You are here: Agreements > Manufacturing Agreement > MANUFACTURING AND SUPPLY AGREEMENT

SITE SEARCH
AGREEMENTS / CONTRACTS
(optional)
(optional)
Try our advanced search >>
CLAUSES Search Contract Clauses >>
Browse Contract Clause Library>>

Manufacturing And Supply Agreement

Manufacturing Agreement

Legal Documents
You are currently viewing:

 This Manufacturing Agreement involves

BioMimetic Therapeutics, Inc | Novartis Vaccines and Diagnostics, Inc

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
 

Title: MANUFACTURING AND SUPPLY AGREEMENT
Governing Law: New York     Date: 3/12/2010
Industry: Biotechnology and Drugs     Sector: Healthcare

join now
50 of the Top 250 law firms use our Products every day

 

 

EXHIBIT 10.56

 

AMENDED AND RESTATED

 

MANUFACTURING AND SUPPLY AGREEMENT

 

This Amended and Restated Manufacturing And Supply Agreement ( “Agreement” ), effective as of 01 December, 2009 ( “Effective Date” ), is made by and between Novartis Vaccines and Diagnostics, Inc with its headquarters located at 350 Massachusetts Avenue, Cambridge, MA 02139 USA ( “Novartis” ), and BioMimetic Therapeutics, Inc., a Delaware corporation with its headquarters located at 389 Nichol Mill Lane, Franklin, Tennessee 37067 ( “BMTI” ).

 

BACKGROUND

 

BMTI and Chiron Corporation (“Chiron”) previously entered into an exclusive, Manufacturing and Supply Agreement effective July 28, 2004 (“Original Agreement”) .

 

On April 20, 2006, Novartis acquired Chiron and thereby assumed Chiron’s rights and responsibilities under the Original Agreement.  Under the Original Agreement Novartis has manufactured and supplied BMTI with a Product consisting of purified bulk recombinant human platelet derived growth factor (“PDGF”), as described in Novartis' FDA-approved Biological License Application therefor (“Novartis' BLA”), for use in the Exclusive Fields (as defined below).

 

The parties now wish to amend and restate the Original Agreement to better define the parties’ rights and obligations regarding the Product (as defined below).  The parties therefore hereby agree to the terms and conditions set forth herein, including the Exhibits, which are attached hereto and incorporated herein, by reference.

 

 In the event of any conflict between any Exhibit and this Agreement, this Agreement shall be controlling.

 

AGREEMENT

 

1.

Definitions.

 

For purposes of this Agreement, the following definitions shall apply, and the terms defined herein in plural shall include the singular and vice-versa.

 

 

1.1.

“Affiliate” means any corporation or other entity that controls, is controlled by or is under common control with Novartis or BMTI, as applicable, as of the Effective Date or during the term of this Agreement. “Control” means the ownership, directly or indirectly, of 50% or more of the voting stock of a corporate entity, or of 50% or more of the beneficial interest of an entity other than a corporation.

 

 

1.2.

“cGMPs” means t he then-current Good Manufacturing Practices   applicable to the manufacture, processing, packaging, testing and release of bulk pharmaceutical products for human use, established by regulatory authorities within any relevant jurisdiction of the European Union, United States and Canada.

 

 

1.3.

“Changed Services” has the meaning given in Section 2.3.

 

 

1.4.

“Novartis' BLA” has the meaning given in the second paragraph of the Background, above.

 

 

1.5.

“Claims” has the meaning given in Section 8.3.

 

 

1.6.

“Confidential Information” has the meaning given in Section 7.1.

 

 

1.7.

“Conforming” or “Conformity,” (a) in reference to Product, means Product that is shown to have been manufactured in accordance with applicable cGMPs and to meet the Specifications.

 

 

1.8.

“FDA” means the U.S. Food and Drug Administration.

 

** REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.


 

 

1.9.

“Facility” or “Facilities” means Novartis’, its Affiliate’s, or any Subcontractor’s licensed biological production facilities located in Vacaville, California.

 

1.10.

“Exclusive Field(s)” means the treatment of: (1) periodontal and dental diseases, (2) craniomaxillofacial applications and, (3) other skeletal applications including the healing of bone, cartilage, tendon and ligaments of the skeletal systems.  Field shall include treatments in humans and animals. For the avoidance of doubt, the Parties agree that the treatment of Parkinson disease and Huntington disease, and/or any other brain-related disease will be specifically excluded from the Exclusive Field(s).

 

1.11.

“Nonconforming” or “Nonconformity,” means Product that is shown not to be Conforming.

 

1.12.

“Notice Period” has the meaning given in Section 11.1.

 

1.13.

“Product” means Saccharomyces derived cGMP purified bulk recombinant human platelet derived growth factor, rhPDGF-BB, packaged in ** bottles containing approximately ** grams of rhPDGF-BB, as specified in Novartis' BLA.

 

1.14.

“Quality Agreement” has the meaning given in Section 6.8.

 

1.15.

“Registrations” shall mean any and all government approvals necessary for the import, storage or handling of the Product and the manufacturing, import, marketing, distribution and sale of the product containing the Product as labeled, packaged and presented for sale to the health care trade or any part of the manufacturing process.

 

1.16.

“Regulatory Authorities” shall mean any governmental authority in any country or group of countries competent to grant any Registrations.

 

1.17.

“Specifications” shall mean the specifications for the Product as set forth in the Quality Agreement which may only be amended upon mutual written agreement of the parties.

 

1.18.

“Subcontractor(s)” shall mean any Affiliates of Novartis and/or other third parties subcontracted by Novartis to perform part or all of its obligations hereunder.

 

1.19.

“Sublicensee(s)” shall mean any Affiliates of BMTI and/or other third parties sublicensed by BMTI to exercise part or all of its rights hereunder.

 

2.

Product Manufacture, Supply And Use.

 

2.1.

Product Supply And Purchase. During the term of this Agreement, and specifically limited to the use of the Product in the Exclusive Fields, Novartis shall manufacture exclusively for and supply exclusively to BMTI, and BMTI shall purchase exclusively from Novartis, Product for use in the Exclusive Fields.  For the avoidance of doubt, Novartis shall be entitled to manufacture and supply the Product to third parties for use in fields other than the Exclusive Fields.  Subject to Section 11.1, Novartis shall be entitled to subcontract or delegate all or any portion of its obligations hereunder to any Subcontractor. Novartis shall use its commercially reasonable efforts to ensure that any Subcontractor performs its obligations pursuant to the terms of this Agreement, and Novartis shall remain ultimately responsible for performance under this Agreement.

 

2.2.

Use Restrictions. BMTI understands and acknowledges that Novartis' rights to supply Product are derived in part from third-party licenses that restrict the uses of Product; accordingly, BMTI agrees not to use, sell, import, or sublicense Product, or to make, use, sell, import, or sublicense any product incorporating Product, other than in the Exclusive Fields.

 

2.3.

Changed Services. Changes to the Products and manufacturing may only be made in accordance with the Quality Agreement. Actual and direct costs incurred by a party as a result of changes will be allocated as follows:

 

2.3.1.

Novartis shall solely bear all actual and related costs resulting from:

 

** REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

2


 

2.3.1.1.

Changes requested by Novartis (on its own behalf or on behalf of any Subcontractor); and

 

2.3.1.2.

Changes requested or required by the Regulatory Authorities relating to the Facility, Process, or Product and all investments related to the establishment, maintenance and improvement of cGMP compliance shall be fully borne by Novartis; and

 

2.3.1.3.

Changes in the materials and/or Novartis of key components of the Product.

 

2.3.2.

BMTI shall solely bear all actual and related costs resulting from:

 

2.3.2.1.

Changes requested by BMTI;

 

2.3.2.2.

Changes requested or required by the Regulatory Authorities relating to the marketing of any BMTI product containing the Product (other than listed under Section 2.3.1.2 above);

 

2.3.2.3.

Changes in text of prescribing information (package insert) and labeling to the extent that this is relevant to this Agreement.

 

2.4.

BMTI Sublicensees . In the event that BMTI sublicenses any of its rights in the Exclusive Field to an Affiliate or third party BMTI shall ensure that such Sublicensee complies with the terms of this Agreement, to the extent that they apply and BMTI shall be responsible for any breach of this Agreement that is caused (directly or indirectly) by the performance (or failure to perform) of such Sublicensee.

 

2.5.

Novartis warrants that it holds and will continue to hold throughout the term of this Agreement all Registrations required by it in connection with its obligations under this Agreement.  Novartis warrants that it will not produce Product outside of the United States during the Term of this Agreement.  BMTI warrants that it or it’s Sublicensees holds and will continue to hold throughout the term of this Agreement all Registrations required by it in connection with any product containing the Product and/or its obligations under this Agreement.

 

3.

Forecasts, Purchase Orders And Shipment

 

3.1.

Forecast

 

3.1.1.

Subject to Section 3.2 below, upon execution of this Agreement, BMTI shall provide Novartis with a written non-binding ** (**) month, rolling forecast (“Forecast”) of the number of grams of Product that BMTI will require in each month of the ** (**) month period (the “Forecasted Requirements”) ,   and the requested delivery date(s). The Forecasted Requirements shall be in increments of ** grams per container.  With the exception of the first ** months of the Forecast which shall be binding, and subject to Section 3.1.2 below, such Forecasted Requirements shall be updated quarterly. BMTI will use all commercially reasonable efforts to provide accurate and consistent Forecasts, acting in good faith.

 

3.1.2.

The first ** months of the Forecast shall be binding upon the parties (“Binding Requirements”) and may not be changed without each party’s prior written consent. The ** up to and including the ** month of the Forecast shall be binding on the parties to the extent that BMTI may not increase or decrease the monthly requirements for Product by more than **% (in whole **-gram increments), without Novartis' prior written consent.

 

3.1.3.

At least ** (**) months prior to the date on which BMTI would like Product delivered, BMTI shall submit to Novartis a binding purchase order covering the Binding Requirements and, if desired, any additional Product (in **-gm/container increments) that BMTI would like to receive at that time (each, a “Purchase Order”). The Purchase Order shall specify the requested dates of delivery of the ordered Product. Novartis will acknowledge receipt, in writing, of all Purchase Orders received hereunder within ** days.

 

3.1.4.

Subject to compliance by BMTI with Section 3.1.1 Novartis will fill each properly-submitted Purchase Order, to the extent of the Binding Requirements, by the delivery date requested therein or another date mutually agreed upon by the parties, in writing. If BMTI agrees to delay a delivery date at Novartis’ request, with respect to the Binding Requirements such an agreement shall not be deemed a waiver of BMTI’s rights hereunder with respect to Novartis’ failure to meet the original delivery date. Novartis will use commercially reasonable efforts to supply any additional Product ordered but does not guarantee that such Product will be supplied.

 

** REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

3


 

3.2.

Minimum Shelf Life .  At the time of delivery to BMTI's designated carrier, Product shall have a remaining shelf life of not less than ** months unless otherwise agreed between the parties.

 

4.

Delivery, Inspection, Acceptance And Rejection Of Product.

 

4.1.

Delivery. Novartis shall make Product and related Deliverables available to BMTI's designated carrier on or before the delivery date set forth in the Purchase Order. All shipments shall be FCA (Incoterms 2000) the Facility, provided that the Facility is located in the United States.

 

4.2.

Acceptance And Rejection. BMTI shall have ** (**) business days from the date of receipt of the Product to determine whether it is Conforming.  BMTI shall promptly notify Novartis, in writing, of any Nonconforming Product and the specific reasons for such Nonconformity.  Failure to reject Product within such ** business days shall be deemed acceptance of the Product.

 

4.3.

Disputes Re Conformity. If BMTI notifies Novartis of any alleged Nonconformity of Product, the invoice for such Product shall not be due or payable until the Nonconformity issue is resolved, and BMTI has accepted such Product or replacement Product. The parties shall in good faith attempt to resolve the issue within ** (**) days of BMTI's notice, and if unable to do so, shall follow the Dispute Resolution process set forth in Section 14.9.

 

4.4.

Exclusive Remedy. If any  Products received by BMTI are Nonconforming, Novartis, shall replace the Nonconforming Product as soon as is reasonably commercially practicable, at no additional charge to BMTI if BMTI has already paid for the Nonconforming Product or in the event that BMTI has not paid the original invoice BMTI will be responsible for paying the invoice for the replacement Product. Such replacement shall be Novartis' sole liability and BMTI's sole remedy with respect to Nonconforming Product.

 

5.

Compensation.

 

5.1.

Product Pricing. BMTI will pay Novartis the amounts set forth in Annex 2, at the times specified therein and in accordance with the payment terms described in Section 6.6 of Annex 2.

 

5.2.

Taxes. Prices and fees do not include any national, state or local sales, use, value-added or other taxes, customs duties, or similar tariffs or fees that Novartis may be required to pay or collect upon the delivery of Product hereunder or upon collection of the prices and fees or otherwise. Should any tax or levy be made (other than any such tax based on the income of Novartis), BMTI agrees to pay such tax or levy and to indemnify Novartis for any claim for such tax or levy demanded, including applicable penalties and interest, other than to the extent (if any) due to Novartis' failure to comply with its obligations to collect or to remit such tax. BMTI agrees to provide Novartis with appropriate resale certificate numbers and other documentation satisfactory to the applicable taxing authorities to substantiate any claim of exemption from any such taxes or fees.

 

5.3.

Third Party Royalties. BMTI shall reimburse Novartis for all royalties that Novartis is required to pay to third parties, in order to manufacture and supply Product to BMTI, including the royalties described in Annex 2. If either party is put on notice by a third party of alleged infringement of the intellectual property rights of such third party by Novartis or any of its Subcontractors in the manufacture of Product, such party shall promptly inform the other party thereof. BMTI shall promptly resolve any matter relating to such alleged infringement that relates solely to Products supplied hereunder, and shall timely pay all amounts due resulting from or relating to the manufacture of Product supplied hereunder or the commercial sale of any product incorporating Product supplied hereunder.   These payments shall be in addition to the compensation payable to Novartis provided in Annex 2.  Notwithstanding the foregoing, Novartis shall be responsible for resolving any infringement issues that relate exclusively to the manufacturing methods used by Novartis to produce the Product and do not result from BMTI’s reformulation or configuration of the Product into BMTI products or the manner in which BMTI products are used.

 

** REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

4


 

5.4.

Payments. All payments shall be made in United States Dollars by wire transfer of immediately available funds to an account as specified by Novartis in writing from time to time. If any payment due hereunder is not paid in full on the due date, interest at the prime rate (as announced from time to time by Bank of America N.A.) plus two percent, or the maximum permitted by law, whichever is lower, shall accrue and become payable upon any unpaid balance from the date such payment was due until it is paid in full.

 

6.

Quality And Regulatory Matters.

 

6.1.

Novartis shall operate its facilities, process equipment, software and programs such as environmental monitoring, calibration, validation, compliance, cGMP training and maintenance in accordance with cGMPs, Novartis’ Standard Operating Procedures, Novartis’ applicable regulatory licenses and requirements, and the relevant terms of the Quality Agreement.

 

6.2.

Right to Review Processes. Novartis shall maintain all quality assurance manufacturing records, batch production records and other records directly related to Product manufactured in accordance with the Quality Agreement. The requirements for Inspections and Audits are defined in the Quality Agreement.  All information obtained by BMTI pursuant to this Section 6.2 shall be subject to the confidentiality provisions of Article 7.

 

6.3.

Product Complaints. Subject to Section 8.3 of this Agreement, BMTI shall be responsible for handling all complaints regarding products that incorporate the Product. Novartis will notify BMTI of any complaints it receives and will provide, at BMTI's expense, such assistance in investigating such complaints as provided in the Quality Agreement. Should such investigation show that the complaint was a result of Nonconforming Product manufactured under the control of Novartis  or any of its Subcontractors, then any expenses owed or paid by BMTI pursuant to this Section 6.3 for Novartis' assistance shall be cancelled or refunded to BMTI. The parties shall in good faith freely exchange information that will enable them to determine the nature and cause of such complaints. BMTI shall have the authority to resolve any outstanding complaints. BMTI shall promptly notify Novartis if such a complaint is based upon an alleged defect in the manufacture of Product.

 

6.4.

Recalls. The handling of recalls and withdrawals of products incorporating Product shall be governed by the terms of the Quality Agreement.  Where Novartis is deemed responsible pursuant to Section 4, Novartis will cooperate fully with BMTI in the event of any such recall or withdrawal and will provide such assistance in connection therewith as BMTI may reasonably request. Costs related to a Product recall or return will be borne by the party determined to be responsible for the costs of replacing the Product in accordance with Section 4.  

 

6.5.

Cross-Reference Rights. BMTI shall have the right to reference Novartis' BLA on the Product, (and manufacturing information submitted by Novartis to Regulatory Authorities in connection therewith), in their applications to Regulatory Authorities for investigational or marketing approval of any product containing Product for use within the Exclusive Field. Novartis shall be responsible for maintaining such Novartis BLA on the Product in good standing with regulatory Authorities, at no expense to BMTI. Any other work with respect to regulatory filings shall be subject to Section 2.3 (Changed Services).

 

6.6.

European Cross-Reference Rights. Novartis recognizes the critical importance of BMTI having access to an acceptable Drug Substance Master File covering the Product in the European Union.  Novartis will use its commercially reasonable endeavors to work with BMTI to prepare an acceptable Drug Substance Master File, at BMTI’s cost and expense and/or provide BMTI with reasonable information and documents that enable BMTI or its Sublicensees to obtain regulatory approval and continue selling products containing the Product in Europe.

 

6.7.

Environmental, Health and Safety.   Novartis shall comply with the Novartis Health, Safety and Environmental Protection Policy set forth in Annex 4 hereof.

 

6.8.

Quality Agreement. Concurrently herewith, the parties shall execute a Quality Agreement ( “Quality Agreement” ) to fulfill applicable legal and regulatory requirements.

 

** REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

5


 

6.9.

Trading Services Procedure. The parties agree to the terms and procedures set forth in the Trading Services Procedures, attached hereto as Annex 3.

 

7.

Confidential Information.

 

7.1.

Definition. During the term of this Agreement, the parties may provide to one another confidential information, including but not limited to each party's proprietary materials and/or technologies, economic information, business or research strategies, trade secrets and material embodiments thereof which may be disclosed by such party and/or its Affiliates to the other party and/or its Affiliates which (a) if in written form, is clearly marked “confidential,” (b) if in oral form, is summarized in writing and marked “confidential” delivered to the recipient within thirty (30) days after the oral disclosure, (c) if further disclosed, could reasonably be expected to result in competitive harm to the disclosing party, or (d) consists of or relates to any unpublished patent application (herein defined as “Confidential Information”).

 

7.2.

Exclusions. Confidential Information shall not include information that (a) is shown by contemporaneous documentation of the recipient to have been in its possession prior to receipt from the disclosing party, (b) is or becomes, through no fault of the recipient, publicly known, (c) is furnished to the recipient by a third party without breach of an obligation of confidentiality, (d) is independently developed by the recipient without use of the disclosing party's Confidential Information or (e) is required to be disclosed by law, provided that the recipient gives the disclosing party as much advance notice of the requirement as is reasonably possible.

 

7.3.

Obligations. During the term of this Agreement and for ** (**) years thereafter, the recipient shall maintain the disclosing party's Confidential Information in confidence, except that BMTI may disclose this Agreement in its entirety to parties evaluating a business relationship with BMTI, provided that such parties are under written obligations of confidentiality and non-use with respect to this Agreement at least as restrictive as those set forth herein with respect to Novartis' Confidential Information. The recipient shall use the disclosing party's Confidential Information solely to exercise its rights and perform its obligations under this Agreement, unless otherwise mutually agreed in writing, and shall at all times protect the disclosing party's Confidential Information with at least the same degree of care it uses to protect its own Confidential Information, such care to be of the type and degree that would be used by a reasonable and prudent business person. The recipient acknowledges that breach of confidentiality may result in irreparable financial harm to the disclosing party and that the disclosing party may seek all remedies in law or equity for such a breach.

 

7.4.

Return of Confidential Information. Upon request by the disclosing party, the recipient shall return or destroy (as evidenced by a written certificate of destruction) all Confidential Information of the disclosing party in its possession; provided, however, that one copy of such Confident


continue to document