Quality Assurance Inspections. (a) During regular business hours and upon reasonable advance notice and in a manner that does not disrupt or interfere with the business of PEKO, PEKO will permit ViewRay and its agents and its customers to inspect the facilities of PEKO, pertaining to the Products and provide access to PEKO’s manufacturing quality control documentation related to the Products to the extent necessary for, and for the purpose of assessing PEKO’s compliance with this Agreement. As a condition of provision to ViewRay agents or ViewRay customers of access to PEKO’s facilities and documentation, all information obtained by ViewRay agents or ViewRay customers as a result of such access will be PEKO Confidential Information for purposes of this Agreement. PEKO may require any agent or customer of ViewRay seeking access to PEKO’s facilities under this Section 4.3(a), as a condition to such access, to execute a standard confidentiality agreement with PEKO under which such agent agrees to treat information disclosed during such inspection as the Confidential Information of PEKO under terms and conditions no less restrictive than the terms contained in Section 6.2. (b) If an inspection pursuant to Section 4.3(a) reveals that the facilities used to manufacture or Assembly of Products do not satisfy the Applicable Standards in all material respects, then ViewRay will promptly provide to PEKO written notice of such fact, which notice will contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps ViewRay believes PEKO should undertake in order to remedy such deficiencies. PEKO will remedy such deficiencies within a reasonable period of time after receipt of such written notice and provide evidence of this corrective action to ViewRay as requested. (c) PEKO will maintain manufacturing and Assembly quality documentation and will certify that Product was manufactured and tested in accordance with the Specifications and Applicable Standards. ViewRay may request copies of such certifications as part of the inspections permitted under Section 4.3(a). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (d) PEKO will comply with the Specifications and Applicable Standards in its Assembly of the Products. Prior to shipping any Product, PEKO will carry out the Product tests specified in the applicable Specifications on each unit of Product. If a Product or any part of a Product fails to meet the Specifications, through fault of PEKO, the Product will be repaired or replaced by PEKO as set forth in Section 7.3 and the relevant test will be repeated until such Product passes such test requirements. No Product will be shipped to ViewRay or its designee without passing all tests specified in the Specifications. Certification of conformance and/or test reports will be provided on request with each unit as evidence of compliance.
Appears in 6 contracts
Samples: Development and Supply Agreement (ViewRay, Inc.), Development and Supply Agreement (ViewRay, Inc.), Development and Supply Agreement (ViewRay, Inc.)
Quality Assurance Inspections. (a) During regular business hours and upon reasonable advance notice and in a manner that does not disrupt or interfere with the business of PEKOnotice, PEKO QED will permit ViewRay and its agents and its customers to inspect the facilities of PEKOQED, pertaining to the Products and provide access to PEKOQED’s manufacturing quality control documentation related to the Products to the extent necessary for, and for the purpose of assessing PEKOQED’s compliance with this Agreement. As a condition of provision to ViewRay agents or ViewRay customers of access to PEKOQED’s facilities and documentation, all information obtained by ViewRay agents or ViewRay customers as a result of such access will be PEKO QED Confidential Information for purposes of this Agreement. PEKO QED may require any agent or customer of ViewRay seeking access to PEKOQED’s facilities under this Section 4.3(a), as a condition to such access, to execute a standard confidentiality agreement with PEKO QED under which such agent agrees to treat information disclosed during such inspection as the Confidential Information of PEKO QED under terms and conditions no less restrictive than the terms contained in Section 6.2.
(b) If an inspection pursuant to Section 4.3(a) reveals that the facilities used to manufacture or Assembly of Products do not satisfy the Applicable Standards in all material respects, then ViewRay will promptly provide to PEKO QED written notice of such fact, which notice will contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps ViewRay believes PEKO QED should undertake in order to remedy such deficiencies. PEKO QED will remedy such deficiencies within a reasonable period of time after receipt of such written notice and provide evidence of this corrective action to ViewRay as requested.
(c) PEKO will maintain manufacturing and Assembly quality documentation and will certify that Product was manufactured and tested in accordance with the Specifications and Applicable Standards. ViewRay may request copies of such certifications as part of the inspections permitted under Section 4.3(a). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) QED will maintain manufacturing quality documentation and will certify that Product was manufactured and tested in accordance with the Specifications and Applicable Standards. ViewRay may request copies of such certifications as part of the inspections permitted under Section 4.3(a).
(d) PEKO QED will comply with the Specifications and Applicable Standards in its Assembly manufacturing of the Products. Prior to shipping any Product, PEKO QED will carry out the Product tests specified in the applicable Specifications on each unit of Product. If a Product or any part of a Product fails to meet the Specifications, through fault of PEKO, the Product will be repaired or replaced by PEKO QED as set forth in Section 7.3 and the relevant test will be repeated until such Product passes such test requirements. No Product will be shipped to ViewRay or its designee without passing all tests specified in the Specifications. Certification of conformance and/or test reports will be provided on request with each unit as evidence of compliance.
Appears in 5 contracts
Samples: Development and Supply Agreement (ViewRay, Inc.), Development and Supply Agreement (ViewRay, Inc.), Development and Supply Agreement (ViewRay, Inc.)
Quality Assurance Inspections. (a) During regular business hours and upon reasonable advance notice and in a manner that does not disrupt or interfere with the business of PEKO3D Line, PEKO 3D Line will permit ViewRay and its agents and its customers to inspect the facilities of PEKO, pertaining to the Products 3D Line and provide access to PEKO3D Line’s manufacturing quality control documentation and regulatory files related to [***] Certain information in this document has been omitted and filed separately with the Products Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. the 60-Leaf MLCs to the extent necessary for, and for the sole purpose of of, assessing PEKO3D Line’s compliance with this Agreementany applicable regulations of a Regulatory Authority associated with the ViewRay System incorporating the 60-Leaf MLCs (including Applicable GMP requirements). As a condition of provision to ViewRay agents or ViewRay customers of access to PEKO3D Line’s facilities and documentation, all information obtained by ViewRay agents or ViewRay customers as a result of such access will be PEKO 3D Line Confidential Information for purposes of this Agreement. PEKO 3D Line may require any employee or agent or customer of ViewRay seeking access to PEKO3D Line’s facilities under this Section 4.3(a3.3(a), as a condition to such access, to execute a standard confidentiality agreement with PEKO 3D Line under which such agent agrees to treat information disclosed during such inspection as the Confidential Information of PEKO 3D Line under terms and conditions no less restrictive than the terms contained in Section 6.25.2.
(b) 3D Line will allow representatives of the FDA or any other applicable Regulatory Authority to tour and inspect or audit the facilities utilized by 3D Line in the manufacture of such 60-Leaf MLCs and will cooperate with such representatives in all reasonable respects. 3D Line will promptly provide ViewRay notice of all inspections of 3D Line’s facilities by inspectors of the FDA or any other Regulatory Authority reasonably related to 3D Line’s performance under this Agreement or the subject matter of this Agreement and will permit ViewRay to attend such inspections unless otherwise restricted by the FDA or other Regulatory Authority, or applicable law. 3D Line will provide ViewRay with copies of any FDA Form 483 notices of adverse findings, regulatory letters or similar writings it receives from any Regulatory Authority setting forth adverse findings or non-compliance with applicable laws, regulations or standards relating to the 60-Leaf MLCs supplied by 3D Line hereunder as soon as is reasonably practicable following receipt thereof but in all events within five (5) days following its receipt thereof unless a shorter time period is specified for the provision of such notice under applicable law, and of 3D Line’s written response to such Regulatory Authority as soon as is reasonably practicable following the submission thereof but in all events within five (5) days following its submission thereof unless a shorter time period is specified for the provision thereof under applicable law.
(c) If an inspection pursuant to Section 4.3(a3.3(a) reveals that the facilities used to manufacture or Assembly of Products 60-Leaf MLCs do not satisfy the Applicable Standards requirements above in all material respects, then ViewRay will promptly provide to PEKO 3D Line written notice of such fact, which notice will contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps ViewRay believes PEKO 3D Line should undertake in order to remedy such deficiencies. PEKO 3D Line will remedy such deficiencies within a reasonable period of time after receipt of such written notice and provide evidence of this corrective action to ViewRay as requestednotice.
(cd) PEKO 3D Line will maintain manufacturing and Assembly quality documentation and documentation, including records of 3D Line’s 60-Leaf MLC tests in accordance with the applicable regulations of the applicable Regulatory Authorities. 3D Line will certify that Product was 60-Leaf MLCs supplied to ViewRay under this Agreement were manufactured and tested in accordance with the applicable Specifications and Applicable Standardsregulatory requirements. ViewRay may request copies of such certifications certification documents as part of the inspections permitted under Section 4.3(a)3.3(a) to the extent that they relate to the 60-Leaf MLCs incorporated into ViewRay Systems. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(de) PEKO 3D Line will comply with the Specifications and Applicable Standards GMP requirements in its Assembly manufacturing of the Products60-Leaf MLCs. Prior to shipping any Product60-Leaf MLCs, PEKO 3D Line will carry out the Product 60-Leaf MLCs tests specified in the applicable Specifications on each unit of Product60-Leaf MLCs. If a Product 60-Leaf MLCs or any part of a Product 60-Leaf MLCs fails to meet the Specifications, through fault of PEKO, the Product 60-Leaf MLCs will be repaired or replaced by PEKO 3D Line as set forth in Section 7.3 4.3 and the relevant test will be repeated until such Product 60-Leaf MLCs passes such test requirements. No Product 60-Leaf MLCs will be shipped to ViewRay or its designee without passing all tests specified in the Specifications. Certification All tests, repair/rework and retests must be documented in the production history.
(f) Each 3D 60-Leaf MLCs supplied to ViewRay is to carry a unique serial number traceable to its dated production and quality history records, and shipping record for purposes of conformance and/or test reports will any needed problem investigations or quality trending. Serial numbers may not be provided on request with each unit as evidence of complianceused twice.
Appears in 4 contracts
Samples: Joint Development and Supply Agreement (ViewRay, Inc.), Joint Development and Supply Agreement (ViewRay, Inc.), Joint Development and Supply Agreement (Viewray Inc)
Quality Assurance Inspections. (a) During regular business hours and upon reasonable advance notice and in a manner that does not disrupt or interfere with the business of PEKOJastec, PEKO Jastec will permit ViewRay and its agents and its customers to inspect the facilities of PEKOJastec, pertaining to the Products and provide access to PEKOJastec’s manufacturing quality control documentation related to the Products to the extent necessary for, and for the purpose of assessing PEKOJastec’s compliance with this Agreement. As a condition of provision to ViewRay agents or ViewRay customers of access to PEKOJastec’s facilities and documentation, all information obtained by ViewRay agents or ViewRay customers as a result of such access will be PEKO Jastec Confidential Information for purposes of this Agreement. PEKO Jastec may require any agent or customer of ViewRay seeking access to PEKOJastec’s facilities under this Section 4.3(a), as a condition to such access, to execute a standard confidentiality agreement with PEKO Jastec under which such agent agrees to treat information disclosed during such inspection as the Confidential Information of PEKO Jastec under terms and conditions no less restrictive than the terms contained in Section 6.2.
(b) Jastec will allow representatives of the FDA or any other Regulatory Authority with jurisdiction over the manufacture, marketing, distribution and sale of the Products to tour and inspect the facilities utilized by Jastec in the manufacture of the Product, and will cooperate with such representatives in every reasonable manner. Jastec [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. will promptly (within twenty four (24) hours) provide ViewRay notice of all inspections of Jastec’s facilities by inspectors of the FDA or any other Regulatory Authority reasonably related to its performance hereunder or the subject matter of this Agreement and will permit ViewRay to attend such inspections. Jastec will provide ViewRay with copies of any notices of adverse findings, regulatory letters or similar writings it receives from any Regulatory Authority setting forth adverse findings or non-compliance with Applicable Laws, regulations or standards relating to the Products supplied by Jastec hereunder within two (2) working days of its receipt thereof, and Jastec’s written response to such Regulatory Authority not later than the date of its submission thereof.
(c) If an inspection pursuant to Section 4.3(a4.3 (a) reveals that the facilities used to manufacture or Assembly of Products do not satisfy the Applicable Standards in all material respects, then ViewRay will promptly provide to PEKO Jastec written notice of such fact, which notice will contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps ViewRay believes PEKO Jastec should undertake in order to remedy such deficiencies. PEKO Jastec will remedy such deficiencies within a reasonable period of time after receipt of such written notice and provide evidence of this corrective action to ViewRay as requested.
(cd) PEKO Jastec will maintain manufacturing and Assembly quality documentation and will certify that Product was manufactured and tested in accordance with the Specifications and Applicable Standards. ViewRay may request copies of such certifications as part of the inspections permitted under Section 4.3(a). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(de) PEKO Jastec will comply with the Specifications and Applicable Standards in its Assembly manufacturing of the Products. Prior to shipping any Product, PEKO Jastec will carry out the Product tests specified in the applicable Specifications on each unit of Product. If a Product or any part of a Product fails to meet the Specifications, through fault of PEKO, the Product will be repaired or replaced by PEKO Jastec as set forth in Section 7.3 and the relevant test will be repeated until such Product passes such test requirements. No Product will be shipped to ViewRay or its designee without passing all tests specified in the Specifications. Certification of conformance and/or test reports will be provided on request with each unit as evidence of compliance.
Appears in 3 contracts
Samples: Manufacturing Agreement (ViewRay, Inc.), Manufacturing Agreement (ViewRay, Inc.), Manufacturing Agreement (Viewray Inc)
Quality Assurance Inspections. (a) During regular business hours and upon reasonable advance notice and in a manner that does not disrupt or interfere with the business of PEKOMSC, PEKO MSC will permit ViewRay and its agents and its customers to inspect the facilities of PEKO, pertaining to the Products MSC and provide access to PEKOMSC’s manufacturing quality control documentation related to the Products to the extent necessary for, and for the purpose of assessing PEKOMSC’s compliance with this Agreement. As a condition of provision to ViewRay agents or ViewRay customers of access to PEKOMSC’s facilities and documentation, all information obtained by ViewRay agents or ViewRay customers as a result of such access will be PEKO MSC Confidential Information for purposes of this Agreement. PEKO MSC may require any agent or customer of ViewRay seeking access to PEKOMSC’s facilities under this Section 4.3(a), as a condition to such access, to execute a standard confidentiality agreement with PEKO MSC under which such agent agrees to treat information disclosed during such inspection as the Confidential Information of PEKO MSC under terms and conditions no less restrictive than the terms contained in Section 6.2.
(b) If an inspection pursuant to Section 4.3(a) reveals that the facilities used to manufacture or Assembly of Products do not satisfy the Applicable Standards in all material respects, then ViewRay will promptly provide to PEKO written notice of such fact, which notice will contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps ViewRay believes PEKO should undertake in order to remedy such deficiencies. PEKO will remedy such deficiencies within a reasonable period of time after receipt of such written notice and provide evidence of this corrective action to ViewRay as requested.
(c) PEKO will maintain manufacturing and Assembly quality documentation and will certify that Product was manufactured and tested in accordance with the Specifications and Applicable Standards. ViewRay may request copies of such certifications as part of the inspections permitted under Section 4.3(a). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(b) If an inspection pursuant to Section 4.3(a) reveals that the facilities used to manufacture Products do not satisfy the Applicable Standards in all material respects, then ViewRay will promptly provide to MSC written notice of such fact, which notice will contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps ViewRay believes MSC should undertake in order to remedy such deficiencies. MSC will remedy such deficiencies within a reasonable period of time after receipt of such written notice.
(c) MSC will maintain manufacturing quality documentation and will certify that Product was manufactured and tested in accordance with the applicable Specifications and Applicable Standards. ViewRay may request copies of such certifications as part of the inspections permitted under Section 4.3(a).
(d) PEKO MSC will comply with the applicable Specifications and Applicable Standards in its Assembly manufacturing of the Products. Prior to shipping any Product, PEKO MSC will carry out the Product tests specified in the applicable Specifications on each unit of Product. If a Product or any part of a Product fails to meet the Specifications, through fault of PEKO, the Product will be repaired or replaced by PEKO MSC as set forth in Section 7.3 7.4.3 and the relevant test will be repeated until such Product passes such test requirements. No Product will be shipped to ViewRay or its designee without passing all tests specified in the Specifications. Certification of conformance and/or test reports will be provided on request with each unit as evidence of compliance.
Appears in 3 contracts
Samples: Development and Supply Agreement (ViewRay, Inc.), Development and Supply Agreement (ViewRay, Inc.), Development and Supply Agreement (Viewray Inc)
Quality Assurance Inspections. (a) During regular business hours and upon reasonable advance notice and in a manner that does not disrupt or interfere with the business of PEKO3D Line, PEKO 3D Line will permit ViewRay and its agents and its customers to inspect the facilities of PEKO, pertaining to the Products 3D Line and provide access to PEKO3D Line’s manufacturing quality control documentation and regulatory files related to the Products [***] MLCs to the extent necessary for, and for the sole purpose of of, assessing PEKO3D Line’s compliance with this Agreementany applicable regulations of a Regulatory Authority associated with the ViewRay System incorporating the [***] MLCs (including Applicable GMP requirements). As a condition of provision to ViewRay agents or ViewRay customers of access to PEKO3D Line’s facilities and documentation, all information obtained by ViewRay agents or ViewRay customers as a result of such access will be PEKO 3D Line Confidential Information for purposes of this Agreement. PEKO 3D Line may require any employee or agent or customer of ViewRay seeking access to PEKO3D Line’s facilities under this Section 4.3(a3.3(a), as a condition to such access, to execute a standard confidentiality agreement with PEKO 3D Line under which such agent agrees to treat information disclosed during such inspection as the Confidential Information of PEKO 3D Line under terms and conditions no less restrictive than the terms contained in Section 6.2.
(b) If an inspection pursuant to Section 4.3(a) reveals that the facilities used to manufacture or Assembly of Products do not satisfy the Applicable Standards in all material respects, then ViewRay will promptly provide to PEKO written notice of such fact, which notice will contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps ViewRay believes PEKO should undertake in order to remedy such deficiencies. PEKO will remedy such deficiencies within a reasonable period of time after receipt of such written notice and provide evidence of this corrective action to ViewRay as requested.
(c) PEKO will maintain manufacturing and Assembly quality documentation and will certify that Product was manufactured and tested in accordance with the Specifications and Applicable Standards. ViewRay may request copies of such certifications as part of the inspections permitted under Section 4.3(a)5.2. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(b) 3D Line will allow representatives of the FDA or any other applicable Regulatory Authority to tour and inspect or audit the facilities utilized by 3D Line in the manufacture of such [***] MLCs and will cooperate with such representatives in all reasonable respects. 3D Line will promptly provide ViewRay notice of all inspections of 3D Line’s facilities by inspectors of the FDA or any other Regulatory Authority reasonably related to 3D Line’s performance under this Agreement or the subject matter of this Agreement and will permit ViewRay to attend such inspections unless otherwise restricted by the FDA or other Regulatory Authority, or applicable law. 3D Line will provide ViewRay with copies of any FDA Form 483 notices of adverse findings, regulatory letters or similar writings it receives from any Regulatory Authority setting forth adverse findings or non-compliance with applicable laws, regulations or standards relating to the [***] MLCs supplied by 3D Line hereunder as soon as is reasonably practicable following receipt thereof but in all events within [***] following its receipt thereof unless a shorter time period is specified for the provision of such notice under applicable law, and of 3D Line’s written response to such Regulatory Authority as soon as is reasonably practicable following the submission thereof but in all events within [***] following its submission thereof unless a shorter time period is specified for the provision thereof under applicable law.
(c) If an inspection pursuant to Section 3.3(a) reveals that the facilities used to manufacture [***] MLCs do not satisfy the requirements above in all material respects, then ViewRay will promptly provide to 3D Line written notice of such fact, which notice will contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps ViewRay believes 3D Line should undertake in order to remedy such deficiencies. 3D Line will remedy such deficiencies within a reasonable period of time after receipt of such written notice.
(d) PEKO 3D Line will maintain manufacturing quality documentation, including records of 3D Line’s [***] MLC tests in accordance with the applicable regulations of the applicable Regulatory Authorities. 3D Line will certify that [***] MLCs supplied to ViewRay under this Agreement were manufactured and tested in accordance with applicable Specifications and regulatory requirements. ViewRay may request copies of such certification documents as part of the inspections permitted under Section 3.3(a) to the extent that they relate to the [***] MLCs incorporated into ViewRay Systems.
(e) 3D Line will comply with the Specifications and Applicable Standards GMP requirements in its Assembly manufacturing of the Products[***] MLCs. Prior to shipping any Product[***] MLCs, PEKO 3D Line will carry out the Product [***] MLCs tests specified in the applicable Specifications on each unit of Product[***] MLCs. If a Product [***] MLCs or any part of a Product [***] MLCs fails to meet the Specifications, through fault of PEKO, the Product [***] MLCs will be repaired or replaced by PEKO 3D Line as set forth in Section 7.3 4.3 and the relevant test will be repeated until such Product [***] MLCs passes such test requirements. No Product [***] MLCs will be shipped to ViewRay or its designee without passing all tests specified in the Specifications. Certification All tests, repair/rework and retests must be documented in the production history. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(f) Each 3D [***] MLCs supplied to ViewRay is to carry a unique serial number traceable to its dated production and quality history records, and shipping record for purposes of conformance and/or test reports will any needed problem investigations or quality trending. Serial numbers may not be provided on request with each unit as evidence of complianceused twice.
Appears in 2 contracts
Samples: Joint Development and Supply Agreement, Joint Development and Supply Agreement (Viewray Inc)
Quality Assurance Inspections. (a) During regular business hours and upon reasonable advance notice and in a manner that does not disrupt or interfere with the business of PEKOMSC, PEKO MSC will permit ViewRay and its agents and its customers to inspect the facilities of PEKO, pertaining to the Products MSC and provide access to PEKOMSC’s manufacturing quality control documentation related to the Products to the extent necessary for, and for the purpose of assessing PEKOMSC’s compliance with this Agreement. As a condition of provision to ViewRay agents or ViewRay customers of access to PEKOMSC’s facilities and documentation, all information obtained by ViewRay agents or ViewRay customers as a result of such access will be PEKO MSC Confidential Information for purposes of this Agreement. PEKO MSC may require any agent or customer of ViewRay seeking access to PEKOMSC’s facilities under this Section 4.3(a), as a condition to such access, to execute a standard confidentiality agreement with PEKO MSC under which such agent agrees to treat information disclosed during such inspection as the Confidential Information of PEKO MSC under terms and conditions no less restrictive than the terms contained in Section 6.2.
(b) If an inspection pursuant to Section 4.3(a) reveals that the facilities used to manufacture or Assembly of Products do not satisfy the Applicable Standards in all material respects, then ViewRay will promptly provide to PEKO MSC written notice of such fact, which notice will contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps ViewRay believes PEKO MSC should undertake in order to remedy such deficiencies. PEKO MSC will remedy such deficiencies within a reasonable period of time after receipt of such written notice and provide evidence of this corrective action to ViewRay as requestednotice.
(c) PEKO MSC will maintain manufacturing and Assembly quality documentation and will certify that Product was manufactured and tested in accordance with the applicable Specifications and Applicable Standards. ViewRay may request copies of such certifications as part of the inspections permitted under Section 4.3(a). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(d) PEKO MSC will comply with the applicable Specifications and Applicable Standards in its Assembly manufacturing of the Products. Prior to shipping any Product, PEKO MSC will carry out the Product tests specified in the applicable Specifications on each unit of Product. If a Product or any part of a Product fails to meet the Specifications, through fault of PEKO, the Product will be repaired or replaced by PEKO MSC as set forth in Section 7.3 7.4.3 and the relevant test will be repeated until such Product passes such test requirements. No Product will be shipped to ViewRay or its designee without passing all tests specified in the Specifications. Certification of conformance and/or test reports will be provided on request with each unit as evidence of compliance.
Appears in 1 contract
Quality Assurance Inspections. (a) During regular business hours and upon reasonable advance notice and in a manner that does not disrupt or interfere with the business of PEKO3D Line, PEKO 3D Line will permit ViewRay and its agents and its customers to inspect the facilities of PEKO, pertaining to the Products 3D Line and provide access to PEKO3D Line’s manufacturing quality control documentation and regulatory files related to the Products [***] MLCs to the extent necessary for, and for the sole purpose of of, assessing PEKO3D Line’s compliance with this Agreementany applicable regulations of a Regulatory Authority associated with the ViewRay System incorporating the [***] MLCs (including Applicable GMP requirements). As a condition of provision to ViewRay agents or ViewRay customers of access to PEKO3D Line’s facilities and documentation, all information obtained by ViewRay agents or ViewRay customers as a result of such access will be PEKO 3D Line Confidential Information for purposes of this Agreement. PEKO 3D Line may require any employee or agent or customer of ViewRay seeking access to PEKO3D Line’s facilities under this Section 4.3(a3.3(a), as a condition to such access, to execute a standard confidentiality agreement with PEKO 3D Line under which such agent agrees to treat information disclosed during such inspection as the Confidential Information of PEKO 3D Line under terms and conditions no less restrictive than the terms contained in Section 6.25.2.
(b) If an inspection pursuant 3D Line will allow representatives of the FDA or any other applicable Regulatory Authority to Section 4.3(a) reveals that tour and inspect or audit the facilities used to utilized by 3D Line in the manufacture or Assembly of Products do not satisfy the Applicable Standards such [***] MLCs and will cooperate with such representatives in all material reasonable respects, then ViewRay . 3D Line will promptly provide to PEKO written ViewRay notice of all inspections of 3D Line’s facilities by inspectors of the FDA or any other Regulatory Authority reasonably related to 3D Line’s performance under this Agreement or the subject matter of this Agreement and will permit ViewRay to attend such factinspections unless otherwise restricted by the FDA or other Regulatory Authority, which notice or applicable law. 3D Line will contain provide ViewRay with copies of any FDA Form 483 notices of adverse findings, regulatory letters or similar writings it receives from any Regulatory Authority setting forth adverse findings or non-compliance with applicable laws, regulations or standards relating to the [***] MLCs supplied by 3D Line hereunder as soon as is reasonably practicable following receipt thereof but in reasonable detail all events within [***] following its receipt thereof unless a shorter time period is specified for the deficiencies found in the manufacturing facilities and, if practicable, those steps ViewRay believes PEKO should undertake in order to remedy such deficiencies. PEKO will remedy such deficiencies within a reasonable period of time after receipt provision of such notice under applicable law, and of 3D Line’s written notice and provide evidence of this corrective action response to ViewRay such Regulatory Authority as requested.
(c) PEKO will maintain manufacturing and Assembly quality documentation and will certify that Product was manufactured and tested in accordance with the Specifications and Applicable Standards. ViewRay may request copies of such certifications soon as part of the inspections permitted under Section 4.3(a). is reasonably [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. practicable following the submission thereof but in all events within [***] following its submission thereof unless a shorter time period is specified for the provision thereof under applicable law.
(c) If an inspection pursuant to Section 3.3(a) reveals that the facilities used to manufacture [***] MLCs do not satisfy the requirements above in all material respects, then ViewRay will promptly provide to 3D Line written notice of such fact, which notice will contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps ViewRay believes 3D Line should undertake in order to remedy such deficiencies. 3D Line will remedy such deficiencies within a reasonable period of time after receipt of such written notice.
(d) PEKO 3D Line will maintain manufacturing quality documentation, including records of 3D Line’s [***] MLC tests in accordance with the applicable regulations of the applicable Regulatory Authorities. 3D Line will certify that [***]f MLCs supplied to ViewRay under this Agreement were manufactured and tested in accordance with applicable Specifications and regulatory requirements. ViewRay may request copies of such certification documents as part of the inspections permitted under Section 3.3(a) to the extent that they relate to the [***] MLCs incorporated into ViewRay Systems.
(e) 3D Line will comply with the Specifications and Applicable Standards GMP requirements in its Assembly manufacturing of the Products[***] MLCs. Prior to shipping any Product[***] MLCs, PEKO 3D Line will carry out the Product [***] MLCs tests specified in the applicable Specifications on each unit of Product[***] MLCs. If a Product [***] MLCs or any part of a Product [***] MLCs fails to meet the Specifications, through fault of PEKO, the Product [***] MLCs will be repaired or replaced by PEKO 3D Line as set forth in Section 7.3 4.3 and the relevant test will be repeated until such Product [***] MLCs passes such test requirements. No Product [***] MLCs will be shipped to ViewRay or its designee without passing all tests specified in the Specifications. Certification All tests, repair/rework and retests must be documented in the production history.
(f) Each 3D [***] MLCs supplied to ViewRay is to carry a unique serial number traceable to its dated production and quality history records, and shipping record for purposes of conformance and/or test reports will any needed problem investigations or quality trending. Serial numbers may not be provided on request with each unit as evidence of complianceused twice.
Appears in 1 contract
Samples: Joint Development and Supply Agreement (Viewray Inc)
Quality Assurance Inspections. (a) During regular business hours and upon reasonable advance notice and in a manner that does not disrupt or interfere with the business of PEKOJastec, PEKO Jastec will permit ViewRay and its agents and its customers to inspect the facilities of PEKOJastec, pertaining to the Products and provide access to PEKOJastec’s manufacturing quality control documentation related to the Products to the extent necessary for, and for the purpose of assessing PEKOJastec’s compliance with this Agreement. As a condition of provision to ViewRay agents or ViewRay customers of access to PEKOJastec’s facilities and documentation, all information obtained by ViewRay agents or ViewRay customers as a result of such access will be PEKO Jastec Confidential Information for purposes of this Agreement. PEKO Jastec may require any agent or customer of ViewRay seeking access to PEKOJastec’s facilities under this Section 4.3(a), as a condition to such access, to execute a standard confidentiality agreement with PEKO Jastec under which such agent agrees to treat information disclosed during such inspection as the Confidential Information of PEKO Jastec under terms and conditions no less restrictive than the terms contained in Section 6.2.
(b) If an inspection pursuant Jastec will allow representatives of the FDA or any other Regulatory Authority with jurisdiction over the manufacture, marketing, distribution and sale of the Products to Section 4.3(a) reveals that tour and inspect the facilities used to utilized by Jastec in the manufacture or Assembly of Products do not satisfy the Applicable Standards Product, and will cooperate with such representatives in all material respects, then ViewRay every reasonable manner. Jastec will promptly (within twenty four (24) hours) provide to PEKO written ViewRay notice of such fact, which notice will contain in reasonable detail all inspections of Jastec’s facilities by inspectors of the deficiencies found in FDA or any other Regulatory Authority reasonably related to its performance hereunder or the manufacturing facilities and, if practicable, those steps ViewRay believes PEKO should undertake in order to remedy such deficiencies. PEKO will remedy such deficiencies within a reasonable period of time after receipt of such written notice and provide evidence subject matter of this corrective action to ViewRay as requested.
(c) PEKO will maintain manufacturing and Assembly quality documentation Agreement and will certify that Product was manufactured and tested in accordance permit ViewRay to attend such inspections. Jastec will provide ViewRay with the Specifications and Applicable Standards. ViewRay may request copies of any notices of adverse findings, regulatory letters or similar writings it receives from any Regulatory Authority setting forth adverse findings or non-compliance with Applicable Laws, regulations or standards relating to the Products supplied by Jastec hereunder within two (2) working days of its receipt thereof, and Jastec’s written response to such certifications as part Regulatory Authority not later than the date of the inspections permitted under Section 4.3(a)its submission thereof. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) If an inspection pursuant to Section 4.3 (a) reveals that the facilities used to manufacture Products do not satisfy the Applicable Standards in all material respects, then ViewRay will promptly provide to Jastec written notice of such fact, which notice will contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps ViewRay believes Jastec should undertake in order to remedy such deficiencies. Jastec will remedy such deficiencies within a reasonable period of time after receipt of such written notice and provide evidence of this corrective action to ViewRay as requested.
(d) PEKO Jastec will maintain manufacturing quality documentation and will certify that Product was manufactured and tested in accordance with the Specifications and Applicable Standards. ViewRay may request copies of such certifications as part of the inspections permitted under Section 4.3(a).
(e) Jastec will comply with the Specifications and Applicable Standards in its Assembly manufacturing of the Products. Prior to shipping any Product, PEKO Jastec will carry out the Product tests specified in the applicable Specifications on each unit of Product. If a Product or any part of a Product fails to meet the Specifications, through fault of PEKO, the Product will be repaired or replaced by PEKO Jastec as set forth in Section 7.3 and the relevant test will be repeated until such Product passes such test requirements. No Product will be shipped to ViewRay or its designee without passing all tests specified in the Specifications. Certification of conformance and/or test reports will be provided on request with each unit as evidence of compliance.
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Quality Assurance Inspections. (a) During regular business hours and upon reasonable advance notice and in a manner that does not disrupt or interfere with the business of PEKOJastec, PEKO Jastec will permit ViewRay and its agents and its customers to inspect the facilities of PEKOJastec, pertaining to the Products and provide access to PEKOJastec’s manufacturing quality control documentation related to the Products to the extent necessary for, and for the purpose of assessing PEKOJastec’s compliance with this Agreement. As a condition of provision to ViewRay agents or ViewRay customers of access to PEKOJastec’s facilities and documentation, all information obtained by ViewRay agents or ViewRay customers as a result of such access will be PEKO Jastec Confidential Information for purposes of this Agreement. PEKO Jastec may require any agent or customer of ViewRay seeking access to PEKOJastec’s facilities under this Section 4.3(a), as a condition to such access, to execute a standard confidentiality agreement with PEKO Jastec under which such agent agrees to treat information disclosed during such inspection as the Confidential Information of PEKO Jastec under terms and conditions no less restrictive than the terms contained in Section 6.2.
(b) Jastec will allow representatives of the FDA or any other Regulatory Authority with jurisdiction over the manufacture, marketing, distribution and sale of the Products to tour and inspect the facilities utilized by Jastec in the manufacture of the Product, and will cooperate with such representatives in every reasonable manner. Jastec will promptly (within [***]) provide ViewRay notice of all inspections of Jastec’s facilities by inspectors of the FDA or any other Regulatory Authority reasonably related to its performance hereunder or the subject matter of this Agreement and will permit ViewRay to attend such inspections. Jastec will provide ViewRay with copies of any notices of adverse findings, regulatory letters or similar writings it receives from any Regulatory Authority setting forth adverse findings or non-compliance with Applicable Laws, regulations or standards relating to the Products supplied by Jastec hereunder within [***] of its receipt thereof, and Jastec’s written response to such Regulatory Authority not later than the date of its submission thereof.
(c) If an inspection pursuant to Section 4.3(a4.3 (a) reveals that the facilities used to manufacture or Assembly of Products do not satisfy the Applicable Standards in all material respects, then ViewRay will promptly provide to PEKO Jastec written notice of such fact, which notice will contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps ViewRay believes PEKO Jastec should undertake in order to remedy such deficiencies. PEKO Jastec will remedy such deficiencies within a reasonable period of time [***] after receipt of such written notice and provide evidence of this corrective action to ViewRay as requested.
(c) PEKO will maintain manufacturing and Assembly quality documentation and will certify that Product was manufactured and tested in accordance with the Specifications and Applicable Standards. ViewRay may request copies of such certifications as part of the inspections permitted under Section 4.3(a). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(d) PEKO Jastec will maintain manufacturing quality documentation and will certify that Product was manufactured and tested in accordance with the Specifications and Applicable Standards. ViewRay may request copies of such certifications as part of the inspections permitted under Section 4.3(a).
(e) Jastec will comply with the Specifications and Applicable Standards in its Assembly manufacturing of the Products. Prior to shipping any Product, PEKO Jastec will carry out the Product tests specified in the applicable Specifications on each unit of Product. If a Product or any part of a Product fails to meet the Specifications, through fault of PEKO, the Product will be repaired or replaced by PEKO Jastec as set forth in Section 7.3 and the relevant test will be repeated until such Product passes such test requirements. No Product will be shipped to ViewRay or its designee without passing all tests specified in the Specifications. Certification of conformance and/or test reports will be provided on request with each unit as evidence of compliance.
Appears in 1 contract
Quality Assurance Inspections. (a) During regular business hours and upon reasonable advance notice and in a manner that does not disrupt or interfere with the business of PEKOMSC, PEKO MSC will permit ViewRay and its agents and its customers to inspect the facilities of PEKO, pertaining to the Products MSC and provide access to PEKOMSC’s manufacturing quality control documentation related to the Products to the extent necessary for, and for the purpose of assessing PEKOMSC’s compliance with this Agreement. As a condition of provision to ViewRay agents or ViewRay customers of access to PEKOMSC’s facilities and documentation, all information obtained by ViewRay agents or ViewRay customers as a result of such access will be PEKO MSC Confidential Information for purposes of this Agreement. PEKO MSC may require any agent or customer of ViewRay seeking access to PEKOMSC’s facilities under this Section 4.3(a), as a condition to such access, to execute a standard confidentiality agreement with PEKO MSC under which such agent agrees to treat information disclosed during such inspection as the Confidential Information of PEKO MSC under terms and conditions no less restrictive than the terms contained in Section 6.2.
(b) If an inspection pursuant to Section 4.3(a) reveals that the facilities used to manufacture or Assembly of Products do not satisfy the Applicable Standards in all material respects, then ViewRay will promptly provide to PEKO MSC written notice of such fact, which notice will contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps ViewRay believes PEKO MSC should undertake in order to remedy such deficiencies. PEKO MSC will remedy such deficiencies within a reasonable period of time after receipt of such written notice and provide evidence of this corrective action to ViewRay as requested.
(c) PEKO will maintain manufacturing and Assembly quality documentation and will certify that Product was manufactured and tested in accordance with the Specifications and Applicable Standards. ViewRay may request copies of such certifications as part of the inspections permitted under Section 4.3(a)notice. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) MSC will maintain manufacturing quality documentation and will certify that Product was manufactured and tested in accordance with the applicable Specifications and Applicable Standards. ViewRay may request copies of such certifications as part of the inspections permitted under Section 4.3(a).
(d) PEKO MSC will comply with the applicable Specifications and Applicable Standards in its Assembly manufacturing of the Products. Prior to shipping any Product, PEKO MSC will carry out the Product tests specified in the applicable Specifications on each unit of Product. If a Product or any part of a Product fails to meet the Specifications, through fault of PEKO, the Product will be repaired or replaced by PEKO MSC as set forth in Section 7.3 7.4.3 and the relevant test will be repeated until such Product passes such test requirements. No Product will be shipped to ViewRay or its designee without passing all tests specified in the Specifications. Certification of conformance and/or test reports will be provided on request with each unit as evidence of compliance.
Appears in 1 contract
Quality Assurance Inspections. (a) During regular business hours and upon reasonable advance notice and in a manner that does not disrupt or interfere with the business of PEKOnotice, PEKO QED will permit ViewRay and its agents and its customers to inspect the facilities of PEKOQED, pertaining to the Products and provide access to PEKOQED’s manufacturing quality control documentation related to the Products to the extent necessary for, and for the purpose of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. assessing PEKOQED’s compliance with this Agreement. As a condition of provision to ViewRay agents or ViewRay customers of access to PEKOQED’s facilities and documentation, all information obtained by ViewRay agents or ViewRay customers as a result of such access will be PEKO QED Confidential Information for purposes of this Agreement. PEKO QED may require any agent or customer of ViewRay seeking access to PEKOQED’s facilities under this Section 4.3(a), as a condition to such access, to execute a standard confidentiality agreement with PEKO QED under which such agent agrees to treat information disclosed during such inspection as the Confidential Information of PEKO QED under terms and conditions no less restrictive than the terms contained in Section 6.2.
(b) If an inspection pursuant to Section 4.3(a) reveals that the facilities used to manufacture or Assembly of Products do not satisfy the Applicable Standards in all material respects, then ViewRay will promptly provide to PEKO QED written notice of such fact, which notice will contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps ViewRay believes PEKO QED should undertake in order to remedy such deficiencies. PEKO QED will remedy such deficiencies within a reasonable period of time after receipt of such written notice and provide evidence of this corrective action to ViewRay as requested.
(c) PEKO QED will maintain manufacturing and Assembly quality documentation and will certify that Product was manufactured and tested in accordance with the Specifications and Applicable Standards. ViewRay may request copies of such certifications as part of the inspections permitted under Section 4.3(a). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(d) PEKO QED will comply with the Specifications and Applicable Standards in its Assembly manufacturing of the Products. Prior to shipping any Product, PEKO QED will carry out the Product tests specified in the applicable Specifications on each unit of Product. If a Product or any part of a Product fails to meet the Specifications, through fault of PEKO, the Product will be repaired or replaced by PEKO QED as set forth in Section 7.3 and the relevant test will be repeated until such Product passes such test requirements. No Product will be shipped to ViewRay or its designee without passing all tests specified in the Specifications. Certification of conformance and/or test reports will be provided on request with each unit as evidence of compliance.
Appears in 1 contract
Quality Assurance Inspections. (a) During regular business hours and upon reasonable advance notice and in a manner that does not disrupt or interfere with the business of PEKO, PEKO will permit ViewRay and its agents and its customers to inspect the facilities of PEKO, pertaining to the Products and provide access to PEKO’s manufacturing quality control documentation related to the Products to the extent necessary for, and for the purpose of assessing PEKO’s compliance with this Agreement. As a condition of provision to ViewRay agents or ViewRay customers of access to PEKO’s facilities and documentation, all information obtained by ViewRay agents or ViewRay customers as a result of such access will be PEKO Confidential Information for purposes of this Agreement. PEKO may require any agent or customer of ViewRay seeking access to PEKO’s facilities under this Section 4.3(a), as a condition to such access, to execute a standard confidentiality agreement with PEKO under which such agent agrees to treat information disclosed during such inspection as the Confidential Information of PEKO under terms and conditions no less restrictive than the terms contained in Section 6.2. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(b) If an inspection pursuant to Section 4.3(a) reveals that the facilities used to manufacture or Assembly of Products do not satisfy the Applicable Standards in all material respects, then ViewRay will promptly provide to PEKO written notice of such fact, which notice will contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps ViewRay believes PEKO should undertake in order to remedy such deficiencies. PEKO will remedy such deficiencies within a reasonable period of time after receipt of such written notice and provide evidence of this corrective action to ViewRay as requested.
(c) PEKO will maintain manufacturing and Assembly quality documentation and will certify that Product was manufactured and tested in accordance with the Specifications and Applicable Standards. ViewRay may request copies of such certifications as part of the inspections permitted under Section 4.3(a). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(d) PEKO will comply with the Specifications and Applicable Standards in its Assembly of the Products. Prior to shipping any Product, PEKO will carry out the Product tests specified in the applicable Specifications on each unit of Product. If a Product or any part of a Product fails to meet the Specifications, through fault of PEKO, the Product will be repaired or replaced by PEKO as set forth in Section 7.3 and the relevant test will be repeated until such Product passes such test requirements. No Product will be shipped to ViewRay or its designee without passing all tests specified in the Specifications. Certification of conformance and/or test reports will be provided on request with each unit as evidence of compliance.
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