Exhibit 10.16
Manufacturing and Supply Agreement:
Peptisyntha for Helix BioMedix, Inc. This Manufacturing and Supply Agreement (the " Agreement" ) is made as of January 9, 2008 (the " Effective Date" ) by and between Helix BioMedix, Inc., a Delaware corporation, its principal offices being located at 22118 20th Ave. SE, Suite 204, Bothell, WA 98021 (" Helix" ) and Peptisyntha, Inc., a Delaware corporation, its principal offices being located at 20910 Higgins Court, Torrance, CA 90501 (" Peptisyntha" ).
AGREEMENT In consideration of the mutual covenants, promises, and conditions set forth below, the parties, intending to be bound, agree as follows: 1. Definitions . The following capitalized terms when used in this Agreement shall have the respective meanings set forth below. a." Bill of Material" shall mean any materials and components lists and related instructions and information provided by Helix to Peptisyntha and concerning components required or preferred for the manufacture of a Peptide by Peptisyntha pursuant to this Agreement.
b." Disclosing Party" shall have the meaning stated in Section 10 hereof. c." Effective Date" shall have the meaning stated in the preamble of this Agreement. d." Intellectual Property" shall mean trade secrets, ideas, inventions, designs, developments, devices, methods or processes (whether patented or able to be patented and whether or not reduced to practice) and all patents and patent applications related thereto; copyrightable works and mask works (whether or not registered); trademarks, service marks and trade dress; and all registrations and applications for registration related thereto; and all other intellectual or industrial property rights of any sort.
e." Losses" shall mean any and all damages, liabilities, costs and expenses (including reasonable attorneys fees and expenses), and amounts paid in settlement.
f." Peptides" shall mean the amino acid sequences identified in Exhibit A hereto, as may be amended from time to time by agreement of the parties.
g." Proprietary Information" shall have the meaning stated in Section 10. h." Recipient" shall have the meaning stated in Section 10.
i." Specifications" shall mean the requirements for Peptides set forth in Exhibit B , as may be amended from time to time by agreement of the parties.
2. Supply Obligations . During the Term of this Agreement, Peptisyntha shall manufacture for Helix its requirements for the Peptides (including the requirements of Helix' s licensees of Peptides), subject to and in accordance with the terms and conditions set forth in this Agreement, including without limitation the Specifications.
Confidential treatment has been requested for portions of Exhibit A. This exhibit omits the information subject to the confidential treatment request. Omissions are designated as ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 3. Document Control and Process .
a. Document Control . All Specifications, Bills of Material and other documents provided to Peptisyntha pursuant to this Agreement, including without limitation all modifications, revisions, updates, supplements and amendments thereto, will be maintained by Peptisyntha in an orderly manner promptly upon receipt thereof. b. Manufacturing . Peptisyntha will maintain records pertaining to the manufacture and quality control of the Peptides. c. Design Changes . Helix shall be responsible for providing Peptisyntha with any desired modifications, updates or other changes to the Specifications, which shall be processed by Peptisyntha in accordance with the foregoing provisions of this Section 3. If a change results in an increase in Peptisyntha' s cost of production, Peptisyntha will provide a quote to Helix for revised pricing associated with the change and substantiating such increased cost of production.
d. Testing and Quality; Certificate of Analysis . Peptisyntha will establish and perform customary quality assurance and quality control procedures relating to its obligations hereunder. Helix may perform testing procedures at its discretion and as may be agreed by the parties. Procedures to be performed by Peptisyntha will be incorporated into its manufacturing quality system. Peptisyntha will provide to Helix a certificate of analysis promptly upon completion of production of each Peptide lot, which will include customary data, including without limitation Peptide name (not the sequence), lot number, quantity, purity level determined by HPLC/UV with chromatogram included, mass analysis by HPLC co-eluent analysis using a previously characterized peptide standard, counter ion, color, formula weight, and release date. Any comments related to any unusual observations should also be included. No Peptide from any lot will be shipped by Peptisyntha to a Helix licensee until Helix has approved the associated certificate of analysis.
e. Helix Accessibility . Upon reasonable prior notice, Helix shall have access to the areas of any Peptisyntha facility where Peptides are being manufactured or stored or where parts and materials are being processed or stored at all times during normal business hours for purposes of quality inspection, verification of manufacturing procedures and other legitimate purposes. Without limiting the generality of the foregoing, Helix may inspect a sample or the entirety of any Peptide lot produced by Peptisyntha upon Helix' s request. Upon request by Helix, Peptide samples will be shipped to Helix for inspection. f. Regulatory Requirements . Helix will be responsible for compliance with all applicable regulatory and related matters which may require regulatory agency notification including FDA IND / NDA, and other agency notifications. Peptisyntha shall provide such assistance and cooperation as Helix shall reasonably request, including without limitation the provision of relevant manufacturing records. Each party shall obtain and bear costs associated with all domestic and foreign governmental licenses, permits and approvals required for such party' s performance under this Agreement. Without limiting the generality of the foregoing: (i) Helix shall be responsible for complying with all applicable foreign and U.S. federal, state and local laws, rules, regulations and orders and for obtaining all applicable U.S. FDA and other governmental agency product approvals and applicable foreign agency approval in each case relating to the sale of products containing its Peptides; and (ii) Peptisyntha shall be responsible for complying with all foreign and U.S. federal, state and local laws, rules, regulations and orders applicable to its performance and obligations hereunder.
*** Confidential treatment requested 2 g. Labeling . Peptisyntha will label Peptide according to specifications and label copy provided by Helix. Unless otherwise notified by Helix, Peptisyntha will use the label copy attached hereto as Exhibit C for all Peptides supplied hereunder. Helix will be solely responsible for liabilities arising from Peptide labeling in accordance with its instructions (including without limitation claims of misbranding or unapproved indications) and will indemnify Peptisyntha as set forth in Section 11.
h. Product Recall . In the event of a product recall conducted by Helix, Peptisyntha shall cooperate with Helix recall investigations, including providing manufacturing-related records as they relate to the recall. Peptisyntha and Helix shall cooperate in jointly assessing the root cause of a product recall. If Helix is solely responsible for defect giving rise to the recall, Helix will reimburse Peptisyntha for all reasonable costs and expenses incurred by Peptisyntha directly as a result of its cooperation in such recall. If Peptisyntha is solely responsible for the defect giving rise to the recall, Helix will not reimburse Peptisyntha for expenses incurred in providing replacement components. This section will not be deemed to limit either party' s obligations under Section 11 (Indemnification).
4. Cost Reductions . Peptisyntha and Helix agree to seek ways to reduce the cost of manufacturing Peptides by methods such as obtaining alternate sources of materials and improved synthesis or test methods. Peptisyntha and Helix agree to meet at least every six (6) months to identify cost reduction opportunities.
5. Orders, Changes and Cancellation .
a. Orders . Peptisyntha shall initiate manufacturing of Peptide upon receipt of a written production order (" Production Order" ) from Helix. Production Orders will specify which Helix licensees may set up a direct account with Peptisyntha and purchase Peptide synthesized under that Production Order; no party other than Helix and such licensees may obtain Peptides from Peptisyntha. Peptisyntha will use best commercial efforts to complete production of Peptide under a Production Order (or, at Peptisyntha' s option, prepare and store resin sufficient for such production) within 8 to 12 weeks of receiving a Production Order from Helix. Peptide produced under a Production Order will not be shipped by Peptisyntha until Peptisyntha receives a purchase order (" Purchase Order" ) from Helix or a licensee approved by Helix with respect to the applicable Production Order. Peptisyntha will provide a delivery schedule upon receipt of the Purchase Order, and will use best commercial efforts to make delivery with respect to Purchase Orders made under completed Production Orders within 3 to 4 weeks of their receipt. If any Peptide inventory remains un-purchased with Peptisyntha 12 months after completion of production under a Production Order (or another period pre-negotiated between Helix and Peptisyntha), Helix will purchase such remaining inventory. Peptisyntha will not be obligated to satisfy more than one Production Order at a time, but will consider the possibility depending on its current production schedule.
b. Order Changes . The terms of any Production Order or Purchase Order may be adjusted by mutual written agreement of Peptisyntha and Helix (or Peptisyntha and an authorized licensee of Helix with respect to a Purchase Order placed by a licensee). Peptisyntha shall use its best commercial efforts to accommodate any changes requested by Helix or such authorized licensee. *** Confidential treatment requested 3 c. Cancellation . Helix may cancel any Production Order; provided that in the event Helix cancels a Production Order, Peptisyntha shall stop any work-in-process and Helix shall purchase from Peptisyntha al ...
*End of Preview*
Click the 'Add to Cart' button to download the complete and formatted agreement.