Master services agreement

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Master services agreement

This Master Services Agreement (“Agreement”) is made and effective as of [DATE] (the “Effective Date”) by and between _______ Operations Limited (“_______”), having its registered office at __________ and its business address at Business Center, _______, _______, an private limited company (“_______”), and _________ Limited, having its registered office at

and its business address at _____________ (“Provider”).
RECITALS
WHEREAS, _______ is in the business of developing, making, marketing and selling pharmaceutical products, including the Product (as defined below), and desires to engage Provider to provide certain consulting and other services to _______ in the Territory;
WHEREAS, Provider is in the business of providing certain services, including marketing, promotion and other support services, and whereas Provider is willing to provide such services to _______; and
WHEREAS, _______ and Provider desire to enter into this Agreement to provide the terms and conditions upon which _______ may engage Provider from time to time to provide the Services under individual Work Orders (defined below), executed by the Parties, specifying the details of the Services and the related terms and conditions.
NOW, THEREFORE, in consideration of the foregoing premises and the covenants set forth below, the Parties hereby agree as follows:
1. DEFINITIONS.
1.1 “Applicable Law” means the laws, regulations, court orders, and standards, guidance or other requirements from any governmental authority, Regulatory Authority, or self-regulatory body, including, without limitation, GMP guidance and GDP guidance, as may be amended from time to time and as such laws, regulations, court orders, and standards, guidance or other requirements apply in each individual country in the Territory, and any permits, licenses, approvals and authorizations having jurisdiction over or related to the registration, approval, marketing, promotion, distribution, storage and sale of the Product in the Territory.
1.2 “Change Order” shall have the meaning set forth in Section 4.1 of this Agreement.
1.3 “Confidential Information” means confidential or proprietary information of one Party disclosed to the other Party in connection with this Agreement. “Confidential Information” includes know-how, scientific information, clinical data, efficacy and safety data, Adverse Event information, formulas, methods and processes, specifications, pricing information (including discounts, rebates, and other price adjustments), and other terms and conditions of sales, customer information, business plans, and all other Intellectual Property.
1.4 “Data” shall have the meaning set forth in Section 9.1 of this Agreement.
1.5 “Deliverables” means any goods, materials, articles, substances, models, samples, software, data, records, reports, notices, documents, photographs, recordings, drawings, designs, specifications, information and the like (whether physical, digital, verbal or other form) that Provider is specifically obligated to furnish to _______ under this Agreement or any Work Order.
1.6 “Expenses” means pass-through or third party out-of-pocket charges Provider incurs in executing its responsibilities hereunder, including but not limited to, travel-related expenses, shipping charges, and other similar costs.
1.7 “_______” shall mean the United States Foreign Corrupt Practices Act of 1977, as amended, and the regulations promulgated thereunder.
1.8 “Fees” means Provider’s compensation for the Services performed under this Agreement in accordance with the Project parameters, Project timeline, and task detail and description defined and outlined in an applicable Work Order, including, where applicable, labor fees, unit fees and other fees. Unless otherwise set forth in an applicable Work Order, labor fees are based on hourly rates and unit fees a fixed unit price for a unit of work.
1.9 “Materials” shall mean all materials, drug products, active pharmaceutical ingredients, compounds, samples (including without limitation, biological samples and chemical samples) and other substances provided to Provider by or on behalf of _______ or in connection with Services under an Work Order hereto.
1.10 “Marketing Authorization” means an authorization by the relevant authorities for the sale and placing on the market of the Product in a country within the Territory.
1.11 “Partial Work Order” shall have the meaning set forth in Section 3.1 of this Agreement.
1.12 “Party” means either _______ or Provider, as applicable. “Parties” means _______ and Provider together.
1.13 “Product” means Synacthen Depot (including variations and updates from time to time), and any other drug product agreed to by the parties in writing
1.14 “Project” means those Services provided by Provider to _______ hereunder, as agreed to by Provider and as set forth in the applicable Work Order hereto.
1.15 “Protocol” means the formal description of procedures and information for a Project hereunder, prepared and/or approved by _______, and as may be amended by _______ from time to time.
1.16 “Records” shall have the meaning set forth in Section 7.1 of this Agreement.
1.17 “Regulatory Approvals” means the approval of every Regulatory Authority required for the promotion, marketing, distribution, reimbursement and/or sale of the Product in any country within the Territory, or any province, county, city, district, or other area or division thereof, including where applicable Marketing Authorizations, and any supplement, amendment or variation thereto, any pricing and reimbursement approvals required prior to the commencement of commercial sales of the Product in the Territory, or any province, county, city, district, or other area or division thereof, and any export and import approvals for the Product.
1.18 “Regulatory Authorities” means any national, provincial, regional, state or local regulatory agency, department, bureau, commission, or other governmental authority in any jurisdiction.
1.19 “Rejected Work” shall have the meaning set forth in Section 5.2 of this Agreement.
1.20 “Services” shall mean all marketing and pormotional services and other support services, as further described in the Work Orders hereto. All Services shall be performed by Provider in accordance with the provisions of this Agreement, including without limitation, the Work Orders hereto, and any amendments thereto included in the scope of work under the applicable Work Order.
1.21 “Territory” means ___________.
1.22 “Work Order” shall have the meaning set forth in Section 3.1 of this Agreement.
2. SCOPE.
2.1 Scope of Agreement. As a master form of contract, this Agreement governs the terms and conditions for all Projects and Services described in executed Work Orders hereto.
3. PROJECT SERVICES.
3.1 Work Orders. The specific details of Services to be provided by Provider with respect to each Project under this Agreement will be separately negotiated and specified in writing in Work Orders to be agreed upon and executed by the Parties, each of which such Work Orders shall be attached hereto and incorporated herein by reference (each, a “Work Order”). Each Work Order will describe the scope of work and Project timeline, corresponding Project budget, and Project-specific compensation terms, if applicable. The form of Work Order to be used is attached hereto as Appendix A. When Services for a Project must commence prior to the final agreement and execution of a full Work Order, a partial Work Order with a limited term may be executed by the Parties, which Partial Work Order will specify the scope of work and Project timeline, corresponding Project budget, and Project-specific compensation terms, if applicable, of such Project to the extent agreed upon by the Parties at that point in time (“Partial Work Order”), to be replaced with a full Work Order as soon as the full details of the Project are known and agreed upon by the Parties. For purposes of this Agreement reference to Work Order(s) includes Partial Work Order(s).
3.2 Completion of Services. Provider will complete all Services described in each applicable executed Work Order in a diligent manner and in accordance with the terms and conditions of this Agreement and of such Work Order. Provider will provide Services within the budget amounts in the applicable Work Order, subject to Change Orders as described in Section 4 of this Agreement.
3.3 Consistency. Provider shall use commercially reasonable efforts to maintain consistency of Provider’s processes and methods applicable to the Services, as may be set forth in more detail under a Work Order. Provider will notify _______ of any material change to such processes and methods (i) no less than thirty (30) days before the change is implemented or (ii) as soon as practicable under the circumstances.
3.4 Terms of Work Order. Each Work Order will be subject to all of the terms and conditions of this Agreement, in addition to the specific terms and conditions set forth in the Work Order. Except as expressly otherwise permitted in this Agreement, in the event that any term or condition of a Work Order conflicts with the terms or conditions of this Agreement, the terms and conditions of this Agreement shall control, unless the terms and conditions of such Work Order expressly supersede the terms or conditions of the Agreement, in which case the terms and conditions of the Work Order shall control.
3.5 Primary Contact. Each Work Order will identify the primary contact of Provider providing Services thereunder (including, to the extent requested by _______, a description of proposed responsibilities). Provider agrees to use best efforts to maintain such primary contact, and must seek _______’s prior written consent with respect to any substitutions or replacements of such personnel proposed during the course of a Project.
4. CHANGE ORDERS.
4.1 Change Orders. Any change in the scope of work, timeline, the corresponding Project budget, and/or the Project-specific compensation terms or payment schedule for an individual Project will require a written amendment to the applicable Work Order (a “Change Order”). Each Change Order will detail the requested changes to the applicable scope of work, timeline, corresponding Project budget, Project-specific compensation terms, or payment schedule.
4.2 Change Order Process. Both Parties agree to act in a timely, good faith manner when considering a Change Order requested by the other Party provided that neither Party is obligated to execute a Change Order unless the changes embodied therein are required by Applicable Law and/or a Regulatory Authority. The Change Order will become effective as an amendment to such Work Order upon the execution of the Change Order by both Parties’ authorized representatives. Provider will then be given a reasonable period of time to implement the changes set forth in the Change Order, as specified in the Change Order.
5. COMPENSATION TERMS.
5.1 Project Budgets. For each Project budget, Services shall be defined in a draft scope of work prepared by Provider for purposes of presenting the Project budget to _______. The final scope of work and budget for the Project will be agreed upon by the Parties, and will be included in the applicable Work Order to be attached to this Agreement. _______ will pay Provider the Fees and Expenses incurred by Provider in the performance of the Services hereunder, in accordance with the Project budget and Project compensation terms, if applicable, set forth in the applicable Work Order (as may be amended by a Change Order as described in Section 4 of this Agreement). _______ will have no obligation to pay Provider any amount for Services performed, or Expenses incurred, under any Work Order in excess of the applicable budget, except as may be otherwise agreed in writing by _______.
5.2 Rejected Work. _______ will have the authority to reject work (the “Rejected Work”) that in its reasonable, good faith judgment does not meet (i) the requirements of Applicable Law, or (ii) the quality criteria required to meet Protocol/Project requirements or as specified in the applicable Work Order. Provider’s costs in bringing Rejected Work up to the foregoing standards will not be charged to _______. Any dispute over the Rejected Work will be governed by Section 5.5 of this Agreement.
5.3 Expenses. Profit factors and overhead will not be applied to Expenses. _______ will have the right to contest Expenses, which in its reasonable, good faith judgment require further documentation from Provider prior to approval and payment. Contested Expenses will not be considered due until _______ and Provider negotiate a resolution of the disputed amounts. _______ and Provider will negotiate in a timely, good faith manner to resolve disputes regarding Expenses. It is understood that Provider shall use its best efforts to control and limit Expenses associated with the Services under this Agreement.
5.4 Summary Invoices. By the pre-determined date each month set forth in the applicable Work Order, Provider will send summary invoices, containing a level of detail as agreed in the applicable Work Order, to _______ for Fees and Expenses (including reasonable and customary documentation thereof as agreed to by the Parties). Together with each monthly summary invoice, Provider will also provide an invoicing report that itemizes the Fees and Expenses to date for both the prior month and for all prior months during the term of this Agreement. The invoicing report will be provided in the mutually agreed, Project-specific format that is consistent with the format in the applicable Work Order. _______ will pay each invoice within sixty (60) days of (i) _______’s receipt and approval of such summary invoice and (ii) _______’s receipt and acceptance of Deliverables identified in the applicable invoicing report, unless expressly otherwise set forth in the applicable Work Order.
5.5 Disputed Invoices. If _______ identifies items in an invoice which are disputed (the “Disputed Charges”), _______ will notify Provider within a reasonable period of time after receiving the invoice. Provider will promptly provide to _______ adequate documentation to support all Disputed Charges. _______ and Provider will negotiate in a timely, good faith manner to resolve billing queries.
5.6 Final Invoices. Unless otherwise set forth in the applicable Work Order, Provider will provide _______ with its final invoice for each Project within sixty (60) days after: (i) Provider’s completion of all Services under an Work Order or (ii) Provider’s completion of wind-down Services after Provider’s receipt of written notice from _______ that such Work Order or Project has been terminated in accordance with Section 13 of this Agreement.
5.7 Reporting. Provider acknowledges and agrees that it will be solely Provider’s obligation to report all compensation received by Provider hereunder for Services as may be required by Applicable Law, and that _______ may be required to report and or withhold from payments made to Provider under this Agreement as required by Applicable Law.
6. ADDITIONAL RIGHTS AND OBLIGATIONS OF PROVIDER.
6.1 INTENTIONALLY OMITTED.
6.2 Compliance with Laws. In performing all Services, Projects, obligations and activities hereunder, Provider will comply with all Regulatory Approvals, Applicable Law and industry standards. Without limiting the generality of the foregoing, in connection with the performance of its obligations under this Agreement, Provider will not, and will ensure that its employees, directors, officers, agents, subcontractors or other persons acting on its behalf do not, make any payment, contribution or gift to any governmental official, hospital, medical insurance company or similar provider organization, customer or other person (including, without limitation, any payoff, influence payment, bribe, rebate or kickback) for the purpose of obtaining or paying for Regulatory Approvals, medical coverage, favorable treatment in securing or maintaining business or any other special concession.
6.3 Notification of Regulatory Agency Requests. If any local, state, federal or foreign governmental or regulatory authority (or any entity representing such an authority) (each, a “Regulatory Authority” and collectively, “Regulatory Authorities”) requests access to the Records, facilities and/or personnel of Provider with respect to any Project or the Services performed under this Agreement, or conducts an unannounced inspection of Provider, then Provider will (i) promptly notify _______ by telephone or email; (ii) keep _______ informed of the progress of such access or inspection; and (iii) with respect to access or inspection of Provider, provide a copy to _______ of any documents produced to the Regulatory Authority in the course of such access or inspection. _______ will have the right to be present at any Provider audit or inspection by Regulatory Authority that relates to any Project or the Services performed under this Agreement, and, where time permits, to conduct a pre-audit Provider inspection.
6.4 Notification of Regulatory Agency Communications. Provider will promptly provide _______ copies of all communications between Provider and any Regulatory Authority relating to any Project or the Services performed under this Agreement. Where Provider is required (or intends) to respond to any communication from a Regulatory Authority, Provider will provide _______ with a copy of such communication and Provider’s proposed response sufficiently in advance of the date that such response is to be submitted in order to permit _______ to review and comment upon such response. Provider will incorporate all such _______ comments into such response prior to submission.
6.5 Medical Information Requests. Any requests for medical information concerning the Product that Provider receives from its customers or from healthcare professionals or patients shall be directed to: [_______________].
6.6 Complaints and Inquiries as to Safety, Quality or Efficacy. During the Term of this Agreement, Provider shall collect, document and investigate complaints and inquiries as to the safety, quality or efficacy of the Product. Provider shall pass on the complaints and inquiries on to _______’s Quality Department who shall respond to all complaints and inquiries relating to the Product in a timely manner. If an investigation by _______ is needed in response to a complaint or inquiry, Provider shall assist _______ as reasonably requested by _______ and _______ shall forward the results of the investigation to Provider within a reasonable time. Provider shall maintain an intake log of any complaints or inquiries received for the Product and shall retain records of all Product-related complaints and inquiries for a period of not less than five (5) years beyond the termination or expiration of this Agreement or for such longer period as may be required by Applicable Law. Provider shall forward all complaints and inquiries to _______ within two (2) business days of Provider’s receipt of such complaint or inquiry, and to such other persons as may be required to comply with Applicable Law in the Territory.
6.7 Sales Outside the Territory. During the Term, Provider shall not (a) market or promote the Product outside the Territory, or (b) perform any other services under this Agreement or applicable Work Order outside the Territory.
6.8 Non-Compete. During the Term, Provider shall not, unless otherwise approved in writing by _______, provide any services, including marketing, selling, advertising, and promoting, in the Territory for any other product that, in _______’s reasonable opinion, competes with the Product.
6.9 Report Adverse Events. Provider shall report immediately to _______ all Adverse Events of which it becomes aware whether or not considered casually related to the Product.
6.10 To Protect Reputation of _______. The Provider agrees not to take any action or do anything calculated or likely to harm _______’s reputation or the reputation of the Product or of the Marks.
7. RECORDS AND AUDITS
7.1 Creation of Records. At its own expense, Provider will create and maintain all records and documentation (i) required by this Agreement and Applicable Law that relate to this Agreement or to Provider’s performance under this Agreement; (ii) sufficient to demonstrate that any and all amounts invoiced to _______ under this Agreement are accurate and proper in both kind and amount; (iii) sufficient to demonstrate the accuracy of any representations or reports submitted to _______ under this Agreement; and (iv) sufficient to enable _______ to comply with Applicable Law (collectively, the “Records”).
7.2 Maintenance of Records. Provider will maintain all Records for the longest of the following retention periods: (i) any period required by Applicable Law or stated expressly in this Agreement or in any Work Order; (ii) for Records that relate to invoices for five (5) years after payment of the invoice by _______; (iii) for Records that relate to reports submitted to _______, for five (5) years after the report is submitted; and (iv) for all Records not addressed by one of the foregoing, for five (5) years after the term of this Agreement. At the termination or expiration of the foregoing retention periods, as applicable, the Records will be returned to _______ as specified in such Work Order or as instructed by _______.
7.3 Audit of Records. Provider will allow _______ to inspect the Records that Provider is required to create or maintain under this Agreement for the purposes of evaluating and verifying: (i) compliance with the requirements of this Agreement, and any applicable Work Order; (ii) compliance with Applicable Law related to this Agreement or to Provider’s performance under this Agreement; (iii) the accuracy and propriety of any invoice submitted to _______; and (iv) the accuracy of any representations or reports submitted to _______. For Records generated by electronic databases, spreadsheets, programs or the like, _______’s rights to access and inspection under this Section 7 extend to the database, spreadsheet or program that generated the Record as well as the Record itself.
7.4 _______and _______ Anti-Corruption Compliance Policy Audits. Provider shall permit, upon the request of and at the sole discretion of _______, audits by _______ or its agents, and agree that such auditors shall have full and unrestricted access to conduct reviews of all records related to the work performed by Provider and its Affiliates, agents and Subcontractors for _______, and to report any violation of the _______, other Applicable Law, or the _______ Anti-Corruption Compliance Policy with respect to (a) the effectiveness of Provider’s existing compliance programs and codes of conduct, (b) the origin and legitimacy of any funds paid to _______, (c) Provider’s books, records and accounts, or those of any of its subsidiaries, joint ventures or Affiliates, related to work performed for _______, (d) all disbursements made for or on behalf of _______, and (e) all funds received from _______ in connection with work performed for _______.
7.5 Audit of Facilities. At reasonable times and with reasonable advance notice, _______ may enter and inspect any facilities where Records are maintained or Services are performed as _______ deems necessary to examine and/or audit the work performed by Provider in connection with the Services in order to, among other things, accomplish the evaluations and verifications described in Section 7.3 of this Agreement. Provider will cooperate with _______ and provide reasonable assistance to _______ to facilitate the examination and/or audit, and _______ will reasonably cooperate with Provider to mitigate disruption to Provider’s operations. In the event that Records are maintained or Services are performed at facilities that Provider does not control, Provider will secure rights of entry and inspection sufficient to allow _______ to exercise its rights under this Section 7.4.
7.6 Audit by Regulatory Authorities. With respect to any inquiries or inspections of any Regulatory Authority, or an audit for cause by a Regulatory Authority, _______ will have the right to inspect the Records and facilities where Records are maintained or Services are performed at any time, during normal business hours with twenty-four (24) hours prior notice.
7.7 Reimbursement of Expenses. _______ will pay its own expenses for any inspection of the Records. However, if in any audit, _______ determines that material issues exist that result, resulted or will result in an overcharge of ten percent (10%) or more of the invoiced amount for the audited period, Provider will reimburse _______ for its out-of-pocket costs incurred in conducting the audit within thirty (30) days, in addition to any remedies that _______ may have for the overcharge (such as a refund). This Section 7.6 is intended as a fair allocation of audit expenses, not as damages or a penalty.
7.8 Exercise of Rights. _______, its employees or designees may exercise _______’s rights of entrance and inspection under this Section 7.
8. CONFIDENTIALITY
8.1 General Obligations. Both Parties hereby agree:
(a) not to use any Confidential Information of the other Party except for the purpose of conducting the applicable Project and Services hereunder, or as otherwise expressly authorized in writing by the other Party; and
(b) not to disclose or transfer any Confidential Information of the other Party, or any Materials which contain such Confidential Information, to any third party, including without limitation, through any so-called “expert networks,” without the express prior written consent of the disclosing Party, other than to those persons set forth in Section 8.5 of this Agreement and the receiving Party’s employees, agents and approved independent contractors who require such Confidential Information for the purpose hereof and who are bound by like written obligations of confidentiality and non-use with respect to such Confidential Information.
8.2 Limitations. The obligations set forth in Section 8.1 of this Agreement will not apply to any information to the extent that:
(a) the receiving Party can demonstrate by written records was known to it prior to its receipt of such information hereunder;
(b) it is now or later becomes publicly available, other than by breach of this Agreement by receiving Party; or
(c) it is lawfully disclosed to receiving Party on a non-confidential basis by a third party who is not subject to an obligation of confidentiality with respect to such information.
8.3 Additional Obligations. Provider understands that _______’s securities are publicly traded and that unauthorized disclosure of material non-public information regarding _______ and its business and research and development activities would violate federal and other securities laws. Provider understands that the protections of _______’s Confidential Information under this Section 8 are necessary to protect the integrity of trading in _______’s securities. Provider shall ensure that the foregoing acknowledgments are included in all confidentiality agreements and provisions under which _______’s Confidential Information may be disclosed.
8.4 Disclosure Required by Law. Either Party may disclose Confidential Information of the other Party to the extent required to be disclosed by Applicable Law or judicial or governmental order, provided that the receiving Party takes all reasonable steps to give the disclosing Party sufficient prior notice in order to contest such order and, in the event the receiving Party is ultimately required to disclose such Confidential Information, that the receiving Party discloses only such portion of such Confidential Information as required to be disclosed and seeks a protective order to protect the confidentiality of such Confidential Information.
8.5 Applicability to Employees, Agents, Contractors. Provider shall ensure by binding written agreement that its employees, agents, and approved independent contractors involved in the Services shall comply with the provisions of this Section 8. Provider shall disclose Confidential Information of _______ only to those of its employees, agents, and approved independent contractors who reasonably need to know Confidential Information of _______. Without limiting the foregoing, Provider shall not disclose any Confidential Information of _______ to any third party that is expected to generate, has generated or has access to any Project results unless such third party has signed an agreement in a form acceptable to _______ which: (i) protects the Confidential Information of _______ in a manner equivalent to this Section 8, and (ii) provides _______ with all rights in information, inventions and works of authorship equivalent to Section 9 hereof. Any material modification to such approved agreement must be approved by _______ in advance of it use.
8.6 Return or Destruction of Confidential Information. At the completion or early termination of a Project, Provider will request directions in writing from _______ on whether to return _______’s Project-related Confidential Information to _______ or to destroy all such Confidential Information. _______ will have thirty (30) days from its receipt of such notice to notify Provider that it desires to receive such Confidential Information and to provide delivery instructions for such Confidential Information. Such Confidential Information will be delivered to _______ or its designee at _______’s expense. If _______ does not request return of such Confidential Information, or does not notify Provider that it desires to receive such Confidential Information within such thirty-day period, then Provider shall destroy such Confidential Information.
8.7 No Grant, Option or License. The furnishing of Confidential Information under this Agreement will not constitute any grant, option or license to Provider under any patent or other rights now or hereafter held by _______. Provider will not acquire any rights of any kind whatsoever with respect to any _______ product, technology or intellectual property right as a result of this Agreement or the activities hereunder.
9. INTELLECTUAL PROPERTY.
9.1 Ownership of Data and Other Information. All data, results, Materials, Records, information (including, without limitation, Confidential Information), and suggestions of every kind and description supplied to Provider by _______, or developed in the course of any Project, or prepared or developed by Provider in the course of providing Services under this Agreement (except for Provider’s proprietary materials, procedural manuals, personnel data, and computer software developed by Provider for purposes outside of this Agreement) (collectively, the “Data”) shall be the sole and exclusive property of _______ and _______ shall have the right to make whatever use it deems desirable of the Data, including without limitation, to reproduce, modify, distribute, publish and use all Data or any portion thereof. Provider shall not use the Data for any purpose other than use described in this Agreement or an applicable Work Order, and shall not transfer the Data to any third party without the express written consent of _______.
9.2 Ownership of Inventions and Works of Authorship. All inventions, discoveries and improvements conceived of or made by, and all works of authorship created by, Provider or its employees, agents or approved independent contractors in the course of providing the Services, whether solely or jointly with others and whether or not patentable or copyrightable, and all intellectual property rights therein and thereto (collectively, the “Inventions and Works of Authorship”) will be the sole and exclusive property of _______. Provider will promptly disclose all Inventions and Works of Authorship to _______. Provider hereby assigns to _______ all right, title and interest in and to all Inventions and Works of Authorship. Provider will, at _______’s expense, perform any and all acts necessary to assist _______ in preparing and filing any patent or copyright applications and enforcing any patents or copyrights covering Inventions and Works of Authorship, or in otherwise perfecting its rights thereto, without further compensation. Provider will, and will cause its employees, agents and approved independent contractors who perform the Services to, execute all documents and perform all acts deemed reasonably necessary by _______ to evidence _______’s ownership of the Inventions and Works of Authorship. All Inventions and Works of Authorship will be deemed _______’s Confidential Information.
9.3 Trademarks, Service Marks and Trade Names. Use of Marks (whether owned by _______ or licensed by _______) shall, as between the Parties, remain the exclusive property of, and shall inure to the exclusive benefit of, _______. _______ hereby grants to Provider a non-exclusive license, which shall terminate upon the expiration or termination of this Agreement, to use the Marks in the Territory in connection with promotional and sales activities in the form in which they are displayed on the labels, packaging and advertising for the Products as provided by _______, or as approved in writing in advance by _______. Provider shall not use the Marks or any other _______ trademark, trade or brand name for any other purpose other than as provided in this Section 6.2. Provider shall not alter the Marks without the prior written consent of _______. Provider acknowledges that the Marks are and shall remain the property of _______ or its licensors, and Provider disclaims any rights to such Marks other than the rights granted pursuant to this Section 6.2.
9.4 Protection of the Marks. Provider shall not at any time during or after the Term do or permit any act to be done which may in any way impair or challenge the rights of _______ and its Affiliates in the Marks. Provider acknowledges and agrees that no ownership rights are vested or created in the Marks in the Territory by the licenses and other rights granted in this Agreement and that all use of the Marks by Provider, whether in combination with or apart from Provider’s corporate names, including any goodwill generated in connection therewith, inures to the benefit of _______, and _______ may call for a confirmatory assignment thereof. Provider shall not either during or after the Term take any action that may be detrimental to any goodwill connected with the Marks. Provider shall promptly advise _______ in writing of any conflict of which Provider becomes aware between the Marks and the name, trademarks or trade names of any Third Party in the Territory or elsewhere.
9.5 Prohibited Actions. Provider may use the Marks only as permitted by, and in conformance with, this Agreement and Applicable Law. Provider shall not during or after the Term:
(a) Adopt or use any trademarks, brand names, words, logos, symbols, or designs (i) in combination with the Marks in a manner that would create combination Marks, or (ii) in any manner that would be confusingly similar to, misleading or deceptive with respect to or that dilutes any (or any part) of the Marks;
(b) Register or attempt to register any of the Marks;
(c) Use the Marks on or in connection with any goods or services other than the Product; or
(d) Take any other action that could diminish the value of the Marks or damage the goodwill or reputation for quality associated with the Marks.
9.6 Infringement of Intellectual Property. Provider shall notify _______ promptly if it becomes aware of (a) any alleged infringement by _______ of a trademark, trade name, service mark, brand name, patent, trade secret or similar right of any third party in the Territory, or (b) the alleged infringement of _______’s Intellectual Property.
10. USE OF THIRD PARTIES AND AFFILIATES.
10.1 Subcontractors. Provider will not use or delegate to any subcontractor or agent any Services or Projects hereunder without the prior written consent of _______. If _______ consents in any Work Order to Provider entering into any contract with a third party in connection with such Project, including without limitation, any independent subcontractors, then (i) any contract entered into between Provider and such third party will be made in a form consistent with this Agreement and approved in advance by _______, and (ii) Provider shall remain responsible for all obligations under this Agreement and for all Services provided by such third party under this Agreement.
11. REPRESENTATIONS AND WARRANTIES.
11.1 Representations and Warranties of Provider. Provider represents and warrants to _______ that:
(a) it has the authority to execute this Agreement;
(b) it is not a party to any agreement, and will not enter into any agreement, that would in any way prevent it from fulfilling its obligations under this Agreement or would interfere with the rights of _______ hereunder;
(c) the Services shall be performed in a professional and workmanlike manner and will comply with Applicable Law;
(d) neither it nor any of its employees or consultants is under investigation by any Regulatory Authority for debarment (or similar regulatory action) or presently debarred by any Regulatory Authority or has been disqualified by any Regulatory Authority. Provider will immediately notify _______ if, during the term of this Agreement, Provider or any of its employees or consultants (i) comes under investigation by any Regulatory Authority for a debarment action or disqualification, or (ii) becomes debarred or disqualified;
(e) none of its officials or employees have been convicted of a felony under Applicable Law for conduct otherwise relating to the regulation of any drug product or medical device;
(f) it (i) is aware of the terms of the _______and the _______ Anti-Corruption Compliance Policy, (ii) is not an employee, officer or agent of a governmental authority or Regulatory Authority within the Territory, (iii) has never been subject to any disciplinary action relating to fraud or corruption by any governmental authority or Regulatory Authority within the Territory, and (iv) has never been the subject of a governmental investigation or litigation involving allegations of fraud or corruption. Provider agrees that in performing its obligations under the Product Agreements it will refrain from any violation of the _______and the _______ Anti-Corruption Compliance Policy. Without limiting the generality of the foregoing, Provider agrees that it will not pay money or provide any other thing of value to any government officials or other third parties in violation of the, any other Applicable Law in the Territory or the _______ Anti-Corruption Compliance Policy. _______ may terminate this Agreement immediately in the event of any violation by Provider of the _______, any other Applicable Law or the _______ Anti-Corruption Compliance Policy. Provider shall sign and provide an annual certification, in the form attached as Exhibit A to _______ by July 1 of each year confirming Provider’s compliance with this certification. In no event shall _______ be obligated under this Agreement to take any action or omit to take any action that _______ believes in good faith would cause it to be in violation of any anti-corruption laws of any country, including, without limitation, the _______. Provider represents and warrants that all of the information and certifications Provider has provided to _______ was and remains accurate and complete. If subsequent developments cause such information or the certifications provided herein to no longer be accurate or complete, Provider shall immediately notify _______ of such change in circumstances. Provider agrees to indemnify and hold _______ harmless from any breaches of, or misrepresentations concerning, the above;
(g) the Deliverables that are goods, if any, are free from defects in material and workmanship;
(h) the Deliverables, if any, are free from all liens, claims, demands, lawsuits, administrative proceedings and encumbrances;
(i) the Services and all Deliverables, if any, do not infringe any rights (including trademark rights, copyrights, patents, trade secrets, privacy rights, publicity rights, moral rights or contractual rights) of any third party, and use thereof by _______ consistent with this Agreement does not infringe such rights; provided, however, that this representation and warranty does not apply to infringement arising solely from _______’s use of the Deliverables or Services in a manner that is contrary to Provider’s recommendations, or in combination with other materials or services, if Provider was not aware and could not reasonably anticipate such combined use;
(j) it shall neither disclose to _______, nor induce _______ to use, any secret or confidential information or material belonging to any third party;
(k) all individuals and entities that perform any Services under this Agreement are under a written obligation to assign all right, title and interest in any intellectual property arising from such Services to _______ and to keep confidential and use Confidential Information in accordance with Section 8 and Section 9 of this Agreement; and
(l) it shall promptly inform _______ in writing of any event or circumstance that could reasonably affect its ability to perform under this Agreement in the manner contemplated by _______, including without limitation, any debarment or of the commencement of a debarment or like proceedings against Provider during the term of this Agreement.
11.2 Disclaimer of Representations and Warranties by _______.
11.3 INDEMNIFICATION AND INSURANCE.
11.4 Indemnification Obligations of _______. Subject to the conditions of indemnification in this Section 12, _______ will indemnify, defend and hold harmless Provider and its directors, officers, employees, Affiliates and permitted subcontractors (each a “Provider Indemnitee,” and collectively, the “Provider Indemnitees”) from and against any and all losses, damages, liabilities, reasonable attorney fees, court costs, and expenses (collectively, the “Losses”) resulting from third party claims, actions or proceedings arising from (i) the negligence, or intentional misconduct of _______, or (ii) any breach of any of _______’s obligations, covenants, representations and/or warranties under this Agreement, including without limitation, any Work Order, except to the extent such Losses arise a from (i) the negligence, or willful misconduct of a Provider Indemnitee, or (ii) breach of any of Provider’s obligations, covenants, representations and/or warranties under this Agreement by any Provider Indemnitee, including without limitation, a failure to adhere to any Project Protocol or a breach of any Applicable Law.
11.5 Indemnification Obligations of Provider. Subject to the conditions of indemnification in this Section 12, Provider will indemnify, defend and hold harmless _______ and its directors, officers, employees, and subcontractors (each a “_______ Indemnitee,” and collectively, the “_______ Indemnitees”) from and against any and all Losses resulting from any third party claims, actions or proceedings arising from (i) the negligence, or intentional misconduct of any Provider Indemnitee, (ii) any failure to adhere to any Project Protocol by any Provider Indemnitee, (iii) breach of any of Provider’s obligations, covenants, representations and/or warranties under this Agreement, including without limitation, any Work Order hereto by any Provider Indemnitee, (iv) any infringement of any third party Intellectual Property rights by Provider or its Affiliates or agents, including its subcontractors, in the marketing of the Product, except to the extent that such claim is solely related to the composition of the Product as supplied by _______ to Provider, or the method of manufacture of the Product by _______; provided, that Provider’s indemnification obligations under this Section 12.2 shall not apply to the extent that _______ is required to indemnify Provider for any such Losses under Section 12.1 above.
11.6 Indemnification Procedure. Each Party’s agreement to indemnify, defend and hold the other harmless is conditioned on the indemnified Party: (i) providing written notice to the indemnifying Party of any claim, demand, cause of action or suit arising out of the indemnified activities within twenty (20) days after the indemnified Party has knowledge of such claim, demand or action (except that the indemnifying Party shall not be released from its indemnity obligation if the failure to notify the indemnifying Party within twenty (20) days does not materially prejudice the defense of such claim or suit); (ii) permitting the indemnifying Party to assume full responsibility to investigate, prepare for and defend against any such claim, demand, causes of action or suit; (iii) assisting the indemnifying Party, at the indemnifying Party’s reasonable expense, in the investigation of, preparation for and defense of any such claim, demand, causes of action or suit; and (iv) not compromising or settling such claim, demand, causes of action or suit without the indemnifying Party’s prior written consent. Notwithstanding the foregoing, the indemnifying Party will not enter into any settlement that would adversely affect the indemnified Party’s rights hereunder or impose any obligations on the indemnified Party in addition to those set forth herein without the indemnified Party’s prior written consent, which will not be unreasonably withheld or delayed. The indemnified Party will have the right, but not the obligation, to be represented in such defense by counsel of its own selection and at its own expense. The indemnifying Party will not be responsible for any attorneys’ fees or other costs incurred other than as provided herein.
11.7 Insurance Obligations. During the term of this Agreement, Provider shall maintain, at its own expense, insurance coverage of the kind and with liability limits appropriate to the circumstances to protect itself and _______ against any claims or liabilities that may arise directly or indirectly from Provider’s performance of the Services. On written request by _______, Provider will provide _______ with documentation of such insurance coverage. Provider will promptly notify _______ if it is unable to obtain appropriate insurance coverage or if its coverage is canceled or unable to be renewed. Failure to maintain adequate insurance coverage does not relieve or reduce the liability of Provider under this Agreement.
12. TERM AND TERMINATION.
12.1 Term. This Agreement will commence on the Effective Date, and shall continue for a period of three (3) years, or until terminated in accordance with this Section 13 (the “Initial Term”). Upon the expiration of the Initial Term, unless a Party provides the other Party with notice at least one hundred and eighty (180) days prior to the expiration of the Initial Term of its intention not to renew this Agreement, this Agreement will automatically renew for one successive one (1) year period, except in the case where this Agreement is terminated under Section 13 when no such renewal shall occur. The obligations of Provider under this Agreement will survive the expiration or termination of this Agreement as necessary to allow completion of a Project under an applicable Work Order that extends beyond this Agreement’s expiration or termination.
12.2 Termination.
(a) Breach of Agreement. Either Party may terminate this Agreement by delivery of written notice to the other Party if the other Party breaches any of the material terms and conditions of this Agreement; provided, however, such notice shall not be effective unless and until such breach remains uncured for a period of thirty (30) days after delivery of such notice, except in the case of a payment default by Provider, as to which the cure period shall be fifteen (15) days rather than thirty (30) days.
(b) Insolvency; Change of Control. Either Party may terminate this Agreement, effective immediately upon delivery of written notice to the other Party, if the other Party (i) ceases to actively conduct its business, (ii) suffers a Bankruptcy Event, or (iii) experiences a Change of Control.
(c) Withdrawal or Rejection of Regulatory Approval. Either Party may terminate this Agreement with respect to one or more countries in the Territory upon thirty (30) days prior written notice in the event that Regulatory Approval or the Marketing Authorization of the Product in such country or countries in the Territory has been withdrawn or the application for Regulatory Approval or Marketing Authorization transfer in such country or countries has been rejected and such decision has not been reversed within ninety (90) days of its issuance, in each case by the applicable Regulatory Authority; provided, however, that the foregoing termination right shall not be available to a Party where such withdrawal or rejection was primarily caused by the breach by that Party of its obligations under any of the Product Agreements.
(d) Termination by _______. _______ may terminate this Agreement, (i) upon ninety (90) days prior written notice to Provider if _______ desires to cease manufacturing the Product, (ii) in accordance with Section 6 of this Agreement, immediately upon written notice to Provider in the event of any violation of the _______, other Applicable Law or of the _______ Anti-Corruption Compliance Policy by Provider, or (iii) any time during the Term without cause upon ninety (90) days prior written notice to Provider.
(e) Termination Required by Law. Either may terminate this Agreement if required by law.
(f) Cease of Manufacturing. In the case that _______ is ordered by the applicable regulatory body to cease manufacturing the Product, both _______ and Provider may terminate this Agreement.
12.3 Survival. The following provisions will survive the expiration or any termination of this Agreement or any Work Order: Sections 5.4 -5.7, 6.3, 6.4, 7, 8, 9, 11, 12, 13, and 14. Termination of this Agreement will not (i) relieve either Party of any liability which accrued hereunder prior to the effective date of such termination, (ii) preclude either Party from pursuing all rights and remedies it may have hereunder at law or in equity with respect to any breach of this Agreement, or (iii) prejudice either Party’s right to obtain performance of any obligation.
13. MISCELLANEOUS.
13.1 Regulatory Matters. _______, at its sole cost and expense, shall use Commercially Reasonable Efforts and take all appropriate actions, in cooperation with Provider, to seek, obtain and maintain Regulatory Approvals for the Product, including amendments and updates to the Product, in the Territory and for the Importation, Marketing and sale of same. _______ shall be responsible for seeking, obtaining and maintaining (a) all licenses, registrations and permits required to be obtained by _______ to enable Provider to act perform its obligations under this Agreement, and (b) all approvals from the Regulatory Authorities regarding marketing and advertising materials to be used by Provider to promote and sell the Product in the Territory. Provider shall reasonably cooperate with _______ in making and maintaining all filings that may be necessary or desirable in connection with obtaining and maintaining any Regulatory Approvals necessary for Provider to fulfill its obligations under this Agreement. _______ shall apply for all Regulatory Approvals as agreed, subject to the following condition:
(a) Applications and Registrations. All applications for registrations of the Product, including amendments and updates to the Product, shall, where permitted by law, be made by _______. Distributor shall neither assert any claims to such registrations nor contest _______’s exclusive right to all such Product registration approvals.
13.2 Independent Contractor. For the purposes of this Agreement, the Parties hereto are independent contractors and nothing contained in this Agreement will be construed to place them in the relationship of partners, principal and agent, employer/employee or joint venturers. Neither Party will have the power or right to bind or obligate the other Party except as may be expressly agreed and delegated by other Party, nor will it hold itself out as having such authority.
13.3 Use of Names; Public Announcements. Neither Party will use the other Party’s name in connection with any publication or promotion without the other Party’s prior written consent. Provider shall make no public announcements or presentations concerning this Agreement or the subject matter thereof, nor disclose the provisions of this Agreement to any third party.
13.4 Notices and Deliveries. All notices, requests and other communications provided for herein will be given or made in writing and will be deemed to have been duly given if (i) delivered by hand; (ii) mailed by certified mail, return receipt requested; or (iii) delivered by a recognized courier service, with appropriate documentation of delivery, to the intended recipient and, in the case of mail or courier service, at the following address:
If to _______:

If to Provider:

Each Party may change its address and/or contact person for such notices, requests and communications by written notice to the other Party in accordance with this Section 14.3.
13.5 Assignment. Provider may not assign or transfer this Agreement or any rights or obligations hereunder without the prior express written consent of _______. Any approved successor or assignee of Provider’s rights and/or obligations hereunder promptly will, in writing to _______, expressly assume performance of such rights and/or obligations. Any assignment or attempted assignment by Provider in violation of the terms of this Section 14.4 will be null and void and of no legal effect. This Agreement will be binding upon and will inure to the benefit of each Party’s permitted successors-in-interest and permitted assigns.
13.6 Remedies. The remedies provided under this Agreement are cumulative, and are not exclusive of other remedies available to a Party at law or in equity.
13.7 Governing Law. This Agreement and all Work Orders will be governed, construed and enforced under this Agreement in accordance with the laws of England, without regard to any conflicts or choice of law rules
13.8 Dispute Resolution. If a dispute, controversy or claim arises out of or relates to this Agreement or the breach, termination or validity thereof, the matter under dispute is to be referred to each party’s designated executive, who shall negotiate in good faith, for a period of at least thirty (30) days, to resolve such dispute prior to proceeding with any other forms of adjudication
13.9 Severability. If any provisions herein are found to be unenforceable, it is the intent of the Parties that such provisions be replaced, reformed or narrowed so that their original business purpose can be accomplished to the extent permitted by law, and that the remaining provisions will not in any way be affected or impaired thereby.
13.10 Counterparts. This Agreement may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument.
13.11 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
13.12 Ambiguities. Ambiguities, if any, in this Agreement will not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.
13.13 Headings. The headings for each Article and Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Section or Section.
13.14 Force Majeure. Except for each Party’s confidentiality and indemnity obligations, any delay in the performance of any of the duties or obligations of either Party hereto (except the payment of money), to the extent caused by an event outside the affected Party’s reasonable control, shall not be considered a breach of this Agreement, and unless provided to the contrary herein, the time required for performance shall be extended for a period equal to the period of such delay. Such events (hereinafter referred to as “Force Majeure” events) shall include without limitation, acts of God; acts of public enemies; war, terrorism, insurrections; riots; injunctions; embargoes; labor disputes affecting Third Parties providing services to a Party under this Agreement (including strikes, lockouts, job actions, or boycotts); fires; explosions; floods; shortages of material or energy; acts or orders of any government or agency thereof or other unforeseeable causes beyond the reasonable control and without the fault or negligence of the Party so affected. The Party so affected shall give prompt written notice to the other Party of such cause and a good faith estimate of the continuing effect of the Force Majeure condition and duration of the affected Party’s nonperformance, and shall take whatever reasonable steps are appropriate to relieve the effect of such causes as rapidly as possible
13.15 Non-Solicitation. During the term of this Agreement and for a period of two (2) years after the expiration or termination of this Agreement, unless otherwise agreed to in writing, the Parties shall not, directly or indirectly through third parties, hire, try to hire or enter into any employment relationship with employees of the other Party or any of its Affiliates.
13.16 No Waiver. Any delay in enforcing a Party’s rights under this Agreement or any waiver as to a particular default or breach or other matter will not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, excepting only as provided in an express written and signed waiver as to a particular matter for a particular period of time.
13.17 _______ Retained Rights. _______ shall retain all rights not specifically granted in this Agreement. Those rights include, but are not limited to, the right to perform educational seminars in the Territory, to establish commercial operations, and to promote and market products that _______, in its own discretion, deems helpful for the development of Product sales in the Territory.
13.18 Entire Agreement; Amendment. This Agreement sets forth the complete, final and exclusive agreement between the Parties with respect to the subject matter hereof, and all of the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto with respect to such subject matter, and supersedes and terminates all prior agreements and understandings between the Parties with respect to such subject matter. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties with respect to such subject matter other than as are set forth herein. No subsequent alteration, amendment, change or addition to this Agreement will be binding upon the Parties unless reduced to writing and signed by an authorized representative of each Party.
IN WITNESS WHEREOF, this Agreement has been executed by the Parties hereto through their duly authorized officers.

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