Document:

pfnx-ex102_12.htm

Exhibit 10.2

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. INFORMATION THAT HAS BEEN OMITTED HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.

 

DEED OF ASSIGNMENT AND AMENDMENT 

 

THIS DEED OF ASSIGNMENT AND AMENDMENT (this “Deed”) is made as of this 21 April 2020 (the “Deed Effective Date”) by and among: 

 

 

	
(1)
	
Pfenex Inc. (“Pfenex”), a Delaware corporation;

 

	
(2)
	
China NT Pharma Group Company Limited (“NT Pharma”), a company incorporated in Cayman Islands;

 

	
(3)
	
NT Pharma International Company Limited (“NT International”), a company incorporated in Hong Kong; and

 

	
(4)
	
Beijing Kangchen Biological Technology Co., Ltd. (“Kangchen”), a company incorporated in the People’s Republic of China (the “PRC”, solely for the purpose of this Deed, excluding Hong Kong, Macau and Taiwan),

 

(Pfenex, NT Pharma, NT International and Kangchen, each is referred to herein below by name or as a “Party” and collectively the “Parties”).

 

WHEREAS:

 

	
(A)
	
Pfenex and NT Pharma have entered into the Development and License Agreement dated April 18, 2018 (the “License Agreement”). 

 

	
(B)
	
Kangchen is currently a wholly owned subsidiary of Beijing Konruns Pharmaceutical Co., Ltd (“Konruns”).

 

	
(C)
	
NT Pharma (Overseas) Holding Co., Ltd. (“NT Holding”, a wholly owned BVI subsidiary of NT Pharma) intends to transfer 100% of the issued and outstanding share capital of NT International to Kangchen, following which NT Pharma Pacific Company Ltd. (an affiliate of NT Pharma) will subscribe to the additional equity interest issued by Kangchen, representing 40% of its registered capital, thus converting Kangchen into a joint venture (the “Proposed Transaction”). The Proposed Transaction will be memorialized in an asset purchase agreement (“APA”) and certain other agreements to be entered into by NT Pharma, Kangchen, Konruns, NT International and other relevant parties (collectively, once executed, the “Transaction Documents”), such that NT Pharma Pacific Company Ltd. will hold 40% of the registered stock of Kangchen and Konruns will hold the remaining 60%.  

 

	
(D)
	
Contingent upon and coincident with the execution of the APA by all parties thereto, NT Pharma hereby transfers to Kangchen any and all of its interest, rights and obligations under the License Agreement (the “Assignment”) with the execution of this Deed.

 

	
(E)
	
Contingent upon and coincident with the execution of the APA by all parties thereto, Kangchen will appoint NT International as the submission agent for filings related to the Product in each of Hong Kong, Malaysia, Singapore and Thailand, and NT International will accept the appointment, to all necessary activities necessary to file for and register the MAA and obtain 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

		
and maintain the Regulatory Approval for the Product in each such country.  

 

IT IS AGREED as follows:

 

	
1.
	
Defined term

 

In this Deed, unless otherwise specified herein, capitalized terms used in this Deed but not otherwise defined herein shall have the meanings ascribed to them in the License Agreement. 

	
2.
	
Assignment

 

Contingent upon and coincident with NT Pharma, NT International and Kangchen notifying Pfenex of the execution of APA by all parties thereto and provided that the APA is signed on the date no later than April 24, 2020 (the “Signing Date”), (a) Pfenex hereby irrevocably and unconditionally gives its consent to the Assignment pursuant to Article 12.7 of the License Agreement to Kangchen and (b) Kangchen hereby irrevocably and unconditionally accepts such Assignment.  Accordingly, the Assignment shall take effect upon the Signing Date.  For clarity, if the Signing Date does not occur by April 24, 2020 this Deed shall become null and void ab initio.

	
3.
	
Change of control

 

Pfenex understands and acknowledges that, if the Proposed Transaction is to be proceeded and closed, the sole shareholder of NT International would be changed from NT Holding to Kangchen (the “Change of Control”).  Under such circumstances, Pfenex undertakes to raise no objection to the Change of Control and waive any right or claim (if any) that it may assert against NT International under the License Agreement or the Applicable Law solely as a result of the Change of Control.

 

	
4.
	
PRC and all Territory Regulatory Affairs

 

	
 
	
(a)
	
From and after the Signing Date, each of Pfenex and Kangchen (as parties to the License Agreement after the assignment) hereby agree that Kangchen shall perform regulatory matters with respect to the Product in the PRC,  according to the License Agreement (as modified in this Deed),  including but not limited to: 

 

-IND (Investigational New Drug) submission 

-CTA (Clinical Trial Authorization) 

-Clinical Trial

-NDA (New Drug Application)

-Application of the Import Drug License (IDL)

 

All applications and submissions filed by Kangchen shall be submitted to the competent authorities in the PRC, including but not limited to Centre for Drug Evaluation of National Medicine Products Administration of the PRC (“CDE”) and China Food and Drug Administration (now known as the China National Medical Products Administration, “CFDA”).

 

From and after the Signing Date, Kangchen hereby agrees to conduct such activities in strict 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

2

 

 

accord with the License Agreement (as expressly modified in this Deed) including keeping Pfenex timely informed with respect to all such activities.

 

	
 
	
(b)
	
 Pfenex confirms and undertakes the obligation, from and after the APA  Signing Date, to provide to Kangchen (or NT International) any and all necessary assistance for all purposes of facilitating all processes of regulatory affairs within the Territory, including but not limited to issuance of authorization, consent or any other instruments or documents that are required by including but not limited to  CDE, CFDA or FDA to Kangchen (or NT International) for the Territory, in each case to the extent required by and in accordance with the License Agreement.  

 

	
5.
	
Amended Timeline

 

	
 
	
(a)
	
Pfenex and Kangchen agree that, with effect from the Signing Date, the original Timeline (as defined and referred to in the License Agreement) and/or any other agreement or mutual understanding in respect of such Timeline between Pfenex and NT Pharma shall be terminated immediately and cease to have any legal effect.  Further effective on the Signing Date, each of Pfenex and NT Pharma shall release and discharge the other party and its directors, officers, affiliates, agents, successors, and assigns (collectively, the “Releasees”) from any and all the claims, liabilities and obligations that arise from or related to any breach or failure to meet the Timeline by the prior Releasees prior to the APA Signing Date.

 

	
 
	
(b)
	
Upon the APA Signing Date, Pfenex and Kangchen agree that the new timeline hereby replaces the original Timeline (the “New Timeline”, as detailed in Exhibit A hereto) and that the application for the Regulatory Approval for the Product in each jurisdiction in the Territory shall be officially submitted or processed as follows: (i) by NT International (as Kangchen’s agent) in Hong Kong, Singapore, Thailand and Malaysia no later than [***]; and (ii) by Kangchen in the PRC no later than, [***], provided that Pfenex furnishes to Kangchen (and NT International) (as the case may be) all available technical information and materials required for applications of the Regulatory Approvals in the Territories (to the extent set out in Exhibit B hereto together with such other mutually agreed information (with the Parties acting in good faith), collectively the “Technical Information”) no later than [***].  Upon the APA Signing Date, the New Timeline shall be applied throughout the entire and all sections of License Agreement.

 

	
 
	
(c)
	
For the avoidance of any doubts, the official submission or processing of application for Regulatory Approval to any Territory shall mean receipt of a serial number of acceptance or similar document assigned or issued by relevant Regulatory Agency for: (i) MAA application filed by Kangchen, or the communications between Kangchen and the Regulatory Agency in the PRC, in any case, indicating that the application will be subject to substantive review by such Regulatory Agency; or (ii)  any MAA application filed by NT International in other jurisdictions of the Territories, in accordance with the New Timeline. 

 

	
 
	
(d)
	
Kangchen and NT International agree to use Commercially Reasonable Efforts to expedite the application process and aim for obtaining the relevant Regulatory Approvals that they are in charge of within the timeframe stipulated in Exhibit C hereto (the “Timeframes”).  For the avoidance of doubt, the Timeframes shall be considered as non-binding estimates only and shall not give rise to any rights of a party to terminate either the License Agreement or this Deed or claim any fees, damages or compensation whatsoever.

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

3

 

 

 

	
6.
	
Amendments to the License Agreement

 

From the Signing Date:

 

	
 
	
(a)
	
Pfenex and Kangchen agree and acknowledge that any failure to comply with the New Timeline by Kangchen (or NT International) due to: (A) any Force Majeure event arising from and after the Deed Effective Date (including but not limited to a material adverse change in circumstances after the Deed Effective Date from COVID-19 pandemic or any other Force Majeure event outside of  the reasonable control of Kangchen (or NT International) (provided that Kangchen (or NT International) shall promptly resume performance of its obligations after the end of such event)) only for so long as such event is transpiring; or (B) any breach of this Agreement by Pfenex, shall in no event trigger the termination right of Pfenex, or result in Kangchen (or NT International) being liable for the [***] termination fee as provided in the License Agreement.

 

	
 
	
(b)
	
Accordingly, the relevant provisions of the License Agreement shall be amended as follows:

 

Section 3.1(a)(iii) of the License Agreement shall be amended and replaced with the following clause:

 

“Pfenex will have the right to terminate this Agreement and receive a termination fee in the amount of [***] in accordance with Section 10.2(a)(iii), should Kangchen (or NT International) fail to comply with the New Timeline, unless such failure is (A) due to any circumstance arising from and after the Deed Effective Date (including but not limited to a material adverse change in circumstances after the Deed Effective Date from COVID-19 pandemic or any other Force Majeure event) outside of  the reasonable control of Kangchen (or NT International) (provided that Kangchen (or NT International) shall promptly resume performance of its obligations after the end of such Force Majeure event, or (B) due to any breach of this Agreement by Pfenex.”

 

Section 10.2(a)(iii) of the License Agreement shall be amended and replaced with the following clause:

 

“upon sixty (60) days' prior written notice to Kangchen if Kangchen (or NT International) shall fail to comply with the New Timeline as set forth in Section 3.1 (a)(i) and fails to cure such breach within such sixty (60) day period, in which case Kangchen shall pay to Pfenex a termination fee in the amount of [***] within five (5) Business Days following the effective date of such termination; provided, however, that such termination right shall not apply if such failure to comply with the New Timeline is (A) due to any circumstance arising from and after the Deed Effective Date (including but not limited to a material adverse change in circumstances after the Deed Effective Date from COVID-19 pandemic or any other Force Majeure event) outside of  the reasonable control of Kangchen (or NT International) (provided that Kangchen (or NT International) shall promptly resume performance of its obligations after the end of such Force Majeure event, or (B) due to any breach of this Agreement by Pfenex.

 

	
7.
	
Duty to notify

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

4

 

 

Kangchen agrees to notify Pfenex as soon as practicable, but in any event within ten (10) Business Days upon occurrence of (i) the Signing Date, (ii) the Change of Control, (iii) appointment of NT International as an agent for submission and applications for the Regulatory Approvals in Hong Kong, Malaysia, Singapore and Thailand, (iv) the Transaction Closing Date, and (v) any milestones of the New Timeline as achieved by Kangchen (or NT International) in the course of applications for any and all Regulatory Approvals in each jurisdiction in the Territory.

 

	
8.
	
Further Assurance

 

The Parties shall execute and deliver all other documents and instruments and do all other things necessary to implement and carry out the terms of this Deed.

 

	
9.
	
Guarantee

 

	
 
	
(a)
	
In order to induce Pfenex to enter into this Deed, Konruns being the ultimate parent corporation of Kangchen and, from and after the Transaction Closing Date, NT Pharma being the other ultimate parent corporation of Kangchen (individually and together, the “Parents”) to which the License Agreement is to be assigned, hereby guarantee (jointly and severally) the punctual performance by Kangchen of any and all obligations of Kangchen to Pfenex, arising pursuant to the License Agreement (including all undertakings and obligations therein) (collectively, the “Guaranteed Obligations”).

 

	
 
	
(b)
	
Each Parent agrees that the Guaranteed Obligations may be extended, renewed, modified, amended or compromised in any way in accordance with the License Agreement, with or without notice to or the consent of Parents.

 

	
 
	
(c)
	
The guarantee provided above shall be an irrevocable, continuing, absolute and unconditional guarantee of performance by Kangchen of the Guaranteed Obligations.  Each Parent hereby expressly waives (i) discharge due to the disability of Kangchen with respect to any Guaranteed Obligations, (ii) any requirement that Pfenex exhaust any right, power or remedy or proceed against Kangchen or any other Person that may be liable for any Guaranteed Obligation and (iii) any requirement that Pfenex file suit or proceed to assert any claim for judgment against Kangchen in respect of any Guaranteed Obligation; however, Pfenex agrees to copy Kangchen on any notice to either Parent seeking to enforce the foregoing guarantee to allow Kangchen to fulfil its obligations.

 

	
 
	
(d)
	
Each Parent represents and warrants to Pfenex as follows, upon which Pfenex relies in acceptance of the guarantee provided hereunder: that each (i) is the ultimate parent corporation of Kangchen, and (ii) as such, receives benefit from the License Agreement between Pfenex and Kangchen and sufficient consideration for the guarantee.

 

	
10.
	
Binding effect

 

The provisions of this Deed will inure to the benefit of and be binding upon the respective successors and permitted assigns of NT Pharma and the Releasees.

 

	
11.
	
Language 

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

5

 

 

This Deed shall be written and executed in the English language.  Any translation into any other language shall not be an official version hereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.

 

	
12.
	
Governing law

 

This Deed shall be governed by and construed in accordance with the laws of the State of New York, USA without giving effect to any conflicts of law principles.

 

	
13.
	
Dispute resolution

 

The provisions of Section 12.4 (Internal Dispute Resolution) and Section 12.5 (Arbitration) of the License Agreement shall apply mutatis mutandis to this Deed, provided that references to the “Agreement” therein shall be construed as references to this Deed and references to the “Parties” shall be to the parties to this Deed.

 

	
14.
	
Ratification

 

Except as expressly modified herein, the License Agreement shall remain in full force and effect.

 

[The remainder of this page is intentionally left blank. Signature page to follow]

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

6

 

 

SIGNATURE PAGE TO THE DEED OF ASSIGNMENT

 

IN WITNESS WHEREOF this Deed has been executed as a deed and is delivered and takes effect on the date stated at the beginning of it. 

 

		
	
Signed, sealed and Delivered as a Deed

 

SEALED with the COMMON SEAL of

Pfenex Inc. and signed by

 

 
By/s/ Eef SchimmelpenninkName: Eef SchimmelpenninkTitle:CEO, President and Secretory
 

 

 

SEALED with the COMMON SEAL of

China NT Pharma Group Company Limited
中國泰凌醫藥集團有限公司
and signed by

 

 
By/s/ NG TITName: NG TITTitle:Director
 
Witness Signature:/s/ Cheung Janicekit ChingWitness name: Cheung Janicekit Ching
 
By/s/ CHIN YUName: CHIN YUTitle:Director
 
Witness Signature:/s/ Cheung Janicekit ChingWitness name: Cheung Janicekit Ching
 

 
	
 

 

SEALED with the COMMON SEAL of

NT Pharma International Company Limited

泰凌醫藥國際有限公司

and signed by

 

 
By/s/ NG TITName: NG TITTitle:Director
 
Witness Signature:/s/ Cheung Janicekit ChingWitness name: Cheung Janicekit Ching
 
By/s/ CHIN YUName: CHIN YUTitle:Director
 
Witness Signature:/s/ Cheung Janicekit ChingWitness name: Cheung Janicekit Ching
 

 

 

Beijing Kangchen Biological Technology Co., Ltd.

 
By/s/ Legal RepresentativeName: Title:Legal Representative
 

 

Affix official chop:

 

 

Beijing Konruns Pharmaceutical Co., Ltd

(solely for purposes of Section 9 above)

 
By/s/ Legal RepresentativeName: Title:Legal Representative
 

 

Affix official chop:

 

 

Exhibit A New Timeline

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

7

 

 

 

		
	
COUNTRY
	
Submission ( Due Date)

	
PRC
	
[***]

	
HONG KONG
	
[***]

	
MALAYSIA
	
[***]

	
SINGAPORE
	
[***]

	
THAILAND
	
[***]

 

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

8

 

 

Exhibit B Technical Information

 

Each of the following with respect to the Product:

[***]

 

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

9

 

 

Exhibit C Estimated Timeframe for Regulatory Approvals

 

 

		
	
COUNTRY
	
Estimated Approval Timeframe*

	
PRC
	
[***]

	
HONG KONG
	
[***]

	
MALAYSIA
	
[***]

	
SINGAPORE
	
[***]

	
THAILAND
	
[***]

 

* Does not limit any Party’s obligations with respect to the New Timeline.

 

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

10pfnx-ex103_105.htm

Exhibit 10.3

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. INFORMATION THAT HAS BEEN OMITTED HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.

 

AMENDMENT NO. 3 TO THE DEVELOPMENT AND LICENSE AGREEMENT

This Amendment No. 3 to the Development and License Agreement (“Amendment No. 3”) is entered into as of May 26, 2020 (“Amendment No. 3 Effective Date”) by and between Pfenex Inc., a Delaware corporation (“Pfenex” or “Party”) and Alvogen Malta (Out-Licensing) Ltd., a Maltese corporation (“Alvogen” or “Party”, and together with Pfenex, the “Parties”).

BACKGROUND

	
 
	
A.
	
Pursuant to that certain Development and License Agreement, dated as of February 28, 2019 as subsequently amended (the “Agreement”), Pfenex granted Alvogen certain development and commercialization rights with respect to the Product worldwide, excluding the Excluded Territory, all as set forth therein in more detail therein;

 

	
 
	
B.
	
In connection with Alvogen negotiating a sub-licensing agreement with [***] for Brazil, Colombia, Mexico, Ecuador, Paraguay and Peru markets (“South America Markets”) (“South America Sub-Licensing Agreement”), the Parties now desire to amend the Agreement as set forth below;

 

NOW THEREFORE THE PARTIES AGREE AS FOLLOWS:

 

	
 
	
1.
	
Capitalized terms not defined herein shall have the meaning set forth in the Agreement.

 

	
 
	
2.
	
The Parties agree to amend the Agreement as follows:

 

	
1.1
	
During the term of the South America Sub-Licensing Agreement, the definition of the Competing Product in the Agreement shall not apply to the South America Markets and the South America Sub-licensing Agreement, subject to Paragraph 1.2 of this Amendment No. 3.

	
1.2
	
Definition of the South America Competing Product is introduced and shall be applicable for the South America Markets and the South America Sub-licensing Agreement, as follows: 

”South America Competing Product” means (a) the Reference Product and (b) an approved therapeutic product that contains API (teriparatide), strength, formulation, presentation and delivery method as the Product, to the extent such product is labeled for use for the same approved indication as the Reference Product as of the Effective Date of the South America Sub-Licensing Agreement”

Accordingly, solely for purposes of and during the term of the South America Sub-Licensing Agreement, the term Competing Product will be replaced by South America Competing Product in the Agreement.

	
1.3
	
Section 2.2.(b) of the Agreement is supplemented by the addition of subparagraph (b)1, as follows:

”Section 2.2.(b).1. Alvogen is entitled for the South America Markets to grant to [***] as its Sublicensee right to sub-license to [***] Affiliates (as listed below).” 

	
1.4
	
New Section 2.5 is added, as follows: 

“During the term of the South America Sub-Licensing Agreement, the non-competition limitation stipulated in Section 2.4 shall not apply to the South America Markets for which non-competition limitation as described in this Section 2.5 shall apply only to Alvogen, which shall not through 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

 

[***] (as listed below) in the South America Markets sell a South America Competing Product throughout the exclusivity of the Sub-Licensing Agreement for the benefit of [***].

[***] Affiliates are: [***]

For the sake of clarity, limitations stipulated in this Section 2.5 shall apply to [***] Affiliates for as long as they are considered Affiliates of [***].”

	
1.5
	
Section 3.4(c) of the Agreement shall not be applicable with respect to the South America Markets. Accordingly, Pfenex shall not have right of reference over Regulatory Materials, MAA Approval and other Regulatory Approvals, other documents, information and data contained in such filings or approvals filed in the South America Markets without previous written consent of [***].

	
1.6
	
Notwithstanding Section 4.3 of the Agreement, if Alvogen is obligated to [***] received from [***] for the South America Sub-License Agreement as a result of [***] terminating the South America Sub-License Agreement for: a)  [***] 

Without limiting Alvogen’s reporting obligations under Section 3.4(a) and (b) Agreement, Alvogen shall keep Pfenex informed regarding the progress toward obtaining the MAA Approval in Brazil and promptly notify Pfenex of any issues that arising with respect to the meeting such requirement within the timelines therefor.

	
1.7
	
If additional studies, clinical trials, data and other development activities relating to the Product are requested to be conducted for the purpose of grant of the Regulatory Approval, either by the Regulatory Authorities or [***], Alvogen shall inform Pfenex and the Parties shall discuss in good faith on the way to finance such activities including ownership of any resulting Intellectual Property. If the Parties decide not to finance such work, then Section 6.2 shall not apply to the Clinical Intellectual Property (as defined below) created and paid by or on behalf of [***] in relation to the South America Sub-License Agreement. Accordingly, [***] shall own all results, including, but not limited to any invention, result, documentation, information, improvement and/or Intellectual Property (“Clinical Intellectual Property”) arising as a consequence of additional studies, clinical trials, data and other development activities relating to the Product and upgrade of the Regulatory Materials for the South America Markets needed to obtain the Regulatory Approvals, including the MAA, in the Territory. Nevertheless, if the Parties agree not to finance such work, then Alvogen shall undertake reasonable efforts to negotiate with [***] grant of non-exclusive, worldwide, irrevocable license (with the right of sublicense) under any Patents obtained by [***] Clinical Intellectual Property to Pfenex.

	
1.8
	
Section 10.1 of the Agreement shall not be applicable for the South America Markets and the term for the South America Markets shall be as follows: 

Term. This Agreement shall for the South America Markets become effective on the Effective Date and continue for ten (10) years following the First Commercial Sale in the South America Markets (“Initial Term”) subject to automatic renewal for successive one (1) year periods (”Renewal Terms”) unless notice of non-renewal is provided by either Party at least one hundred and eighty (180) days prior to the expiration of the then current renewal term. 

	
1.9
	
In case of termination of the Agreement for the South America Markets, or if [***] notifies Alvogen on termination of the South America Sub-License Agreement, then Alvogen shall put Pfenex in contact with [***] in order for Pfenex and [***] to negotiate execution of agreement within a period of twelve (12) months between [***] and Pfenex pursuant to which [***] would Commercialize the Product for the South America Markets (“New License Agreement”). If Pfenex and [***] execute the New License Agreement, then: (a) Pfenex and [***] shall notify Alvogen on the consequences of such New License Agreement on the MAAs submitted and any 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

2

 

 

 

		
MAA Approvals held by Sublicensee and other relevant terms, (b) Alvogen shall comply with written instruction of Pfenex and [***] and (c) [***] shall retain the Product License for the South America Markets until the earlier of: (y) expiry or termination of the New License Agreement or (z) the expiry of the original term of the South America Sub-License Agreement. If Pfenex and [***] fail to execute the New License Agreement within abovementioned timeline, then (i) [***] shall be entitled to continue to sell Products ordered prior to termination of the Agreement in the ordinary course for twelve (12) months (“Sell Off Period”) and at expiry of the Sell Off Period, Pfenex may: i) purchase back inventory at the price paid for the Products by [***] (“Buyback”) or ii) allow sales to continue until exhaustion of inventory (“Extended Sell Off Period”) and (ii) Alvogen shall continue supplying [***] with Products necessary to complete any outstanding tender commitments (“Tender Commitments”).  After fulfillment of all such Tender Commitments or end of the Sell Off Period or Extended Sell Off Period, whichever is later in the South America Markets, [***] shall initiate cancellation of the MAAs and MAA Approvals held by Sublicensee. 

	
1.10
	
Termination clauses stipulated in Sections 10.4. and 10.7 shall not be applicable for termination of the Agreement for the South America Markets and all references to such Sections as well as to Section 6.2 in Section 10.3 shall not apply in case of termination of the Agreement for the South America Markets, except for Section 10.4.(a) which shall be applicable only after failure of Pfenex and [***] to execute the New License Agreement to the extent not contradicting Paragraphs 1.5, 1.6, 1.7, 1.8 and 1.9 of this Amendment No. 3. 

	
1.11
	
No limitation of liability shall apply in case of Pfenex’s breach of exclusivity stipulated in Section 2.1.(a) of the Agreement in the South America Market that remains uncured after 60 days of notice to Pfenex referencing such Section 2.1(a) and specifying the particulars of such breach. 

 

	
 
	
a)
	
All other provisions of the Agreement not amended by this Amendment No. 3 shall remain valid in un-amended form and content.

 

	
 
	
b)
	
This Amendment No. 3 shall become effective of the Amendment No. 3 Effective Date.

 

	
 
	
c)
	
This Amendment No. 3 may be executed in one or more counterparts, each of which will be deemed to be an original copy and all of which, when taken together, will be deemed to constitute one and the same Amendment No. 3. The exchange of copies of this Amendment No. 3 and of signature pages by facsimile transmission shall constitute effective execution and delivery of this Amendment No. 3 as to the Parties and may be used in lieu of the Amendment No. 3 for all purposes. Signatures of the Parties transmitted by facsimile shall be deemed to be their original signatures for all purposes.

IN WITNESS WHEREOF, each Party has caused this Amendment No. 3 to be executed by its duly authorised representative:

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

3

 

 

 

PFENEX INC.

By: /s/ Eef Schimmelpennink

Name:Eef Schimmelpennink

Title:CEO

ALVOGEN MALTA (Out-Licensing) LTD.

By: /s/ Mark Decesare

Name:Mark Decesare

Title:Senior Finance Director

 

 

 

[***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

4

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