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Contract analysis / affidavit-mendez-draft.docx
affidavit-mendez-draft.docx
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1. I have been employed by Penterra Pharmaceuticals Corp. since June 2015. I was initiall
1. I have been employed by Penterra Pharmaceuticals Corp. since June 2015. I was initially hired as a Senior Distribution Analyst within the Commercial Operations division and was promoted to Manager of Distribution Operations in January 2017. I assumed my current position as Director of Distribution & Logistics in March 2018. I have served continuously in that role from March 2018 to the present date.
2. In my role as Director of Distribution & Logistics, I am responsible for overseeing th
High
⚑ Non-compete / exclusivity restraint
2. In my role as Director of Distribution & Logistics, I am responsible for overseeing the distribution logistics framework for all Penterra products across the United States. My responsibilities include the management of relationships with regional exclusive distributors and national specialty pharmacy partners, the configuration and maintenance of Penterra's distribution management and order-fulfillment systems, th
3. The products for which I oversee distribution include, among others, Oncalaris® (pegvi
3. The products for which I oversee distribution include, among others, Oncalaris® (pegvisomant-axel), which is available in 20 mg and 40 mg vials and is indicated for the treatment of certain advanced solid tumors in adult patients, and Renuvesta® (cilosporin-beta), 5 mg capsules, which is indicated for the management of chronic inflammatory conditions. I am familiar with the distribution channels, logistics require
4. I report directly to Steven Kapoor, Vice President of Commercial Operations at Penterr
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⚑ Non-compete / exclusivity restraint
4. I report directly to Steven Kapoor, Vice President of Commercial Operations at Penterra. In my capacity as Director of Distribution & Logistics, I also work closely with Jennifer Chao, General Counsel of Penterra, on contractual distribution matters, including the implementation and enforcement of territorial exclusivity provisions contained in Penterra's various distribution agreements.
5. Penterra Pharmaceuticals Corp. is a corporation organized and existing under the laws
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⚑ Non-compete / exclusivity restraint
5. Penterra Pharmaceuticals Corp. is a corporation organized and existing under the laws of the State of Delaware. The Company is publicly traded on the Nasdaq Stock Market under the ticker symbol "PTRA" and is headquartered in Princeton, New Jersey. For fiscal year 2021, Penterra reported consolidated revenue of approximately $1.87 billion. Oncalaris® accounted for approximately $412 million of that revenue, represe
6. I am familiar with the Exclusive Distribution Agreement (the "EDA") dated July 1, 2017
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⚑ Non-compete / exclusivity restraint
6. I am familiar with the Exclusive Distribution Agreement (the "EDA") dated July 1, 2017, entered into between Penterra Pharmaceuticals Corp., as "Supplier," and Vantage Medical Distribution, LLC ("Vantage"), as "Distributor." I was directly involved in the logistics implementation of the EDA, including the configuration of Penterra's internal distribution systems to reflect the territorial boundaries and product al
7. The EDA granted Vantage the exclusive right to distribute Oncalaris® and Renuvesta® wi
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⚑ Non-compete / exclusivity restraint
7. The EDA granted Vantage the exclusive right to distribute Oncalaris® and Renuvesta® within the "Territory," as that term is defined in Exhibit A to the EDA. The exclusive distribution rights conferred upon Vantage were expressly limited to the geographic area specified in Exhibit A and did not extend to any territory or geographic region not enumerated therein.
8. Exhibit A to the EDA defines the Territory as follows: "The states of Connecticut, Mai
8. Exhibit A to the EDA defines the Territory as follows: "The states of Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont (collectively, the 'New England States')." A true and correct copy of Exhibit A to the EDA is attached hereto and incorporated herein as Exhibit 1 to this affidavit.
9. Section 2.3 of the EDA contains an express territorial restriction on Vantage's distri
9. Section 2.3 of the EDA contains an express territorial restriction on Vantage's distribution activities. Section 2.3 provides, in relevant part: "Distributor shall not actively solicit orders for, or deliver, the Products outside the Territory without Supplier's prior written consent." This provision unambiguously prohibits Vantage from soliciting orders for, or delivering, Oncalaris® or Renuvesta® to customers lo
10. Section 13.1 of the EDA sets forth the requirements for any modification of the agree
10. Section 13.1 of the EDA sets forth the requirements for any modification of the agreement. Section 13.1 provides, in relevant part, that "no amendment, modification, or waiver of any provision of this Agreement shall be effective unless set forth in a written instrument signed by both parties." This provision establishes that oral statements, email correspondence, or informal communications cannot serve as a basi
11. The EDA has a five-year initial term commencing on July 1, 2017 and expiring on June
11. The EDA has a five-year initial term commencing on July 1, 2017 and expiring on June 30, 2022, with two successive one-year automatic renewal options, each subject to 180 days' prior written notice by either party. In addition, Section 5.2 of the EDA establishes a minimum annual purchase commitment, pursuant to which Vantage was required to purchase no less than $9.5 million of Oncalaris® at Wholesale Acquisition
12. As Director of Distribution & Logistics, I was responsible for configuring Penterra's
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⚑ Non-compete / exclusivity restraint
12. As Director of Distribution & Logistics, I was responsible for configuring Penterra's distribution management and order-fulfillment systems to implement the territorial boundaries established in each of the Company's exclusive distribution agreements, including the EDA with Vantage. This configuration process is a core function of my role and is undertaken each time Penterra enters into, amends, or terminates a d
13. Penterra's internal distribution system operates on an enterprise resource planning (
13. Penterra's internal distribution system operates on an enterprise resource planning ("ERP") platform, supplemented by a proprietary order management module developed for the Company's pharmaceutical distribution operations (internally referred to as "PentraConnect"). The system is configured to route orders based on the ship-to address of the end customer — that is, the hospital, oncology clinic, specialty pharma
14. For the Vantage territory, my team and I configured the PentraConnect system so that
14. For the Vantage territory, my team and I configured the PentraConnect system so that Penterra directed product shipments to Vantage — or authorized Vantage to fulfill orders — only for orders where the end-customer ship-to address was located in one of the six New England states defined in Exhibit A to the EDA: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, or Vermont. This configuration was impl
15. At no time was the PentraConnect system configured to include addresses in the State
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⚑ Non-compete / exclusivity restraint
15. At no time was the PentraConnect system configured to include addresses in the State of New York, the State of New Jersey, or the Commonwealth of Pennsylvania as part of Vantage's authorized territory. Orders for customers with ship-to addresses in New York, New Jersey, or Pennsylvania were handled through other distribution channels maintained by Penterra, including direct-ship arrangements and other regional di
16. Penterra maintains a broad network of regional exclusive distributors and two nationa
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⚑ Non-compete / exclusivity restraint
16. Penterra maintains a broad network of regional exclusive distributors and two national specialty pharmacy partners to ensure comprehensive coverage of the United States market for its pharmaceutical products. At the time the EDA was executed on July 1, 2017, the tri-state area encompassing New York, New Jersey, and Pennsylvania was not assigned to any exclusive regional distributor and was instead serviced throug
17. At no time did I receive any instruction, directive, memorandum, email, or other form
17. At no time did I receive any instruction, directive, memorandum, email, or other form of authorization from any officer or executive of Penterra — including Dr. Marcus Lindholm, Chief Executive Officer; Jennifer Chao, General Counsel; Steven Kapoor, Vice President of Commercial Operations; or any other member of Penterra's senior leadership team — to expand or modify the PentraConnect system configuration to incl
18. At no time did I, or any member of my distribution team, issue any written consent, a
18. At no time did I, or any member of my distribution team, issue any written consent, approval, authorization, or directive for Vantage to ship, deliver, or distribute Oncalaris® or any other Penterra product to customers located outside the six New England states defined in Exhibit A to the EDA. My team and I were never asked to provide such consent or authorization, and none was ever given.
19. To my knowledge, no signed written amendment to Exhibit A of the EDA was ever execute
19. To my knowledge, no signed written amendment to Exhibit A of the EDA was ever executed by authorized representatives of both Penterra and Vantage that would expand the Territory beyond the six New England states of Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont. I have reviewed Penterra's contract files maintained by the Legal Department in connection with the preparation of this affi
20. On or about January 2021, I became aware that Vantage had begun shipping Oncalaris® t
20. On or about January 2021, I became aware that Vantage had begun shipping Oncalaris® to hospitals and oncology clinics located in New York, New Jersey, and Pennsylvania — states that are outside the Territory as defined in Exhibit A to the EDA. This information initially came to my attention through reports from Penterra's field-based commercial team, which had received inquiries from healthcare providers in the t
21. Based on Vantage's sales records produced in discovery in this litigation, including
21. Based on Vantage's sales records produced in discovery in this litigation, including documents bearing Bates numbers VTG-00004217 through VTG-00004893, Vantage commenced its tri-state shipments on or about September 14, 2020. The records reflect that Vantage shipped Oncalaris® to at least seventeen distinct end-customer locations in New York, twelve in New Jersey, and nine in Pennsylvania during the period from a
22. These shipments were not routed through Penterra's authorized distribution system for
22. These shipments were not routed through Penterra's authorized distribution system for the tri-state area. Specifically, the shipments did not originate from orders processed through the PentraConnect system for tri-state end-customers, and Vantage was not designated as an authorized distributor for any ship-to addresses in those states. Based on my review of available records and the discovery materials produced
23. According to Vantage's sales records produced in this litigation, Vantage generated a
23. According to Vantage's sales records produced in this litigation, Vantage generated approximately $6.4 million in revenue from sales of Oncalaris® to customers in the tri-state area between approximately September 2020 and March 2021. This figure is derived from invoices and sales reports produced by Vantage bearing Bates numbers VTG-00005102 through VTG-00005487. These sales were made entirely outside the Territ
24. I never approved, facilitated, or had any role in directing Oncalaris® product to Van
24. I never approved, facilitated, or had any role in directing Oncalaris® product to Vantage for redistribution into the tri-state area. These shipments were entirely outside the scope of the logistics framework that Penterra had established under the EDA. At no point did Vantage seek my approval or the approval of any member of my distribution team before commencing, or at any time during, its tri-state distributio
25. I have access to, and have reviewed in connection with the preparation of this affida
25. I have access to, and have reviewed in connection with the preparation of this affidavit, Penterra's internal records of Vantage's Oncalaris® purchases throughout the term of the EDA. These records are maintained in the ordinary course of Penterra's business within the PentraConnect system and the Company's financial reporting systems. All of Vantage's Oncalaris® purchases from Penterra were understood by Penterr
26. Vantage's Oncalaris® purchases from Penterra, at Wholesale Acquisition Cost, by fisca
26. Vantage's Oncalaris® purchases from Penterra, at Wholesale Acquisition Cost, by fiscal year were as follows:
27. While Vantage's purchases of Oncalaris® grew significantly over the course of the EDA
27. While Vantage's purchases of Oncalaris® grew significantly over the course of the EDA term, my team and I attributed this growth to Vantage's increasing penetration of the New England oncology market, including the expansion of its customer base among hospitals and oncology clinics throughout the six New England states. Oncalaris® experienced strong overall market growth during this period nationally, and growing
28. The increase in Vantage's purchase volumes did not prompt any change to the system-le
28. The increase in Vantage's purchase volumes did not prompt any change to the system-level territory configuration for Vantage within the PentraConnect system. The New England states — Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont — remained the sole authorized territory assigned to Vantage in Penterra's distribution systems at all times throughout the term of the EDA. No modification
29. I am aware that on or about February 15, 2021, Penterra executed a non-binding term s
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⚑ Non-compete / exclusivity restraint
29. I am aware that on or about February 15, 2021, Penterra executed a non-binding term sheet with Meridian National Distributors, Inc. ("Meridian"), a corporation organized under the laws of the State of New York with its principal offices located at 520 Seventh Avenue, 12th Floor, New York, New York 10018. The term sheet contemplated the appointment of Meridian as an exclusive regional distributor of Oncalaris® in
30. As part of the contemplated Meridian arrangement, my team began preliminary planning
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⚑ Non-compete / exclusivity restraint
30. As part of the contemplated Meridian arrangement, my team began preliminary planning to configure the PentraConnect distribution system to route tri-state and Maryland Oncalaris® orders through Meridian. This planning included the identification of end-customer ship-to addresses in those states, preliminary territory mapping within the system, and the development of logistics timelines for onboarding Meridian as
31. The fact that Penterra was independently negotiating and executing a separate distrib
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⚑ Non-compete / exclusivity restraint
31. The fact that Penterra was independently negotiating and executing a separate distribution arrangement with Meridian for the tri-state area confirms that Penterra did not consider the tri-state area — New York, New Jersey, and Pennsylvania — to be part of Vantage's exclusive territory under the EDA. Had Penterra understood or intended the tri-state area to fall within Vantage's Territory, there would have been no
32. I am aware of the email dated January 12, 2018, sent by Steven Kapoor, Vice President
32. I am aware of the email dated January 12, 2018, sent by Steven Kapoor, Vice President of Commercial Operations, to Donald Farnham, President of Vantage Medical Distribution, LLC. In that email, which has been produced in discovery in this litigation and bears Bates number PTRA-00012847, Mr. Kapoor stated: "Don — good catching up yesterday. We're definitely open to exploring expansion into NY/NJ/PA once your New E
33. At no time following the sending of this email did I receive any instruction, directi
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⚑ Non-compete / exclusivity restraint
33. At no time following the sending of this email did I receive any instruction, directive, or communication from Steven Kapoor, or from any other officer, executive, or employee of Penterra, to modify Penterra's distribution logistics systems — including the PentraConnect system — to include New York, New Jersey, or Pennsylvania within Vantage's authorized territory. No changes were made to the system configuration
34. To my knowledge, no follow-up agreement, written amendment to Exhibit A, formal autho
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⚑ Liability cap to check against exposure
34. To my knowledge, no follow-up agreement, written amendment to Exhibit A, formal authorization, or other written instrument was ever executed or issued by Penterra as a result of, or in connection with, the January 12, 2018 Kapoor email. The email expressed an openness to future discussions regarding a potential expansion, but no concrete steps were taken to effectuate any such expansion, and no modification to th
35. In summary, based on my personal knowledge as Director of Distribution & Logistics at
35. In summary, based on my personal knowledge as Director of Distribution & Logistics at Penterra Pharmaceuticals Corp., my direct involvement in the implementation and administration of the EDA, and my review of Penterra's distribution records and systems in connection with this affidavit: (a) Penterra's distribution system — specifically, the PentraConnect order management and fulfillment platform — was configured
36. I make this affidavit based on my personal knowledge of the facts stated herein. The
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⚑ Non-compete / exclusivity restraint
36. I make this affidavit based on my personal knowledge of the facts stated herein. The foregoing statements are true and correct to the best of my knowledge, information, and belief. I am aware that this affidavit is submitted in support of Penterra Pharmaceuticals Corp.'s Motion for Summary Judgment and that the Court will rely upon the truthfulness and accuracy of the statements contained herein. ________________