1.1.3BILLION INC., located at 416 Teheran-ro, Gangnam-gu, Seoul, South Korea (“3BILLION”) is responsible for the business of genetic and biomolecular testing services related to the analysis of biologic samples of patients suspected to have rare genetic disorders as well as in the supply and sales of certain affiliated services to customers.
1.2.The rare disease diagnosis services provided by 3BILLION (hereinafter “Service”) is any laboratory and analytical services including but not limited to sample collection, biomarker and biomolecular testing, whole genome sequencing (“WGS”), whole exome sequencing (“WES”), Sanger sequencing, raw data generation, manipulation and interpretation, analysis and reanalysis, disease informatics, symptom suggestion system, medical interpretation, report production, and any other services listed and updated on the website of 3BILLION (the“Website”, https://3billion.io). and the portal of 3BILLION (the "Portal", https://portal.3billion.io).
1.3.A Partner shall be any person who is legally entitled to place order for the Service, including but not limited to physicians, reference laboratories, hospitals, pharmaceutical companies, and any other entity. Responsible Physician shall be defined as a person licensed and legally qualified to practice medicine and legally authorized to request genetic and biomolecular testing Services.
1.4.These General Terms and Conditions (“General Terms”) comply with the law regarding the electric communication enterprise and the enforcement ordinance in South Korea on the utilization and procedure of all related services provided by 3BILLION.
1.5.These General Terms may be amended from time to time, and all amendments shall prevail over these General Terms.
2.Enrollment of a Membership, Offer and Acceptance
2.1.Access to certain Website pages is limited by a user identifier (“User ID”) and password, which are obtained by registering for a service account with 3BILLION. By registering, a Partner represent, warrant, and covenant that he/she:
is at least 18 years of age;
is using his/her actual identity;
has provided true, accurate, current and complete personal information during the registration process;
will maintain up-to-date information to keep it true, accurate, current and complete; and
will have obtained registration and will use the Website only for the activities permitted by such registration.
2.1.1.By logging onto the Website using the User ID and password, a Partner represents, warrants, and covenants that he/she is authorized to use such User ID and password and to engage in the activities conducted thereunder. The Partner agrees to be solely responsible for the security of his/her User ID and password and for any activities conducted on or through theWebsite. The Partner also agrees not to disclose or share the User ID and password with any third party.
2.1.2A Partner agrees not to gain or attempt to gain unauthorized access to any part of the Website with restrict access or to make any unauthorized use of the Website or information accessible on the Website.
2.1.33BILLION may deny or revoke access to the Website at any time in its sole discretion, with or without cause. A Partner must notify 3BILLION immediately in case of any loss, theft or unauthorized use of a password.
2.2.All offers of 3BILLION for Services shall be free of any obligation and non-binding and shall be exclusive of VAT, shipping costs and possible administration costs unless explicitly stated otherwise.
2.3.Any order of a Partner (“Order”) shall become valid only if partner places an order on the 3billion portal, https://portal.3billion.io, and the patient's specimen arrives at 3billion along with the hard copy of signed informed consent form and signed requisition form.
3.1.Ordering and shipment of samples
3.1.1.A Partner may Order the Service for analyzing clinical samples of patient(s), collected, processed and stored in accordance with applicable regulations and required conditions (“Sample”). The Partner must make the Order in accordance with 3BILLION’s instructions published on the Website and the Portal.
3.1.2.A Partner shall ship the Sample to 3BILLION together with uniquely assigned Sample identifier (“3billion ID”), containing the hard copy of signed informed consent form and signed requisition form.
220.127.116.11BILLION will charge the shipping cost separately, and the shipping cost shall exclude all applicable taxes, government levies and fees charged by the originating country. 3BILLION shall not be held accountable for any damage or loss occurred during the shipping process, before the arrival of the shipment at 3BILLION.
3.1.4.If a Partner is located in South Korea, the Order must contain (i) a copy of the informed consent form for genetic testing (“ICF”) and (ii) a 3billion requisition form ("RF")signed by a patient/legal guardian and the Partner, together with the Sample.
3.1.5.If a Partner is located outside of South Korea, the Partner may submit the ICF and RF, as same with the section e).
18.104.22.168BILLION reserve the right to reject any Sample or to refuse the processing of any Order, if (i) ICF and RF are not provided or if (ii) such are incomplete or (iii) such do not fulfill the standards required under the Korean Bioethics and Safety Act.
3.2. Analysis and report
22.214.171.124BILLION shall proceed to the analysis of the Sample registered with complete Order information and documentation, in accordance with the specific Order details.
126.96.36.199BILLION shall prepare and make available the completed report in relation to all provided Samples (“Report”) for the Partner through 3BILLION’s own customer portal or via Partner’s registered email.
3.2.3.Any provided Report contains the result of the analysis of a specific Sample tested according to the stated methods and conditions, and the results do not necessarily indicate or predict the qualities of other identical or similar test, experiment, or operating conditions. 3BILLION shall not be held liable for any generalizations, deductions, assumptions or conclusions drawn by the Partner, Responsible Physician, or any other parties based on the Report.
3.2.4.Should additional laboratory work or analysis to be undertaken by 3BILLION for further verification of a Report, and 3BILLION shall have the right to claim reasonable costs incurred for the additional work, provided the original findings are verified.
3.2.5.Depending on the patient’s consent and the local applicable laws, a Partner’s Responsible Physician may disclose the Report to the patient, primary care physician or any third parties. The Report shall not be modified or changed in any way under no circumstances and shall be provided in its original form only.
3.2.6.In case of any deficiencies, uncertainties, or any other possible defects in the Report, the Responsible Physician or its point of contact shall immediately inform 3BILLION in writing or by phone, and request an additional explanation, clarification or eventual modification to the provided Report. 3BILLION will investigate such a request without delay, and if the claims are justified, will use commercially reasonable efforts to amend the Report.
3.2.7.The Service provided by 3BILLION encompasses from processing of a Sample, genetic and biomolecular testing to analysis based on the most updated scientific and analytical standards. 3BILLION shall not be held liable, however, for the few cases genetic or biomolecular tests may show incorrect results due to unforeseen or unknown factors including but not limited to the quality of the Sample provided by a Partner to 3BILLION or the failure of any tests not influenced by 3BILLION. In such cases, 3BILLION shall not be responsible or held liable for the incomplete, potentially misleading or even inaccurate result of any tests if such issue could not be recognized by 3BILLION in advance.
188.8.131.52BILLION may, upon a written request of a Responsible Physician and/or a reference laboratory and subject to a respective consent of the Patient, provide solely to the Responsible Physician the raw data of a conducted analysis.
3.3. Data Usage
3.3.1.By providing an Order to 3BILLION, the Partner agrees, confirms and warrants to 3BILLION that, subject to the Patient’s specific ICF and RF, 3BILLION are entitled and legally permitted to store, retain and utilize for commercial, non-commercial, scientific and/or research purposes, all and any (i) corresponding Patient information sent by a Partner, (iii) generated raw sequencing data and variant interpretation and (iv) copies of all Reports ((ii) (iii) and (iv) collectively the “Data”).
3.3.2.By providing an Order, the Partner is responsible for (i) obtaining all necessary approvals (including that of the Patient), and (ii) contractual undertakings and permissions as may be required in accordance with applicable laws in order to ensure that 3BILLION can store, retain and utilize the Data (“Data Utilization”). The Partner shall use 3BILLION’s ICF and RF or equivalent forms of such to obtain all necessary approvals.
3.3.3.With regard to Data Utilization, 3BILLION shall take all necessary steps to ensure that the Data is fully de-identified.
184.108.40.206BILLION may store, retain and utilize the Data. 3BILLION will discard and destroy all used Samples once the Service is fulfilled, according to Bioethics and Safety Act.
4. Representations and Warranties
4.1.Each Party represents and warrants to the other Party:
4.1.1.by entering into an Agreement, each Party will comply with all laws, regulations, rules, and orders applicable to its performance of the Agreement and will adhere to the principles of good clinical practice;
4.1.2.each Party has obtained all and any approvals, permits, and consents as may be required to perform its tasks under the Agreement;
4.1.3.that it is a corporation duly organized and validly existing under the laws of the jurisdiction of its incorporation. The performance, execution, and delivery of any Agreement have been duly authorized by its authorized body. Such Party has obtained all consents, approvals, and authorizations, necessary for the execution and delivery under the Agreement,and otherwise to perform such Party’s obligations under the Agreement;
4.1.4.there is no pending or, to its knowledge, threatened litigation or any other legal process which would have any material adverse effect on the Agreement or on its ability to perform its obligations hereunder; and
4.1.5.there is no contract or agreement by which it is bound and which prohibit it to perform the execution and delivery under the terms or conditions of the Agreement.
5. Intellectual Propertyand Trademarks
5.1.All know-how and intellectual property rights to the Services, including patent rights, copyrights, and/or trademark rights, are entitled to 3BILLION in all territories (“IP Rights”).
5.2.The trademarks of 3BILLION used on the result of the Service may not be modified or removed. A Partner may use the trademarks and logos of 3BILLION, contained in the Reports provided under the Services, with prior written consent by 3BILLION. To obtain such consent, the Partner shall provide in writing or by email copies of such materials at least 15 business days before their proposed use.
5.3.A Partner may not in its name obtain protection for or register trademarks, trade names or other designations identical, similar, or confusing to those of 3BILLION or file for intellectual property rights in any territory. A Partner is likewise not entitled to adopt or register the aforesaid IP Rights and/or designations as a part of its commercial or any other public register.
5.4.A Partner agrees that it will not contest the IP Rights or support third parties in contesting the same in any form or register such in its own name. If Partner is in breach of this provision, 3BILLION are entitled to terminate the Agreement with immediate effects without prior notice, may claim damages and reserve the right to take further legal measures.
5.5.Partner shall not advertise, promote or sell the Services in any way which might result in public deception or confusion as to the fact that 3BILLION are the source of the advertisement.
6. Time and Delivery
6.1.Dates and time of completion of a Service and delivery of the Report given by 3BILLION are estimates only and shall not constitute a term or condition.
6.2.3BILLION shall use their commercially reasonable efforts to process the Service and deliver the Report within the estimated time frame as communicated or as agreed in the Order or Agreement. If any circumstances which delay or hinder the performance of the Service and/or delivery of the Report arise, 3BILLION shall, as soon as reasonably possible, notify the Partner of such delay. The completion time shall be extended accordingly upon the occurrence of any such circumstances.
6.3.While 3BILLION will use all reasonable efforts to meet any time estimation, they reserve the right to amend such estimation if necessary. Partners shall not be entitled to claim compensation or to suspend or terminate the respective Order or Agreement orto reject the deliveries of the Report when 3BILLION fail to timely process one or more of Services or Reports.
7. Payment Terms
7.1.3BILLION will invoice Partner or the person will pay the testing cost (“Payer”) for provided Services with its standard prices (“Price”) as published on the Website at the time of Partner’s respective Order and in accordance with provisions of an Agreement. Any deviations and discounts shall in each case be determined in writing in an Agreement.
7.2.3BILLION shall invoice the Partner or the Payer according to the payment option. Partner or the Payer shall make the payment in the indicated currency within thirty calendar days after the date of order.
7.3.Any taxes or duties, where applicable, due within the Partner’s country shall be covered by the Partner.
7.4.In the event of overdue payment, 3BILLION may charge interest on the due amount at the rate of nine percent.
7.5.3BILLION may withhold or reject any further performance of the Services if the due payments are not paid by the Partner within sixty days of the date of order.
8. Liability and Indemnity
8.1.3BILLION shall be liable in accordance with the statutory provisions for their material breach of contractual obligations of the Agreement.
8.2.3BILLION shall not be liable for any other breaches of an Agreement or other contracts related to the Agreement, unless damage has been caused pursuant to the gross negligence or intentional acts of 3BILLION.
8.3.3BILLION shall also not be liable or responsible for any delays, damages or failures of the genetic and biomolecular testing and the subsequent analysis arising due to or in connection with unsuitable or inappropriate Sample provided by a Partner.
8.4.A Partner shall indemnify and hold 3BILLION harmless from and against all and any suits, claims, actions, assessments, demands, or judgments asserted against 3BILLION, and any and all direct, indirect, or consequential losses, damages, liabilities, costs and expenses incurred by a breach of any of the provisions of the Agreement by the Partner, including but not limited to the provisions of the Article 7 herein.
9. Term and Termination
9.1.The term of the Agreement shall be the period commencing on the day a Partner provides an Order and continuing until the later date of (i) delivery of the Report (“Expiry” or “Expiration”), or (ii) termination in accordance with section 9.2 (“Termination”, together the “Term”).
9.2.Besides upon the Expiry of the Agreement, the Agreement may be terminated by either Party:
9.2.1.with 15 days’ prior written notice by a Party;
9.2.2.with 15 days’ prior written notice to the breaching Party upon a material breach of this Agreement, specifying in such notice the breaching Party’s material breach and demanding its cure, with such termination being effective upon the end of such 15-day cure period if not cured;
9.2.3.if Partner has failed to pay three (3) subsequent invoices;
9.2.4.if, at any time, (i) the other Party files in any court or agency pursuant to any statute or regulation of any state, country or jurisdiction, a petition in bankruptcy or for reorganization pursuant to bankruptcy or insolvency laws or liquidation or for an arrangement or for the appointment of a receiver or trustee of such other Party or of its assets, (ii) upon the Partner’s making of a general assignment for the benefit of creditors, or (iii) upon the Partner ́s dissolution or ceasing to conduct business in the ordinary course; or
9.2.5.upon written notice in case of a change in ownership or control in the Partner. For the purposes of this provision, a transfer of twenty-five percent or more of ownership interest or voting rights shall be considered a change of ownership or control.
9.3.Unless the Agreement is terminated pursuant to a breach of a Partner, all Orders issued prior to the Termination of an Agreement shall be fulfilled pursuant to and subject to the terms of the Agreement, even if the agreed delivery dates are after Expiration. Upon Termination of the Agreement pursuant to a breach of a Partner, 3BILLION may, at its sole discretion, cancel or fulfill any outstanding Orders. For all fulfilled Orders and outstanding Orders, the Partner is obliged to pay the agreed price for the Services.
9.4.Both Parties acknowledge that they have considered the possibility of expenditures necessary in preparation for the performance of the Agreement and the possible losses and damages in the event of Termination. Neither Party shall be liable to the other for indirect, incidental or consequential damages including but not limited to loss of profits or other economic loss, by reason of the Termination of the Agreement at any time.
9.5.A Partner does not act as an authorized dealer or a sales agent of 3BILLION, and any Expiration or Termination of the Agreement shall not entitle:
9.5.13BILLION to claim any delivery or assignment of the contact details of the Partner’s customers; and
9.5.2the Partner to claim from 3BILLION any authorized dealers’ indemnity or compensation payment of any kind or to a settlement, on any legal ground whatsoever.
10. Confidentiality Obligations
10.1.Each Party may disclose to the other Party, for purposes of the implementation and performance of the Agreement, nonpublic, confidential or proprietary information and/or data, which has been either marked or identified as confidential at the time of disclosure, or is of such a nature that it is reasonably considered to be confidential (hereinafter “Confidential Information”).
10.2.During the Term and for a period of 3 years after Expiration or Termination of the Term, for as long as it has not fallen into the public domain and is considered as a trade secret under the applicable Laws, each Party agrees:
10.2.1not to use disclosing Party’s Confidential Information for any purpose other than for purposes of exercising its rights and performing its obligations under this Agreement;
10.2.2use reasonable efforts (at least the level of efforts that receiving Party uses for its own information of like importance) to safeguard disclosing Party’s Confidential Information from unauthorized use and disclosure; and
10.2.3not to disclose disclosing Party’s Confidential Information to any person other than its and its affiliates’ representatives who need to know such information for the purposes of this Agreement, provided that such persons are bound by similar obligations with respect to such Confidential Information as set forth in this Section 10.2. The receiving Party will be responsible and liable for acts or omissions of any person to which it discloses Confidential Information which would be a breach of this Section 10.2 by the receiving Party.
10.3.The obligations set forth in Section 10.2 will not apply to the extent that such Confidential Information:
10.3.1is or becomes publicly available without breach of this Agreement by receiving Party or any person that received Confidential Information through receiving Party;
10.3.2was rightfully in receiving Party’s possession prior to receipt from disclosing Party, and was not acquired directly or indirectly from disclosing Party, as documented by receiving Party’s written records;
10.3.3is obtained from a third party with no obligation of confidentiality to the disclosing Party, and provided that such third party has a right to disclose such Confidential Information to the receiving Party;
10.3.4is independently developed by the receiving Party or its affiliates or their respective representatives without use of or reference to the Confidential Information, as evidenced by receiving Party’s or its affiliates’ or their respective representatives’ written records; or
10.3.5is required to be revealed in response to a court decision or administrative order, or to otherwise comply with applicable law, applicable rules of any recognized stock exchange or quotation system or applicable rules or requirements of the securities and exchange commission or other governmental authority; provided, that, in each case: (i) the receiving Party will promptly inform the disclosing Party of any such requirement by written notice and cooperate with the disclosing Party using its commercially reasonable efforts either to seek protective measures for such Confidential Information, seek confidential treatment of such Confidential Information, and otherwise limit disclosure, and (ii) the receiving Party will disclose only such portion of the Confidential Information which is required in the advice of its legal counsel to be disclosed.
10.4.Any combination of features or disclosures will not be deemed to fall within section 10.3 merely because individual features are published or available to the general public or in the rightful possession of the receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the receiving Party.
11. Force Majeure
11.1.Neither Party will be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement to the extent such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, potentially including, but not limited to, embargoes, war, acts of war (whether war be declared or not), acts of terrorism, insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, earthquake or other acts of God, or acts, omissions or delays in acting by any governmental authority or the other Party, unavailability of materials related to the Sample, failures of international or domestic transportation, or other events which are accepted as force majeure in general international commercial practice.
11.2.In the event of force majeure, the Parties shall immediately consult with each other in order to find an equitable solution and shall use all reasonable efforts to minimize the consequences of such force majeure. If the consequences of force majeure materially and adversely affect the rights of a Party under the Agreement and the Parties have not found an equitable solution within a period of three months after the occurrence of the event of force majeure, then the affected Party may terminate the Agreement.
12.1.The Parties are independent contractors, and the relationship between the Parties established under the Agreement does not designate a Party as a partner, employee, agent or joint venture partner of or with the other. Unless otherwise agreed by the Parties in writing, neither Party shall have any right or authority to create or assume any obligation, or to make any representation or warranty, on behalf of the other Party or to bind the other Party in any manner whatsoever.
12.2.Neither Party shall use the name, trademark, logo, symbol or other image of the other Party, or of any employee, affiliate, or agent of the other Party, in any advertising, promotional or sales literature or in any publicity without a prior written approval of the Party or individual whose name, trademark, logo, symbol or other image is to be used.
12.3.No Party shall assign the Agreement to any third party without a prior written consent of the other Party.
12.4.Any dispute arising out of or in connection with this Agreement, including any question regarding its existence, validity or Termination, shall be referred to and finally resolved by arbitration under the Arbitration Rules of the International Chamber of Commerce (ICC) (“Rules”), which Rules are deemed to be incorporated by reference into this clause. The legal venue of arbitration arising out of or in relation to the Agreement and the aforesaid matters shall be Seoul, South Korea, and the language to be used in the arbitral proceedings shall be Korean or English.
12.5.The waiver by either Party hereto of any right hereunder, or any failure of either Party to enforce any of the terms or conditions hereunder, shall not be deemed a waiver of such party’s right to enforce the Agreement.
12.6.If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein will not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties will in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.
12.7.3BILLION reserve the right to amend these General Terms at any time, in which case the Partner shall be duly informed in advance.