Henlius and KG Bio Enter into Exclusive License Agreement for Henlius Novel Anti-PD-1 mAb HLX10

On September 30, 2019 Shanghai Henlius Biotech and PT Kalbe Genexine Biologics (hereinafter referred to "KG Bio"), a holding subsidiary to PT Kalbe Farma, an Indonesian pharmaceutical company, today entered into an Exclusive License Agreement for HLX10 – a recombinant humanized anti-programmed cell death (PD-1) monoclonal antibody (mAb) injection independently developed by Henlius (Press release, Shanghai Henlius Biotech, SEP 30, 2019, View Source [SID1234635133]). With the collaboration, KG Bio will be granted exclusive rights to develop and commercialize HLX10 in relation to (i) the first monotherapy for the treatment of solid tumour (MSI-high) (ii) the two combination therapies and (iii) two new indications KG Bio may in license in accordance with the Agreement in the Asia Pacific territory including the Philippines, Indonesia, Malaysia, Singapore, Thailand, Laos, Myanmar, Cambodia, Brunei and Vietnam. The estimated maximum payment may reach the total value of US$ 692 million including 1) non-creditable payment of US$10 million; 2) commercial sales milestone payments not exceeding US$650 million depending on the level of accumulative net sales of relevant products; 3) regulatory milestone payments not exceeding US$22 million; 4) US$10 million to fund the trials of two combination therapies to be initiated and performed by Henlius.

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Through the collaboration with KG Bio and Kalbe Farma, Henlius will strengthen its market access to Southeast Asia for HLX10 as a part of its international strategy through Kalbe Farma’s extensive sales networking in the market with the aim of sharpening its global competitiveness and brand awareness in the field of immuno-oncology. Moreover, the overall population of Southeast Asia hits 650 million, which translates into significant unmet needs. With the long-term commitment to "affordable innovation", through the collaboration, Henlius will also provide patients in Southeast Asia access to high-quality, affordable and novel biological therapies.

The collaboration also further strengthens the globalization of its immuno-oncology combination therapy in Southeast Asia. Although Anti-PD-1 mAb, as a broad-spectrum immunosuppressant, can be widely applied in the immunotherapy of cancer, it shows low efficacy as mono-therapy. Henlius thus adopts "Combo plus Global" strategy to differentiate its immuno-oncology combination therapy strategy with proprietary mAbs including HLX10 and HLX20 (anti-PD-L1 mAb) as backbones in combination with other therapies and with global multi-center clinical trials ongoing in various countries and regions worldwide.

Looking into the future, Henlius will proactively expand its global presence through continued strategic collaboration with international leading pharmaceutical companies, underscoring its mission to deliver quality products and effective treatment to patients worldwide.

Entry into a Material Definitive Agreement.

On September 30, 2019, Thermo Fisher Scientific Inc. (the "Company") reported that issued €800,000,000 aggregate principal amount of 0.125% Senior Notes due 2025 (the "2025 Notes"), €800,000,000 aggregate principal amount of 0.500% Senior Notes due 2028 (the "2028 Notes"), €900,000,000 aggregate principal amount of 0.875% Senior Notes due 2031 (the "2031 Notes"), €900,000,000 aggregate principal amount of 1.500% Senior Notes due 2039 (the "2039 Notes") and €1,000,000,000 aggregate principal amount of 1.875% Senior Notes due 2049 (the "2049 Notes", and, together with the 2025 Notes, 2028 Notes, 2031 Notes and 2039 Notes, the "Notes"), in a public offering (the "Euro Offering") pursuant to a registration statement on Form S-3 (File No. 333-229951), and a preliminary prospectus supplement and prospectus supplement related to the offering of the Notes, each as previously filed with the Securities and Exchange Commission (the "SEC") (Filing, 8-K, Thermo Fisher Scientific, SEP 30, 2019, View Source [SID1234551118]).

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On October 8, 2019, the Company plans to issue $900,000,000 aggregate principal amount of 2.600% Senior Notes due 2029 (the "USD Offering").

The Notes are subject to a Paying Agency Agreement (the "Paying Agency Agreement"), dated as of September 30, 2019, between the Company and The Bank of New York Mellon, London Branch, as paying agent. The Notes were issued under an indenture, dated as of November 20, 2009 (the "Base Indenture"), and the Eighteenth Supplemental Indenture, dated as of September 30, 2019 (the "Supplemental Indenture" and, together with the Base Indenture, the "Indenture"), between the Company, as issuer, and The Bank of New York Mellon Trust Company, N.A., as trustee. The sale of the Notes was made pursuant to the terms of an Underwriting Agreement, dated September 24, 2019 (the "Underwriting Agreement"), among the Company, as issuer, and Merrill Lynch International, Goldman Sachs & Co. LLC, Citigroup Global Markets Limited and J.P. Morgan Securities plc as lead managers of the several underwriters named in Schedule A to the Underwriting Agreement. The Underwriting Agreement was separately filed with the SEC on September 25, 2019 as Exhibit 1.1 to the Company’s Current Report on Form 8-K.

The 2025 Notes will mature on March 1, 2025, the 2028 Notes will mature on March 1, 2028, the 2031 Notes will mature on October 1, 2031, the 2039 Notes will mature on October 1, 2039 and the 2049 Notes will mature on October 1, 2049. Interest on the 2025 Notes and the 2028 Notes will be paid annually in arrears on March 1 of each year, beginning on March 1, 2020, and interest on the 2031 Notes, the 2039 Notes and the 2049 Notes will be paid annually in arrears on October 1 of each year, beginning on October 1, 2020.

Prior to February 1, 2025, in the case of the 2025 Notes (one month prior to their maturity), December 1, 2027, in the case of the 2028 Notes (three months prior to their maturity), July 1, 2031, in the case of the 2031 Notes (three months prior to their maturity), April 1, 2039, in the case of the 2039 Notes (six months prior to their maturity), and April 1, 2049, in the case of the 2049 Notes (six months prior to their maturity) (each such date, a "Par Call Date"), the Company may redeem the Notes of any series, in whole at any time or in part from time to time, at a redemption price equal to the greater of (1) 100% of the principal amount of the notes to be redeemed and (2) the sum of the present values of the remaining scheduled payments of principal and interest in respect of the notes being redeemed (not including any portion of the payments of interest accrued but unpaid as of the date of redemption and assuming that such notes to be redeemed matured on their applicable Par Call Date), discounted to the date of redemption on an annual basis (ACTUAL/ACTUAL (ICMA)), using a discount rate equal to the Comparable Bond Rate (as defined in the Indenture) plus 20 basis points, in the case of the 2025 Notes, 20 basis points, in the case of the 2028 Notes, 25 basis points, in the case of the 2031 Notes, 30 basis points, in the case of the 2039 Notes, and 35 basis points, in the case of the 2049 Notes, plus, in each case, accrued and unpaid interest on the Notes being redeemed, if any, to, but excluding, the date of redemption.

In addition, on and after the applicable Par Call Date, the Company may redeem some or all of the Notes at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding the date of redemption.

Upon the occurrence of a change of control (as defined in the Indenture) of the Company and a contemporaneous downgrade of the Notes below an investment grade rating by at least two of Moody’s Investors Service, Inc., S&P Global Ratings, a division of S&P Global, Inc., and Fitch Ratings Limited, the Company will, in certain circumstances, be required to make an offer to purchase the Notes at a price equal to 101% of the principal amount of the Notes, plus any accrued and unpaid interest, if any, to, but excluding, the date of repurchase.

The Notes are general unsecured obligations of the Company. The Notes rank equally in right of payment with existing and any future unsecured and unsubordinated indebtedness of the Company, including any debt securities issued in the USD Offering, and will rank senior in right of payment to

any existing and future indebtedness of the Company that is subordinated to the Notes. The Notes are also effectively subordinated to any existing and future secured indebtedness of the Company to the extent of the assets securing such indebtedness, and are structurally subordinated to all existing and any future indebtedness and any other liabilities of its subsidiaries.

The Indenture contains limited affirmative and negative covenants of the Company. The negative covenants restrict the ability of the Company and its subsidiaries to incur debt secured by liens on Principal Properties (as defined in the Indenture) or on shares of stock of the Company’s Principal Subsidiaries (as defined in the Indenture) and engage in sale and lease-back transactions with respect to any Principal Property. The Indenture also limits the ability of the Company to merge or consolidate or sell all or substantially all of its assets.

Upon the occurrence of an event of default under the Indenture, which includes payment defaults, defaults in the performance of affirmative and negative covenants, bankruptcy and insolvency related defaults and failure to pay certain indebtedness, the obligations of the Company under the Notes may be accelerated, in which case the entire principal amount of the Notes would be immediately due and payable.

The Company expects that the net proceeds will be approximately €4.33 billion from the Euro Offering and $890.68 million from the USD Offering, each after deducting underwriting discounts and estimated offering expenses. The Company intends to use the net proceeds of the offerings (together with cash on hand) to repay commercial paper issued to fund the redemption on September 27, 2019 of $300 million aggregate principal amount of 4.70% Senior Notes due 2020 and $800 million aggregate principal amount of 3.15% Senior Notes due 2023, and to fund the redemption of approximately $4.5 billion aggregate principal amount of outstanding senior notes issued by the Company or its subsidiaries, including all of the outstanding 6.00% Senior Notes due 2020 and 5.00% Senior Notes due 2021 issued by its subsidiary Life Technologies Corporation, of which notice was provided to holders on September 25, 2019, and all of the October 15 Redeemed Notes (as defined below).

Wilmer Cutler Pickering Hale and Dorr LLP, U.S. counsel to the Company, has issued an opinion to the Company, dated September 30, 2019, regarding the Notes. A copy of this opinion is filed as Exhibit 5.1 hereto.

The foregoing description of certain of the terms of the Indenture does not purport to be complete and is qualified in its entirety by reference to the full text of each of the Base Indenture and the Supplemental Indenture, which are filed with this report as Exhibits 4.1 and 4.2 hereto, respectively. Each of the foregoing documents is incorporated herein by reference.

Entry into a Material Definitive Agreement.

On September 30, 2019, Cardinal Health Funding, LLC ("CHFunding"), an indirectly owned receivables financing subsidiary of Cardinal Health, Inc. (the "Company"), Griffin Capital, LLC, an indirectly owned receivables financing subsidiary of the Company, Wells Fargo Bank, N.A., Liberty Street Funding LLC, The Bank of Nova Scotia, Atlantic Asset Securitization LLC, Credit Agricole Corporate and Investment Bank New York Branch, U.S. Bank National Association, PNC Bank, National Association, Victory Receivables Corporation and MUFG Bank, Ltd. ("MUFG Bank"), entered into a Fourth Amendment and Joinder (the "RPA Amendment") to the Fourth Amended and Restated Receivables Purchase Agreement (as amended, the "Receivables Purchase Agreement") (Filing, 8-K, Cardinal Health, SEP 30, 2019, View Source [SID1234540011]). The RPA Amendment extends the term of the Company’s $1.0 billion committed receivables sales facility program until September 30, 2022. The RPA Amendment is filed as Exhibit 10.1 to this Current Report on Form 8-K and the foregoing description is qualified by reference to the full text of the RPA Amendment set forth in Exhibit 10.1.

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In connection with the RPA Amendment, the Company, CHFunding and MUFG Bank entered into Amendment No. 3 to Seventh Amended and Restated Performance Guaranty (the "Guaranty Amendment"), which requires the Company to maintain a maximum Consolidated Net Leverage Ratio at the end of every fiscal quarter from September 2019 through December 2020 of no greater than 4.00-to-1.00. The maximum ratio permitted at the end of any fiscal quarter will reduce to 3.75-to-1.00 in March 2021. The Guaranty Amendment is filed as Exhibit 10.2 to this Current Report on Form 8-K and the foregoing description is qualified by reference to the full text to the Guaranty Amendment set forth in Exhibit 10.2.

From time to time, the financial institutions party to the Receivables Purchase Agreement or their affiliates have performed, and may in the future perform, various commercial banking, investment banking and other financial advisory services for the Company, for which they receive customary fees and expenses. Wells Fargo Bank, N.A. serves as a dealer under the Company’s commercial paper program. In addition, MUFG Bank, Wells Fargo Bank, N.A., The Bank of Nova Scotia, PNC Bank, National Association, Credit Agricole Corporate and Investment Bank and U.S. Bank National Association or their affiliates currently act as members of the lending syndicate under the Company’s revolving credit facility.

Sangamo Therapeutics Appoints Bettina M. Cockroft, MD, MBA, as Senior Vice President and Chief Medical Officer

On September 30, 2019 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported the appointment of Bettina M. Cockroft, MD, MBA, as Senior Vice President and Chief Medical Officer (Press release, Sangamo Therapeutics, SEP 30, 2019, View Source [SID1234539988]). Dr. Cockroft will oversee all clinical development activities and operations and will report to the Executive Vice President of Research and Development.

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"Bettina brings over 20 years of clinical development experience, having worked across multiple therapeutic areas and leading programs in several countries," said Adrian Woolfson, BM., B.Ch., Ph.D., Executive Vice President, Research and Development. "This is an important time to welcome Bettina to Sangamo, as we expect a steady flow of readouts from our ongoing clinical trials and expect to initiate additional trials in the coming year. We look forward to Bettina’s contributions and believe she will be a key player in helping us realize our mission of translating our groundbreaking science into genomic medicines that transform patients’ lives."

Dr. Cockroft has 23 years of experience in the biopharmaceutical industry and joins Sangamo from Cytokinetics, Inc., where she was a member of the senior leadership team responsible for clinical development of fast skeletal muscle troponin activators in diseases such as Amyotrophic Lateral Sclerosis and Spinal Muscular Atrophy. Before that, Dr. Cockroft served as Chief Medical Officer of Auris Medical AG, where she led and grew the clinical development team responsible for two Phase 3 programs. Dr. Cockroft also held roles of increasing responsibility at Merck Serono S.A., Novartis Consumer Health and Menarini Ricerche earlier in her career.

Dr. Cockroft earned her MBA at MIT Sloan School of Management and her MD from the University of Genoa.

Celldex Therapeutics to Present at the Cantor Global Healthcare Conference

On September 30, 2019 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported that Anthony Marucci, Co-founder, President and Chief Executive Officer, and Tibor Keler, PhD, Cofounder, Executive Vice President and Chief Scientific Officer, will present a corporate overview at the Cantor Global Healthcare Conference on Friday, October 4, 2019 at 10:40 a.m. EDT in New York (Press release, Celldex Therapeutics, SEP 30, 2019, View Source [SID1234539983]).

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The live webcast will be available on the "Events & Presentations" page of the "Investors & Media" section of the Celldex website. A replay will be available for seven days following the event.