Document:

exh_106.htm

EXHIBIT 10.6

 

*** Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

 

AMENDMENT NO. 1

 TO

SUPPLY AGREEMENT

AND

SUPPLY AND PURCHASE AGREEMENT

AND

ADDENDUM TO SUPPLY & PURCHASE AGREEMENT

This Amendment No. 1 is made and entered into as of September 30, 2014 (the “Effective Date”), by and between Sucampo Pharma Americas, LLC (formerly known as Sucampo Pharma Americas, Inc., which was further formerly known as Sucampo Pharmaceuticals, Inc.) (“SPA”), Takeda Pharmaceutical Company Limited (“Takeda”) and R-Tech Ueno, Ltd. (“RTU”).  SPA, Takeda and RTU are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

WHEREAS, SPA, RTU and Takeda are parties to the Supply Agreement dated October 29, 2004 (the “Supply Agreement”), the Supply and Purchase Agreement dated January 25, 2006 (the “Supply and Purchase Agreement”), and the Addendum to Supply and Purchase Agreement dated November 6, 2013; (collectively the “Supply Agreements”); and

WHEREAS, the Parties now desire to amend certain terms of the Supply Agreements.

NOW, THEREFORE, in consideration of the foregoing and the mutual agreements set forth below, the Parties agree as follows:

1. Reference to SPI in the Agreement.  It is understood by the Parties that references to “SPI” in the changes set forth in this Amendment No. 1 are made for consistency with the other terms and conditions of the Supply Agreements which contain references to “SPI,” and that references to “SPI” in the Supply Agreements (including those effectuated by the changes herein) will refer to SPA.

2.  Amendments to the Supply Agreements.

 

2.1 Definition of Best Efforts.  All instances of the term “Best Efforts” in the Supply Agreements are hereby amended to read “Commercially Reasonable Efforts”, which is defined as follows:

‘“Commercially Reasonable Efforts” means, with respect to the efforts to be expended, or considerations to be undertaken, by a Party or its Affiliate with respect to any objective, activity or decision to be undertaken hereunder, reasonable, good faith efforts to accomplish such objective, activity or decision as such Party would normally use to accomplish a similar objective, activity or decision under similar circumstances, it being understood and agreed that with respect to the development, manufacture, seeking and obtaining regulatory approval, or commercialization of the Compound or Product, such efforts and resources shall be consistent with those efforts and resources commonly used

 

  

1

  

by a Party under similar circumstances for similar compounds or products owned by it or to which it has similar rights, which compound or product, as applicable, is at a similar stage in its development or product life and is of similar market potential taking into account: (a) issues of efficacy, safety, and expected and actual approved labeling, (b) the expected and actual competitiveness of alternative products sold by third parties in the marketplace, (c) the expected and actual product profile of the Compound or Product, (d) the expected and actual patent and other proprietary position of the Compound or Product, (e) the likelihood of regulatory approval given the regulatory structure involved, including regulatory or data exclusivity, (f) the expected and actual profitability and return on investment of the Compound or Product, or other compounds or products in a Party’s portfolio of compounds or products, taking into consideration, among other factors, expected and actual (1) third party costs and expenses, (2) royalty, milestone and other payments to third parties and SPI, and (3) the pricing and reimbursement relating to the Product(s).  Commercially Reasonable Efforts shall be determined on an indication/dosage-by-indication/dosage basis for the Compound or Product, as applicable, and it is anticipated that the level of effort and resources that constitute “Commercially Reasonable Efforts” with respect to a particular indication will change over time, reflecting changes in the status of the Compound or Product, as applicable.  Notwithstanding the foregoing, neither Party shall be obligated to Develop, seek Regulatory Approval for, or Commercialize a Compound or Product: (i) which, in its reasonable opinion after discussion with the other Party, caused or is likely to cause a fatal, life-threatening or other serious adverse safety event that is reasonably expected, based upon then available data, to preclude obtaining Regulatory Approval for such Product or Compound, or, if Regulatory Approval of such Product has already been obtained, to preclude continued marketing of such Product; or (ii) in a manner inconsistent with applicable laws.’

 

2.2 Definition of Takeda Affiliates.  The definition of “Takeda Affiliates” in the Supply Agreements is hereby amended in its entirety to read as follows:

‘“Takeda Affiliates” shall mean those Affiliates of Takeda listed on Exhibit D to the Collaboration and License Agreement.’

2.3 Amendment to Article 6.  The following new Section 6.8 is hereby added to Article 6 the Supply and Purchase Agreement:

‘6.8           Separate Lots.  RTU shall supply Product and Samples to Takeda from lots used exclusively to supply Takeda and no other RTU customers.’

2.4 Amendment to Article 8.  Article 8 of the Supply and Purchase Agreement among Takeda, SPA and RTU is hereby amended adding the following paragraphs after the existing paragraph in Article 8 with the following:

‘Not later than April 1, 2016, SPI shall identify one or more third party contract manufacturers (“Backup Supplier”) reasonably acceptable to RTU and Takeda to act as a secondary source for the Manufacture and supply of the Product.  Within ninety (90) days

 

  

2

  

after October 1, 2014, SPI shall use Commercially Reasonable Efforts to provide Takeda with a written list of potential Backup Suppliers identified by SPI.  Not later than twelve (12) months after April 1, 2016 (“Qualification Period”), with assistance of RTU, SPI shall use Commercially Reasonable Efforts to obtain all Regulatory Approvals required for the Backup Supplier to Manufacture and supply the Product for use in Development and Commercialization of the Product in the United States (“Required Approvals”).  If SPI does not obtain the Required Approvals prior to the expiration of the Qualification Period, then beginning on the first day after the expiration of the Qualification Period, the provisional price paid by Takeda to RTU for the Product and Samples as determined under Section 3.3 will be [...***...] until the date on which SPI notifies Takeda in writing that the Required Approvals have been obtained.  Beginning on the first day of the second full calendar month after Takeda receives such notice from SPI, [...***...].

 

Not later than twelve (12) months after April 1, 2016 or the date on which the Product is approved for commercial sale in Canada, whichever is later, SPI , with assistance of RTU shall use Commercially Reasonable Efforts to obtain all Regulatory Approvals necessary for the Backup Suppliers to manufacture and supply the Product for Development and Commercialization of the Product in Canada.

 

SPI and RTU will be responsible for all costs associated with qualifying the Backup Supplier, including costs for materials, start up, validation and test batches, stability testing and equipment.  Upon written request by SPI or Takeda from time to time, RTU shall provide a reasonably detailed written report of RTU’s efforts and progress to qualify the Backup Suppliers as required hereunder.

 

SPI and RTU shall ensure that the Backup Supplier has the capacity to Manufacture and supply the Product in sufficient quantities to meet Takeda’s Binding Forecast in any given quarter in the event of an interruption to the primary source of supply.  SPI and RTU, at their cost, shall prepare and submit to the applicable Regulatory Authorities in the Initial Territory all information and filings, and take such other actions reasonably required, to obtain and maintain the Regulatory Approvals required for the Back-up Supplier to manufacture and supply the Product for clinical and commercial use in the Initial Territory during the term of this Agreement.

 

For the avoidance of doubt, Takeda shall continue to purchase the Product and the Samples directly from RTU in the event that it is necessary for RTU to use the Backup Supplier to Manufacture, and supply to Takeda, the Product.  Under no circumstances shall RTU willfully withhold supply of the Compound, the Product or the Samples from Takeda during the term of this Agreement, including, but not limited to, during a dispute with Takeda or a dispute between Takeda and SPI.’

 

*Confidential Treatment Requested

  

3

  

2.5 Amendment to Article 8.  Section 8.3 of the Supply Agreement among Takeda, SPA and RTU is hereby amended by replacing the last sentence of that section with the following:

‘In addition, the receiving Party may disclose Confidential Information to its Affiliates and its and their officers, directors, employees, contractors, consultants, agents and advisors on a “need-to-know” basis in order for the receiving Party to exercise its rights or fulfill its obligations under this Agreement, each of whom prior to disclosure must be bound by obligations of confidentiality and restrictions on use of such Confidential Information that are no less restrictive than those set forth in Article 8.’

2.6 Amendment to Article 9.  Article 9 of the Supply and Purchase Agreement among Takeda, SPA and RTU is hereby amended in their entirety to read as follows:

‘The term of this Agreement shall commence on the Effective Date and shall continue in full force and effect until termination of the Collaboration and License Agreement in accordance with Article 13 of the Collaboration and License Agreement.  SPI shall notify RTU of the termination of the Collaboration and License Agreement when such termination occurs.’

2.7 Amendment to Article 10. Paragraph (a) of Article 10 of the Supply Agreement among Takeda, SPA and RTU is hereby amended in their entirety to read as follows:

‘(a)           The term of this Agreement shall commence on the Effective Date and shall continue in full force and effect until termination of the Collaboration and License Agreement in accordance with Article 13 of the Collaboration and License Agreement.  SPI shall notify RTU of the termination of the Collaboration and License Agreement when such termination occurs.’

3.  Miscellaneous.

 

	
3.1  

	
Full Force and Effect.  The provisions of the Supply Agreements, as amended by this Amendment No. 1 effective as of its Effective Date, remain in full force and effect; provided that the rights and obligations of the Parties as accrued under the Supply Agreements prior to this Amendment No. 1 will remain unchanged and continue to be binding on the Parties.

	
3.2  

	
Entire Agreement.  The Supply Agreements and this Amendment No. 1 constitute the entire agreement, both written and oral, between the Parties with respect to the subject matter hereof, and any and all prior agreements with respect to the subject matter hereof, either written or oral, expressed or implied, are superseded hereby, merged and canceled, and are null and void and of no effect.

  

4

  

 

	
3.3  

	
Counterparts.  This Amendment No. 1 may be executed in one or more counterparts, each of which will be an original and all of which together will constitute one instrument.

 

 

[Signature Page Follows]

 

 

 

  

5

  

IN WITNESS WHEREOF, the Parties have executed this Amendment No. 1 as of the date first written above.

 

	TAKEDA PHARMACEUTICAL COMPANY LIMITED	 	SUCAMPO PHARMA AMERICAS, LLC
	 	 	 
	
By: 

	 	 	
By:

	
 

	Name:	
Christophe Weber

	 	Name:	
 

	Title:	
President & COO

	 	Title:	
 

	 	  	 	 	   
	 	  	 	 	  
	R-TECH UENO, LTD.	 	 	  
	 	 	 	 
	
By:

	
 

	 	 	  
	Name:	
Yukihiko Mashima

	 	 	  
	Title: 	
President

	 	 	  

 

 

 

 

 

 

 

[Signature page to Amendment No. 1 to Supply Agreement dated October 29, 2004; Supply and Purchase Agreement dated January 25, 2006; and Addendum to Supply and Purchase Agreement dated November 6, 2013]Contract # 1201/2006

 EXHIBIT 10.1

Contract # BNSCK20140922

Shanghai                                         

       Date: 10.28.2014

CHAOAN CHANCES STAINLESS STEEL PRODUCTS FACTORY, China (hereinafter referred to as "Seller"),  represented by Mr. Weijiang Lin, general manager on the one hand 

And

LISSOME TRADE CORP., USA (hereinafter referred to as “Buyer”) represented by Ms. Yuxia Song, president, on the other side, concluded the present Contract about the following:

1. Subject of the Contract

1.1. Seller undertakes to sell, Byer undertakes to   pay and accept cookware and kitchenware in variety further “Goods” in quantity of nomenclature according to Specifications, which are integral parts of the Present Contract.

1.2. Price and quantity may be changed on base of Additional Agreement make by Sides to the Present Contract.

1.3. Country of origin “Goods” – China.

2. Price and total amount of the Contract

2.1. Price and sum on each batch of the “Goods” is set to appropriate Specifications of the Present Contract.

2.2. Total amount of the present Contract is: 500,000 USD (Five Hundred Thousand).

2.3. Price on the “Goods” is agreed on each separate shipment and it’s installed including all custom formalities in Country of “Seller” and also the cost on non-returnable packing, labeling, packing of the “Goods” and it hasn’t change after signing of each Specification, which it’s integral part of the present Contract.

3. Terms and Conditions of Delivery

3.1. Delivery of the “Goods” must be done in 20 or 40 foot containers on conditions FOB Shantou (according to the Incortems 2010).

3.2. Shipment of “Goods” to “Buyer” must be performed during the period 30 (thirty) from the date of advance payments in accordance with specifications to the account of the “Seller”. 

3.3. The seller must notify the "Buyer" of the expected date of shipment no later than five days before the date of shipment from the number of seats and gross weight.

3.4. Together with the load "Seller" shall provide the following commodity and supporting documents:

-invoice- (8 pieces) origin;

-packing list;

-bill of lading;

-specification;

-certificate of analyses;

-certificate of origin.

3.5. After shipment of “Goods,"Seller" shall send by fax or e-mail address in the "Buyer" copies of the following documents:

-copy of invoice;

-copy of packing list; 

-copy of certificate of origin;

-copy of certificate of analysis;

4.  Payment terms

4.1. Currency of the contract and payment - U.S. dollars

4.2. "Buyer" makes an advance payment by transferring funds to the account of the seller.

All bank charges associated with sending money according to the contract value of this Agreement shall be paid by the Buyer.

5. Delivery and acceptance of good

5.1. Goods pointed in specifications which it is integral part of the Present Contract to be considered as delivered by the Seller and accepted by the Buyer:

a) in respect of gross weight and number of packages shown on the Seller’s packing list;

b) in respect of quality- as per quality indicated in the Certificate of Quality or Certificate of Analysis issued by Manufacturing works;

c) the delivery will be evidenced by following documents:

Invoice; Certificate of Quality or Certificate of Analysis, issued by certifying the conformity of the quality of the delivered lot to the stipulated in the present contract; Certificate of Origin Specification.

5.2. The Buyer must check up the quantity and state of the package immediately after the arrival of the truck and in presence of the driver. In case of any discrepancy with the weight specification or any apparent damage of goods the Buyer has to fill in proper section of the shipping documents and certify it by the driver’s and signature of custom Officer.

6. Packing and marking

6.1. Goods to be packed and shipped in accordance with the packaging sheet.

6.2. The seller is liable to the purchaser for any damages, claims, losses that have occurred with the goods as a result of poor and / or improper packaging and / or labeling.

6.3. On the packaging should be marked in English with the obligatory indication:

- The trade name products;

- Country of origin;

- The net weight;

- The gross weight;

- The batch number;

- The date of manufacture.

7. Sanction and claims

7.1. Claims may be announced according to the:

•  quality -  discrepancy in the quality of the goods which is foresee in this Contract;

• quantity – discrepancy in the quantity of the goods to the documents, weight, number of package.

7.2. During 30(thirty) days from the moment of receiving goods Buyer may declare the claim to the Seller , Seller examines it during 10 days from the moment of receiving,  claim may be given to the Seller’s representative by attested copy according the point 7.1. with original stamp to the customs official or local Chamber of Commerce).

7.3. In the case of untimely delivery of Goods at the Seller’s guilt according to the conditions of the Present Contract expounded in p.3, Seller pays fine at the rate of 0, 01% from the sum of the tardy delivered separate consignment of Goods, according to the specification for each day of the delay, if Seller couldn’t documentary or in another case to prove his innocence.

7.4. The sum of the fine for the tardy delivered of Goods is paid by Seller by transferring money on the settlement account of Buyer in term of 90(ninety) calendars days from the date of bill, if Seller and Buyer didn’t negotiate about another.

7.5. Side which undertakes all available measures of attention and circumspection for protection of the interest of another Side for appropriate fulfillment at the Present Contract, which are corresponded to the liability and conditions of the business intercourse, is recognized not guilty.

7.6. Absence of the guilt for nonfulfillment or improper fulfillment of liability at the Present Contract is proved by the Side which broke engagements.

8. Arbitration

8.1. All disputes which are connected with this Contract should be solved with help of negotiations between the representatives of the sides. If the Parties don’t come to an agreement, all disputes and differences are to be finally settled by arbitration with application of the rules of the International Commercial Arbitration Court at the Chamber of Industry and Commerce of China in accordance with the Regulations of the present Court.

8.2. Substantive law of this Contract for posses a solution, belong to China.

8.3. The Arbitration Award is final and binding upon all Parties to the Contract.

9. Force  majeure

9.1. Parties are not responsible for the partial or complete default of its obligations hereunder, if it was a result of force majeure arising after the conclusion of the Contract: fires, natural disasters, embargoes, interference by public authorities and others. In this case, the term of the obligations is extended according to the time during which such circumstances.

9.2. The Party for which have come of force majeure must immediately give written notice the other party thereof, but not later than 15 days from occurrence of such circumstances. Fact the presence and duration of the force majeure to be confirmed by a written document of Commerce and industrial chamber of State or the competent authorities of the Party of the Contract.

9.3. Delayed, more than 15 days, notice of the occurrence or the termination of force majeure deprives side for which they occurred, the right to refer to them in the future.

9.4. In case of force majeure continues for more than 60 days, either party has the right to terminate this Contract and is not liable for such termination, provided that it shall notify the other party not later than 15 days prior to termination.

10. Additional terms

10.1. All taxes, custom fees and dues levied in the territory of the China are paid by the Seller and those levied bound the territory of the China are paid by the Buyer.

10.2. The Seller to provide any licence or state authority permission that could be required by the legislation of the Seller’s   country for the import/export of goods under the Present Contract.

10.3. The Buyer provide all licence or state authorities permission that could be required by the legislation of the Buyer’s country for the import/export of goods under, the present Contract.

11. Effect of the Agreement

11.1. The present Contract goes into effect since signing by the representative persons and valid to 12.31.2016 or up to complete implementation of obligations by both Parties.

11.2. None of the Parties has the right to assign their right and obligations under the present Contract to any third party unless upon the written consent of the other Party.

11.3. Current issues of the contract parties have the right to decide on the means telephone or Skype.

11.4. This Contract shall be confidential and shall not be disclosed or used by the Parties for any purpose not related to the execution of this Agreement.

11.5. All notices, claims, expressed or arising out of this Contract, the Parties undertake to communicate by means of e-mail or fax. While allowing protection from unauthorized falsification or counterfeiting of information and documents must contain attributes that enable clear identification of the sender and his powers.

11.6. All supplements and amendments to the present Contract are valid only if made in writing and sighed by both Parties concerned.

11.7. Ending of the Contract doesn’t excuse Parties from responsibility for it violation, which happened during the action of this Contract.

11.8. The text of the present Contract is worked out in two copies, in English, both have equal legal force.

12. Legal addresses and bank references of the parties:

		
	SELLER:

	BUYER:

	CHAOAN CHANCES STAINLESS 

STEEL PRODUCTS FACTORY

Jinhe Rd., Chaoan, 

Chaozhou City, Guangdong Province, 

China, 515641

Phone/fax: 0086-768-6550316

e-mail: cywm@cnchances.com

Hang Seng Bank Limited

Swift code: HASE HKHH

Acc No : 383-811296883

	                LISSOME TRADE CORP.

108 Ningshanzhong St., 1-25-4, Huanggu   District,  Shenyang, Liaoning Province, China , 110031

e-mail: lissometrade@gmail.com

	For and on behalf of the Seller:

/S/ Weijiang Lin

 Weijiang Lin

	For and on behalf of the BUYER:

/S/ Yuxia Song

Yuxia Song

page 1 of 1

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00237-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00237-of-00352.parquet"}]]