Document:

exhibit10-22.htm -- Converted by SEC Publisher, created by BCL Technologies Inc., for SEC Filing

	Exhibit 10.22

	 	LICENSE AND SUPPLY AGREEMENT

This Agreement is made as of the 23rd of November 2007 by ABIOGEN PHARMA SPA, a corporation organized and existing under the Laws of Italy and having its principal offices at Via Meucci 36, 56014 Ospedaletto Pisa Italy, represented by the Managing Director, Dr. Massimo Di Martino (hereinafter called "ABIOGEN"), and

Samaritan Pharmaceuticals Ireland Inc. Limited a corporation organised and existing pursuant to the Laws of Ireland, located at Daneswalle Business Park, Monksland, Athlone, Country Roscommon, Ireland represented by Dr. Christos Dakas, Managing Director Europe, (hereinafter called "SAMARITAN").

WITNESSETH

WHEREAS ABIOGEN has rights on a pharmaceutical PRODUCT (as hereinafter defined) whose active ingredient is named Clodronate for use in the treatment of Tumoral Osteolysis.

AND WHEREAS ABIOGEN is the lawful holder of the Know-how (as hereinafter defined) related to such PRODUCT;

AND WHEREAS SAMARITAN desires to license in, market and distribute the PRODUCT (as hereinafter defined) directly or through an AFFILIATE (as hereinafter defined) as pharmaceutical speciality in the Territory (as hereinafter defined), and to have a right to do so; Now, therefore, the parties hereto agree as follows:

ARTICLE 1 DEFINITIONS

The following terms as used hereinafter in this Agreement shall have the meaning set forth in this Article:

	1.1  	  	"PRODUCT shall mean those pharmaceutical compositions or formulations, containing the  
	  	  	SUBSTANCE as sole active ingredient, listed in Appendix A, finished in a dosage form, for human  
	  	  	use, under the Trademark, provided that, for greater certainty, “PRODUCT” does not include the  
	  	  	Intrarticular formulation developped by Abiogen.  
	  
	1.2  	  	“SUBSTANCE” shall mean the compound identified by the generic name DISODIUM  
	  	  	CLODRONATE.  
	  
	1.3  	  	"REGISTRATIONS" shall mean the governmental approvals and/or authorizations which are  
	  	  	required under laws and regulations to sell the PRODUCT in each country of the Territory.  
	  
	1.4  	  	"TRADEMARK" shall mean a trademark registered in the Territory in the name of ABIOGEN, or a  
	  	  	trademark registered in the name of SAMARITAN and which, after being approved by ABIOGEN,  
	  	  	will be assigned, free of any charge, to ABIOGEN, before commercialization of the PRODUCT by  
	  	  	SAMARITAN in the Territory.  

	1.5  	  	"TERRITORY" shall mean Greece, Cyprus and Turkey.  
	  
	1.6  	  	"NET SALES" shall mean the gross sales of the PRODUCT (value added taxes excluded) less: (i)  
	  	  	trade discounts and rebates, (ii) returns and allowances including promotional allowances, not to  
	  	  	exceed of gross sales, actually credited to third parties and (iii) sales and excise taxes and other  
	  	  	taxes paid (other than income taxes), which are levied or borne on sales price of the PRODUCT;.  
	  
	1.7  	  	"ABIOGEN" shall mean ABIOGEN and shall also include any company controlling, controlled by  
	  	  	or under common control with ABIOGEN which has been appointed by ABIOGEN to perform, on its  
	  	  	behalf, any of its obligations arising out of this Agreement and which will be responsible for the  
	  	  	fulfilment thereof provided that ABIOGEN retains its responsibility for performance of such  
	  	  	obligations.  
	  
	1.8  	  	“KNOW-HOW" shall mean all technical information, documents, data, trade secrets and information  
	  	  	relating to the PRODUCT, as described in Article 1.1, and which is necessary or useful for the filing,  
	  	  	prosecuting and obtaining and maintaining of the Registrations and for the marketing, use,  
	  	  	distribution and sale of the PRODUCT in each country of the Territory in accordance with the terms  
	  	  	of this Agreement.  
	  
	1.9  	  	“DOSSIER” shall mean the available documentation supplied by ABIOGEN to SAMARITAN  
	  	  	necessary for the filing by the Regulatory authority (as hereinafter defined) in order to obtain the  
	  	  	marketing authorization in each country of the Territory.  
	  
	1.10  	  	“REGULATORY AUTHORITY” means the Greek, the Cypriot and the Turkish and\or any  
	  	  	provincial government ministry, department or agency, the regulatory body or other person  
	  	  	responsible in the territory of Greece, Cyprus and Turkey in question for issuing licences and\or for  
	  	  	enacting, monitoring and\or forcing the applicable laws or related to the sale of pharmaceutical  
	  	  	PRODUCT in such market or jurisdiction.  
	  
	 1.11  	  	“cGMP” means the current Good Manufacturing Practices of the EU (as in effect from time to  
	  	  	time).  	  	  
	  
	 1.12  	  	“SAMARITAN” shall mean SAMARITAN and shall also include its “AFFILIATES”, that is any  
	  	  	company which is controlling, controlled by or under common control with SAMARITAN and which  
	  	  	has been appointed by SAMARITAN to perform, on its behalf, any of its obligations arising out of  
	  	  	this Agreement and which will be responsible together with SAMARITAN for the fulfilment thereof.  
	  
	  	  	ARTICLE 2  
	  	  	GRANTS  
	  
	 2.1  	  	For the term of this Agreement ABIOGEN grants to SAMARITAN, and SAMARITAN hereby  
	  	  	accepts, subject to the conditions and limitations stated hereinbelow, a non-assignable exclusive  
	  	  	licence to use the Know-How and the Dossier to register and to market, distribute and sell the  
	  	  	PRODUCT under the Trademark in each country of the Territory.  
	  
	 2.2  	  	Licence rights granted under article 2.1 above do not automatically include new formulations of the  
	  	  	PRODUCT developed by ABIOGEN.  

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	2.3 SAMARITAN undertakes to sell the PRODUCT only as a pharmaceutical speciality, on its finished  
	dosage form. SAMARITAN shall refrain from:  
	  
	(i) bringing any alteration or modification to any data contained in the Dossier; or  
	  
	(ii) using any part of the Dossier or any other data upon the PRODUCT for any other purpose than for  
	obtaining the authorization for the sale of the PRODUCT in each country of the Territory or performing any  
	of its obligation under this Agreement; or  
	  
	(iii) assigning, transferring or selling the Licence to any third party.  
	  
	2.4 This Agreement grants SAMARITAN a licence for the sole and only purpose of registration, marketing,  
	distributing and selling the PRODUCT in each country of the Territory. SAMARITAN will not have any  
	right to use the PRODUCT and/or the Know-how for other purposes.  
	  
	2.5 Within thirty (30) days of the execution of this Agreement, ABIOGEN shall deliver to SAMARITAN  
	the Dossier currently in its possession or under its control and which is useful for the purposes of  
	marketing the PRODUCT and shall thereafter promptly deliver to SAMARITAN any additional  
	information and documentation which comes into its possession or under its control relating to the  
	PRODUCT which will aid, assist or facilitate the marketing of the PRODUCT in each country of the  
	         Territory.  
	  
	ARTICLE 3 
	CONFIDENTIALITY 
	  
	3.1 SAMARITAN acknowledges the confidential nature of the Know-how and unless required by law or  
	legal process, SAMARITAN undertakes not to reveal to any third parties (other than Regulatory  
	Authorities in furtherance of the intent and implementation of this Agreement) and to consider and  
	treat as confidential all data and information communicated to it by ABIOGEN, as well as all data  
	and information generated by SAMARITAN according to Article 2.4, for the term of this Agreement  
	and ten (10) years thereafter, and to oblige all its personnel having access to the said data and  
	             information to act in a similar manner. The foregoing obligation shall not apply to:  
	  
	         (a)  	  	data which at the time of disclosure is in the public domain,  
	  
	         (b)  	  	data which after disclosure become part of the public domain by publication or otherwise,  
	  	  	except by breach of this Agreement by SAMARITAN,  
	  
	         (c)  	  	data which SAMARITAN can establish by competent proof were in SAMARITAN's  
	  	  	possession at the time of disclosure by ABIOGEN and were not acquired directly or indirectly  
	  	  	from ABIOGEN.,  
	  
	         (d)  	  	Information that is required to be disclosed under law or by order of a court of competent  
	  	  	jurisdiction, provided, however, that ABIOGEN is granted due advance notice of such a  
	  	  	requirement and the information so required is identified in order to be able to contest the  
	  	  	same and then only to the minimum extent of disclosure so required.  
	  
	             The provisions of this Article 3.1 shall survive the expiration or termination of this Agreement.  

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	ARTICLE 4 
	REGISTRATION 
	  
	4.1.            ABIOGEN agrees to, after execution of this Agreement, execute or cause to have executed all  
	             documents reasonably requested by SAMARITAN, and at SAMARITAN’s expense, as required to  
	             permit to SAMARITAN to obtain the Registration for the PRODUCT in each country of the Territory  
	             under the name of SAMARITAN. If the documents requested by SAMARITAN include additional  
	             studies to be performed by ABIOGEN, ABIOGEN is entitled to evaluate the feasibility of such  
	             additional studies and to decide to perform them or not. Should ABIOGEN decide to perform the  
	             additional studies requested by SAMARITAN the costs for such studies will be on SAMARITAN’s  
	             account. In case ABIOGEN decides not to perform such additional studies the parties will meet in  
	             good faith in order to find an amicable solution. SAMARITAN shall diligently take all steps as  
	             required to have said Registration approved by the Health Authorities in each country of the Territory  
	             on or before _______________ . SAMARITAN undertakes to maintain at its own expense all  
	             Registrations held by SAMARITAN hereunder and to bear all expenses and costs involved to any  
	             additional information and/or activities required by the Health Authorities in each country of the  
	             Territory.  
	  
	 4.2.           In the event that, due to negligence or failure of SAMARITAN, SAMARITAN will not obtain such  
	             Registration within the term established in article 4.1., ABIOGEN has the right to terminate this  
	             Agreement, by giving a written notice thereof to SAMARITAN which notice of termination shall be  
	             immediately effective upon receipt by SAMARITAN.  
	  
	             Within twenty (20) working days from the receipt of the DOSSIER, SAMARITAN will examine the  
	             DOSSIER supplied by ABIOGEN. Should the DOSSIER be not conformable with the standard  
	             requirements of the Health Authorities SAMARITAN will notify ABIOGEN of such non-conformity  
	             and ABIOGEN will refund SAMARITAN of the instalment paid by SAMARITAN upon signature of  
	             this Agreement.  
	  
	             After the filing, if the application for registration is rejected either party is entitled to terminate this  
	             Agreement with one month written notice. In this case ABIOGEN will be entitled to withhold the  
	             instalment paid by SAMARITAN upon the signature of this Agreement.  

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	4.3.      SAMARITAN shall use reasonable commercial efforts to launch the PRODUCT within three (3)  
	         months from the date of the price approval by the authorities. In the event that SAMARITAN does  
	         not launch the PRODUCT in each country of the Territory within the time period herein  
	         contemplated, ABIOGEN may, prior to the launch, terminate this Agreement by giving a written  
	         notice thereof to SAMARITAN, which notice of termination shall be immediately effective upon  
	         receipt by SAMARITAN: in this case ABIOGEN will be entitled to withold the instalment paid by  
	         SAMARITAN upon the signature of this Agreement and SAMARITAN shall transfer free of charge  
	         to ABIOGEN, or to a third party designated by ABIOGEN, the Registration relating to the  
	         PRODUCT in each country of the Territory within thirty (30) days from ABIOGEN’s request.  
	         SAMARITAN may terminate this Agreement prior to launch by notice in writing to ABIOGEN if  
	         SAMARITAN is unable to launch by the date herein contemplated as a result of the failure of  
	         ABIOGEN to provide SAMARITAN with any required data or information: in this event  
	         SAMARITAN shall transfer to ABIOGEN, or to a third party designated by ABIOGEN, the  
	         Registration relating to the PRODUCT in each country of the Territory within thirty (30) days from  
	         ABIOGEN’s request, at ABIOGEN’s expense. In such a case SAMARITAN will have the only right  
	         to receive back the instalment paid by SAMARITAN upon the signature of this Agreement, other  
	         rights being excluded.  
	  
	4.4.      All activity to be carried out by SAMARITAN to obtain and/or maintain the Registrations and/or to  
	         satisfy the requirements of the Regulatory Authorities in each country of the Territory as herein  
	         contemplated shall be conducted in strict accordance with the requirements of the applicable  
	         Regulatory Authority. No act which could adversely affect the Registrations and no clinical trial for  
	         whatever purpose may be commenced, undertaken or carried out by SAMARITAN.  
	  
	4.5. During the terms of this Agreement ABIOGEN agrees to give SAMARITAN and its personnel such  
	         reasonable support, co-operation and information regarding the Registration of the PRODUCT as  
	         SAMARITAN may reasonable request from time to time, being understood what is stated in Article  
	         4.1 above.  
	  
	ARTICLE 5  
	TRADEMARK  
	  
	5.1     SAMARITAN shall sell the PRODUCT under the Trademark which is and shall remain of Abiogen’s  
	         property. During the term of this Agreement ABIOGEN grants to SAMARITAN a royalty-free non-  
	         assignable license to use the Trademark in each country of the Territory for the commercialization of  
	         the PRODUCT in each country of the Territory.  
	  
	  
	ARTICLE 6 
	  
	PROMOTION AND MARKETING 
	  
	6.1 Promotion  
	  
	     (a)  	  	SAMARITAN will use reasonable commercial efforts to promote and sell the PRODUCT in  
	  	  	the Territory. All expenses of marketing, particularly those of promotion and advertising of  
			 the PRODUCT in each country of the Territory, shall be borne by SAMARITAN

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	     (b)  	  	SAMARITAN shall send to ABIOGEN, not later than sixty (30) days after signature of this  
	  	  	Agreement, a sales budget and a promotional plan for the commercialization of the  
	  	  	PRODUCT. Subsequently, SAMARITAN shall send to ABIOGEN, during the term of this  
	  	  	Agreement a yearly sales budget and promotional plan, within the month of November of each  
	  	  	year.  
	  
	     (c)  	  	The PRODUCT shall be promoted strictly in accordance with the scientific profile,  
	  	  	therapeutic indications, governmental approved data sheet and promotional guidelines and  
	  	  	requirements for post-marketing surveillance which, in any case, have been previously  
	  	  	approved in writing by ABIOGEN. In all respect, as for clinical work, SAMARITAN will  
	  	  	proceed in close co-operation with ABIOGEN, in order most efficiently to ensure consumer  
	  	  	protection, serving public health interest and complying with the requirements of the health  
	  	  	authorities in each country of the Territory. SAMARITAN agrees and undertakes that some  
	  	  	of its representatives and/or employees shall participate at SAMARITAN expenses to a  
	  	  	training course at ABIOGEN’s facilities in order to improve their knowledge about the  
	  	  	PRODUCT and the methods of marketing of the PRODUCT anywhere in each country of the  
	  	  	Territory.  
	  
	     (d)  	  	All promotional materials, including sales aids and advertisements relating to the PRODUCT,  
	  	  	shall be submitted by mail and by fax for ABIOGEN’s approval prior to their use, that will be  
	  	  	considered as automatically given if ABIOGEN does not oppose to it in a maximum term of  
	  	  	ten (10) working days from the date of receipt .  
	  
	     (e)  	  	SAMARITAN agrees that it will not solicit customers for the PRODUCT outside the  
	  	  	Territory, nor establish any branch or maintain any depot for the distribution of the  
	  	  	PRODUCT outside each country of the Territory.  
	  
	     (f)  	  	Sales: SAMARITAN shall send to ABIOGEN at the end of January, April, August and  
	  	  	October in each calendar year specific information about the following items relating to the  
	  	  	previous calendar quarter, where available:  
	  
	     (g)  	  	Monthly sales, in units and in values of the PRODUCT and its competitors in the same  
	  	  	therapeutic group and in other relevant therapeutic groups.  
	  
	     (h)  	  	Moving annual total and year to date sales.  
	  
	6.2.   Competitive Specialities: SAMARITAN agrees that, during the term of this Agreement, it will not  
	         market, directly or indirectly, in each country of the Territory, any PRODUCT containing clodronate  
	         or any other bisphosphonate for the same therapeutic indications of the PRODUCT, nor other  
	         PRODUCT with oral administration in therapeutic class M5B having the same therapeutic indications  
	         of the PRODUCT.  

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	6.3. 	  	  	Adverse drug reaction: Both parties will exchange adverse drug reactions and safety information  
	  	  	  	reports in a manner and time frame that will allow compliance with regulatory reporting and ongoing  
	  	  	  	safety review of the PRODUCT. The parties shall agree upon standard operating procedures in a  
	  	  	  	separate pharmacovigilence and safety procedure document which will ensure the reporting of these  
	  	  	  	events to regulatory authorities and to each other before starting any clinical trials and/or before  
	  	  	  	marketing of the PRODUCT commences under terms of this Agreement, as well as compliance with  
	  	  	  	any other regulatory requirement regarding the safety of the PRODUCT. In any event, it shall be  
	  	  	  	assured that ABIOGEN will centralize all information related to adverse drug reactions and safety  
	  	  	  	information on a world wide basis in the global safety data base. Each of SAMARITAN and  
	  	  	  	ABIOGEN shall immediately inform the other of any new information and/or findings concerning  
	  	  	  	side effects, toxicity or safety of the PRODUCT which come to its attention during the term of this  
	  	  	  	Agreement. All information referring to toxicological and/or adverse side-effects related to the  
	  	  	  	PRODUCT shall be centralized by ABIOGEN.  
	  
	6.4. 	  	  	PRODUCT recall: In the event that SAMARITAN shall be required to initiate a recall, PRODUCT  
	  	  	  	withdrawal or field correction of any PRODUCT (a “Recall”), SAMARITAN shall notify ABIOGEN  
	  	  	  	and ABIOGEN shall fully co-operate with SAMARITAN in notifying SAMARITAN’s customers to  
	  	  	  	return all PRODUCT and shall follow any other instructions provided by SAMARITAN. In the  
	  	  	  	event that ABIOGEN believes that a Recall may be necessary and\or appropriate, prior to taking any  
	  	  	  	action ABIOGEN shall immediately notify SAMARITAN and ABIOGEN and SAMARITAN co-  
	  	  	  	operate with each other in determining the necessity and nature of the action to be taken. With  
	  	  	  	respect to any Recall, SAMARITAN shall be responsible for co-ordinating all necessary activities in  
	  	  	  	connection with such Recall and ABIOGEN and SAMARITAN shall each co-operate with the other  
	  	  	  	in recalling the affected PRODUCT. In the event that a Recall results solely from any cause or event  
	  	  	  	arising from the manufacture, testing, storage, handling, packaging or labelling of the PRODUCT by  
	  	  	  	ABIOGEN or those for whom it is responsible or any other cause or event attributable to ABIOGEN  
	  	  	  	or those for whom it is responsible, ABIOGEN shall be responsible for all expenses of such Recall.  
	  	  	  	In the event that a Recall results solely from any cause or event arising from the transportation,  
	  	  	  	receiving, storage, handling, marketing or distribution of the PRODUCT by SAMARITAN or any  
	  	  	  	other cause or event attributable to SAMARITAN or those for whom it is responsible, SAMARITAN  
	  	  	  	shall be responsible for all expenses of such Recall. In all other cases the parties shall share the  
	  	  	  	expenses of the Recall equally and each party shall reimburse the other for fifty percent (50%) of any  
	  	  	  	expenses of Recall incurred by such other party. Recall expenses shall include, but not be limited to,  
	  	  	  	the expenses of notification, destruction or return of Recalled PRODUCT and SAMARITAN and  
	  	  	  	ABIOGEN’s reasonable out-of-pocket costs in connection with such Recall including, but not limited  
	  	  	  	to, reasonable attorney’s fees and expenses and credits and expenses claimed or paid to customers.  
	  	  	  	Each party shall use reasonable commercial efforts to minimize the Recall expenses which it incurs  
	  	  	  	and shall provide to the other, upon request, reasonable evidence of the out-of-pocket expenses being  
	  	  	  	claimed by it. In no case ABIOGEN shall be liable to SAMARITAN for any direct or aindirect loss  
	  	  	  	of profit, damages and expenses as a result of a recall except for what provided herein.  
	  
	6.5.            Minimum purchases: SAMARITAN shall order for delivery during each of the successive twelve-  
	  	  	  	month periods immediately following the date of first launch of the PRODUCT (herein referred to as  
	  	  	  	"Marketing Year") within the term of this Agreement, the following minimum amounts of  
	  	  	  	PRODUCT:  

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	  	  	- capsules 400 mg.: at least one batch of capsules for each country of the Territory where one batch is  
	  	  	formed by 100.000 capsules (hereinafter “batch size”);  
	  
	  	  	ABIOGEN shall have the right to terminate this Agreement if the above minimum is not respected.  
	  
	6.6.  	  	SAMARITAN agrees to indemnify, save harmless and compensate ABIOGEN and its officers,  
	  	  	directors and employees from and against any and all claims, demands, actions, causes of action,  
	  	  	suits, proceedings, judgments, liabilities, damages, losses, costs, expenses, fines, penalties and other  
	  	  	similar assessments including, but not limited to, reasonable attorney’s fees and expenses incurred  
	  	  	and documented relating to or arising out of a breach by SAMARITAN of any of its obligations.  
	  
	  
	  
	  	  	ARTICLE 7  
	  	  	SUPPLY  
	  
	     7.1. 		 In order to ensure the quality of the PRODUCT, SAMARITAN agrees that, during the term of this  
	  	  	Agreement, it will buy the PRODUCT only from ABIOGEN or from a third party designated by  
	  	  	ABIOGEN.  
	  
	     7.2.   		 Obligation to manufacture.
	  
	  	  	(a) ABIOGEN will manufacture (or cause to be manufactured) and supply to SAMARITAN, in  
	  	  	accordance with the terms herein and in a timely fashion, the quantity of the PRODUCT ordered by  
	  	  	SAMARITAN from time to time. Each PRODUCT supplied by ABIOGEN pursuant hereto shall be  
	  	  	manufactured in accordance with the following (collectively, the “Manufacturing Requirements):  
	  	  	(i) the Specifications for the PRODUCT including the purity, potency and physical and chemical  
	  	  	properties, stability and formulation, (ii) applicable cGMP;  
	  
	  	  	(b) ABIOGEN warrants that all PRODUCT supplied by it to SAMARITAN pursuant to this  
	  	  	Agreement shall (i) be manufactured, packaged, tested, stored and handled in accordance with the  
	  	  	Manufacturing Requirements, (ii) be capable of maintaining its purity, potency and other property  
	  	  	characteristics contemplated in its Specifications until the expiration date for such PRODUCT, and  
	  	  	(iii) at the time of delivery of the PRODUCT to the carrier (Ex-Works, ABIOGEN factory) the  
	  	  	PRODUCT will have a remaining shelf life of at least twenty-four (24) months.  
	  
	  	  	(c) ABIOGEN will communicate in a reasonable advanced time, during the term of this Agreement,  
	  	  	any changes to the formulation of the PRODUCT, site of manufacture, methods of manufacture  
	  	  	(including equipment used in the manufacture), sources of raw materials, sources or nature of  
	  	  	packaging materials, testing procedures or any other matter relating to the Specifications of the  
	  	  	PRODUCT as contained in the Dossier.  
	  
	7.3.   		 Supply Price: The supply price (the “Supply Price”) of PRODUCT from ABIOGEN to SAMARITAN
	  	  	is fixed in Euro currency and such Supply Price shall be intended for goods delivered ex-works  
	  	  	ABIOGEN factory: shipment and insurance costs shall be covered by SAMARITAN. The Supply  
	  	  	Price is set out in Appendix B, which constitutes an integral part of this Agreeement.  

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	 7.4        The payment of each invoice issued by ABIOGEN will be made by SAMARITAN within 30 days  
	  	  	 following the date of the invoice, by bank transfer on the bank account indicated by ABIOGEN. In  
	  	  	 case SAMARITAN delays the payment interest will be due to ABIOGEN according to the Italian  
	  	  	 Law D. Lgs. 9 ottobre 2002 n. 231. In case of a delay longer than fifteen (15) days ABIOGEN will be  
	  	  	 entitled to suspend the supply of the PRODUCT until the payment is made.  
	  
	7.5.  	  	Before commencement of each calendar quarter (being a three (3) month period ending on March 31,  
	  	  	 June 30, September 30 and December 31) ("Q"), SAMARITAN shall provide ABIOGEN with the  
	  	  	 rolling forecast of its expected requirements of the PRODUCT over the next four (4) calendar  
	  	  	 quarters (Q1 to Q4). The quantities for the first two calendar quarters covered by each rolling forecast  
	  	  	 (Q1 and Q2) will be considered as a firm order and at the time that SAMARITAN delivers such  
	  	  	 forecast it will deliver to ABIOGEN a purchase order for the Specialties consistent with its  
	  	  	 commitments as aforesaid (to the extent not previously delivered).  
	  
	7.6.  	  	All purchase orders submitted by SAMARITAN shall contemplate the purchase of PRODUCT in  
	  	  	 minimum batch sizes (for each presentation of the PRODUCT) as contemplated above, and shall  
	  	  	 specify, among other things, the required delivery date, which delivery date shall be at least ninety  
	  	  	 (90) days following delivery of the purchase order; provided further that SAMARITAN may not  
	  	  	 request more than one (1) delivery date in any calendar quarter without the prior consent of  
	  	  	 ABIOGEN.  
	  
	 7.7.       The quantities of PRODUCT ordered by SAMARITAN which have been manufactured by or on  
	  	  	 behalf of ABIOGEN in accordance with its manufacturing and quality obligations hereunder shall be  
	  	  	 supplied by ABIOGEN or its designated supplier "Ex-Works" manufacturing plant, and neither  
	  	  	 ABIOGEN nor any of its designated suppliers will have, thereafter, any liability for loss or damage to  
	  	  	 the PRODUCT arising during transit or following receipt by SAMARITAN as a result of any acts or  
	  	  	 omissions by or on behalf of the carrier or SAMARITAN. Transfer of goods will be carried out by  
	  	  	 SAMARITAN.  
	  
	 7.8.        The specifications of the PRODUCT are set forth in the Registrations for the PRODUCT and may  
	  	  	 only be changed by ABIOGEN from time to time. ABIOGEN guarantees that the PRODUCT will  
	  	  	 conform to all specifications set forth in the Dossier.  
	  
	7.9.        Within thirty (30) days of the receipt of a delivery of a PRODUCT, SAMARITAN shall inspect such  
	  	  	 PRODUCT and shall advise ABIOGEN in writing (with full particulars) if a shipment of the  
	  	  	 PRODUCT is not in conformity with ABIOGEN’s obligations hereunder or is otherwise defective;  
	  	  	 provided, however, that SAMARITAN’s failure to advise ABIOGEN in a timely manner that a  
	  	  	 shipment of the PRODUCT does not conform shall not prejudice SAMARITAN’s right to  
	  	  	 subsequently reject or return such PRODUCT if the defect or other non-conforming condition which  
	  	  	 justifies rejection could not reasonably have been detected by an inspection in accordance with cGMP  
	  	  	 standards. If any PRODUCT is appropriately rejected by SAMARITAN, ABIOGEN shall promptly  
	  	  	 replace such PRODUCT with conforming goods within sixty (60) days. Such replacement  
	  	  	 PRODUCT shall be delivered to SAMARITAN at no cost to SAMARITAN. Alternatively, at  
	  	  	 SAMARITAN’s request, ABIOGEN shall provide to SAMARITAN a credit for the Supply Price  
	  	  	 therefore and all delivery charges and taxes and duties incurred by SAMARITAN to deliver the  
	  	  	 defective PRODUCT from ABIOGEN’s manufacturing facility to SAMARITAN’s designated  
	  	  	 delivery destination in each country of the Territory. SAMARITAN shall, at ABIOGEN's request  
	  	  	 and expense, follow any reasonable instructions to return to ABIOGEN or dispose of any PRODUCT  

9

		 	as aforesaid which are not in compliance with the agreed specifications and are replaced as regulated  
		 	in this Paragraph.  	  	  
		 	  
	7.10.	 	If ABIOGEN does not agree with SAMARITAN that the PRODUCT rejected under the provisions of  
		 	this Article fail to conform to the agreed Specifications, the matter will be submitted to an  
		 	independent laboratory agreed between the parties. The decision of such independent laboratory  
		 	following its analysis of the PRODUCT under question shall be final. The cost of the analysis shall  
		 	be borne by the party who was in error.  
		 	  
	7.11.	 	In the event that ABIOGEN is unable to supply the PRODUCT to SAMARITAN for three (3)  
		 	consecutive months, for any reason other than SAMARITAN's fault, ABIOGEN shall immediately  
		 	notify SAMARITAN thereof and both parties will try to identify an alternative source of supply (who  
		 	will be qualified to supply the PRODUCT with the Regulatory Authorities at ABIOGEN’s expense).  
		 	  
	7.12	 	 ABIOGEN shall not be responsible for any damages or losses suffered by SAMARITAN resulting from  
		 	the storage, testing, use or sale of PRODUCT, or the use or administration of PRODUCT by or to  
		 	third parties  	  	  
		 	  
		 	ARTICLE 8  
		 	QUALITY CONTROL  
		 	  
	8.1.	 	SAMARITAN shall carefully follow the directions and specifications of ABIOGEN in the analysis,  
		 	handling and storage of the PRODUCT, provided all such directions and specifications are consistent  
		 	with the Dossier and cGMP, and ABIOGEN shall provide to SAMARITAN all reasonable assistance  
		 	in connection therewith as SAMARITAN may reasonably request.  
		 	  
		 	ARTICLE 9  
		 	COMPENSATION  
		 	  
	9.1.	 	 For the right to use the Know How , the Trademark and the Dossier in each country of the Territory  
		 	subject to the conditions of this Agreement, SAMARITAN shall pay to ABIOGEN an up front  
		 	payment of ______________ . This sum shall be paid as follows:  
		 	  
	9.2.	 	 With respect to the sales of the PRODUCT in each country of the Territory by SAMARITAN the total  
		 	net compensation payable to ABIOGEN in respect of supplies of the PRODUCT (inclusive of the  
		 	Supply Price) will be of SAMARITAN's Net Sales of the PRODUCT in each country  
		 	of the Territory, as provided by Schedule A.  
		 	  
	9.3	 	 At the end of each calendar year, the difference between the agreed percentage according to Article 9.2  
		 	on the Net Sales of the PRODUCT sold during such calendar year and the sums of Supply Price paid or  
		 	payable for the PRODUCT pursuant to Subparagraph 7.3 and utilized in such Net Sales will be  
		 	established and, if the agreed percentage is greater, the amounts corresponding to such difference  
		 	(hereinafter referred to as "Adjustment") will be paid by SAMARITAN. Inventory on hand and not  
		 	utilized in the sales will not be taken into consideration. Calculations will be made by SAMARITAN  
		 	and notified to ABIOGEN within thirty (30) working days following the end of the year and subject to  
		 	ABIOGEN approval. In case the total net compensation results lower than the sums of Supply Prices  
		 	paid or payable by SAMARITAN for the PRODUCT, ABIOGEN shall not be obliged to pay any  
		 	adjustment to SAMARITAN.  	  	  

10

	9.4	 	The payment of the Adjustment will be carried out by SAMARITAN within thirty (30) working days  
		 	following the end of each calendar year by bank transfer. Each payment shall be accompanied by a  
		 	report in writing showing the period for which said payment is made, the Net Sales of the PRODUCT  
		 	during said period and the amount of the Adjustment accrued thereon. Failure by SAMARITAN to pay  
		 	the due amount at the due time will entitle ABIOGEN to stop the supply of the PRODUCT until the  
		 	payment is made. Adjustment accrued shall be payable to ABIOGEN in Euros and wired to the account  
		 	to be specified by ABIOGEN.  
		 	  
	9.5	 	SAMARITAN shall keep complete and accurate books and records of all sales and calculations upon  
		 	which royalties hereunder accrue and those books and records shall be open for inspection for a period  
		 	of two (2) years from the end of the calendar year in which such sales took place by a certified public  
		 	accountant or private consulting firm selected by ABIOGEN (other than one to whom SAMARITAN  
		 	has reasonable objection) who shall, at ABIOGEN's expense, have access to said records during normal  
		 	business hours, for the purpose of verifying the Adjustment accrued as herein provided. Such  
		 	accountant shall not disclose to ABIOGEN any information relating to the business of SAMARITAN  
		 	including the identity of any customers of SAMARITAN other than to indicate whether and to what  
		 	extent any reporting by SAMARITAN pursuant to Article 9.5 is inaccurate. SAMARITAN shall be  
		 	entitled to require such accountant to execute a reasonable confidentiality agreement prior to providing  
		 	such accountant with access to its books and records.  
		 	  
	9.6.	 	Where required by law, SAMARITAN shall have the right to withhold applicable taxes from any  
		 	payments made by SAMARITAN to ABIOGEN pursuant to this Agreement (whether such obligation  
		 	to withhold arises by reason of a re-categorization by the applicable physical authority of the payments  
		 	made by SAMARITAN to ABIOGEN pursuant hereto or otherwise). However, even if SAMARITAN  
		 	does not withhold taxes from any payment, ABIOGEN remains liable for all such taxes, if the  
		 	applicable taxing authority at a later date determines that such liability does exist. SAMARITAN shall  
		 	promptly provide ABIOGEN with receipts from the appropriate taxing authorities for all payments of  
		 	taxes withheld and paid by SAMARITAN to such authorities on behalf of ABIOGEN as herein  
		 	contemplated.  
		 	  
		 	ARTICLE 10 
		 	             INFORMATIONS AND LITIGATION ABOUT INTELLECTUAL PROPERTY RIGHTS  
		 	  
	10.1.	 	SAMARITAN shall disclose to ABIOGEN all information received by SAMARITAN concerning the  
		 	institution of any opposition, re-examination, reissue, revocation, nullification or any official  
		 	proceeding involving the Trademark and the Know-how anywhere in each country of the Territory.  
		 	  
	10.2.	 	
In the event of the institution of any suit by a third party against ABIOGEN (or its Affiliates),  

		 	SAMARITAN or another licensee of ABIOGEN for any infringement involving the manufacture,  
		 	use, sale, distribution or marketing of the PRODUCT, Know-how and Trademark anywhere in each  
		 	country of the Territory, the party sued shall promptly notify the other party in writing.  
		 	SAMARITAN shall have the right to defend any suit brought against it at its own expense (subject to  
		 	indemnification hereunder), but shall, at all times, follow any technical considerations of ABIOGEN.  
		 	ABIOGEN and SAMARITAN shall assist one another and cooperate in any such litigation at the  
		 	request and expense of the requesting party (subject to SAMARITAN’s rights of indemnification and  
		 	reimbursement contemplated below).  

11

	10.3.	 	In the event that ABIOGEN or SAMARITAN becomes aware of actual or threatened infringement of a  
		 	Trademark in each country the Territory, that party shall promptly notify the other party in writing.  
		 	ABIOGEN shall have the exclusive right but not the obligation to bring, at its own expense, any  
		 	infringement action against any third party. SAMARITAN agrees to assist ABIOGEN and cooperate  
		 	in any such litigation at the request and expense of ABIOGEN.  
		 	  
	10.4.	 	The parties shall keep one another informed of the status of their respective activities regarding any  
		 	litigation or settlement thereof concerning the PRODUCT and/or the Trademark.  
		 	  
		 	ARTICLE 11  
		 	TERM -TERMINATION  
		 	  
	11.1.	 	Term: This Agreement will take effect from the date of execution and will continue in force until the  
		 	fifth (5th) anniversary of the date of first sale of the last of the PRODUCT’s formulation to be  
		 	launched by SAMARITAN, in each country of the Territory. This Agreement will thereafter be  
		 	automatically extended for subsequent periods of two (2) years, except if either of the parties gives a  
		 	minimum of six (6) months notice prior to the date of expiration of its desire not to extend it. The  
		 	notice of intention not to extend the Agreement can also be given partially with reference to each  
		 	country of the Territory. Neither party shall be entitled to claim any indemnity or compensation from  
		 	the other party as a result of the termination or non-renewal of this Agreement under the provisions of  
		 	this section.  	  	  
		 	  
	11.2.	 	Termination:
		 	                 a) Each party may terminate this Agreement totally or partially by a registered letter to the other party:  
		 	  
		 	                 (i) in case the other party fails to fulfil any of its obligations under this Agreement and does not correct  
		 	                  such default of obligations within sixty (60) days counting from the day on which a registered letter  
		 	                  requiring to correct such default of obligations is received by the other party;  
		 	  
		 	                 (ii) in the case provided by Article 4.2.  
		 	  
		 	                 (b)  	  	ABIOGEN may terminate this Agreement totally or partially at its sole discretion by a  
		 	                 registered letter to SAMARITAN with immediate effect in the following cases:  
		 	  
		 	  	  	(i)  	  	If SAMARITAN does not register the PRODUCT according to Article 4, or  
		 	  
		 	  	  	(ii)  	  	If SAMARITAN doesn’t launch the PRODUCT according to Article 4.3, or  
		 	  
		 	  	  	(iii)  	  	If SAMARITAN, on its own initiative, ceases to market the PRODUCT in each  
		 	  	  	  	  	country of the Territory for six consecutive months.  
		 	  
		 	  	  	(iv)  	  	If the control of SAMARITAN, shall become vested into another company or firm,  
		 	  	  	  	  	or if SAMARITAN merges with any other company.  
		 	  
		 	  	  	(v)  	  	In accordance with the provisions of Article 6.6.;  
		 	  
		 	  	  	(vi)  	  	If SAMARITAN does not fulfill the obligations provided by Articles 2.3.; 3; 4.4.  

12

	(vii)  	  	In case of the bankruptcy or insolvency of SAMARITAN, or in case of the filing by  
	  	  	SAMARITAN of any petition or answer seeking reorganization, readjustment, or  
	  	  	rearrangement of its business under any law or any government regulation relating to  
	  	  	bankruptcy or insolvency, or in case of the institution by SAMARITAN of any  
	  	  	proceedings for the liquidation or winding up of its business, or for the termination of  
	  	  	its corporate charter.  
	  
	11.3. Provisions upon early termination: Upon expiration of the term of this Agreement or early termination  
	                far any reasons mentioned in article 11.2 SAMARITAN undertakes:  
	  
	             (a) to return to ABIOGEN within thirty (30) days all confidential documents and data of any kind  
	             communicated by ABIOGEN which would concern the PRODUCT and the Combination except  
	             those submitted to the applicable health authorities;  
	  
	             (b) to cease marketing the PRODUCT, than SAMARITAN shall 180 days to sell down its inventory  
	             of the PRODUCT, being firm that SAMARITAN shall pay to ABIOGEN the compensation provided  
	             by this Agreement for such sales;  
	  
	             c) to make available to ABIOGEN, free of charge, all data and information relating to the regulatory  
	             approval of PRODUCT, upon being so requested by ABIOGEN in writing;  
	  
	             d) to transfer, and assist to ABIOGEN in taking all necessary action with the competent authorities in  
	             order to transfer to ABIOGEN or its designee, within thirty (30) days from the date of request by  
	             ABIOGEN, any rights, titles, applications, Registration and/or authorizations necessary to sell the  
	             PRODUCT in each country of the Territory, subject to SAMARITAN’s rights under paragraph (b)  
	             above;  	  	  
	  
	             e) to interrupt immediately the use of the Trademark, subject to SAMARITAN’s rights under  
	             paragraph (b) above;  
	  
	             f) to consider and treat as strictly confidential and refrain from making use of, during a period of ten  
	             (10) years from the date of termination, any information communicated by ABIOGEN as long as the  
	             same has not been made public;  
	  
	             g) to interrupt immediately the use of the Know-How.  
	  
	          Termination of this Agreement shall be without prejudice to any other rights or remedies the Party  
	          terminating this Agreement may have against the defaulting party arising out of the default in question.  
	  
	11.4. ABIOGEN shall have the right to receive all payments accrued hereunder prior to the effective date of  
	               termination and, subject to its continuing obligations, to keep all payments previously received.  
	  
	           11.5. Survival: The obligations of the parties set forth in article 3, 6.8., 9.5, 11.3 and 13 hereof shall survive  
	               the expiration or termination of this Agreement.  

13

	ARTICLE 12 
	GENERAL PROVISION 
	  
	   12.1.          Independent status of the parties: SAMARITAN and ABIOGEN are independent contractors and  
	                 neither shall bind or attempt to bind the other to any contract or obligations outside of the license  
	                 agreement. Nothing contained or done under the Agreement shall be interpreted as constituting either  
	                 party the agent of the other in any sense of the term whatsoever.  
	  
	   12.2.          Substitution: Abiogen may at any time designate, for the benefit or charge of any of the rights or  
	                 obligations resulting from this Agreement, any physical person or legal entity. Additionally,  
	                 ABIOGEN shall be entitled to, at any time, assign this Agreement to any third party.  
	  
	   12.3.          This Agreement may not be, directly or indirectly, assigned or transferred, in whole or in part, by  
	                 SAMARITAN, without the written consent of ABIOGEN.  
	  
	   12.4.           Compliance with law: Each party shall comply with, and shall not be in violation of any valid  
	                 applicable international, national, state or local statutes, laws, ordinances, rules, regulations, or other  
	                 governmental orders of each country of the Territory in which the PRODUCT are either  
	                 manufactured or sold which affect the research, purchase, sale, shipment, distribution and storage of  
	                 the PRODUCT.  
	  
	    12.5.          Force majeure: No party shall be responsible for a failure or delay in performance of any of the  
	                 obligations hereunder due to force majeure such as wars, insurrections, strikes, acts of God,  
	                 Governmental actions or controls or any other contingency beyond the direct control of such party. A  
	                 party whose performance of obligations has been delayed by force majeure shall use its best efforts to  
	                 overcome the effect of the force majeure as soon as possible. In these cases, the party affected by the  
	                 force majeure shall notify immediately to the other party the existence of the force majeure. The other  
	                 party will have no right to demand indemnity for damage, provided, however, that if the event of  
	                 Force Majeure preventing performance shall continue for more than six (6) months, either party may  
	                 terminate this Agreement with a written notice to the other without any liability hereunder, except the  
	                 obligation to make payments due to such date.  
	  
	   12.6.            Notices and amendments: all notices and communications related to this Agreement shall be hand  
	                 delivered, or sent via teIefax, courier or by registered air-mail to the other party at its address  
	                 hereinabove given, and immediately confirmed by registered air-mail (when hand-delivered or sent  
	                 by fax or courier).  
	  
	   12.7.          This Agreement embodies all of the understandings and obligations between the parties concerning the  
	                 PRODUCT; any amendments and supplements shall not be valid unless executed in writing by duly  
	                 authorized officers of both parties.  
	  
	   12.8.          Waiver: The waiver of relief from any breach or non-fulfillment of any term and condition of this  
	                 Agreement does not constitute a waiver of any relief from any other breach or non-fulfillment of that  
	                 or any other term and condition.  
	  
	   12.9.          Severability: in the event any portion of this Agreement shall be held illegal, invalid, void or  
	                 ineffective, the remaining portion hereof shall remain in full force and effect. If any of the terms or  
	                 provisions of this Agreement are in conflict with any applicable statute or rule of law, then such terms  
	                 or provisions shall be deemed inoperative to the extent that they may conflict therewith and shall be  
	                 deemed to be modified to conform with such statute or rule of law.  

14

	ARTICLE 13  
	GOVERNING LAW AND DISPUTE RESOLUTION  
	13.1	 	This Agreement shall be governed and construed in accordance with the laws of Switzerland  
		 	applicable therein.  	  	  
	13.2	 	Any disputes arising with respect to or in connection with this agreement (including the validity,  
		 	invalidity, breach or termination) that the parties cannot solve amicably, shall be resolved by  
		 	arbitration in accordance with the Swiss Rules of International Arbitration of the Swiss Chambers  
		 	of Commerce in force on the date when the Notice of Arbitration is submitted in accordance with  
		 	these rules.  	  	  
		 	The numbers of arbitrator shall be one.  
		 	The seat of arbitration shall be Geneva.  
		 	The arbitral proceeding shall be conducted in English.  
		 	ARTICLE 14  
		 	ENTIRE AGREEMENT  
	14.1	 	This Agreement sets out the entire agreement between ABIOGEN and SAMARITAN relating to its  
		 	subject matter and supersedes all prior oral or written agreements, arrangements or understandings between  
		 	them relating to such subject matter.  	  	
 

 

		 	IN WITNESS WHEREOF, the parties have signed this Agreement in duplicate originals by their qualified  
		 	representatives in the dates set forth.  	  	  
		 	  
		 	ABIOGEN PHARMA S.p.A.  	  	SAMARITAN PHARMACEUTICALS IRELAND  

15ex1023.htm -- Converted by SEC Publisher, created by BCL Technologies Inc., for SEC Filing

	
EXHIBIT 10.23

	
SUPPLY AND DISTRIBUTION AGREEMENT

	 	
1. PARTIES

This Agreement is made between:

Siraeo Ltd having its principal address at 15 Yakinton St Ramat-Poleg 42207 Netanya, Israel (Hereinafter referred to as: "the Company”)

and

Samaritan Pharmaceuticals Ireland Inc. Limited , having its principal address at Daneswell Business Park, Monksland, Athlone, County Roscommon, Ireland (Hereinafter referred to as
“the Distributor”)

2. PURPOSE

The purpose of this Agreement is to grant the Distributor the exclusive right to market, sell and distribute the Product within the Territory as defined in Exhibit A and in accordance
with the terms and conditions expressed herein.

3. DEFINITIONS

In this Agreement, each time the following terms are used with initial capitals, their meanings shall be as specified hereunder.

- "Affiliated Companies" shall mean, in relation to a given company, any company which, directly or indirectly, controls, is controlled by or is under control with such company.

- "Batch" and "Lot" shall mean a defined quantity of the Product, which has been produced during a defined cycle of manufacture, and which is identified by a unique production
number.

- “Contract Year” shall mean any period of 12 (twelve) consecutive calendar months following the Effective Date, as defined hereunder, or anniversary thereof.

     - “Distribution Record" shall mean the record sheet detailing every shipment of the Product made by the Distributor to any of its customers including, but not limited to, the customer's name, address, batch number, number of units and date of shipment.

- “Effective Date” shall mean the fist day of the month following the month during which the Distributor is granted the "Product License", hereinafter "PL", as hereunder
defined.

- “Know How” shall mean any and all secret and confidential, technical, scientific, clinical, pharmacological and marketing information and data pending to the Products,
developed and used by the Company and its Affiliated Companies and supplied to the Distributor under this Agreement and possible future additions.

- “Parties” shall mean the Company and the Distributor.

- “Party” shall mean either the Company or the Distributor.

- “PL” shall mean the Product License (or authorization under a physician prescription/named patient program) granted by the competent local medical authorities for allowing
the sale and distribution of the Product in file Territory.

- “Price” shall mean the price of the Product as described in Exhibit B.

- “Product” shall mean “Infasurf” a pharmaceutical product containing Calfactant, for the specific medical indication: “prevention and treatment of Respiratory Distress Syndrome in newborns”.

- “Recall Operation” shall mean the operation for recalling the Product if it is suspected or known to be defective.

4. APPOINTMENTS

The Company hereby appoints the Distributor as its exclusive Distributor for the Product in the Territory (as defined in Exhibit A) and Distributor hereby accepts such appointment in
accordance with the

	5 	.  	  	PRODUCE PURCHASE AND SUPPLY COMMITMENTS  
	  
	  
	  	  	 5.1  	Distributor and Company agree to the purchase and supply of the following U.S. Dollar Purchase of Product over the initial term of this Agreement per the following

Performance Schedule, subject to the terms and conditions herein expressed.  		 
	  	  	  
	  	  	  
	  
	6 	.  	  	PRODUCT REGISTRATION  	  	  
	  
	  	  	  	6.1  	  	The Company will provide a copy of the file provided to the US FDA, for registration purposes in the Territory. This file is to be held in the strictest confidence and is to be used only for rite purpose

of registration in the Territory. Distributor will protect this information as it does its own most highly secret information.
	  	  	  	  	  
	  	  	  	6.2  	  	
The Distributor shall expeditiously take all necessary measures in order to obtain and maintain appropriate approvals from the local regulatory authorities, which shall include, but not be limited to an

authorization to sell and distribute the Product within the Territory. All costs and expenses associated with obtaining regulatory approval and the necessary permitsto sell the Product in the Territory,

including plant inspection if necessary, shall be borne by the Distributor.  

	  	  	  	  	  
	  	  	  	6.3  	  	If the PL has not been obtained within 2 years of the signing of this agreement, the Company will

have the right to terminate this agreement. In the event of such termination no monies whatsoever paid

by the Distributor to the Company under the terms of this agreement will be refundable.  
	  	  	  	  	  
				6.4

	

	
If the Product has not been launched within 30 months of the signing of this agreement, the Company will have the right to terminate this agreement. 

In the event of such termination no monies whatsoever paid by the Distributor to the Company under the terms of this agreement will be refundable. 

	  	  	  	6.5  	  	The Distributor must transfer $_________to the Company if the product has not obtained a valid PL, in within 24 months of the date of signing this agreement.  
	  	  	  	6.6  	  	The Distributor must transfer $_________ to the Company if the product has not beenlaunched (where launchisdefined as"placed onthe marketsuchthatitisable to be freely purchased by any person

authorized to purchase medicines") in within 24 months of the date of signing this agreement.
	  	  	  	  	  
	  	  	  	6.7  	  	The Distributor must transfer $_________to the Company 12 months of the date of launch of the product.
	  	  	  	  	  
	  	  	  	6.8  	  	The Distributor must transfer an additional $_________to the Company within 24 months of the date of launch of the product.
	  	  	  	6.9  	  	
The Distributor must transfer an additional $_________to the Company within 36 months of the date of launch of the product.

	  	  	  	6.10  	  	All PL shall be maintained in force by the Distributor. If the PL expires due to failure to renew or to cause attributable to Distributor, the Company shall have the right to terminate the Agreement. In the

event of such termination no monies paid under the terms of this agreement will be refundable.  
	  	  	  	  	  
	  	  	  	6.11  	  	If the product is eligible for Orphan drug protection, or data exclusivity, or marketing exclusivity or similar protection in the Territory, the Distributor will at its own expense diligently apply for and

maintain those rights in the name of the Company. If this is not possible under local law, then the Distributor will be nominated as the holder of these rights in the Territory. If the contract is

terminated for any reason whatsoever, the Distributor undertakes at its own expense to transfer those rights to the Company. 
	  	  	  	  	  

2

	6.12      	
The Distributor shall pay all regulatory and governmental registration fees, all the registration maintenance fees and all other fees required for the sale of the Product as promulgated by any local, regional or national governmental authority.

	6.13      	
The Distributor will send the Company two (2) copies of all registration certificates and related documentation, including governmental reimbursement approval, and any other data or documentation from the responsible authorities forthwith upon their issuance, together with an English translation. The distributor specifically agrees to provide the Company with English language copies of all correspondence with the registration authorities as well as any and all government agencies.

	6.14      	
Each party shall furnish the other with information on any observed unexpected side effects, injury, toxicity or sensitivity reaction associated with the clinical use, studies, investigations or tests of the Product in accordance with Exhibit D, which contains a sub-agreement.

	6.15      	
Distributor will register the Product in the Territory at its own cost and will be named as the owner of the PL. Immediately following termination of the Agreement for any cause the Distributor shall, at its own expense, transfer all LP/Marketing and reimbursement approvals to the name of Company or any body named by Company. For the purposes of the removal of doubt, neither ONY Inc. nor Company will be responsible for any costs associated with Product registration or the transfer of the PL, except as outline in paragraph 6.16 below.

	6.16      	
C o m p a n y will pay up to $________in each Territory to defray actual registration fees incurred by Samaritan in transferring the PL to Company (or body designated by Company). This payment will be made within 30 days of Company receiving from Samaritan certified copies of the amended PL in the name of the Company (or designated body).

	7.      	
 

COMPETITION, REPORTS, FORECASTS, INFORMATION AND INVENTORY

	7.1      	
Obligation Not to Compete

	 	
The Company shall refrain front selling the Product in the Territory and shall not grant nor appoint any other person or entity as Distributor of the Product in the Territory as long as this agreement is in farce and has not been terminated.

	 	
The Distributor shall not manufacture, sell or distribute any other producers far the same indications as Infasurf in the assigned Territory during the term of this agreement and for a period of two years following its expiry or termination for any reason.

	 	
Sub-Distributors maybe appointed with the written consent of Siraeo.

	 	
The Distributor hereby warrants that it shall not, either directly or through any third party, seek customers for the Product outside the Territory, sell and/or export the Product outside the Territory, or establish any branch or maintain any distribution depot outside the Territory without the express written agreement of the Company. Oral permission will not suffice.

 

	7.2      	
Reports and Agreements

	 	
The Distributor agrees to furnish the company within 30 (thirty) days after each calendar quarter, with a true and accurate report on all sales of the Product in the Territory, as specified herein. The Distributor agrees to also furnish the Company with copies of all agreements, brochures, pamphlets and documents which may relate to the Product, including those developed, produced or used by the Distributor in connection with the sale of the Product.

	 	
At any time upon reasonable request of the Company, Distributor agrees to provide the Company with information, including but not limited to, selling prices, market trends, competitive environment and competitor’s prices, technical or commercial information useful for the adaptation of the Product to market requirements. Distributor agrees to send to the Company a quarterly report on market developments in the Territory and Distributor’s sales progress relating to the Product.

3

At any time and upon reasonable request of the Company, Distributor shall permit the Company's representative(s) to accompany Distributor's representative(s) on visits made to customers in order to have the Company better acquainted with the specificity of the market for the Product in the Territory. The Company agrees to send a letter of notice of at least 30 calendar days prior to the visits.

At any time upon reasonable request of The Company, Distributor Shall grant representatives of The Company and/or ONY Inc. reasonable access to areas of their facilities in which Product is or is to be packaged, tested, labeled or stored during the times of such operations for the purpose of confirming the compliance of such operations with Good Manufacturing Practice or the storage instructions accompanying this product.

	7.3      	
Forecasts

	 	
Following PL approval, the Distributor shall submit to the Company each calendar quarter during each calendar year a rolling forecast for the following 4 (four) quarters showing the planned purchase quantities of the Product. The Distributor shall place its firm orders for the Product for the following quarter with the rolling forecast. Before approval by the Company, the Distributor shall submit each month a rolling forecast for the following twelve months connected with firm orders for the Product for the following quarter.

		
	7.4      	
Information

	 	
The Company shall provide the Distributor with all presently available data, information and documents necessary for the execution of this Agreement, including technical documents and advertising material. The Company will provide suitable expert lecturers to assist with the product launch. The Distributor will be responsible for the cost of the abovementioned lectures including travel, board and any honoraria payable.

		
	7.5      	
Inventory

	 	
The Distributor shall buy and maintain, at his own cost, an inventory of the Product equaling no less than the amount forecast for the following quarter. The Distributor must undertake to keep the Product in good condition and in particular must maintain the product under the storage conditions laid down in Annex C during storage and transport. All necessary precautions must be taken to prevent the deterioration of the Product. Any deterioration due to transport or storage deficiencies will void the product warranty. All liability including product liability in such cases (in which an unbroken storage record showing compliance with the storage instructions cannot be produced) will be the sole responsibility of the Distributor. Similarly, is such cases all expenses involved with the necessity of recalling product, including (but not limited to) such steps as destroying product and purchasing replacement product will be the sole responsibility of the Distributor.

		
	8.      	
THE DISTRIBUTOR

			
	 	8.1      	
Independency

	 	8.1.1      	
For Its Own Account

	 	
The Distributor shall buy and sell the Product in its own name and for its own account and act in all respects as an independent contractor. The Distributor shall organize the distribution of the Product in such manner as to most effectively promote the sale of the Product and maintain a level of product support necessary for the proper selling, marketing and distribution of the Product.

	 	8.1.2      	
Independent Contractor

	 	
The Agreement does not designate the Distributor to be the agent, partner or legal representative of the Company for any purpose whatsoever, and the business conducted by the Distributor pursuant to this Agreement with third parties shall be wholly at the Distributor's own risk and account as an independent contractor.

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The Distributor is not granted any right or authority to assume or create any obligation or responsibility, express or implied on behalf of or to the name of the Company or to bind the Company in any manner whatsoever.

8.2 Unfair Competition and Infringement of Rights

The Distributor shall immediately inform the Company of all acts of unfair competition and of all infringement of patents, trade mark, trade names, or similar rights of the Company which have come to its attention to the extent that the rights of the Company have been violated If requested by the Company, the Distributor shall assist the Company at the Company's expense in any action or litigation involving each acts or infringements.

	9.      	
CONDITIONS OF SALE

 

	 	9.1.1      	
Purchase Orders

 

	 	
The Distributor shall send all orders for the Product to be purchased under this Agreement to the Company. Attempts should be made to place the order within a period of three (3) months from the intended date of delivery. Written Orders presented by the Distributor shall bind the Distributor after confirmation of acceptance thereof by the Company.

 

	 	
9.2      

	
Price Guidelines

 

	 	9.2.1      	
Price and Conditions

 

	 	
The Distributor shall purchase the Product at prices and on conditions set forth by the Company from time to time in Exhibit B. Notwithstanding the above, any price increase will be mutually discussed in good faith by the parties, and Exhibit B shall be deemed as amended accordingly. In the case of an increase in cost of raw material, the Company and Distributor agree to negotiate in good faith increases in the Price.

	 	
 

9.2.2 Payment Terms

 

	 	
The Distributor shall pay the Company for the Product supplied according to payment terms set forth in Exhibit B.

	 	
 

9 . 3 Advertising and Promotion

 

	 	
9.3.1 Best Efforts

 

	 	
The Distributor shall use its best efforts and diligence in promoting and initiating effectively the sales of the Product throughout the whole of its Territory.

	 	
 

9.3.2 Advertising and Promotional Activities

 

	 	
The Distributor shall ensure the advertising and the promotion of the Product and the participation in relevant conventions, trade shows and exhibitions held in the Territory. The costs of advertising and promotion are to be borne by the Distributor.

	 	
 

9 . 3 . 3 Conformity with Applicable Laws

 

	 	
The Distributor shall be responsible for any advertising and promotional material for the Product and for their conformity with applicable laws and regulations, as well as with the Company's branding guidelines as may be prepared from time to time. The Distributor agrees not to use any material that violates any law or good ethical practice as embodied in the ABPI Code of Practice for the Pharmaceutical

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	 	industry.

9.3.4 Distributors shall be responsible for delivering copy to the Company of any text in the local language that may be required under law, rule or regulation.

Distributor undertakes to cooperate with the Company in preventing all breaches of patents trademarks know how or other Intellectual Property rights relating to the products upon the terms of the subsequent paragraph and in any event to prevent said breaches using its best efforts.

In the case of possible breaches of patents trademarks know how or other Intellectual Property rights relating to the product on the part of third patties, Distributor undertakes to cooperate with the Company and with the Company's attorneys in order to allow the correct carrying out of legal actions.

Costs and expenses for legal actions or proceedings shall be borne by the Company, which, however, will not be obliged to act.

In the event the Company decides not to act, the Distributor may, after having received the permission of the Company, bring a legal action against a third-party infringer. In this case Distributor will be liable for all costs and expenses.

Distributor shall not institute or bring legal actions or proceedings against such infringers without prior written authorization from the Company. If requested by Distributor, the Company shall assist Distributor, at Distributor’s request in any action or litigation involving such acts or infringements.

10.  ASSIGNMENT

The Company shall have the right to assign this agreement. The Distributor may not assign this Agreement, without the prior consent of the Company.

Each Party reserves the right to terminate this Agreement if the control of the other Party passes over to another Party, other than the Party controlling it at the time of signature of this present Agreement.

11.  FORCE MAJEURE

If due performance of this Agreement by either party is affected in whole or in part by reason of any event, omission, accident, general shortage of commodities, legal circumstances or other matters beyond the reasonable control of such party, it shall give prompt notice thereof to the other party and shall be under no liability for any loss, damage, injury or expense suffered by the other party for this reason. Both parties shall use all reasonable effects to avoid or overcome the causes affecting performance and the party whose performance is affected by such force majeure shall fulfill all outstanding obligations as soon as possible.

12.  WARRANTIES AND LIABILITIES

12.1  The Company warrants to the Distributor that the product delivered hereunder shall comply with the specifications set for the in the PL and consistent with Exhibit C.

a) If the parties agree that a certain lot of the product supplied hereunder fails to meet said specification or is otherwise defective or such lot is recognized as defective by an independent laboratory as provided for hereafter in this section, and unless otherwise agreed upon, the Distr ib utor shall send such lot back to the company and the Company shall replace it at its own expense, with a new lot of the product conforming with said specifications. The Company shall also be held responsible for any liability that defective merchandise may cost, if and when it is proven that the liability has been derived from manufacturing defect and not from handling and storage conditions by the distributor or third parties.

 

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b) If the parties fail to agree that a certain lot of the product supplied hereunder meets said specification, a Party may request an expert appraisal by an independent laboratory, not associated with any of the parties hereto, to determine whether the product complies with said specification. Should the other Party disagree with the choice of laboratory, the first Party has the right to request that the laboratory is appointed by the International Chamber of Commerce. The Report of the laboratory shall be conclusive and binding on the Parties. All expenses related to such appraisal shall be borne by the party, whose opinion of which has been found not to be correct. No other warranties, expressed or implied, including, without limitation, merchantability or fitness for a particular purpose, or made or will be deemed to have been made by the company regarding the products, except to the extent expressly expressed herein. Neither the distributor, nor any of its employees, agents or representatives is authorized to give any warranties or make any representation on behalf of the company. In no event shall the company be held liable for any lost profits or any other incidental or consequential damages in connection with any claims arising out of or related to any products supplied by the company to the distributor.

	12.1.1      	
The Distributor shall indemnify and hold the company harmless from and against any and all liability, damage, loss, cost or expense arising out of or resulting from any claims made or suits brought against the company or the distributor, which arise out of or result from the distributor's negligent act or omission in the marketing, selling, transport, storage or distribution of the product.

	12.1.2      	
The Distributor has, and shall at all times during the term of this agreement and for a period of two years thereafter, shall have full insurance coverage with reputable and sound insurance, covering all and any risk, including (without limitation) any liabilities to third parties and the public (including without limitation product liability). The Company will have the right to review the insurance policies in order to make sure that Distributor' s insurance coverage is sufficient.

	12.1.3      	
Compliance with applicable laws

The distributor agrees that it will, on its own, comply with all laws, statutes and ordinances in the territory relating to the import and selling of the product and agrees to indemnify and hold the company harmless in the event that any claim is made against it by reason of the distributor failure to so comply. In particular, the distributor agrees to comply with all safety laws and regulations relating to the product.

12.2 Taxes

The distributor shall pay all excise or sales taxes that may be required to be paid by the company or the distributor by any statute, ordinance or regulation of any taxation authority. In the event that the company is required to or does pay any of such taxes, the distributor, upon being informed of such payment, shall at once repay the amount thereof to the company.

	13. 	 	  	DURATION AND TERMINATION  
	  	  	  	13.1 Duration  

This Agreement shall have immediate force and effect and shall remain in effect until the completion of a ten (10) year period, and shall continue thereafter for an additional three (3) year term and continue thereafter for two automatic three (3) year terms unless and until terminated by either party giving to the other six (6) months notice in writing prior to the end of the Initial Term or any Subsequent Term.

	13.2      	
Termination

	13.2.1      	
Failure to Fulfill Obligations or to Obtain or Maintain PL

This Agreement may be terminated with three (3) months written notice forthwith by either party if the other party fails to fulfill any of its obligations under this Agreement including the attached minimum volume of sales and such default is not remedied within thirty (30) days of the date on which a written notice thereof has been dispatched to the defaulting party or if the Distributor fails to obtain or maintain the PL as set forth in Article 6. Product Registration.

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13.2.2 Termination for Bankruptcy or Insolvency

This Agreement may be terminated immediately in the event that either party is declared insolvent, is adjudged bankrupt or files a petition for bankruptcy or reorganization under any bankruptcy law, is expropriated or sequestrated or submits or has to submit to any other administrative or judicial measures of control.

Insolvency is defined to mean the inability to pay debts, as they become due and the excess of liabilities over assets.

13.2.3 Termination for Loss of License to Sell Product

The Company shall have a right to terminate this Agreement with immediate effectshould the Company's license to sell the Product be withdrawn.

13.3 Effect of Termination

On the termination of this agreement, the Distributor shall return, without delay, all registration and permission documents to the Company together with all formulas, manufacturing procedures andother confidential documentation which the Distributor has obtained from the Company. The Distributor agrees that it shall not make any further use of this documentation. The Company shall have the option to repurchase any paid unsold Product at prices paid by the Distributor to the Company.

13.4 Notice of Termination

Notice of termination shall be in writing and shall be deemed given: (i) upon personal delivery to the appropriate address, (ii) upon delivery to the appropriate address if sent by certified or registered mail, (iii) one business day after the date of deposit with an express mail overnightcourier,or(iv)ifbyfacsimile, upon the transmittal of same with printed confirmation of receipt.

13.5 Exclusive and Non-Exclusive Distribution Rights

In the event Distributor fails to achieve seventy percent (70%) of thesalesfigures set forth under “Performance Schedule” in paragraph 5.1, then the exclusive distribution rights as set forth herein may be cancelled by the company, and shall notify the Distributor with a written notice of no less than three (3) months prior to the cancellation date.

13.6 Termination Compensation

Neither party hereto shall be liable to the other for any termination compensation whether based on goodwill, loss of income or otherwise.

14. FINAL PROVISIONS

14.1 Language

The English test of this Agreement shall prevail.

14.2 Arbitration

Any dispute in connection with this agreement shall be definitely and incontestably solved by the arbitration and conciliation statute according to the rules of the International Chamber of Commerce in Paris by three arbitrators who will be designated according to this statute. The arbitration seat will be in Ireland for the Distributor and Israel for the Company. The arbitration language will be English and the law of the defending party, Ireland for the Distributor and Israel for the Company will be applicable to the merits of the disputes.

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14.3 Modifications

All modifications and amendments to this Agreement shall be in writing and signed by the Parties. 12.4 Notices and Communications All notices in connection with this Agreement shall be in writing and be in the English language, as shall all other written communications and correspondence, and may be given by personal delivery, prepaid registered airmail letters facsimile, or telegram addressed to the Party required or entitled to receive the same at its address or facsimile number set out below, or to such other address or facsimile number as such Party shall have designated by like notice to the other Party. Notice of termination of this Agreement if given by facsimile or telegram shall be confirmed by prepaid registered airmail letter dated and posted within 24 hours. The effective date of any notice if served by personal delivery, facsimile or telegram shall be deemed the first business day in the city of destination following the dispatch and if given by prepaid registered airmail only, it shall be deemed served seven days after the date of posting.

14.4 Exhibits

All Exhibits attached hereto shall be made a part of this Agreement.

14.5 No Waiver

The omission by either party to exercise any right hereunder shall not constitute a waiver thereof and shall not prevent the subsequent enforcement of that right and shall not be deemed to be a waiver of any subsequent right.

14.6 Survival of Provisions

The provisions of this Agreement shall survive its termination for so long as may be necessary to give efficacy thereto.

14.7 Entire Agreement

This Agreement, which includes the Exhibits attached hereto, contains the entire understanding and supersedes all prior agreements of the parties with respect to the transactions contemplated hereby anal it supersedes any previous agreement. There are no agreements, promises, warranties, covenants or understandings other than those expressly set forth herein.

14.8 Invalidity

Any provision of this Agreement that is invalid or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such invalidity or unenforceability without invalidating the remaining provisions hereof or affecting the validity or enforceability of such provision in any other jurisdiction.

IN WITNESS WHEREOF the parties hereto have hereunto set their hands the day and year indicated below.

	COMPANY  	DISTRIBUTOR  
	SIRAEO, LTD.  	SAMARITAN PHARMACEUTICALS, SA  

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