Shuwen Biotech Announce Agreement with Devyser to Commercialize Breast Cancer Tests in China

On March 7, 2022 Shuwen Biotech, an integrated in vitro diagnostic company with focuses on breast cancer and reproductive health, reported that it has entered into a distribution agreement with Devyser Diagnostics AB, a Stockholm, Sweden-based diagnostic company, to market and support Devyser BRCA NGS and other oncology kits in China (Press release, Shuwen Biotech, MAR 7, 2022, View Source [SID1234609735]). Under the terms of the agreement, Shuwen will distribute the Devyser kits in China and also offer testing and NGS data analysis services with the Devyser kits in its CAP-accredited clinical labs in China.

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Devyser BRCA NGS is a CE-certified next-generation sequencing (NGS) library prep kit for fast and complete characterization of BRCA1 and BRCA2. The kit employs a unique single-tube approach which simplifies the workflow, reduces hands-on time and minimizes the risk of sample mix-up and contamination. The kit provides full and uniform coverage of BRCA1 and BRCA2, covering all exons and exon/intron junctions, and also allows downstream CNV analysis, thus enabling detection of point mutations, indels, and large rearrangements based on a single-tube reaction.

"We are pleased to add Devyser BRCA NGS and other oncology kits to our portfolio of cancer testing products. They further strengthen our leading position in breast cancer product and service offerings in China, which already feature MammaTyper and EndoPredict, and other tests for precision medicine in breast cancer," commented Jay Z. Zhang, Chairman and CEO of Shuwen Biotech.

Turning Point Therapeutics to Participate in 42nd Annual Cowen Healthcare Conference – Update

On March 7, 2022 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that due to a conference schedule change, the fireside chat with President and CEO Athena Countouriotis, M.D., will now take place on Tuesday, March 8 from 2:50 to 3:20 p.m. ET (Press release, Turning Point Therapeutics, MAR 7, 2022, View Source [SID1234609684]).

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The session will be accessible via webcast through the Investors page of www.tptherapeutics.com.

MARKER THERAPEUTICS TO PRESENT AT TWO UPCOMING MARCH INVESTOR CONFERENCES

On March 7, 2022 MARKER THERAPEUTICS, INC. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that Anthony H. Kim, Chief Financial Officer of Marker Therapeutics, will present at two upcoming investor conferences in March (Press release, Marker Therapeutics, MAR 7, 2022, View Source [SID1234609683]).

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Conference Details

ROTH Annual Conference
Fireside Chat
Date: Monday, March 14, 2022
Time: 11:00 a.m. ET

Oppenheimer Virtual Annual Healthcare Conference
Presentation
Date: Thursday, March 17, 2022
Time: 10:40 a.m. ET

Webcasts of the presentations will be accessible in the Investors section of the Company’s website at MARKERTHERAPEUTICS.COM and will be available for replay following the events.

Entry into a Material Definitive Agreement

On March 7, 2022, UroGen Pharma Ltd. (the "Company"), UroGen Pharma, Inc., as the borrower (the "Borrower"), and certain direct and indirect subsidiaries of the Company party thereto from time to time, as guarantors (the "Guarantors" and, collectively with the Company and Borrower, the "Credit Parties") reported that entered into a loan agreement (the "Loan Agreement") with BPCR Limited Partnership (as a "Lender"), BioPharma Credit Investments V (Master) LP (as a "Lender"), and BioPharma Credit PLC, as collateral agent for the Lenders (in such capacity, the "Collateral Agent), pursuant to which the Lenders agreed to make term loans to the Borrower in an aggregate principal amount of up to $100,000,000 (the "Term Loans") (Filing, 8-K, UroGen Pharma, MAR 7, 2022, View Source [SID1234609654]). The proceeds of the Term Loans will be used to fund the Credit Parties’ general corporate and working capital requirements.

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Pursuant to the terms of the Loan Agreement, the Term Loans will be advanced in two tranches. The first tranche (the "Tranche A Loan") is expected to be advanced in the amount of $75,000,000, 10 business days following the effective date of the Loan Agreement ("Tranche A Closing Date"), subject to entering into security agreement and delivery of other customary deliverables. The second tranche (the "Tranche B Loan") of $25,000,000 will be advanced at the Borrower’s election, subject to the customary bring down conditions and deliverables, and in no event later than December 31, 2022. The Term Loans will mature on the 5th year anniversary of the Tranche A Closing Date ("Maturity Date").

The Term Loans bear interest at 8.25% plus three-month LIBOR per annum with a LIBOR floor of 1.25%. In the event of the cessation of LIBOR, the benchmark governing the interest rate will be replaced with a rate based on the secured overnight financing rate published by the Federal Reserve Bank of New York as described in the Loan Agreement. Interest is payable quarterly in arrears. Repayment of outstanding principal of the Term Loans will be made in four equal quarterly payments of principal commencing after the 17th-quarter anniversary of the Tranche A Closing Date.

The Borrower will pay to the Lenders a funding fee equal to 1.75% of the Lenders’ total committed amount to fund the Tranche A Loan and Tranche B Loan, payable on the Tranche A Closing Date. The Borrower may elect to prepay the Term Loans in whole prior to the Maturity Date with such prepayments being subject to a prepayment premium equal to the principal amount so prepaid multiplied by 3% if made prior to the 3rd anniversary of the Tranche A Closing Date, 2% if made on or after the 3rd anniversary of the Tranche A Closing Date but prior to the 4th anniversary of the Tranche A Closing Date, and 1% if made on or after the 4th anniversary of the Tranche A Closing Date but prior to the Maturity Date. In addition to the prepayment premium, prepayments of the Tranche A Loan prior to the 2nd anniversary of the Tranche A Closing Date and prepayments of the Tranche B Loan prior to the 2nd anniversary of the Tranche B Closing Date are subject to a makewhole amount equal to the sum of all interest that would have accrued through such 2nd anniversary. If the Term Loans are accelerated following the occurrence of an event of default, the Borrower shall immediately pay to Lenders the sum of all obligations for principal, interest, and the applicable makewhole and prepayment premium. The Borrower is also required to prepay the Term Loans upon a change of control and prior to certain prepayments or redemptions of permitted convertible debt, subject to exceptions for refinancings and conversions or exchanges for equity.

The obligations of the Borrower under the Loan Agreement are guaranteed on a full and unconditional basis by the Company and the other Guarantor and are secured by substantially all of the respective Credit Parties’ tangible and intangible assets and property, including intellectual property, subject to certain exceptions.

The Loan Agreement contains customary affirmative and restrictive covenants and representations and warranties. The Credit Parties are bound by certain affirmative covenants setting forth actions that are required during the term of the Loan Agreement, including, without limitation, certain information delivery requirements, obligations to maintain certain insurance, and certain notice requirements. Additionally, the Credit Parties are bound by certain restrictive covenants setting forth actions that are not permitted to be taken during the term of the Loan Agreement without Lender’s prior written consent, including, without limitation, (i) selling or disposing of assets, including certain intellectual property, (ii) amending, modifying or waiving certain material agreements or organizational documents, (iii) consummating certain change in control transactions, (iv) incurring certain additional indebtedness, (v) incurring any non-permitted lien or other encumbrance on the Credit Parties’ assets, (vi) paying dividends or making any distribution or payment on or redeeming, retiring or purchasing any equity interests, and (vii) making payments of certain subordinated indebtedness. The Loan Agreement does not contain any financial covenants. The Loan Agreement also contains the following customary events of default: (i)the Borrower’s failure to pay principal, interest and other amounts when due, (ii) the Credit Parties’ breach of the covenants under the Loan Agreement, (iii) the occurrence of a material adverse change, (iv) certain attachments of the Credit Parties assets and restraints on their business, (v) certain bankruptcy or insolvency events, (vi) cross-default of third-party indebtedness, (vii) the failure by the Credit Parties to pay judgements rendered against them, (viii) material misrepresentations, (ix) the loan documents ceasing to create a valid security interest in a material portion of the Collateral, (x) the occurrence of certain ERISA events, and (xi) a material default or breach under any intercreditor or subordination agreement by any parties thereto. Upon the occurrence of an event of default, the Lenders may, among other things, accelerate the Borrower’s obligations under the Loan Agreement.

Entry into a Material Definitive Agreement

On March 7, 2022, Syros Pharmaceuticals, Inc. (the "Company") reported that it entered into a Master Collaboration Agreement and a project schedule (collectively, the "Agreement"), with QIAGEN Manchester Limited ("QIAGEN") (Filing, 8-K, Syros Pharmaceuticals, MAR 7, 2022, View Source [SID1234609627]). Pursuant to the Agreement, QIAGEN has agreed to develop and commercialize an assay as a companion diagnostic test to determine the expression level of the Company’s proprietary RARA biomarker for use with tamibarotene, a selective retinoic acid receptor alpha, or RARα, agonist, in newly diagnosed higher-risk MDS patients.

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Under the Agreement, QIAGEN is responsible for developing, and obtaining and maintaining regulatory approvals for the companion diagnostic test in the United States and, at the request of Syros and subject to the negotiation of mutually agreed payments, in the following additional markets: Canada, the United Kingdom, the member states of the European Economic Area, Switzerland, Mexico, Australia, Russia, Israel and Brazil (the "Additional Markets"). In addition, QIAGEN has agreed to use commercially reasonable efforts to manufacture the companion diagnostic test and, upon negotiation of mutually agreed terms, to make the companion diagnostic test commercially available in the United States, the Additional Markets and such other countries as the parties may mutually agree. QIAGEN has agreed to undertake specified actions to minimize the risk of an inability of supply occurring for the manufacture of the companion diagnostic test.

Subject to the terms of the Agreement and upon achievement of specified technical and development milestones, the Company is obligated to pay QIAGEN an amount up to a high single-digit million-dollar payment over the term of the initial project schedule in connection with developing and obtaining and maintaining regulatory approval for the companion diagnostic in the United States. In addition, the Company will reimburse QIAGEN for certain pass-through costs. These amounts are subject to adjustment if the parties determine that changes in the scope of the development program are required. In addition, QIAGEN will retain all proceeds from the commercialization of the companion diagnostic test. Syros has no financial obligations to QIAGEN under the Agreement on the commercialization of tamibarotene.

The initial term of the Agreement expires on the later to occur of (i) the fifth anniversary of the Agreement and (ii) the expiration or termination of all project schedules executed under the Agreement. Thereafter, the Agreement automatically renews for additional periods of one year. The Company may terminate the Agreement or a project schedule executed under the Agreement for convenience upon 90 day’s prior written notice to QIAGEN. Either party may terminate the Agreement or any project schedule executed under the Agreement, as applicable, upon a material breach of the other party that is not cured within 30 days after written notice of such breach, immediately upon the bankruptcy or insolvency of the other party, or in certain other circumstances described in the Agreement. In the event of a termination of the Agreement by the Company for reasons other than QIAGEN’s material breach or bankruptcy, the Company will be obligated to pay QIAGEN wind-down and other costs and other final payments.

The foregoing description of the material terms of the Agreement is qualified in its entirety by reference to the complete text of the Agreement, which the Company intends to file, with confidential terms redacted, with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022.