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Form 10-Q XERIS PHARMACEUTICALS For: Mar 31

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May 13, 2021 4:41 PM EDT

Exhibit 10.1

FIRST AMENDMENT TO
API SUPPLY AGREEMENT
This first Amendment (“First Amendment”) is entered into as of February 26, 2021 (the “First Amendment Effective Date”), by and between Xeris Pharmaceuticals, Inc. (“Xeris”) and Bachem Americas, Inc. (“Bachem”). Xeris and Bachem may be referred to individually as a “Party” or collectively as the “Parties.” Capitalized terms used in this First Amendment without definition shall have the same meaning as set forth in the Agreement (defined below).

WHEREAS Xeris and Bachem entered into that certain API Supply Agreement for Glucagon, dated and effective January 1, 2018 (“the Agreement”); and
WHEREAS the Parties have agreed to amend the Agreement to change the product code for Glucagon, delete certain storage provisions and make the other changes described herein;
NOW THEREFORE in consideration of the mutual promises contained herein, effective as of the First Amendment Effective Date, the Parties affirm and agree as follows:
1.The first paragraph of the Agreement and Section 11.5 of the Agreement are each hereby amended to delete the reference to “Suite 1800” in Xeris’ address and insert in lieu thereof “Suite 1600”.
2.Section 1.2 of the Agreement is hereby amended to delete the reference to “product code [***]” and replace with “Product Code [***]”.
3.Section 1.15 of the Agreement “Warehouse” is deleted in its entirety.
4.Section 2.4 of the Agreement “Shipping and Warehousing” is deleted in its entirety and replaced with the following:
2.4 Shipping. BACHEM shall deliver quantities of API ordered by XERIS in accordance with Section 2.3 above, to the locations specified in the applicable Purchase Order. Shipments may be shipped DDP (Incoterms 2010) direct to XERIS US locations specified on a Purchase Order. Pricing excludes shipping, duties and taxes and other applicable shipping fees, which shall be invoiced separately. BACHEM shall ensure API is shipped and stored according to cGMP’s and Specifications. BACHEM shall request advance import and customs information from XERIS as required and ship API, together with all relevant documentation relating to the API, including, but not limited to those documents listed in Exhibit 2, in accordance with any agreed-upon shipment specifications or as otherwise reasonably directed by XERIS in writing and in accordance with this Agreement. XERIS shall only be obligated to pay for quantities of API actually delivered in compliance with the applicable Purchase Order and the terms of this Agreement.



5.Exhibit 2 of the Agreement is hereby amended by deleting the last line of Exhibit 2 is deleted in its entirety and replaced with the following:
“Temperature data logger for BBU/Xeris shipments”
6.The Agreement is hereby amended by inserting new Section 11.13 immediately after Section 11.12 as follows:
“11.13 Equal Opportunity Clause. If applicable, BACHEM shall abide by the requirements of 41 CFR Sections 60-1.4(a), 60- 300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities and prohibit discrimination against all individuals based on their race, color religion, sex, sexual orientation, gender identity, or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability. This contract may also be subject to Executive Order 13496.”
This First Amendment shall be governed by, and construed in accordance with, the laws of the State of New York, as if entered into by New York residents and executed and wholly performed within the State of New York. This First Amendment may be executed in counterparts, each of which shall be deemed an original, but which together shall constitute one and the same instrument. All other terms, conditions and obligations of the Agreement shall remain in force. To the extent any provision of the Agreement conflicts with any provision of this First Amendment, this First Amendment shall control.



IN WITNESS THEREOF, each of Xeris and Bachem have caused this First Amendment to be executed by their respective duly authorized representatives as of the First Amendment Effective Date.

Xeris Pharmaceuticals, Inc.Bachem Americas, Inc.
By : /s/ Ronald MihalceanBy: /s/ Peter Hutchings
Ronald MihalceanPeter Hutchings
Title: VP, Supply ChainTitle: VP, BD and Sales Americas
By: /s/ Michael Brenk
Michael Brenk
Title: VP, Finance/HR




Exhibit 31.1


CERTIFICATION PURSUANT TO RULE 13a-14(a) OR 15d-14(a) OF
THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002


I, Paul R. Edick, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Xeris Pharmaceuticals, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a)     Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b)     Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c)     Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d)    Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a)    All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b)    Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

                    
Date: May 13, 2021By:/s/ Paul R. Edick
Paul R. Edick
Chairman and Chief Executive Officer
(Principal Executive Officer)



Exhibit 31.2


CERTIFICATION PURSUANT TO RULE 13a-14(a) OR 15d-14(a) OF
THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002


I, Barry M. Deutsch, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Xeris Pharmaceuticals, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a)     Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b)     Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c)     Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d)    Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a)    All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b)    Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

                
Date:May 13, 2021By:/s/ Barry M. Deutsch
Barry M. Deutsch
Chief Financial Officer
(Principal Financial Officer)



                                                Exhibit 32.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002


    We, Paul R. Edick and Barry M. Deutsch, of Xeris Pharmaceuticals, Inc., certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, to the best of our knowledge, that:

1.    The quarterly report on Form 10-Q for the quarter ended March 31, 2021 (Periodic Report) to which this statement is an exhibit fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and

2.    Information contained in the Periodic Report fairly presents, in all material aspects, the financial condition and results of operations of Xeris Pharmaceuticals, Inc.

Date: May 13, 2021

/s/ Paul R. Edick
Paul R. Edick
Chairman and Chief Executive Officer
(Principal Executive Officer)

 
/s/ Barry M. Deutsch
Barry M. Deutsch
Chief Financial Officer
(Principal Financial Officer)



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