MANUFACTURING AND OPTION AGREEMENT BY AND BETWEEN INTERNATIONAL WEX TECHNOLOGIES INC. AND SABEX 2002 INC.

 

 

1.1 Definitions

1.2 Schedules

1.3 Currency

1.4 Choice of Law

1.5 Interpretation Not Affected by Headings of Party Drafting

1.6 Number and Gender

1.7 Time of essence

 

 

2.1 Regulatory Approvals

 

 

3.1 Manufacture and Supply of Finished Products

 

 

4.1 Term

4.2 Termination

4.3 Results of Expiry or Termination

 

5.1 Monthly Estimated Requirements

5.2 Forecast Updates

5.3 Purchase Orders

5.4 Increase over updated Forecasts

 

 

6.1 Price

6.2 Payment

6.3 Interests

 

 

7.1 Delivery of Finished Products, Transfer of Risks and Property, Costs

7.2 Requirements at delivery

7.3 Delivery Date

7.4 Compliance of Finished Products

 

 

8.1 Compliance with Specifications and Regulations

8.2 Reviewing of Specifications

8.3 Records of Operations

8.4 Governmental Bodies and Other Inquiries

 

 

9.1 GRANT

9.2 EXERCISE

9.3 Undertakings of WEX

9.4 Undertakings of Sabex

 

 

10.1 Corporate Existence

10.2 Warranties of Sabex Regarding the Finished Products

10.3 Execution and Delivery of Agreement

10.4 Veracity of Representations and Warranties

10.5 Limitation of Representations or Warranties

 

 

11.1 Corporate Existence

11.2 Execution and Delivery of Agreement

11.3 Compliance with applicable laws in the Research Area

11.4 Ownership of Commercialization Rights

11.5 No Litigation

11.6 No Infringement of Third Parties Intellectual Property Rights

11.7 Veracity of Representations and Warranties

 

 

12.1 Indemnification by Sabex

12.2 Indemnification by WEX

12.3 Insurance

 

 

13.1 Event of Force Majeure

 

 

14.1 Confidentiality of information

 

 

 

 

17.1 Assignability

17.2 Independent Contractors

17.3 Waiver

17.4 Binding Effect

17.5 Validity

17.6 Counterparts

17.7 Entire Agreement

17.8 Survival

17.9 Public Disclosure

17.10 Further Assurances

17.11 Cost and Expenses of Transaction

17.12 English language

THIS AGREEMENT is made and entered into this                     ^th day of March, 2004.

BY AND BETWEEN:

INTERNATIONAL WEX TECHNOLOGIES INC., a corporation duly incorporated under the Canada Business Corporations Act having its head office at ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇ ▇▇▇ herein represented by ▇▇. ▇▇▇▇▇ ▇▇▇▇, its Chief Executive Officer and Chairman, duly authorized for the purposes hereof as he so declares;

 

 

 

AND:

SABEX 2002 INC., a corporation duly incorporated under the Canada Business Corporations Act having its head office at ▇▇▇ ▇▇▇▇▇-▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇ ▇▇▇, herein represented by ▇▇. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, its President and Chief Operating Officer, duly authorized for the purposes hereof as he so declares;

 

 

“Act” shall mean the Canadian Food and Drug Act, as amended from time to time and including the rules and regulations promulgated thereunder;

“Affiliate” shall mean any individual, corporation or other entity that, directly or indirectly, through stock ownership or otherwise, controls, is controlled by, or is under common control with, the designated party, but only for so long as the relationship exists.

“API” shall mean Tetrodotoxin, a poison extracted from the “puffer” fish or “blow” fish, excreted from the fish’s liver, ovaries and intestines and which enters into the composition of the Finished Products;

“Certificate of Analysis” shall mean the analytical certificate for each batch of Finished Products to be delivered pursuant to Section 7.2 evidencing that the Finished Products conform to the Specifications;

“cGMP” shall mean current Good Manufacturing Practices as promulgated by the HPFB, the FDA and the EMEA; a code of regulations set forth for methods to be used in the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports to;

“Clinical Trials” shall have the meaning ascribed to this term in the fourth paragraph of the Preamble;

“Commercialization Rights” shall have the meaning ascribed to this term in Subsection 9.1.1 and as further defined in Subsection 9.1.2;

“Confidential Information” shall have the meaning ascribed to this term in Subsection 14.1.1;

“Effective Date” shall be the date first written above;

“EMEA” shall mean the European Agency for the Evaluation of Medicinal Products, any of its successor agencies or departments, or any other agency serving the same or similar function;

“Event of Force Majeure” shall have the meaning ascribed to this term in Section 13.1;

“EXW” shall have the meaning set out in the Incoterms of 2000 published by the International Chamber of Commerce, as modified from time to time;

“FDA” shall mean shall mean the Food and Drug Administration; the United States of America federal government agency that regulates the quality, safety and effectiveness of biological and pharmaceutical products in the United States of America, any of its successor agencies or departments, or any other agency serving the same or similar function;

“Finished Product(s)” shall mean the clinical lots for the following three products currently being developed by WEX based on a sodium channel blocking compound named Tetrodotoxin and its derivatives, namely Tetrodin™, Tectin™ and Tocudin™; in finished form and in any formulation, as further described in the Specifications;

“First Right of Refusal” shall have the meaning ascribed to this term in Subsection 9.1.1;

“Forecast(s)” shall mean the Initial Forecast and all Forecast Updates;

“Forecast Updates” shall have the meaning ascribed to this term in Section 5.2;

“Governmental Body” shall mean:

any domestic or foreign national, federal, provincial, state, municipal or other government or body;

any international or multilateral body;

any subdivision, ministry, department, secretariat, bureau, agency, commission, board or authority of any of the foregoing governments or bodies;

any quasi-governmental or private body exercising any regulatory, expropriation or taxing authority under or on behalf of any of the foregoing governments or bodies; or

any domestic, foreign, international, multilateral or multinational judicial, quasi-judicial, arbitration or administrative court, grand jury, tribunal, commission, board or panel.

“HPFB” shall mean the Health Products and Food Branch, a division of Health Canada, any of its successor agencies or departments, or any other agency serving the same or similar function;

“Initial Forecast” shall have the meaning ascribed to this term in Section 5.1;

“Know-How” means the skill or ingenuity based upon the body of knowledge which comprises all of the methods, processes, designs, information, formulas, manuals, guidelines and trade secrets relating to the API’s, the Finished Products and their formulation, including, without limitation, and all information necessary for obtaining the Regulatory Approvals;

“Lead Time” shall have the meaning ascribed to this term in Subsection 5.3.1;

“Licence Agreement” shall have the meaning ascribed to this term in Subsection 9.1.1;

“Licence Term” shall have the meaning ascribed to this term in Subsection 9.1.4;

“Loss” or “Losses” shall mean all liability claims, demands, damages, actions, suits, and judgments instituted by third parties against either of the parties hereunder attributable to bodily injury, sickness, disease, death, injury to property, infringement of intellectual property rights or otherwise, including, without limitation, reasonable attorney’s fees and investigation and other costs;

“New Drug Application” or “NDA” – an application to the FDA for marketing approval for a new therapeutic agent made upon successful completion of clinical trials;

“New Drug Submission” or “NDS” – an application to the HPFB for marketing approval for a new therapeutic agent made upon successful completion of clinical trials;

“Net Manufacturing Costs” shall mean the costs incurred by Sabex in the manufacturing of the Finished Products pursuant to the terms and conditions of this Agreement, as such costs are defined in Schedule “1.1.26” attached hereto;

“Notice of Compliance” or “NOC” means a notice issued under section C.08.004 of the Food and Drug Regulations enacted under the Act to allow the commercialization of a new pharmaceutical product;

“Person(s)” shall mean and include any individual, corporation, partnership, firm, joint venture, syndicate, association, trust, Governmental Body, and any other form of entity or organisation;

“Purchase Order” shall have the meaning ascribed to this term in Subsection 5.3.1;

“Regulatory Agency” or “Regulatory Agencies” shall mean any appropriate Governmental Body having jurisdiction over the approval of drugs and pharmaceutical products in any jurisdiction of the Research Area;

“Regulatory Approval(s)” shall mean all the necessary permits, licences and approvals from the appropriate Regulatory Agencies, to market, sell and distribute the Finished Products in the Research Area;

“Remaining Inventory” shall have the meaning ascribed to this term in Section 4.3;

“Research Area” shall mean the countries of Canada, the United States of America and the member states of the European Community;

“Specifications” shall mean the Finished Products’ process and manufacturing specifications and instructions, quality assurance and other applicable procedures, and product descriptions applicable to the Finished Products provided by WEX to Sabex, as such Specifications are set forth in Schedule “1.1.36” attached hereto;

“Term” shall mean the period set forth under Section 4.1;

“Territory” shall mean the country of Canada; and

“Third Party Offer” shall have the meaning ascribed to this term in Subsection 9.2.5.

 

Sabex’s Net Manufacturing Costs

Specifications

Patents or Patent Applications

Initial Forecast

WEX shall be responsible at its sole cost and expense for conducting any necessary clinical trials to obtain any and all Regulatory Approvals to commercialize the Finished Products anywhere in the Research Area; Sabex not to be incurring any liability for failure of WEX of obtaining such Regulatory Approvals.

Sabex acknowledges that it will fully co-operate with WEX and provide to WEX the technical information in its possession concerning the Finished Products to be manufactured so that WEX can obtain the Regulatory Approvals as soon as reasonably possible. WEX shall reimburse Sabex any and all reasonable costs and expenses that Sabex may incur in providing this assistance and information. All costs associated with any required validations relating to the Finished Products will be invoiced to WEX at Sabex’s Net Manufacturing Costs.

All documentation necessary to obtain the Regulatory Approvals shall be prepared and filed by WEX, who shall confer regularly with Sabex to report on the status of the clinical trials and the related regulatory filings. Sabex shall have the right to receive any such documentation submitted by WEX to the Regulatory Agencies in the Territory promptly upon a simple request from Sabex.

WEX shall inform Sabex immediately upon receipt of any such Regulatory Approvals and shall provide Sabex with copies thereof as well as of any correspondence from the Regulatory Agencies relating to same. WEX also agrees not to make any decisions likely to have a material effect on the development toward commercialization of the Finished Products in the Territory without consulting Sabex.

WEX agrees to disclose to Sabex all the technical instructions for the analysis of the API’s as well as the Know-How for the processing and analysis of same which are necessary in order to obtain the Regulatory Approvals and to allow Sabex to effectively manufacture Finished Products meeting the Specifications. WEX shall also provide Sabex with all pre-clinical and clinical data, marketing information, safety and stability testing and any other results of studies in its possession relating to the API’s.

During the Term of this Agreement, Sabex shall, subject to the terms and conditions of this Agreement, manufacture and sell exclusively to WEX the Finished Products (including placebo) ordered by WEX pursuant to Section 5.3 for completion of the Clinical Trials, subject to a maximum of one hundred thousand (100,000) Finished Products for the Term.

WEX agrees to exclusively purchase the Finished Products from Sabex for the Term, subject to the following exceptions: (i) to satisfy WEX’s requirements in excess of the limitation set forth in Subsection 3.1.1 above, (ii) to comply with any FDA or EMEA instructions requesting that the Finished Products be sourced in their respective jurisdiction and (iii) to conduct a clinical study before it reaches the Phase II b).

WEX agrees to provide Sabex free of charge at its Boucherville facilities all necessary API’s entering into the composition of Finished Products to be manufactured by Sabex for the Term in accordance with Subsection 5.3.4.

It is acknowledged by Sabex that WEX is already engaged in discussions to enter into a global agreement with a third party with regard to the commercialization of the Finished Products outside the Territory. The parties agree to negotiate in good faith the entering into of a global manufacturing agreement for the supply of Finished Products to WEX for sale outside the Territory, directly or through third parties, upon a request to that effect from WEX.

In the event that either party materially breaches or defaults on any of its obligations, representations, warranties, or covenants under this Agreement, the other party may give written notice to the defaulting party setting forth in reasonable details the nature of such breach or default. If the defaulting party fails to cure such breach or default within sixty (60) days from the date of such notice, this Agreement shall be subject to immediate termination upon additional written notice to the defaulting party. The non-defaulting party shall have available to it and may pursue all other rights and remedies under applicable laws.

WEX shall authorize the manufacture and packaging of Finished Products by issuing a firm purchase order (“Purchase Order”) to Sabex which is reasonably consistent with the Forecast and Sabex shall supply the Finished Products so ordered to WEX. Each Purchase Order shall be in a form and contain terms previously agreed to by the parties and shall indicate the quantities of each of the Finished Products requested. The proposed delivery date recited in the Purchase Order shall always be at least three (3) months (the “Lead Time”) following the date when the API’s necessary for Sabex to manufacture the Finished Products have arrived at Sabex’s Boucherville facilities pursuant to Subsection 5.3.4.

The packaging of Finished Products shall be as per Sabex’s standard packaging formats.

Sabex shall promptly acknowledge each Purchase Order by signing and returning to WEX the acknowledgement copy of each Purchase Order promptly after its receipt. By signing such Purchase Order, Sabex will confirm its approval of such order. If accepted by Sabex, such Purchase Order shall be binding upon WEX. Failure of Sabex to deliver to WEX a written notice objecting to a Purchase Order within five (5) business days after receipt of the Purchase Order shall constitute Sabex’s acceptance of the Purchase Order.

Upon confirmation or deemed confirmation of approval of a Purchase Order by Sabex pursuant to Subsection 5.3.3, WEX shall ship to Sabex’s Boucherville facilities the quantities of API’s necessary to manufacture the Finished Products so ordered, within a period of ten (10) days of such confirmation or deemed confirmation of approval.

In the event of any conflict between the terms and conditions of this Agreement and the terms and conditions of any Purchase Order, the terms and conditions of this Agreement shall prevail.

WEX shall have the right to reject or revoke acceptance of any Finished Products which are not as warranted in Section 10.2, at any time during the period of twenty (20) days following the date of arrival of such Finished Products to WEX’s facilities.

In the event WEX tests the Finished Products to determine whether the Finished Products meet the Specifications and finds that the Finished Products do not conform to the Specifications, WEX shall report any adverse findings to Sabex within the twenty (20) day period following delivery of the Finished Products to WEX’s facilities. All Finished Products not meeting the Specifications and not capable of being reworked into Finished Products meeting Specifications, shall be returned to and disposed of by Sabex, after proof has been established that they were handled and stored properly by WEX.

Sabex shall replace at WEX’s location any Finished Products which are mutually determined not to meet Specifications. Such replacement Finished Products shall conform to the Specifications and shall be at no additional cost to WEX.

If the analysis or assay of a sample of the Finished Products performed by or for WEX indicates that the batch of Finished Products does not meet Specifications and Sabex’s analysis or assay of its sample from the same batch indicates that the batch does meet Specifications, Sabex will so advise WEX and a joint investigation will be conducted to determine the cause of the failure.

The party who was responsible for causing the product not to meet the Specifications shall bear all risk of loss with respect thereto, including but not limited to the cost of the joint investigation and any independent third party testing of Finished Products as well as destruction costs.

In consideration for the manufacture and supply to WEX of Finished Products for the conduct of the Clinical Trials, WEX hereby grants to Sabex a first right of refusal (the “First Right of Refusal”) to acquire an exclusive license in the Territory (the “Licence Agreement”), to all of WEX’s rights required to make, have made, use, sell, have sold, offer for sale, market, and distribute each of the Finished Products, in any injectable pharmaceutical formulation, once a NOC has been obtained from the HPFB for each of the Finished Products (the “Commercialization Rights”).

The Commercialization Rights include all the rights necessary for the manufacture, promotion, testing, marketing, distribution and sale, of the Finished Products including, but not limited to, information, data, formulae, inventions, patents or patent applications (a list of such patents or patent applications existing as of the Effective Date is attached hereto as Schedule “9.1.2”). improvements, manufacturing and medical information, copyrights, know-how and trade secrets, whether protectable or not as trade secrets, including copies of any standard operating procedures that apply to the production, manufacturing and packaging of the Finished Products, as well as the WEX’s current analytical test methods and all other intellectual property rights related to the Finished Products; it however being understood that (i) all research and Clinical Trials for the Finished Products shall always be accomplished by WEX as provided in this Agreement, (ii) WEX shall have complete control over such research and clinical trials, and (iii) Sabex shall be granted access to the results of such research and Clinical Trials as part of the Commercialization Rights.

As part of the Licence Agreement, Sabex shall have the complete exclusivity of the manufacture and sale of Finished Products in the Territory. WEX will undertake in the Licence Agreement not to, directly or indirectly, supply the Finished Products or the API’s to any other entity for the manufacturing of Finished Products intended for sale in the Territory.

The term of this License Agreement shall be variable for each of the Finished Products, and shall be the date upon which the last of the licensed patent(s) claims covering the Commercialization Rights expires for each of the Finished Products, whether by statute or otherwise (the “Licence Term”) and the effective date shall also be variable for each of the Finished Products, starting from the notice received from the HPFB confirming the granting of the NOC for each of the Finished Products. Each time such an approval from the HPFB has been received for one of the Finished Products, it shall be added to the Licence Agreement.

It is understood that Sabex shall be free to manufacture and sell the Finished Products in the Territory without any further restrictions or payments after the expiration of the Licence Term, subject however to Sabex exclusively purchasing its API’s from WEX, at a reasonable and competitive price to be mutually agreed upon and subject to the payment of a reasonable royalty to be agreed upon for use of WEX’s trade-marks used in connection with each such Finished Products.

Following a notice sent by WEX to Sabex advising it of the incoming grant of a NOC for the first of the Products, according to the information reasonably available to it, the parties will have three (3) months to negotiate in good faith and fairness and in a diligent manner mutually acceptable and reasonable terms and conditions for the Licence Agreement, which are standard and competitive in the Canadian pharmaceutical industry.

The Licence Agreement shall also include the licensing of the trademarks owned by WEX for each of the Finished Product in consideration of the payment by Sabex of either a royalty or profit sharing mechanism to be agreed upon. The terms and conditions of such compensation will depend on drug acceptability, market potential and market shares captured.

If the parties arrive to an agreement within this three (3) month period, it shall be in writing and it shall be conditional upon the granting of the NOC for this Finished Product within the following twelve (12) months. If such NOC is not granted within this twelve (12) month period, the negotiated agreement will be of no further force and effect and WEX shall have an obligation to send a new notice to Sabex to negotiate the terms and conditions for the Licence Agreement within a new three (3) month period, before having the right to negotiate the Commercialization Rights for the Territory with a third party.

This procedure shall apply for as long as the parties have not had a three (3) month period to negotiate an agreement for the Commercialization Rights in the Territory and that a NOC is not granted for any of the Finished Products within the next twelve (12) months.

If no agreement can be arrived at during this three (3) month period to negotiate the terms of the Licence Agreement, it is understood that WEX will not be allowed to enter into an agreement of the same nature for the Commercialization Rights in the Territory for any of the Finished Products, with a third party making a bona fide offer (the “Third Party Offer”), before having notified and sent to Sabex on a confidential basis as hereinafter provided a copy of such Third Party Offer, for any of the Finished Products in order for Sabex to fully appreciate the extent and consequences of such Third Party Offer on the manufacturing and distribution of the Finished Products for the Territory.

Sabex shall then have twenty (20) days to decide if it shall exercise its First Right of Refusal. Sabex agrees to sign and be bound by the terms of a non-disclosure agreement, concurrently with the receipt of the Third Party Offer, as may be reasonably necessary to maintain confidential the information contained therein.

Should Sabex decide to avail itself of its First Right of Refusal, WEX shall notify the third party offeror of its refusal of the Third Party Offer and Sabex shall enter into the Licence Agreement with WEX on terms and conditions not less favourable than those of the Third Party Offer. If Sabex decides not to avail itself of its First Right of Refusal, WEX shall be free to enter into an agreement on the exact terms of the Third Party Offer with such third party offeror.

WEX shall then notify in writing Sabex, within the next ten (10) business days of such event, of the conclusion or non conclusion of this agreement with such third party offeror. If WEX does not enter into such an agreement, the First Right of Refusal shall remain in effect for any new third party bona fide offer WEX may receive thereafter and the procedure set out herein shall apply mutatis mutandi.

WEX undertakes to supply Sabex with all necessary API’s for the manufacture and sale of Finished Products by Sabex for the term of the Licence Agreement, at a set price, including an adjustment mechanism, to be mutually agreed to by the parties in the Licence Agreement.

WEX undertakes not to distribute directly the Finished Products in the Territory, thereby depriving Sabex of its First Right of Refusal to acquire a license to the Commercialization Rights, should the parties fail to negotiate acceptable terms and conditions for the Licence Agreement. However, this restriction shall not be interpreted as to prevent WEX from selling each of the Finished Products in the Territory under the Special Access Programme of the HPFB or any equivalent program until the NOC for such Finished Product is obtained or definitively refused.

WEX hereby represents and warrants as follows and hereby acknowledges and confirms that Sabex is relying on such representations and warranties in connection with the purchase by it of the Finished Products:

WEX is a company duly organized, validly existing and in good standing under the laws of Canada, has the corporate power to own its properties and carry on its business as the business is now being conducted.

The execution and delivery of this Agreement by WEX and the observance and performance of the terms and provisions of this Agreement on the part of WEX to be observed and performed have been duly authorized and do not constitute a violation of applicable laws or a violation or a breach of WEX’s charter documents or by-laws or any provision of any contract or other instrument to which WEX is a party or by which it is bound, or any order, writ, injunction, decree, statute, rule, by-law or regulation applicable to it, nor do they constitute a default (or would with the passage of time or the giving of notice or both, or otherwise, constitute a default) under any contract, agreement or instrument to which WEX is a party or by which WEX is bound; WEX is not a party to or bound by any mortgage, lien, deed of trust, or any material lease, agreement or instrument, or any order, judgment or decree which would require the consent of another to the execution of this Agreement or prohibit or require the consent of another to fully give effect to any of the transactions referred to in or contemplated by this Agreement.

In the conduct of the Clinical Trials, WEX shall be solely responsible for complying with all laws and regulations applicable in the Research Area including, without limitation, laws and regulations relating to the importation of the Finished Products.

WEX represents and warrants that it is the owner of record of the Commercialization Rights and it has the right to apply for patents that are part of the Commercialization Rights.

There are no suits, actions or legal, administrative, arbitration or other proceedings or governmental investigations affecting WEX or the right of WEX to manufacture, sell or use the API’s or grant a licence to the Commercialization Rights and no such suits, actions or legal, administrative, arbitration or other proceedings or governmental investigations affecting the ownership of the API’s, the right to sell the API’s or the grant of a licence to the Commercialization Rights have been served on WEX.

WEX is not subject to any liability, claim, or threatened claim, accrued, contingent or otherwise by any person under any law, rule, regulation or order of any Governmental Body, which could likely adversely affect the supply of the API’s to Sabex including, without limitation, any third party personal liability claims, environmental damage or order for remediation or non compliance with any environmental laws with respect to the production of the API’s.

Sabex shall, at its expense, defend any action or claim instituted against WEX or its Affiliates and indemnify and hold harmless WEX and its Affiliates, together with their respective officers, directors, employees, agents, and insurers for any Loss arising out of Sabex’s breach of (i) its warranties or (ii) Sabex’s covenants each as set forth in this Agreement.

In such event, WEX shall not settle any such claim without the prior written consent of Sabex, which consent shall not be unreasonably withheld or delayed, and Sabex shall have the right, if it so wishes, to conduct negotiations to settle or to conduct any litigation arising out of any such claim, at its expense. WEX shall provide prompt and written notice of any claim to Sabex and WEX shall cooperate in the defense of the claim.

WEX shall, at its expense, defend any action or claim instituted against Sabex or its Affiliates and indemnify and hold harmless Sabex and its Affiliates, together with their respective officers, directors, employees, agents, and insurers for any Loss arising out of WEX’s breach of (i) its warranties or (ii) WEX’s covenants each as set forth in this Agreement.

In such event, Sabex shall not settle any such claim without the prior written consent of WEX, which consent shall not be unreasonably withheld or delayed, and WEX shall have the right, if it so wishes, to conduct negotiations to settle or to conduct any litigation arising out of any such claim at its expense. Sabex shall provide prompt and written notice of any claim to WEX and Sabex shall cooperate in the defense of the claim.

“Event of Force Majeure” means any event or circumstance occurring after the Effective Date which was beyond the reasonable control of the party invoking such event or circumstance (including fire, flood, earthquake, elements of nature or acts of God, acts of war, terrorism, riots, civil disorders, rebellions, power outages, strikes or lockouts, or acts of a Regulatory Agency) and which event or circumstance was either (i) unforeseeable, or (ii) foreseeable, but could not have been avoided, prevented or overcome through the exercise of reasonable diligence. “Event of Force Majeure” does not include (i) any event or circumstance which was caused by the negligence or willful act outside the scope of the duties and obligations under this Agreement of the party invoking an Event of Force Majeure or the employees or agents of such party, and (ii) financial inability to perform or changes in market conditions.

A party shall be excused from its failure to perform any of its obligations hereunder if such party is unable to perform such obligation by reason of an Event of Force Majeure.

If a party wishes to invoke an Event of Force Majeure, such party shall:

immediately notify the other party of (i) the occurrence of such Event of Force Majeure, (ii) the estimated date on which the Event of Force Majeure began, and (iii) the nature of the Event of Force Majeure;

not be entitled to suspend performance under this Agreement of any greater scope or longer duration than is required by the Event of Force Majeure;

use all commercially reasonable efforts to (i) mitigate the effects of the Event of Force Majeure (including through the reasonable use of alternate sources, work-around plans or other means), (ii) cure its inability to perform, (iii) resume full performance hereunder as soon as practicable, and (iv) keep the other party apprised of such efforts on a continuous basis; and

as soon as reasonably practicable, submit to the other party evidence of the Event of Force Majeure.

The party invoking an Event of Force Majeure shall:

forthwith after the termination of the Event of Force Majeure notify the other party of such termination; and

as soon as practicable after the termination of the Event of Force Majeure resume performance of the obligations affected by such Event of Force Majeure and notify the other party of such resumption.

Sabex shall not, as long as the Licence Agreement referred to in Subsection 9.1.1 shall not have been entered into by and between Sabex and WEX, without the consent of WEX, directly or indirectly communicate or disclose to any person any confidential knowledge or information howsoever acquired including, without limitation, information received relating to or concerning the Clinical Trials, customers, API’s, Finished Products, technology, Know-How, intellectual property rights, systems, operations or other confidential information regarding WEX’s business or that of any of its Affiliates (“WEX Confidential Information”), nor shall it use or make available any such WEX Confidential Information directly or indirectly in connection with any business or activity in which it is or proposes to be involved, or in connection with the solicitation or acceptance of employment with any person. WEX undertakes to do likewise with respect to any confidential knowledge or information howsoever acquired or other confidential information regarding Sabex’s business or that of any of its Affiliates (the “Sabex Confidential Information”). For the purposes of this article, shall be excluded from the obligations of confidentiality and non-disclosure hereunder the WEX Confidential Information ant the Sabex Confidential Information (collectively the “Confidential Information”) which the recipient thereof demonstrates:

is a part of the public domain through no act or omission of such party or its officers, employees, agents, advisor or other representatives;

was lawfully within its possession prior to its receipt thereof from the disclosing party;

was received in good faith by the receiving party from a third party, who was lawfully in possession of, and had the right to disclose, the same; or

is information which such party is required by law to disclose, provided that such party first notifies the other party that it believes it is required to disclose such information and it allows the other party a reasonable period of time to contest the disclosure of such information.

The obligations of this Agreement regarding Confidential Information shall survive expiry or termination of this Agreement for as long as they remain confidential.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The provisions contained in Articles and Sections 1, 2, 4.3, 6, 8.3, 9, 12, 14, 15, 16 and 17, as well as any other provisions which, by their terms, are stated or required to survive termination or expiration of this Agreement shall survive expiration or termination of this Agreement and remain in force until discharged in full. In addition, any other provisions required to interpret and enforce the parties’ rights and obligations or to wind up their outstanding obligations under this Agreement shall survive to the extent required.

However, it is agreed by the parties that the Right of First Refusal granted to Sabex pursuant to Article 9, including WEX’s obligation pursuant to Subsection 9.2.5 and undertaking pursuant to Subsection 9.3.2 shall survive the expiration of this Agreement as well as the termination of this Agreement provided that such termination is not caused by Sabex’s default.

mutually agreed upon by the parties in writing; or

in the reasonable opinion of legal counsel for the party making such announcements are required by law. If a party believes a public announcement to be required by law with respect to this Agreement, it will give the other party such notice as is reasonably practicable and an opportunity to comment upon the announcement.

Signed in

PRODUIT:

PRODUCT:

 

FABRICANT:

MANUFACTURER:

 

Vérifié par

Verified by

 

 

Approuvé par

Approved by

 

 

Approuvé par

Approved by

 

 

Description

 

 

Solubilité
Solubility

 

Identification

 

 

 

 

 

Transmittance

Transmittancy

 

[ILLEGIBLE] de la solution

Clarity of solution

 

Perte au séchage

Loss on drying

 

Substances apparentées

Released [ILLEGIBLE]

 

     Impuretés [ILLEGIBLE]

     Known [ILLEGIBLE]

 

Dosage

[ILLEGIBLE]

Initial 12 month forecast:

 

 

 

 

TTX Extraction Method

Systemic Analgesia by TTX

Local Analgesia by TTX

TTX Extraction System

TTX Purification Method

TTX Formulation for Analgesia, Anesthesia and Drug Addiction Treatment

▇▇▇-TTX Extraction Method

Local Analgesia by TTX

Synergistic Analgesia by TTX and Morphine

Synergistic Analgesia by TTX and Aspirin

Powder for injection