OCPI Purchase Order Terms and Conditions

TERMS AND CONDITIONS OF PURCHASE ORDERS

In the event of any conflict between the terms of another existing Agreement between the parties, such as but not limited to a Master Services Agreement, a Consultation Agreement, and /or a Task Order and this Purchase Order, the prevalence shall respect the following order of interpretation: 1st) A Master Services Agreement (or similar Agreement), 2nd) a Task Order and 3rd) the Purchase Order, except to the extent written evidence clearly specifically states the parties intent to mutually agree upon a different interpretation

If there are no other agreements between the parties, these Terms and Conditions will apply.

INVOICING

Supplier or its Affiliate shall submit an invoice detailing the following:

(i)               Travel and/or other pass-through expenses for the invoice period;

(ii)             The type of Services provided for the invoice period;

(iii)            Time spent performing such Service(s) for the invoice period and cumulative through the invoice period;

(iv)            Total amount charged for such Services for the invoice period and cumulative through the invoice period;

(v)              Total amount of invoice (i.e.: Services and travel) for the invoice period and cumulative through the invoice period.

Invoices must reference a valid contract database number, Supplier Project number and Task Order or Purchase Order number as applicable. Failure to reference applicable numbers may result in delayed payment.

Supplier shall submit invoices using only one of the following:

  1. All Purchase Orders will be routed to you electronically via the Ariba Network. You will receive a purchase order e-mail notification from SAP Ariba instructing you how to confirm the Purchase orders and submit all future invoices via the Ariba Network.
  2. If for any reason you cannot conduct business on the Ariba Network, please e-mail your invoices to Otsuka_AP@onlinecapturecenter.com.
  3. If you do not conduct business electronically or no email address can be provided, then invoices should be sent to:

OTSUKA

P.O. Box 2709

Portland, OR  97208

E-mailed invoices must be in PDF-file format and considered to be the “original” invoice. No other electronic format will be accepted.

Payment: Otsuka shall pay correct invoices within 45 days of receipt unless otherwise agreed upon.

1-      SERVICES: Supplier agrees to perform for Otsuka Canada Pharmaceutical Inc (“Otsuka”) the services (“Services”) listed in an applicable Purchase Order (“Purchase Order”).  Supplier agrees to perform all Services in accordance with Otsuka’s written requirements and all applicable laws, regulations, rules, ordinances, guidelines and professional standards, including those pertaining to confidentiality, and the use and disclosure of patient health information. Purchase Orders, as applicable, shall contain Statements of Work/Quotes/Proposals (“SOW”) and a Budget in a form acceptable to Otsuka. All of which is to be attached to the Purchase Order.  In the event that the Services will exceed the term or the budget, or if there is a change in scope or scale of Services during the term, a revised SOW needs to be provided by the Vendor to Otsuka.  Once the revised SOW is mutually agreed upon, a revised Purchase Order will be sent to the Vendor.

2-      OFFER AND ACCEPTANCE: This PO constitutes Company’s entire offer, subject to any applicable Master Services Agreement (“MSA”), Task Order or other formal Agreement, to Supplier and shall become a binding contract on the terms and conditions set forth herein upon acceptance by Supplier, either by acknowledgment or commencement of performance. Any terms or conditions (including prices and delivery dates) proposed by Supplier in accepting Company’s offer which are inconsistent with, or in addition to, the terms and conditions herein set forth, are hereby objected to and shall be void and of no effect unless and to the extent expressly accepted by Company in writing.

3-      CHANGES / CANCELLATIONS / TERMINATION: Company shall have the right by written notice to change the quantity or description of Services, the extent of the work covered by this PO, the drawings, specifications, or other descriptions herein, the time and/or the place of delivery, or the method of shipment or packaging, or to suspend or cancel this PO. Upon receipt of any such notice, Supplier shall promptly make the changes in accordance with the terms of the notice.

Company may cancel this PO for cause immediately upon written notice to Supplier. In Company’s discretion, Company may allow for a cure period, not to exceed thirty (30) days, and any Services rendered during the cure period shall be unpaid unless otherwise agreed by Company.  Upon notice of cancellation, Supplier shall discontinue all Services under this PO and shall not, without written authorization from Company, perform further Services, incur additional expenses, or make additional

commitments in connection with Services. Company shall pay all reasonably substantiated costs incurred by Supplier in connection with this PO prior to date of notification of cancellation and additional costs thereafter if authorized in writing by Company. Company’s obligation to compensate Supplier for Services shall be limited to actual and reasonable costs incurred by Supplier as a result of its satisfactory performance of Services. The cancellation of this PO shall be executed in an orderly manner. Upon cancellation, Supplier shall deliver to Company all work, in whatever state of completion. Upon completion, cancellation, or termination of this contract, Supplier shall return to Company on demand all Company Information, including data, drawings, specifications, and other information (along with copies made by Supplier).

In the event of cancellation, Supplier’s limit of recovery and Company’s extent of liability shall be limited to general money damages not to exceed Supplier’s non-cancelable actual out of pocket costs incurred up to the date of cancellation.

4-      DEFAULT: Company may, by written notice to Supplier, in addition to other rights afforded by law, cancel for default this PO, in whole or in part, (a) if Supplier fails to deliver the Services or perform the Services strictly within the time specified herein, or if no time is specified, within a reasonable time, (b) if the Services delivered do not conform to the requirements herein or if Supplier fails to fulfill any of the other conditions of the PO, or so fails to make progress as to endanger performance of the PO in accordance with its terms, or (c) if any proceedings in bankruptcy or insolvency, voluntary or involuntary, are commenced by, or against Supplier, or if any receiver is appointed with or without Supplier’s consent, or if Supplier makes any assignment for the benefit of creditors, or if Supplier commits any other act of bankruptcy or becomes insolvent or unable to meet its debts as they mature.

5-      COMPENSATION: The Parties agree that Supplier will be compensated according to the Purchase Order unless otherwise agreed upon.  No other costs are authorized, and no payments will be made for any cost not set forth in writing and agreed upon.

6-      FOREIGN SUPPLIERS – TAX WITHHOLDING: Where a Supplier is not a Canadian resident, Supplier agrees and acknowledges that Otsuka may deduct from its payment to Supplier any applicable Canadian non-resident withholding tax imposed by and payable under Canadian law, unless Supplier has satisfied Otsuka in writing that any payment under these terms and conditions is qualified for an exemption under Canadian law before Supplier invoices Otsuka. Where applicable, Supplier shall describe in an applicable Statement of Work what portions of the Services are being performed by a non-resident in Canada. In addition, invoices for Services rendered must clearly reflect when Supplier’s Services are performed in Canada versus when Supplier’s Services are performed in the U.S. for Otsuka in Canada.

7-      AMENDMENTS: No amendment to these terms and conditions will be of any force or effect unless it is (i) reduced to writing and signed by the Parties, and (ii) is expressly referred to as being an amendment to these terms and conditions.

8-      WORK PRODUCT: It is understood and agreed to by the Parties that all data collected under this Purchase Order, including any compilations, tabulations, or analyses of such data, and all work product related thereto shall be owned by Otsuka. All rights, title and interest in and to any ideas, discoveries, innovations, new uses, and/or inventions conceived, developed, or reduced to practice by Supplier in the course of or as a result of performing Service(s) under this Purchase Order shall be the sole property of Otsuka. Supplier shall assist Otsuka in securing protection for any such property rights and will execute any applications, assignments and/or documents required to secure such protection. The costs incurred by Supplier in securing such protection shall be paid by Otsuka. Supplier agrees to assign to Otsuka all rights, title and interest in and to all copyrightable material created by Supplier pursuant to this Purchase Order.

9-      CONFIDENTIALITY: Supplier acknowledges that Supplier may have access to information that Otsuka regards as proprietary and confidential, including, without limitation, manufacturing specifications, techniques and know-how; process information; information pertaining to products, product plans and product ideas; customer lists, including the identity of customer contacts, customer information, including customer inquiries, needs, practices and preferences; employee information, including positions, capabilities, compensation and labour relations; and other trade secrets concerning Otsuka and its business (collectively “Confidential Information”).  Supplier may also acquire personal information pertaining to Otsuka employees, and/or third parties when providing the Services. Supplier acknowledges that the Confidential Information is a valuable and unique asset of Otsuka and agrees that, both during and after the Term, Supplier will hold all Confidential Information in the strictest confidence and will not discuss, publish or use any Confidential Information except in the performance of Supplier’s duties and responsibilities hereunder. The same obligation applies to any personal information obtained during the provision of Services. The obligation of nondisclosure shall not apply to the Confidential Information or personal information which: a) at or after such time that it is or becomes publicly available through no fault of Supplier; b) at or after such time that it is disclosed to Supplier by a third party entitled to disclose such information; c)that is already known to Supplier as shown by its prior written records, provided Supplier so advises Sponsor within fifteen (15) days after disclosure of Confidential Information hereunder; d)is required by law to be disclosed to federal, provincial or local authorities.

For a period of ten (10) years after termination of our business relationship, Supplier shall treat as confidential all Confidential Information and take every reasonable precaution and use all reasonable efforts to prevent the unauthorized disclosure of the same. Supplier agrees to take all steps necessary and appropriate to ensure that Supplier’s officers, employees, and agents treat the Confidential Information as confidential and to ensure that such officers, employees, and agents are familiar with and abide by the terms of these terms and conditions. Supplier shall also abide by all privacy laws as applicable.

10-   DATA PRIVACY/DATA SECURITY:   a) Supplier, its employees, agents, subcontractors and any authorized third parties shall comply with all provincial and federal laws and regulations applicable to the performance of the Services including, without limitation, those laws and regulations governing the privacy and security of Personal Information.  “Personal Information” means personally identifiable information including, without limitation, a person’s name, address, telephone number, fax number, e-mail address, social insurance number or other government-issued identifier, credit card information, biometric identifiers, and face or other personal images, in any media or format including computerized or electronic records and paper-based files, collected or used by Supplier on Otsuka’s behalf from consumers, patients, Otsuka employees, physicians, and other business-to-business customers (collectively, “Individuals“).

b) Supplier, its employees, agents, subcontractors and any authorized third parties will establish commercially reasonable controls to ensure the confidentiality of Personal Information and to ensure that Personal Information is not disclosed contrary to the provisions of these terms and conditions; provided, further, without limiting the foregoing, Supplier, its employees, agents, subcontractors and any authorized third parties agree to implement and/or maintain an information security program that includes appropriate administrative, technical and physical safeguards and other security measures that are designed to: (i) ensure the security and confidentiality of Personal Information; (ii) protect against any anticipated threats or hazards to the security, confidentiality and integrity of Personal Information; and (iii) protect against unauthorized access to or use of Personal Information that could result in the destruction, use, modification or disclosure of Personal Information, or the substantial harm or inconvenience to Otsuka or any Individual.

c) If and where applicable, Supplier, its employees, agents, subcontractors and any authorized third parties will provide Otsuka or Otsuka’s representatives, at Otsuka’s expense, the right to audit Supplier’s business processes and practices that involve the collection, use, disclosure or retention of Personal Information in relation to the Services rendered under these terms and conditions as per section 13 of these terms and conditions.

d) Supplier, its employees, agents, subcontractors and any authorized third parties will provide to Otsuka, and as otherwise required by law, prompt written notice of all security incidents that involve, or which Supplier reasonably believe involve, the unauthorized access, use, or disclosure of Personal Information; provided, further, such notice shall summarize in reasonable detail the impact on Otsuka of the breach or unauthorized use or disclosure of, or access to, Personal Information and the corrective action taken or to be taken by Supplier; provided, further, Supplier shall promptly take all necessary and appropriate corrective action including, without limitation, at the request of Otsuka and at Supplier’s expense, to provide notices to Individuals whose Personal Information may have been affected, whether or not such notice is required by law.

11.  SAFETY INFORMATION, CUSTOMER FEEDBACK AND PRODUCT QUALITY COMPLAINT REPORTING:  a) For the purposes of these terms and conditions: “Adverse Event” means any untoward medical occurrence in a patient or clinical investigation subject administered the product and which does not necessarily have a causal relationship with the treatment for which the product is used. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the product, whether or not related to the product. A pre-existing condition that worsened in severity after administration of the Product would be considered an adverse event. “Safety Information” means any information from any source containing information including: Adverse event or suspicion thereof; Lack of efficacy; Overdose/incorrect dosage (accidental or intentional); Abuse/misuse (e.g. patients sharing medication) -even without resulting adverse reaction; Accidental exposure (e.g. child takes parent’s medication); Medication error; Withdrawal reactions; Disease progression/exacerbation of existing disease; Drug-drug/drug-food interactions; Exposure during pregnancy where the embryo or fetus may have been exposed to medicinal products (either through maternal exposure or transmission of a medicinal product via semen following paternal exposure); Suspected counterfeit product; Suspected transfer of infectious disease/agent by the medicinal product concerned; Product quality complaint (PQC) with safety related/medically important information; Pediatric use (if not an approved use); Occupational exposure; Off-label use.

b) Supplier will promptly notify Otsuka, in writing or by phone, of any Safety Information which is brought to the attention of Supplier. Supplier shall forward Safety Information within twenty-four (24) hours after the date when Vendor first becomes aware of such information. Safety Information must be sent, in English, to Otsuka via telephone contact to the Otsuka call center, or via overnight courier, fax or email at the address below: Otsuka Canada Pharmaceutical, Inc., 2250 Blvd. Alfred-Nobel, Suite 301, Saint-Laurent, Québec, Canada, H4S 2C9, Tel:   +1-877-341-9245, Fax: +1-905-689-1465, Email: OCPI-MedInfo@otsuka-ca.com

12- INJUNCTIVE RELIEF: Supplier acknowledges and agrees that any violation of these terms and conditions relating to the disclosure or use of Confidential Information may result in irreparable injury and damage to Otsuka that may not be adequately compensable in money damages, and for which Otsuka may have no adequate remedy at law. Supplier, therefore, consents and agrees that Otsuka may obtain injunctions, orders, or decrees as may be necessary to protect its Confidential Information.

13-   AUDIT RIGHTSOtsuka or Otsuka’s designee, shall have the right to audit Supplier’s records, premises and facilities as applicable, in order to enable Otsuka to assess Supplier’s compliance with these terms and conditions.  Otsuka will provide Supplier with reasonable advance notice of any audit and such audits will be conducted during normal business hours.  If there are any audit findings Supplier shall address the findings in a corrective and preventive action plan.  Otsuka’s audit rights extend to any of Supplier’s subcontractors who are providing Services related to Otsuka regulatory filings. An audit may be general or related to specific areas (for example, Financial, Regulatory, Compliance, Pharmacovigilance, Personal Information management, Information Security, etc.), depending on the nature of the services provided by Supplier.

14-   INDEMNIFICATION: Supplier shall be solely liable for and expressly agrees to indemnify and hold harmless Otsuka, its Affiliates and their respective officers, directors, employees, agents and other representatives from any and all claims, loss, damage, and/or costs, including reasonable attorneys’ fees, with respect to any liability arising out of Supplier’s negligent or wrongful acts, omissions, or failure to comply with the requirements of these terms and conditions or any Task Order or Purchase Order.

Otsuka shall be solely liable for and expressly agrees to indemnify and hold harmless Supplier from any and all liability, claims, loss, damage and/or costs, including attorneys’ fees, with respect to any liability arising out of Otsuka’s, its Affiliates and their respective officers, directors, employees, agents and other representatives’ negligent or wrongful acts, omissions, or failure to comply with the requirements of this Purchase Order.

15-   INDEPENDENT CONTRACTORS: Each Party shall act as an independent contractor and shall not be construed for any purpose as the agent, employee, servant, or representative of the other Party.  Accordingly, the employee(s) of one Party shall not be considered to be employee(s) of the other Party, and neither Party shall enter into any contract or agreement with a third party which purports to obligate or bind the other Party.

16-   INSURANCE: Supplier represents that Supplier has adequate insurance to cover Supplier’s obligations hereunder.  In the event of any change in Supplier’s insurance situation, Supplier will promptly procure the appropriate insurance coverage to meet Supplier’s obligations.  Supplier shall provide Otsuka with proof of insurance coverage upon request.

17-   ASSIGNMENT AND SUBCONTRACTING: Neither Party may assign or subcontract any portion of this Purchase Order without the prior written consent of the other Party, except that Otsuka may, without the consent of the other, assign this Purchase Order to an Otsuka Affiliated Company. An Otsuka Affiliated Company is one that is majority owned by Otsuka Pharmaceutical Co. Ltd. or one of its subsidiaries.

18-   NOTICE TO OTSUKA: All notices, certificates and acknowledgments hereunder will be in writing in English and will be deemed properly delivered when delivered by hand, sent by telefax, duly mailed by first class mail, or delivered by courier to Otsuka as follows:  Michael Laranjo, 2250 Blvd. Alfred-Nobel, Suite 301, Saint-Laurent, Québec, Canada, H4S 2C9with a courtesy copy via fax to the attention of Canadian Corporate Counsel: (514) 332-3107.

19-   NOTICE FOR VENDOR: All notices, certificates and acknowledgments hereunder will be in writing in English and will be deemed properly delivered when delivered by hand, sent by telefax, duly mailed by first class mail, or delivered by courier to the other Party at the address found on their invoice or any other main business addresses.

20-   WAIVER: Waiver of any provision of these terms and conditions will not be deemed a waiver of any other provision, nor will waiver of any breach of these terms and conditions be construed as a continuing waiver of other breaches of the same or other provisions of these terms and conditions.

21-   FORCE MAJEURE: Neither Party will be liable to the other for any delay in, nor failure of performance of their respective obligations under these terms and conditions caused by occurrences beyond the control of the Party (as the case may be) including but not limited to fire, strike, war (declared or undeclared), insurrection, acts of terror, government restriction or prohibition, force majeure or other causes reasonably beyond its control and without its fault, but the Party failing to perform shall use all reasonable endeavours to resume performance of this Purchase Order as soon as practically possible.

22-   ANTI-CORRUPTION Compliance Policy:  It is the policy of Otsuka to comply fully with all applicable laws and regulations of all jurisdictions in which it does business.  Supplier warrants and represents that it will not take any action that would constitute a violation, or implicate Otsuka in a violation, of any law of any jurisdiction in which it performs business including, without limitation, the Canadian Corruption of Foreign Public Officials Act (“CFPOA”), the Canadian Competition Act,  as amended from time to time (“CCA”) and related provisions in the Canadian Criminal Code (“CCC”), the United States Foreign Corrupt Practices Act of 1977, as amended (“FCPA”), and where applicable, any other anti-bribery/corruption legislation enacted by countries in which the Supplier provides services to Otsuka.

The parties i) are not to unduly offer, give, promise, solicit, accept or authorize any payment, advantage or thing of value (or imply that they will or might do so in the future) to or from anyone (such as government officials, employees and agents, public office holders or candidates, political party officials or agents, Health Care Professionals, payer or patient association representatives and agents, etc.), directly or indirectly, that is in any way connected with this Purchase Order or as an inducement to obtain or retain business or an advantage (the “Prohibited Actions”), ii) have not done any Prohibited Actions prior to this Purchase Order, and iii) have taken reasonable measures to prevent their directors, officers, employees, subcontractors, agents or any other third parties subject to their control or determining influence from carrying out any Prohibited Actions.  Non-Compliance: Supplier understands and acknowledges that any non-compliance with this Anti-Corruption section will constitute grounds for immediate termination of this Purchase Order, and of any other agreements Supplier has entered into with Otsuka or any Otsuka Affiliated Companies.

23-   DISCLOSURE OF PAYMENTS: Where applicable, pursuant to applicable state and federal laws, including the Physician Payment Sunshine Act in the U.S., Otsuka is required to report to the U.S. Department of Health and Human Services all payments and transfers of value made to U.S. Healthcare Professionals (aka Consultants or Suppliers), including but not limited to, compensation for services, travel expenses, and meals.

24-   SEVERABILITY: If any part, term or provision of these terms and conditions will be held void, illegal, unenforceable, or in conflict with any law of any federal or provincial government having jurisdiction over these terms and conditions, or its subject matter, the validity of the remaining portions or provisions will not be affected thereby.

25-   GOVERNING LAW: This Purchase Order shall be governed by and construed in accordance with the laws of Québec and Canada as applicable.

26-   CODE OF CONDUCT AND BUSINESS ETHICS: Where applicable and as requested by Otsuka, Supplier shall, within twenty-five (25) days of being assigned to provide Services, require all persons, including subcontractors, to read Otsuka’s Code of Conduct (“Code”) as may be updated from time to time, abide by the Code, and complete the Code attestation.  The Code will be provided if necessary.  In the event that revision to the Code of Conduct occur during the course of this Purchase Order, Supplier shall ensure that within twenty-five (25) days of notice and receipt of a revised Code, all persons assigned to provide Services shall read the revised Code and complete a new Code attestation. Supplier shall retain Code attestations for the duration of this Purchase Order and provide copies to Otsuka if requested.

27-   LANGUAGE: The Parties hereof acknowledge that they are satisfied that these terms and conditions are drawn up in the English language only.  Les Parties aux présentes reconnaissent qu’elles sont satisfaites que les Termes et conditions du présent Bon de commande soient rédigées en anglais.

Valid as November 6th 2018

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