Legal Agreed CMO Contract

Legal Agreed CMO Contract

This Contract Manufacturing Agreement (the Agreement) is entered into as of Day: Month: Year: (the Effective Date), by and between Company Name: , a legal entity organized as Corporation LLC, and Contract Manufacturer Name: , a legal entity organized as Corporation LLC. Each a Party and together the Parties.

RECITALS

WHEREAS, Sponsor develops, owns or licenses certain formulations and specifications for pharmaceutical or other products identified as Product(s) and desires a contract manufacturer to produce Product(s) under the terms set forth in this Agreement.

WHEREAS, Contract Manufacturer has represented that it is duly qualified, equipped and licensed to manufacture Product(s) in accordance with Sponsor specifications, applicable quality standards and applicable laws and regulations.

WHEREAS, the Parties desire to set forth their respective rights and obligations with respect to the manufacture, testing, release, delivery and quality oversight of Product(s).

NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, the Parties agree as follows:

1. Definitions

1.1 "Product(s)" means the pharmaceutical, biologic or other products to be manufactured by Contract Manufacturer pursuant to Purchase Orders and the Specifications incorporated herein. Specifications means the written manufacturing, packaging and testing requirements provided by Sponsor.

1.2 "cGMP" means current good manufacturing practices required by applicable law and regulation governing the manufacture of Product(s). "Release" means written authorization by Sponsor or Contract Manufacturer, as specified in Section 4, allowing shipment of Product(s).

2. Appointment and Scope of Services

2.1 Appointment. Sponsor hereby appoints Contract Manufacturer, and Contract Manufacturer accepts such appointment, to manufacture, package, test and supply Product(s) in accordance with the Specifications and the terms of this Agreement.

2.2 Purchase Orders. Manufacturing services shall be initiated by Sponsor's issuance of Purchase Orders specifying Product identity, quantity, delivery schedule and applicable Specifications. Each Purchase Order accepted in writing by Contract Manufacturer becomes a part of this Agreement.

3. Term and Termination

3.1 Term. The initial term of this Agreement shall commence on the Effective Date and continue for a period of years, unless earlier terminated in accordance with this Agreement.

3.2 Termination for Cause. Either Party may terminate this Agreement for material breach by the other Party, provided that the non-breaching Party gives written notice describing the breach and the breaching Party fails to cure within thirty (30) days after receipt of such notice, or such longer cure period as is reasonably necessary.

3.3 Termination for Convenience. Sponsor may terminate for convenience upon days prior written notice to Contract Manufacturer; Sponsor shall pay for all work in progress and non-cancellable obligations upon termination.

4. Manufacturing, Quality and Release

4.1 Manufacturing Standards. Contract Manufacturer shall perform services in accordance with the Specifications and applicable cGMP and industry standards and shall maintain records sufficient to demonstrate compliance.

4.2 Testing and Release. Product(s) shall be tested by Contract Manufacturer per the Specification. Release shall occur only upon written confirmation that Product(s) conform to Specification. Sponsor shall have the right to review test data and reject nonconforming Product(s).

4.3 Change Control. Any proposed change to Specifications, manufacturing process, facility or testing methods affecting Product quality shall be subject to Sponsor's prior written approval. Contract Manufacturer shall document change control and, if required, perform validation at its expense.

5. Price, Invoicing and Payment

5.1 Price. Sponsor shall pay Contract Manufacturer the fees set forth in each Purchase Order. Unit price (per batch or per unit): .

5.2 Payment Terms. Unless otherwise agreed in a Purchase Order, Contract Manufacturer shall invoice Sponsor upon shipment or release, and Sponsor shall pay invoices within days of invoice receipt. Overdue amounts accrue interest at the lesser of 1.5% per month or the maximum lawful rate.

6. Confidentiality

6.1 Confidential Information. Each Party acknowledges that the other may disclose confidential information, including Specifications and manufacturing data. Recipient shall protect Confidential Information with at least the same degree of care it uses to protect its own confidential materials, and in no event less than a reasonable degree of care.

6.2 Permitted Disclosures. Information may be disclosed to affiliates, subcontractors or regulatory authorities as reasonably required, provided that such recipients are bound by confidentiality obligations no less protective than this Agreement.

7. Intellectual Property

7.1 Ownership. Sponsor retains all right, title and interest in Sponsor's Intellectual Property, including Specifications and formulations. Contract Manufacturer shall acquire no rights in such Intellectual Property except the limited right to use it to perform the services.

7.2 Improvements. Any process improvements or inventions specifically developed by Contract Manufacturer in the performance of services that are solely directed to Sponsor's Product and paid for by Sponsor shall be assigned to Sponsor upon invention disclosure and necessary execution.

8. Warranties and Representations

8.1 Mutual Representations. Each Party represents that it has authority to enter into this Agreement and that the performance will not violate any applicable agreement or law.

8.2 Manufacturer Warranties. Contract Manufacturer warrants that Product(s) will be manufactured in accordance with the Specifications and cGMP and will conform to the quality standards set forth in the Specifications at the time of Release.

9. Indemnification

9.1 Indemnity by Sponsor. Sponsor shall indemnify, defend and hold Contract Manufacturer harmless from claims arising out of Sponsor's Specifications, Sponsor-supplied materials or Sponsor's negligence.

9.2 Indemnity by Manufacturer. Contract Manufacturer shall indemnify, defend and hold Sponsor harmless from claims arising out of Contract Manufacturer's breach of its warranties, negligence or willful misconduct in the manufacture of Product(s).

10. Limitation of Liability

Except for liability arising from willful misconduct, fraud or indemnification obligations for bodily injury or third-party claims, the Parties' aggregate liability under this Agreement shall be limited to direct damages up to the greater of (i) the total fees paid under the applicable Purchase Order in the twelve (12) months preceding the claim, or (ii) .

11. Insurance

Contract Manufacturer shall maintain insurance coverages customary for contract manufacturers, including general liability, product liability and professional liability, and shall provide certificates evidencing such coverage upon Sponsor's reasonable request. Minimum product liability coverage: .

12. Compliance with Laws

Each Party shall comply with all applicable laws, regulations and regulatory requirements applicable to its performance under this Agreement, including but not limited to those governing manufacturing, labeling, handling and transportation of Product(s).

13. Data Protection

Where personal data is processed in connection with this Agreement, the Parties shall comply with applicable data protection laws. The Parties shall implement and maintain appropriate technical and organizational measures to protect personal data against unauthorized processing.

14. Notices

All notices under this Agreement shall be in writing and delivered to the address of the Party set forth below or to such other address as either Party may notify the other in writing.

15. Assignment

Neither Party may assign this Agreement without the prior written consent of the other, except that Sponsor may assign to an affiliate or in connection with a sale of substantially all assets or stock provided the assignee assumes Sponsor's obligations hereunder.

16. Amendments; Waiver

Any amendment to this Agreement must be in writing and signed by authorized representatives of both Parties. Failure to enforce any provision shall not constitute a waiver of future enforcement.

17. Governing Law; Dispute Resolution

This Agreement shall be governed by and construed in accordance with the laws of the State or jurisdiction specified: , without regard to conflicts of law principles. The Parties shall attempt to resolve disputes in good faith before initiating litigation.

18. Entire Agreement; Severability

This Agreement, together with accepted Purchase Orders and exhibits, constitutes the entire agreement between the Parties with respect to the subject matter and supersedes all prior agreements. If any provision is found invalid or unenforceable, the remainder shall remain in full force and effect.

19. Counterparts; Execution

This Agreement may be executed in two or more counterparts, each of which shall be deemed an original but all of which together constitute one and the same instrument. Electronic or facsimile signatures shall have the same effect as originals.

20. Additional Provisions

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