News and research before you hear about it on CNBC and others. Claim your 1-week free trial to StreetInsider Premium here.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

QUIDEL CORPORATION

(Exact Name of Registrant as Specified in Charter)

Section 1 – Conflict Minerals Disclosure

Item 1.01    Conflict Minerals Disclosure and Report

Quidel Corporation has filed a Conflict Minerals Report, which is attached as Exhibit 1.01 hereto. The Conflict Minerals Report is also publicly available at www.quidel.com through the “Investor Relations” link under the heading “Corporate Governance.” The content of any website referred to in this Form SD is included for general information only and is not incorporated by reference in this Form SD.

Item 1.02    Exhibit

The Conflict Minerals Report for the calendar year ended December 31, 2021 is filed as Exhibit 1.01 hereto.

Section 2 – Exhibits

Item 2.01    Exhibits

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the duly authorized undersigned.

Date: May 26, 2022

Exhibit 1.01

CONFLICT MINERALS REPORT

For The Year Ended December 31, 2021

Introduction

This Conflict Minerals Report (“Report”) of Quidel Corporation for the year ended December 31, 2021 is presented to comply with Rule 13p-1 under the Securities Exchange Act of 1934, as amended (“Rule”).  Numerous terms in this Report are defined in Item 1.01 of Form SD promulgated under the Rule, and the reader is referred to Form SD and Release No. 34-67716 issued by the Securities and Exchange Commission (“SEC”) on August 22, 2012 for such definitions. Unless the context otherwise requires, references below in this Conflict Minerals Report to “Quidel”, “we”, “our” or “us” refer to Quidel Corporation and its consolidated subsidiaries.

The terms “Conflict Minerals” or “3TG” are defined as columbite-tantalite (coltan), cassiterite, gold, wolframite, or their derivatives, which are limited to tantalum, tin, and tungsten. The Rule requires us to undertake in good faith a reasonable country of origin inquiry to determine whether any of the 3TG in our products originated in the Democratic Republic of the Congo (“DRC”) or an adjoining country, which for the purposes of the Rule are Angola, Burundi, the Central African Republic, the Republic of the Congo, Rwanda, South Sudan, Tanzania, Uganda and Zambia (together with the DRC, collectively defined as the “Covered Countries”) or were from recycled or scrap sources.

Company Overview

Quidel’s products are marketed under various brand names, including, among others, Quidel®, QuickVue®, QuickVue+®, Sofia®, Triage®, Savanna®, Solana®, Virena®, MicroVueTM, Lyra®, FreshCellsTM, D3®, FastPoint®, ReadyCells®, Super E-MixTM, InflammaDry®, AdenoPlus®, ELVIRA®, ELVIS® and Thyretain®. Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, infectious diseases, cardiovascular diseases and conditions, women’s health, gastrointestinal diseases, autoimmune diseases, bone health and thyroid diseases. Quidel’s principal executive offices are located at 9975 Summers Ridge Road, San Diego, CA 92121.

Description of Our Products Covered by this Report

This Report relates to Quidel products: (i) for which 3TG are necessary to the functionality or production of that product; (ii) that were manufactured, or contracted to be manufactured, by Quidel; and (iii) for which the manufacture was completed during calendar year 2021. During this reporting period, we identified that our Sofia®, Sofia® 2, Virena®, AmpliVue®, Solana®, Triage® and Savana® equipment and QuickVue® iFOB products that include test strips that we manufactured or contracted to manufacture may contain 3TG that are necessary to the functionality of the products.

Quidel’s supply chain is complex and there are many third parties in the supply chain between the ultimate manufacture of Quidel products and the original sources of Conflict Minerals. In this regard, Quidel does not purchase 3TG directly from mines, smelters or refiners. Quidel must therefore rely on its suppliers to provide information regarding the origin of the 3TG that is contained in Quidel products. Moreover, Quidel believes that

the smelters and refiners of the 3TG are best situated to identify the sources of 3TG, and therefore has taken steps to identify the applicable smelters and refiners of 3TG in Quidel’s supply chain.

Conflict Minerals Compliance Program

Our due diligence processes and efforts have been designed to conform with the five-step framework recommended by the Second Edition of The Organisation for Economic Co-operation and Development (“OECD”) Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas and the related Supplements for gold and for tin, tantalum and tungsten (the “OECD Guidance”). In addition, we used the standard Conflict Minerals Reporting Template (the “Template”), along with other resources employed by a third-party consultant, to obtain information necessary to prepare this Report.

(1) Establish Strong Management Systems

Conflict Minerals Compliance Team – We have established a team comprised of representatives from our Operations, Supply Chain management, Finance, and Legal departments to review the Rule, the adopting release associated with the Rule and the related FAQs published by the SEC staff. As in prior years, we have continued to focus our efforts on processes to communicate with suppliers and record and store responses to our inquiries. In 2021, we also engaged a recognized third party professional agency to assist us in our efforts to implement the due diligence process in accordance with the OECD Guidance.

Conflict Minerals Policy – We have adopted a policy on Conflict Minerals, which is posted on our website at quidel.com through the “Investor Relations” link under the heading “Corporate Governance.” Our policy includes principles that we expect all of our suppliers to: prohibit human rights abuses and unethical practices; source materials from socially responsible suppliers and sub-suppliers in pursuit of conflict free supply chains; abide by applicable legal standards and requirements; and cooperate with us as necessary for us to meet our disclosure requirements.

System of Controls and Transparency over Supply Chain – We continue to try to identify upstream actors in our supply chain through the utilization of the Template and the resources employed by our third-party consultant.

Supplier Engagement – As in the prior years, in 2021, we engaged a recognized third-party professional agency to assist us in engaging suppliers, including by providing access to the third-party’s Conflict Minerals Supplier Resource Center and to escalate communications as needed to obtain requested information and raise awareness of our Conflicts Minerals Compliance Program.

Grievance Mechanism – We provide an ethics hotline to report any concerns about violations of Quidel’s Code of Conduct, which provides a mechanism for escalating any issues and concerns, including those related to Conflict Minerals.

Maintain Records – We retain documentation with respect to our due diligence compliance process and in accordance with record retention requirements that are designed to to ensure the retaining of relevant documentation.

(2) Identify and Assess Risk in the Supply Chain

We seek to identify and assess risks in the supply chain, including by adopting processes to identify whether 3TG “necessary to the functionality of the products” has been identified and by implementing processes to collect, review, and record data from suppliers and follow up with suppliers regarding source information. We also conducted a third party analysis of the collected supplier information, comparing the information against a national database gathered from various industries over the years. Utilizing the database and other data points, we collaborated with our third-party consultant to establish a ranking system that identified possible risk patterns in the supplier/smelter data, allowing us to further scrutinize the supply chain and country of origin information.

(3) Design and Implement a Strategy to Respond to Identified Risks

If, based on red flags that are identified, we determine that there is a reasonable risk that a supplier is sourcing Conflict Minerals that are directly or indirectly financing or benefiting armed groups, we encourage suppliers to comply with our Conflict Minerals Policy. Our third-party consultant also applied quality assurance measures in connection with aggregation of the collected data.

(4) Third Party Audit

We do not have a direct relationship with 3TG smelters and refiners, nor do we perform direct audits of these entities that provide our supply chain with Conflict Minerals. However, we do rely upon the industry (for example, the Responsible Minerals Initiative (“RMI”) efforts to influence smelters and refiners to get audited and certified through RMI’s Responsible Minerals Assurance Process (“RMAP”), the London Bullion Market Association Good Delivery Program or the Responsible Jewellery Council Chain-of-Custody Certification.

(5) Reporting

We filed Form SD and this Report with the SEC and have made this Report available on our website at quidel.com through the “Investor Relations” link under the heading “Governance.” The content of any website referred to in this Report is included for general information only and is not incorporated by reference in this Report.

Reasonable Country of Origin Inquiry

Quidel has conducted a reasonable country of origin inquiry (“RCOI”) that was designed to determine whether any 3TG in Quidel’s products originated in the DRC or an adjoining country or were from recycled or scrap sources through use of the Template and engagement with our third-party consultant.  As a part of our RCOI, through our third-party consultant, we surveyed the 30 suppliers that were identified as in-scope for conflict mineral regulatory purposes. These suppliers were each contacted as part of the RCOI process and given a deadline of May 1, 2022 to respond to inquiries. 63% of these suppliers responded to us.

For those supply chains with smelters or refiners and associated mine countries of origin that are thought to be sourcing from a Covered Country, additional investigation was done to determine the source and chain-of-custody of the regulated metals. We relied on the following internationally accepted audit standards to determine which smelters or refiners are considered “DRC Conflict Free”: the Responsible Minerals Assurance Process, the London Bullion Market Association Good Delivery Program and the Responsible Jewellery Council Chain-of-Custody Certification. If the smelter or refiner is not certified by these internationally-recognized schemes, our third-party consultant may attempt to contact the smelter to gain more information about their sourcing practices. Internet research is also performed to determine whether there are any outside sources of information regarding the smelter’s sourcing practices, including through access to data and working groups as a vendor member of the RMI. Up to three contact attempts are made to gather information on mine country of origin and sourcing practices.

None of our suppliers were able to identify the smelters or refiners used for a particular part, component, or product that was supplied to us and that was later incorporated into our Products. Therefore, we are unable to identify with certainty the specific facilities used to process the 3TG in our products. There were approximately 340 identified smelters/refiners that have been reported to us by our suppliers. A list of smelters and refiners identified by our suppliers is included on Annex I below along with certain country of origin information provided to us.

Independent Private Sector Audit

An independent private sector audit of this Report is not required at this time.

Limitations

As a downstream purchaser of 3TG, our due diligence measures cannot provide absolute assurance regarding the

source and chain of custody of the necessary Conflict Minerals. Our due diligence processes are based on the necessity of seeking data from our suppliers and those suppliers seeking similar information within their supply chains to identify the original sources of the necessary Conflict Minerals.  We also rely on third-party audit programs and other industry efforts and information. 

A number of factors could introduce errors or otherwise affect our determinations, including, but not limited to, gaps in supplier data, gaps in smelter data, errors or omissions by suppliers, errors or omissions by smelters, confusion over requirements of SEC final rules, gaps in supplier education and knowledge, timeliness of data, public information not discovered during a reasonable search, errors in public data, language barriers and translation, supplier and smelter unfamiliarity with the reporting process, oversights or errors in conflict free smelter audits, Covered Country sourced materials being declared secondary materials, certification programs not being equally advanced for all industry segments and metals, and smuggling of Conflict Minerals to countries beyond the Covered Countries.

Forward-Looking Statements

This Report contains forward-looking statements, which are based on our current expectations and involve numerous risks and uncertainties that may cause these forward-looking statements to be inaccurate. These statements include statements regarding our future plans and initiatives for our due diligence process and to mitigate the risk about the sourcing of 3TG. All forward-looking statements involve risk and uncertainty. Risks that may cause these forward-looking statements to be inaccurate include: failure to carry out these plans in a timely manner or at all; lack of cooperation or progress by our suppliers, their respective suppliers and smelters; lack of progress in smelter or refiner validation programs for conflict minerals (including the possibility of inaccurate information, fraud and other irregularities) or these plans not being effective. In addition, you should also consider the important factors described in reports and documents that we file from time to time with the SEC, including the factors described under the sections titled “Risk Factors” in the Company’s most recently submitted Quarterly or Annual Reports. Except as required by law, we undertake no obligation to update information contained in these forward-looking statements whether as a result of new information, future events, or otherwise.

Continuous Improvement

To help mitigate the risk that 3TG in our products benefit armed groups in the Covered Countries, we endeavor to continuously improve upon our supply chain due diligence efforts, including through the following measures:

•Continue to assess the presence of 3TG in our supply chain;

•Communicate with suppliers to continue to obtain a high response rate for the RCOI process; and

•Continue to compare RCOI results to information collected via independent conflict free smelter validation programs such as the RMAP.

Annex I

Smelters and Refiners

In connection with our reasonable country of origin inquiry and due diligence, as applicable, our suppliers identified to us the smelters and refiners listed below, sorted by mineral, as potentially having processed the necessary 3TG contained in our in-scope products in 2021.

We note the following in connection with the information in the table above: The smelters and refiners listed in the table were identified by our suppliers as being part of our 2021 supply chain. Some of the suppliers may have reported to us smelters and refiners that were not in our supply chain (i) since they reported at a “company level,” meaning that they reported to us the 3TG contained in all of their products, not just the products that they sold to us, or (ii) due to over-inclusiveness in the information received from their suppliers. In addition, the smelters and refiners reflected above may not be all of the smelters and refiners in our 2021 supply chain, since many of the suppliers were unable to identify all of the smelters and refiners used to process the necessary 3TG content contained in our in scope products. All information in the table is as of May 1, 2022.

Country of Origin Information

For 2021, we were not able to determine the country of origin of the 3TG processed by approximately 2% of the identified smelters or refiners. In addition, approximately 31% of the identified smelters and refiners have not been certified as currently compliant with RMAP assessment protocols of the RMI or other accredited organizations.

The countries of origin of the 3TG processed by the smelters and refiners listed above may have included countries in each of the categories listed below. The countries below are sorted by OECD risk level, with L1 being the lowest level of risk and L3 being the highest.

L1 – Countries with little to no risk countries with known active metal production but are not identified as conflict regions or plausible areas of smuggling, export or transit of minerals out of conflict affected regions, such as Argentina, Armenia, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Czech Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Ghana, Guinea, Guyana, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Korea, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Turkey, the United States, and Zimbabwe.

L2 – Low to medium risk countries with known plausible involvement in the smuggling, export or transit of mineral out of conflict affected regions, such as Kenya, Mozambique, South Africa, and United Arab Emirates.

L3 – High risk countries currently defines as the Democratic Republic of Congo (DRC) and its nine adjoining countries (Angola, Burundi, Central African Republic, Republic of the Congo, Rwanda, South Sudan, Tanzania, Uganda, Zambia).

In addition, some of the listed smelters and refiners may have processed 3TG originating from recycled or scrap sources.