Document:

Exhibit 10.1

 

 

	

July 30, 2014

Pernix Therapeutics Holdings, Inc.

Worrigan Limited (to be renamed Pernix Ireland Ltd.)

c/o Pernix Therapeutics Holdings, Inc.

10 Park Place, Suite 201

Morristown, New Jersey 07960

Pozen Inc.

1414 Raleigh Road, Suite 400 Chapel Hill, NC 27517

CPPIB Credit Investments Inc. One Queen Street East, Suite 2600 P.O. Box 101

Toronto, Ontario M5C 2W5, Canada

	
 

	

Glaxo Group

Limited 980 Great

West Road

Brenttord

Middlesex VV8 9GS

 

r44 (0)20 8047 5000 

www (jsk.,Ioni

 

Gentlemen:

 

1.            Reference, etc. Reference is made to that certain letter agreement dated May 13, 2014 (the "Letter Agreement"), under which Pozen Inc. ("Pozen") and CPPIB Credit Investments Inc. ("CPPIB") consented to the sale by Glaxo Group Limited and certain of its affiliates (collectively, "GSK") and purchase by Pernix Therapeutics Holdings, Inc. ("Pemix") of certain assets relating to the pharmaceutical product marketed under the Treximete trademark pursuant to an asset purchase agreement dated May 13, 2014 between GSK and Pemix (the "Asset Purchase Agreement"). Capitalized terms used herein and not otherwise defined shall have the meanings set forth in the Letter Agreement. Pursuant to the Letter Agreement, as extended by the extension letter dated July 27, 2014, if the closing of the Asset Purchase Agreement (the "Closing") does not occur by July 30, 2014 for any reason, the Letter Agreement, together with (i) the amendment to the GSK-Pozen Agreement referred to in the first sentence of the sixth paragraph of the Letter Agreement (the "Amendment") and the CPPIB consent dated May 13, 2014 relating thereto (the "CPPIB Amendment Consent"), (ii) the Pozen Consent and (iii) the CPPIB Consent will each be null and void ab initio as if the Letter Agreement, the Amendment, the CPPIB Amendment Consent, the Pozen Consent and the CPPIB Consent had not been executed by the parties thereto. As of the date hereof, the Closing has not occurred and is not anticipated to occur by July 30, 2014.

2.            Extension. GSK and Pernix are continuing their efforts to close the Asset Purchase Agreement and desire to extend the time for the requirement of Closing under the Letter Agreement, the Amendment, the CPPIB Amendment Consent, the Pozen Consent and the CPPIB Consent until August 6, 2014. Accordingly, the undersigned hereby agree that the Letter Agreement, the Amendment, the CPPIB Amendment Consent, the Pozen Consent and the CPPIB Consent shall continue in full force and effect as set forth therein unless the Closing does not occur on or before August 6, 2014, in which case, each of this letter agreement, the Letter Agreement, the Amendment, the CPPIB Amendment Consent, the Pozen Consent and the CPPIB Consent will be null and void ab initio as if each of this letter agreement, the Letter Agreement, the Amendment, the CPPIB Amendment Consent, the Pozen Consent and the CPPIB Consent had not been executed by the parties hereto.

 

3.            Consent to Substitute Pernix Ireland Ltd., etc. Each of the undersigned hereby agrees that (a) the Assignment shall be made to Worrigan Limited (which is in the process of changing its name to Pernix Ireland Ltd.)("Pernix Ireland") instead of to Pernix, (b) further amendment will be made to the GSK-Pozen Agreement, in the form attached hereto as Annex A (the "Further Amendment"), by Pernix, Pernix Ireland and Pozen to substitute Pernix Ireland for Pernix and to permit Pemix Ireland to assign the GSK-Pozen Agreement and its rights and obligations thereunder, as collateral security, to the extent specified therein, (c) the CPPIB Amendment Consent, the Pozen Consent and the CPPIB Consent shall each be deemed to refer to (i) the Assignment as modified by the substitution of Pernix Ireland, as set forth in clause (a) above, and (ii) the Amendment, as modified by the Further Amendment, (d) the reference to Pernix in the first sentence of the eighth paragraph of the Letter Agreement shall be deemed to be replaced with a reference to Pernix Ireland and (e) all references in this letter agreement, the Letter Agreement, and the GSK-Pozen Agreement to the GSK-Pozen Agreement shall be deemed to refer to the GSK-Pozen Agreement, as amended by the Amendment and the Further Amendment. In connection with the foregoing, Pernix and Pernix Ireland, jointly and severally, represent and warrant to each of the other parties to this letter agreement that the representations and warranties set forth in Section 9.1(a), (b) and (c) of the GSK-Pozen Agreement will be true and correct as of the date of the Closing, as if made on the date of the Closing by Pernix Ireland after giving effect to the transactions occurring on the Closing, including, without limitation, the Amendment and the Further Amendment.

4.            Pernix Guaranty.

(a)     Guaranty. In consideration of the provisions of Section 3 of this letter agreement, Pernix hereby unconditionally guarantees (i) the full and punctual payment of all financial obligations of Pernix Ireland under the GSK-Pozen Agreement, the Letter Agreement and this letter agreement (the "Financial Obligations") and (ii) the full and punctual performance of all other obligations of Pernix Ireland under the GSK-Pozen Agreement, the Letter Agreement and this letter agreement (the "Non-Financial Obligations" and together with the Financial Obligations, the "Obligations"). Upon failure by Pemix Ireland to (x) pay punctually any such Financial Obligation, Pernix shall forthwith on demand pay the amount not so paid at the place and in the manner and the currency specified in the GSK-Pozen Agreement and (y) perform punctually any such Non-Financial Obligation, Pernix shall forthwith on demand perform, or cause to be performed, such Non-Financial Obligation in the manner specified in the GSK-Pozen Agreement.

 

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(b)     Guaranty Unconditional. The obligations of Pernix under this Section 4 shall be unconditional and absolute and, without limiting the generality of the foregoing, shall not be released, discharged or otherwise affected by: (i) any extension, renewal, settlement, compromise, waiver or release in respect of any Obligation, by operation of law or otherwise; (ii) any modification or amendment of or supplement to the GSK-Pozen Agreement, the Letter Agreement, this letter agreement or any other document referred to herein or therein; (iii) any release, non-perfection or invalidity of any direct or indirect security for any Obligation; (iv) any change in the existence, structure or ownership of Pernix Ireland, or any insolvency, bankruptcy, reorganization or other similar proceeding affecting Pernix Ireland or its assets or any resulting release or discharge of any Obligation; (v) the existence of any claim, set-off or other rights which Pernix may have at any time against Pernix Ireland, any of the parties to this letter agreement or any other corporation, entity or person, whether in connection with the transactions contemplated hereby, by the Letter Agreement or by the GSK-Pozen Agreement or any unrelated transactions, provided that nothing herein shall prevent the assertion of any such claim by separate suit or compulsory counterclaim; (vi) any invalidity or unenforceability relating to or against Pernix Ireland for any reason of this letter agreement, the Letter Agreement or the GSK­Pozen Agreement, or any provision of applicable law or regulation purporting to prohibit the payment by Pernix Ireland of any Financial Obligation or the performance by Pernix Ireland of any Non-Financial Obligation; or (vii) any other act or omission to act or delay of any kind by any of the parties to this letter agreement or any other corporation, entity or person or any other circumstance whatsoever which might, but for the provisions of this paragraph, constitute a legal or equitable discharge of Pernix's obligations hereunder.

(c)     Discharge Only Upon Payment in Full; Reinstatement In Certain  Circumstances. Pernix's obligations under Section 4(a) shall remain in full force and effect until all Financial Obligations shall have been irrevocably and unconditionally paid in full and all Non-Financial Obligations have been irrevocably and unconditionally performed in full. If at any time any payment made of any Financial Obligation is rescinded or must be otherwise restored or returned upon the insolvency, bankruptcy or reorganization of Pernix Ireland or otherwise, Pemix's obligations hereunder with respect to such payment shall be reinstated as though such payment had been due but not made at such time.

(d)     Waiver by Pernix. Pernix irrevocably waives acceptance hereof, presentment, demand, protest and any notice not expressly provided for herein, as well as any requirement that at any time any action be taken by any of the parties to this letter agreement or any other corporation, entity or person against Pernix Ireland or any other corporation, entity or person.

(e)      Subrogation. Upon making any payment hereunder with respect to Pernix Ireland, Pernix shall be subrogated to the rights of the payee against Pernix Ireland with respect to such payment; provided that Pernix shall not enforce any payment right by way of subrogation until all Financial Obligations have been irrevocably and unconditionally paid in full and all Non-Financial Obligations have been irrevocably and unconditionally performed in full.

 

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(f)       Representation and Warranties. Each of Pernix and Pernix Ireland, jointly and severally, represents and warrants that: (i) each of Pernix and Pernix Ireland is duly organized, validly existing and (where such concept exists there) in good standing under the laws of its jurisdiction of organization; (ii) the execution, delivery and performance by Pernix and Pernix Ireland of this letter agreement, the Letter Agreement, the Amendment, the Further Amendment and the GSK-Pozen Agreement, and the transactions contemplated hereby and thereby, are within their respective powers, have been duly authorized by all necessary action, require no action by or in respect of, or filing with, any governmental body, agency or official, and do not and will not contravene, or constitute a default under, any provision of applicable law or regulation or of the organizational documents or by-laws of Pernix or Pernix Ireland or of any agreement, judgment, injunction, order, decree or other instrument binding upon Pernix or Pernix Ireland or result in the creation or imposition of any lien or encumbrance on any asset of Pernix or Pernix Ireland; and (iii) each of this letter agreement and the Letter Agreement constitutes, and upon the closing under the Asset Purchase Agreement. the Amendment, the Further Amendment and the GSK-Pozen Agreement will constitute, a valid and binding agreement of Pernix and Pernix Ireland, as the case may be, enforceable in accordance with its terms.

5.            Miscellaneous. No failure or delay by Pozen or CPPIB in exercising any right, power or privilege under this letter agreement, the Letter Agreement, the Amendment, the Further Amendment or the GSK-Pozen Agreement shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege. The rights and remedies provided in this letter agreement, the Letter Agreement, the Amendment, the Further Amendment and the GSK-Pozen Agreement shall be cumulative and not exclusive of any rights or remedies provided by law. This letter agreement, the Letter Agreement, the Amendment, the Further Amendment and the GSK-Pozen Agreement shall not be amended, waived or supplemented without the prior written consent of each of the parties to this letter agreement, provided that the consent of GSK shall not be required if such amendment, waiver or supplement will not adversely affect the rights of GSK hereunder or thereunder. The parties hereto acknowledge that nothing contained in this letter agreement, the Letter Agreement, the Amendment, the Further Amendment or any other communication or document shall be deemed to be, or taken as, a waiver by Pozen or CPPIB of the rights set forth in Section 14.2 of the GSK-Pozen Agreement, except to the extent expressly set forth in the Further Amendment. This letter agreement shall be governed by and construed in accordance with the laws of the State of North Carolina. Each of Pernix and Pernix Ireland irrevocably submits to the exclusive jurisdiction of any North Carolina State or Federal court sitting in North Carolina, as set forth in Section 13.2 of the GSK-Pozen Agreement, in connection with any dispute arising under this letter agreement, the Letter Agreement, the Amendment, the Further Amendment or the GSK-Pozen Agreement.

Please confirm your agreement and acceptance of the foregoing terms by signing and this letter agreement in the space provided below.

[Signature Page Follows]

 

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GLAXO GROUP LIMITED

By:/s/ Paul Williamson

Name: Paul Williamson

Title:   Authorized Signatory

For and on behalf of

Edinbourgh Pharmaceuticals

Industries Limited

Corporate Director

Acknowledged and agreed to on the date set forth above:

PERNIX THERAPEUTICS HOLDINGS, INC.

	
/s/ Terry Novak

	 
	
Name:

	
Terry Novak

	 
	
Title:

	
Chief Operating Officer

	 

WORRIGAN LIMITED

	
/s/ Tracy S. Clifford

	 
	
Name:

	
Tracy S. Clifford

	 
	
Title:

	
Secretary

	 

POZEN INC.

	
/s/ Dennis McNamara

	 
	
Name:

	
Dennis McNamara

	 
	
Title:

	
SVP Chief Business Officer

	 

CPPIB CREDIT INVESTMENTS INC.

	
/s/ Adam Vigan

	 
	
Name:

	
Adam Vigan

	 
	
Title:

	
VP, Head of Private Debt

	 

[Signature Page - Side Letter (Extension of Acknowledgement)]Exhibit 10.2

 

FIRST AMENDMENT TO PRODUCT DEVELOPMENT AND

COMMERCIALIZATION AGREEMENT

This First Amendment to Product Development and Commercialization Agreement (this "Amendment") is executed as of the 13th day of May, 2014, by and among POZEN Inc., a Delaware corporation ("POZEN") and Pernix Therapeutics Holdings, Inc., a Maryland corporation ("Pernix"). Unless otherwise indicated, capitalized terms not otherwise defined in this Amendment shall have the meanings set forth in the Agreement (as defined below).

WITNESSETH

WHEREAS, POZEN and Glaxo Group Ltd. ("GSK') are parties to that certain Product Development and Commercialization Agreement dated as of June 11, 2003, as amended and supplemented by that certain letter agreement dated as of June 11, 2003 executed by GSK and accepted and agreed by POZEN (collectively, the "Product Agreement") and the Consent Agreement dated as of August 15, 2011 (the "consent" and, together with the Product Agreement, the "Agreement");

WHEREAS, on or about the date hereof, Pernix has entered into an asset purchase agreement with GSK (the "Asset Purchase Agreement"), pursuant to which Pernix will acquire certain assets of and assume certain obligations from GSK, including GSK's rights and obligations under the Agreement;

WHEREAS, in anticipation of the closing of the Asset Purchase Agreement, POZEN and Pernix desire to amend the Agreement in accordance with its terms in order to reflect certain understandings between them;

WHEREAS, this Amendment will be effective upon the closing of the Asset Purchase Agreement;

WHEREAS, the closing of the Asset Purchase Agreement is subject to certain customary closing conditions, including receipt of regulatory approval and financing;

WHEREAS, in the event that the Asset Purchase Agreement is terminated by GSK or Pernix for any reason or the closing of the Asset Purchase Agreement does not occur by that date that is seventy five (75) days after the date hereof for any reason, POZEN and Pernix acknowledge that this Amendment will not be effective and will be null and void ab initio as if this Amendment was never executed by the parties hereto; and

NOW, THEREFORE, in consideration of the mutual covenants and promises contained in this Amendment and other good and valuable consideration, POZEN and Pernix agree as follows:

 

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ARTICLE 1: GENERAL

1.1            This Amendment is entered into in accordance with the provisions of Section 14.5 of the Agreement. Nothing in this Amendment shall diminish, obviate or render unenforceable Section 14.5 of the Agreement.

1.2            POZEN and Pernix acknowledge and agree that the Asset Purchase Agreement is subject to customary closing conditions set forth therein and that this Amendment will not become effective unless and until the closing of transactions contemplated by the Asset Purchase Agreement (such date, the "Amendment Effective Date"). For the avoidance of doubt, if the Asset Purchase Agreement expires or is terminated for any reason or if the closing of the Asset Purchase Agreement does not occur by that date that is seventy five (75) days after the date hereof for any reason, the terms of this Amendment will be null and void ab initio, as if this Amendment was never executed by the parties hereto.

ARTICLE 2: PAYMENTS

2.1            Minimum Royalty. POZEN and Pernix agree that the royalties set forth in Section 7.4 shall be amended to provide for a quarterly minimum payment and an annual reconciliation. Accordingly, POZEN and Pernix hereby amend the Agreement by:

2.1.1. renumbering the current Section 7.4 as Section 7.4(a);

 

2.1.2. agreeing that all references in the Agreement to Section 7.4 shall instead be to Section 7.4(a); and

 

2.1.3. adding the following as new Sections 7.4(b) and (c):

7.4(b) For each calendar quarter falling within the period commencing January 1, 2015 and ending March 31, 2018, Pernix will pay POZEN a payment (the "Top-Up Payment") equal to the excess, if any, of (i) $4,000,000 over (ii) the amount payable to POZEN in respect of such calendar quarter pursuant to Section 7.4(a), such payment to be made within 45 days of the end of such calendar quarter.

7.4(c) If, in any calendar year ending December 31, 2015, December 31, 2016 or December 31, 2017, (i) the sum of all payments made by Pernix to POZEN in respect of such calendar year pursuant to Sections 7.4(a) and 7.4(b) exceeds $16,000,000 and (ii) Pemix shall have made a Top-Up Payment to POZEN in respect of a calendar quarter falling within such calendar year pursuant to Section 7.4(b), then Pernix shall be entitled to a credit in an amount equal to the lesser of (x) the amount of the excess referred to in clause (i) above and (y) the sum of the Top-Up Payments made by Pernix to POZEN in respect of the calendar quarters falling within such calendar year pursuant to Section 7.4(b). The calculation of such credit shall be set forth in a statement delivered by Pemix to POZEN within 30 days of the end of such calendar year and, unless Pernix shall have received written notice disagreeing with the calculation set forth in such statement, Pernix shall be entitled to offset the amount of such credit against the payment owed by it pursuant to Sections 7.4(a) and 7.4(b) in respect of the first calendar quarter following the end of such calendar year.

 

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ARTICLE 3: ADDITIONAL DEVELOPMENT

3.1            Adolescent Strength Product. POZEN and Pernix agree that Pernix will use its Commercially Reasonable Efforts to submit a supplementary N.DA to NDA #21-926 for a MT 400 containing 10 mg Sumatriptan and 60 mg Naproxen sodium by December 31, 2014. Accordingly, POZEN and Pernix hereby amend the Agreement by:

3.1.1. amending the definition of NDA in Section 1.48 as follows:

1.48 "NDA" means a New Drug Application filed with the FDA in compliance with applicable laws and regulations, including all applicable supplements and amendments that may be filed with respect thereto, to obtain approval to market a pharmaceutical product in the United States.

3.1.2. adding the following as new Section 3.7(a):

3.7 Development of Alternative Strengths

(a)          Notwithstanding any provision of this Agreement to the contrary, Pernixwill use its Commercially Reasonable Efforts to prepare and file no later than December 31, 2014, in its own name and at its own expense, an NDA for a solid oral dose MT 400 containing 10 mg Sumatriptan and 60 mg Naproxen sodium (the "Low Strength Product"), and any other regulatory filings in the Territory necessary to obtain NDA Approval for the Low Strength Product. Notwithstanding the foregoing, the Parties acknowledge the receipt by GSK of that certain letter dated May 2, 2014 from Dr. Ellis Unger of FDA disclosing a "procedural error" by FDA in FDA's letter dated April 22, 2014 relating to studies for the Low Strength Product. The Parties agree that depending upon FDA's response and disclosure of the nature of such "procedural error," the December 31, 2014 date in the first sentence of this Section 3.7(a) may become impracticable and, in such case, the Parties agree to negotiate in good faith a fair and reasonable new date; provided, however, that Pernix will prepare and file an NDA for the Low Strength Product no later than the later of December 31, 2014 and that date that is six (6) months following receipt by Pernix of a written request from the FDA to submit the NDA for the Low Strength Product.

3.2            Sufficiency of Assets.  Pernix acknowledges and agrees that POZEN is relying on the sufficiency of the assets transferred by GSK to Pernix under the Asset Purchase Agreement in order for Pernix to satisfy its development obligations under the Agreement. Accordingly, Pernix represents and warrants that it owns or controls, or GSK has covenanted to provide, all Know-How necessary to satisfy its development obligations with respect to the Low Strength Product under the Agreement.

 

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3.3            Intermediate Strength Product. POZEN and. Pernix agree that Pernix will use its Commercially Reasonable Efforts to conduct all clinical, regulatory and manufacturing work necessary to submit an NDA for a MT 400 containing 50 mg Sumatriptan and 500 mg Naproxen sodium, and submit such NDA to the FDA not later than July 1, 2016. Accordingly, POZEN and Pernix hereby amend the Agreement by adding the following as new Sections 3.7(b), (c), (d) and (e):

3.7(b) Notwithstanding any provision of this Agreement to the contrary, Pemix will use its Commercially Reasonable Efforts to prepare and file no later than July 1, 2016, in its own name and at its own expense, an NDA for a solid oral dose MT 400 containing 50 mg Sumatriptan and 500 mg Naproxen sodium (the "Intermediate Strength Product"), and any other regulatory filings in the Territory necessary to obtain NDA Approval for the Intermediate Strength Product.

(c)          In connection with the development of the Intermediate Strength Product, POZEN will provide Pernix with a development plan describing the development of the Intermediate Strength Product, including a proposed budget, duties and responsibilities, and timeline. Pernix will not be obligated to spend any sums of money in excess of the amount provided for in such development plan.

 

(d)         POZEN will use its Commercially Reasonable Efforts to: (i) consult with Pernix and answer questions regarding the development plan provided pursuant to Section 3.7(c), and (ii) at Pemix's reasonable request, provide Pernix with such POZEN Know-How in its possession and a right and license to use such Pozen Know-How as necessary or advisable in connection with the prefonnance of its obligations hereunder; provided that (A) Pernix will reimburse POZEN for reasonable costs and expenses incurred by POZEN in providing Pernix with the assistance and consultation set forth in this Section 3.7(d); and (B) POZEN shall not perform any development activities under the development plan except as agreed pursuant to Section 3.8. POZEN acknowledges and agrees that as of the date hereof there are no accrued reimbursable costs and expenses as provided in Section 3.7(d)(ii)(A).

 

(e)          For the avoidance of doubt, Pernix and POZEN acknowledge and agree that (i) the terms "MT 400," "Product," "Collaboration Product" and "Lead Product" shall include Treximet as well as the Low Strength Product and the Intermediate Strength Product and (ii) the terms "Other Marketed Product," "Other Novel Product" and "Other Product" shall not include Treximet, the Low Strength Product or the Intermediate Strength Product. Notwithstanding anything to the contrary contained herein, in no event will Pernix be obligated to make any payments under Sections 7.2 of the Agreement with respect to the Low Strength Product or the Intermediate Strength Product.

3.4          Right of First Refusal to Conduct Development Activities. POZEN and Pernix agree that POZEN will have the right of first refusal to conduct any and all development activities for MT 400, including post-marketing studies, and any alternate fonns and/or dosage strengths. Accordingly, POZEN and Pernix hereby amend the Agreement by adding the following as new Sections 3.8:

 

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3.8          POZEN shall have a right of first refusal to perform, or have performed, development activities related to MT 400. In the event that Pernix decides to conduct any development work related to MT 400, including any phase 4 clinical studies and development of alternate forms and/or dosage strengths, Pernix shall first give written notice thereof to POZEN prior to offering such work to any Third Party and POZEN shall have the right of first refusal to conduct such development activities. The Parties shall negotiate in good faith and use diligent efforts to conclude negotiations and agree the conditions that shall be applicable to POZEN's conduct of the development work as promptly as possible, which conditions shall include economic terms comprising pass-through of any Third Party costs and expenses and payment of for POZEN's services at the then-current per hour rates for those employees of POZEN carrying out those activities. if the Parties cannot reach agreement on such conditions within sixty (60) days of Pernix giving such written notice to POZEN, then Pernix will be free to offer such work to a Third Party; provided that prior to entering into a definitive agreement with such Third Party, Pernix will offer such work to POZEN on the same terms and conditions as such Third Party, and POZEN will have thirty (30) days to accept or reject such offer.

ARTICLE 4: GRANT OF LICENSES AND RIGHTS OF REFERENCE

4.1            POZEN and Pernix agree that POZEN will be free to commercialize, or enable its licensees to commercialize, outside of the Territory, any dosage strength of the MT 400 Product that is approved for sale inside the Territory. To facilitate such rights, Pernix agrees to grant to POZEN certain rights of reference to any MT 400 Product NDA and other regulatory filings related to the MT 400 Product. Accordingly, POZEN and Pernix hereby amend the Agreement by:

4.1.1. deleting Section 2.2 in its entirety and replacing it as follows:

[RESERVED]

4.1.2. adding the following as new Section 2.4(d)-(h):

2.4(d) Pernix hereby grants to POZEN and its designees an exclusive, royalty-free, perpetual and irrevocable license, with a right to grant sublicenses, to cross-reference Pernix's MT 400 Product NDAs and other regulatory filings, for the purposes of developing, making, using, offering to sell, selling and importing MT 400 Products in the Field outside the Territory.

(e)          Pernix hereby grants to POZEN and its designees an exclusive, royalty-free, perpetual and irrevocable license, with a right to grant sublicenses, to use GSK Know-How for the purposes of developing, making, using, offering to sell, selling and importing MT 400 Products in the Field outside the Territory.

(f)          Pernix will provide POZEN with an electronic version of the then-current NDA #21-926, as such NDA may be amended or supplemented from time to time, and other regulatory submissions for MT 400, including the IND, upon POZEN's request, provided that POZEN may not request an electronic copy of such NDA or other regulatory submission in each case more than two times per calendar year.

 

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(g)          Pernix will provide POZEN with any Certificate of Pharmaceutical Product or Free Sale Certificate or similar documents, upon POZEN's request.

(h)          Pernix will: (i) assist POZEN or one or more of its designees to secure commercial supply of MT 400 from GSK or its contract manufacturer; and (ii) assist POZEN in the transfer of manufacturing methods to a facility for manufacture of supply for sale outside of the Territory, in each case at POZEN's sole cost and expense. For the avoidance of doubt, Pernix will not enter into any agreement or arrangement with any Third Party, including GSK and its Affiliates, pursuant to which such Third Party would be restricted from supplying MT 400 to POZEN or which includes restrictions on the transfer of manufacturing methods to a facility for manufacture of supply for sale outside of the Territory. POZEN will use Commercially Reasonable Efforts to secure commercial supply of MT 400 from Pernix's then-current supplier for sale outside of the Territory; provided, however, that in the event that POZEN is unable to secure commercial supply from such supplier on reasonable terms, Pernix shall negotiate in good faith with POZEN to provide commercial supply of MT 400 to POZEN for sale outside of the Territory. In the event Pernix and POZEN are not able to reach such agreement, then Pernix shall assist POZEN with securing a supplier for MT 400 for sale outside of the Territory.

4.1.3. deleting the last sentence of Section 3.1.

ARTICLE 5: Miscellaneous

5.1            No Other Changes; Execution.

5.1.1. Except as set forth herein, the execution and delivery of this Amendment is without prejudice to any rights that accrued to the benefit of either Party under the Agreement prior to the Amendment Effective Date.

 

5.1.2. This Amendment contains the entire agreement among the Parties with respect to the subject matter hereof and the term sheet between POZEN and Pernix titled Considerations for Consent to Assignment of Product Development and Commercialization Agreement and Amendment Thereto for Treximet dated May 8, 2014, is superseded hereby.

 

5.1.3. Except as explicitly set forth in this Amendment, no amendment or modification to the Agreement is hereby made. This Amendment may be executed in counterparts.

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

 

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IN WITNESS WHEREOF, the parties hereto have executed this Amendment effective as of the Amendment Effective Date.

POZEN INC.

	
By:

	
/s/ John R. Plachetka

	 
	
Name.

	
John R. Plachetka

	 
	
Title:

	
Chairman, President and CEO

	 

PERNIX THERAPEUTICS HOLDINGS, INC.

	
By:

	
/s/ Douglas Drysdale

	 
	
Name:

	
Douglas Drysdale

	 
	
Title:

	
CEO

	 

[SIGNATURE PAGE TO FIRST AMENDMENT]

 

 

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