Manufacturing And Supply Agreement Sample Contracts

Vapotherm Inc – MANUFACTURING AND SUPPLY AGREEMENT DATED AS OF January 1, 2013 BETWEEN VAPOTHERM, INC. AND MEDICA, S.p.A. (October 19th, 2018)
Vapotherm Inc – MANUFACTURING AND SUPPLY AGREEMENT DATED AS OF January 1, 2013 BETWEEN VAPOTHERM, INC. AND MEDICA, S.p.A. (October 2nd, 2018)
Vapotherm Inc – First Amendment to the Manufacturing and Supply Agreement (October 2nd, 2018)
Osmotica Pharmaceuticals Ltd – This Exhibit Has Been Redacted and Is the Subject of a Confidential Treatment Request. Redacted Material Is Marked With [***] and Has Been Filed Separately With the Securities and Exchange Commission. Manufacturing and Supply Agreement (September 14th, 2018)

THIS MANUFACTURING AND SUPPLY AGREEMENT (the Agreement) is made and entered into this 8th day of March, 2010 (the Effective Date), by and between MIKART, INC. (Mikart) and VERTICAL PHARMACEUTICALS, INC. (Vertical). Mikart is a Georgia corporation with its principal place of business at 1750 Chattahoochee Avenue, Atlanta, Georgia 30318. Vertical is a New Jersey corporation with its principal place of business at 2400 Main Street, Suite 6, Sayerville, New Jersey 08872.

Columbia Laboratories, Inc. – Amendment No. 2 to Manufacturing and Supply Agreement (August 9th, 2018)

THIS AMENDMENT NO. 2 (this "Amendment") to the Manufacturing and Supply Agreement dated as of December 8, 2009 (as amended by an amendment agreement dated 31 December 2013) (the "Existing Agreement"), by and between Columbia Laboratories, (Bermuda) Ltd., a limited company existing and organised under the laws of Bermuda, having a place of business at Canon's Court, 22 Victoria Street, Hamilton HM12, Bermuda ("Columbia"), and Fleet Laboratories Limited, a limited private company existing and organised under the laws of England, having a place of business at 94 Rickmansworth Road, Watford Herts, WD18 7JJ, United Kingdom ("Fleet") is entered into on 2018 (the "Effective Date").

Amendment No. 2 to Manufacturing and Supply Agreement (August 2nd, 2018)

Amendment No. 2 to the Manufacturing and Supply Agreement, dated ___ April, 2018 (the "Amendment") between Nevro Corp. ("Nevro") and Nordson MEDICAL Design and Development, Inc., fka Vention Medical Design and Development, Inc. ("Nordson MEDICAL").

Establishment Labs Holdings Inc. – Manufacturing and Supply Agreement (July 17th, 2018)

This Manufacturing and Supply Agreement (this "Agreement") is entered into as of the Effective Date (as defined below) by and between (1) Apollo Endosurgery, Delaware corporation having offices at 1120 S Capital of Texas Highway #300, Austin, TX 78746 ("APOLLO"), and (2) Establishment Labs, S.A a corporation organized under the laws of Costa Rica and having a principal place of business at Coyol Free Zone, B15, Alajuela, 20113, Costa Rica ("ESTABLISHMENT"). APOLLO and ESTABLISHMENT shall hereinafter be individually referred to as a "Party" and collectively as the "Parties."

Establishment Labs Holdings Inc. – Manufacturing and Supply Agreement (July 13th, 2018)

This Manufacturing and Supply Agreement (this "Agreement") is entered into as of the Effective Date (as defined below) by and between (1) Apollo Endosurgery, Delaware corporation having offices at 1120 S Capital of Texas Highway #300, Austin, TX 78746 ("APOLLO"), and (2) Establishment Labs, S.A a corporation organized under the laws of Costa Rica and having a principal place of business at Coyol Free Zone, B15, Alajuela, 20113, Costa Rica ("ESTABLISHMENT"). APOLLO and ESTABLISHMENT shall hereinafter be individually referred to as a "Party" and collectively as the "Parties."

Establishment Labs Holdings Inc. – Manufacturing and Supply Agreement (June 21st, 2018)

This Manufacturing and Supply Agreement (this "Agreement") is entered into as of the Effective Date (as defined below) by and between (1) Apollo Endosurgery, Delaware corporation having offices at 1120 S Capital of Texas Highway #300, Austin, TX 78746 ("APOLLO"), and (2) Establishment Labs, S.A a corporation organized under the laws of Costa Rica and having a principal place of business at Coyol Free Zone, B15, Alajuela, 20113, Costa Rica ("ESTABLISHMENT"). APOLLO and ESTABLISHMENT shall hereinafter be individually referred to as a "Party" and collectively as the "Parties."

Osmotica Pharmaceuticals Ltd – This Exhibit Has Been Redacted and Is the Subject of a Confidential Treatment Request. Redacted Material Is Marked With [***] and Has Been Filed Separately With the Securities and Exchange Commission. Manufacturing and Supply Agreement (May 9th, 2018)

THIS MANUFACTURING AND SUPPLY AGREEMENT (the Agreement) is made and entered into this 8th day of March, 2010 (the Effective Date), by and between MIKART, INC. (Mikart) and VERTICAL PHARMACEUTICALS, INC. (Vertical). Mikart is a Georgia corporation with its principal place of business at 1750 Chattahoochee Avenue, Atlanta, Georgia 30318. Vertical is a New Jersey corporation with its principal place of business at 2400 Main Street, Suite 6, Sayerville, New Jersey 08872.

Amendment No. 1 Clinical and Commercial Manufacturing and Supply Agreement (May 8th, 2018)

This Amendment No. 1 ("Amendment No. 1") is entered into by JAZZ PHARMACEUTICALS IRELAND LIMITED ("JAZZ") and BAXTER ONCOLOGY GmbH ("Baxter") as of January 18, 2018 ("Amend No. 1 Effective Date").

Commercial Manufacturing and Supply Agreement (March 8th, 2018)

This Commercial Manufacturing and Supply Agreement (this "Agreement") is made effective as of the 22nd day of November, 2013 (the "Effective Date") by and between Baxter Pharmaceutical Solutions LLC, a Delaware limited liability company having a place of business at 927 South Curry Pike, Bloomington, Indiana 47403 ("Baxter"), and Dynavax Technologies Corporation, a Delaware corporation having a principal place of business at 2929 Seventh Street, Suite 100, Berkeley. California 94710 ("Dynavax").

Amendment #1 to Manufacturing and Supply Agreement (February 28th, 2018)

THIS AMENDMENT #1 TO MANUFACTURING AND SUPPLY AGREEMENT (this "Amendment #1") dated the 12th day of December, 2017 (the "Amendment #1 Effective Date") is made by and between Intercept Pharma Europe Ltd., having a location at 2 Pancras Square, Floor 1, London, United Kingdom N1C 4AG ("Intercept"), and PharmaZell GmbH, a corporation organized under the laws of Germany ("PharmaZell"). Intercept and PharmaZell are sometimes referred to herein individually as a "Party" and collectively as the "Parties."

Clinical and Commercial Manufacturing and Supply Agreement (February 27th, 2018)

THIS CLINICAL AND COMMERCIAL MANUFACTURING AND SUPPLY AGREEMENT (this "Agreement") is made effective as of the 22nd day of December, 2010 ("Effective Date") by and between BAXTER ONCOLOGY GmbH, with an address at Kantstrasse 2, 33790 Halle / Westphalia, Germany ("Baxter") and CELATOR PHARMACEUTICALS, INC., a Delaware corporation, having offices at 303B College Road East, Princeton, New Jersey 08540 ("Celator").

Manufacturing and Supply Agreement (February 23rd, 2018)

This MANUFACTURING AND SUPPLY AGREEMENT (this "Agreement") dated as of 20 October 2017 (the "Effective Date") is made by and between Insmed Incorporated, a Virginia corporation having its principal place of business at 10 Finderne Avenue, Building 10, Bridgewater, New Jersey 08807, USA ("Client"), and Patheon UK Limited, a company incorporated in England and Wales having its principal place of business at Kingfisher Drive, Covingham, Swindon, SN35BZ, United Kingdom ("Patheon"). Client and Patheon are sometimes referred to herein individually as a "Party" and collectively as the "Parties."

Biofrontera AG – Manufacturing and Supply Agreement (Projekt H 2000) (February 6th, 2018)

This Manufacturing and Supply Agreement (together with its Attachments, which are incorporated herein by reference, the "Agreement") is made on June 1st, 2015 (the "Effective Date") by and between Hapila GmbH, Otto-Schott-Strasse 9, 07552 Gera, Germany ("Hapila") and Biofrontera Pharma GmbH, HemmelratherWeg 201, D-51377 Leverkusen, Germany ("Biofrontera"). Hapila and Biofrontera are hereinafter also referred to individually as "Party" or collectively as "Parties".

Biofrontera AG – Manufacturing and Supply Agreement (Projekt H 2000) (January 12th, 2018)

This Manufacturing and Supply Agreement (together with its Attachments, which are incorporated herein by reference, the "Agreement") is made on June 1st, 2015 (the "Effective Date") by and between Hapila GmbH, Otto-Schott-Strasse 9, 07552 Gera, Germany ("Hapila") and Biofrontera Pharma GmbH, HemmelratherWeg 201, D-51377 Leverkusen, Germany ("Biofrontera"). Hapila and Biofrontera are hereinafter also referred to individually as "Party" or collectively as "Parties".

Isoray – Manufacturing and Supply Agreement (January 8th, 2018)

This Manufacturing and Supply Agreement (the "Agreement"), effective as of January 3, 2018 (the "Effective Date"), is made by and between IsoRay Medical, Inc., a Delaware corporation with offices at 350 Hills St., Suite 106, Richland, WA 99354 ("IsoRay"), and GT MEDICAL TECHNOLOGIES, INC., a Delaware corporation, having its principal place of business at 245 W 2nd St Mesa, AZ 85201 ("GT MED TECH"). IsoRay and GT MED TECH may be referred to herein individually as a "Party", and collectively as the "Parties".

Biofrontera AG – Manufacturing and Supply Agreement (Projekt H 2000) (December 22nd, 2017)

This Manufacturing and Supply Agreement (together with its Attachments, which are incorporated herein by reference, the "Agreement") is made on June 1st, 2015 (the "Effective Date") by and between Hapila GmbH, Otto-Schott-Strasse 9, 07552 Gera, Germany ("Hapila") and Biofrontera Pharma GmbH, HemmelratherWeg 201, D-51377 Leverkusen, Germany ("Biofrontera"). Hapila and Biofrontera are hereinafter also referred to individually as "Party" or collectively as "Parties".

Edge Therapeutics, Inc. – MANUFACTURING AND SUPPLY AGREEMENT BETWEEN EDGE THERAPEUTICS, INC. AND OAKWOOD LABORATORIES, L.L.C. June 30, 2017 (August 1st, 2017)

This MANUFACTURING AND SUPPLY AGREEMENT (this "Agreement"), dated as of June 30, 2017 (the "Effective Date"), is made by and between Edge Therapeutics, Inc., having a place of business at 300 Connell Drive, Suite 4000, Berkeley Heights, NJ 07922 ("Edge") and Oakwood Laboratories, L.L.C., a limited liability company organized and existing under the laws of Delaware having an address of 7670 First Place, Suite A, Oakwood Village, OH 44146 ("Oakwood"). Edge and Oakwood are sometimes referred to herein individually as a "Party" and collectively as the "Parties".

Amendment to Manufacturing and Supply Agreement (July 27th, 2017)

This Amendment to Manufacturing and Supply Agreement (this Amendment) is executed as of October 5, 2011 by and among Eli Lilly and Company (Lilly), Lilly Del Caribe, Inc. (Lilly Del Caribe), and United Therapeutics Corporation (United Therapeutics), and together, the Parties.

Second Amendment to Manufacturing and Supply Agreement (July 27th, 2017)

THIS SECOND AMENDMENT TO MANUFACTURING AND SUPPLY AGREEMENT (the Amendment) is made and entered into as of May 17, 2017 (the Execution Date), effective as of the Effective Date, by and among Eli Lilly and Company, an Indiana corporation, having its principal place of business at Lilly Corporate Center, Indianapolis, Indiana 46285, (Lilly), Lilly del Caribe, Inc., a Cayman Island corporation, having its principal place of business at Km 12.6 65th Infantry Avenue, Carolina, PR 00985 (Lilly del Caribe) and United Therapeutics Corporation, a Delaware corporation, having its principal place of business at 1040 Spring Street, Silver Spring, Maryland 20910 (United Therapeutics). Lilly, Lilly del Caribe and United Therapeutics are referred to individually as a Party and collectively as the Parties.

Kala Pharmaceuticals, Inc. – Confidential Materials Omitted and Filed Separately With the Securities and Exchange Commission. Double Asterisks Denote Omissions. MANUFACTURING AND SUPPLY AGREEMENT (June 23rd, 2017)

THIS MANUFACTURING AND SUPPLY AGREEMENT (Agreement), is effective on January 10th 2017 (the Effective Date), by and between KALA PHARMACEUTICALS, INC., a Delaware corporation with a principal place of business at 100 Beaver St., #201, Waltham, Massachusetts 02453, USA (Kala) and CHEMO IBERICA SA, a Spanish company with a principal place of business at Gran Via Carlos III, 98, Planta 7, 08028, Barcelona (Spain) (Supplier).

Airxpanders Inc – Manufacturing and Supply Agreement (June 16th, 2017)

This Manufacturing and Supply Agreement (the "Agreement") is entered into as of the 4th day of January, 2017, by and between Vention Medical Costa Rica, S.A. with its principal place of business at Zona Franca Metropolitana, Barreal de Heredia 201-3006, Heredia, Costa Rica, ("Supplier") and AirXpanders, Inc., a Delaware corporation having its principal place of business at 1047 Elwell Court, Palo Alto, CA, 94303 ("Customer").

Elite Pharmaceuticals, Inc. – Manufacturing and Supply Agreement (June 14th, 2017)

This MANUFACTURING AND SUPPLY AGREEMENT (this "Agreement") is made as of May _, 2011, (the "Effective Date") by and between Mikah Pharma, LLC, organized and existing under the laws of the State of Delaware, having offices at 20 Kilmer Drive, Hillsborough, New Jersey 08844, (referred to herein as "Mikah") and Epic Pharma, LLC, a company organized under the laws of Delaware having offices at 227-15 N. Conduit Avenue, Laurelton, NY 11413 (referred to herein as "Epic" or "Manufacturer"). Mikah and Epic are each a "Party" and together constitute the "Parties" to this agreement

Kala Pharmaceuticals, Inc. – Confidential Materials Omitted and Filed Separately With the Securities and Exchange Commission. Double Asterisks Denote Omissions. MANUFACTURING AND SUPPLY AGREEMENT (June 2nd, 2017)

THIS MANUFACTURING AND SUPPLY AGREEMENT (Agreement), is effective on January 10th 2017 (the Effective Date), by and between KALA PHARMACEUTICALS, INC., a Delaware corporation with a principal place of business at 100 Beaver St., #201, Waltham, Massachusetts 02453, USA (Kala) and CHEMO IBERICA SA, a Spanish company with a principal place of business at Gran Via Carlos III, 98, Planta 7, 08028, Barcelona (Spain) (Supplier).

Airxpanders Inc – Manufacturing and Supply Agreement (May 1st, 2017)

This Manufacturing and Supply Agreement (the Agreement) is entered into as of the 4th day of January, 2017, by and between Vention Medical Costa Rica, S.A. with its principal place of business at Zona Franca Metropolitana, Barreal de Heredia 201-3006, Heredia, Costa Rica, (Supplier) and AirXpanders, Inc., a Delaware corporation having its principal place of business at 1047 Elwell Court, Palo Alto, CA, 94303 (Customer).

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED MANUFACTURING AND SUPPLY AGREEMENT by and Between (April 5th, 2017)

WHEREAS, the Parties have entered into a license agreement for the PRODUCT (as defined below) dated February 13, 2017 (the License Agreement) under which ENDOCEUTICS granted the distribution rights of the PRODUCT to AMAG in the Territory (as defined below).

Omeros Corp. – Third Amendment to Pharmaceutical Manufacturing and Supply Agreement (March 16th, 2017)

This is an Amendment (this "Amendment") to the Pharmaceutical Manufacturing and Supply Agreement dated March 5, 2014, as previously amended July 7, 2015 and August 24, 2016 between DSM Pharmaceuticals, Inc. ("DSM") and Omeros Corporation ("Omeros") (the "Master Agreement"), and is entered into as of December 05, 2016 (the "Amendment Effective Date"). All initially capitalized terms in this Amendment shall have the same meaning as set forth in the Master Agreement unless otherwise defined herein.

Recro Pharma, Inc. – First Amendment to Development, Manufacturing and Supply Agreement (March 9th, 2017)

This First Amendment to Development, Manufacturing and Supply Agreement (this "Amendment") is made and entered into as of October 19, 2016 by and between Alkermes Pharma Ireland Limited, a private limited company organized and existing under the laws of the Republic of Ireland ("Alkermes"), and Recro Pharma, Inc., a corporation organized and existing under the laws of Pennsylvania ("Recro"), Recro and Alkermes are sometimes hereinafter referred to each as a "Party" and collectively as the 'Parties."

Recro Pharma, Inc. – Second Amendment to Development, Manufacturing and Supply Agreement (March 9th, 2017)

This Second Amendment to Development, Manufacturing and Supply Agreement (this "Second Amendment") is made and entered into as of February 1, 2017 by and between Alkermes Pharma Ireland Limited, a private limited company organized and existing under the laws of the Republic of Ireland ("Alkermes"), and Recro Pharma, Inc., a corporation organized and existing under the laws of Pennsylvania ("Recro"). Recro and Alkermes are sometimes hereinafter referred to each as a "Party" and collectively as the "Parties."

Manufacturing and Supply Agreement (February 28th, 2017)

This Manufacturing and Supply Agreement (this "Agreement") is effective as of December 15, 2015 (the "Effective Date") and is made by and between Clinical Micro Sensors, Inc. d.b.a. GenMark Diagnostics, Inc. ("GenMark"), a Delaware corporation with its principal place of business at 5964 La Place Court, Carlsbad, California 92008, and Plexus Corp. ("Plexus"), a Wisconsin corporation with its principal place of business at One Plexus Way, Neenah, Wisconsin 54956.

Bioverativ Inc. – MANUFACTURING AND SUPPLY AGREEMENT by and Between BIOGEN INC. And BIOVERATIV INC. Dated as of January 31, 2017 (February 2nd, 2017)

This Manufacturing and Supply Agreement (the Agreement) is made and entered into as of January 31, 2017, by and between Biogen Inc., a Delaware corporation (Biogen), and Bioverativ Inc., a Delaware corporation (Bioverativ). Each of the parties hereto are referred to collectively as the Parties and individually as a Party.

Elite Pharmaceuticals, Inc. – Manufacturing and Supply Agreement (November 17th, 2016)

This Manufacturing and Supply Agreement (the "Manufacturing Agreement ") is entered into as of the 23rd day of June, 2011 (the " Effective Date "), by and between ThePharmaNetwork, LLC, a New Jersey limited liability company and its wholly owned subsidiary, Ascend Laboratories, LLC (together "TPN"), and Elite Pharmaceuticals, Inc. and Elite Laboratories, Inc. (a subsidiary of Elite Pharmaceuticals, Inc.), both Delaware corporations ("ELITE").

Omeros Corp. – Second Amendment to Pharmaceutical Manufacturing and Supply Agreement (November 9th, 2016)

This is an Amendment (this "Amendment") to the Pharmaceutical Manufacturing and Supply Agreement dated March 5, 2014, as previously amended July 7, 2015 between DSM Pharmaceuticals, Inc. ("DSM") and Omeros Corporation ("Omeros") (the "Master Agreement"), and is entered into as of August 24, 2016 (the "Amendment Effective Date"). All initially capitalized terms in this Amendment shall have the same meaning as set forth in the Master Agreement unless otherwise defined herein.