EX-10.13 13 d547651dex1013.htm EX-10.13 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406...
Exhibit 10.13
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
Xeris/Bachem | Quality Assurance Agreement |
This Quality Assurance Agreement (the “Quality Assurance Agreement”) is made as of November 20, 2015 (“Effective Date”) between Bachem AG, an entity organized under the laws of Switzerland, with its principal place of business at Xxxxxxxxxxxx 000, XX-0000 Xxxxxxxxx, Xxxxxxxxxxx (“Bachem”), and Xeris Pharmaceuticals, Inc. an entity organized under the laws of Texas with its principal place of business at 0000 Xxx Xxxxx Xxxxxx, Xxxxx 000, Xxxxxx, XX 00000, XXX (“Xeris”).
WHEREAS, the Parties now desire to set forth in this Quality Assurance Agreement a plan, prepared by Xeris and Bachem, for determining the conformity of Product supplied by Bachem to Xeris under this Agreement to the Specifications (as defined below).
ARTICLE 1
Section 1.1 Preamble. The preamble to this Quality Assurance Agreement forms an integral part hereof.
Section 1.2 Definitions. Unless the context otherwise requires, the following terms as used in this Quality Assurance Agreement shall have the following meaning:
“Annex” means an exhibit annexed lo and forming part of this Quality Assurance Agreement.
“Competent Authorities” mean the FDA in the United States or any other applicable national, supranational, federal, state or local regulatory agency or entity having the responsibility, jurisdiction, and authority to approve the clinical manufacture, use, importation, packaging, labeling, marketing, and sale of Product or Xeris’ Pharmaceutical Products in any country where Bachem has authorized Xeris to access Bachem’s DMF.
Page 1 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
“Xeris’ Pharmaceutical Products” means Xeris’ pharmaceutical medications or formulations, including those in any manner arising or resulting from the use of the Product in connection with the above medications.
“Certificate of Analysis” means a certificate In writing for each batch of Product, signed by a Qualified Person or its deputy, that provides full analytical results of the batch of Product, a TSE-Safely-Certificate and certifies (a) the conformity of the batch of Product to the Specifications and (b) that manufacturing and release records of the respective batch of Product were reviewed by Bachem and manufacturing and release of the respective batch of Product is in accordance with all applicable cGMP requirements. All Product batches delivered to Xeris or its designee shall comply with provisions of this Quality Assurance Agreement.
“Confidential Information” means, with respect to a Party, all information of a confidential nature which may be disclosed by or on behalf of that Party to the other Party including, but not limited to, the Product Information and information relating to the disclosing Party’s business or scientific strategies, research, product development, marketing, customers. Opportunities, finances, sales and pricing of products, processes, and all other written information clearly identified as “Confidential” when submitted by the disclosing Party to the receiving Party.
“DMF” means Drug Master File maintained with the FDA or its equivalent maintained with a Competent Authority in any other country mutually agreed between the Parties.
“GMP or cGMP” means the (a) current regulations for Good Manufacturing Practice as outlined in the US Code of Federal Regulations and applicable FDA guidance documents as amended and (b) the ICH 07 guideline for the production and release of active substances and in EC Directive 2003/94/EC as amended from time to time and transposed into the respective national laws at the member states of the European Union and the equivalent US (FDA) laws and regulations.
“Latent Defect” means, with respect to Product, a hidden or latent defect not detected by the analytical test methods in operation at the date of shipment to Xeris of the relevant Product by Bachem and which was not detected by Xeris during the initial Testing Period.
“Manufacture” means the manufacture, processing, packing, or holding of a product including packaging and labelling operations, testing, and quality control and QA release.
“Major Deviation” means a deviation with the potential to have an impact on Product quality, safety, efficacy or stability.
“Minor Deviation” means any deviation that will not have an impact on Product quality, safety, efficacy or stability.
“Major Change” means a change that may adversely impact quality, safely, efficacy, stability, or regulatory compliance of the Product. Any change that will require regulatory authority approval is also defined as a Major Change.
Page 2 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
“Minor Change” means a change that will not have any adverse impact on Product quality, safely, efficacy, stability, or regulatory compliance, and will not require authority approval.
“OOS” means out of specification and, with respect to a Product or testing of a Product, means that the Product does not conform to the Specifications or the results of testing of the Product indicate non-conformance of the Product to the Specifications.
“Party” or “Parties” shall mean Bachem or Xeris, Individually or collectively as the context requires.
“Product” means synthetically manufactured human Glucagon as described in more detail in the Specifications in Annex 1 of this Quality Assurance Agreements non-sterile active pharmaceutical ingredient(s) in bulk form, manufactured under GMP requirements.
“Qualified Person” has the meaning ascribed to it in EC Directive 2003/94/EEC as amended or as m any other applicable GMP regulation.
“Specifications” means the specifications for the Product, as more specifically described in Annex 1 of this Quality Assurance Agreement. Annex 1 may be modified from time to time by written amendment to this Quality Assurance Agreement in accordance with Section 12.4.
“Testing Period” means the time after Xeris’ receipt of any shipment of Product to subject such Shipment, on a sample basis, to quality control testing to determine conformity with the relevant Specifications (including COAs and COCs), and whether or not a Product is free from defects in workmanship or materials, and manufactured according to cGMP.
“TSE-Safety-Certificate” means a certificate certifying that a batch of the Products) complies with or is outside the scope of monograph 5.2.8 of the European Pharmacopeia.
“USP” means current United States Pharmacopeia official compendia of standards.
“EP” means current European Pharmacopoeia official compendia of standards.
ARTICLE 2
SUBJECT OF THIS QUALITY ASSURANCE AGREEMENT
Section 2.1 The purpose of this Quality Assurance Agreement is to define and to establish the obligations and responsibilities of Bachem and Xeris relating to the quality assurance requirements of the manufacture, release and supply of the Product pursuant to the Agreement by Bachem in accordance with GMP guidelines tor active pharmaceutical ingredients (APIs), namely the US Code of Federal Regulation, Parts 11, 210, 211, applicable
Page 3 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
FDA guidance documents and ICH 07 GMP Guide for APIs as accepted and implemented by the national and international regulations of the European Community, the United States of America, Japan and the member slates of the Pharmaceutical inspection Convention (PIC) scheme.
ARTICLE 3
QUALITY ASSURANCE AGREEMENT CONTACT INFORMATION
Bachem AG, Xxxxxxxxxxxx 000
0000 Xxxxxxxxx, Xxxxxxxxxxx
[***]
[***]
[***]
[***]
Section 3.3 Notices to Xeris. Any notice to Xeris Shall be addressed to:
Xeris Pharmaceuticals Inc., 0000 Xxx Xxxxx Xxxxxx, Xxxxx 000
Xxxxxx, XX 00000
[***]
[***]
[***]
ARTICLE 4
ARTICLE 5
Page 4 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
Section 5.5 Manufacturing Process. Product must be manufactured, tested, released and packed in compliance with the requirements of the provisions of this Quality Assurance Agreement and CGMPs. Any changes made to the established manufacturing process are subject to Bachem’s change control process as described in Article 7 of this Quality Assurance Agreement hereunder. Xeris shall be notified in advance of any Major Changes associated with the manufacture and quality control of Product.
Section 5.9 Re-Test Date. The re-test date for Product shall be allocated based on the date of manufacture together with the retest period established by stability data generated using Product produced by the validated manufacturing process.
Section 5.10 Rework and Reprocessing. Reprocessing and rework of Product is permitted with rework steps that have been validated as part of the manufacturing process and in accordance with the provisions of the ICH Q7 guideline Bachem will notify Xeris prior to any reworking.
Page 5 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
Section 5.11 Manufacturing and Equipment Data. Bachem shall be responsible for keeping records of equipment usage, cleaning, raw material batch numbers and certification as well as in process results and parameters. Such documentation shall be retained by Bachem as described in Section 6.9 hereunder.
Section 5.13 Drug Master File. In mutually agreed countries, Bachem will maintain the Product DMF according to requirements defined by each local Competent Authority. Bachem will provide a letter to the specified Competent Authority at Xeris’ request in accordance with Section 5.2 of the Agreement allowing such Competent Authority to review Bachem’s Product DMF relative to any Xeris submission.
ARTICLE 6
QUALITY ASSURANCE AND QUALITY CONTROL
Section 6.2 Testing of Raw Materials. Bachem shall ensure that materials and packaging components used to manufacture the Product’s) are in compliance with the specifications as defined by Bachem and, if applicable, disclosed to Xeris for on-site review in Bubendorf. Reduced testing shall be permitted for vendors that have been formally qualified by Bachem and have a demonstrated history of meeting all test specifications, per an approved Bachem SOP. In this case raw materials for use in the manufacture of the Product shall be tested at a minimum for identity on each shipment delivered. Bachem will store retention samples of all STARTING MATERIALS and IMTERMEDIATES used sufficient to perform at least [***] full specification analyses and meaningful use tests, in containers that are equivalent to or more protective than the commercial packaging. In all cases, sample packaging and storage conditions shall maintain the physical and chemical integrity of the sample. Samples are to be retained for [***]. However, there will be no retains (or compressed gasses and extremely hazardous materials.
Page 6 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
Section 6.3 In-Process Testing. Bachem shall be responsible for ensuring that all required in-process testing is completed using suitable methods, when applicable, and documented. This will include environmental controls where required. Bachem shall also be responsible for defining appropriate tests and criteria.
Section 6.5 Approval to ship the Product. Bachem shall be responsible for ensuring that the Product conforms to the Specifications and has been made and tested in accordance with the manufacturing procedure and with all provisions or this Quality Assurance Agreement This will be carried out by Bachem’s Qualified Person or deputy before any shipment of Product to Xeris.
Section 6.7 Release of Product for use by Xeris. Bachem shall release Products under their quality system ensuring compliance with applicable regulations Release documentation shall accompany a CoA / CoC as described in this document. Xeris shall be responsible for release of the Products for further use. Xeris shall alto be responsible for ensuring that all further medicinal use of Product is in accordance with the relevant laws and regulations.
Page 7 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
Page 8 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
Bachem processes, facilities and personnel during any audit Responses to audit findings will be provided by Bachem within [***] of Bachem’s receipt of an audit findings report from Xeris. Initial responses to critical observations that have the potential to impact safety, identity, strength purity or quality (SISPQ) of the Product will be provided to Xeris within [***].
1. | [***] per year; |
2. | [***] additional technical meeting associated with the NOA review as agreed between the parties; |
3. | For cause audits may be conducted by Xeris with reasonable notice. |
Interactions with Competent Authorities. In the cases of responses to findings by inspectors representing Competent Authorities, Bachem will meet mandatory response timelines and m the case where time is needed to provide a complete response. Bachem will notify the Competent Authority and work aggressively to ensure the complete responses meet timelines specified by the Competent Authorities Bachem will provide Xeris with copies of all correspondence including corrective actions for those observations impacting Xeris products. In the case when DMF queries received by Bachem from Competent Authorities are associated with third parties’ applications, Bachem will notify Xeris if the regulatory queries may impact Xeris’s Pharmaceutical Products and program timelines. In the case when queries or requested changes from regulators may produce a conflict between Xeris’s Pharmaceutical Products and program(s) and Bachem’s’ changes relative to a third party’s application. Bachem will reasonably cooperate with Xeris in order to limit impact on Xeris’s Pharmaceutical Products and programs. Xeris will also cooperate in good faith to support the intended change.
Page 9 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
Section 6.21 Product Recall. Xeris shall be responsible for instituting a medical product recall scheme for Xeris’ Pharmaceutical Product. Bachem will inform Xeris as soon as possible, but no later than [***] after Bachem becomes aware of such information. In case Xeris does not agree then Xeris releases Bachem from all consequent financial and liability obligations. Xeris shall notify Bachem of any recall of Xeris’ Pharmaceutical Product, which may be due to manufacture, components or tests performed on Product(s) by Bachem. Bachem shall provide a rapid initial response and then a full report as soon as possible The Parties shall cooperate on the response to the authorities.
ARTICLE 7
Section 7.3 OOS Results, and Failure Investigations. Bachem shall be responsible for investigating any OOS results that occur with testing of the Product. According to Bachem’s OOS procedure, an initial tab error investigation will clarify whether the OOS result was caused by a lab error or by a batch failure. In case of a batch failure the Investigation will be expanded at minimum to evaluate the cause of the failure and its impact on earlier and later production lots. Each investigation must give use to an explanation and/or corrective action which must be reviewed and approved by Bachem’s quality assurance. OOS and failure investigations must be completed prior to Product release.
ARTICLE 8
Page 10 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
regarding the technical implications Bachem’s quality assurance and regulatory affairs will evaluate the acceptability of the changes to Product regarding GMPs, the impact on Product quality end stability as well as on conformity with regulatory submissions. Bachem will notify Xeris of any/all proposed Major Changes to the manufacturing process, quality controls, specifications, methods of control, prior to initiation.
ARTICLE 9
ARTICLE 10
Without limiting each Party’s rights and obligations as otherwise set forth in this Quality Assurance Agreement, the following chart sets forth each Party’s specific responsibilities in connection with quality assurance matters relating to the manufacture of Product:
RESPONSIBILITY | Bachem | Xeris | ||
Manufacture | — | |||
Manufacture of the API | [***] | [***] | ||
Development of manufacturing process for the API | [***] | [***] | ||
Manufacturing documentation for the API | [***] | [***] | ||
Ownership of manufacturing process and documentation for the API | [***] | [***] |
Page 11 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
RESPONSIBILITY | Bachem | Xeris | ||||||
Procurement of the API raw and starting materials | [***] | [***] | ||||||
Analytical, Laboratory, Sampling and Control | ||||||||
Retain and store samples of all materials and the API | [***] | [***] | ||||||
Sampling, analysis and release of materials for API | [***] | [***] | ||||||
In-process analyses for manufacture of the API | [***] | [***] | ||||||
Reference standards for laboratory analysis performed by Bachem | [***] | [***] | ||||||
Incoming material testing of the API upon receipt and keeping retained samples as required by competent authorities | [***] | [***] | ||||||
Quality Assurance Activities for API | ||||||||
Batch numbering _ | [***] | [***] | ||||||
Approval of master batch documents | [***] | [***] | ||||||
Preparation and review of the batch production, analytical and packaging records as well as of associated documents | [***] | [***] | ||||||
Assurance of correct storage conditions for the API prior to shipment to Xeris | [***] | [***] | ||||||
Release of API to Xeris | [***] | [***] | ||||||
Release of API for Xeris’ Pharmaceutical Product manufacture | [***] | [***] | ||||||
Shipping documentation | [***] | [***] | ||||||
Material safety data sheet provision | [***] | [***] | ||||||
Maintain a change control system | [***] | [***] | ||||||
Provide API Specification as maintained in DMF | [***] | [***] | ||||||
Approve API Specifications and ensure that Specifications are appropriate for further use | [***] | [***] | ||||||
Change Control for Specifications (Bachem for technical feasibility, Xeris for further use) | [***] | [***] | ||||||
Failure investigation in case of batch failure | [***] | [***] | ||||||
Regulatory Documentation for API | ||||||||
Scheduling and ordering the regulatory work documentation and submissions for API section of Xeris’ Drug Products, as needed | [***] | [***] | ||||||
Submission and maintenance of DMF for API | [***] | |||||||
Stability studies for The API | [***] | [***] | ||||||
NDA or MAA submission and maintenance (or Xeris1 Drug Products | [***] | [***] | ||||||
Hosting GMP Inspections for the API by the Competent Authorities | [***] | [***] | ||||||
Maintain site registration licenses | [***] | [***] | ||||||
Validation for API | ||||||||
Qualification of equipment for manufacturing and analysis | [***] | [***] |
Page 12 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
RESPONSIBILITY | Bachem | Xeris | ||||||
Cleaning validation and cleaning verification | [***] | [***] | ||||||
Validation of test methods | [***] | [***] | ||||||
validation of manufacturing process | [***] | [***] | ||||||
Validation of computerized systems | [***] | [***] | ||||||
Complaint Handling, Drug Safety | ||||||||
Review and resolution of Xeris’ Pharmaceutical Product quality complaints when applicable to API | [***] | [***] | ||||||
Decisions regarding the notification of critical API quality issues to Swissmedic and Xeris | [***] | [***] | ||||||
Decisions regarding recalls and field alerts of Xeris’ Pharmaceutical Product | [***] | [***] |
ARTICLE 11
ARTICLE 12
Page 13 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
Section 12.6 Language. This Quality Assurance Agreement is made in the English language.
Section 12.7 Number of Copies. Two master copies exist, one with each of the Parties.
Page 14 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
Bubendorf .Switzerland
Bachem AG | ||||||
By | /s/ Xxxxxx Xxxx December 9, 2015 | By: | /s/ Xxx xxx Xxxxxx December 9, 2015 | |||
Xx Xxxxxxx Xxxx | Xx. Xxx xxx Xxxxxx | |||||
VP QAVRA | Director QA/XX |
Xxxxxx. TX USA
Xeris Inc. | ||
By | /s/ Xxxx Xxxxxxxxx November 20, 2015 | |
Xxxx Xxxxxxxxx | ||
Chief Operating Officer | ||
By | /s/ Banir Xxxxx November 20, 2015 | |
Banir Xxxxx | ||
XX of Global Manufacturing & Tech Ops | ||
By | /s/ Xxxxxxx Xxxxxxxxx December 2, 2015 | |
Xxxxxxx Xxxxxxxxx | ||
VP of Quality |
Page 15 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
Xeris / Bachem Quality Assurance Agreement | ANNEX 1
SPECIFICATIONS | Glucagon |
The Product shall be released against the following Specifications:
Page 16 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
Product: Glucagon, Pharma Grade Material
[***]
[***]
Page 17 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
CONFIDENTIAL
Xeris / Bachem Quality Assurance Agreement | ANNEX 2
APPROVED CONTRACT LABORATORIES | Glucagon |
Certain analytical services are provided (or Bachem AG by contract laboratories. Following please find the list of these institutes / companies including their potential service(s). All listed subcontractors are appropriately Qualified by Bachem Alternatively to using a contract laboratory these tests may be performed in house at Bachem provided that the specific technique is available.
Contract laboratory | Description of typical service(s) | |
[***] | [***] | |
[***] | [***] | |
[***] | [***] | |
[***] |
Page 18 of 18
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
Amendment 1 to the
Quality Assurance Agreement
This Amendment 1 (the “Amendment 1”) is made as of October 31, 2016 (the “Effective Date”) by and between Bachem AG, an entity organized under the laws of Switzerland, with its principal place of business at Xxxxxxxxxxxx 000, XX-0000 Xxxxxxxxx, Xxxxxxxxxxx (“Bachem”), and Xeris Pharmaceuticals, Inc., an entity organized under the laws of Texas, with its principal place of business at 0000 Xxx Xxxxx Xxxxxx, Xxxxx 000, Xxxxxx, XX 00000, XXX (“Xeris”).
NOW THEREFORE, the Parties hereto, intending to be legally bound, agree as follows:
1. | Definitions |
The capitalized terms used in this Amendment 1 shall have the meaning ascribed to such terms in the Quality Assurance Agreement, unless otherwise stated.
2. | Amendments |
The Parties agree that, as of the Effective Date, the Quality Assurance Agreement is amended as set forth in this Section 2.
2.1 Section 3.3 (Notices to Xeris) of the Quality Assurance Agreement shall be deleted in its entirety and replaced by the following:
Section 3.3 Notices to Xeris. Any notice to Xeris shall be addressed to:
Xeris Pharmaceuticals, Inc., 0000 Xxx Xxxxx Xxxxxx, Xxxxx 000
Xxxxxx, XX 00000
[***]
3. | MISCELLANEOUS |
3.1 The Parties agree that the provisions of this Amendment 1 shall be applied with immediate effect. For the avoidance of doubt it is acknowledged that the provisions of this Amendment 1 shall be valid for future manufacturing and release of the Product.
3.2 In the event of any conflict between the terms of this Amendment 1 and the terms of the Quality Assurance Agreement the terms of this Amendment 1 shall prevail.
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
3.3 Except as expressly modified by this Amendment 1, the terms and provisions of the Quality Assurance Agreement remain and shall remain in full force and effect.
Bubendorf, November 3, 2016
Bachem AG
By: | /s/ Xxxxxx Xxxx | By: | /s/ Xxx xxx Xxxxxx | |||
Xx. Xxxxxxx Xxxx | Xx. Xxx xxx Xxxxxx | |||||
Vice President QA/RA | Director QA/RA |
Austin, TX USA, November 7, 2016
Xeris Inc.
By: | /s/ Benir Xxxxx | |
Benir Xxxxx | ||
XX of Global Manufacturing & Tech Ops |
By: | /s/ Xxxxxx Xxxxxx | |
Xxxxxx Xxxxxx | ||
VP of QA |
2
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
Amendment 2 to the
Quality Assurance Agreement
This Amendment 2 (the “Amendment 2”) is made as of January 26, 2017 (the “Effective Date”) by and between Bachem AG, an entity organized under the laws of Switzerland, with its principal place of business at Xxxxxxxxxxxx 000, XX-0000 Xxxxxxxxx, Xxxxxxxxxxx (“Bachem”), and Xeris Pharmaceuticals, Inc., an entity organized under the laws of Texas, with its principal place of business at 0000 Xxx Xxxxx Xxxxxx, Xxxxx 000, Xxxxxx, XX 00000, XXX (“Xeris”).
NOW THEREFORE, the Parties hereto, intending to be legally bound, agree as follows:
1. | DEFINITIONS |
The capitalized terms used in this Amendment 2 shall have the meaning ascribed to such terms in the Quality Assurance Agreement, unless otherwise stated.
2. | AMENDMENTS |
The Parties agree that, as of the Effective Date, the Quality Assurance Agreement is amended as set forth in this Section 2.
2.1 Exhibit A (Specifications) of the Quality Assurance Agreement shall be deleted in its entirety and replaced by the following:
(The remainder of this page is intentionally left blank)
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
Xeris / Bachem Quality Assurance Agreement | ANNEX 1
SPECIFICATIONS | Glucagon |
The Product shall be released against the following Specifications:
[***]
Tests | Specifications | Controls | ||
Appearance R | [***] | |||
Appearance of solution R | [***] | |||
Identification (HPLC) | [***] | |||
Identification (HPLC)1,2 | [***] | |||
Identification (amino acid analysis) | [***] [***] [***] [***] [***] [***] [***] [***] | |||
Identification (MS)2 | [***] | |||
Specific optical rotation | [***] | |||
Related substances (HPLC) R | [***] | |||
Peptide content R (elemental analysis) | [***] | |||
Assay (HPLC) 1,2,R | [***] | |||
Bioassay | [***] | |||
Mass balance | [***] | |||
Water content (Xxxx Xxxxxxx)R | [***] | |||
Residue on ignition | [***] | |||
Acetic acid content (HPLC) | [***] | |||
Ammonium content (IC) | [***] | |||
Chloride content (titration) | [***] | |||
Residual organic solvents (GC) | [***] |
2
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
[***] | ||||
Nitrogen content R (elemental analysis) | [***] | |||
Zinc content (ICP-OES) | [***] | |||
Bacterial endotoxins (USP <85>) | [***] | |||
Microbial limit test (USP <61>) Total aerobic microbial count (TAMC) | [***] | |||
Total yeasts and moulds count (TYMC) | [***] |
R | performed for retest |
1 | the analytical test method is based on the Glucagon monograph of [***] |
2 | report separately as Additional Data |
To be analyzed according to [***]
Product: Glucagon, Pharma Grade Material
Bachem No.: [***]
Peptide Sequence: [***]
3. | MISCELLANEOUS |
3.1 The Parties agree that the provisions of this Amendment 2 shall be applied with immediate effect. For the avoidance of doubt it is acknowledged that the provisions of this Amendment 2 shall be valid for future manufacturing and release of the Product.
3.2 Both Parties acknowledge and Xeris agrees that there will be a Major Change to the existing Quality Assurance Agreement within the next months (Change request letter dated February 22, 2016) and therefore the Agreement will be amended with the new Quality Standard reflecting such Change as soon as available.
3.3 In the event of any conflict between the terms of this Amendment 2 and the terms of the Quality Assurance Agreement or the terms of the Amendment 1, the terms of this Amendment 2 shall prevail.
3.4 Except as expressly modified by this Amendment 2, the terms and provisions of the Quality Assurance Agreement and Amendment 1 remain and shall remain in full force and effect.
3
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
Bubendorf, February 8, 2017
Bachem AG
By: | /s/ Xxxxxx Xxxx | /s/ Xxx xxx Xxxxxx | ||
Xx. | Xxxxxxx Xxxx | Xx. Xxx xxx Xxxxxx | ||
Vice President QA/RA | Director QA/RA | |||
Austin, TX USA, February 16, 2017 | ||||
Xeris Inc. | ||||
By: | /s/ Benir Xxxxx | /s/ Xxxxxx Xxxxxx | ||
Benir Xxxxx | Xxxxxx Xxxxxx | |||
XX of Global Manufacturing & Tech Ops | VP of QA |
4