TERMS OF USE

1. Acceptance of the Terms and Conditions.

1.1 Allena Pharmaceuticals, Inc. (herein referred to as the “Company,” “we,” “us” or “our“) provides and makes available this web site (the “Web Site“). All use of the Web Site is subject to the terms and conditions contained in this Terms of Use Agreement (the “Agreement“). Please read this Agreement carefully. By accessing, browsing or otherwise using the Web Site, you acknowledge that you have read, understood, and agree to be bound by this Agreement. If you do not accept the terms and conditions of this Agreement, you shall not access, browse or use the Web Site.

1.2 You understand and agree that we may change this Agreement at any time without prior notice. You may read a current, effective copy of this Agreement at any time by selecting the “Terms of Use” link on the Web Site. The revised terms and conditions will become effective at the time of posting. Any use of the Web Site after such date shall constitute your acceptance of such revised terms and conditions. If any change to this Agreement is not acceptable to you, your sole remedy is to cease accessing, browsing and otherwise using the Web Site.

2. Use of the Web Site.

2.1 This Web Site contains material, including but not limited to software, text, graphics and images (collectively referred to as the “Content“). We may own the Content or portions of the Content may be made available to us through arrangements that we have with third-parties. The Content is protected by United States and foreign intellectual property laws. Unauthorized use of the Content may result in violation of copyright, trademark, and other laws. You have no rights in or to the Content, and you will not use, copy or display the Content except as permitted under this Agreement. No other use is permitted without our prior written consent. You must retain all copyright and other proprietary notices contained in the original Content on any copy you make of the Content. You may not sell, transfer, assign, license, sublicense, or modify the Content or reproduce, display, publicly perform, make a derivative version of, distribute, or otherwise use the Content in any way for any public or commercial purpose. The use or posting of any of the Content on any other web site or in a networked computer environment for any purpose is expressly prohibited. If you violate any part of this Agreement, your right to access and/or use the Content and Web Site shall automatically terminate and you shall immediately destroy any copies you have made of the Content.

2.2 The trademarks, service marks, and logos of the Company (the “Company Trademarks“) used and displayed on this Web Site are registered and unregistered trademarks or service marks of the Company. Other company, product, and service names located on the Web Site may be trademarks or service marks owned by third-parties (the “Third-Party Trademarks“, and, collectively with the Company Trademarks, the “Trademarks“). Nothing on this Web Site or in this Agreement should be construed as granting, by implication, estoppel, or otherwise, any license or right to use any Trademark displayed on this Web Site without the prior written consent of the Company specific for each such use. The Trademarks may not be used to disparage the Company or the applicable third-party, the Company’s or third-party’s products or services, or in any manner (using commercially reasonable judgment) that may damage any goodwill in the Trademarks. Use of any Trademarks as part of a link to or from any web site is prohibited without the Company’s prior written consent. All goodwill generated from the use of any Company Trademark shall inure to the Company’s benefit.

2.3 You agree not to: (a) take any action that imposes an unreasonable load on the Web Site’s infrastructure, (b) use any device, software or routine to interfere or attempt to interfere with the proper working of the Web Site or any activity being conducted on the Web Site, (c) attempt to decipher, decompile, disassemble or reverse engineer any of the software comprising or making up the Web Site, (4) delete or alter any material posted on the Web Site by the Company or any other person or entity, or (5) frame or link to any of the materials or information available on the Web Site.

2.4 The Web Site contains links to third-party web sites (“External Sites“). These links are provided solely as a convenience to you and not as an endorsement by us of the content on such External Sites. The content of such External Sites is developed and provided by others. You should contact the site administrator or Webmaster for those External Sites if you have any concerns regarding such links or any content located on such External Sites.

We are not responsible for the content of any linked External Sites and do not make any representations regarding the content or accuracy of any materials on such External Sites. You should take precautions when downloading files from all web sites to protect your computer from viruses and other destructive programs. If you decide to access any External Sites, you do so at your own risk.

2.5 Certain elements of the Web Site are protected by trade dress, trademark, unfair competition, and other state and federal laws and may not be copied or imitated in whole or in part, by any means, including but not limited to, the use of framing or mirrors, except as otherwise expressly permitted by Section 2.1 of the Agreement. None of the Content for this Web Site may be retransmitted without the express written consent from the Company for each and every instance.

2.6 The website contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning the future clinical, regulatory and commercial potential of its pipeline, including reloxaliase and ALLN-346, and statements regarding Allena’s financial position. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: market and other conditions, the timing for completion of Allena’s clinical trials of its product candidates, risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Allena’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risks associated with Allena’s financial condition and its need to obtain additional funding to support its business activities, including the future clinical development of its pipeline products and its ability to continue as a going concern; risks associated with Allena’s dependence on third parties; and risks related to the COVID-19 coronavirus. Allena undertakes no duty to update an forward-looking statements on this website in the event of changing circumstances or otherwise, and such statements are current only as of the date they are made.

3. Limitation of Liability and Disclaimer of Warranties.

3.1 THE COMPANY, ITS AFFILIATES, THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, SUPPLIERS, OR LICENSORS (COLLECTIVELY, THE “COMPANY PARTIES“) MAKE NO WARRANTIES OR REPRESENTATIONS ABOUT THE CONTENT, INCLUDING BUT NOT LIMITED TO ITS ACCURACY, RELIABILITY, COMPLETENESS, TIMELINESS OR RELIABILITY. THE COMPANY PARTIES SHALL NOT BE SUBJECT TO LIABILITY FOR THE TRUTH, ACCURACY OR COMPLETENESS OF THE CONTENT OR ANY OTHER INFORMATION CONVEYED TO THE USER OR FOR ERRORS, MISTAKES OR OMISSIONS THEREIN OR FOR ANY DELAYS OR INTERRUPTIONS OF THE DATA OR INFORMATION STREAM FROM WHATEVER CAUSE. YOU AGREE THAT YOU USE THE WEB SITE AND THE CONTENT AT YOUR OWN RISK.

THE COMPANY PARTIES DO NOT WARRANT THAT THE WEB SITE WILL OPERATE ERROR FREE OR THAT THE WEB SITE, ITS SERVER, OR THE CONTENT ARE FREE OF COMPUTER VIRUSES OR SIMILAR CONTAMINATION OR DESTRUCTIVE FEATURES. IF YOUR USE OF THE WEB SITE OR THE CONTENT RESULTS IN THE NEED FOR SERVICING OR REPLACING EQUIPMENT OR DATA, NO COMPANY PARTY SHALL BE RESPONSIBLE FOR THOSE COSTS.

THE WEB SITE AND CONTENT ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS WITHOUT ANY WARRANTIES OF ANY KIND. THE COMPANY PARTIES DISCLAIM ALL WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE WARRANTIES OF TITLE, MERCHANTABILITY, NON INFRINGEMENT OF THIRD PARTIES RIGHTS, AND FITNESS FOR PARTICULAR PURPOSE.

3.2 IN NO EVENT SHALL ANY COMPANY PARTY BE LIABLE FOR ANY DAMAGES WHATSOEVER (INCLUDING, WITHOUT LIMITATION, INCIDENTAL AND CONSEQUENTIAL DAMAGES, LOST PROFITS, OR DAMAGES RESULTING FROM LOST DATA OR BUSINESS INTERRUPTION) RESULTING FROM THE USE OR INABILITY TO USE THE WEB SITE AND THE CONTENT, WHETHER BASED ON WARRANTY, CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER LEGAL THEORY, EVEN IF SUCH COMPANY PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

3.3 Some states do not allow exclusion of implied warranties or limitation of liability for incidental or consequential damages, so the above limitations or exclusions may not apply to you. IN SUCH STATES, THE LIABILITY OF THE COMPANY PARTIES SHALL BE LIMITED TO THE GREATEST EXTENT PERMITTED BY LAW.

4. Indemnification.

You agree to defend, indemnify, and hold harmless the Company Parties from and against any claims, actions or demands, including, without limitation, reasonable legal and accounting fees, arising or resulting from your breach of this Agreement or your access to, use or misuse of the Content or Web Site. The Company shall provide notice to you of any such claim, suit, or proceeding. The Company reserves the right to assume the exclusive defense and control of any matter which is subject to indemnification under this section. In such case, you agree to cooperate with any reasonable requests assisting the Company’s defense of such matter.

5. Termination of the Agreement.

5.1 The Company reserves the right, in its sole discretion, to restrict, suspend, or terminate this Agreement and your access to all or any part of the Web Site or the Content at any time and for any reason without prior notice or liability. The Company reserves the right to change, suspend, or discontinue all or any part of the Web Site or the Content at any time without prior notice or liability.

5.2 Sections 2 (Use of the Web Site), 3 (Limitation of Liability and Warranty), 4 (Indemnification), 5 (Termination of Agreement), and 8 (Miscellaneous) shall survive the termination of this Agreement.

6. User Must Comply with Applicable Laws.

6.1 This Web Site is based in Boston, Massachusetts. We make no claims concerning whether the Content may be downloaded, viewed, or be appropriate for use outside of the United States. If you access the Web Site or the Content from outside of the United States, you do so at your own risk. Whether inside or outside of the United States, you are solely responsible for ensuring compliance with the laws of your specific jurisdiction.

6.2 The United States controls the export of products and information. You expressly agree to comply with such restrictions and not to export or re-export any of the Content to countries or persons prohibited under the export control laws. By downloading the Content, you are expressly agreeing that you are not in a country where such export is prohibited or are a person or entity for which such export is prohibited. You are solely responsible for compliance with the laws of your specific jurisdiction regarding the import, export, or re-export of the Content.

7. U.S. Government Restricted Rights.

The Content is provided with “RESTRICTED RIGHTS.” Use, duplication, or disclosure by the Government is subject to the restrictions contained in 48 CFR 52.227-19 and 48 CFR 252.227-7013 et seq. or its successor. Use of the Web Site or Content by the Government constitutes acknowledgement of our proprietary rights in the Web Site and Content.

8. Miscellaneous.

This Agreement is governed by the internal substantive laws of the Commonwealth of Massachusetts, without respect to its conflict of laws provisions. You expressly agree to submit to the exclusive personal jurisdiction of the state and federal courts sitting in the City of Boston in the Commonwealth of Massachusetts. If any provision of this Agreement is found to be invalid by any court having competent jurisdiction, the invalidity of such provision shall not affect the validity of the remaining provisions of this Agreement, which shall remain in full force and effect. Failure of the Company to act on or enforce any provision of the Agreement shall not be construed as a waiver of that provision or any other provision in this Agreement. No waiver shall be effective against the Company unless made in writing, and no such waiver shall be construed as a waiver in any other or subsequent instance. Except as expressly agreed by the Company and you, this Agreement constitutes the entire Agreement between you and the Company with respect to the subject matter, and supercedes all previous or contemporaneous agreements, whether written or oral, between the parties with respect to the subject matter. The section headings are provided merely for convenience and shall not be given any legal import. This Agreement will inure to the benefit of our successors, assigns, licensees, and sublicensees. Any information submitted or provided by you to the Web Site might be publicly accessible. Important and private information should be protected by you. The Company is not liable for protection of privacy of electronic mail or other information transferred through the Internet or any other network that you may use.

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Jerome Gangitano

Vice President of Manufacturing and Process Development

Jerome Gangitano is the Vice President of Manufacturing and Process Development at Allena Pharmaceuticals. He is an experienced operations executive with more than 30 years of experience in the pharmaceutical and device industries. He has developed, commercialized, and supplied numerous products.

Prior to joining Allena, Jerome was a Site Head at Sanofi where he led a site including Safety and Environmental, Quality, Manufacturing, Process Development – MSAT; Facilities-Engineering, Supply Chain, Materials Purchasing, and Operational Excellence. Prior to his time at Sanofi, Jerome held various leadership positions in Operations, Manufacturing, and Quality at Genzyme, Focal, Johnson & Johnson, and Multiple Peptide Systems. Jerome received his BS in Chemistry from San Diego State University.

Kevin Brennan

Vice President, Finance

Kevin Brennan is the Vice President Finance at Allena Pharmaceuticals. Kevin joined the Allena team in 2011 as the Associate Director, Finance and has played an integral role in financial strategy, planning and operations, and the development and monitoring of systems designed to manage the organization’s finance and reporting. Kevin brings over twenty years of experience in the life science industry. Prior to joining Allena, Kevin held various positions at Alnara Pharmaceuticals, Altus Pharmaceuticals, and Genzyme, where he worked cross-functionally to drive strategic initiatives and optimize planning and reporting processes.

Kevin holds a B.S. in Accounting from Boston College.

Stephen Yu

Senior Vice President, Corporate Quality

Stephen Yu is Senior Vice President of Corporate Quality at Allena Pharmaceuticals. Stephen provides leadership for the internal Quality Assurance and Quality Control functions and oversight across internal and external GxP activities for Allena’s programs and facilities.

Stephen brings over 40 years of drug development and commercialization experience in technical and quality compliance roles. Over the past year, he has worked as Senior Vice President of Quality at Lyndra Therapeutics, a private company based in Watertown. In addition to serving previously as Vice President of Quality Assurance at Allena, Stephen has led his self-directed consultancy, Sky Pharma Consulting, and held prior roles as Vice President of Corporate Quality at Immunogen, as well as roles in Quality and Manufacturing at Genzyme, Merck & Co and Schering-Plough Research Institute.

Stephen earned a B.S. in Chemical Engineering from M.I.T. and an M.B.A. from Rutgers University.

Richard Katz, M.D.

Chief Financial Officer

Richard Katz, M.D. has served as chief financial officer since January 2021. Richard brings to Allena more than 20 years of experience in healthcare finance and corporate development.

Prior to joining Allena, Richard served as the chief financial officer of several biopharmaceutical companies, including Liquidia Technologies, Argos Therapeutics, Viamet Pharmaceuticals and Icagen, Inc. At Icagen, he played an instrumental role in the company’s initial public offering and subsequent financings, the formation of several strategic collaborations and the company’s sale to Pfizer. Richard began his career as a vice president in the healthcare investment banking group at Goldman, Sachs & Company, where he executed a broad range of transactions, including equity and debt financings, mergers and acquisitions, and corporate restructurings.

He holds a B.A. in applied mathematics from Harvard University, an M.D. from the Stanford University School of Medicine and an M.B.A. from Harvard Business School.

Alicja Januszewicz, PhD.

Vice President, People & Culture

Alicja Januszewicz, Ph.D., has served as the Head of People & Culture since 2019. Before joining Allena, she consulted with small organizations in Cambridge within talent management: employee development, organizational development, succession management, high potentials, and workforce planning. Previously, she had served as the Head of Talent Management at Baxalta Innovation Center, where she supported global R&D teams until the Shire acquisition.

Prior to joining Baxalta, Alicja served as Head of Talent Management at Epizyme and Boston Scientific HQ. She also supported the organizational development of Genzyme’s global HR manufacturing group.

Alicja holds a Ph.D. in Sociology from the Polish Academy of Science. She is a graduate of the Talent Management Institute, University of North Carolina, Kenan-Flagler Business School.

David J. Clark, M.D.

Chief Medical Officer

David J. Clark, M.D. has served as Chief Medical Officer since November 2020. He has over 20 years of global industry experience in biopharmaceutical companies based in the United States and Europe.

Before joining Allena, David served as the Chief Medical Officer of Aldeyra Therapeutics, a publicly-traded biotechnology company developing medicines for immune-mediated ocular and systemic diseases. He also served as Chief Medical Officer of Wilson Therapeutics, a privately-held biotechnology company developing novel pharmaceuticals to treat Wilson Disease, a rare autosomal recessive disorder of copper metabolism. David further served as Chief Medical Officer at NormOxys Inc. and TransTech Pharma, LLC. He has held leadership positions at a range of pharmaceutical companies including Pfizer, GlaxoSmithKline, and SmithKline Beecham.

David received his medical degree from the University of Edinburgh, trained in internal medicine, and conducted respiratory medicine academic research.

Geoffrey Swire

Acting Chief Operating Officer and Senior Vice President, Corporate Development

Geoffrey Swire joined Allena in 2018 and currently serves as Acting Chief Operating Officer and Senior Vice President, Corporate Development. Geoffrey has 20 years of leadership experience in business, product, and commercial development for life sciences companies.
 
Geoff previously worked at Radius Health, where he served as head of business development and alliance management, and earlier as program leader for the global Phase 3 osteoporosis development program. Prior to that, Geoff spent seven years at Genzyme, where he held various leadership positions in the Transplant and  Oncology business units, including as head of program and portfolio management, as well as vice president of global commercial operations. Geoff played a central role in the acquisition, development, regulatory approvals, and global commercial launch of Mozobil for patients undergoing stem cell transplants. He started his career in strategy and product development consulting at Integral, Inc., and Accenture’s Health & Life Sciences practice.

Geoff holds a B.A. in French and History from Dartmouth College and a Master’s in Public Policy from Harvard University

Hugh Wight

Senior Vice President, Technical Operations

Hugh Wight is senior vice president of technical operations at Allena Pharmaceuticals. He is an experienced manufacturing executive with more than 20 years in pharmaceutical and biopharmaceutical development, manufacturing, validation and quality assurance.

Prior to joining Allena, Hugh was vice president, technical operations for Alnara Pharmaceuticals, where he led manufacturing, project management, quality assurance and control, and fostered strategic partnerships with manufacturing organizations. Prior to his time at Alnara, Hugh held various quality assurance and validation leadership positions at Altus Pharmaceuticals, Alkermes, Aquila Biopharmaceuticals, AutoImmune and InSite Vision.

Hugh holds a B.S. in microbiology from the University of Maine-Orono.

Louis Brenner, MD

President and Chief Executive Officer

Lou Brenner, MD, has served as chief executive officer of Allena since February 2019 and as president since February 2017. He previously served as chief operating officer from April 2015 to January 2019.

Lou has more than a decade of industry leadership experience, including pharmaceutical development strategy, regulatory affairs, business development, and commercialization. Prior to joining Allena, Lou served as chief medical officer at Idera Pharmaceuticals, chief medical officer at Radius Health, and senior vice president at AMAG Pharmaceuticals. He began his industry career at Genzyme Corporation, where he led successful product development programs for medicines that are currently marketed in the renal and metabolic areas.

He holds an MD from Duke University, an MBA from Harvard Business School, and a BS from Yale University, He completed his residency in internal medicine at Brigham and Women’s Hospital and his fellowship in nephrology at Brigham and Women’s Hospital and Massachusetts General Hospital. Lou holds a clinical appointment at Brigham and Women’s Hospital.