CONFIDENTIALTREATMENT REQUESTED FOR BRACKETED ITEMS CompanyPlasmid DNA Production Agreement

 

AFFILIATE of a party hereto shall mean any entity that controls or is controlled by such party, or is under common control with such party. For purposes of this definition, an entity shall be deemed to control another entity if it is able, directly or indirectly, to direct or cause the direction of the management and policies of an entity (other than a natural person), whether through the majority ownership of voting capital stock, by contract or otherwise.

 

ALTHEA SOPs shall mean ALTHEA’s Standard Operating Procedures, which will be customized on a product specific basis, as necessary, for manufacture of Company Plasmid DNA. CLIENT will review and approve each product specific SOP prior to production of Company Plasmid DNA and any subsequent revisions to these SOPs.

 

BATCH shall mean a specific quantity of Company Plasmid DNA mutually agreed upon between CLIENT and ALTHEA, and that (a) is intended to have uniform character and quality within specified limits, and (b) is produced according to a single manufacturing order during the same cycle of manufacture.

(iii) 

is or becomes part of the public domain through no fault of the recipient;

EMEA shall mean the European Medicines Agency or any successor entity thereto.

 

Foreign Corrupt Practices Act. CLIENT acknowledges that it is not the agent of ALTHEA and represents and warrants that it has not, and covenants that it will not, pay anything of value to any government employee in connection with the resale of the Product.

 

Deposits and Payment for Company Plasmid DNA Production: Pursuant to the execution of this Agreement, and the Project Plan and subject to performance of a satisfactory preliminary audit by CLIENT, CLIENT shall pay ALTHEA [***] described in the Project Plan as a pre-payment. Thereafter, ALTHEA will invoice CLIENT upon completion of each project activity as outlined in Project Plan. CLIENT shall pay all invoices [***]. Any payment due under this Agreement not received within the times noted above shall bear interest at the lesser of (a) the maximum rate permitted by law, and (b) [***].

Returns: Company Plasmid DNA returned by third parties is the responsibility of CLIENT.

 

Non-Conforming Company Plasmid DNA: Upon ALTHEA’s release of either a GMP or non-GMP batch of Company Plasmid DNA, ALTHEA shall provide CLIENT, or CLIENT’s designee, copies of Master Batch records, test results and a Certificate of Analysis, if appropriate to the batch, stating the test results from the quality control assay performed by ALTHEA. Within thirty (30) calendar days after receipt by CLIENT of the documentation, CLIENT shall determine whether Company Plasmid DNA conforms to Specifications and has been manufactured in accordance with the Master Batch Record, ALTHEA’s current SOPs, and the Proposal.

 

Existing Intellectual Property: Except as the parties may otherwise expressly agree in writing, each party shall continue to own its existing patents, trademarks, copyrights, trade secrets and other intellectual property, without conferring any interests therein on the other party. Without limiting the generality of the preceding sentence, CLIENT shall retain all right, title and interest arising under the United States Patent Act, the United States Trademark Act, the United States Copyright Act and all other applicable laws, rules and regulations in and to all Drug Products, Bulk Drug Substance, Labeling and trademarks associated therewith (collectively, “CLIENT’s Intellectual Property”). Neither ALTHEA nor any third party shall acquire any right, title or interest in CLIENT’s Intellectual Property by virtue of this Agreement or otherwise, except to the extent expressly provided herein.

 

Individually Owned Inventions: Except as the parties may otherwise agree in writing, all Inventions (as defined herein) which are conceived, reduced to practice, or created by a party in the course of performing its obligations under this Agreement shall be solely owned and subject to use and exploitation by the inventing party without a duty to account to the other party. For purposes of this Agreement, “Invention” shall mean information relating to any innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on which contained and whether or not patentable or copyrightable.

 

Jointly Owned Inventions: All Inventions which are conceived, reduced to practice, or created jointly by the parties and/or their respective agents (i.e., employees or agents who would be or are properly named as co-inventors under the laws of the United States on any patent application claiming such inventions) in the course of the performance of this Agreement shall be owned jointly by the parties. Each party shall have full rights to exploit such Inventions for its own commercial purposes without any obligation to the other. The parties shall share equally in the cost of mutually agreed patent filings with respect to all such jointly owned Inventions. The decision to file for patent coverage on jointly owned Inventions shall be mutually agreed upon, and the Parties shall select a mutually acceptable patent counsel to file and prosecute patent applications based on such joint Inventions.

 

Disclaimer: Except as otherwise expressly provided herein, nothing contained in this Agreement shall be construed or interpreted, either expressly or by implication, estoppel or otherwise, as: (i) a grant, transfer or other conveyance by either party to the other of any right, title, license or other interest of any kind in any of its Inventions or other intellectual property, (ii) creating an obligation on the part of either party to make any such grant, transfer or other conveyance or (iii) requiring either party to participate with the other party in any cooperative development program or project of any kind or to continue with any such program or project.

 

Rights in IP: The party owning any IP shall have the world wide right to control the drafting, filing, prosecution and maintenance of patents covering the Inventions relating to such IP, including decisions about the countries in which to file patent applications. Patent costs associated with the patent activities described in this Section shall be borne by the sole owner. Each party will cooperate with the other party in the filing and prosecution of patent applications. Such cooperation will include, but not be limited to, furnishing supporting data and affidavits for the prosecution of patent applications and completing and signing forms needed for the prosecution, assignment and maintenance of patent applications.

 

Confidentiality of IP: IP shall be deemed to be the Confidential Information of the party owning such IP. The protection of each party’s Confidential Information is described in Article 9. Any disclosure of information by one party to the other under the provisions of this Section 10 shall be treated as the disclosing party’s Confidential Information under this Agreement. It shall be the responsibility of the party preparing a patent application to obtain the written permission of the other party to use or disclose the other party’s Confidential Information in the patent application before the application is filed and for other disclosures made during the prosecution of the patent application.

 

Mutual Representations: Each party hereby represents and warrants to the other party that (a) the person executing this Agreement is authorized to execute this Agreement; (b) this Agreement is legal and valid and the obligations binding upon such party are enforceable by their terms; and (c) the execution, delivery and performance of this Agreement does not conflict with any agreement, instrument or understanding, oral or written, to which such party may be bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.

 

ALTHEA Warranty: ALTHEA represents and warrants that a) Company Plasmid DNA shall be Produced in accordance with cGMP. ALTHEA represents and warrants that it has obtained (or will obtain prior to Producing Company Plasmid DNA), and will remain in compliance with during the term of this Agreement, all permits, licenses and other authorizations (the “Permits”) which are required under federal, state and local laws, rules and regulations applicable to the Production only of Company Plasmid DNA as specified in the Project Plan; provided, however, ALTHEA shall have no obligation to obtain Permits relating to the sale, marketing, distribution or use of Company Plasmid DNA or with respect to the Labeling of Company Plasmid DNA. ALTHEA makes no representation or warranty with respect to the sale, marketing, distribution or use of the product or as to printed materials supplied by CLIENT or its consignee; b) it has the right to implement the Production Process and that it has no knowledge of any patents or other intellectual rights that would be infringed by Production of Company Plasmid DNA under this Agreement, or proprietary rights of third parties which are violated by ALTHEA’s performance of the Production Process; c) It has know-how, required expertise, experience, has reviewed the product and believes it is able to meet specifications and supply it in accordance with time table specified in the Proposal.

 

Disclaimer of Warranties: Except for those warranties set forth in Sections 11.1 and 11.2 of this Agreement, ALTHEA makes no warranties, written, oral, express or implied, with respect to Company Plasmid DNA or the Development and Production of Company Plasmid DNA. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT HEREBY ARE DISCLAIMED BY ALTHEA. NO WARRANTIES OF ALTHEA MAY BE CHANGED BY ANY REPRESENTATIVES OF ALTHEA. CLIENT accepts Company Plasmid DNA subject to the terms hereof.

 

CLIENT Warranties: CLIENT warrants that (a) it has the right to give ALTHEA any information provided by CLIENT hereunder, and that ALTHEA has the right to use such information for the Production of Company Plasmid DNA, and (b) CLIENT has no knowledge of any (i) patents or other intellectual rights that would be infringed by ALTHEA’s Production of Company Plasmid DNA under this Agreement, or (ii) proprietary rights of third parties which would be violated by ALTHEA’s performance hereunder. CLIENT further warrants that the Bulk Drug Substance provided to ALTHEA hereunder (1) conforms to the Bulk Drug Substance Specifications and (2) is not adulterated or misbranded within the meaning of the FD&C Act.

 

Limitation of Liability: CLIENT’s sole and exclusive remedy for breach of this Agreement is limited to those remedies set forth in Article 5 [***] as stated in the Project Plan. Under no circumstances shall ALTHEA be liable for loss of use or profits or other collateral, special, consequential or other damages, losses, or expenses, including but not limited to the cost of cover or the cost of a recall in connection with, or by reason of the Production and delivery of Company Plasmid DNA under this Agreement whether such claims are founded in tort or contract. All claims by CLIENT for breach or default under this Agreement shall be brought within one (1) year after the cause of action accrued or shall be deemed waived.

 

Waiver of Subrogation: All ALTHEA Supplied materials and equipment used by ALTHEA in the Production of Company Plasmid DNA (collectively, “ALTHEA Property”) shall at all times remain the property of ALTHEA and ALTHEA assumes risk of loss for such property until delivery of Company Plasmid DNA to a common carrier as specified under Section 2.10. ALTHEA hereby waives any and all rights of recovery against CLIENT and its Affiliates, and against any of their respective directors, officers, employees, agents or representatives, for any loss or damage to ALTHEA Property to the extent the loss of damage is covered or could be covered by insurance (whether or not such insurance is described in this Agreement). CLIENT assumes all risk of loss for all CLIENT Supplied Materials, all Bulk Drug Substance supplied by CLIENT, and all Company Plasmid DNA [***] (collectively, “CLIENT Property”). CLIENT hereby waives any and all rights of recovery against ALTHEA and its Affiliates, and against any of their respective directors, officers, employees, agents or representatives, for any loss or damage to the CLIENT Property to the extent the loss of damage is covered or could be covered by insurance (whether or not such insurance is described in this Agreement).

 

Waiver of Claims: In connection with providing Development Services, ALTHEA represents only that it will use reasonable care in providing such information solely as it relates to development studies, formulation, primary packaging and manufacturing process development. ALTHEA makes no representation or warranty, and CLIENT expressly waives all claims against ALTHEA and its Affiliates, and any of their respective agents or employees, arising out of or in connection with any claims relating to the stability, efficacy, safety, or toxicity of Company Plasmid DNA developed, formulated, packaged or manufactured in accordance with the Development Services provided by ALTHEA.

 

CLIENT Indemnification: CLIENT shall indemnify, defend and hold harmless ALTHEA and its Affiliates, and any of their respective directors, officers, employees, subcontractors and agents (collectively the “Indemnified Parties”) from and against any and all liabilities, obligations, penalties, claims, judgments, demands, actions, disbursements of any kind and nature, suits, losses, damages, costs and expenses (including, without limitation, reasonable attorney’s fees) arising out of or in connection with property damage or personal injury (including without limitation death) of third parties (collectively “Claims”) including without limitation Claims allegedly resulting solely from (a) CLIENT’s storage, promotion, labeling, marketing, distribution, use or sale of Bulk Drug Substance or Company Plasmid DNA, (b) CLIENT’s negligence or willful misconduct, (c) CLIENT’s breach of this Agreement, or (d) any claim that the use, sale, Production, marketing or distribution of Bulk Drug Substance or Company Plasmid DNA by ALTHEA or CLIENT violates the patent, trademark, copyright or other proprietary rights of any third party, except to the extent any of the foregoing (a) or (d) is caused in part by the negligence or willful misconduct of the Indemnified Parties or solely by the breach by ALTHEA of its obligations under this Agreement.

 

ALTHEA Indemnification: ALTHEA shall indemnify, defend and hold harmless CLIENT and its Affiliates and any of their respective directors, officers, employees, subcontractors and agents from and against a) any and all Claims resulting solely from the Indemnified Parties’ negligence or willful misconduct, or b) any and all Claims resulting from the ALTHEA’s breach of its obligations under this Agreement, or c) any and all Claims resulting form Althea’s storage, promotion, labeling, marketing, distribution, use or sale of any of the materials required for the production process, or d) any and all Claims resulting from Althea’s violation of patent, trademark, copyright or other proprietary rights of any third party.

 

Indemnitee Obligations: A party (the “Indemnitee”) which intends to claim indemnification under this Article 13 shall promptly notify the other party (the “Indemnitor”) in writing of any action, claim or other matter in respect of which the Indemnitee or any of its Affiliates, or any of their respective directors, officers, employees, subcontractors, or agents, intend to claim such indemnification; provided, however, that failure to provide such notice within a reasonable period of time shall not relieve the Indemnitor of any of its obligations hereunder except to the extent the Indemnitor is prejudiced by such failure. The Indemnitee shall permit, and shall cause its Affiliates, and their respective directors, officers, employees, subcontractors and agents to permit, the Indemnitor, at its discretion, to settle any such action, claim or other matter, and the Indemnitee agrees to the complete control of such defense or settlement by the Indemnitor. Notwithstanding the foregoing, the Indemnitor shall not enter into any settlement that would adversely affect the Indemnitee’s rights hereunder, or impose any obligations on the Indemnitee in addition to those set forth herein, in order for it to exercise such rights, without Indemnitee’s prior written consent, which shall not be unreasonably withheld or delayed. No such action, claim or other matter shall be settled without the prior written consent of the Indemnitor, which shall not be unreasonably withheld or delayed. The Indemnitee, its Affiliates, and their respective directors, officers, employees, subcontractors and agents shall fully cooperate with the Indemnitor and its legal representatives in the investigation and defense of any action, claim or other matter covered by the indemnification obligations of this Article 13. The Indemnitee shall have the right, but not the obligation, to be represented in such defense by counsel of its own selection and at its own expense.

 

Injunction: In the event that the Production or sale of a Company Plasmid DNA is enjoined due to alleged infringement by either party of the proprietary rights of a third party, such action shall be deemed a breach of this Agreement by said Party and subject to the terms of Article 3.

 

CLIENT Insurance: CLIENT shall procure and maintain, during the Term of this Agreement and for a period one (1) year beyond the expiration date of Company Plasmid DNA, Commercial General Liability Insurance, including without limitation, Product Liability and Contractual Liability coverage (the “CLIENT Insurance”). The CLIENT Insurance shall cover amounts not less than [***] combined single limit and shall be with an insurance carrier reasonably acceptable to ALTHEA. ALTHEA shall be named as an additional insured on the CLIENT Insurance and CLIENT promptly shall deliver a certificate of CLIENT Insurance and endorsement of additional insured to ALTHEA evidencing such coverage. If CLIENT fails to furnish such certificates or endorsements, or if at any time during the Term of this Agreement ALTHEA is notified of the cancellation or lapse of the CLIENT Insurance, and CLIENT fails to rectify the same within ten (10) calendar days after notice from ALTHEA, in addition to all other remedies available to ALTHEA hereunder, ALTHEA, at its option, may obtain the CLIENT Insurance and CLIENT promptly shall reimburse ALTHEA for the cost of the same. Any deductible and/or self insurance retention shall be the sole responsibility of CLIENT.

 

ALTHEA Insurance: ALTHEA shall procure and maintain, during the Term of this Agreement and for a period of one (1) year beyond the expiration date of Company Plasmid DNA, Commercial General Liability Insurance, including without limitation, Product Liability and Contractual Liability coverage (the “ALTHEA Insurance”). The ALTHEA Insurance shall cover amounts not less than [***] combined single limit. CLIENT shall be named as an additional insured on the ALTHEA Insurance and ALTHEA promptly shall deliver a certificate of ALTHEA Insurance and endorsement of additional insured to CLIENT evidencing such coverage. If ALTHEA fails to furnish such certificates or endorsements, or if at any time during the Term of this Agreement CLIENT is notified of the cancellation or lapse of the ALTHEA Insurance, and ALTHEA fails to rectify the same within ten (10) calendar days after notice from CLIENT, in addition to all other remedies available to CLIENT hereunder, CLIENT, at its option, may obtain the ALTHEA Insurance and ALTHEA promptly shall reimburse CLIENT for the cost of the same. Any deductible and/or self insurance retention shall be the sole responsibility of ALTHEA.

 

Notices: All notices hereunder shall be delivered by facsimile (confirmed by overnight delivery), or by overnight delivery with a reputable overnight delivery service, to the following address of the respective parties:

 

Entire Agreement; Amendment: The parties hereto acknowledge that this Agreement sets forth the entire agreement and understanding of the parties and supercedes all prior written or oral agreements or understandings with respect to the subject matter hereof.  No modification of any of the terms of this Agreement, or any amendments thereto, shall be deemed to be valid unless in writing and signed by an authorized agent or representative of both parties hereto. No course of dealing or usage of trade shall be used to modify the terms and conditions herein.

 

Waiver: None of the provisions of this Agreement shall be considered waived by any party hereto unless such waiver is agreed to, in writing, by authorized agents of both parties. The failure of a party to insist upon strict conformance to any of the terms and conditions hereof, or failure or delay to exercise any rights provided herein or by law shall not be deemed a waiver of any rights of any party hereto.

 

Obligations to Third Parties: Each party warrants and represents that this Agreement is not inconsistent with any contractual obligations, expressed or implied, undertaken with any third party.

 

Assignment: This Agreement shall be binding upon and inure to the benefit of the successors or permitted assigns of each of the parties and may not be assigned or transferred by either party without the prior written consent of the other, except that no consent shall be required in the case of a transfer to a wholly-owned subsidiary or transaction involving the merger, consolidation or sale of substantially all of the assets of the party seeking such assignment or transfer and such transaction relates to the business covered by this Agreement and the resulting entity assumes all the obligations under this Agreement. ALTHEA may, without such consent, assign this Agreement to an Affiliate of ALTHEA, provided that the assignee assumes all obligations of ALTHEA under this Agreement. No assignment shall relieve any party of responsibility for the performance of its obligations hereunder.

 

Successors and Assigns: This Agreement shall be binding upon and shall inure to the benefit of the parties hereto, their successors and permitted assigns.

 

Taxes: CLIENT shall pay all national, state, municipal or other sales, use excise, import, property, value added, or other similar taxes, assessments or tariffs assessed upon or levied against the sale of Company Plasmid DNA to CLIENT pursuant to this Agreement or the sale or distribution of Company Plasmid DNA by CLIENT (or at CLIENT’s sole expense, defend against the imposition of such taxes and expenses). ALTHEA shall notify CLIENT of any such taxes that any governmental authority is seeking to collect from ALTHEA, and CLIENT may assume the defense thereof in ALTHEA’s name, if necessary, and ALTHEA agrees to fully cooperate in such defense to the extent of the capacity of ALTHEA, at CLIENT’s expense. ALTHEA shall pay all national, state, municipal or other taxes on the income resulting from the sale by ALTHEA of the Company Plasmid DNA to CLIENT under this Agreement, including but not limited to, gross income, adjusted gross income, supplemental net income, gross receipts, excess profit taxes, or other similar taxes.

 

Independent Contractor: ALTHEA shall act as an independent contractor for CLIENT in providing the services required hereunder and shall not be considered an agent of, or joint venturer with, CLIENT. Unless otherwise provided herein to the contrary, ALTHEA shall furnish all expertise, labor, supervision, machining and equipment necessary for performance hereunder and shall obtain and maintain all building and other permits and licenses required by public authorities.

 

Governing Law: This Agreement shall be governed in all respects by the laws of the United Kingdom, without regard to the principals of conflicts of laws. The courts of the United Kingdom shall have personal jurisdiction over the parties hereto in all matters arising hereunder, and venue for such suit will be in the County Court, Central London.