Development and Commercialization Agreement Sample Contracts

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Development and Commercialization Agreement • October 2nd, 2003 • Aderis Pharmaceuticals Inc • Pharmaceutical preparations • New York
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Samsung Bioepis, Merck in biosimilars deal
Development and Commercialization Agreement • August 4th, 2021
Navidea Enters Lymphoseek® Development and Commercialization Agreement for China
Development and Commercialization Agreement • October 19th, 2023

DUBLIN, Ohio--(BUSINESS WIRE)-- Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) has entered an exclusive agreement with a wholly-owned subsidiary of Hainan Sinotau Pharmaceutical Co., Ltd., a pharmaceutical organization with a broad China focus in oncology and other therapeutic areas, who will develop and commercialize Lymphoseek® (technetium Tc 99m tilmanocept) Injection in China. In exchange, Navidea will earn revenue based on unit sales to Sinotau, a royalty based on Sinotau’s sales of Lymphoseek and up to

Contract
Development and Commercialization Agreement • August 12th, 2019

Theravance Biopharma and Mylan Expand YUPELRI® (revefenacin) Development and Commercialization Agreement to Include China and Adjacent Territories

AMENDMENT TO DEVELOPMENT AND COMMERCIALIZATION AGREEMENT RELATING TO PHASE 3 CHF CLINICAL TRIAL
Development and Commercialization Agreement • November 2nd, 2015 • Mesoblast LTD • Biological products, (no disgnostic substances) • New York

This Amendment to Development and Commercialization Agreement relating to Phase 3 CHF Clinical Trial (this “Amendment”) is entered into as of the 24th day of September, 2013, by and between Mesoblast, Inc., as successor to Angioblast Systems, Inc. (“Mesoblast”), and Cephalon, Inc. (collectively with its Affiliates, “Cephalon,” and, together with Mesoblast, the “Parties” and, each, a “Party”).

DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Development and Commercialization Agreement • May 13th, 2013 • Epizyme, Inc. • Pharmaceutical preparations • New York

THIS DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (this “Agreement”) is effective as of February 28, 2013 (“Effective Date”), by and between Abbott Molecular Inc., a corporation organized under the laws of Delaware (“Abbott”), and Epizyme, Inc. (“Epizyme”), a corporation organized under the laws of Delaware.

SECOND AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION AGREEMENT between Swedish Orphan Biovitrum AB (publ) and Biogen Idec Hemophilia Inc. CONFIDENTIAL TREATMENT REQUESTED FOIA EXEMPTION CLAIMED AND PRIOR NOTIFICATION REQUESTED BEFORE ANY...
Development and Commercialization Agreement • December 20th, 2016 • Bioverativ Inc. • Pharmaceutical preparations • New York

THIS SECOND AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (the “Agreement”), dated as of April 10, 2014 (the “Effective Date”) is entered into between Swedish Orphan Biovitrum AB (publ), a Swedish corporation having a place of business at Tomtebodavägen 23A, Solna, Stockholm, SE-112 76, Sweden (“Sobi”) and Biogen Idec Hemophilia Inc., a Delaware corporation having a place of business at 14 Cambridge Center, Cambridge, MA 02142 USA (“Biogen Idec”). Each of Sobi and Biogen Idec shall be referred to herein as a “Party,” and collectively as the “Parties”.

DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Development and Commercialization Agreement • February 26th, 2021 • Theravance Biopharma, Inc. • Pharmaceutical preparations • New York

This Development and Commercialization Agreement ("Agreement") dated January 30, 2015 (the "Effective Date") is made by and between THERAVANCE BIOPHARMA R&D, INC., a Cayman Islands exempted company having its principal office at Ugland House, South Church Street, George Town, Grand Cayman, Cayman Islands E9 KY1-1104 ("THERAVANCE"), and MYLAN IRELAND LIMITED, a limited company organized and existing under the laws of Ireland with its offices at South Bank House, Barrow Street, 6th Floor, Dublin 4, Ireland ("MYLAN"). THERAVANCE and MYLAN may be referred to, individually, as a "Party" or, together, as the "Parties."

EX-10.2 3 a09-30855_1ex10d2.htm EX-10.2 Development and Commercialization Agreement between ImmuPharma (France) S.A. as “ImmuPharma” and Anesta AG as “Anesta” relating to Lupuzor ** Portions of the Exhibit have been omitted and have been filed...
Development and Commercialization Agreement • May 5th, 2020

THIS DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (this “Agreement” is made as of the Effective Date as defined hereinafter and is made

BACKGROUND
Development and Commercialization Agreement • January 8th, 2001 • Third Wave Technologies Inc /Wi • Biological products, (no disgnostic substances) • California
Biocon, Amylin to jointly develop diabetes drug
Development and Commercialization Agreement • May 29th, 2022
DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Development and Commercialization Agreement • September 21st, 2015 • Mesoblast LTD • Biological products, (no disgnostic substances) • New York

THIS DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (“Agreement”) dated as of December 7, 2010 (“Effective Date”), is entered into by and between Angioblast Systems Inc., a Delaware corporation having its principal place of business at 275 Madison Ave., 4th floor, New York, New York 10016 (“Angioblast”) and Cephalon, Inc., a Delaware corporation having its principal place of business at 41 Moores Road, Frazer, Pennsylvania 19355 (“Cephalon”).

CONFIDENTIAL TREATMENT REQUESTED Redacted Portions are indicated by [****] DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Development and Commercialization Agreement • May 18th, 2009 • La Jolla Pharmaceutical Co • Biological products, (no disgnostic substances) • California

THIS DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (“Agreement”) dated as of January 4, 2009 (“Effective Date”), is entered into between La Jolla Pharmaceutical Company, a Delaware corporation having its principal place of business at 6455 Nancy Ridge Drive, San Diego, California 92121 (“La Jolla”) and BioMarin CF Limited, an Irish corporation having its registered place of business at 2 Earlsfort Terrace, Dublin 2, Ireland (“BioMarin CF”).

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. AMENDED AND RESTATED DEVELOPMENT AND...
Development and Commercialization Agreement • February 29th, 2012 • Xenoport Inc • Pharmaceutical preparations • Delaware

* CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

AMENDMENT NO. 6 TO DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Development and Commercialization Agreement • April 14th, 2021 • Organon & Co. • Pharmaceutical preparations

This Amendment No. 6 to Development and Commercialization Agreement (this “Amendment No. 6”) is effective as of December 19, 2018 (the “Amendment Date”) and is entered into by and between:

AMENDMENT TO DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Development and Commercialization Agreement • December 22nd, 2008 • ProUroCare Medical Inc. • Surgical & medical instruments & apparatus

THIS AMENDMENT TO DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (this “Amendment”) is made as of the 19th day of December, 2008, by and between Artann Laboratories, Inc. (“Artann”), a New Jersey corporation and ProUroCare Medical, Inc. (“ProUroCare”), a Nevada corporation.

Contract
Development and Commercialization Agreement • April 19th, 2023 • VectivBio Holding AG • Biological products, (no disgnostic substances) • New York

[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) customarily and actually treated by the registrant as private or confidential.

FOURTH AMENDMENT TO DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Development and Commercialization Agreement • May 25th, 2012 • ProUroCare Medical Inc. • Surgical & medical instruments & apparatus

THIS FOURTH AMENDMENT TO DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (this “Fourth Amendment”) is made as of the 24th day of May, 2012, by and between Artann Laboratories, Inc. (“Artann”), a New Jersey corporation and ProUroCare Medical Inc. (“ProUroCare”), a Nevada corporation.

DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Development and Commercialization Agreement • February 11th, 2011 • Cephalon Inc • Pharmaceutical preparations • New York

THIS DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (“Agreement”) dated as of December 7, 2010 (“Effective Date”), is entered into by and between Angioblast Systems Inc., a Delaware corporation having its principal place of business at 275 Madison Ave., 4th floor, New York, New York 10016 (“Angioblast”) and Cephalon, Inc., a Delaware corporation having its principal place of business at 41 Moores Road, Frazer, Pennsylvania 19355 (“Cephalon”).

ARTICLE I DEFINITIONS
Development and Commercialization Agreement • November 12th, 2004 • Par Pharmaceutical Companies, Inc. • Pharmaceutical preparations • Delaware
AMENDMENT NO. 3 TO AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Development and Commercialization Agreement • August 9th, 2024 • Insulet Corp • Surgical & medical instruments & apparatus

This Amendment No. 3 to the Amended and Restated Development and Commercialization Agreement ("Amendment") is dated as of March 20, 2024 ("Effective Date"), by and between Insulet Corporation ("Insulet") and Abbott Diabetes Care Inc. ("ADC").

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BIOMARIN CF LIMITED Dominion House
Development and Commercialization Agreement • January 30th, 2009 • Biomarin Pharmaceutical Inc • Pharmaceutical preparations • California

BioMarin CF Limited, an Irish corporation (“BioMarin CF”), and La Jolla Pharmaceutical Company, a Delaware corporation (“La Jolla”), are parties to that certain Development and Commercialization Agreement (the “Development Agreement”) dated as of January 4, 2009 (as amended). BioMarin CF and La Jolla hereby delete the last sentence of Section 14.2.1 of the Development Agreement. Notwithstanding such amendment to the Development Agreement, BioMarin Pharmaceutical Inc., on behalf of itself and its Affiliates, shall vote or cause such Affiliates to vote any voting securities of La Jolla then held by it or them, as the case may be, on the record date applicable to any such specific vote referred to in the last sentence of Section 14.2.1 of the Development Agreement (after taking into account the provisions of this letter agreement) in favor of such proposal.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS ([***]), HAS BEEN OMITTED BECAUSE
Development and Commercialization Agreement • August 6th, 2021 • Pacific Biosciences of California, Inc. • Laboratory analytical instruments

This Amendment No. 1 to the Development and Commercialization Agreement (“Amendment”) amends the Development and Commercialization Agreement by and between Invitae Corporation, a Delaware corporation, having a place of business at 1400 16th St., San Francisco, CA 94103 (“Invitae”) and Pacific Biosciences of California, Inc., a Delaware corporation, having a place of business at 1305 O’Brien Dr., Menlo Park, CA 94025 (“PacBio”) effective January 12, 2021 (the “Agreement”). This Amendment shall be effective as of January 12, 2021 (the “Amendment Effective Date”)

AMENDMENT NO. 1 TO SECOND AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Development and Commercialization Agreement • October 21st, 2016 • Bioverativ Inc. • Pharmaceutical preparations

This Amendment No. 1 (this “Amendment”), dated August 13, 2014 (the “Amendment Effective Date”), to the Second Amended and Restated Development and Commercialization Agreement, dated April 10, 2014 (the “Agreement”), is entered into by and between Biogen Idec Hemophilia Inc., a Delaware corporation (“Biogen Idec”), and Swedish Orphan Biovitrum AB (publ), a Swedish corporation (“Sobi”). Unless otherwise defined herein, capitalized terms used herein shall have the respective meanings set forth in the Agreement and the Agreement shall be amended to incorporate any additional definitions provided for in this Amendment.

FIFTH AMENDMENT TO DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Development and Commercialization Agreement • November 16th, 2012 • ProUroCare Medical Inc. • Surgical & medical instruments & apparatus

THIS FIFTH AMENDMENT TO DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (this “Fifth Amendment”) is made as of the 27th day of October, 2012, by and between Artann Laboratories, Inc. (“Artann”), a New Jersey corporation and ProUroCare Medical Inc. (“ProUroCare”), a Nevada corporation.

DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Development and Commercialization Agreement • August 12th, 2014 • Idera Pharmaceuticals, Inc. • Biological products, (no disgnostic substances) • New York

THIS DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (this “Agreement”) is effective as of May 1, 2014 (“Effective Date”), by and between Abbott Molecular Inc., a corporation organized under the laws of Delaware (“Abbott”), and Idera Pharmaceuticals, Inc., a corporation organized under the laws of Delaware (“Idera”).

Novacea Contacts: Schering-Plough Contacts: Media: Paul Laland Mary-Frances Faraji
Development and Commercialization Agreement • May 30th, 2007 • Novacea Inc • Pharmaceutical preparations

SOUTH SAN FRANCISCO, CA and KENILWORTH, NJ — May 30, 2007—Novacea, Inc. (NASDAQ: NOVC) and Schering-Plough Corporation (NYSE: SGP) today announced that they have entered into an exclusive worldwide license agreement for the development and commercialization of Asentar™ (DN-101). Novacea is currently conducting a large international Phase 3 trial (ASCENT-2) evaluating Asentar in 900 patients with androgen-independent prostate cancer (AIPC). Asentar is a novel, proprietary, high-dose oral formulation of calcitriol, a potent hormone that exerts its effects through the vitamin D receptor (VDR).

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS ([***]), HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND
Development and Commercialization Agreement • February 26th, 2021 • Pacific Biosciences of California, Inc. • Laboratory analytical instruments • California

This DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (the “Agreement”), effective as of January 12, 2021 (the “Effective Date”), is made by and between Pacific Biosciences of California, Inc., a Delaware corporation, having a place of business at 1305 O’Brien Dr., Menlo Park, CA 94025 (“PacBio”) and Invitae Corporation, a Delaware corporation, having a place of business at 1400 16th St., San Francisco, CA 94103 (“Invitae” and, together with PacBio, the “Parties” and each, a “Party”).

AMENDMENT NO. 1 TO DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Development and Commercialization Agreement • April 14th, 2021 • Organon & Co. • Pharmaceutical preparations

This Amendment No. 1 to Development and Commercialization Agreement (this “Amendment”) is effective as of July 21, 2014 (the “Amendment Date”), and is entered into by and between SAMSUNG BIOEPIS CO., LTD., a corporation organized and existing under the laws of the Republic of Korea (“Samsung”) and MERCK SHARP & DOHME CORP., a corporation organized and existing under the laws of the State of New Jersey, USA (“Merck”).

Liver-targeted antisense therapy in Phase III development for the treatment of transthyretin amyloidosis, a systemic, progressive and fatal condition
Development and Commercialization Agreement • December 7th, 2021

AstraZeneca has entered into a new global development and commercialisation agreement with Ionis Pharmaceuticals, Inc. (Ionis) for eplontersen, formerly known as IONIS-TTR- LRX. Eplontersen is a ligand-conjugated antisense investigational medicine currently in Phase III clinical trials for amyloid transthyretin cardiomyopathy (ATTR-CM)

CONFIDENTIAL MATERIAL APPEARING IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION IN ACCORDANCE WITH THE SECURITIES ACT OF 1933, AS AMENDED, AND RULE 24B-2 PROMULGATED THEREUNDER. OMITTED INFORMATION...
Development and Commercialization Agreement • May 5th, 2011 • Cephalon Inc • Pharmaceutical preparations • New York

THIS DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (“Agreement”) dated as of December 7, 2010 (“Effective Date”), is entered into by and between Angioblast Systems Inc., a Delaware corporation having its principal place of business at 275 Madison Ave., 4th floor, New York, New York 10016 (“Angioblast”) and Cephalon, Inc., a Delaware corporation having its principal place of business at 41 Moores Road, Frazer, Pennsylvania 19355 (“Cephalon”).

Development and Commercialization Agreement By and between Combustion Technologies USA, LLC And AGE, Inc.
Development and Commercialization Agreement • October 24th, 2018 • Advance Green Energy Inc • Hazardous waste management • Florida

This Development and Commercialization Agreement (this "Agreement"), dated as of September 9, 2016 is being entered into by and between Combustion Technologies USA, LLC, a limited liability company incorporated under the laws of the State of Utah and having its principal office at 179 East Main Street, Suite B, Sandy, Utah 84070, ("CT"), and Advance Green Energy, Inc., a corporation organized and existing under the laws of the state of Florida and having its principal office at 2 North Broad Street, Brooksville, Florida 34601 ("AGE"). Each or both of CT and AGE are hereinafter referred to as "Party" or "Parties," as intended in the given context.

James E. Fickenscher/CFO William Q. Sargent Jr./ VP IR Auxilium Pharmaceuticals, Inc. Auxilium Pharmaceuticals, Inc.
Development and Commercialization Agreement • December 18th, 2008 • Auxilium Pharmaceuticals Inc • Pharmaceutical preparations

MALVERN, PA and New York, NY, (December 17, 2008)— Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) and Pfizer, Inc. (NYSE: PFE) announced today that they have entered into a strategic alliance for the development, commercialization and supply of XIAFLEX™ (clostridial collagenase for injection), a novel, first-in-class, late-stage biologic, for the treatment of Dupuytren’s contracture and Peyronie’s disease. Under the terms of the agreement, Pfizer will receive exclusive rights to commercialize XIAFLEX in the 27 member countries of the European Union (EU) and 19 other European and Eurasian countries. In addition, Pfizer will be primarily responsible for regulatory activities for XIAFLEX in these countries.

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