LEGAL Terms of Use Compliance Program Summary Access to Investigational Products Terms of Use Last updated on March 9, 2016 This Terms of Use (“Terms”) is a legal agreement between you and Omeros Corporation (“Omeros,” “we,” or “us”) governing your access to and use of the online services that Omeros operates through websites and other online services that link to these Terms, including, without limitation, the Content (collectively, the “Services”). Please read the Terms carefully before using the Services. Using the Services indicates that you accept and agree to be bound by the Terms. Do not use the Services if you do not accept the Terms. Omeros may change or modify the Services or the Terms at any time. Such changes, revisions, or modifications shall be effective immediately upon being posted in relation to the Services. Any use of the Services by you after we post changes to the Terms constitutes your acceptance of those changes. THESE TERMS CONTAIN DISCLAIMERS OF WARRANTIES (SECTION V), DISCLAIMERS OF LIABILITY AND AN EXCLUSIVE REMEDY (SECTION VII), AS WELL AS INFORMATION ABOUT CERTAIN LimitationS ON YOUR ABILITY TO Bring A Claim AGAINST US (SECTION XV). I. The Services Do Not Provide Medical Advice The Services are designed to offer you general health information for educational and informational purposes only, and the Services are not intended to replace personal consultation with a qualified medical professional. Omeros is not engaged in rendering medical or similar professional services or advice via the Services, and the information provided is not a substitute for the professional judgment of a health care professional in diagnosing and treating patients. Your reliance upon any content or information provided through the Services is solely at your own risk. You should always seek the advice of a medical professional for questions related to your disease, disease symptoms, and treatment. You should not construe our publication of this content as an endorsement by Omeros of the views expressed herein, or any warranty or guarantee of any strategy, recommendation, treatment, action, or application of medication or preparation made by the author of the content. II. Restrictions on Use You may not access or use, or attempt to access or use, the Services to take any action that could harm us or any third party, interfere with the operation of the Services, or use the Services in a manner that violates any laws. Without limiting the foregoing, you agree not to: Impersonate any person or entity or falsely state or otherwise misrepresent your affiliation with any person or entity or the origin of any information you provide; Use any device, software, or routine to interfere or attempt to interfere with the proper working of the Services or any activity conducted on the Services or attempt to probe, scan, test the vulnerability of, or breach the security of any system or network; Circumvent, reverse engineer, decipher, decompile, disassemble, decrypt, or otherwise alter or interfere with (or attempt, encourage, or support anyone else’s attempt to engage in such activities) any of the software comprising or in any way making up a part of the Services. The use or distribution of tools designed for compromising security (e.g., password guessing programs, cracking tools or network probing tools) is strictly prohibited; Engage in unauthorized spidering, scraping, or harvesting of content or information, or use any other unauthorized automated means to compile information; Obtain or attempt to gain unauthorized access to other computer systems, materials, information or any services available on or through the Services; Take any action that imposes an unreasonable or disproportionately large load on our network or infrastructure; Upload or otherwise transmit any communication, software, or material that contains a virus or is otherwise harmful to our users’ computers or systems; or Engage in any other conduct that restricts or inhibits any person from using or enjoying the Services, or that, in our sole judgment, exposes us or any of our users, affiliates, or any other third party to any liability, damages, or detriment of any type. Violations of system or network security and certain other conduct may result in civil or criminal liability. We may investigate and work with law enforcement authorities to prosecute users who violate the Terms. We may suspend or terminate your access to the Services for any or no reason at any time without notice. III. Intellectual Property All content, information, materials, text, images, audio, video, computer code and software appearing on the Services (collectively, the “Content”) is the property of Omeros or third parties. No title or ownership rights are transferred to you under these Terms, and nothing herein shall be construed as a license to you under any Omeros patent, trademark, copyright, or trade secret. You may access, use and display the Services without modification or alteration in any way, and only so long as you comply with these Terms. You may access, use and display the Services on a single computer or device and download and print copies of the Content only for non-commercial, informational, and personal use. Copyright. The Content is protected under the copyright laws of the United States and other countries. All copyrights in the Services are owned by Omeros or its third-party licensors to the full extent permitted under the United States Copyright Act and all international copyright laws. Unless expressly permitted in writing, you may not copy, reproduce, distribute, publish, enter into a database, display, perform, modify, create derivative works from, transmit, or in any way exploit any part of the Content except that you may make use of the Content for educational and non-commercial purposes only, provided that you maintain all copyright and other notices posted along with the Content. To obtain written consent to use a copyrighted work, please contact terms@omeros.com. Copying or downloading these materials for anything other than your personal use is a violation of these Terms of Use and may be a violation of copyright laws. Trade and Service Marks. All rights in product names, the Omeros name, trade names, logos, service marks, trade dress, slogans, product packaging, and designs of Omeros products or services, whether or not appearing in large print or with the trademark symbol, belong exclusively to Omeros or its licensors and are protected from reproduction, imitation, dilution, or confusing or misleading uses under national and international trademark and copyright laws. The use or misuse of these trademarks or any materials, except as permitted herein, is expressly prohibited, and nothing stated or implied on the Services confers on you any license or right under any patent or trademark of Omeros, its affiliates, or any third party. To obtain written permission to use the trade and service mark rights of Omeros, please contact terms@omeros.com. Patents. Omeros’ products, product candidates, therapeutic methods and technologies described on our websites that provide the Services are protected by one or more of the following U.S. Patents owned by Omeros: U.S. Patent Nos. 6,228,639; 6,740,100; 6,969,601; 7,060,267; 7,067,144; 7,083,786; 7,091,181; 7,112,414; 7,268,128; 7,297,348; 7,309,576; 7,585,842; 7,737,118; 7,786,139; 7,794,955; 7,919,094; 7,932,250; 7,973,068; 8,003,125; 8,006,700; 8,173,707; 8,278,327; 8,298,777; 8,343,970; 8,377,930; 8,426,439; 8,450,309; 8,551,790; 8,586,633; 8,609,818; 8,637,528; 8,652,477; 8,679,845; 8,685,975; 8,785,717; 8,790,696; 8,795,973; 8,840,893; 8,901,315; 8,951,522; 8,993,719; 8,999,654; 9,005,905; 9,096,676; 9,011,860; 9,066,856; 9,102,643; 9,102,724; 9,119,822; 9,220,715; 9,254,271; 9,273,119; 9,278,101. Other U.S. and foreign patents owned or controlled by Omeros are issued or pending. IV. User Submissions Unless otherwise indicated in Omeros’ Privacy Policy or otherwise agreed to in a writing signed by an authorized officer of Omeros, or as may otherwise be required by law, any questions, comments, suggestions, inventions, concepts, know-how, techniques, ideas, or any other information that a user submits or transmits to Omeros, through the Services, is submitted by the user without restriction, and will be treated as non-confidential and non-proprietary information. Omeros shall have no obligation of any kind with respect to such information, and may use such information for any purpose whatsoever, including, but not limited to, reproduction, disclosure, transmission, publication, broadcast and display. Omeros shall also be free to use all such information for any purpose whatsoever, including research and development, improvement, manufacturing, and commercialization of Omeros’ current and future products using or incorporating such information. Omeros reserves the right, and you authorize Omeros, to use and assign all information regarding your use of the Services and all information provided by you in any manner consistent with these Terms of Use, the Privacy Policy, and applicable law. V. Disclaimers of Warranties Your use of the Services is at your own risk. The Services, including text, graphics, links, or other items, are provided “as is.” We make no representations or warranties about the operation of the Services or the information, materials, goods, or services appearing or offered on the Services. Without limiting the generality of the foregoing, we disclaim all warranties, express, statutory, or implied, including but not limited to the warranties of merchantability, fitness for a particular purpose, non-infringement of any third party intellectual property or proprietary rights, freedom from computer virus, and any warranties relating to the accuracy, reliability, correctness, or completeness of the information made available on the Services. Further, we make no warranty that the Services will meet your needs or requirements or the needs or requirements of another person. Omeros does not warrant that the Services, Content, functions, or materials contained therein will be timely, secure, accurate, complete, up-to-date, free of viruses or errors, or uninterrupted. If applicable law does not allow the exclusion of some or all of the above implied warranties, those exclusions will apply to you to the fullest extent permitted by applicable law. Omeros’ websites through which the Services are provided contain forward-looking information about Omeros’ business, operations and financial condition. Words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,” “seeks” and similar expressions that may be used on the Services are intended to identify forward-looking statements that are subject to various known and unknown risks and uncertainties beyond Omeros’ reasonable control. Such risks and uncertainties include, but are not limited to, those arising from research and development, clinical trials, regulatory approvals, third-party reimbursement, reliance on third-party manufacturers and suppliers, commercialization, competition, patents, product liability and adequate financing. Actual results may differ materially from the forward-looking information provided, and such forward-looking information is only current as of the time it was originally included on the Services. The information on the Services is not intended and should not be construed as an offer to sell securities. VI. Links to other Sites Omeros’ websites on which the Services are provided may contain links to other websites or online services that are operated and maintained by other persons and that are not under the control of or maintained by Omeros. Such links do not constitute an endorsement by Omeros of those other websites or online services, the content displayed therein, or the persons associated therewith. These Terms do not apply to such other websites and online services, and such websites and online services are not part of the Services. We encourage you to review the privacy policies and terms of use of these other websites or services. VII. Exclusive Remedy and Limitation of Liability YOUR SOLE AND EXCLUSIVE REMEDY IS TO STOP USING THE SERVICES. UNDER NO CIRCUMSTANCES, INCLUDING WITHOUT LIMITATION NEGLIGENCE, WILL OMEROS, ITS AFFILIATES, OR ANY PARTY INVOLVED IN CREATING, PRODUCING, OR DELIVERING THE SERVICES BE LIABLE FOR DAMAGES OR LOSSES INCLUDING WITHOUT LIMITATION DIRECT, INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL, OR PUNITIVE DAMAGES AND LOST PROFITS ARISING OUT OF THE TERMS OR YOUR ACCESS, USE, MISUSE, OR INABILITY TO USE THE SERVICES OR ANY SITES LINKED FROM THE SERVICES, HOWEVER CAUSED, WHETHER IN CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, EVEN IF OMEROS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, OR IN CONNECTION WITH ANY FAILURE OF PERFORMANCE, ERROR, OMISSION, INTERRUPTION, DEFECT, DELAY IN OPERATION OR TRANSMISSION, COMPUTER VIRUS, OR LINE OR SYSTEM FAILURE. BECAUSE SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, OMEROS’ LIABILITY IN SUCH JURISDICTIONS SHALL BE LIMITED TO THE EXTENT PERMITTED BY LAW. VIII. Privacy Policy By using the Services, you acknowledge that you have reviewed, understand, and accept the terms of our Privacy Policy. IX. Indemnification You agree to indemnify, hold harmless, and defend Omeros, and its affiliates and licensors, and each of their respective officers, directors, contractors, agents, employees, successors and assigns from and against any and all demands, claims, damages, liabilities, judgments, fines, interest, penalties, losses, costs, expenses and harms, including without limitation reasonable attorneys’ fees and fees of other professional advisers, arising out of or in connection with (i) your use of the Services, (ii) your online conduct, (iii) your violation or breach of these Terms, (iv) your failure to comply with any applicable laws or regulations, (v) your negligence, willful misconduct, or violations of the intellectual property or other rights of any person, or (vi) any of your dealings or transactions with other persons resulting from use of the Services. You shall not settle any such claim without the prior written consent of Omeros. These obligations will survive any termination of these Terms. X. Separate Terms and Conditions In connection with your use of the Services, you may be asked to consent to policies or terms and conditions in addition to these Terms. Please read these supplemental policies and terms carefully before making any use of such portions of the Services. Any supplemental terms will not vary or replace these Terms regarding any use of the Services, unless otherwise expressly stated. XI. Termination Omeros may terminate this agreement for any reason at any time. Omeros reserves the right, in its sole discretion, to restrict, suspend, or terminate your access to and use of the Services, with or without prior notice. Otherwise applicable sections of the Terms shall survive termination. Omeros also reserves the right to seek all remedies available at law and in equity for violations of these Terms of Use. Upon termination, you must cease all use of the Services. XII. Integration & Severability These Terms constitute the entire agreement between Omeros and you, superseding any prior or contemporaneous communications and proposals (whether oral, written or electronic) between you and us. In the event any provision of these terms is held unenforceable, it will not affect the validity or enforceability of the remaining provisions and will be replaced by an enforceable provision that comes closest to the intention underlying the unenforceable provision. XIII. No Waiver Our failure to enforce any provisions of the Terms or respond to a breach by you or other parties shall not in any way waive our right to enforce subsequently any terms or conditions of the Terms or to act with respect to similar breaches. XIV. Assignment and Binding Effects You must not assign these Terms or any rights or obligations herein without the prior written consent of Omeros and any attempted assignment in contravention of this provision is null and void and of no force or effect. Omeros has the right to assign these Terms, and any of its rights or obligations herein. These Terms are binding upon each party and its respective successors, heirs, trustees, administrators, executors and permitted assigns. XV. Location, Governing Law and Arbitration Your access to and use of the Services under these Terms are governed by and will be construed in accordance with the laws of the State of Washington, as applicable, without regard to principles of conflicts of laws. By using the Services, you waive any claims that may arise under the laws of other countries or territories. With respect to any and all disputes arising out of or in connection with the Services, these Terms, or Privacy Policy, Omeros and you agree to negotiate in good faith and undertake reasonable efforts to cooperate with one another in order to achieve a mutually satisfactory resolution. If you and Omeros do not resolve any dispute by informal negotiation, any other effort to resolve the dispute will be conducted exclusively by binding arbitration as described in this section. You are giving up the right to litigate (or participate in as a party or class member) all disputes in court before a judge or jury. Instead, all disputes will be resolved before a neutral arbitrator, whose decision will be final except for a limited right of appeal under the Federal Arbitration Act. Any court with jurisdiction over the parties may enforce the arbitrator’s award. Any proceedings to resolve or litigate any dispute in any forum will be conducted solely on an individual basis. Neither you nor Omeros will seek to have any dispute heard as a class action or in any other proceeding in which either party acts or proposes to act in a representative capacity. No arbitration or proceeding will be combined with another without the prior written consent of all parties to all affected arbitrations or proceedings. Omeros and you agree that all disputes arising under these Terms that cannot be settled through informal negotiation will be settled exclusively through confidential binding arbitration in King County, Washington, U.S.A. The arbitrator’s award shall be binding and may be entered as a judgment in a court of competent jurisdiction. You agree that Omeros may seek any interim or preliminary relief from a court of competent jurisdiction in King County, Washington, U.S.A, necessary to protect its rights or property pending the completion of arbitration. To the extent permitted by law, any claim or dispute under this agreement must be filed within one year in an arbitration proceeding. The one-year period begins when the claim or notice of dispute first could be filed. If a claim or dispute isn’t filed within one year, it’s permanently barred. If any other provision of this section is found to be illegal or unenforceable, that provision will be severed, with the remainder of this section remaining in full force and effect. XVI. Contact Us Please direct any questions, complaints or claims related to the Services or your use of the Services, or requests to use a copyrighted work or trade or service mark right to terms@omeros.com. Omeros Corporation Compliance Program Summary Omeros Corporation is committed to supporting an effective comprehensive compliance program (“Compliance Program”) in accordance with the April 2003 publication titled “Compliance Program Guidance for Pharmaceutical Manufacturers,” developed by the Office of Inspector General, U.S. Department of Health and Human Services (the “HHS-OIG Guidance”). The purpose of our Compliance Program is to ensure compliance with the laws and regulations that apply to the biopharmaceutical industry, as well as our own internal company policies, to prevent, detect, and correct violations of such laws, regulations, or policies. Omeros expects all of its employees to comply with its Code of Business Conduct and Ethics and Policy on Code of Pharmaceutical Industry Business Conduct and Ethics (together the “Code”) and associated policies. If Omeros becomes aware of any violations of law or company policy, we will investigate the matter and, as appropriate, take disciplinary action and implement corrective measures to prevent future violations. The fundamental elements of our Compliance Program are laid out below. Our Compliance Program is dynamic; we regularly review and update our Compliance Program to ensure it remains current with applicable laws and regulations. 1. Leadership and Structure. The Compliance Officer serves as the focal point for our compliance activities and is charged with the responsibility for developing, operating and monitoring the Compliance Program, including regular reporting to the CEO and Board of Directors. We are committed to ensuring that the Compliance Officer has the ability to effectuate change within the organization as necessary and to exercise independent judgment. The Compliance Committee, which includes members of senior management across our business functions, supports the Compliance Officer in fulfilling his or her responsibility in implementing and operating our Compliance Program. 2. Written Standards. The Code is our statement of ethical and compliance principles that guide our daily operations. The Code establishes that we expect management, employees, and agents of the company to act in accordance with applicable federal and state laws and regulations and related company policy. The Code articulates our fundamental principles, values and framework for action within our organization. We have established state-specific guidelines where applicable. For example, we have established a specific annual dollar limit of $2,000 per medical or health professional in California on educational items and promotional activities in accordance with Cal. Health & Safety Code § 119402. 3. Education and Training. A critical element of our Compliance Program is the education and training of our employees on their legal and ethical obligations under applicable federal and state health care program requirements. As a condition of new or continued employment, we require all employees to receive training on the Code and its associated policies. We are committed to taking all necessary steps to effectively communicate our standards and procedures to all affected personnel. To ensure that our training programs capture the intended activities and stay current with applicable laws and regulations, we will periodically review and update our training programs, as well as identify additional areas of training as needed. 4. Internal Lines of Communication. We are committed to encouraging dialogue between management and employees. Our goal is for all employees, when seeking answers to questions or when acting in good faith to report potential instances of fraud and abuse, to know who to turn to for a meaningful response and to be able to do so without fear of retribution. We expect our employees, officers and directors to promptly report any concerns about any suspected violation of the Code to their supervisor, manager, or directly to the Compliance Officer. 5. Auditing and Monitoring. Our Compliance Program includes efforts to monitor, audit, and evaluate compliance with our compliance policies and procedures. These actions are intended to identify potential or existing problem areas and to take corrective measures in an effort to prevent the recurrence of non-compliance. The nature of our reviews, as well as the extent and frequency of our compliance monitoring and auditing, varies according to a variety of factors, including new regulatory requirements, changes in business practices and other considerations. 6. Responding to Potential Violations. The Compliance Officer reviews all reports of non-compliance and determines whether further investigation or action is necessary. If deemed necessary, the Compliance Officer, or a designee, will conduct an investigation to determine whether a violation of the Compliance Program has occurred. Our Compliance Program includes disciplinary policies that set out the consequences of violating the law or company policy. Although each situation is considered on a case-by-case basis, we will consistently undertake appropriate disciplinary action to address inappropriate conduct and deter future violations. 7. Corrective Action Procedures. Our Compliance Program requires the company to respond promptly to potential violations of law or company policy, take appropriate disciplinary action, assess whether the violation is in part due to gaps in our policies, practices, or internal controls, and take action to prevent future violations. This Compliance Program Summary is not intended to nor does it act to create any contractual right. Click here for a PDF copy of the Compliance Program Summary State Specific Requirements Click here for a PDF copy of the California Declaration of Compliance Access to Investigational Products Omeros is committed to helping patients by discovering, developing, and obtaining regulatory approval for novel therapeutics. As part of therapeutic development, we engage in clinical research to evaluate our product candidates’ safety and efficacy. For information about our clinical trials that are currently recruiting, visit clinicaltrials.gov. Omeros is aware that some patients may not be able to wait until a product is approved to treat their illness or condition and may not be able to participate in a clinical trial. Omeros is sometimes able to provide such patients with early access to investigational products based on considerations including, but not limited to, the following criteria: The patient has a serious or immediately life-threatening disease or condition. There is no comparable or satisfactory alternative therapy for the disease or condition available to the patient. The patient does not qualify for participation in, or have access to, any of Omeros’ ongoing clinical trials. There is sufficient clinical evidence to anticipate that the patient might well experience a clinically meaningful benefit and that the investigational product will have an acceptable safety profile in the relevant indication such that the potential benefit justifies the potential risks. Providing expanded access to the investigational product will not interfere with the development of the product. Omeros has adequate supply of the investigational product. The request for expanded access to the product has been made by a qualified and licensed physician in the United States with expertise and facilities appropriate for the administration of the therapy and for the monitoring, managing, and reporting of side effects as well as clinical outcomes. Omeros will consider the above criteria in determining whether to offer expanded access to its investigational products; however, Omeros cannot guarantee that the investigational product will be made available to a particular patient. A patient’s physician may request additional information on how to apply for access to one of Omeros’ investigational products by contacting Omeros Medical Affairs at compassionateuse@omeros.com. Omeros will endeavor to acknowledge expanded access requests within 5-10 business days of receipt. Physicians who receive any of Omeros’ investigational products through expanded access are required to comply with all applicable laws and regulations, as well as any contractual conditions, including those relating to safety reporting. ©2020 Omeros Corporation, All rights reserved. Site Map Contact Us Privacy Policy Legal We use cookies to ensure our website works properly and to collect statistics about users in order for us to improve the website. If you continue to browse this site, you will accept our use of cookies. For more information, please read our Privacy Policy. AGREE