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Royalty Bearing Licence Agreement And Supply Agreement Re Erwinia-derived Asparaginase

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JAZZ PHARMACEUTICALS PLC | JOINT MANAGEMENT | Michael Hacker, Board | OPI SA

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Title: ROYALTY BEARING LICENCE AGREEMENT AND SUPPLY AGREEMENT RE ERWINIA-DERIVED ASPARAGINASE
Date: 8/9/2012
Industry: Biotechnology and Drugs     Sector: Healthcare

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Exhibit 10.11

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

(1) THE HEALTH PROTECTION AGENCY

(2) OPI S.A.

 

 

ROYALTY BEARING LICENCE AGREEMENT

AND SUPPLY AGREEMENT RE ERWINIA-DERIVED

ASPARAGINASE


CONTENTS

 

Clause

 

 

  

Page

 

1.

 

DEFINITIONS AND INTERPRETATION

  

 

3

  

2.

 

LICENCE

  

 

5

  

3.

 

SUPPLY OF PRODUCT

  

 

6

  

4.

 

ROYALTIES

  

 

8

  

5.

 

UNDERTAKINGS

  

 

9

  

6.

 

JOINT MANAGEMENT TEAM

  

 

13

  

7.

 

CONFIDENTIALITY

  

 

14

  

8.

 

INTELLECTUAL PROPERTY INFRINGEMENT

  

 

16

  

9.

 

PRODUCT LIABILITY CLAIMS

  

 

18

  

10.

 

HPA ASSISTANCE

  

 

19

  

11.

 

PAYMENT

  

 

20

  

12.

 

ASSIGNMENT

  

 

20

  

13.

 

DURATION AND TERMINATION

  

 

20

  

14.

 

SUPERVENING LAW

  

 

23

  

15.

 

DISPUTE RESOLUTION, LANGUAGE, LAW AND JURISDICTION

  

 

23

  

16.

 

MISCELLANEOUS

  

 

24

  

SCHEDULE 1 PRODUCT SPECIFICATION

  

 

26

  

SCHEDULE 2 [ * ] QUANTITY AND OTHER TERMS OF SUPPLY

  

 

27

  

SCHEDULE 3 HPA’S CHARGES TO OPi FOR ASSISTANCE REQUESTED BY OPi

  

 

29

  

SCHEDULE 4 [ * ]

  

 

30

  

SCHEDULE 5 THE TECHNICAL AGREEMENT #

  

 

31

  

SCHEDULE 6 THE TRADE MARKS

  

 

32

  

  

# REMOVED BY AMENDMENT

  

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


THIS AGREEMENT is made this 22 day of July, 2005

BETWEEN:

 

(1)

THE HEALTH PROTECTION AGENCY of Porton Down, Salisbury, Wiltshire SP4 0JG (which expression shall include its successors in title) (“HPA”); and

 

(2)

OPi S.A. whose registered office is at Les Jardins d’Eole, 3 allée des Séquoias, 69760, Limonest (“OPi”).

WHEREAS

 

(1)

HPA wishes to license OPi to market, sell and distribute the Product (as hereinafter defined) in the Territory, on the terms and conditions hereinafter appearing.

 

(2)

HPA wishes to supply and OPi wishes to purchase the Product on the terms and conditions hereinafter appearing.

NOW IT IS HEREBY AGREED as follows:-

 

1.

DEFINITIONS AND INTERPRETATION

 

1.1

In this Agreement unless the context otherwise requires:-

Batch ” means the quantity represented by the output of Product subject to a single freeze-drying operation.

Effective Date ” means the date of this Agreement.

Dossier ” means all medical, scientific and other information or data required to be provided to a Regulatory Agency in order to vary, obtain, maintain or renew a relevant Marketing Authorisation.

GMP ” shall have the meaning set forth in Schedule 5 (the Technical Agreement)

OPi Group Company ” means a member of the group consisting of OPi, any holding company of OPi and any subsidiary of OPi or any subsidiary of any holding Company of OPi (the expressions “holding Company” and “subsidiary” bearing the same meanings as they respectively bear in Companies Act 1985).

Improvements ” means any and all improvement, developments, alterations or modifications to the Know How and or the Intellectual Property made or developed by OPi or HPA.

Intellectual Property ” means all registered and unregistered trade marks, patents, patent applications, registered and unregistered designs, design rights, copyright works or other intellectual property rights from time to time owned by HPA in relation to the Product.

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


“[ * ]” means the holder as of the date of this Agreement of the Marketing Authorisations throughout the Territory (other than the United Kingdom).

Know-how ” means all of the drawings, designs, specifications, processes, knowledge, technical information and expertise from time to time owned by HPA relating to the Manufacture of the Product including any information relating to the Organism.

Manufacture ” includes Product manufacture, production, testing, analysis, quality control, filling and finishing Vials, storage and packing as specified in the Technical Agreement and “Manufacturing” shall be construed accordingly.

Marketing Authorisation ” means a licence or approval from the appropriate Regulatory Agency to market, sell or distribute the Product in a particular country of the Territory including in the case of the United States of America the treatment IND for the Product.

Minimum Calculation Year ” means each period of 12 consecutive calendar months ending on 31st March during the currency of this Agreement except for the first Minimum Calculation Year which shall be the period from the Effective Date to 31st March 2007.

MHRA ” means the Regulatory Agency in the United Kingdom.

“[ * ]” means the [ * ] specified in [ * ].

Net Sales ” means the aggregate amount of the income received by OPi in respect of the sale of the Product whether before or after the termination of this Agreement after making reasonable deductions therefrom for commissions, returns, credit notes and the cost of any transport insurance, packing, freight, taxes, duties, rebates and trade discounts expressly included in any invoice price provided that in any case where the Product is (a) directly or indirectly sold by OPi to any member of the OPi Group or (b) is sold other than on arm’s length terms then the Net Sales value of any Product so sold shall be [ * ] and [ * ]. Where Product is used for research and/or clinical trials purposes or is distributed [ * ] by way of samples or charitable donations then such Product shall not be deemed to have been sold by OPi for the purpose of calculating the Net Sales of this Agreement.

OPi Know How ” means all of the drawings, designs, specifications, processes, knowledge, technical information, results of clinical trials, knowledge of the customer and distributor base for the Product anywhere in the Territory, Product sales information, marketing and market intelligence and OPi expertise as from time to time owned or developed by OPi in addition including any Improvements.

Organism ” means the organism defined in Schedule 1.

Product ” means the product defined in Schedule 1.

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Purpose ” means the treatment of neoplastic conditions where depletion of asparagine might be expected to have a useful effect, including but not limited to Acute Lymphoblastic Leukaemia (ALL), Acute Myeloid Leukaemia (AML) and Non-Hodgkin’s Lymphoma.

Quarter ” means each period of three (3) months ending on the last days of March, June, September and December.

Regulatory Agency ” means the appropriate government or regulatory body or agency in each country of the Territory empowered to grant Marketing Authorisations.

Subsidiary ” and “ Holding Company ” shall have the meanings ascribed thereto by the Companies Act 1989.

Specification ” means the Manufacturing and technical specification for the Product and its packaging vials (including information on testing and storage) as set out in the Technical Agreement.

Technical Agreement ” means the agreement to be entered into between the parties in the terms agreed and contained in Schedule 5.

Territory ” means anywhere in the world.

Trade Mark ” means the trade mark Erwinase as registered or applied for registration in the Territory details of which are set out in Schedule 6.

United Kingdom ” means the United Kingdom of Great Britain and Northern Ireland.

Vial ” means a container of the Product as specified in the Technical Agreement.

 

1.2

References to the singular shall include the plural and vice versa.

 

1.3

References to Clauses and Schedules are to clauses of and schedules to this Agreement. The headings to the Clauses in this Agreement are for convenience only and have no legal effect.

 

2.

LICENCE

 

2.1

HPA hereby grants to OPi upon the terms and conditions hereinafter appearing an exclusive licence to market, sell or distribute the Product in the Territory solely for the Purpose and to use the Trademark solely for the Purpose and a non exclusive licence to use the Intellectual Property and the Know How to the extent reasonably required by OPi in accordance with the proper performance of this Agreement and in order to carry out further research and development in relation to the Product for the Purpose.

 

2.2

Subject to prior written notification of HPA OPi may appoint such sub-distributors against whom HPA cannot raise any reasonable objection to market, sell or distribute the Product in the Territory subject to the restrictions imposed by this Agreement but

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

otherwise on such terms as OPi in its sole discretion shall determine provided however, that the rights of any sub-distributor in relation to the Product shall terminate at the same time as this agreement.

 

2.3

OPi shall ensure that any sub-distributor performs its obligations under any distribution agreement granted hereunder.

 

2.4

OPi shall indemnify HPA against all losses, damages, expenses, and costs, which may be incurred by HPA as a result of any third party claims arising directly from a sub-distributor’s failure to perform its obligations under any such distribution agreement. Subject to the provisions of Clause 9.4, 9.5 and 9.6, HPA shall indemnify OPi against all losses, damages, expenses, and costs, which may be incurred by OPi as a result of any third party claims arising directly from OPi’s failure to supply Product to its sub-distributor or perform its obligations under any such distribution agreement as a result of HPA’s failure to provide Product to OPi in accordance with the terms of this Agreement.

 

2.5

OPi shall not save as permitted in respect of the rights for OPi to use the Trademark pursuant to Clause 2.1 use the name or any trademark(s) of the HPA or the names of any of its employees in any advertising or sales promotional material or in any publication without prior written permission of HPA; provided, however, that OPi may use the name of HPA in filings for Marketing Authorisations and other regulatory filings including packaging elements and as required by any applicable law.

 

3.

SUPPLY OF PRODUCT

 

3.1

Over the duration of the Agreement (and its extensions, if applicable), HPA shall:

 

 

3.1.1

Manufacture the Product;

 

 

3.1.2

Maintain the Manufacturing site held in Porton Down or (if such Manufacturing site is to be closed down) HPA shall maintain such other relocated Manufacturing site as HPA may reasonably determine at HPA’s cost. In the event that any such closure and relocation is proposed by HPA, HPA will consult with OPi in advance to ensure that OPi’s views on the impact and significance of the closure and on the suitability of HPA’s proposals for relocation of the Manufacturing site are taken into consideration by HPA in good faith; or;

 

 

3.1.3

Subject to the quality of Product at all times being compliant with the provisions of this Agreement, HPA may sub-contract the Manufacture of all or part of the Product to third parties, after consultation with OPi under clause 6.7 and subject to the prior written approval of any Regulatory Agency. HPA shall ensure that any sub-contractor performs its obligations under any sub-contract and notwithstanding any such sub-contracting HPA shall remain responsible for Manufacture and the performance of this Agreement.

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


3.2

HPA shall supply the Product to OPi:

 

 

3.2.1

at the price per Vial specified in Schedule 2 which shall be revised:

(a) [ * ] at the [ * ] by [ * ] of the [ * ] in the [ * ] by the [ * ];

and

(b) [ * ] to take into account [ * ] in the [ * ] of the [ * ] and [ * ] as a result of [ * ] in the [ * ]. HPA acknowledges and agrees that it will co-operate in good faith with OPi [ * ] to [ * ] which [ * ] shall be [ * ]

 

 

3.2.2

on such other terms and conditions as are set out in Schedule 2.

The standard terms and conditions of business of neither party shall have any effect in respect of the supply or purchase of Product.

 

3.3

OPi shall order from HPA [ * ] the Product (as specified in Schedule 2) and OPi shall pay for the actual quantity of Product complying with the terms of this Agreement and supplied by HPA. HPA shall ensure that it supplies [ * ] the Product. It is acknowledged by the Parties that any delay in transferring the Marketing Authorisations of the Product could impact negatively the Sales of the Product expected by OPi.Both Parties thus undertake to use all reasonable endeavours to timeously transfer the Marketing Authorisations to OPi.

 

3.4

[ * ] following the Effective Date OPi shall order [ * ] the Product (the “Initial Order”). HPA shall supply such quantity of Product [ * ] following receipt of the Initial Order and OPi shall purchase the Initial Order in accordance with the terms of this Agreement.

 

3.5

OPi shall maintain sufficient levels of the Product in stock at all times throughout the term of this Agreement in order to meet the following [ * ] sales demand based on the forecast provided by OPi pursuant to paragraph 3.1 of Schedule 2. HPA shall maintain such levels of the Organism and other ingredients, excipients and packaging required and set aside appropriate Manufacturing and other facilities necessary to Manufacture the Product at all times throughout the term of this Agreement as may be reasonably expected to be necessary in order to meet the forecasts and orders [ * ] provided by OPi from time to time pursuant to this Agreement. The forecasts for the [ * ] shall be binding on both parties as specified in Clause 3.1 of Schedule 2.

 

3.6

If at any time HPA and OPi shall agree to change or add to the Specification or definitions in Schedule 1 they shall be amended accordingly to reflect such changes together if necessary with the price per Vial provided for in Schedule 2.

 

3.7

HPA shall in good faith make available to OPi all information reasonably required to enable OPi to verify the amount of [ * ] or [ * ] under [ * ].

 

3.8

The parties shall enter into and perform their respective obligations as set out in the Technical Agreement, the form of which is specified in Schedule 5. To the extent that there is any conflict between any of the provisions of the Technical Agreement and the other terms of this Agreement then the other terms of this Agreement shall prevail.

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


4.

ROYALTIES

 

4.1

In consideration of the assistance and services hereby agreed to be rendered and of the licence hereby granted, OPi shall both during the term of this Agreement in respect of all the Product sold by OPi and after the termination of this Agreement in respect of any stocks of the Product held by OPi at the date of termination and sold on or after such date by OPi pay to HPA in addition to any other sums payable hereunder a royalty equal to [ * ] per cent of the Net Sales for sales up [ * ], [ * ] per cent for sales between [ * ] and [ * ], [ * ] per cent for sales between [ * ] and [ * ] and [ * ] per cent for sales over [ * ] in anyone Minimum Calculation Year. To the extent that OPi is required by applicable law to deduct any amounts from such royalty payable by way of withholding or other tax, it shall make such deduction, pay the appropriate amount of tax deducted to the appropriate taxation authorities and provide HPA with an appropriate certificate of tax deduction.

 

4.2

Within [ * ] after the end of each Quarter OPi shall furnish to HPA a written statement setting out Net Sales of Product in such Quarter and the amount that will be payable at the end of the relevant Minimum Calculation Year by OPi by way of royalties in respect thereof in such Quarter. The statement for the last Quarter in any Minimum Calculation Year shall include details of all amounts payable by OPi by way of royalties in respect of that Minimum Calculation Year. Following receipt thereof, HPA shall provide to OPi an invoice in respect of such royalties. Within [ * ] of the date of such invoice, OPi will make payment (less any income tax OPi is required by statute to deduct) in favour of HPA for the amount due to HPA in respect of the preceding Minimum Calculation Year.

 

4.3

Information as to the Net Sales and the quantities of Product sold or otherwise distributed or provided by OPi, the identity of the countries within the Territory to which such sales or other distributions or provisions have been made and the quantity and Net Sales in respect of such sales or other distributions or provisions of Product made within each such country and such other information as may be requested by HPA shall be furnished to HPA by OPi by [ * ] each year in respect of the preceding Minimum Calculation Year.

 

4.4

A sale of the Product shall be deemed to have been made on the earliest of (i) [ * ] following the date shown as the date of the invoice relating to such sale, or (ii) [ * ] following the date of delivery of the Product, or (iii) the date of receipt of payment in respect of such Product. Any invoice made or income or sums received in whole or in part in foreign currency shall be converted to sterling for the purpose of calculating the royalties by reference to the average of the middle market exchange rate of National Westminster Bank plc during the relevant Quarter.

 

4.5

OPi shall at all times during the continuance of this Agreement keep at its usual place of business all proper books of account and other records of sales or other distributions or provisions of the Product by OPi (including details of the countries within the Territory to which such sales or other distributions or provisions have been made) and royalties due on Net Sales to HPA and shall make true and complete entries therein at the earliest

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

practical opportunity of all the particulars necessary or convenient to substantiate the information required by the written statements hereinbefore mentioned and HPA and/or its authorised representative shall have reasonable access following prior written notice to OPi’s books of account and other records in order to determine the accuracy of the said statements and/or to determine or ascertain whether the amounts payable to HPA pursuant to this Agreement have been paid to it.

 

4.6

If [ * ] the [ * ] under [ * ] are [ * ] the [ * ] as set out in [ * ], OPi may elect to [ * ] which [ * ] under [ * ] is [ * ] the [ * ] specified in [ * ], in which event such [ * ] with the [ * ] will be [ * ] the [ * ] in accordance with the provisions of [ * ]. Any [ * ] by OPi in respect of any [ * ] shall be [ * ] so as to be taken into account when [ * ] in the [ * ].The [ * ] can be [ * ] the [ * ] but not [ * ].

 

 

4.6.1

If during the term of this Agreement OPi shall fail (a) to make payment in accordance with the provisions of clause 4.2 of this Agreement following the end of each Minimum Calculation Year [ * ], or (b) to [ * ] as provided in [ * ] in any Minimum Calculation Year, HPA may at its option:

 

 

(a)

as its sole and exclusive remedy [ * ] on [ * ] written notice to OPi (provided always that in the event of [ * ] OPi accepts that [ * ] under the terms of this Agreement to [ * ] which is in compliance with the provisions of this Agreement [ * ]); or

 

 

(b)

as its sole and exclusive remedy [ * ] on [ * ] written notice to OPi;

 

 

4.6.2

It is acknowledged by HPA that OPi sales forecasts are based on an average selling price of [ * ]. OPi undertakes to use its best endeavours to reach such Average Selling Price, and HPA will, at OPi’s cost, provide OPi with all reasonable assistance in its negotiations with the Pricing Authorities.

 

5.

UNDERTAKINGS

 

5.1

Subject to HPA’s compliance with its obligations under Clauses 5.2 and 5.8, OPi hereby undertakes with HPA that:

 

 

5.1.1

OPi will at its own cost:

 

 

(a)

transfer as soon as reasonably practicable following the Effective Date into its own name such of the Marketing Authorisations in such countries of the Territory (except the United Kingdom) as OPi may specify;

 

 

(b)

vary, obtain, maintain or renew (as appropriate) the Marketing Authorisations (except for that granted for the United Kingdom) as OPi may require from time to time during the term of this Agreement;

 

 

(c)

as soon as reasonably practicable following the transfers in paragraph (a) above and during the term of this Agreement use its best endeavors to market, sell and distribute the Product (or procure the same by its distributors) in the [ * ] subject always to the limitations imposed by the relevant Marketing Authorisations in such countries and applicable law;

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

(d)

as soon as reasonably practicable following the transfers in paragraph (a) above and during the term of this Agreement use its reasonable endeavors to market, sell and distribute the Product (or procure the same by its distributors) in all such other countries within the Territory subject always to the limitations imposed by the relevant Marketing Authorisations in such countries and applicable law;

In relation to the United States of America it is acknowledged by the parties that the existing Treatment IND may not be transferable or renewable but OPi undertakes to use its best endeavors to ensure appropriate Marketing Authorisation is obtained in OPi’s name for the United States of America to enable the Product to be supplied as widely as possible in the United States of America based on the current Dossier. HPA shall provide all reasonable assistance to OPi in respect of the obtaining of such Treatment IND.

 

 

5.1.2

OPi will supply to HPA from time to time such evidence of OPi’s fulfillment of the undertaking specified in Clause 5.1.1 as may be reasonably requested by HPA;

 

5.2

In respect of the Marketing Authorisations

 

 

5.2.1

HPA hereby Undertakes to provide to OPi free of charge within [ * ] following execution of the Agreement the Dossier which supports the current Marketing Authorisation in the United Kingdom, the various available modules of the Common Technical Document of the Product and any recent correspondence relating to the Product between HPA and the MHRA. HPA hereby undertakes to provide (or procure the provision by [ * ]) timeously to OPi free of charge the Dossiers and all other information or data in HPA’s or [ * ] possession or control as is reasonably required by OPi in order for OPi to transfer into its own name, vary, obtain, maintain or renew (as appropriate) the Marketing Authorisations specified by OPi under Clause 5.1.1. Where any Regulatory Agency requires HPA or [ * ] to complete any documentation HPA undertakes to do (or undertakes to procure that [ * ] does) so as soon as reasonably possible. In relation to the Marketing Authorisation for the United Kingdom, HPA undertakes to maintain and renew the Marketing Authorisation and as soon as reasonably possible to vary the Marketing Authorisation to specify OPi as the distributor for the Product.HPA hereby undertakes to provide (or procure the provision by [ * ]) timeously to OPi free of charge all information relating to the pharmacovigilance of the Product (including but not limited to source document, CIOMS forms and PSUR) as well as appropriate line listing covering the period from the last PSUR to the date of transfer of the last licence in HPA’s or [ * ] possession or control. Subject to the agreement of [ * ], HPA hereby undertakes to ensure (or procure the provision by [ * ]) that the pharmacovigilance database of the Product will be transferred to OPi [ * ] within [ * ] after transfer of all registrations held for the product in the respective territories.

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

5.2.2

HPA warrants that the Common Technical Document, Module 3 reflects the current manufacturing process of the Product.

 

 

5.2.3

HPA agrees that the sale of Product in countries where a Marketing Authorisation exists will be limited until such Marketing Authorisation has been transferred to OPi and that any delay in obtaining the various Marketing Authorisations could impact OPi actual sales compared to its non-binding forecasts.

 

5.3

OPi hereby undertakes to [ * ] and [ * ] pursuant to sub clauses 5.1 and 5.2 above during the term of this Agreement.

 

5.4

OPi hereby undertakes to provide HPA with such forecasts and updates hereto as detailed in Schedule 2, Clause 3.1.

 

5.4

Where, notwithstanding the parties’ respective efforts under this Clause 5 it is or becomes commercially unviable to transfer into OPi’s name or vary, obtain, maintain or renew (as appropriate) any Marketing Authorisations in any particular country in the Territory, the parties shall refer the matter to the Joint Management Team for resolution but neither party shall be deemed to be in breach of this Agreement solely by reason thereof.

 

5.5

OPi shall at its own cost undertake or procure the undertaking of an optimum dosage and dose regimen trial and such other Phase IV clinical trials on such terms as may be agreed between the parties from time to time and in connection therewith HPA will supply to OPi free of charge [ * ] of Product for use by OPi in such clinical trials during the period of [ * ]. The dates and quantities of such supply shall be [ * ] and [ * ] or, as otherwise agreed between the parties from time to time (such agreement not to be unreasonably withheld or delayed). HPA shall also make available to OPi during such [ * ] period a further quantity of [ * ] Product (having a shelf-life remaining of [ * ]) free of charge for clinical trials, subject to the availability of Product in stock held by HPA. Notwithstanding anything contained in this sub clause OPi may elect at any time to carry out any clinical trials at its own cost as it may determine.

 

5.6

OPi and HPA will at frequent intervals and where necessary at meetings of the Joint Management Team discuss Marketing Authorisation matters and Regulatory Agency submissions and approvals in the Territory.

 

5.7

HPA acknowledges that OPi will market, sell and distribute products other than the Products and that nothing contained in Clause 5.1 will prevent OPi from the development, marketing, sale or distribution of such other products.

 

5.8

HPA hereby undertakes with OPi that from the Effective Date and during the term of this Agreement it will at all times:

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

5.8.1

at the written request of OPi apply to obtain and maintain in the name of HPA the registration of such of the Intellectual Property as is reasonably capable of protection by registration in the Territory and is identified in OPi’s written request provided that OPi shall reimburse HPA in respect of all reasonable external or out-of-pocket costs incurred in complying with this obligation. Neither OPi nor HPA hereby make any representation that any such registration shall be granted or if granted shall be valid;

 

 

5.8.2

ensure that the contracts of engagement of its agents, employees, consultants and contractors are consistent with the terms of this Agreement and HPA shall subject to the provisions of Clause 9.4, 9.5 and 9.6 indemnify OPi against all losses, damages, expenses and costs which may be incurred by OPi as a result of any third party claims arising directly from a failure by any of HPA’s agents, employees, consultants or contractors to perform their obligations under any contract of engagement with HPA concerning the Product;

 

 

5.8.3

not waive performance of any obligations of any agent, employee, consultant or contractor of HPA or amend the terms of any contract of engagement with any of them without the prior written consent of OPi if to do so would directly or indirectly prejudice the terms of this Agreement or the performance by any party of its obligations under this Agreement.

 

 

5.8.4

Provide such information as is consistent with the standards of the pharmaceutical industry and as may be reasonably necessary for OPi to negotiate prices under the UK Pharmaceutical Price Regulation Scheme.

 

5.9

OPi shall not waive performance of any obligations of any distributor of OPi or amend the terms of any distribution agreement granted pursuant to Clause 2.1 if to do so would directly or indirectly prejudice the terms of this Agreement or the performance by any party of its obligations under this Agreement.

 

5.10

In the event of a recall of the Product:

 

 

5.10.1

the provisions of the Technical Agreement shall apply; and

 

 

5.10.2

to the extent that HPA is responsible for the recall, whether due to a breach of its obligations in respect of the Manufacture of the Product or otherwise HPA shall subject to the provisions of Clause 9.4, 9.5 and 9.6 indemnify OPi against all losses liabilities and costs and expenses suffered or incurred by OPi or any OPi Group Company or a consequence thereof; and

 

 

5.10.3

the extent that OPi is responsible for the recall, whether due to a breach of its obligations in respect of the sale and distribution of the Product or otherwise OPi shall subject to the provisions of Clause 9.4, 9.5 and 9.6 indemnify HPA against all losses liabilities and costs and expenses suffered or incurred by HPA as a consequence thereof.

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


6.

JOINT MANAGEMENT TEAM

 

6.1

The parties undertake to establish a Joint Management Team to be made up of 4 representatives from each of HPA and OPi, as nominated from time to time in writing. A nominated representative may by notice in writing appoint a deputy to attend a meeting in his place.

 

6.2

The Joint Management Team will meet as frequently as the Joint Management Team shall deem necessary but in any event not less than [ * ] in each Minimum Calculation Year during the term of this Agreement. Meetings can be held at HPA’s offices or such other venue as the Joint Management Team may reasonably determine.

 

6.3

A resolution in writing signed by all the members of the Joint Management Team shall be as valid and effectual as if it had been passed at a meeting of the Joint Management Team duly convened and held. Any such resolution may be sent by electronic communication and may consist of several documents in the like form each signed by one or more members.

 

6.4

Any member (including any deputy) of the Joint Management Team may participate in a meeting by means of a conference telephone, video link or similar communications equipment whereby all persons participating in the meeting can hear each other and participation in such meeting shall be deemed to constitute presence in person at such meeting.

 

6.5

Resolutions required at a meeting of the Joint Management Team shall require unanimity of all the members attending the meeting. No resolutions on matters regarding funding shall be passed unless notice of the proposed resolution has been sent to all members of the Joint Management Team in advance with the agenda for the meeting.

 

6.6

The Joint Management Team shall be responsible for ensuring that accurate minutes are taken at each meeting and for providing copies thereof to each member.

 

6.7

The Joint Management Team shall be the key body for communicating between the parties in relation both to day-to-day and significant matters or events relating to this Agreement. The Parties acknowledge that in relation to the business of the Joint Management Team, the HPA representatives will have primary responsibility for matters relating to Manufacture of the Product and the OPi representatives will have primary responsibility for matters relating to regulatory issues and the sale, marketing and distribution of the Product. The Joint Management Team will be responsible for proposing to the parties, for the final decision by the parties, the Joint Management Team’s written recommendations or requests in relation to:

 

 

6.7.1

any matters that require the agreement of the parties pursuant to the terms of this Agreement;

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

6.7.2

any matters arising which could adversely impact on any Marketing Authorisation, the Manufacture, the timely supply of Product, the timely purchase of Product;

 

 

6.7.3

the cost of Manufacturing the Products and in particular opportunities to achieve efficiencies and reductions in costs;

 

 

6.7.4

marketing strategy for the Products and the Manufacturing strategy;

 

 

6.7.5

possible work in support of securing Market Authorisations for the Product;

 

 

6.7.6

any unexpected or unplanned events which could impact on the obligations or rights of the parties under this Agreement; and

 

 

6.7.7

such other matters as the members of the Joint Management Team may reasonably consider appropriate.

 

6.8

If the Joint Management Team is unable to reach unanimity in relation to any matter any member thereof may notify the Chief Executive Officer of OPi and the Director of the Centre for Emergency Preparedness and Response of HPA.

 

6.9

Nothing in this Clause shall prevent or restrict the parties from reaching any agreement in relation to any matter which is different from that recommended by the Joint Management Team, but the parties undertake to take the views of the Joint Management Team into account when considering any matter relating to this Agreement.

 

7.

CONFIDENTIALITY

 

7.1

OPi acknowledges that HPA is the owner and shall retain ownership of the Organism, the Know-how and the Intellectual Property and that neither OPi nor any distributor of OPi shall acquire any right, title or interest therein save for the licence granted hereunder. In the event that OPi [ * ] or [ * ] or [ * ], HPA shall be entitled to [ * ] on notice in writing to OPi. HPA acknowledges that OPi is the owner and shall retain ownership of the OPi Know How.

 

7.2

OPi acknowledges that the Know-how with which it is furnished pursuant to this Agreement (in particular pursuant to HPA’s obligation under Clause 10) is furnished in circumstances imparting an obligation of confidence and agrees to keep the Know-how secret and confidential and to respect HPA’s proprietary rights therein and not at any time during the continuance of this Agreement for any reason whatsoever to disclose or permit to be disclosed the Know-how to any third party save as provided by Clause 7.3 without HPA’s prior written consent provided that the Know-how may be disclosed insofar as such disclosure is necessary to any distributor or prospective distributor under any distribution agreement if that distributor or prospective distributor has undertaken confidentiality obligations the same as those set out in Clause 7, and provided further that OPi may disclose the Know-how on a confidential basis to any relevant Regulatory Agency.

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


7.3

OPi shall take all reasonable steps to ensure that each of its agents, employees, consultants and contractors or prospective contractors having access to the Know-how is made aware that the same is secret and confidential and shall obtain from each of them enforceable written undertakings that they shall not during the continuance of this Agreement make any disclosure thereof.

 

7.4

HPA shall take all reasonable steps to ensure it does not during the continuance of this Agreement disclose or transfer to third parties any part of the Know-how or the OPi Know How otherwise than as may be disclosed or transferred in accordance with the provisions of this Agreement and shall obtain from its agents, employees, consultants and contractors having access to the Know-how or OPi Know How enforceable written undertakings that they shall not during the continuance of this Agreement make any transfer or disclosure thereof.

 

7.5

Neither OPi nor HPA shall (without the written consent of the other) during the continuance of this Agreement or for a period of [ * ] following the expiration or termination of this Agreement make any disclosure or use of information relating to the business or affairs of the other party which is stated in writing by the other party to be confidential, except as otherwise expressly permitted under this Agreement.

 

7.6

Without prejudice to Clause 7.5, OPi and HPA shall each ensure that all of its agents, employees, consultants and contractors having access to the information specified in Clause 7 are made aware that the same is secret and confidential and shall be bound by undertakings of confidentiality (whether in their contracts of employment or otherwise) not to make any disclosure or use of such information but to keep the same confidential.

 

7.7

Each of OPi and HPA (the “First Party”) shall at its own expense give all reasonable assistance required by the other (the “Other Party”) to prevent any improper disclosure or use of the Know-how or the OPi Know How or the information specified in Clause 7.5 by any agents, employees, consultants and contractors of the First Party and the First Party shall be directly responsible to the Other Party for any such improper disclosure or use thereof.

 

7.8

The obligations of confidence referred to in this Clause 7 shall not extend to any information which:

 

 

7.8.1

is or shall become generally available to the public otherwise than by reason of a breach by OPi or HPA (as the case may be) (“the Recipient”), or any distributor of OPi or any agents, employees, consultants or contractors of OPi or HPA of the provisions of this Clause 7;

 

 

7.8.2

is known to the Recipient or any distributor of OPi and is at its free disposal prior to its receipt from HPA or OPi (as the case may be) (the “Disclosing Party”);

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

7.8.3

is subsequently disclosed to the Recipient or any distributor of OPi without obligations of confidence by a third party owing no such obligations in respect thereof,

 

 

7.8.4

is developed by the Recipient independently of the Disclosing Party.

 

7.9

The obligations of the parties under this clause shall survive the expiration or termination of this Agreement for whatever reason except where otherwise specified in this Clause 7.

 

8.

INTELLECTUAL PROPERTY

 

8.1

HPA hereby warrants and represents:

 

 

8.1.1

the Product, the Know-how, the Dossier and the Intellectual Property (including for the avoidance of doubt the Trademarks) were each developed by HPA (or its predecessor) without reliance upon or licence from any third party and HPA requires no third party approval or consent to enter into and comply with the obligations of this Agreement;

 

 

8.1.2

as far as HPA is aware there is no reason why the Marketing Authorisations cannot be transferred into OPi’s name or varied, obtained or renewed as contemplated by this Agreement;

 

 

8.1.3

as far as HPA is aware all information or data in respect of the Intellectual Property and the Product provided to OPi by HPA in writing was when given and remains at the date hereof true and accurate in all material respects;

 

 

8.1.4

as far as HPA is aware there are no claims, disputes, proceedings or litigation active, pending or threatened against HPA concerning the Product, the Manufacture, the Know-how, the Dossier or the Intellectual Property;

 

 

8.1.5

as far as HPA is aware there is no unauthorised use of the Intellectual Property or the Know-how; and

 

 

8.1.6

the Intellectual Property including for the avoidance of doubt the Trademark, the Know-how and Manufacture, marketing, sale or distribution of the Product in the Territory does not and will not infringe any rights of any third party.

Where a Warranty refers to the knowledge or awareness of HPA, HPA is deemed to have the knowledge of HPA’s Chief Executive Officer from time to time and of all such employees of HPA with whom OPi has been in contact during the due diligence and negotiation period and the knowledge which such persons should have after due and careful enquiry into the matters referred to.

 

8.2

Except as expressly incorporated or provided in this Agreement all conditions, warranties, representations and understandings (whether express or implied, statutory or otherwise) with respect to the subject matter of this Agreement are excluded to the extent permitted by law.

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


8.3

Each of HPA and OPi will immediately bring to the attention of the other:

 

 

8.3.1

any claim of any third party that the Intellectual Property is invalid or the Know-how is in the public domain; or

 

 

8.3.2

any claim that the use of the Intellectual Property or the Manufacture, marketing, sale or distribution of the Product in the Territory infringes any rights of any third party; or

 

 

8.3.3

any unauthorised use of the Intellectual Property or the Know-how.

 

8.4

In the event of:

 

 

8.4.1

any claim being made or action brought against OPi or any distributor arising out of the matters referred to in Clause 8.3.1 or 8.3.2; or

 

 

8.4.2

any unauthorised use as is referred to in Clause 8.3.3,

then the parties shall within ten (10) working days of one of them becoming aware of any claim, action or any use which is unauthorised refer the matter to the Joint Management Team and use their reasonable endeavours to agree an appropriate course of action. If both parties consider that action should be taken to protect the Organism, the Know-how, the Intellectual Property or any other intellectual property relating to the Product they shall consult with each other concerning the steps to be taken to pursue such action and take such steps provided that [ * ], if it considers it necessary to protect the Organism, the Know-how, the Intellectual Property or any other intellectual property relating to the Product, take control of the conduct of any relevant litigation and of the settlement of any such claim or infringement but will inform [ * ] of the progress of any relevant litigation and consider [ * ] interests under this Agreement in reaching any settlement of such claim or infringement. The costs of any such action shall be borne equally unless the parties agree otherwise or unless [ * ] takes control as aforesaid in which case it will bear the costs. If [ * ] notifies [ * ] that it does not consider the proposed action to be necessary to protect the Organism, the Know-how, the Intellectual Property or any other intellectual property in the Product [ * ] shall be entitled to continue the proposed action without further consultation at its own cost. [ * ] shall not [ * ] make any admission that may be prejudicial to [ * ]. [ * ] shall [ * ] give all available assistance for the purpose of contesting or supporting any such claim or action. Any amounts recovered shall be shared between HPA and OPi [ * ].

 

8.5

If [ * ] does not wish to take any action to protect the Organism, the Know-how, the Intellectual Property or any other intellectual property in the Product, [ * ] may take such action as it considers appropriate to do so and [ * ] shall give [ * ] such reasonable assistance in so doing [ * ] which are satisfactory to [ * ] and to [ * ] in accordance with [ * ] and [ * ].[ * ] shall not make any admission prejudicial to [ * ] action under this Clause 8.5 [ * ].

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


9.

PRODUCT LIABILITY

 

9.1

HPA shall not be liable to any third parties or to OPi for any claims whatsoever (including but not limited to infringement of intellectual property rights and product liability claims) arising out of or in any way related to:-

 

 

9.1.1

the distribution, sale or use of the Product by or on behalf of OPi, its sub contractors, or distributors; or

 

 

9.1.2

the actions of OPi or its sub-contractors or distributors or their respective agents or employees; or

 

 

9.1.3

any contracts or other commitments made by OPi or its sub-contractors or distributors or their respective agents or employees with any other parties,

and OPi agrees to indemnify HPA against all losses, damages, expenses and costs which may be incurred by HPA as a result of any such claims by third parties arising directly from any matter referred to in this Clause 9.1.

 

9.2

OPi shall, while this Agreement is in force and for so long after expiry or termination as there is any possibility of a claim against HPA (or its officers or employees), at OPi’s cost, keep in force adequate insurance with a reputable insurance company against all risks arising under this Agreement. OPi shall provide HPA with such evidence of insurance cover as HPA may request from time to time and shall procure that the insurance carrier undertakes to give HPA reasonable notice prior to any termination or expiry of the insurance cover.

 

9.3

HPA warrants that all Product supplied to OPi under this Agreement will conform to the Specification and the Technical Agreement, be manufactured in accordance with GMP, be free from contamination and adulteration, be in compliance with the United Kingdom Marketing Authorisation and the relevant provisions of Schedule 2 and [ * ]. HPA will in addition use reasonable commercial endeavours to procure that all Product will conform with variations made to the Marketing Authorisations for all countries in addition to the United Kingdom and with any new Marketing Authorisations to be granted for any country in the Territory (subject always to the provisions of Schedule 3).

 

9.4

The liability of either party to the other in respect of any claim or loss arising from or in relation to this Agreement shall not exceed:

 

 

9.4.1

in respect of any claim or series of connected claims, [ * ]; and

 

 

9.4.2

in respect of the aggregate of all claims, [ * ].

 

 

9.4.3

During the [ * ], the liability either party to the other in respect of any claim or series of connected claims shall not exceed [ * ].

 

 

9.4.4

During the [ * ], the liability either party to the other in respect of the aggregate value of all claims shall not exceed [ * ].

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


9.5

The obligations of OPi under Clauses 9.1 and 9.2 and of HPA under Clause 9.3 and the provisions of this sub-clause and Clauses 9.4 and 9.6 shall survive the expiration or termination of this Agreement for any reason.

 

9.6

Neither party shall have any liability to the other party for any indirect or consequential loss or damage howsoever occurring in contract, tort or otherwise under or in connection with this Agreement for: [ * ]

 

9.7

Nothing in this Agreement is meant to limit or exclude liability for fraudulent misrepresentation or liability for death or personal injury caused by either party’s negligence or any other liability which may not be lawfully excluded. The parties expressly agree that should any limitation or provision contained in this Agreement be held to be invalid under any applicable statute or rule of law it shall to that extent be deemed omitted but if any party thereby becomes liable for loss or damage which would otherwise legally have been excluded such liability shall be subject to the other limitations and provisions set out in this Agreement.

 

10.

HPA ASSISTANCE

 

10.1

HPA agrees that in addition to its obligations under Clause 5, it will during the term of this Agreement if requested in writing by OPi use its reasonable endeavors to assist OPi in relation to any matters notified to HPA by OPi and concerning the Product,


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