SECOND AMENDMENT TO Restated Agreement dated July 24, 2009 between Gen-Probe Incorporated and Grifols Diagnostic Solutions Inc.

This Second Amendment (the “Second Amendment”), effective January 15, 2015, to the Restated Agreement dated July 24, 2009 and as amended on November 8, 2013 (collectively, the “Agreement”) is made by and between Gen-Probe Incorporated (hereinafter, “Gen-Probe”), a Delaware corporation with a place of business at 10210 Genetic Center Drive, San Diego, CA 92121-4362, and Grifols Diagnostic Solutions Inc. (hereinafter, “Grifols”), a Delaware corporation with a place of business at 4560 Horton Street, Emeryville, CA 94608. Capitalized terms not defined in this Second Amendment shall have the same meaning given them in the Agreement.

WHEREAS, Novartis Vaccines and Diagnostics, Inc. (hereinafter, “Novartis V&D”) and Gen-Probe entered into the Agreement relating to the development, manufacture, marketing and distribution of products in the Blood Screening Field;

WHEREAS, on November 10, 2013, Novartis V&D and Grifols entered into a definitive agreement pursuant to which Novartis V&D agreed to sell, and Grifols agreed to acquire, the blood transfusion diagnostics business unit of Novartis V&D. The assets acquired by Grifols include, but are not limited to, nucleic acid testing assays, software, instrumentation and equipment for blood screening, as well as related patents, brands, licenses and royalties, together with the antigen production facilities and global headquarter offices in Emeryville, California, and commercial offices located in Switzerland and Hong Kong; the foregoing transaction closed on January 9, 2014;

WHEREAS, the parties to the Agreement wish to have Grifols succeed to the rights and responsibilities of Novartis V&D under the Agreement;

WHEREAS, Grifols wishes to pursue the nucleic acid testing business in Thailand, to include a tender being offered, or which will imminently be offered, by the Thai Red Cross (hereinafter, “TRC”);

WHEREAS, in preparation for Grifols’ response to the TRC Tender (as defined below), the parties desire to set forth terms and conditions which shall specifically govern the sale of Products in Thailand, including, without limitation, pricing and the modified structure by which revenue is reported and Gen-Probe is compensated;

WHEREAS, the parties hereto have come to an agreement regarding settlement of potential warranty claims for the Procleix® Tigris® instrument, the Procleix® Panther® instrument and the Reagent Preparation Incubator (“RPI”) for the years 2012 and 2013, and for future claims; and

WHEREAS, the parties hereto now desire to amend the Agreement to revise and clarify their rights and obligations under the Agreement with respect to the foregoing.

NOW, THEREFORE, in consideration of the mutual representations, warranties and covenants set forth in the Agreement, as amended, and in this Second Amendment and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Gen-Probe and Grifols agree as follows:

“1.48    “Territory” shall mean the entire world, subject to Section 3.1.9(g).”

“1.57    “Out-of-Box Failure” shall mean a Blood Screening Instrument, or a component or module thereof, purchased from Gen-Probe hereunder, which, when opened and installed or made ready for use at its final destination, fails to operate in accordance with the applicable specifications for such Blood Screening Instrument, or component or module thereof.”

“(g)    Sales to the Thai Red Cross (“TRC”). The TRC may tender with a mix of pooling and Individual Donation Testing (IDT) and, therefore, the parties have identified a price structure for both pooling in mini-pools of four (4) and IDT as outlined in this Section 3.1.9(g).

    

 

(g) shall only become effective if Grifols is the prevailing party in a future national tender expected to be offered by the TRC between the effective date of the Second Amendment of this Agreement and the end of the 2016 calendar year (hereinafter, collectively, the “TRC Tender”), and will apply as of the first invoice Grifols issues to the TRC for the sale of Products in Thailand. Grifols, or its Affiliate, as applicable, shall compensate Gen-Probe for the aforementioned sale of Blood Screening Assays in accordance with Section 6.1 of this Agreement as modified by this Section 3.1.9(g). Subject to Section 1.3.3 of this Agreement, with respect to each Blood Screening Assay sold in Thailand to the TRC pursuant to the TRC Tender, the “Applicable Purchase Price” shall mean, on a per unit basis, the price calculated as follows (the “Applicable Purchase Price for Thailand”):

For the avoidance of doubt, the parties acknowledge and agree that the Applicable Purchase Price for Thailand only applies to the initial term of the TRC Tender and, unless otherwise mutually agreed by the parties, the Applicable Purchase Price shall revert to the standard formula set forth in the Agreement without giving effect to the terms of this Section 3.1.9(g) for any renewal or extension of the TRC Tender beyond the initial term of the TRC Tender.

“5.7    Warranty.

5.7.1    Blood Screening Instruments. Except as otherwise set forth in Section 5.7.4 below, Gen-Probe warrants to Grifols that all the Blood Screening Instruments delivered to Grifols pursuant to this Agreement shall conform to the applicable specifications, shall be free from defects in material and workmanship, and shall be manufactured in compliance with applicable laws and regulations. Except as otherwise set forth in Section 5.7.4 below, the foregoing warranties with respect to Blood Screening Instruments shall apply until the earlier to occur of (a) eighteen (18) months from the date of shipment of the Blood Screening Instrument from Gen-Probe to Grifols (or Grifols’ designee) or (b) twelve months following installation of the Blood Screening Instrument at Grifols’ Customer location.

5.7.2    Blood Screening Assays. Gen-Probe warrants to Grifols that all the Blood Screening Assays delivered to Grifols pursuant to this Agreement shall conform to the applicable specifications, shall be free from defects in material and workmanship, and shall be manufactured in compliance with applicable laws and regulations. The foregoing warranties with respect to Blood Screening Assays shall apply until the expiration date of each such Blood Screening Assay.

5.7.3    Out-of-Box Failure Reporting. Grifols acknowledges that certain Blood Screening Instruments are manufactured for Gen-Probe by subcontract manufacturers and that Gen-Probe has represented that it is entitled to submit certain warranty claims to such subcontract manufacturers pursuant to the terms of the agreements between Gen-Probe and such subcontract manufacturers. To facilitate Gen-Probe’s efforts to maximize recoveries for warranty claims that may be submitted to such subcontract manufacturers, Grifols commits to reporting at least ninety percent (90%) of all module failures and Out-of-Box Failures to Gen-Probe each calendar quarter on a timely basis and pursuant to a warranty recovery process mutually agreed to by Gen-Probe and Grifols.

5.7.4    Pass-Through Warranty. Notwithstanding anything to the contrary set forth elsewhere in this Agreement, to the extent a Blood Screening Instrument is manufactured by a subcontract manufacturer(s), in whole or in part, and such subcontract manufacturer(s) provide(s) a warranty on the Blood Screening Instrument, in whole or in part, Gen-Probe shall not provide Grifols any warranty on any such Blood Screening Instruments manufactured by a subcontract manufacturer(s) (or any applicable part(s) thereof) other than the warranty(ies) offered by such subcontract manufacturer(s). Gen-Probe agrees to provide warranty information (including, without limitation, information on the process for submitting warranty claims, warranty claim requirements, list of applicable Blood Screening Instrument parts and their warranty periods) to Grifols on any and all Blood Screening Instruments (or any applicable parts(s) thereof) manufactured by a subcontract manufacturer upon Grifols’ request. Notwithstanding anything to the contrary contained in this Agreement, such warranty information as updated from time to time by any subcontract manufacturer(s) shall be (a) provided by Gen-Probe to Grifols so that Grifols has notice of such updates, and (b) automatically made a part of this Agreement as if fully set forth herein and incorporated by reference without the necessity of an amendment therewith. Except as otherwise set forth in Section 5.4.2(c) of this Agreement with respect to certain Spare Parts, and to the extent that Grifols and Gen-Probe have mutually agreed that Gen-Probe shall be

the sole provider to Grifols of certain Blood Screening Instruments (or any applicable part(s) thereof) or Spare Parts, Gen-Probe shall be the sole authorized party to process returns or credits relating to warranties for such Blood Screening Instruments (or any applicable part(s) thereof) and Spare Parts that are manufactured by a subcontract manufacturer. As of the effective date of this Second Amendment, Grifols acknowledges that Gen-Probe is the sole provider to Grifols of Tigris Instruments, Panther Instruments and Spare Parts for the Panther Instrument and, accordingly, Gen-Probe is the sole authorized party to process returns or credits relating to warranties for Tigris Instruments, Panther Instruments and Spare Parts for the Panther Instrument.

5.7.5    LIMITATION OF LIABILITY. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, GEN-PROBE MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS. GEN-PROBE DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.

5.7.6    Complaint Resolution. The parties agree that prompt investigation is required of any complaint concerning product quality, in order to minimize product scrap and provide optimal customer service. The parties shall use best efforts to respond promptly to any complaint that potentially implicates product quality, in accordance with the September 19, 2013 Quality Agreement for Alliance Partnership and the parties’ “Complaint Handling Plan.”

“6.3    Invoicing.

By Regular Mail:

Grifols Diagnostic Solutions Inc.

Attention: Accounts Payable

2410 Lillyvale Avenue

Los Angeles, California 90032

Invoicing by Electronic Mail:

Gen-Probe may also send electronic invoices to ***@***

(or such address as Grifols may provide to Gen-Probe under separate cover).

**On the subject line of the email note the following information in the specific order listed as follows:

“If to Grifols:    Grifols Diagnostic Solutions Inc.

Attention: President

4560 Horton Street

Emeryville, CA 94608

Carbon copy to:

Grifols Diagnostic Solutions Inc.

Attention: Assistant General Counsel

4560 Horton Street

Emeryville, CA 94608”

The remainder of Section 12.1 shall remain unmodified.

the Product Development Addendum for the Panther Instrument and Ultrio Elite Assay), other than the instrument credits contemplated hereby.

All of the other tables, addenda, terms and conditions of the Agreement shall continue in full force and effect. This Second Amendment, together with the Agreement, as amended, constitute the entire agreement between the parties hereto regarding the subject matter hereof and supersede any prior or contemporaneous agreement, understanding or negotiations with respect to such subject matter.

If there is any conflict between the Agreement, as amended, and any provision of this Second Amendment, this Second Amendment will control. Except as otherwise provided in this Second Amendment, the Agreement will continue in full force according to its terms.

This Second Amendment may be signed by the parties in counterparts, which signatures, taken as a whole, shall constitute an effective Amendment. Signature pages sent via facsimile or e-mail shall be deemed valid and binding to the same extent as the original, provided that the parties promptly provide originally signed documents thereafter.

IN WITNESS WHEREOF, the parties hereto, through their authorized representatives have set their hands below, whereby they evidence their intent to be legally bound as of the effective date of this Second Amendment.