EXHIBIT10.3 Execution Copy CONFIDENTIAL MASTERPRODUCT SALE AGREEMENT

 

A.           VGX has developed specific expertise and technology relating to production and testing of DNA plasmids and is in the business of developing, manufacturing and testing plasmid based products for research and therapeutic benefit, in a manner complying with cGMP as appropriate.

B.           CUSTOMER desires to have VGX produce, from time to time, certain quantities of products for human clinical and/or non-human use (“Contract Materials”), on each occasion, on the terms and conditions set forth in this Agreement and Purchase Order therefore.

NOW, THEREFORE, in consideration of the above premises and the mutual covenants hereinafter recited, the Parties agree as follows:

1.           Definitions.

When used in this Agreement, each of the following terms shall have the meanings as set forth in this Article

1.1.                     “VGX Background Technology” shall mean VGX proprietary information, trade secrets, and/or know-how used by VGX in the performance of this Agreement and owned by VGX prior to the date hereof, including, but not limited to, information relating to materials, devices and methods for fermenting bacteria and the purification and testing of DNA Plasmids.

1.2.                      “Affiliates” shall mean any corporation, firm, limited liability company, partnership or other entity, which directly or indirectly controls or is controlled by or is under the common control with a Party, or any corporation, firm, limited liability company, partnership or other entity of behalf of which either Party is acting as an agent, advisor, or distributor.

1.3.                     “Agreement” shall mean this Master Product Sale Agreement, as amended from time to time.

1.4.                     “Bill of Testing” shall be the tests agreed to for each particular Purchase Order. The Bill of Testing will be considered a draft until mutually agreed upon in writing for a particular Purchase Order.

1.5.                     “Biosafety Level I” shall mean a basic level of containment that relies on standard microbiological practices with no special primary or secondary barriers recommended other than a sink for hand washing, in which work is done with defined and characterized strains of viable microorganisms not known to cause disease in healthy adult humans and classified as such by the relevant authorities, regulations or law.

 

Execution Copy

CONFIDENTIAL

1.6.                     “Calendar Year” shall mean each successive period of twelve (12) consecutive calendar months commencing on January 1 and ending on December 31.

1.7.                     “Cell Banking Activities” shall mean the creation, testing, and maintenance of a Master Cell Bank (MCB) and/or a Manufacturer’s Working Cell Bank (MWCB) under cGMP conditions, containing copies of the Parent Plasmid, each of which will meet the Specifications as finalized pursuant to a particular Purchase Order.

1.8.                     “Commencement Date” with respect to any particular order, shall mean the first date specified in the Purchase Order.

1.9.                     “Contract Materials” shall mean all of the materials to be produced by VGX for CUSTOMER as specified in a particular Purchase Order including Product. The Parties hereto will prepare and sign new Purchase Order for each new DNA plasmid that VGX is to produce hereunder.

1.10.                   “CUSTOMER Materials” shall mean all materials sent by CUSTOMER to VGX related to this Agreement and to the applicable Purchase Order and documentation.

1.11.                   “CUSTOMER Background Technology” shall mean all data, information, know-how, trade secrets, copyrights, designs, databases, discoveries, improvements and inventions (whether patentable or not) related to the Information and/or the CUSTOMER Materials that are owned, licensed or controlled by CUSTOMER or its Affiliates prior to the date hereof.

1.12.                   ‘‘Direct Materials Costs” shall mean the cost to VGX of materials utilized in the performance of Production Services, including freight-in costs, sales and excise taxes imposed thereon and customs duty and charges levied by government authorities, and all costs of packaging components.

1.13.                   “External Testing Costs” shall mean the cost of any tests listed as “contract” on the draft or final Bill of Testing, as well as any other testing not performed at the VGX facility.

1.14.                   “FDA” shall mean the U.S. Food and Drug Administration.

1.16.                   “Good Manufacturing Practices” or “GMP” shall mean the good manufacturing practices required by the U.S. Food and Drug Administration for the manufacture and testing of pharmaceutical and biological materials, and the corresponding requirements of the European Union, Member States of the European Union, and other countries to the extent they are applicable. “cGMP” or “current GMP” shall mean the GMP practices in effect at a particular time.

 

 

1.17.                   “Information” means all (a) techniques and data pertaining and/or related to the Contract Materials, including, but not limited to, ideas, inventions (including patentable inventions), practices, methods, knowledge, know-how, trade secrets, skill, experience, documents, apparatus, clinical and regulatory strategies, test data, including pharmacological, toxicological and clinical test data, analytical and quality control data, manufacturing, patent and legal data or descriptions and (b) chemical formulations, compositions of matter, product samples and assays pertaining and/or related to the Contract Materials.

1.18.                   “Manufacturer’s Working Cell Bank” or “MWCB” shall mean viable E. coli containing Parent Plasmid, cultured from the MCB under GMP conditions, diluted in glycerol and stored in sealed vials at less than minus sixty degrees Celsius.

1.19.                   “Master Cell Bank” or “MCB” shall mean viable E. coli containing Parent Plasmid, transformed directly from CUSTOMER supplied stock under GMP conditions, diluted in glycerol and stored in sealed vials at less than minus sixty degrees Celsius.

1.20.                   “Party” shall mean either CUSTOMER or VGX as the case may be.

1.21.                   “Parent Plasmid” shall mean the original DNA plasmid construct, prepared by CUSTOMER and provided to VGX, listed in a particular Purchase Order.

1.22.                   “Person” shall mean a natural person, a corporation, a partnership, a trust, a joint venture, any governmental authority or any other entity or organization.

1.23.                   “Pilot DNA Services” shall mean the production of Research DNA at a sufficiently large scale as to provide a reasonable indication of the growth, quality and yield of a GMP batch produced with the same cell bank.

1.24.                   “Pilot DNA” shall mean the Research DNA produced as a result of the Pilot DNA Services.

1.25.                   “Price” shall mean the amount payable to VGX in U.S. dollars for the performance of Production Services hereunder with respect to any Purchase Order.

1.26.                   “Product” shall mean finished goods in final container/closure or other deliverable listed as a line item in any Purchase Order to be delivered to CUSTOMER.

1.27.                   “Production Services” shall mean the activities to be performed by VGX hereunder, which shall mean the production of the Contract Materials and relevant supporting documentation accordingly to the Purchase Order.

1.28.                   “Project Technology” shall mean and include all data, information, know-how, trade secrets, copyrights, designs, databases, processes, compounds, discoveries, new uses, improvements and inventions (whether patentable or not) that are conceived, generated, derived, developed or reduced to practice solely by one Party or jointly by both Parties and that arise out of the performance of this Agreement and all patents and other intellectual property rights relating thereto.

1.29.                   “Purchase Order” means a purchase order agreement for a specific project.

1.30.                   “Research Cell Bank” or “RCB” shall mean a small cell bank produced under research conditions used for the production of Research DNA only. This material is provided “as-is”.

1.31.                   “Research DNA” shall mean a small amount of DNA prepared by VGX under Research Laboratory Conditions from the RCB as an initial indication of growth, yield, and quality characteristics. This material is provided “as-is”

1.32.                   “Research Laboratory Conditions” shall mean practices and policies generally accepted by trained scientists to assure quality and integrity of laboratory experiments. Such practices include, but are not necessarily limited to, aseptic techniques to avoid microbial contamination, accurate measurements and calculations and documentation of research results.

1.33.                   “Resuspension Buffer” shall mean the liquid used to resuspend DNA in the finished Product and having the composition specified by the CUSTOMER.

1.34.                   “Sample Plasmid” shall mean a DNA plasmid supplied by CUSTOMER, of sufficiently similar characteristics to the Parent Plasmid to perform initial quality control assay evaluations and/or initial process development testing. Sample Plasmid and Parent Plasmid should be the same plasmid whenever possible to ensure the validity of the results.

1.35.                   “Specifications” means, with respect to any Product, the specifications therefore as set forth in a Purchase Order for such Product.

1.36.                   “Third Party” means any person or entity other than VGX or CUSTOMER.

2.           Purchase Orders.

2.1.                     Supply. During the term of, and subject to the terms and conditions in this Agreement, CUSTOMER may purchase from, and have Contract Materials produced by, VGX. Neither shall CUSTOMER have any commitment to purchase any minimum quantity of Contract Materials nor shall VGX have any commitment to produce and sell any minimum quantity of Contract Materials. CUSTOMER shall become obligated to purchase, and VGX shall be obligated to produce Contract Materials only upon execution and delivery by both VGX and CUSTOMER of a Purchase Order for such Contract Material, as set forth below.

Neither VGX nor CUSTOMER may amend a Purchase Order after it has been executed, except according to the provisions of Section 12 or by mutual agreement in writing as provided in Section 13.5. CUSTOMER may cancel an existing Purchase Order prior to the Commencement Date and forfeit any prepayments made for such Purchase Order. For each new Product that is to be produced by VGX pursuant to this Agreement, the Parties will prepare and sign a Purchase Order, and upon signing, such new Purchase Order shall become a part of this Agreement. Each such new Purchase Order shall specifically reference this Agreement and be signed by both Parties hereto. Each new Purchase Order will contain project details for the production and testing of some or all of the Contract Material.

2.2.                    Project Specifications. VGX will produce under cGMP conditions the specified amounts or number of cycles of Contract Materials and Product. Such Product will be produced, tested, released and delivered to CUSTOMER according to the schedule in the Purchase Order. VGX shall ship the Contract Materials directly to CUSTOMER, or to a recipient address provided by the CUSTOMER to VGX in writing. VGX will keep in its possession any required documentation, regulatory retains, and will maintain certain additional samples and/or cell banks at the request of CUSTOMER for an additional fee (to be determined in the applicable Purchase Order).

2.3.                    Laboratory Test Production of Research DNA. To the extent not previously completed with respect to any Purchase Order, within one (1) week of the Commencement Date, CUSTOMER will supply VGX with more than fifteen (15) milligrams of each Parent Plasmid or more than ten (10) vials of a qualified cell bank containing Parent Plasmid for VGX use and retain. If required, VGX shall perform, under Research Laboratory Conditions, the experiments listed as scheduled in the particular Purchase Order to establish optimum fermentation and purification conditions for the Parent Plasmid, to determine yield, stability, purity and form of the plasmid DNA.

2.4.                    Modification If Research Results Not Satisfactory. If the Research DNA produced pursuant to Section 2.3 above does not meet the draft productivity or purity standards set forth in the Purchase Order, CUSTOMER and VGX shall then meet and negotiate, in good faith, appropriate modifications to the Agreement to address the failure to meet the criteria. VGX will produce additional Research DNA batches if deemed necessary by mutual written agreement between VGX and CUSTOMER. The cost of producing the additional batches will be borne by CUSTOMER if the Research DNA does not meet the draft productivity or purity standards set forth in the Purchase Order in whole or in part as a result of the negligence of CUSTOMER. The cost of producing the additional batches will be borne by VGX, if the Research DNA does not meet the draft productivity or purity standards set forth in the Purchase Order in whole or in part as a result of the negligence of VGX. If the Parties dispute whether Research DNA is conforming or non-conforming, or the reasons for non-conformity, samples of the batch of Research DNA will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof if non-conforming, shall be binding upon the Parties. The Party decided to be in the wrong shall bear the costs of such laboratory or consultant. If the Parties agree that VGX should take other actions to address the purity or productivity problems, they will also agree upon the appropriate modifications to the payments and execute on appropriate amendment. If the Parties are unable to reach an agreement despite good faith negotiations, either Party may terminate this Agreement or Purchase Order by written notice to the other.

2.5.                    Testing to Release Manufacture. If the Research DNA produced meets the standards, VGX shall produce and perform relevant testing needed to release the MCB and/or MWCB into its facility, or evaluate and test any CUSTOMER supplied MCB and/or MWCB as appropriate. Such work shall be performed in accordance with the schedule in the Purchase Order.

2.6.                    Pilot Production of Research DNA. To the extent not previously completed with respect to any Purchase Order, if required, VGX shall perform, under Research Laboratory Conditions, the Pilot DNA Services as defined in Section 1.23 above, pursuant to the Specifications set forth in the Purchase Order.

2.7.                    Finished Product Production. If the Pilot DNA produced by VGX meets the standards in the draft Bill of Testing, the final Bill of Testing will be signed by VGX and the CUSTOMER and attached to the Purchase Order Agreement. VGX shall then commence with preparing for each Parent Plasmid under GMP conditions the specified number of production cycles of finished Product. Such finished Product will be produced, tested, released and delivered to CUSTOMER according to the schedule in the particular Purchase Order.

2.8.                     Pilot Production Unsatisfactory. If the Pilot DNA produced by VGX does not meet the standards in the draft Bill of Testing, VGX and CUSTOMER will discuss the possible amendment of the Bill of Testing. VGX will produce an additional Pilot DNA batch if deemed necessary by mutual written agreement between VGX and CUSTOMER. The cost of producing the additional batch will be borne by CUSTOMER if the Pilot DNA does not meet the standards in the draft Bill of Testing as a result of the negligence of CUSTOMER. The cost of producing the additional batches will be borne by VGX, if the Pilot DNA does not meet the standards in the draft Bill of Testing as a result of the negligence of VGX. If the Parties dispute whether Pilot DNA is conforming or non-conforming, or the reasons for non-conformity, samples of the batch of Pilot DNA will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof if non-conforming, shall be binding upon the Parties. The Party decided to be in the wrong shall bear the costs of such laboratory or consultant. If the Parties agree that VGX should take other actions to address the purity or productivity problems, they will also agree upon the appropriate modifications to the payments in the Purchase Order and execute an appropriate amendment. If the Parties are unable to reach an agreement despite good faith negotiations, either Party may terminate this Agreement or Purchase Order by written notice to the other.

3.           Materials and Information.

4.           Production.

4.2.                      Quality Control and Assurance.

 

(ii)              Subject to the provisions of Section 4.7 below, if the Parties determine, prior to the delivery of any batch of Product that such Product fail to meet any of the Specifications, VGX shall, at its sole cost, either discard the Product and shall bear the loss resulting therefrom, or if it is possible, correct the deficiency in and/or repackage such batch of Products, as CUSTOMER may, in its sole discretion, direct.

(iii)             CUSTOMER shall be entitled to carry out such procedures as CUSTOMER requires for the analysis and validation of the Products prior to acceptance thereof.
 

(iv)             VGX shall promptly notify CUSTOMER in writing of any major incidents or anomalous results observed by VGX during the manufacture of the Products. VGX shall take all reasonable measures to ensure that the affected Products are not released until the Parties reach agreement on appropriate corrective measures and/or other actions to be taken by VGX.

4.3.                     Change Order.

The Specifications shall be amended to the extent necessary to comply with changes in applicable laws and/or regulations or the requirements of applicable regulatory agencies. In addition, the Specifications shall be amended as CUSTOMER may reasonably request from time to time with the mutual consent of the Parties. VGX shall not make without CUSTOMER’s prior written consent any change in (i) the manufacturing facility which would have an impact on the Product or require submissions to or approvals from any regulatory agency or, (ii) the manufacturing process. VGX undertakes that any such change(s) shall, in each case, comply with cGMP, this Agreement, the requirements of all applicable regulatory agencies and all applicable laws, rules and regulations, including but not limited to the Federal Food, Drug and Cosmetic Act and the regulations promulgated pursuant thereto, and without limiting the foregoing, with the standard of care customary in the industry. In the event such amendment (whether as a result of changes in applicable laws or the requirements of applicable regulatory agencies or at CUSTOMER’s reasonable request or otherwise) requires additional cost or schedule adjustments for the manufacture of the Product hereunder, the Parties shall agree in good faith on an equitable adjustment to Price and/or schedule, as appropriate.

4.4.                     Delays in Production.

Each Party will promptly notify the other Party in writing if it believes that there are likely to be changes in the work schedule contained in the Purchase Order. Such notice will include the reasons for such changes in the schedule and the proposed new schedule for the incomplete portion of the work. VGX is responsible for any delays in the production or delivery of Contract Materials except for delays caused by the lack of delivery by CUSTOMER of material Information or CUSTOMER Materials in a timely manner, as agreed to in advance. In the event of any delays in the production or delivery of Contract Materials for which VGX is responsible pursuant to this Section 4.4, the payment schedule set forth in the Purchase Order shall be amended accordingly. In addition, the aggregate amount payable to VGX pursuant to the Purchase Order shall be reduced by 5% per each month of delay. In the event that a delay is for a period of less than an entire month, the penalty amount for such partial period shall be adjusted proportionately (e.g. in the event of a delay of 75 days, the aggregate amount payable pursuant to the Purchase Order will be reduced by 25%). In the event that CUSTOMER requests VGX to delay the production or delivery of Contract Materials, than the aggregate amount payable to VGX pursuant to the Purchase Order shall be increased by 5% per each month of delay. In the event that a delay is for a period of less than an entire month, the penalty amount for such partial period shall be adjusted proportionately.

A delay of less then 30 days, at the first month of delay, will not be considered as a delay.

4.5.                     Audits by CUSTOMER.

(i)               Upon the written request of CUSTOMER, VGX shall permit CUSTOMER or an independent consulting firm specializing in pharmaceutical manufacturing facility inspections selected by CUSTOMER and reasonably acceptable to VGX, at CUSTOMER’S expense, to have access during VGX normal business hours to inspect such of the records and facilities of VGX, as may be reasonably necessary to verify that Products manufactured by VGX are manufactured in accordance with Good Manufacturing Practices and conform to the Specifications as outlined in a Purchase Order which is dated not more than twelve (12) months prior to the date of such request. CUSTOMER’s right to inspection shall continue until twelve (12) months from delivery of the Products. Only information that is related to this Agreement will be the subject of such inspection. VGX shall make all efforts to address any GMP or Specifications deficiencies found by CUSTOMER in such inspection

(ii)              CUSTOMER may make a preproduction inspection of the facilities upon reasonable notice, prior to signing the first Purchase Order. VGX shall make all good faith efforts to address any GMP deficiencies found by CUSTOMER in any pre-production inspection. If deficiencies are addressed to CUSTOMER’s satisfaction in a reasonable time period, this Agreement or the applicable Purchase Order will continue. If deficiencies are not addressed to CUSTOMER’s satisfaction, CUSTOMER may terminate this Agreement or the applicable Purchase Order by written notice to VGX and neither Party shall have any further liability hereunder as a result of such termination.

(iii)             CUSTOMER shall treat all information subject to review under this Section 4.5 in accordance with the confidentiality provisions of this Agreement, and shall cause its consultants who review such information to be bound by the same confidentiality provisions.

4.6.                     Certificate of Release and Analysis. Concurrent with its delivery of Product, VGX shall deliver to CUSTOMER the certificate of pharmaceutical release and a written report summarizing analytical and manufacturing documentation which will include the final certificate of analysis for such Product.

(i)               Upon VGX’s release of a batch of Product, VGXI shall provide CUSTOMER, or CUSTOMER’s designee, copies of 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 VGX. Within sixty (60) calendar days after receipt by CUSTOMER of the documentation, CUSTOMER shall determine whether the Product conforms to Specifications and has been manufactured in accordance with the batch record, VGX’s current SOPs, and the Purchase Order.

(ii)              If (i) any batch of Product conforms to the Specifications, or (ii) CUSTOMER fails to notify VGX within the applicable time period that any batch of Product does not conform to the Specifications, then CUSTOMER shall be deemed to have accepted the Product and waived its right to revoke acceptance.

(iii)             If CUSTOMER believes any batch of Product does not conform to the Specifications, it shall notify VGX by telephone, including a detailed explanation of the non-conformity, and shall confirm such notice in writing via overnight delivery to VGX. Upon receipt of such notice, VGX will investigate such alleged non-conformity, and (i) If VGX agrees such Product is non-conforming, deliver to CUSTOMER a corrective action plan within thirty (30) calendar days after receipt of CUSTOMER’s written notice of non-conformity, or (ii) if VGX disagrees with CUSTOMER’s determination that the batch of Product is non-conforming, VGX shall so notify CUSTOMER by telephone within the thirty (30) calendar day period and provide CUSTOMER with evidence to substantiate its claim as well as confirm such notice in writing by overnight delivery.

(iv)             If the Parties dispute whether Product is conforming or non-conforming, samples of the batch of Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof if non-conforming, shall be binding upon the parties. The Party decided to be in the wrong shall bear the costs of such laboratory or consultant.

4.8.                     Remedies for Non Conforming Product. In the event VGX agrees that the batch of Product is non-conforming in whole or in part as a result of the negligence of VGX or the laboratory determines that the shipment of Product is non-conforming in whole or in part as a result of the negligence of VGX, then CUSTOMER, shall subject to the provisions of Section 4.4 above, allow VGX at its expense to replace such non-conforming Product within forty-five (45) calendar days from the date Product is determined to be non-conforming, and in the event that VGX is unable to timely replace such non-conforming Product asset forth above, than CUSTOMER, shall be granted a full refund of the payments paid pursuant to the Purchase Order. In addition, the due date for the final invoice issued at completion of production of the Product will be extended until the date at which replacement Product is released and determined to be conforming by VGX and CUSTOMER.

4.9.                     Samples and Batch Records. VGX shall prepare and maintain or cause to be prepared and maintained batch records and samples, properly stored, from each lot or batch of Product manufactured and shipped hereunder sufficient to perform each quality control test identified in the Specifications. Batch records will be reviewed and approved by VGX and the CUSTOMER prior to commencement of production of Contract Materials. Any material change to an approved batch record will be reviewed and approved by VGX and the CUSTOMER prior to said change being implemented. Any deviation from the manufacturing process specified in the batch record must be documented in the copy of the batch record for that batch. All batch records will be made available to CUSTOMER in English upon completion of each batch. Copies of the batch records will be sent to the CUSTOMER with the certificate of analysis. All documentation related to the manufacturing of Contract Materials shall be archived with VGX during and after the manufacturing, in accordance with its document retention policies and cGMP, for at least one (1) year after the expiration date of each respective batch manufactured. CUSTOMER shall be contacted before destruction of any specific records regarding Contract Materials and shall be given the option to retain such documents. All batch record and related documentation shall be regarded as Confidential Information hereunder.

If a DMF/BMF will be required by the regulatory authorities (such as the FDA, EMEA etc), VGX will submit such a file at a time which will be sufficient enough for these authorities to approve the submission before the full release of the batch. VGX will provide the CUSTOMER with authorization letter that enables the regulatory authorities to review the DMF/BMF regarding the production process of the Product.

4.10.                   Inspections by Government Agencies.

(i)               If any governmental agency shall inspect any facility at which any Product is manufactured or the records with respect to the Production Services or the compliance by VGX with laws and regulations applicable to the manufacturing of such Product, VGX shall notify CUSTOMER of such inspection, the results thereof and, if VGX was required, as a result of any such inspection, to take any corrective action in order to comply with any applicable law or regulation, any such action it has taken in response to such requirement.

(ii)              VGX will notify CUSTOMER promptly upon receipt of any correspondence from a regulatory agency, which relates to the Production Services and promptly provide the CUSTOMER a copy thereof. CUSTOMER shall be entitled to review and approve in advance VGX’s responses and submissions, but such approval shall not be unreasonably withheld. In addition and subject to the foregoing, VGX shall provide to the regulatory agencies all documents and information requested by such authority, and shall submit to all inquiries, audits and inspections by the regulatory agencies.

(iii)             VGX hereby agrees to provide (i) all information and assistance which is reasonably necessary for or useful in the preparation of comprehensive and complete regulatory submissions including without limitation applications or materials required to obtain marketing approval of Product, and (ii) access to the manufacturing facility and pertinent information to applicable regulatory agencies inspectors conducting the pre-approval inspection. CUSTOMER shall have the sole right to prepare and make any such submissions, applications or materials and shall own any and all rights and interest therein.

5.           Shipment and Delivery.

5.1.                     Storage. VGX shall store each batch of Product ordered pursuant to a Purchase Order in accordance with the specifications in that Purchase Order, or, if not specified therein, in accordance with good commercial standards. In no case will VGX be responsible for the storage of a batch for greater than two months from quality release. Without derogating from the foregoing, VGX shall store the Contract Materials in accordance with the instructions provided by CUSTOMER from time to time and in compliance with the requirements of any applicable regulatory agency or other governmental authority and all applicable laws and regulations.

5.2.                     Packing. VGX shall pack each batch of Product ordered pursuant to a Purchase Order in accordance with the specifications in that Purchase Order and as per CUSTOMER instructions, or, if not specified therein, in accordance with good commercial standards. Such packaging shall be at VGX’s expense.

5.3.                     Shipment. Delivery shall take place in the manner and at such times as shall be agreed between the Parties on the Purchase Order. VGX shall notify CUSTOMER, in writing, not less than ten (10) business days before shipment of a batch of Product that such batch will be ready for shipment by the date specified in such notice. CUSTOMER shall be obligated to notify VGX of the route and carrier by which CUSTOMER desires such batch to be shipped to it. If VGX receives notice of the route and carrier by which CUSTOMER desires a batch of Product to be shipped no later than five (5) business days before the date stated in VGX’s notice to CUSTOMER, VGX shall ship such batch in accordance with CUSTOMER’s directions; however, if CUSTOMER fails to notify VGX as provided, VGX may ship such batch of Product by a carrier and on a route selected by VGX. For purposes of this Section 5.3, a “business day” is a day when VGX’s production facilities and administrative offices are generally open for business. Each Product will be considered suitable for shipment following the successful completion of all tests listed in the Purchase Order, or sooner if risk of loss and title are transferred via written request of the Customer.