Document:

Unassociated Document

 

Exhibit 10.27

CONFIDENTIAL TREATMENT

Confidential materials omitted and filed separately with the Securities and Exchange

Commission.  Asterisks denote such omission.

 

FIRST AMENDMENT

TO

JOINT DEVELOPMENT AND LICENSE AGREEMENT

This FIRST AMENDMENT (the “First Amendment”), dated as of December 21, 2010 (the “Amendment Date”), is entered into by and between Dyax Corp., with principal offices at 300 Technology Square, Cambridge, Massachusetts 02139, U.S.A. (“Dyax”), and Defiante Farmacêutica S.A., with registered offices at Rua da Alfândega, n. 78, 3° andar, 9000-059, Funchal, Madeira, Portugal (“Defiante”).  This First Amendment amends that certain Joint Development and License Agreement (the “Original Agreement”), dated effective as of June 18, 2010 (the “Effective Date”) by and between Dyax and Defiante.  All capitalized terms not otherwise defined in this First Amendment shall be as defined in the Original Agreement.

WHEREAS, under the terms of the Original Agreement, Dyax granted Defiante certain rights to Develop, Manufacture and Commercialize products incorporating DX-88 for the treatment of angioedemas and certain other indications;

WHEREAS, under the terms of the Original Agreement, Defiante’s rights with respect to DX-88 were limited to a territory comprised of the countries listed in Exhibit A to the Original Agreement;

WHEREAS, Defiante wishes to amend the terms of the Original Agreement to expand its territory to include the additional countries of Australia and New Zealand; and

WHEREAS, Dyax is willing to agree to such an amendment on the terms set forth herein.

NOW, THEREFORE, in consideration of the promises and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Dyax and Defiante hereby agree as follows:

 

 

1.    Section 1.32 of the Original Agreement is hereby deleted in its entirety and replaced by the following, in lieu thereof:

1.32    “Defiante Territory”.  Defiante Territory shall mean:

 

	 	
(a)

	
the countries listed on Exhibit A, together with (a) any additional countries that join the EU after the Effective Date, and (b) any new countries or territories created or arising after the Effective Date that reside within the geographical boundaries of the countries listed on Exhibit A (the “Original Defiante Territory”); and

 

	 	
(b)

	
Australia and New Zealand (the “Additional Defiante Territory”).

 

 

2.    Section 4.2 of the Original Agreement is hereby deleted in its entirety and replaced by the following, in lieu thereof:

4.2   HAE Indication.

 

	 	
(a) 

	
HAE Development Plan. As soon as practicable after the Effective Date, the JSC shall convene to review and discuss the activities that are necessary to obtain Regulatory Approval of the Product for the treatment of HAE in the Original Defiante Territory.    Furthermore, as soon as practicable after the Amendment Date, the JSC shall convene to review and discuss the activities that are necessary to obtain Regulatory Approval of the Product for the treatment of HAE in the Additional Defiante Territory.  Following this process, Defiante and Dyax shall jointly complete, and the JSC
shall approve, a formal plan to obtain Regulatory Approval for Product in the Defiante Territory for the HAE Indication (the “HAE Development Plan”).  The HAE Development Plan shall set forth all further activities that are necessary to obtain Regulatory Approval of the Product for the treatment of HAE in the Defiante Territory, strategies and timelines for completing such activities, together with the annual budget for expenses related thereto. The HAE Development Plan shall also allocate responsibility between the Parties for such activities, subject to Section 4.2(c), (d) and (e) below and each Party’s financial obligations under Section 7.3. The parties agree that the portion of the HAE Development Plan covering strategies and timelines for Regulatory Approval for Product in the Additional
Defiante Territory shall be approved [*****], such term to be extended in case of unforeseen circumstances or all relevant HAE Development Data being not available.

 

  

  

  

 

	 	
 

	
The JSC shall review and monitor the activities conducted by the Parties under the HAE Development Plan, which shall be updated and modified from time to time to include any additional studies required by any Regulatory Authority in the Defiante Territory, up until filing of an application for Regulatory Approval with such Regulatory Authority, and any Post-Filing Activities required to obtain Regulatory Approval for the treatment of HAE in each country of the Defiante Territory, in accordance with the following process:

 

	 	
(i) 

	
each Party shall review the HAE Development Plan not less frequently than quarterly and shall develop detailed and specific updates to the HAE Development Plan, until the completion of the activities covered thereunder;

 

	 	
(ii) 

	
each Party shall submit all such updates to the JSC for review and approval at each meeting of the JSC; and

 

	 	
(iii) 

	
the JSC shall review proposed updates to the HAE Development Plan at the next scheduled meeting of the JSC, or earlier if the JSC so agrees, and may approve such proposed updates in its discretion and, upon such approval by the JSC, the HAE Development Plan shall be amended accordingly.

 

	 	
(b) 

	
Roles and Responsibilities.  Subject to each Party’s respective financial obligations under Section 7.3:

 

	 	
(i) 

	
HAE Development Data. Dyax shall provide Defiante with all protocols, pharmacology and toxicology data and information, pre-clinical and clinical data and information, registration dossiers and all other data and information (including without limitation documentation filed with the FDA) developed by or available to Dyax and which are relevant, required, or useful for Regulatory Approval of DX-88 in the HAE Indication in the Defiante Territory to safety and efficacy response and a discussion of safety as well as efficacy in the context of alternative treatments (collectively, the “HAE Development Data”).

 

	 	
(ii) 

	
EMA Marketing Authorization Application.  Dyax shall remain responsible for completing the remaining preparation and drafting of the EMA Marketing Authorization Application for the Product in the HAE Indication and for correspondence, meetings and conversations with the EMA until the date the Regulatory Approval is granted by EMA in the name of Defiante. Responsibility for the obtaining and maintenance of such Regulatory Approval shall be assigned to Defiante as soon as practicable according to the
above and to a process approved by the JSC.

 

  

2

  

 

	 	
(iii) 

	
Pediatric Study.  Until the date the Regulatory Approval is granted by the EMA in Defiante’s name, Dyax shall remain responsible for the ongoing preparations relating to the clinical study included in the EMA approved Pediatric Investigational Plan.  Thereafter, responsibility for the preparation and conduct of such study shall be assigned to Defiante as soon as practicable according to a process approved by the JSC.

 

	 	
(iv)

	
Reformulation.  Dyax shall remain responsible for any activities relating to the reformulation of the Product, including those that are conducted in connection with the EMA approved Pediatric Investigational Plan.

 

	 	
(v)

	
Other HAE Activities.  Unless otherwise agreed by the parties under the HAE Development Plan:

 

	 	
(A)

	
Development Activities.  There shall be no further Development activities with respect to the Product in the HAE Indication in the Additional Defiante Territory.

 

	 	
(B)

	
Post-Filing Activities in the EU.  Subject to Section 4.2 (b) (ii) above, Defiante shall be solely responsible for all Post-Filing Activities required to obtain Regulatory Approval for Product for the HAE Indication in the EU.

 

	 	
(C)

	
Regulatory Activities Outside the EU.  Subject to Section 4.2 (b) (i) above, Defiante shall be solely responsible for all Regulatory Activities required to obtain Regulatory Approval for Product for the HAE Indication in any country of the Defiante Territory outside of the EU.

 

 

3.    Section 5.1 of the Original Agreement is hereby deleted in its entirety and replaced by the following, in lieu thereof:

	 	
5.1 

	
[*****] Efforts.

 

	 	
(a)

	
Defiante shall use [*****] Efforts to obtain Regulatory Approval and Commercialize Product in the Original Defiante Territory for the HAE Indication and any Additional Indications that are Jointly Developed by the Parties in the Field.  Notwithstanding the foregoing provisions of this Section 5.1(a), it is understood that the [*****] Efforts obligations set forth in this Section 5.1(a) do not require that Defiante obtain Regulatory Approval and Commercialize Product in all countries in the Original Defiante Territory, or in any particular country of the Original Defiante Territory if undertaking such efforts to obtain Regulatory Approval and Commercialize Product in such country would not be advisable in the exercise of reasonable business judgment; provided that such obligation to exercise [*****] Efforts shall nonetheless require that Defiante exercise such [*****] Efforts to obtain Regulatory Approval and Commercialize Product in all the Major EU Countries for the Product in HAE and all other Indications that are Jointly Developed by the Parties in the Field.

 

	 	
(b)

	
Defiante shall use [*****] Efforts to obtain Regulatory Approval and Commercialize Product in the Additional Defiante Territory for the HAE Indication and any Additional Indications that are Jointly Developed by the Parties in the Field.  The parties acknowledge and agree that Defiante shall file for Regulatory Approval of the Product in Australia in accordance with the timelines set forth in the HAE Development Plan.

 

  

3

  

 

	 	
(c)

	
In connection with its obligation to use [*****]Efforts to obtain Regulatory Approval and Commercialize Product in the Defiante Territory for the HAE Indication and any Additional Indications that are Jointly Developed by the Parties in the Field, Defiante acknowledges and agrees that it shall not directly or indirectly engage in the commercialization of a therapeutic or prophylactic product that competes with the Product in the Field in the Defiante Territory.

 

 

4.    Section 7.1 of the Original Agreement is hereby amended to insert the following Section 7.1 bis at the end of such Section:

	 	
7.1 bis

	
Initial Consideration for the Additional Defiante Territory.

 

	 	
(i) 

	
Additional License Fee. Within ten (10) Business Days of the Amendment Date, upon receipt of the relevant invoice, Defiante shall pay to Dyax an upfront license fee in the amount of Five Hundred Thousand Dollars ($500,000) as partial consideration for the rights granted by Dyax to Defiante in the Additional Defiante Territory.

 

	 	
(ii) 

	
Additional Equity Investment.  Simultaneous with the execution of this First Amendment, Defiante and Dyax will enter into a Stock Purchase Agreement attached hereto as Exhibit A (the “Stock Purchase Agreement”), under which Defiante will purchase, in a private transaction, shares of Dyax common stock for a total of Five Hundred Thousand Dollars ($500,000) at a price per share to be calculated by applying a 50% premium to the average closing price of the Dyax common shares for the preceding twenty (20) Business Days.  It is acknowledged that the premium paid by Defiante shall be paid
as additional consideration for the rights granted by Dyax to Defiante in the Additional Defiante Territory.

 

5.    Section 7.2 of the Original Agreement is hereby amended to insert the following Section 7.2 bis at the end of such Section:

	 	
7.2 bis

	
Milestones for the Additional Defiante Territory.

 

	 	
(i)

	
Filing Milestone.  Within [*****] following the first filing for Regulatory Approval of the Product in the Field in any country of the Additional Defiante Territory, Defiante shall pay to Dyax a one-time milestone payment in the amount of [*****].

 

	 	
(ii) 

	
Approval Milestone. Within [*****] following the first Regulatory Approval of the Product in the Field in any country of the Additional Defiante Territory, Defiante shall pay to Dyax a one-time milestone payment in the amount of [*****].

 

	 	
(iii) 

	
Commercialization Milestone. Within [*****] following the First Commercial Sale of the Product in the Additional Defiante Territory, Defiante shall pay to Dyax a one-time milestone payment in the amount of [*****]; provided however, that such milestone shall only be due if Defiante is able to secure a price reimbursement approval for the Product in excess of [*****] per treatment in any country of the Additional Defiante Territory.

 

6.    Except as expressly provided otherwise in this First Amendment, all provisions of the Original Agreement remain in full force and effect without modification and all such terms are hereby ratified and confirmed.

 

  

4

  

7.    From and after the Amendment Date, the term “Agreement” as used in the Original Agreement shall mean the Original Agreement, as amended by this First Amendment.

 

 

8.    This First Amendment may be executed in one or more counterparts, each of which shall be deemed an original and all of which shall constitute one and the same instrument.

 

IN WITNESS WHEREOF, Dyax and Defiante have caused this First Amendment to be duly executed by their authorized representatives under seal, effective as of the Amendment Date.

 

 

	 	

DYAX CORP.

	 
	 	 	 	 
	 	 	 	 
	 	 	 	 
	
 

	
By: 

	/s/ Ivana Magovcevic-Liebisch 	 
	 	 	Name:  Ivana Magovcevic-Liebisch 	 
	 	 	Title:    Executive Vice President and General Counsel 	 
	 	 	 	 

 

 

	 	 
DEFIANTE FARMACÊUTICA S.A.,

	 
	 	 	 	 
	 	 	 	 
	 	 	 	 
	
 

	
By: 

	/s/ Paulao Viegas 	 
	 	 	Name: Paulo Viegas 	 
	 	 	Title:   CEO 	 
	 	 	 	 

 

  

5Exhibit #10.4 Incentive Stock Option Agreement

 

INCENTIVE STOCK OPTION AGREEMENT

 

UNDER THE CAMDEN NATIONAL CORPORATION

2003 STOCK OPTION AND INCENTIVE PLAN

	
Name of Optionee: 

	
  

	
No. of Option Shares: 

	
  

	
Option Exercise Price per Share: 

	
  

	
Grant Date: 

	
  

	
Expiration Date: 

	
  

 

Pursuant to the Camden National Corporation 2003 Stock Option and Incentive Plan (the “Plan”) as amended through the date hereof, Camden National Corporation (the “Company”) hereby grants to the Optionee named above an option (the “Stock Option”) to purchase on or prior to the Expiration Date specified above all or part of the number of shares of Common Stock, no par value, (the “Stock”) of the Company specified above at the Option Exercise Price per Share specified above subject to the terms and conditions set forth herein and in the Plan.

 

1.           Exercisability Schedule.  No portion of this Stock Option may be exercised until such portion shall have become exercisable.  Except as set forth below, and subject to the discretion of the Administrator (as defined in Section 2 of the Plan) to accelerate the exercisability schedule hereunder, this Stock Option shall be exercisable with respect to the following number of Option Shares on the dates indicated:

 

	
Incremental (Aggregate) Number

of Option Shares Exercisable

	 	
Exercisability Date

	
____________                       (__)

	 	
_____________

	
____________                       (__)

	 	
_____________

	
____________                       (__)

	 	
_____________

	
____________                       (__)

	 	
_____________

	
____________                       (__)

	 	
_____________

 

Once exercisable, this Stock Option shall continue to be exercisable at any time or times prior to the close of business on the Expiration Date, subject to the provisions hereof and of the Plan.

 

2.           Manner of Exercise.

 

(a)           The Optionee may exercise this Stock Option only in the following manner:  from time to time on or prior to the Expiration Date of this Stock Option, the Optionee may give written notice to the Administrator of his or her election to purchase some or all of the Option Shares purchasable at the time of such notice.  This notice shall specify the number of Option Shares to be purchased.

 

  

  

  

Payment of the purchase price for the Option Shares may be made by one or more of the following methods:  (i) in cash, by certified or bank check or other instrument acceptable to the Administrator; (ii) through the delivery (or attestation to the ownership) of shares of Stock that have been purchased by the Optionee on the open market or that have been beneficially owned by the Optionee for at least six months and are not then subject to any restrictions under any Company plan; (iii) with the prior consent of the Administrator, by the Optionee delivering to the Company a properly executed exercise notice together with irrevocable instructions to a broker to promptly deliver to the Company
cash or a check payable and acceptable to the Company to pay the option purchase price, provided that in the event the Optionee chooses to pay the option purchase price as so provided, the Optionee and the broker shall comply with such procedures and enter into such agreements of indemnity and other agreements as the Administrator shall prescribe as a condition of such payment procedure; or (iv) a combination of (i), (ii) and (iii) above.  Payment instruments will be received subject to collection.

 

The delivery of certificates representing the Option Shares will be contingent upon the Company’s receipt from the Optionee of full payment for the Option Shares, as set forth above and any agreement, statement or other evidence that the Company may require to satisfy itself that the issuance of Stock to be purchased pursuant to the exercise of Stock Options under the Plan and any subsequent resale of the shares of Stock will be in compliance with applicable laws and regulations.  In the event the Optionee chooses to pay the purchase price by previously-owned shares of Stock through the attestation method, the number of shares of Stock transferred to the Optionee upon the exercise of the Stock Option
shall be net of the shares attested to.

 

(b)           Certificates for the shares of Stock purchased upon exercise of this Stock Option shall be issued and delivered to the Optionee upon compliance to the satisfaction of the Administrator with all requirements under applicable laws or regulations in connection with such issuance and with the requirements hereof and of the Plan.  The determination of the Administrator as to such compliance shall be final and binding on the Optionee.  The Optionee shall not be deemed to be the holder of, or to have any of the rights of a holder with respect to, any shares of Stock subject to this Stock Option unless and until this Stock Option shall
have been exercised pursuant to the terms hereof, the Company shall have issued and delivered the shares to the Optionee, and the Optionee’s name shall have been entered as the stockholder of record on the books of the Company.  Thereupon, the Optionee shall have full voting, dividend and other ownership rights with respect to such shares of Stock.

 

(c)           The minimum number of shares with respect to which this Stock Option may be exercised at any one time shall be 100 shares, unless the number of shares with respect to which this Stock Option is being exercised is the total number of shares subject to exercise under this Stock Option at the time.

 

(d)           Notwithstanding any other provision hereof or of the Plan, no portion of this Stock Option shall be exercisable after the Expiration Date hereof.

 

3.           Termination of Employment.  If the Optionee’s employment by the Company or a Subsidiary (as defined in the Plan) is terminated, the period within which to exercise the Stock Option may be subject to earlier termination as set forth below.

 

  

2

  

(a)           Termination Due to Death.  If the Optionee’s employment terminates by reason of death, any Stock Option held by the Optionee shall become fully exercisable and may thereafter be exercised by the Optionee’s legal representative or legatee for a period of 12 months from the date of death or until the Expiration Date, if earlier.

 

(b)           Termination Due to Disability.  If the Optionee’s employment terminates by reason of disability (as determined by the Administrator), any Stock Option held by the Optionee shall become fully exercisable and may thereafter be exercised by the Optionee for a period of 12 months from the date of termination or until the Expiration Date, if earlier.  The death of the Optionee during the 12-month period provided in this Section 3(b) shall extend such period for another 12 months from the date of death or until the Expiration Date, if earlier.

 

(c)           Termination for Cause.  If the Optionee’s employment terminates for Cause, any Stock Option held by the Optionee shall terminate immediately and be of no further force and effect.  For purposes hereof, “Cause” shall mean a vote by the Board resolving that the Optionee shall be dismissed as a result of (i) any material breach by the Optionee of any agreement between the Optionee and the Company; (ii) the conviction of or plea of nolo contendere by the Optionee to a felony or a crime involving moral turpitude; or (iii) any material misconduct or
willful and deliberate non-performance (other than by reason of disability) by the Optionee of the Optionee’s duties to the Company.

 

(d)           Other Termination.  If the Optionee’s employment terminates for any reason other than death, disability, or Cause, and unless otherwise determined by the Administrator, any Stock Option held by the Optionee may be exercised, to the extent exercisable on the date of termination, for a period of three months from the date of termination or until the Expiration Date, if earlier.  Any Stock Option that is not exercisable at such time shall terminate immediately and be of no further force or effect.

 

The Administrator’s determination of the reason for termination of the Optionee’s employment shall be conclusive and binding on the Optionee and his or her representatives or legatees.

 

4.           Incorporation of Plan.  Notwithstanding anything herein to the contrary, this Stock Option shall be subject to and governed by all the terms and conditions of the Plan, including the powers of the Administrator set forth in Section 2(b) of the Plan.  Capitalized terms in this Agreement shall have the meaning specified in the Plan, unless a different meaning is specified herein.

 

5.           Transferability.  This Agreement is personal to the Optionee, is non-assignable and is not transferable in any manner, by operation of law or otherwise, other than by will or the laws of descent and distribution.  This Stock Option is exercisable, during the Optionee’s lifetime, only by the Optionee, and thereafter, only by the Optionee’s legal representative or legatee.

 

6.           Status of the Stock Option.  This Stock Option is intended to qualify as an “incentive stock option” under Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”), but the Company does not represent or warrant that this Stock Option qualifies as such.  The Optionee should consult with his or her own tax advisors regarding the tax effects of this Stock Option and the requirements necessary to obtain favorable income tax treatment under Section 422 of the Code, including, but not limited to, holding period
requirements.  If the Optionee intends to dispose or does dispose (whether by sale, gift, transfer or otherwise) of any Option Shares within the one-year period beginning on the date after the transfer of such shares to him or her, or within the two-year period beginning on the day after the grant of this Stock Option, he or she will notify the Company within 30 days after such disposition.

 

  

3

  

7.           Tax Withholding.  The Optionee shall, not later than the date as of which the exercise of this Stock Option becomes a taxable event for Federal income tax purposes, pay to the Company or make arrangements satisfactory to the Administrator for payment of any Federal, state, and local taxes required by law to be withheld on account of such taxable event.  The Optionee may elect to have the minimum required tax withholding obligation satisfied, in whole or in part, by (i) authorizing the Company to withhold from shares of Stock to be issued, or (ii) transferring to the
Company, a number of shares of Stock with an aggregate Fair Market Value that would satisfy the withholding amount due.

 

8.           Miscellaneous.

 

(a)           Notice hereunder shall be given to the Company at its principal place of business, and shall be given to the Optionee at the address set forth below, or in either case at such other address as one party may subsequently furnish to the other party in writing.

 

(b)           This Stock Option does not confer upon the Optionee any rights with respect to continuance of employment by the Company or any Subsidiary.

 

	  	
CAMDEN NATIONAL CORPORATION

	  	  	  
	  	
By:

	  
	  	  	
Title:

 

The foregoing Agreement is hereby accepted and the terms and conditions thereof hereby agreed to by the undersigned.

	
Dated:

	 	
  

	  	
  

	  	  	
Optionee’s Signature

	  	  	  
	  	  	
Optionee’s name and address:

	  	  	  
	  	  	
  

	  	  	  
	  	  	
  

	  	  	  
	  	  	
  

	 

 

  

4

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00185-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00185-of-00352.parquet"}]]