Acquisition and License Agreement dated June 25, 2010 by and between ULURU Inc., Strakan International Limited, and Zindaclin Limited, a subsidiary of Crawford Healthcare Limited

Dated 25th June 2010

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

STRAKAN INTERNATIONAL LIMITED a company incorporated in Bermuda and registered in Scotland under company number F000906, whose registered office is at Galabank Business Park, Galashiels, TD1 1QH (Strakan);

ULURU INC, a company incorporated in Nevada, whose registered office is at 4452 Beltway Drive, Addison, Texas 75001, United States of America (Uluru);

ZINDACLIN LIMITED, a company registered in England with company number ###-###-####, whose registered office is at Cheshire House, 164 Main Road, Goostrey, Crewe, Cheshire, CW4 8JP (Zindaclin); and

CRAWFORD HEALTHCARE LIMITED, a company registered in England with company number 03262015, whose registered office is at Cheshire House, 164 Main Road, Goostrey, Crewe, Cheshire, CW4 8JP (Crawford).

(A)

Zindaclin is a member of the same Group as Crawford.

(B)

Strakan is the registered proprietor of certain registered and unregistered trade marks for “Zindaclin”. Pursuant to an agreement between Strakan and Crawford, dated 10 October 2005 and amended 8 December 2006 (Existing Licence Agreement) (a copy of which is appended to this agreement in Appendix 3), Strakan granted a licence to Crawford to import, promote, market, use, distribute and sell products under the Zindaclin trade marks in certain territories.

(C)

Pursuant to an agreement between Strakan and Access Pharmaceuticals, Inc (Access), dated 26th February 1998, as amended by addenda dated 13th April 1998, 12th March 2001, 7th March 2002, 22nd May 2002 and 11th November 2002 respectively, Strakan has an exclusive licence to use certain patents (now expired) and know how belonging to Access relating to a zinc compound for the purpose of carryin g out further development and commercial exploitation of such zinc compound for human use in dermatological and topical products (Zinc Compound Licence Agreement).  During the course of development work carried out by Strakan under the Zinc Compound Licence Agreement further Patents (as hereinafter defined) were generated.  Pursuant to the third addendum dated 7th March 2002, Strakan assigned its rights under the licence agreement to its affiliate Kanford BV and, pursuant to an agreement dated 25 September 2003, Kanford assigned back such rights to Strakan.  Pursuant to a letter dated 12 October 2005, Access notified Strakan that it had assigned its rights under the agreement to Uluru.

(D)

Strakan has sublicensed its rights for various territories to, inter alia, Crawford and other partners under the terms of certain licence agreements (the “Licence Agreements” as hereinafter defined).

(E)

Strakan agrees to sell and Zindaclin agrees to buy certain trade marks for the name “Zindaclin” owned by Strakan in certain territories in accordance with and subject to the terms and conditions of this agreement.

(F)

Strakan and Uluru agree to sell to Zindaclin the Patents generated under the Zinc Compound Licence Agreement upon receipt of certain payments in accordance with and subject to the terms and conditions of this agreement and, until such time, Strakan agrees (with Uluru’s consent) to sub-license such Patents to Zindaclin, subject to the Licence Agreements.

(G)

Strakan agrees to sell to Zindaclin certain other registered trade marks for the name “Zindaclin” owned by Strakan and used by its partners under the Licence Agreements outside the territories reserved to Crawford (the Reserved Trade Marks as hereinafter defined) upon receipt of certain payments in accordance with and subject to the terms and conditions of this agreement and, until such time, Strakan agrees to license such Reserved Trade Marks to Zindaclin, subject to the Licence Agreements.

1.1  

The definitions and rules of interpretation in this clause apply in this agreement.

(a)  

any information that would be regarded as confidential by a reasonable business person relating to:

(i)  

the business, affairs, customers, clients, suppliers, plans, intentions or market opportunities of the disclosing party or of the disclosing party’s Group; and

(ii)  

the operations, processes, product information, know-how, designs, trade secrets, software or Intellectual Property of the disclosing party or of the disclosing party’s Group; and

(b)  

the existence of and the terms of this agreement;

1.2  

Clause and schedule headings shall not affect the interpretation of this agreement. References to clauses and schedules are to the clauses and schedules of this agreement.

1.3  

The schedules form part of this agreement and shall have effect as if set out in full in the body of this agreement. Any reference to this agreement includes the schedules.

1.4  

Unless the context otherwise requires, words in the singular include the plural and in the plural include the singular and references to one gender shall include a reference to the other genders.

1.5  

A reference to a statute, statutory provision or subordinated legislation is a reference to it as it is in force from time to time taking account of any amendment or re-enactment and includes any statute, statutory provision or subordinate legislation which it amends or re-enacts. A reference to a statute or statutory provision shall include any subordinate legislation made from time to time under that statute or statutory provision.

1.6  

Any words following the terms including, include, in particular or any similar expression shall be construed as illustrative and shall not limit the sense of the words preceding those terms.

2.1  

In consideration of the payment of the Purchase Price by Zindaclin to Strakan on the Completion Date (receipt of which is hereby acknowledged by Strakan), Strakan hereby assigns to Zindaclin with full title guarantee free from all liens, equities, charges and encumbrances, all right, title and interest in and to the Assigned Trade Marks, including:

(a)  

all goodwill attaching to the Assigned Trade Marks; and

(b)  

the right to sue for infringements whether occurring before or after the date of this agreement and to benefit from any damages and other remedies obtained as a result of such action.

2.2  

Upon the Completion Date and upon the assignment pursuant to clause 2.1 and the licence pursuant to clause 3.1 becoming effective, the Existing Licence Agreement shall automatically terminate and:

(a)  

Strakan hereby waives any and all claims, rights and/or remedies (whether in contract or tort) that it may have against Crawford under such agreement other than for the royalties due and owing, as set out in Appendix 5 in respect of the period up to and including 31 May 2010 (and the parties agree that, based on the sales reports provided to Strakan by Crawford, the amount set out in Appendix 5 represents the full amount of royalties due and owing for the period up to and including 31 May 2010) plus any royalties due and owing under such agreement in respect of the period 1 June 2010 up to the Completion Date, and payment of such royalties shall be in full and final settlement of all claims for royalties due and owing under the Existing Licence Agreement;

(b)  

Crawford hereby waives any and all claims and/or rights that it may have against Strakan and/or Uluru under such agreement.

2.3  

Strakan shall be responsible for all registration, maintenance, renewal and all other fees payable in connection with the Assigned Trade Marks up to the Completion Date and Zindaclin shall be responsible for all such costs from the Completion Date.

2.4  

Upon the Completion Date, but subject to clause 2.5, Strakan ceases to have any right, title or interest in or to the Assigned Trade Marks and agrees that it shall not itself use, or permit any other person to use:

(a)  

the Assigned Trade Marks; and/or

(b)  

any name, word or logo which incorporates or is confusingly similar to the Assigned Trade Marks.

2.5  

Zindaclin undertakes not to sell, assign, transfer or otherwise dispose of the Assigned Trade Marks until after payment by Zindaclin of the final payment of the Licence Fee to Strakan pursuant to clause 4.2.

3.1  

In consideration of payment of the Licence Fee in accordance with clause 4.2, Strakan (with Uluru’s consent given hereunder) hereby grants to Zindaclin, subject to the Licence Agreements, from the Completion Date an exclusive, royalty free licence under the Reserved Trade Marks, the Patents, the Know-how and the Documents to develop, manufacture, use, sell, supply and otherwise deal with Licensed Products in the Territory during the Licence Period and to grant a sub-licence to any other person to do so.

3.2  

Uluru and Strakan shall provide to Zindaclin upon the Commencement Date on disk or such other format as agreed by the parties all Know how and deliver up to Zindaclin all and any Documents licensed to Zindaclin pursuant to clause 3.1.

3.3  

Strakan and Uluru each undertake during the Licence Period not to:

(a)  

use the Patents and not to develop, manufacture, use, sell, supply or otherwise deal with the Licensed Products in the Territory;

(b)  

grant a licence to any third party, other than as set out in the Licence Agreements, to use the Patents or the Reserved Trade Marks or to sell, distribute or otherwise exploit the Licensed Products in the Territory; and

(c)  

directly or indirectly, either on its own or in connection with or on behalf of any other person, firm or company, develop, manufacture, use, sell or supply or otherwise deal with any topical product containing zinc and clindamycin for the treatment of acne which competes with the Licensed Product in the Territory.

3.4  

During the Licence Period, Strakan shall continue to prosecute, maintain in force and renew the Reserved IP at Zindaclin’s cost, provided that:

(a)  

the amount that Zindaclin is required to pay in respect of renewals during the Licence Period shall not exceed the sum of £35,000; and

(b)  

Strakan agrees to keep Zindaclin informed and consult with Zindaclin in respect of the prosecution of any of the Reserved IP and will obtain Zindaclin’s consent prior to incurring any fees in respect of the prosecution of the Reserved IP (such consent not to be unreasonably delayed).

3.5  

Strakan shall pay the relevant prosecution, maintenance and renewal fees (including its patent and trade mark attorneys’ fees) and invoice Zindaclin, together with evidence of all fees paid, which invoice Zindaclin shall pay within fourteen (14) days.  Any unpaid invoices shall bear interest at five (5) percent per annum from the date payment was due until the date payment is made.

3.6  

Strakan shall notify Zindaclin promptly of all significant developments with respect to any of the Reserved IP and shall, on request, furnish Zindaclin with copies of all relevant documents and correspondence. On request from Zindaclin, Strakan shall promptly deliver a report of the Reserved IP clearly setting out the details of all the Patents and Reserved Trade Marks, the countries in which they are registered and such other information as Zindaclin reasonably requests from time to time.

3.7  

Strakan shall on demand from Zindaclin produce to Zindaclin evidence of payment of the renewal fees within fourteen (14) days of payment of such renewal.  Strakan shall not permit the Patents or Reserved Trade Marks to lapse or expire without Zindaclin’s prior written consent, such consent not to be unreasonably delayed.

3.8  

Upon the grant of the licence pursuant to clause 3.1, the Licence Agreements will be novated from Strakan to Crawford materially upon the agreed terms set out in Appendix 1 (save as set out in clause 3.8(c) below) and Strakan agrees:

(a)  

to execute the relevant novation agreements;

(b)  

to procure that Kanford BV and Strakan Group Limited both execute the novation agreement in respect of the Licence Agreement to which they are a party;

(c)  

to use commercially reasonable endeavours to procure that the licensee to the Licence Agreement enters into a novation agreement materially upon the terms set out in Appendix 1  and, in respect of Laboratorios Biosintetica, to use commercially reasonable endeavours to procure that Laboratorios Biosintetica enters into a novation agreement materially upon the terms set out in Appendix 7, and Strakan shall deliver to Crawford the executed novation agreements at no cost to Crawford; and

(d)  

not to terminate, or vary or materially amend any of the terms of any of the Licence Agreements prior to their novation to Crawford without the prior written consent of Crawford, such consent not to be unreasonably delayed.

3.9  

In the event that any of the Licence Agreements are not novated to Crawford pursuant to clause 3.8:

(a)  

Strakan will promptly on request assign the benefit of and all rights under such Licence Agreements to Crawford; and

(b)  

unless and until such Licence Agreements are novated or assigned to Crawford, Strakan shall hold any monies, rights or other benefits received under such Licence Agreements as trustee for Crawford and shall give such assistance as Crawford may reasonably require to enable Crawford to enforce its rights under such Licence Agreements (subject to payment of Strakan’s out-of-pocket expenses, including any reasonable attorney’s fees, subject to obtaining Crawford’s prior written consent before incurring any such fees), including assisting Crawford in obtaining payment of any monies due pursuant to the Licence Agreements.

4.1  

Zindaclin shall pay to Strakan and Uluru (50% each) upon the Completion Date the sum of US$100,000 (receipt of which Strakan and Uluru hereby acknowledge) in consideration of the execution of this Agreement and the assignment of the Assigned Trade Marks (Purchase Price), such payment to be satisfied in cash, payable by bank transfer to Strakan and Uluru’s nominated bank accounts (as specified in Appendix 4).

4.2  

In consideration of the licence to use the Reserved IP, Zindaclin shall pay to Strakan and Uluru (50% each) the sum of US$2,000,000 (Licence Fee), payable by bank transfer to Strakan’s and Uluru’s nominated bank accounts (specified on the relevant invoice) as follows:

(a)  

the sum of US$500,000 in cash on the Completion Date (receipt of which Strakan and Uluru hereby acknowledge);

(b)  

two further payments, each of US$250,000, in cash on 1 September 2010 and 1 November 2010;

(c)  

the sum of US$500,000 in cash on the anniversary of the Completion Date; and

(d)  

a final payment of US$500,000 on the second anniversary of the Completion Date,

4.3  

Zindaclin may, at its sole discretion, make payment of the Licence Fee prior to the second anniversary of the Completion Date.

4.4  

In addition to the payments set out in clauses 4.1 and 4.2, in the event that the Zindaclin NDA is approved by the Federal Food and Drug Administration of the United States of America, Zindaclin shall make an additional payment of US$3,000,000 to Strakan and Uluru (50% each) within thirty (30) days of receipt of confirmation of such approval by Zindaclin.  Zindaclin shall use commercially reasonable endeavours to obtain the Zindaclin NDA approval and shall update Strakan and Uluru in writing (including by email) on its progress in that regard on a six (6) monthly basis. The obligation to provide this update shall continue for five (5) years from the Completion Date.

4.5  

In the event that Zindaclin fails to pay any of the instalments of the Licence Fee above within thirty (30) days of the due date for payment pursuant to clause 4.2 and following receipt of an appropriate invoice, then Strakan and Uluru may on ten (10) days written notice terminate this agreement, provided that Zindaclin does not make the payment due within that ten (10) day period. Should Zindaclin during the notice period make payment of the relevant part of the Licence Fee due, Strakan and Uluru shall automatically be deemed to have withdrawn its notice of termination.

4.6  

In the event that Zindaclin fails to pay the Licence Fee in accordance with clause 4.2 then, subject to clause 4.5, Strakan and Uluru shall have the option to re-purchase the Assigned Trade Marks from Zindaclin upon payment of the sum of an aggregate of $100,000 by Strakan and Uluru to Zindaclin.

4.7  

In the event that Zindaclin fails to pay the Licence Fee in accordance with clause 4.2 and Strakan and Uluru terminate this agreement in accordance with clause 4.5, the Existing Licence Agreement shall automatically be deemed to take effect from the date of such termination upon the terms and conditions contained therein, as amended by the deed of amendment to the Existing Licence Agreement appended to this agreement in Appendix 6.

4.8  

Other than as set out in this clause 4, Zindaclin shall not be liable to make any further payments to Strakan or Uluru in respect of the assignment of the Assigned Trade Marks pursuant to clause 2.1, the licence of the Reserved IP pursuant to clause 3.1 and the assignment of the Reserved IP pursuant to clause 5.2.

5.1  

Strakan shall deliver up to Zindaclin on the Completion Date:

(a)  

all registration and renewal documents relating to the Assigned Trade Marks;

(b)  

all registration and renewal documents for the Patents and Reserved Trade Marks;

(c)  

all duly executed, but undated, assignments, forms and such other documents necessary or desirable for the purpose of transferring legal title in and to the Reserved IP in each relevant territory to Zindaclin in order to give effect to the assignment in clause 5.2; and

(d)  

a legal charge in the agreed form duly executed by Strakan, Zindaclin and Crawford over the Reserved IP,

5.2  

Upon payment by Zindaclin of the final payment of the Licence Fee, Strakan and Uluru (together the Assigning Parties) each hereby automatically assign with effect from the Final Payment Date to Zindaclin with full title guarantee free from all liens, equities, charges and encumbrances, all right, title and interest in and to the Reserved IP, including:

(a)  

all goodwill attaching to the Reserved Trade Marks; and

(b)  

the right to sue for infringements whether occurring before or after the date of such assignment and to benefit from any damages and other remedies obtained as a result of such action.

6.1  

Within five (5) Business Days of the Completion Date, the Assigning Parties shall each deposit the Escrow Documents in escrow with the Escrow Agent for the full term of the Licence Period.

6.2  

Within five (5) days of payment of the final instalment of the Licence Fee pursuant to clause 4.2(d), Zindaclin and Strakan shall each provide written notice to the Escrow Agent that the Licence Fee has been paid and instruct the Escrow Agent to release the Escrow Documents relating to the Reserved IP.

7.1  

Each party shall:

(a)  

keep confidential and shall not use any Confidential Information of another party for a purpose other than the performance of its obligations under this agreement;

(b)  

not disclose Confidential Information of another party to any person without the prior written consent of the relevant party; and

(c)  

only disclose the Confidential Information of another party to those of its officers, employees, agents and contractors to whom, and to the extent which, such disclosure is necessary for the purposes contemplated under this agreement and provided that all such personnel have agreed in writing on terms no less onerous than those contained in this agreement to keep such Confidential Information secret and confidential.

7.2  

The provisions of clause 7.1 shall not apply to information that:

(a)  

was known or available on a non-confidential basis to the receiving party before it was disclosed to it by the disclosing party;

(b)  

is or becomes generally available to the public (otherwise than through a breach of this clause 7);

(c)  

the parties agree in writing is not confidential or may be disclosed; or

(d)  

the receiving party is required to disclose by law, court order or any governmental or regulatory authority provided that, to the extent it is legally permitted to do so, it gives the disclosing party as much notice of such disclosure as possible and takes into account the reasonable requests of the disclosing party in relation to the content of such disclosure.

7.3  

The provisions of this clause 7 shall remain in force notwithstanding expiry or earlier termination of this agreement.

8.1  

Strakan and Uluru shall each notify Zindaclin as soon as they become aware of any actual or threatened infringement of any of the Reserved IP during the Licence Period (“IP Infringement”). On service of such notice or otherwise upon Zindaclin becoming aware of such infringement, Zindaclin shall at its cost and expense take such action as it deems fit (acting reasonably) to prevent such IP Infringement and shall notify the owner(s) of the affected Reserved IP (being Strakan or Uluru or both, as applicable) as soon as reasonably possible and, in any event, within 30 days of service of such notice as to what action it proposes to take. Strakan and/or Uluru shall each give such assistance to Zindaclin in respect thereof as Zindaclin reasonably requests (including joining as joint claimant in respect of any legal proceedings), provided that Zindaclin reimburses Strakan and/or Uluru in respect of the costs that Strakan or Uluru  reasonably incurs in giving such assistance.  Unless the parties agree otherwise, any damages recovered by Zindaclin shall be retained by Zindaclin.

9.1  

Strakan warrants that:

(a)  

it is the sole legal and beneficial owner of the Trade Marks;

(b)  

the list of trade marks in Schedule 2 is a complete list of all the registered trade marks for “ZINDACLIN” owned by Strakan and, so far as Strakan is aware, and/or used by its licensees;

(c)  

all application, registration and renewal fees in respect of each of the Trade Marks have been paid as at the date of this agreement and in the case of the Reserved Trade Marks, will, subject to the provisions of clause 3.4, be paid up to the date of assignment of the relevant Trade Mark to Zindaclin;

(d)  

the use of the Trade Marks by Zindaclin will not, so far as Strakan is aware (having made enquiries of the licensees under the Licence Agreements) infringe the Intellectual Property Rights or other proprietary rights of a third party in the country or countries covered by the Licence Agreements and such other countries of the Territory where the relevant Trade Marks are registered;

(e)  

other than the Licence Agreements, it has not assigned or granted any licences to any third party to use any of the Trade Marks;

(f)  

there has not been, and it is not aware of, any infringement or any challenge to the validity of any of the Trade Marks or of anything that might render any of the Trade Marks invalid or prevent any of the Trade Marks being registered;

(g)  

the list of patents in Schedule 2 is a complete and accurate list of all the patents owned by Strakan and/or Uluru, as the case may be, in respect of the zinc compound sold and marketed under the name “Zindaclin”;

(h)  

all application, registration and renewal fees in respect of each of the Patents have been paid as at the date of this agreement and will be paid, subject to clause 3.4, up to the date of assignment of the Patents to Zindaclin;

(i)  

the use of the Patents and Know how will not, so far as it is aware (having made enquiries of the licensees under the Licence Agreements), infringe the Intellectual Property Rights or other proprietary rights of a third party in the country or countries covered by the Licence Agreements and such other countries of the Territory where the Patents are granted;

(j)  

it is not aware (having made enquiries of the licensees under the Licence Agreements) of any third party rights in the country or countries covered by the Licence Agreements and such other countries in which the Patents are registered which will be infringed by the manufacture, importation, promotion, marketing, use, distribution and sale of the Licensed Product in such countries;

(k)  

other than the Licence Agreements, it has not assigned or granted any licences to any third party to use any of the Patents or Know how and will not do so during the Licence Period;

(l)  

there has not been, and it is not aware of, any infringement or any challenge to the validity of any of the Patents or, so far as it is aware, of anything that might render any of the Patents invalid or prevent any of the Patents proceeding to grant; and

(m)  

it has delivered to Zindaclin copies of all the Licence Agreements and all available files, records, correspondence and documents relating thereto.

9.2  

Strakan and Uluru each warrant, severally, and not jointly and severally, that they are the sole legal and beneficial owners of the Patents, as set out in Schedule 2 and the Know how.

9.3  

Uluru warrants that:

(a)  

so far as it is aware, the list of patents in Schedule 2 is a complete and accurate list of all the patents owned by Strakan and/or Uluru, as the case may be, in respect of the zinc compound sold and marketed under the name “Zindaclin”;

(b)  

it has not received notification that the use of any of the Patents and/or Know how infringes the Intellectual Property Rights or other proprietary rights of a third party in the country or countries covered by the Licence Agreements and such other countries of the Territory in which the Patents are granted;

(c)  

other than the Zinc Compound Licence Agreement, it has not assigned or granted any licences to any third party to use any of the Patents or Know how and will not do so during the Licence Period; and

(d)  

it has the requisite corporate power and authority to execute and deliver this agreement and to perform its obligations hereunder and no consent or other agreement is necessary for it to perform its obligations hereunder.

9.4  

Zindaclin warrants that it has the requisite corporate power and authority to execute and deliver this agreement and to perform its obligations hereunder and no consent or other agreement is necessary for it to perform its obligations hereunder.

9.5  

(a) Strakan shall indemnify Zindaclin against all liabilities, costs, expenses, damages or losses (excluding any indirect consequential losses, loss of profit, loss of reputation) and all interest, penalties and legal and other professional costs and expenses (each a Claim) suffered or incurred by Zindaclin, including any Claim brought by Crawford against Zindaclin, arising out of or in connection with a breach of any of the warranties in clause 9.1 and 9.2 up to an amount not exceeding the sum actually paid by Zindaclin to Strakan under this agreement and provided that any individual claim exceeds $10,000 and shall be brought within twelve (12) months from the due date of the final payment of the Licence Fee, thereafter this clause 9.5(a) shall cease to have effect.

 

(b) Uluru shall indemnify Zindaclin against all Claims suffered or incurred by Zindaclin, including any Claim brought by Crawford against Zindaclin, arising out of or in connection with a breach of any of the warranties by Uluru in clause 9.2 and 9.3 up to an amount not exceeding the sum actually paid by Zindaclin to Uluru under this agreement and provided that any individual claim exceeds $10,000 and shall be brought within twelve (12) months from the due date of the final payment of the Licence Fee, thereafter this clause 9.5(b) shall cease to have effect.

9.6  

Strakan shall indemnify Zindaclin and Crawford against any and all liabilities, costs, expenses, damages or losses and all Claims suffered or incurred by Zindaclin or Crawford as a result of a claim made under or in connection with any indemnity provided by Strakan or any member of its Group in any of the Licence Agreements prior to execution of the relevant Novation Agreement.

9.7  

Zindaclin shall indemnify each of Strakan and Uluru against all liabilities, costs, expenses, damages or losses (excluding any indirect consequential losses, loss of profit, loss of reputation) and all Claims suffered or incurred by Strakan or Uluru arising out of or in connection with a breach of the warranty in clause 9.4 up to an amount not exceeding the sum actually paid by Zindaclin under this agreement and provided that any individual claim exceeds $10,000 and shall be brought within twelve (12) months from the due date of final payment of the Licence Fee, thereafter this clause 9.7 shall cease to have effect.

10.1  

Strakan and Uluru shall not without the prior written consent of Zindaclin  assign, transfer, mortgage, charge or otherwise deal in any other manner with any of its obligations under this agreement. Strakan and Uluru may at any time and without the consent of Zindaclin, assign, transfer, mortgage, charge or otherwise deal in any other manner with any or all of its rights under this agreement.

10.2  

Zindaclin shall not without the prior written consent of Strakan and Uluru assign, transfer, mortgage, charge or otherwise deal in any other manner with any of its obligations under this agreement. Subject to clause 10.3, Zindaclin may at any time and without the consent of Strakan or Uluru, assign, transfer, mortgage, charge or otherwise deal in any other manner with any or all of its rights under this agreement.

10.3  

Until payment by Zindaclin of the amount due pursuant to clause 4.4 or until the expiry of five (5) years from the Completion Date, whichever occurs sooner, Zindaclin shall not without the prior written consent of Strakan and Uluru (such consent not to be unreasonably delayed) license, assign or transfer the US patent application number 10/432,848 or any patent resulting therefrom or US Zindaclin trade mark number 826,238 provided that any such licensee, assignee or transferee shall be obliged in writing for the benefit of Strakan and Uluru to assume the obligation to make the payment due on NDA approval pursuant to clause 4.4. If Strakan and/or Uluru fail to provide such consent within ten (10) Business Days of Zindaclin’s request, the consent of the relevant party shall be deemed to have been given. In the event that Strakan and/or Uluru has a receiver, administrator, administrative receiver, trustee or similar officer appointed over it or of any or all of its assets, Zindaclin shall not be required to obtain consent of the affected party pursuant to this clause 10.3. Zindaclin may at any time and without the consent of Strakan or Uluru mortgage or charge its rights in respect of the US patent application 10/432,848 and any patent resulting therefrom and US Zindaclin trade mark number 826,238 to any unaffiliated third party in connection with an arms-length transaction or to any unaffiliated person or entity providing finance to Zindaclin in an arms-length transaction. Zindaclin may only with the consent of Strakan or Uluru mortgage or charge its rights in respect of the US patent application 10/432,848 and any patent resulting therefrom and US Zindaclin trade mark number 826,238 to any affiliated person or entity providing finance to Zindaclin in an arms-length transaction.

10.4  

Zindaclin may, at its own cost, record the licence granted to it in clause 3 in the relevant registries in the Territory.

10.5  

Strakan and/or Uluru shall provide reasonable assistance, at Zindaclin’s cost, to enable Zindaclin to comply with clause 10.4.

11.1  

At its own expense each party shall, as may reasonably be required, perform (or shall procure that any necessary third party shall perform), such acts and things, and execute and deliver (or procure that any third party executes and delivers) all further documents required for the purpose of giving full effect to this agreement, including to effect the assignments of the Patents set out in Schedule 2 and to vest in Zindaclin the full benefit of the right, title and interest assigned to Zindaclin under this agreement, including but not limited to the registration of Zindaclin as applicant for or proprietor of the Assigned Trade Marks and, upon the assignment of the Reserved IP pursuant to clause 5.2, of the Patents and the Reserved Trade Marks.

13.1  

This agreement and the documents referred to in it constitute the whole agreement between the parties and supersede any previous agreement between the parties relating to its subject matter.

13.2  

Each of the parties acknowledges that, in entering into this agreement, it has not relied on, and shall have no right or remedy in respect of, any statement, representation, assurance or warranty (whether negligently or innocently made) other than as expressly set out in this agreement.

13.3  

Nothing in this clause shall limit or exclude any liability for fraud.

15.1  

If any court or competent authority finds that any provision of this agreement (or part of any provision) is invalid, illegal or unenforceable, that provision or part-provision shall, to the extent required, be deemed to be deleted, and the validity and enforceability of the other provisions of this agreement shall not be affected.

15.2  

If any invalid, unenforceable or illegal provision of this agreement would be valid, enforceable and legal if some part of it were deleted the parties shall negotiate in good faith to amend such provision such that, as amended, it is legal, valid and enforceable, and, to the greatest extent possible, achieves the parties' original commercial intention.

17.1  

No person other than a party to this agreement, and their respective successors and permitted assigns, shall have any rights to enforce any term of this agreement.

17.2  

Crawford is only a party to this agreement for the purpose of clause 2.2 and to enforce its rights under clause 3.9 and 9.6. In the event that Crawford enforces its rights against Strakan under such clauses, Zindaclin agrees not to make a claim against Strakan in respect of the losses or damages of Crawford pursuant to such clauses.

20.1  

Any notice required to be given under this agreement shall be in writing and shall be delivered personally, or sent by pre-paid first-class post or recorded delivery or by commercial courier, to each party required to receive the notice at its address as set out below:

(a)  

Strakan: FAO: Legal Department

(b)  

Uluru:FAO: Kerry P. Gray

(c)  

Zindaclin: FAO: Richard Anderson

 

Chief Executive Officer

 

Zindaclin Limited

 

Cheshire House

 

164 Main Road

 

Goostrey

 

Crewe

 

Cheshire, CW4 8JP

 

Tel: +44 (0) 1477 537596

 

Email: ***@***

20.2  

Any notice shall be deemed to have been duly received:

(a)  

if delivered personally, when left at the address and for the contact referred to in this clause; or

(b)  

if sent by pre-paid first-class post or recorded delivery, on the second Business Day after posting; or

(c)  

if delivered by commercial courier, on the date and at the time that the courier's delivery receipt is signed.

20.3  

A notice required to be given under this agreement shall not be validly given if sent by e-mail.

20.4  

The provisions of this clause 20 shall not apply to the service of any proceedings or other documents in any legal action.

21.1  

This agreement and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the law of England and Wales.

 

 

 

ZINDACLIN

 

 

European Community

Registered

1721745

23/06/2000

23/06/2000

ZINDACLIN

Madrid Protocol

 

Designating:

 

Croatia

Russia

Turkey

United States

Registered

 

 

 

 

Protected

Protected

Protected

Protected

826238

31/03/2004

31/03/2004

ZINDACLIN

 

United Kingdom

Registered – renewal instructed

2236795

23/06/2000

23/06/2000

ZINDACLINE

France

Registered

23184061

18/09/2002

18/09/2002

 

 

 

ZINDACLIN

Canada

Registered

TMA690127

22/06/2004

19/06/2007

ZINDACLIN

Hong Kong

Registered

300148419

28/01/2004

28/01/2004

ZINDACLIN

India

Pending

 

 

1589379

10/08/2007

ZINDACLIN

Israel

Registered

171763

28/04/2004

08/02/2006

ZINDACLIN

Korea (South)

Registered

569534

30/09/2002

22/12/2003

ZINDACLIN

in Korean

Korea

(South)

Registered

569533

30/09/2002

22/12/2003

ZINDACLIN

Madrid Protocol

 

Designating:

 

Australia

China

Japan

Morocco

Singapore

Registered

 

 

 

 

Protected

Protected

Protected

Protected

Protected

826238

31/03/2004

31/03/2004

ZINDACLIN

Malaysia

Registered

2004/01588

12/02/2004

12/02/2004

ZINDACLIN

New Zealand

Registered

710663

05/04/2004

28/01/2004

ZINDACLIN

Switzerland

Registered

499520

06/03/2002

06/03/2002

ZINDACLIN

Taiwan

Registered

1140244

11/02/2004

16/02/2005

Australia

Strakan International Limited

2002223091

2002223091

28/11/2001

14/12/2006

Granted

Austria

Strakan International Limited

01998353.5

E 321560

28/11/2001

29/03/2006

Granted

Belgium

Strakan International Limited

01998353.5

1347765

28/11/2001

29/03/2006

Granted

Brazil

Strakan International Limited 

PI0115727-2

28/11/2001

Pending

Canada

Strakan International Limited

2,429,205

28/11/2001

Pending

Croatia

Strakan International Limited

P20030433

P20030433

28/11/2001

16/10/2007

Granted

Cyprus

Strakan International Limited

01998353.5

1347765

28/11/2001

29/03/2006

Granted

Czech Republic

Strakan International Limited 

PV2003-1491

28/11/2001

Pending

Denmark

Strakan International Limited

01998353.5

1347765

28/11/2001

29/03/2006

Granted

Finland

Strakan International Limited

01998353.5

1347765

28/11/2001

29/03/2006

Granted

France

 

Strakan International Limited

01998353.5

1347765

28/11/2001

29/03/2006

Granted

Germany

Strakan International Limited

01998353.5

601 18 441.6

28/11/2001

29/03/2006

Granted

Greece

Strakan International Limited

01998353.5

3058203

28/11/2001

29/03/2006

Granted

Hong Kong

Strakan International Limited

04102115.2

HK1059218

28/11/2001

03/11/2006

Granted

Hungary

Strakan International Limited 

P0400520

28/11/2001

Pending

Ireland

Strakan International Limited

01998353.5

1347765

28/11/2001

29/03/2006

Granted

Israel

Strakan International Limited

152,720

152720

28/11/2001

07/04/2008

Granted

Italy

Strakan International Limited

01998353.5

027591BE/2006

28/11/2001

29/03/2006

Granted

Japan

Strakan International Limited 

2002-545709

4272425

28/11/2001

06/03/2009

Granted

Luxembourg

Strakan International Limited

01998353.5

1347765

28/11/2001

29/03/2006

Granted

Mexico

Strakan International Limited

PA/a/2003/004733

28/11/2001

Pending

Monaco

Strakan International Limited 

01998353.5

1347765

28/11/2001

29/03/2006

Granted

Netherlands

Strakan International Limited

01998353.5

1347765

28/11/2001

29/03/2006

Granted

New Zealand

Strakan International Limited

526170

526170

28/11/2001

11/05/2006

Granted

Poland

Strakan International Limited

P362279

28/11/2001

Pending

Portugal

Strakan International Limited

01998353.5

1347765

28/11/2001

29/03/2006

Granted

Republic of Korea

Strakan International Limited 

10 ###-###-####

10-0629326

28/11/2001

21/09/2006

Granted

Russian Federation

Strakan International Limited 

 

2003119158

2277419

28/11/2001

10/06/2006

Granted

Slovakia

Strakan International Limited 

PV ###-###-####

28/11/2001

Pending

South Africa

Strakan International Limited

2003/5012

2003/5012

28/11/2001

26/04/2005

Granted

Spain

Strakan International Limited

01998353.5

1347765

28/11/2001

29/03/2006

Granted

Sweden

Strakan International Limited

01998353.5

1347765

28/11/2001

29/03/2006

Granted

Switzerland

Strakan International Limited

01998353.5

1347765

28/11/2001

29/03/2006

Granted

Turkey

Strakan International Limited 

01998353.5

1347765

28/11/2001

29/03/2006

Granted

United Kingdom

Strakan International Limited

01998353.5

1347765

28/11/2001

29/03/2006

Granted

USA

Strakan International Limited

10/432,848

28/11/2001

Pending

 -

Assignments from Kanford BV to SIL filed with the Brazilian, Korean and Slovakian Patent Offices, dated 26 October 2009, 3 March 2010 and 3 August 2009 respectively.  Recordal of the assignments at the respective Patent Offices is pending

 -

Assignments from Kanford BV and Access Pharmaceuticals, Inc to SIL filed with the Czech, Hungarian and Japanese Patent Offices, dated 14 January 2009, 16 December 2008 and 15 March 2010  respectively.  Recordal of the assignments at the respective Patent Offices is pending

 -

Assignments from Access Pharmaceutical, Inc. to SIL filed with the Monacan, Russian and Turkish Patent Offices on 23 February 2010, 12 November 2008 and 19 November 2009 respectively.  Recordal of the assignments at the respective Patent Offices is pending

1.  

Agreement between Strakan International Limited and GenePharm Australasia Ltd (assigned from Epitan Pharmaceuticals Pty Limited on 30 September 2006) dated 16 July 2004.

2.  

Agreement between Strakan International Limited and Laboratorios Biosintetica dated 22 December 2003

3.  

Agreement between Kanford BV (1), Strakan Group Limited (2) and Hyun Dai Pharm. Ind. Co. Ltd. (3), dated 23 December 2002

4.  

Agreement between Strakan International Limited and Industrial Farmaceutica Cantabria S.A. dated 26 July 2005

5.  

Agreement between Strakan International Limited (1), Orient Europharma Co. Ltd (2) and Cyntec Co. Ltd (3) dated 5 February 2004

6.  

Agreement between Strakan International Limited and Dankos Laboratories Tbk (now PT Kalbe Farma Tbk) dated 10 November 2003

7.  

Agreement between Strakan International Limited and Taro International Limited dated 5 January 2005

 

(1)  

STRAKAN INTERNATIONAL LIMITED (the "Company") (incorporated in Bermuda and registered in Scotland under company number F000906) with its principal place of business at Galabank Business Park, Galashiels, TD1 1QH, UK (the "Transferor");

(2)  

CRAWFORD HEALTHCARE LIMITED (incorporated and registered in England under company registration number 03262015, the registered office of which is at 25 Cheshire House, 164 Main Road, Goostrey, Crewe, Cheshire, CW4 8JP, UK (the "Transferee"); and

(3)  

[SUBLICENSEE], (incorporated and registered in [   ] under company number [   ]) the registered office of which is at [      ] (the "Continuing Party").

(A)  

This Novation Agreement is supplemental to the existing [distribution] agreement dated [   ] between the Transferor and the Continuing Party (the “Agreement”).

(B)  

Pursuant to an agreement dated [    ] 2010 entered into between (1) the Transferor, (2) Uluru, Inc. and (3) Zindaclin Limited (the "Acquisition and Licence Agreement"), the Transferor, Uluru, Inc. and Zindaclin Limited (“Zindaclin”) have agreed to the sale to Zindaclin of certain assets of the Transferor and Uluru, Inc, including the intellectual property licensed to the Continuing Party under the Agreement.

(C)  

Zindaclin is a member of the same Group as the Transferee. With effect on and from the date of completion of the Acquisition and Licence Agreement (the “Effective Date”), the Transferee shall have an exclusive licence to the assets transferred to Zindaclin under the Acquisition and Licence Agreement.

(D)  

The Transferor wishes to assign and transfer all of its rights, privileges, duties, obligations and liabilities arising out of the Agreement to the Transferee with effect on and from the Effective Date.

(E)  

With effect on and from the Effective Date the Transferor wishes to be released from, and the Transferee wishes to assume and perform, all the obligations of the Transferor under or in respect of the Agreement.

(F)  

The Continuing Party gives its consent to the assignment, transfer and assumption referred to in Recitals (D) and (E) above taking place.

1.1

Except where the context otherwise requires, expressions defined in the Agreement shall have the same meanings when used in this Novation Agreement.

1.2

Words importing the singular only shall import the plural and vice versa.

1.3

References to “Group” mean in relation to a company, that company, any subsidiary or holding company from time to time of that company or of a holding company of that company and references to “holding company” and “subsidiary” are as defined in section 1159 of the Companies Act 2006.

2.1

As from the Effective Date, the Transferor unconditionally and irrevocably releases and discharges the Continuing Party from further performance or discharge of the obligations and liabilities of the Continuing Party owed to the Transferor under the Agreement and from all future claims and demands in respect of the Agreement.

2.2

As from the Effective Date, the Transferee accepts the liability of the Transferor under the Agreement and undertakes with the Continuing Party to observe and perform all the obligations and to discharge all the liabilities of the Transferor arising under the Agreement and shall be bound by the terms of the Agreement in every way as if the Transferee had at all times been a party to the Agreement in place of the Transferor.

2.3

The Continuing Party unconditionally and irrevocably releases and discharges the Transferor from further performance or discharge of the obligations and liabilities of the Transferor owed to the Continuing Party under the Agreement and from all future claims and demands in respect of the Agreement as from the Effective Date and accepts the liability of the Transferee to undertake such performance or discharge pursuant to clause 2.2 of this Novation Agreement in lieu of the liability of the Transferor.

2.4

The Continuing Party agrees to be bound by the terms and conditions of the Agreement in every way as if the Transferee and the Continuing Party had always been named as parties to the Agreement, and accordingly the Continuing Party acknowledges and agrees that the Transferee shall have the right to enforce the Agreement and pursue all future claims and demands by the Transferor in respect of the Agreement as from the Effective Date.

2.5

Nothing in this Novation Agreement shall operate to discharge the Continuing Party or the Transferor from any liability or affect or prejudice any claim or demand which either the Transferor or the Continuing Party may have against the other in respect of matters arising prior to the Effective Date.

3.1

The Transferee agrees to indemnify the Transferor (on a full indemnity basis) from and against all actions, proceedings, claims and demands which may be brought or made against the Transferor and all losses and properly incurred costs which the Transferor may incur or sustain arising from the failure of the Transferee to comply with its obligations under this Novation Agreement.

3.2

The Transferor agrees to indemnify the Transferee (on a full indemnity basis) from and against all actions, proceedings, claims and demands which may be brought or made against the Transferee and all losses and properly incurred costs which the Transferee may incur or sustain arising from the failure of the Transferor to comply with the terms of the Agreement prior to the Effective Date.

3.3

The Transferee and Transferor each acknowledge that no representation, warranty or condition, express or implied is given by or on behalf of the other or their respective officers, staff, employees or agents in relation to this letter.

6.1

This Novation Agreement, and all disputes or claims arising out of or in connection with it, shall be governed by and construed in accordance with English law.

6.2

The parties to this Novation Agreement irrevocably and unconditionally agree that the High Court of Justice in England shall have exclusive jurisdiction in relation to all disputes or claims arising out of or in connection with this Novation Agreement.

 

 

and

and

  

  

 

 

 

(1)  

Strakan International Limited, a company incorporated in Bermuda and registered in Scotland under company number F000906, whose registered office is at Galabank Business Park, Galashiels, TD1 1QH ("Strakan");

(2)  

Zindaclin Limited, a company registered in England with company number ###-###-####, whose registered office is at Cheshire House, 164 Main Road, Goostrey, Crewe, Cheshire, CW4 8JP ("Zindaclin");

(3)  

Wragge & Co LLP of 3 Waterhouse Square, 142 Holborn, London, EC1N 2SW ("Wragge").

(A)  

This agreement is supplemental to the Acquisition and Licence Agreement dated [Ÿ] 2010 between Strakan and Uluru Inc. (together the “Sellers”) and Zindaclin (the "Acquisition and Licence Agreement") whereby the Sellers have agreed upon the terms and subject to the conditions stated therein to sell certain intellectual property to Zindaclin.

(B)  

In addition, Strakan has agreed to deliver certain documents to Wragge to be held in escrow within 5 days of the Completion Date (as defined in the Acquisition and Licence Agreement). The parties are entering into this agreement in order to regulate the operation of such documents being held in escrow by Wragge.

1.1  

In this Agreement unless the context otherwise requires the following words and expressions shall have the following meanings:

1.2  

Unless the context otherwise requires, words and expressions defined in the Acquisition and Licence Agreement shall have the same meaning in this agreement.

1.3  

Reference to a "party" means a party to this agreement and includes its assignees (if any) and/or the successors in title to substantially the whole of its undertaking.

2.1  

The Sellers and Zindaclin hereby appoint Wragge to act as escrow agent under and for the purposes of this Agreement and the Acquisition and Licence Agreement and Wragge hereby accepts such appointment on the terms and conditions set forth herein.

2.2  

Wragge shall have no obligations in connection with the Escrow Account or its administration other than as set out in this agreement.

3.1  

Pursuant to clause 6 of the Acquisition and Licence Agreement, Strakan shall deliver the following documents to Wragge to be held in escrow, within 5 days of the Completion Date (as defined in the Acquisition and Licence Agreement):

(a)  

all registration and renewal (if any) documents for the Patents and Reserved Trade Marks (as defined in the Acquisition and Licence Agreement);

(b)  

engrossed and executed (but undated) version of the assignments of the Reserved IP (as defined in the Acquisition and Licence Agreement) and such other forms or documents required to register such assignments in each relevant territory on terms that these documents are to be held to the order of Strakan pending fulfilment of the escrow conditions pursuant to Clause 6.2 of the Acquisition and Licence Agreement.

3.2  

Wragge shall release the Escrow Documents within 5 days of receipt by Wragge of all of the following: Strakan’s Instructions and Zindaclin’s Instructions. If Strakan’s Instructions are not received within ten days of the date of Zindaclin’s Instructions, then Wragge shall contact Strakan and if no instructions are forthcoming within a further ten (10) days then Strakan’s Instructions shall be deemed to have been received and Wragge shall release the Escrow Documents accordingly.

3.3  

Unless otherwise required by law or regulatory requirement, Wragge shall not release the Escrow Documents to any person save in accordance with the terms of Clause 3.2 of this Agreement.

3.4  

Strakan and Zindaclin confirm to Wragge that the only obligations of Wragge are to hold and release the Escrow Documents in accordance with this Clause 3.

3.5  

On release of the Escrow Documents pursuant to Clause 3.2 of this Agreement, Wragge shall be released and discharged from all further obligations under this Agreement.

7.1  

A waiver of any term, provision or condition of, or consent granted under, this Agreement shall be effective only if given in writing and signed by the waiving or consenting party and then only in the instance and for the purpose for which it is given.

7.2  

No failure or delay on the part of any party in exercising any right, power or privilege under this Agreement shall operate as a waiver thereof, nor shall any single or partial exercise of any such right, power or privilege preclude any other or further exercise thereof or the exercise of any other right, power or privilege.

7.3  

No breach of any provision of this Agreement shall be waived or discharged except with the express written consent of the parties.

(a)  

the validity, legality and enforceability under the law of that jurisdiction of any other provision; and

(b)  

the validity, legality and enforceability under the law of any other jurisdiction of that or any other provision,

9.  

9.1  

Any notice given or made under or in connection with the matters contemplated by this agreement shall be in writing and shall be delivered personally or sent by fax:

Wragge LLP

3 Waterhouse Square

142 Holborn

London

EC1N 2SW

Fax:

+ 44 ###-###-####

Attention:

Patrick Duxbury and/or James Rowlands

Galabank Business Park

Galashiels

TD1 1QH

Fax:

+44 1896 664001

Attention:

***@***

Cheshire House

164 Main Road

Goostrey

Crewe

Cheshire, CW4 8JP

Fax:

[Ÿ]

Attention:

[Ÿ]

(a)  

if personally delivered, upon delivery at the address of the relevant party;

(b)  

if sent by fax, when received;

10.1  

This Agreement may be executed in any number of counterparts which together shall constitute one agreement.  Any party may enter into this Agreement by executing a counterpart and this Agreement shall not take effect until it has been executed by all parties.

10.2  

Delivery of an executed signature page of a counterpart by facsimile transmission or in AdobeTM Portable Document Format (PDF) sent by electronic mail shall take effect as delivery of an executed counterpart of this agreement.  If either method is adopted, without prejudice to the validity of such agreement, each party shall provide the others with the original of such page as soon as reasonably practicable thereafter.

11.1  

This Agreement is personal to the parties and accordingly no party without the prior written consent of the other shall assign, transfer, charge or declare a trust of the benefit of all or any of any other party's obligations or any benefit arising under this Agreement.

 

 

 

 

in the presence of: Steve Dunkerley

)

SIGNED by Kerry P. Gray

)

in the presence of: Daniel G. Moro

)

SIGNED by Richard Anderson

)

in the presence of:

)

SIGNED by Richard Anderson

)

in the presence of:

)