Collaborations and other relationships	12 Months Ended
Jan. 02, 2022
Organization Consolidation And Presentation Of Financial Statements [Abstract]
Collaborations and other relationships	(13) Collaborations and other relationships In the normal course of business, the Company has entered into various collaboration arrangements which provide the Company with rights to develop, produce and market products using certain know-how, technology and patent rights maintained by the Company’s collaborative partners. The arrangements are often entered into in order to share risks and rewards related to a specific program or product. The Company’s collaborative arrangements include agreements with respect to transition services and a number of on-going relationships. Grifols / Novartis Vaccines and Diagnostics, Inc. In 1989, Ortho Diagnostics Systems Inc. (now Ortho U.S.) and Chiron Corporation (a predecessor in interest to Novartis Vaccines and Diagnostics, Inc. (“Novartis”) entered into a 50-year collaboration arrangement (the “Joint Business”) to pursue income generating opportunities through the development of certain intellectual properties (“IP”). In January 2014, Novartis transferred its interest in the Joint Business to Grifols Diagnostic Solutions, Inc. (“Grifols”). The transfer to Grifols has not altered the existing structure or operations of the Joint Business. The Company’s portion of the pre-tax net profit shared under the Joint Business was $57.4 million, $55.6 million and $70.7 million during the fiscal years ended January 2, 2022, January 3, 2021 and December 29, 2019, respectively. This includes the Company’s portion of the pre-tax net profit of $35.5 million, $32.7 million and $46.8 million during the fiscal years ended January 2, 2022, January 3, 2021 and December 29, 2019, respectively, on sales transactions with third parties where the Company is the principal. The Company recognized revenues, cost of revenue and operating expenses on a gross basis on these sales transactions in their respective lines in the consolidated statements of operations. This also includes revenue from collaboration and royalty agreements, which is presented on a net basis within Collaboration and other revenues, of $21.9 million, $22.9 million and $23.9 million during the fiscal years ended January 2, 2022, January 3, 2021 and December 29, 2019, respectively. Quotient limited In January 2015, the Company entered into an exclusive agreement with Quotient, a commercial-stage diagnostics company, to distribute and sell Quotient’s transfusion diagnostics platform MosaiQ™. Under the terms of a Distribution and Supply Agreement, Quotient is responsible for the development and launch of MosaiQ™, while the Company will leverage its worldwide commercial capabilities to sell the product to customers. The Company has exclusive rights to distribute MosaiQ™ for the global patient testing market (for blood grouping) and the donor testing market in the developing world and Japan (for blood grouping and serological disease screening). Quotient retains all rights to commercialize MosaiQ™ in the developed world (excluding Japan) for the donor testing market. On September 4, 2020, the Company and Quotient amended the supply agreement and entered into a binding letter agreement (the “Letter Agreement”). Pursuant to the Letter Agreement, the Company made an initial, non-refundable upfront payment of $7.5 million to Quotient on the date of the Letter Agreement, and recorded a corresponding $7.5 million charge to research and development expense for the fiscal year ended January 3, 2021. In addition to the initial $7.5 million upfront payment, Ortho may be required to make up to an additional $60 million of payments upon achievement of certain regulatory milestones and commercial sales benchmarks, which include up to $25 million of payments upon the achievement by Ortho of certain cumulative revenue milestones. The Company did not make any such payments in fiscal year 2021. In the Letter Agreement, the Company and Quotient have agreed that the Company will have the right to exclusively distribute in the United States, the European Economic Area, the UK and Switzerland a transfusion diagnostic patient immunohematology microarray (“PIM”), intended for use with Quotient’s MosaiQ Instruments, on which multiple compounds are placed which, when exposed to human blood samples, generate reactions that indicate the presence or absence of certain blood characteristics and antigens and is intended for immuno-hematological testing of the blood of medical patients during the course of their care or treatment. During the fiscal years ended January 2, 2022, January 3, 2021 and December 29, 2019 the Company recognized $0.2 million, $0.3 million, and $0.3 million in sales to Quotient. The Company also purchased inventories from Quotient amounting to $22.4 million, $21.1 million, and $20.3 million for the fiscal years ended January 2, 2022, January 3, 2021 and December 29, 2019, respectively. As of January 2, 2022 and January 3, 2021, Accounts payable included amounts related to purchases from Quotient of $4.1 million and $2.3 million, respectively. As of January 2, 2022 and January 3, 2021, Accounts receivable contained immaterial amounts related to sales to Quotient.

Collaborations and other relationships

12 Months Ended

Jan. 02, 2022

Organization Consolidation And Presentation Of Financial Statements [Abstract]

(13) Collaborations and other relationships

In the normal course of business, the Company has entered into various collaboration arrangements which provide the Company with rights to develop, produce and market products using certain know-how, technology and patent rights maintained by the Company’s collaborative partners. The arrangements are often entered into in order to share risks and rewards related to a specific program or product. The Company’s collaborative arrangements include agreements with respect to transition services and a number of on-going relationships.

Grifols / Novartis Vaccines and Diagnostics, Inc.

In 1989, Ortho Diagnostics Systems Inc. (now Ortho U.S.) and Chiron Corporation (a predecessor in interest to Novartis Vaccines and Diagnostics, Inc. (“Novartis”) entered into a 50-year collaboration arrangement (the “Joint Business”) to pursue income generating opportunities through the development of certain intellectual properties (“IP”). In January 2014, Novartis transferred its interest in the Joint Business to Grifols Diagnostic Solutions, Inc. (“Grifols”). The transfer to Grifols has not altered the existing structure or operations of the Joint Business.

The Company’s portion of the pre-tax net profit shared under the Joint Business was $57.4 million, $55.6 million and $70.7 million during the fiscal years ended January 2, 2022, January 3, 2021 and December 29, 2019, respectively. This includes the Company’s portion of the pre-tax net profit of $35.5 million, $32.7 million and $46.8 million during the fiscal years ended January 2, 2022, January 3, 2021 and December 29, 2019, respectively, on sales transactions with third parties where the Company is the principal. The Company recognized revenues, cost of revenue and operating expenses on a gross basis on these sales transactions in their respective lines in the consolidated statements of operations. This also includes revenue from collaboration and royalty agreements, which is presented on a net basis within Collaboration and other revenues, of $21.9 million, $22.9 million and $23.9 million during the fiscal years ended January 2, 2022, January 3, 2021 and December 29, 2019, respectively.

Quotient limited

In January 2015, the Company entered into an exclusive agreement with Quotient, a commercial-stage diagnostics company, to distribute and sell Quotient’s transfusion diagnostics platform MosaiQ™. Under the terms of a Distribution and Supply Agreement, Quotient is responsible for the development and launch of MosaiQ™, while the Company will leverage its worldwide commercial capabilities to sell the product to customers. The Company has exclusive rights to distribute MosaiQ™ for the global patient testing market (for blood grouping) and the donor testing market in the developing world and Japan (for blood grouping and serological disease screening). Quotient retains all rights to commercialize MosaiQ™ in the developed world (excluding Japan) for the donor testing market. On September 4, 2020, the Company and Quotient amended the supply agreement and entered into a binding letter agreement (the “Letter Agreement”).

Pursuant to the Letter Agreement, the Company made an initial, non-refundable upfront payment of $7.5 million to Quotient on the date of the Letter Agreement, and recorded a corresponding $7.5 million charge to research and development expense for the fiscal year ended January 3, 2021. In addition to the initial $7.5 million upfront payment, Ortho may be required to make up to an additional $60 million of payments upon achievement of certain regulatory milestones and commercial sales benchmarks, which include up to $25 million of payments upon the achievement by Ortho of certain cumulative revenue milestones. The Company did not make any such payments in fiscal year 2021.

In the Letter Agreement, the Company and Quotient have agreed that the Company will have the right to exclusively distribute in the United States, the European Economic Area, the UK and Switzerland a transfusion diagnostic patient immunohematology microarray (“PIM”), intended for use with Quotient’s MosaiQ Instruments, on which multiple compounds are placed which, when exposed to human blood samples, generate reactions that indicate the presence or absence of certain blood characteristics and antigens and is intended for immuno-hematological testing of the blood of medical patients during the course of their care or treatment.

During the fiscal years ended January 2, 2022, January 3, 2021 and December 29, 2019 the Company recognized $0.2 million, $0.3 million, and $0.3 million in sales to Quotient. The Company also purchased inventories from Quotient amounting to $22.4 million, $21.1 million, and $20.3 million for the fiscal years ended January 2, 2022, January 3, 2021 and December 29, 2019, respectively. As of January 2, 2022 and January 3, 2021, Accounts payable included amounts related to purchases from Quotient of $4.1 million and $2.3 million, respectively. As of January 2, 2022 and January 3, 2021, Accounts receivable contained immaterial amounts related to sales to Quotient.