Case 1:14-cv-03962-JBS-KMW Document 30-1 Filed 08/14/14 Page 1 of 6 PageID: 466
`
`
`Duane Morris LLP
`By: Sandra A. Jeskie
`30 South 17th Street
`Philadelphia, PA 19103
`Telephone: 215-979-1395
`Facsimile: 215-689-2586
`jeskie@duanemorris.com
`Attorneys for Defendants Metrics, Inc., Coastal
`Pharmaceuticals, Inc., Mayne Pharma Group
`Limited, and Mayne Pharma (USA), Inc.
`
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB, INC. and BAUSCH &
`LOMB HOLDINGS CORP.,
`
`Plaintiffs,
`
`v.
`
`METRICS, INC., COASTAL
`PHARMACEUTICALS, INC., MAYNE
`PHARMA GROUP LIMITED, and MAYNE
`PHARMA (USA), INC.,
`
`Defendants.
`
`
`
`
`
`CIVIL ACTION NO. 1:14-CV-03962-
`JBS-KMW
`
`
`
`
`
`
`
`:::::::::::
`
`:::
`
`
`
`DECLARATION OF STEFAN J. CROSS
`
`
`
`
`
`
`Duane Morris LLP
`By: Sandra A. Jeskie
`30 South 17th Street
`Philadelphia, PA 19103
`Telephone: 215-979-1395
`Facsimile: 215-689-2586
`jeskie@duanemorris.com
`Attorneys for Defendants Metrics, Inc., Coastal
`Pharmaceuticals, Inc., Mayne Pharma Group
`Limited, and Mayne Pharma (USA), Inc.
`
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB, INC. and BAUSCH &
`LOMB HOLDINGS CORP.,
`
`Plaintiffs,
`
`v.
`
`METRICS, INC., COASTAL
`PHARMACEUTICALS, INC., MAYNE
`PHARMA GROUP LIMITED, and MAYNE
`PHARMA (USA), INC.,
`
`Defendants.
`
`
`
`
`
`CIVIL ACTION NO. 1:14-CV-03962-
`JBS-KMW
`
`
`
`
`
`
`
`:::::::::::
`
`:::
`
`
`
`DECLARATION OF STEFAN J. CROSS
`
`
`
`
`
`Case 1:14-cv-03962-JBS-KMW Document 30-1 Filed 08/14/14 Page 2 of 6 PageID: 467
`
`
`I, Stefan J. Cross, hereby declare as follows:
`
`1.
`
`I am currently the President of Mayne Pharma Group Ltd.’s
`
`(“Mayne Pharma’s”) operations in the USA, and have held this position since
`
`November 2013. Prior to assuming my current role, I was Vice President,
`
`Business and Corporate Development for Mayne Pharma. My responsibilities
`
`include leading Mayne Pharma operations in the USA, including the development
`
`and manufacture of U.S. generic and specialty pharmaceutical products, Metrics’
`
`contract services business, as well as other related U.S. business development
`
`initiatives.
`
`2.
`
`I have reviewed the Complaint filed by Senju Pharmaceutical
`
`Co., Ltd., Bausch & Lomb, Inc., and Bausch & Lomb Pharma Holdings
`
`Corporation in the District of New Jersey on June 20, 2014. I submit this
`
`declaration in support of Defendants Metrics, Inc.’s (“Metrics”), Coastal
`
`Pharmaceuticals, Inc.’s (“Coastal”), Mayne Pharma Group Limited’s (“Mayne
`
`Pharma”), and Mayne Pharma (USA), Inc.’s Motion to Dismiss the Complaint.
`
`3.
`
`The information in this declaration is based on my personal
`
`knowledge and information made available to me in the course of performing my
`
`duties as President of Mayne Pharma’s operations in the USA. If called as a
`
`witness, I could and would testify competently to the matters discussed below.
`
`
`
`
`2
`
`
`
`Case 1:14-cv-03962-JBS-KMW Document 30-1 Filed 08/14/14 Page 3 of 6 PageID: 468
`
`
`4. Mayne Pharma is a specialty pharmaceutical company that
`
`specializes in the development and manufacture of specialty and generic
`
`pharmaceutical products.
`
`5. Mayne Pharma does not have any offices, facilities or other real
`
`property in the State of New Jersey. Rather, it is an Australian-based company,
`
`with its primary place of business in Melbourne, Australia. It comprises three
`
`operating segments:
`
`(i) Mayne Pharma International, where revenues and gross profits
`
`are derived principally from Australian manufacture and sale of specialty and
`
`generic pharmaceutical product globally and provision of contract manufacturing
`
`services to third party customers within Australia;
`
`(ii) US Products, where revenues and gross profits are derived
`
`principally from the manufacture and distribution of generic and specialty
`
`pharmaceutical products in the US; and
`
`(iii) Metrics Contract Services, where revenues and gross profits are
`
`derived principally from the provision of contract pharmaceutical development
`
`services to third-party customers principally in the USA.
`
`6.
`
`The first and third business segments are not relevant to the
`
`ANDA which is the subject of the Complaint.
`
`
`
`
`3
`
`
`
`Case 1:14-cv-03962-JBS-KMW Document 30-1 Filed 08/14/14 Page 4 of 6 PageID: 469
`
`
`7.
`
`The second business segment is carried out in part by Metrics
`
`and in part by Libertas Pharma Inc. (“Libertas”), an entity incorporated in Georgia
`
`which is a wholly owned subsidiary of Mayne Pharma. Libertas has no interest in,
`
`or involvement with the ANDA which is the subject of the Complaint.
`
`8. Metrics, a wholly owned subsidiary of Mayne Pharma, is
`
`organized under the laws of North Carolina, with a principal place of business in
`
`Greenville, North Carolina. See, Ex 1, Metrics Cert. of Assumed Name,
`
`7/28/2014. Metrics does not have any offices, facilities or other real property in
`
`the State of New Jersey.
`
`9. Mayne Pharma has no interest in, or involvement with, the
`
`ANDA which is the subject of the Complaint, other than indirectly as the parent of
`
`Metrics.
`
`10. Mayne Pharma USA is not a recognized separate legal entity.
`
`Rather, it is a d/b/a entity of Metrics. Metrics is registered in certain states in the
`
`US (excluding New Jersey) to do business as Mayne Pharma.
`
`11.
`
`I am aware of a non-related company that once traded in New
`
`Jersey under the legal name of Mayne Pharma (USA), Inc., which had a place of
`
`business in Paramus, NJ. I do not know if this entity still exists. It if does exist, it
`
`is not under common ownership or control with Mayne Pharma or Metrics. It does
`
`
`
`
`4
`
`
`
`Case 1:14-cv-03962-JBS-KMW Document 30-1 Filed 08/14/14 Page 5 of 6 PageID: 470
`
`
`not have any interest in, or involvement with, the ANDA which is the subject of
`
`the Complaint.
`
`12. Coastal is also not a recognized separate legal entity. Rather,
`
`Coastal is a trading name (“assumed name”) of Metrics, Inc., used in the
`
`marketplace to distinguish Metric Contract Services business segment from its
`
`pharmaceutical products business. See, Exhibit 2, Coastal Corp. Cert. of Assumed
`
`Name, 4/2/2007.
`
`13.
`
`I am aware that Metrics, by and through its assumed name,
`
`Coastal, submitted to the FDA ANDA No. 206257, seeking approval to market a
`
`generic bromfenac sodium opthalmic solution 0.07% in the United States. The
`
`ANDA was prepared in North Carolina and filed in Maryland. No part of the
`
`ANDA product was developed, tested, or prepared in the State of New Jersey.
`
`14. Metrics, has only one New Jersey employee, who is based out
`
`of a home office and is solely associated with the Metrics Contract Services
`
`business segment and has no association with the development and manufacturing
`
`of pharmaceutical products to be marketed or sold by any entity in the Mayne
`
`Pharma group.
`
`15. There have been no sales of generic bromfenac opthalmic
`
`solutions that are the subject of ANDA No. 206257 in the State of New Jersey.
`
`Further, there have been no direct sales of products or services by Mayne Pharma
`
`
`
`
`5
`
`
`
`Case 1:14-cv-03962-JBS-KMW Document 30-1 Filed 08/14/14 Page 6 of 6 PageID: 471
`
`
`to New Jersey and direct sales of products by Metrics to New Jersey represented
`
`only 4% of Metrics’ overall U.S. product and services sales for the most recent
`
`financial year, ending June 30, 2014.
`
`I declare under penalty of perjury under the laws of the United States
`
`of America that the foregoing is true and correct.
`
`Executed on this 14th day of August, 2014.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`________________________
`
`Stefan J. Cross
`
`6
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
