UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): July 30, 2014
SALIX PHARMACEUTICALS, LTD.
(Exact name of registrant as specified in its charter)
Delaware | 000-23265 | 94-3267443 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
8510 Colonnade Center Drive Raleigh, North Carolina |
27615 | |
(Address of principal executive offices) | (Zip Code) |
Registrants telephone number, including area code: (919) 862-1000
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01. Other Events.
Data Presentations at American College of Gastroenterology 2014 Annual Scientific Meeting
Today, Salix Pharmaceuticals, Ltd. (the Company) announced that presentations related to research of two of the Companys products are scheduled to take place during the American College of Gastroenterology 2014 Annual Scientific Meeting, which is being held in Philadelphia, Pennsylvania from October 17-22. A copy of the press release is attached hereto as Exhibit 99.1.
Amendments to Rifaximin Supply Agreement
On July 30, 2014 and September 4, 2014, Salix Pharmaceuticals, Inc. (Salix Inc.) amended its supply agreement, dated June 24, 1996, with Alfa Wassermann, S.p.A. (Alfa) for rifaximin (the Rifaximin Supply Agreement), which is the active pharmaceutical ingredient in Xifaxan®. The amendments make certain changes to the pricing and termination provisions of the Rifaximin Supply Agreement and are attached hereto as Exhibits 10.1 and 10.2.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit
|
Description |
|
10.1* | Amendment Number Three to Supply Agreement, dated July 30, 2014, between Salix Inc. and Alfa. | |
10.2* | Amendment Number Four to Supply Agreement, dated September 4, 2014, between Salix Inc. and Alfa. | |
99.1 | Press release, dated October 17, 2014. |
* | The Company has requested confidential treatment with respect to portions of this exhibit. Those portions have been omitted from the exhibit and filed separately with the U.S. Securities and Exchange Commission. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
October 17, 2014 | SALIX PHARMACEUTICALS, LTD. | |||||
By: |
/s/ William C. Bertrand |
|||||
William C. Bertrand | ||||||
Senior Vice President and General Counsel |
EXHIBIT INDEX
Exhibit
|
Description |
|
10.1* | Amendment Number Three to Supply Agreement, dated July 30, 2014, between Salix Inc. and Alfa. | |
10.2* | Amendment Number Four to Supply Agreement, dated September 4, 2014, between Salix Inc. and Alfa. | |
99.1 | Press release, dated October 17, 2014. |
* | The Company has requested confidential treatment with respect to portions of this exhibit. Those portions have been omitted from the exhibit and filed separately with the U.S. Securities and Exchange Commission. |
CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Exhibit 10.1
Execution Version
AMENDMENT NUMBER THREE
TO
SUPPLY AGREEMENT
This Amendment Number Three to Supply Agreement (this Amendment ), dated July 30, 2014 (the Amendment Number Three Effective Date ), is made by and between Alfa Wassermann S.p.A., an Italian company ( Alfa ), and Salix Pharmaceuticals, Inc., a California corporation ( Salix ).
Recitals
WHEREAS, Alfa and Salix are parties to that certain Supply Agreement, dated June 24, 1996, and amended on September 10, 2007, and August 6, 2012 (as so amended, the Supply Agreement ); and
WHEREAS, Alfa and Salix desire to enter into this Amendment for the purpose of modifying certain of their agreements set forth in the Supply Agreement;
NOW THEREFORE, in consideration of the foregoing and the mutual promises of the parties set forth herein, Alfa and Salix, intending to be legally bound, agree to the following:
1. Capitalized terms used in this Amendment and not otherwise defined shall have the meanings set forth in the Supply Agreement.
2. Article 1 of the Supply Agreement is hereby amended by adding thereto the following definition:
Amendment Number Three Effective Date shall mean July 30, 2014.
3. The last two sentences of Article 3.1 of the Supply Agreement (as inserted pursuant to Amendment Number Two to Supply Agreement, dated August 6, 2012, between Alfa and Salix) are hereby deleted and replaced by the following sentences:
Notwithstanding the provisions of the preceding sentence (or, for the avoidance of doubt, the provisions of Amendment Number One), the price to be paid by SALIX to ALFA for Compound ordered for delivery from and after the Initial Termination Date shall, subject to the provisions of the following sentences of this Article 3.1, be [***] percent ([***]%) of the following amounts:
U.S. [***].
For the sake of clarity, for the calendar year 2014 only [***] whether before, from and after the Initial Termination Date.
*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
At any time following the Amendment Number Three Effective Date, either SALIX or ALFA may propose to the other an adjustment (either an increase or a decrease) to the price as determined by the provisions of the immediately preceding sentence to be paid by SALIX to ALFA for Compound ordered for delivery from and after the Initial Termination Dale. Thereafter ALFA and SALIX shall discuss such proposal, it being understood, however, that in the event that ALFA and SALIX are unable to reach agreement, following the making of any such proposal, with respect to the adjustment s to be made to the price to be paid by SALIX to ALFA for Compound ordered for delivery following the Initial Termination Date, then hereafter, notwithstanding any provisions to the contrary in Article 2.1, SALIX shall not be obligated to purchase any such Compound from ALFA and ALFA shall not be obligated to supply any such Compound to SALIX.
4. This Amendment shall be governed by and construed in accordance with the laws of Scotland, without giving effect to any conflict of laws principles or rules. The parties agree to exclude the application to this Amendment of the United Nations Convention on Contracts for the International Sale of Goods.
5. This Amendment, along with any exhibits, schedules and agreements referenced herein, states the entire agreement reached between the parties hereto with respect to the transactions contemplated hereby. This Amendment replaces and supersedes any and all previous agreements and understandings between the parties regarding the subject matter hereof, whether written or oral.
6. The Supply Agreement, as amended by this Amendment, shall remain in full force and effect.
7. This Amendment may be executed in any number of counterparts, each of which shall be deemed to be an original and all of which taken together shall constitute one and the same instrument. This Amendment may be executed by the electronic delivery of facsimiles of executed signature pages hereto with the same effect as the delivery of originally executed signature pages.
8. The parties acknowledge and agree that: (a) each party and its counsel reviewed and negotiated the terms and provisions of this Amendment and have contributed to its revision, (b) the rule of construction to the effect that any ambiguities are resolved against the drafting party shall not be employed in the interpretation of this Amendment, and (c) the terms and provisions of this Amendment shall be construed fairly as to all parties hereto and not in a favor of or against any party, regardless of which party was generally responsible for the preparation of this Amendment.
[Signatures appear on next page.]
IN WITNESS WHEREOF, each of the undersigned has caused this Amendment to be duly executed and delivered to be effective as of the Amendment Number Three Effective Date.
ALFA WASSERMANN S.p.A. | SALIX PHARMACEUTICALS, INC. | |||||||
By: |
/s/ Andrea Golinelli |
By: |
/s/ Rick Scruggs |
|||||
Name: |
Andrea Golinelli |
Name: |
Rick Scruggs |
|||||
Title: |
Chief Strategy Officer |
Title: |
EVP of Business Development |
CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Exhibit 10.2
Execution Version
AMENDMENT NUMBER FOUR
TO
SUPPLY AGREEMENT
This Amendment Number Four to Supply Agreement (this Amendment ), dated September 4 th , 2014 (the Amendment Number Four Effective Date ), is made by and between Alfa Wassermann S.p.A., an Italian company ( Alfa ), and Salix Pharmaceuticals, Inc., a California corporation ( Salix ).
Recitals
WHEREAS, Alfa and Salix are parties to that certain Supply Agreement, dated June 24, 1996, and amended on September 10, 2007, and August 6, 2012 (as so amended, the Supply Agreement ); and
WHEREAS, Alfa and Salix desire to enter into this Amendment for the purpose of modifying certain of their agreements set forth in the Supply Agreement;
NOW THEREFORE, in consideration of the foregoing and the mutual promises of the parties set forth herein, Alfa and Salix, intending to be legally bound, agree to the following:
1. Capitalized terms used in this Amendment and not otherwise defined shall have the meanings set forth in the Supply Agreement.
2. Article 1 of the Supply Agreement is hereby amended by adding thereto the following definition:
Amendment Number Three shall mean that certain Amendment Number Three to Supply Agreement, dated July 30, 2014, between ALFA and SALIX.
Amendment Number Four Effective Date shall mean September 4 th , 2014.
3. The last three paragraphs of Article 3.1 of the Supply Agreement (as inserted pursuant to Amendment Number Three) are hereby deleted and replaced in their entirety by the following:
Notwithstanding the provisions of the preceding sentence (or, for the avoidance of doubt, the provisions of Amendment Number One, Amendment Number Two or Amendment Number Three), the price to be paid by SALIX to ALFA for Compound ordered by SALIX from and after the Amendment Number Four Effective Date shall be [***] percent ([***]%) of the following amounts:
U.S. [***].
*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
For the sake of clarity, for the calendar year 2014 only, [***] whether before, from and after the Amendment Number Four Effective Date.
4. Article 10.1 of the Supply Agreement is hereby deleted and replaced to read in its entirety as follows:
This Agreement shall come into force and effect as at the last date of execution of these presents and, subject to Article 10.2, shall continue thereafter until the later of (a) December 31, 2016, and (b) the first date on which either party shall have given not less than 12 months notice in writing to the other party of termination. In the event that ALFA should exercise its right to terminate this Agreement pursuant to clause (b) of the preceding sentence, ALFA shall prior to the effectiveness of any such termination of this Agreement shall use Commercially Reasonable Efforts to accept from SALIX purchase orders for Compound to be supplied by ALFA to SALIX under this Agreement in an amount up to that reasonably necessary to supply SALIXs projected needs for Compound for the [***] period following the termination of this Agreement (but, in any event, an amount not in excess of [***]% of the aggregate Compound forecast to be purchased by SALIX in its 12-month forecast, as contemplated by Article 5.2, in effect as of the date of ALFAs notice of its intent to terminate this Agreement), with such Compound to be supplied by ALFA to SALIX at the purchase price for Compound specified in Article 3.1 and otherwise in accordance with the terms of this Agreement. Any purchase order issued by SALIX pursuant to the provisions of the proceeding sentence shall constitute an obligation of SALIX and ALFA that survives the termination of this Agreement.
5. This Amendment shall be governed by and construed in accordance with the laws of Scotland, without giving effect to any conflict of laws principles or rules. The parties agree to exclude the application to this Amendment of the United Nations Convention on Contracts for the International Sale of Goods.
6. This Amendment, along with any exhibits, schedules and agreements referenced herein, states the entire agreement reached between the parties hereto with respect to the transactions contemplated hereby. This Amendment replaces and supersedes any and all previous agreements and understandings between the parties regarding the subject matter hereof, whether written or oral.
7. The Supply Agreement, as amended by this Amendment, shall remain in full force and effect.
8. This Amendment may be executed in any number of counterparts, each of which shall be deemed to be an original and all of which taken together shall constitute one and the same instrument. This Amendment may be executed by the electronic delivery of facsimiles of executed signature pages hereto with the same effect as the delivery of originally executed signature pages.
*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
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9. The parties acknowledge and agree that: (a) each party and its counsel reviewed and negotiated the terms and provisions of this Amendment and have contributed to its revision, (b) the rule of construction to the effect that any ambiguities are resolved against the drafting party shall not be employed in the interpretation of this Amendment, and (c) the terms and provisions of this Amendment shall be construed fairly as to all parties hereto and not in a favor of or against any party, regardless of which party was generally responsible for the preparation of this Amendment.
[Signatures appear on next page.]
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IN WITNESS WHEREOF, each of the undersigned has caused this Amendment to be duly executed and delivered to be effective as of the Amendment Number Four Effective Date.
ALFA WASSERMANN S.p.A. | SALIX PHARMACEUTICALS, INC. | |||||||
By: |
/s/ Andrea Golinelli |
By: |
/s/ Rick Scruggs |
|||||
Name: |
Andrea Golinelli |
Name: |
Rick Scruggs |
|||||
Title: |
Chief Strategy Officer |
Title: |
EVP of Business Development |
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Exhibit 99.1
Contact: | Adam C. Derbyshire | G. Michael Freeman | ||
Executive Vice President and Chief Financial Officer |
Associate Vice President, Investor Relations and Corporate Communications |
|||
919-862-1000 | 919-862-1000 |
SALIX PHARMACEUTICALS OUTLINES DATA PRESENTATIONS AT AMERICAN COLLEGE OF GASTROENTEROLOGY 2014 ANNUAL SCIENTIFIC MEETING
RALEIGH, NC, October 17, 2014 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that presentations related to research of two of the Companys products are scheduled to take place during the American College of Gastroenterology (ACG) 2014 Annual Scientific Meeting. ACG 2014 is being held in Philadelphia, PA, October 17-22.
Rifaximin
Paper #45: Lembo et al. Efficacy and Safety of Repeat Treatment with Rifaximin for Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D): Results of the TARGET 3 Study
Paper #45 has been selected for oral presentation. The presentation will be given during the Plenary Session which will be held from 2:15 to 3:45 p.m. on Tuesday, October 21, 2014.
UCERIS® (budesonide) Rectal Foam Presentations
Poster P470: Sandborn et al. Efficacy and Tolerability of Budesonide Foam With or Without Baseline 5-Aminosalicylic Acid Use in Patients With Ulcerative Proctitis (UP) or Ulcerative Proctosigmoiditis (UPS): Results of 2 Randomized, Placebo-Controlled, Phase 3 Studies
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Poster P467: Bosworth et al. Budesonide Foam for Ulcerative Proctitis (UP) and Ulcerative Proctosigmoiditis (UPS): Subgroup Analyses of 2 Randomized, Placebo-Controlled, Phase 3 Studies
Important Safety Information about XIFAXAN 550 mg
XIFAXAN® (rifaximin) 550 mg tablets are contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C. difficile . If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
There is increased systemic exposure in patients with more severe hepatic dysfunction. The clinical trials were limited to patients with MELD scores < 25. Therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child-Pugh C).
Concomitant administration of drugs that are P-glycoprotein (P-gp) inhibitors with XIFAXAN can substantially increase the systemic exposure to XIFAXAN. Caution should be exercised when concomitant use of XIFAXAN and a P-gp inhibitor such as cyclosporine is needed. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to XIFAXAN.
Based on animal data, XIFAXAN may cause fetal harm. Discontinue in nursing mothers after taking into account the importance of the drug to the mother.
The most common adverse reactions occurring in ³ 10% of patients and at a higher incidence than placebo in the clinical study were peripheral edema (15%), nausea (14%), dizziness (13%), fatigue (12%), and ascites (11%).
Xifaxan 550 mg is licensed by Alfa Wassermann S.p.A. to Salix Pharmaceuticals, Inc.
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Please see complete Prescribing Information for XIFAXAN.
Important Safety Information for UCERIS rectal foam:
UCERIS (budesonide) rectal foam is contraindicated in patients with a history of a known hypersensitivity to budesonide or any of the ingredients of UCERIS rectal foam. Reactions have included anaphylaxis.
When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Since UCERIS rectal foam contains a glucocorticosteroid, general warnings concerning glucocorticoids should be followed.
Care is needed in patients who are transferred from glucocorticosteroid treatment with higher systemic effects to glucocorticosteroids with lower systemic effects, such as UCERIS rectal foam, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop. Taper patients slowly from systemic corticosteroids if transferring to UCERIS rectal foam. Monitor for withdrawal symptoms and unmasking of allergies.
Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Monitor patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex. More serious or even fatal courses of chickenpox or measles can occur in susceptible patients.
Monitor patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where glucocorticosteroids may have unwanted effects.
The contents of UCERIS rectal foam are flammable. Instruct the patient to avoid fire, flame and smoking during and immediately following administration.
Concomitant use of inhibitors of Cytochrome P450 3A4 (for example ketoconazole and erythromycin) should be avoided and patients should be closely monitored for increased signs and/or symptoms of hypercorticism. Avoid grapefruit juice, which is known to inhibit CYP3A4, when taking UCERIS rectal foam.
Based on animal data, UCERIS rectal foam may cause fetal harm.
Patients with moderate to severe hepatic impairment should be monitored for increased signs and/or symptoms of hypercorticism.
In clinical studies, the most common adverse reactions (incidence ³ 2%) were decreased blood cortisol, adrenal insufficiency, and nausea.
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Please see complete Prescribing Information for UCERIS rectal foam.
About Salix
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products and medical devices for the prevention and treatment of gastrointestinal diseases. Salixs strategy is to in-license late-stage or marketed proprietary therapeutic products, complete any required development and regulatory submission of these products, and market them through the Companys gastroenterology specialty sales and marketing team.
Salix trades on the NASDAQ Global Select Market under the ticker symbol SLXP.
For more information, please visit our Website at www.salix.com or contact the Company at 919-862-1000. Follow us on Twitter (@SalixPharma) and Facebook ( www.facebook.com/SalixPharma ). Information on our Twitter feed, Facebook page and web site is not incorporated in our SEC filings.
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Please Note: The materials provided herein that are not historical facts are or might constitute forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Although we believe the expectations reflected in such forward-looking statements are based on reasonable assumptions, our expectations might not be attained. Forward-looking statements involve known and unknown risks that could cause actual results to differ materially from expected results. Factors that could cause actual results to differ materially from our expectations expressed in the report include, among others: the high cost and uncertainty of the research, clinical trials and other development activities involving pharmaceutical products; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational New Drug Applications; the uncertainty of market acceptance of our products; intense competition, including from generics in an increasingly global market; the possible impairment of, or inability to obtain intellectual property rights and the costs of obtaining such rights from third parties in an increasingly global market; general economic conditions; our need to maintain profitability; the uncertainty of obtaining, and our dependence on, third parties to manufacture and sell our products; results of ongoing and any future litigation and investigations and other risk factors detailed from time to time in our other SEC filings.
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