...***...] DEVELOPMENTS

3.1  

As soon as is practicable following the Commencement Date, and in any event no later than 30th September 2002, the parties shall meet and agree the content, and within ten (10) working days thereafter Prestwick shall prepare, with the co-operation of Cambridge the [...***...] Development Plan (as described below) and shall arrange to attend the Initial FDA Consultation.

3.2  

Following the Initial FDA Consultation the parties shall agree on the [...***...] Development Plan.

3.3  

The obligations of Prestwick regarding [...***...] are based on the assumptions that [...***...] (hereinafter “the Assumptions”). In the event that the Assumptions are not correct the parties will review the obligations of Prestwick. Further, the parties acknowledge that the economic terms of this proposed relationship that are set forth in this agreement are based on the Assumptions. If, following the Initial FDA Consultation and the IND filing, the Assumptions prove to be incorrect, [...***...] , the parties shall negotiate in good faith to [...***...] . If, within [...***...] of commencing any such discussions, agreement cannot be reached the matter shall be referred to the Dispute Escalation procedure set forth in clause 22. Prestwick reserves the right to terminate this agreement should the Assumptions prove materially incorrect in the manner and to the extent set forth above but will only exercise that right following the completion of the steps set forth above.

3.4  

Following the Initial FDA Consultation and based on the comments of the FDA the parties shall meet to determine the indications for which NDAs will be sought in furtherance of the

3.5  

If the advice received from the FDA either at the Initial FDA Consultation or at any other time during the course of the prosecution of the NDAs is that the FDA requires the product that is the subject of the [...***...] Development Plan to be [...***...] , the parties shall meet to discuss in good faith the implications of such a requirement. In the event that the parties believe it is not possible to convince the FDA to waive this requirement, either party shall have the right to terminate this Agreement on provision of written notice provided that the exercise of such right of termination shall not bring to an end Prestwick’s opportunity to co-invest under clause 6.2 if that opportunity would apply to [...***...] . For the sake of clarity, in the circumstances contemplated herein that opportunity shall survive termination and, if Prestwick elects to take up the opportunity to co-invest, the parties shall execute an agreement pertaining to [...***...] on the terms contemplated by clause 6.2.

3.6  

Cambridge will complete the [...***...] and other [...***...] currently in progress for the Product [...***...]. Prestwick will be responsible for any additional costs of completing any additional [...***...] . Cambridge will provide Prestwick a license to [...***...] the [...***...] from the [...***...] for [...***...] of and [...***...] within the [...***...] . In addition Cambridge will provide to Prestwick [...***...] and [...***...] from such [...***...] , as well as all [...***...] and other [...***...] including without limitation [...***...] during the term of and prior to this Agreement regarding the [...***...] and [...***...] .

3.7  

Cambridge and Prestwick will collaborate as needed in compiling and filing any submissions to the FDA , however it will be the obligation of Prestwick to perform the [...***...] Development in all material respects in accordance with the [...***...] Development Plan with such changes as the parties may subsequently agree to or which may be required by the study results or FDA action and submit the application for the NDAs and INDs within the agreed [...***...] Development or [...***...] Development Plans. Prestwick will further be

3.8  

Within [...***...] of the filing of any IND or NDA pertaining to the Product, Prestwick shall provide to Cambridge a complete copy of such filing and shall thereafter provide Cambridge with complete copies of any amendments to or updates of the application.

3.9  

Should the parties decide to seek NDAs for indications for the Product other than Hyperkinesia, Huntington’s and tardive dyskinesia the parties shall agree upon a plan for a [...***...] Development regarding such and the costs of undertaking that [...***...] Development shall be [...***...] . For the sake of clarity the indication of Tourettes will be considered as such an indication. No [...***...] Development may be undertaken without the prior consent of Cambridge.

3.10  

Prestwick will provide [...***...] updates on progress of the [...***...] Development Plan and any [...***...] Development plan and shall make available to Cambridge via an [...***...] license access to all information, materials, assays, data and reports including the final study reports (hereinafter “Data”), to the extent owned or controlled by Prestwick and transferable, arising from the [...***...] Development or any [...***...] Development that may be used by Cambridge to obtain any regulatory approvals in all markets outside the Territory. In addition Prestwick will provide to Cambridge all relevant listings of studies conducted as part of any [...***...] Development Plan or [...***...] Plan. Following termination (unless terminated due to Cambridge’s breach) or expiration of this Agreement, Cambridge shall have the exclusive worldwide right to use such of the Data arising from the [...***...] Development it wishes to use following payment to Prestwick of a sum equal to [...***...] . Notwithstanding the foregoing sentences and the use of the terms [...***...] , the parties agree that Prestwick’s obligations shall (i) not extend to Data consisting of [...***...] or records [...***...] or [...***...] as per [...***...] ; and (ii) be subject to [...***...] by those [...***...] including, without limitation, (a) those [...***...], (b) those [...***...] reference or use of the [...***...] ; and (c) [...***...] of [...***...]. Prestwick shall use reasonable endeavours to secure transferable rights to Data within the foregoing context.

3.11  

Save as set forth above, each party will be responsible for the expenses it incurs in fulfilling its obligations under the [...***...] Development Plan.

3.12  

All INDs and NDAs shall be in the name of Prestwick and shall be held and maintained at all times by Prestwick at its cost, subject to any right of Cambridge to require surrender or transfer of such in accordance with this Agreement or any requirement of the FDA. Prestwick acknowledges that, to the extent permissible under United States law, including, without limitation, the U.S. Food and Drug Act, as amended, and the regulations promulgated thereunder (and in any event as between the parties), the beneficial interest in any INDs and, NDAs is and shall be with Cambridge. Upon termination or expiration of this Agreement, Prestwick shall, [...***...] , do all things necessary to transfer the all INDs and NDAs to Cambridge or Cambridge’s nominee, and Prestwick hereby irrevocably appoints Cambridge as its attorney to sign all such documents and do all such things as are necessary to effect such transfer, should Prestwick fail to do so within the said [...***...] period. The obligations set forth in this clause shall survive termination or expiration of this Agreement.

3.13  

Prestwick shall, as soon as reasonably practicable following the Commencement Date apply for and thereafter maintain during the term of this Agreement, all other approvals, licences and permits, aside from those set forth above, necessary to import and supply the Product, in order to be able to lawfully purchase the Product from Cambridge and distribute the Product in accordance with this Agreement.

4  

[...***...] DEVELOPMENT

4.1  

Prestwick shall not engage in any [...***...] Developments until [...***...] and shall not undertake, directly or indirectly any [...***...] Developments without the prior written agreement of Cambridge.

4.2  

With regard to [...***...] Developments the parties shall, through the forum of quarterly development meetings which shall alternate between the Prestwick and Cambridge offices, set forth their ideas for any [...***...] Developments and keep each other fully appraised of the progress of any [...***...] Developments they are undertaking. Upon notification of any proposed [...***...] Development by either party to the other party, the party receiving notice shall have [...***...] and confirm whether [...***...] , such [...***...] period commencing at the later of the date of [...***...].

4.3  

The party responsible for implementing the endorsed [...***...] Developments shall provide complete and comprehensive progress and financial reports on the endorsed [...***...] Development at the quarterly development meetings.

4.4  

The parties will agree the financial costs associated with any endorsed [...***...] Development Plan at the quarterly meetings. Where the parties have agreed [...***...] of a [...***...] Development Plan the party undertaking such Plan shall [...***...] . A [...***...] shall be agreed at the aforementioned quarterly development meetings.

4.5  

If both parties agree to a [...***...] Development Plan proposed by one party, they shall [...***...] of that [...***...] Development Plan. In such cases where the costs have been [...***...] , the ownership of the Data specifically associated with that [...***...] Development and any Intellectual Property arising therefrom shall be owned [...***...] and the parties will continue to [...***...] the Net Sales Revenue from sales of any Product resulting therefrom.

4.6  

Should Prestwick, having initially endorsed a [...***...] Development Plan elect not to pursue its obligations with respect to such Plan all rights pertaining to the specific [...***...] Development shall revert to Cambridge. Cambridge may thereafter exploit the specific [...***...] Development within the Territory as Cambridge sees fit and the specific [...***...] Development and the Product resulting therefrom shall no longer be subject to the exclusive license set forth in clause 2 hereof.

4.7  

Should Cambridge, having initially endorsed a [...***...] Development Plan elect not to pursue its obligations with respect to such Plan, all work on such Plan shall cease and Cambridge shall [...***...] . For the sake of clarity all Intellectual Property and Data shall revert to the party that brought the technology subject to that Intellectual Property and Data to the [...***...] Development Plan and any new Intellectual Property and Data generated by the [...***...] Development Plan shall be owned by Cambridge. In such circumstances Cambridge shall not be entitled to commercialise that new Intellectual Property and Data generated by the [...***...] Development Plan in the Territory for the duration of this Agreement.

4.8  

If one party initially wishes to pursue a [...***...] Development Plan and the other party does not wish to [...***...] of that [...***...] Development Plan , whether this is the result [...***...] or otherwise, the party wishing to pursue the [...***...] Development Plan may do so but shall, save as set forth below, [...***...] . If the party that did not originally wish to [...***...] of such Development Plan later decides that it would like to, it shall [...***...] in pursuing that [...***...] Development Plan and shall thereafter [...***...] of completing that [...***...] Development.

4.9  

If Prestwick [...***...] then [...***...] shall be [...***...] and the provisions of clauses 11.1 and 11.2 shall apply mutatis mutandis. If Prestwick [...***...] then any Data generated by Prestwick and any Intellectual Property pertaining thereto shall be owned by Prestwick in so far as it relates to the specific [...***...] Development Plan. Similarly if Cambridge [...***...] then [...***...] and, the provisions of clauses 11.1 and 11.2 shall apply mutatis mutandis and any Data generated by Cambridge in such a circumstance and any Intellectual Property pertaining thereto shall in so far as it relates to the specific [...***...] Development will be owned by Cambridge. For the sake of clarity any Data and Intellectual Property arising from [...***...] shall be owned by Cambridge [...***...] .

4.10  

Prestwick shall have an exclusive royalty free license to use Cambridge’s Intellectual Property and Data arising from any [...***...] Development Plan, but specifically excluding any Intellectual Property arising from [...***...] , in the Territory on the terms and subject to the restrictions as set forth in clause 2 above.

4.11  

Cambridge shall have an exclusive, royalty free license to use any Intellectual Property and Data arising from any [...***...] Development that, in accordance with the preceding provisions, shall be owned by Prestwick, anywhere outside the Territory.

5  

[...***...] DEVELOPMENTS GENERALLY

5.1  

Prestwick shall obtain the prior written approval of Cambridge (which approval shall not be unreasonably withheld or delayed) to any experiment or protocol for any clinical or pre-clinical trial it is to undertake as part of any [...***...] Development and any submissions to the FDA or an Ethics Committee regarding such studies and any correspondence it intends to send to the FDA or an Ethics Committee regarding any such studies. Prestwick shall provide Cambridge with as much notice as possible of any meetings it may have with the FDA or an Ethics Committee in respect of any studies undertaken as part of any [...***...] Development Plans together with information on what it intends to say at those meetings. Cambridge shall have the option, at its own cost, to attend any such meetings.

5.2  

Prestwick shall obtain the prior written approval of Cambridge before appointing any third party to assist it with any study undertaken as part of any [...***...] Development Plan including but not limited to any CRO, investigator, IVRS service provider, laboratory, statistical analyst, data management provider or medical writer. Prestwick shall provide Cambridge with such details as Cambridge may reasonably require regarding any such third party and a copy of the written agreement Prestwick intends to enter into with that third party. The consent of

5.3  

Any party undertaking a [...***...] Development shall comply with the protocol, GCP and all requirements of the FDA in undertaking any study as part of the ...***...] Development.

5.4  

Cambridge shall provide to Prestwick, [...***...], such quantities of the Product needed for any [...***...] Development Plan, the Active Substance, any analytical reference standard materials and placebo as Prestwick reasonably requires in order to undertake and complete any study being undertaken as part of a [...***...] Development. For the sake of clarity Cambridge is not required to provide to Prestwick clinical trials packs and Prestwick shall be responsible, [...***...], for putting together such packs.

5.5  

Prestwick shall keep an accurate inventory of all Product, Active Substance, analytical reference standard materials and placebo supplied to it to be used for the purpose of studies to be carried out pursuant to the [...***...] Development Plans and shall, on completion of all such studies:

5.5.1  

either [...***...] for all such unused Product, Active Substance or reference standard materials and placebo under [...***...]; or

5.5.2  

[...***...] any portions thereof.

5.6  

Cambridge may, on reasonable notice and during normal working hours and not more than [...***...] , inspect all records of Prestwick pertaining to any study being undertaken by Prestwick under any [...***...] Development Plans.

5.7  

Prestwick shall provide Cambridge with as much notice as is practical in the circumstances of any inspection by the FDA of Prestwick, or any third party appointed to assist Prestwick, in relation to a study under any [...***...] Development Plans and shall permit Cambridge to attend such inspection should Cambridge so desire.

5.8  

In the event that any of the work undertaken under any of the [...***...] Development Plans results in any Product having a different Specification for manufacture and sale inside the Territory from that which applies for outside the Territory, the parties will, in good faith, review the terms pertaining to the commercial supply of the Product resulting from the [...***...] Development plan in question and Prestwick shall provide to Cambridge,

5.9  

Where any Intellectual Property and/or Data is acquired by Prestwick as a result of any [...***...] Development [...***...] , the following conditions shall apply:

5.9.1  

Where Cambridge has contributed no expertise or financial input to the generation of such Intellectual Property and/or Data, Prestwick:

5.9.1.1  

shall use the Intellectual Property and/or Data, to the extent it has any application to the Product, for the purpose of commercial exploitation of the Product in the Territory;

5.9.1.2  

shall not use such Intellectual Property and/or Data, and shall not assign, license or sell any rights under such Intellectual Property to any third party for use, with any products which might reasonably be seen as competitive with the Product;

5.9.1.3  

subject to clauses 5.9.1.1 and 5.9.1.2, shall otherwise be free to exploit such Intellectual Property and/or Data.

5.9.2  

Where Cambridge has contributed expertise or financial input to the generation of such Intellectual Property and/or Data, Prestwick:

5.9.2.1  

shall use the Intellectual Property and/or Data, to the extent it has any application to the Product, for the purpose of commercial exploitation of the Product in the Territory;

5.9.2.2  

shall not use such Intellectual Property and/or Data, and shall not assign, license or sell any rights under such Intellectual Property and/or Data to any third party for use, with any products which might reasonably be seen as competitive with the Product;

5.9.2.3  

subject to clauses 5.9.2.1 and 5.9.2.2, may otherwise exploit such Intellectual Property and/or Data but only upon prior agreement with Cambridge as to reasonable commercial terms therefor.

5.10  

On termination or expiration of this agreement Prestwick shall sell and assign to Cambridge all of its Intellectual Property (other than any such Intellectual Property which has no possible application to the Product) and Data arising from any [...***...] Development and Cambridge

5.11  

Save as provided herein, the parties agree to share equally the burden of any third party claims, actions, damages, liabilities or losses arising from any clinical trial undertaken pursuant to any [...***...] Development Plans or [...***...] Development Plans and to which Cambridge provided authority.

5.12  

Prestwick indemnifies and shall keep Cambridge indemnified against legal liability to third parties in respect of any claims, actions, damages, liabilities or losses arising from any clinical trial undertaken pursuant to any [...***...] Development to the extent that such arise from the negligence or wilful malfeasance of Prestwick or the failure of Prestwick or any third party appointed to assist Prestwick with any study, to comply with the protocol for the study, or any requirement of GCP or the FDA in relation to such study.

5.13  

Cambridge indemnifies and shall keep Prestwick indemnified against legal liability to third parties in respect of any claims, actions, damages, liabilities or losses arising from any clinical trial undertaken pursuant to any [...***...] Development Plans to the extent that such arise from the negligence or wilful malfeasance of Cambridge resulting in any Product or Active Substance supplied for any clinical trial not complying with the specifications for such.

5.14  

Prestwick indemnifies and shall keep Cambridge indemnified against legal liability to third parties in respect of any claims, actions, damages, liabilities or losses arising from any clinical trial undertaken in relation to the Product that has not been approved by Cambridge or is not in accordance with any [...***...] Development Plans.

6  

[...***...] DEVELOPMENTS

6.1  

Cambridge [...***...] an [...***...] for [...***...] and shall undertake, [...***...], that [...***...] as it sees fit. Cambridge will keep Prestwick appraised of its activities with the [...***...] at the scheduled quarterly development meetings. Prestwick shall not [...***...].

6.2  

For the sake of clarity as related to [...***...], Prestwick shall [...***...] . In the event that Prestwick [...***...] on essentially similar terms as agreed for the Product. Should Prestwick [...***...] then Cambridge shall have the right [...***...] . For the sake of clarity any [...***...] resulting from [...***...] is not a Product or a [...***...] Development the rights to which are subject to the license set forth in clause 2 hereof. The right of Prestwick to [...***...] .

7  

ORPHAN DRUG DESIGNATIONS AND APPLICATIONS

7.1  

Cambridge shall supply to Prestwick such information pertaining to the Product as is required by Prestwick to maintain or obtain orphan drug designations relating to the Product.

7.2  

Cambridge shall, at Prestwick’s cost, transfer to Prestwick ownership of the Existing Orphan Drug Designations. Prestwick shall be responsible for maintaining and enforcing the Existing Orphan Drug Designations at its own cost.

7.3  

If any of the developments of the Product appear that they may qualify for Orphan Drug status the parties shall discuss and agree whether such a status should be sought. The costs of obtaining such status shall, unless otherwise agreed, [...***...] .

7.4  

Prestwick acknowledges that the beneficial interest in any Orphan Drug Designation for the Product shall be and remain the property of Cambridge’s licensor, [...***...] . Upon termination or expiration of this Agreement, Prestwick shall, [...***...], do all things necessary to either:

7.4.1  

transfer any Orphan Drug Designations for the Product in the Territory to Cambridge or Cambridge’s nominee, and Prestwick hereby irrevocably appoints Cambridge as its attorney to sign all such documents and do all such things as are necessary to effect such transfer, should Prestwick fail to do so within the said [...***...] ; or

7.4.2  

should such transfer not be permissible by applicable law or regulation, allow Cambridge or Cambridge’s nominee unfettered reference to and use of the Orphan Drug Designations. In such circumstances, Prestwick shall, at Cambridge’s cost, keep such Orphan Drug Designations current and shall not allow the Orphan Drug Designations to lapse nor act in any way which would render the Orphan Drug Designations liable to be revoked.

8  

THE PRODUCT

8.1  

All Product supplied by Cambridge to Prestwick shall comply with the relevant Specification set forth in the NDA. In the event of any [...***...] Development giving rise to any new Product, this clause shall be read mutatis mutandis.

8.2  

All Product supplied by Cambridge to Prestwick shall have been manufactured in accordance with GMP and other relevant manufacturing standards in the Territory, the provisions of the NDA and at an FDA approved site.

8.3  

Prestwick shall be entitled, if its evidenced requirements for the supply of the Product for the Territory dictate, to request that Cambridge secure a second site of manufacturing to meet the supply requirements of the Territory. The selection of manufacturer will be the sole responsibility of Cambridge provided however that Prestwick shall participate in the decision and be entitled to comment on the suitability of the manufacturer. Cambridge will ensure that the selected manufacturer appointed is able to provide sufficient quantities of the Product to meet the requirements of Prestwick and that all Product supplied to Prestwick is manufactured in accordance with GMP and other relevant manufacturing standards in the Territory the provisions of NDA and at an FDA approved site.

8.4  

If, in the reasonable opinion of Cambridge, it at any time ceases to be commercially practicable to continue to manufacture and supply the Product, Cambridge shall have the right to discontinue the manufacture of the Product and cease supply of the Product to Prestwick provided that it shall give Prestwick as much notice as is, in the circumstances, reasonable and, unless withdrawal is required on safety grounds, not less that six (6) months notice. In such circumstances Cambridge will use reasonable endeavours to assign to Prestwick, should Prestwick so desire, its rights to the Product for the Territory though Prestwick acknowledges that such assignment shall be subject to the consent of [...***...] and is thus ultimately beyond the control of Cambridge.

8.5  

The parties shall discuss periodically during the term of this Agreement, but not less that once in each calendar quarter, supply issues including, specifically [...***...] and [...***...] for Product and Active Substance, (ii) [...***...] of both parties of both Product and Active Substance, (iii) [...***...] concerning the Product, Active Substance or any component of either,(iv) [...***...] or [...***...] , and (v) [...***...] strategies and planning.

9  

COMMERCIALIZATION OF THE PRODUCT

9.1  

Prestwick will sell the Product in the Territory upon the terms set out below.

9.2  

Prestwick shall obtain all Product, Active Substance and analytical reference standard materials directly and solely from Cambridge and Cambridge shall supply such Product in the Territory exclusively to Prestwick.

9.3  

Prestwick shall not seek customers or establish or maintain any branch or distribution depot for the Product outside the Territory provided however that Prestwick may establish and maintain an intermediate storage depot outside the Territory provided such is used solely for the purpose of holding stocks of the Product pending shipment to purchasers in the Territory.

9.4  

Prestwick shall not supply the Product to any customer in any country that is:

9.4.1  

outside the Territory;

9.4.2  

in the Territory if to the reasonable or actual knowledge of Prestwick that customer intends to supply the Product outside the Territory.

9.5  

Prestwick shall specify upon any supply that Cambridge’s rights in the Trade Mark and other Intellectual Property are not exhausted with regard to any re-supply of the Product.

9.6  

Prestwick shall forward to Cambridge, within [...***...] , all enquiries received by Prestwick regarding the Product from persons outside the Territory. Similarly Cambridge shall forward to Prestwick, within two [...***...], all enquiries received by Cambridge regarding the Product from persons in the Territory.

9.7  

Prestwick shall not hold itself out as Cambridge’s agent for sales of the Product or otherwise as being entitled to bind Cambridge in any way.

9.8  

Prestwick shall comply with all laws and regulations in the Territory, all requirements of the FDA in the Territory and, when distributing the Product, all restrictions set forth in any NDA. Without in any way limiting the generality of the foregoing, under no circumstance shall Prestwick, [...***...] .

9.9  

The parties shall, as soon as is practical after the date of this Agreement determine whether [...***...] Prestwick to [...***...] or the parties agree that Prestwick [...***...] , Prestwick and Cambridge shall undertake such actions as are necessary and advisable to [...***...] to Prestwick and Prestwick shall do so and shall comply with all laws and regulations in the Territory and all requirements of the FDA pertaining to [...***...] . In such circumstances Cambridge shall be [...***...] . If the parties decide that Cambridge shall [...***...] then Cambridge shall comply with all laws and regulations in the Territory and all requirements of the FDA pertaining to [...***...] and shall be entitled [...***...] .

9.10  

The initial schedule, of Minimum Sales Quantities will be set forth in schedule 7 to this Agreement following determination of such pursuant to clause 9.11. The parties anticipate that the Minimum Sales Quantities will be revised on an annual basis and subject to the mutual

agreement of the parties. In the event that the parties are unable to agree upon any revision of the Minimum Sales Quantities the parties shall follow the procedure set forth in clause 22.

9.11  

[...***...] the parties shall agree upon the Marketing Plan, the Minimum Sales Quantities and the Minimum Marketing Activities for the Territory. The Marketing Plan, the Minimum Marketing Activities, the Minimum Order Quantities and the Minimum Sales Quantities shall cover activities to be undertaken by Prestwick in the marketing of the Product in the Territory after the grant of the initial NDA. The parties acknowledge that, with the developments of the Product contemplated by this Agreement, there will be a number of Marketing Plans. At the same time the parties shall appoint two members each to the Joint Marketing Committee. The Joint Marketing Committee shall be responsible for day to day consultation regarding the Marketing Plan, any reporting that has to be undertaken regarding any Marketing Plan, the review and evaluation of all Marketing Plans, forecasts, Minimum Order Quantities, Minimum Sales Quantities and the Minimum Marketing Activities. The Joint Marketing Committee shall review all Marketing Plans, forecasts and Minimum Order Quantities quarterly and make such changes as are agreed necessary.

9.12  

Prestwick shall at all times that it is not required to the contrary by any law, regulation, court or governmental agency, market the Product in accordance with the Marketing Plan in all material respect