EX-10.11 14 dex1011.htm BUY-BACK AGREEMENT Portions of this exhibit marked [*] are requested to be treated confidentially. AGREEMENT
EXHIBIT 10.11
Portions of this exhibit marked [*] are requested to be treated confidentially.
AGREEMENT
THIS AGREEMENT (“Agreement”) is entered into as of July 13, 2005 between Takeda San Diego, Inc., a Delaware corporation having its principal place of business at 00000 Xxxxxxx Xxxxxx Xxxxx, Xxx Xxxxx, XX 00000, (formerly known as Syrrx, Inc.) (“TSD”), TAKEDA PHARMACEUTICAL COMPANY LIMITED, a corporation organized under the laws of Japan, having its principal place of business at 0-0 Xxxxxxxxxx 0-xxxxx, Xxxx-xx, Xxxxx, Xxxxx (hereinafter “TPC”), Development Partners, LLC, a Delaware limited liability company having its principal place of business at 0000 Xxxxx 00xx Xxxxxx, Xxxxxxxxxx, XX 00000 (“PPD”), and Pharmaceutical Product Development, Inc., a North Carolina corporation having its principal place of business at 0000 Xxxxx 00xx Xxxxxx, Xxxxxxxxxx, XX 00000 (“PPD, Inc.”). TSD, TPC, and PPD and PPD, Inc. are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.
WHEREAS, TSD, PPD and PPD, Inc. entered into a Collaboration Agreement (as defined below);
WHEREAS, Takeda America Holdings, Inc., a New York corporation having its principal place of business at New York, NY (“Takeda”), acquired TSD effective March 16, 2005;
ARTICLE 1
1.1 “Affiliate” means, (a) with respect to TSD, (i) TPC; (ii) Takeda or (iii) a particular person, corporation, partnership, or other entity that controls, is controlled by or is under common control with TSD, TPC or Takeda; and (b) with respect to PPD, (i) PPD, Inc. or (ii) a particular person, corporation, partnership, or other entity that controls, is controlled by or is under common control with PPD or PPD, Inc. For the purposes of
the definition in this Section 1.1, the word “control” (including, with correlative meaning, the terms “controlled by” or “under the common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct the management and policies of such entity, whether by the ownership of at least fifty percent (50%) of the voting stock of such entity, or by contract or otherwise.
1.2 “BLA” means a biologics license application with the FDA as more fully described at 21 CFR § 601.2, or successor equivalent.
1.3 “Collaboration Agreement” means the collaboration agreement entered into among PPD, PPD, Inc. and TSD (then Syrrx, Inc.) effective as of November 19, 2003 to discover, develop, and commercialize serine protease dipeptidyl peptidase IV inhibitors as human drug products.
1.4 “Collaboration Compound” means any serine protease dipeptidyl peptidase IV inhibitor [*] that (a) has [*] as measured internally by TSD using a [*] assay specific for the Target; or (b) has [*] and has not been shown to have [*] the Target, a list of which has been delivered to PPD by TSD.
1.5 “Collaboration Patent Estate” means (a) those Patents set forth in Schedule 1.5 and any continuation, division, continuation-in-part or foreign equivalents thereof, and (b) any Patents and any continuation, division, continuation-in-part or foreign equivalents thereof that claim a Collaboration Compound, regardless of the nature of the claim (i.e. composition of matter, process, method, etc.).
1.6 “Combination Product” means a formulation including two or more active pharmaceutical ingredients, or a package including two or more different pharmaceutical products, which includes Compound as one of the active pharmaceutical ingredients but does not include a Takeda Proprietary Compound as one of the active pharmaceutical ingredients.
1.7 “Compound” means (a) any Collaboration Compound; and (b) any serine protease dipeptidyl peptidase IV inhibitor discovered by TSD [*] that falls within the scope of the Collaboration Patent Estate. For sake of clarity, an inhibitor of the Target is specifically excluded from the definition of a Compound if such inhibitor (a) has [*] and has been shown to have [*] the Target, or (b) was Controlled by Takeda or an Affiliate of Takeda other than TSD [*].
1.8 “Confidential Information” shall have the meaning set forth in Section 8.1.
1.9 “Control” means, with respect to an item of Information, Material or Intellectual Property right that a Party owns or has a license to, that the Party has the ability to disclose, assign and/or grant a license or sublicense as provided for by this Agreement under such Information, Material or Intellectual Property right without violating the terms of any agreement or other arrangement with any Third Party.
1.10 “CTM” means a Product that is in a finished pharmaceutical dosage form that is (a) suitable for administration and dosing to humans in clinical trials, but (b) not suitable for commercial sale (for example, without limitation, not in packaged form such as blister packs or other containers and not including external packaging and package inserts).
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
1.11 “Development Plan” means the 322 Development Plan and such other development plans that TSD or its Affiliates may prepare in the future (for other Compounds), by which TSD or its Affiliates intend to achieve Regulatory Approval of a Product, including, but not limited to, a description of the CMC, preclinical, clinical, and regulatory activities, with estimated timelines necessary to achieve such approval in the Field in the Territory.
1.12 “322 Development Plan” means the Development Plan for SYR110322 as shown in Schedule 1.12.
1.13 “Diligent Efforts” means the carrying out by TSD, its Affiliate or its licensees or subcontractors of obligations or tasks in a sustained manner consistent with the commercially reasonable efforts TSD and its Affiliates devote to a research, development or marketing project for a pharmaceutical product or products of similar market potential, profit potential or strategic value resulting from its own research efforts, based on conditions then prevailing. Diligent Efforts includes, but is not limited to the requirement that TSD and its Affiliates use commercially reasonable efforts to carry out its obligations in accordance with timelines set forth in a Development Plan by: (a) promptly assigning responsibility for such obligations to specific employee(s) who are held accountable for progress and monitor such progress on an on-going basis, (b) setting and consistently seeking to achieve specific and meaningful objectives for carrying out such obligations, and (c) consistently making and implementing decisions and allocating resources designed to advance progress with respect to such objectives. The Parties understand and agree that delays outside the control of TSD may occur with regard to the clinical development of Compounds and that the occurrence of such delays, in and of themselves, shall not be grounds for PPD to claim that a material breach of this Agreement has occurred so long as TSD used Diligent Efforts to avoid the occurrence of such delays, and is using Diligent Efforts to reduce the impact of such delays following their occurrence.
1.14 “Drug Substance” means a Compound together with any formulation ingredients, that is suitable for administration and dosing to animals, other than humans.
1.15 “Effective Date” means the last date on which the Parties executed this Agreement.
1.16 “EMEA” means the European Medicine Agency.
1.17 “EU” means the European Union established under the Maastricht Treaty on February 7, 1992, as amended from time to time.
1.18 “FDA” means the United States Food and Drug Administration, or a successor federal agency thereto.
1.19 “Field” means all treatments of humans using a Product.
1.20 “Finished Product” means a Product in a finished pharmaceutical dosage form that is suitable for commercial sale (for example, without limitation, in packaged form such as blister packs or other containers and including external packaging and package inserts).
1.21 “First Commercial Sale” means the first sale of a Product by TSD, its Affiliates or its licensees for use, consumption or resale of such Product in a country
where Regulatory Approval of such Product has been obtained by TSD, its Affiliates or its licensees. Sale of a Product by TSD to an Affiliate of TSD or a licensee of TSD shall not constitute a First Commercial Sale unless such Affiliate or such licensee is the end user of the Product.
1.22 “Good Clinical Practices” or “GCP” means current Good Clinical Practices as specified in the United States Code of Federal Regulations, at the time of testing, and all FDA and ICH guidelines, including the ICH Consolidated Guidelines on Good Clinical Practices.
1.23 “Good Laboratory Practices” or “GLP” means current Good Laboratory Practices as specified in the United States Code of Federal Regulations at 21 CFR §58 at the time of testing and all applicable ICH guidelines.
1.24 “Good Manufacturing Practices” or “GMP” means current Good Manufacturing Practices and standards as provided for (and as amended from time to time) in European Community Directive 91/356/EEC (Principles and Guidelines of Good Manufacturing Practice for Medicinal Products) and in the Current Good Manufacturing Practice Regulations of the United States Code of Federal Regulations Title 21 (21 CFR §§210-211) in relation to the production of pharmaceutical intermediates and active pharmaceutical ingredients, as interpreted by ICH Harmonized Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, and subject to any arrangements, additions or clarifications agreed from time to time between the Parties.
1.25 “HSR Act” means Xxxx-Xxxxx-Xxxxxx Antitrust Improvement Act of 1976, as amended.
1.26 “IND” means an Investigational New Drug Application for a Product filed with the FDA necessary to commence human clinical trials in conformance with applicable laws and regulations.
1.27 “Information” means information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including without limitation, databases, inventions, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and patent and other legal information or descriptions.
1.28 “Intellectual Property” means (a) all Regulatory Documentation, all Regulatory Filings and all Regulatory Approvals; and (b) any and all inventions, developments, results, know-how and other Information (including physical, chemical or biological materials) made, conceived or reduced to practice by PPD or its Affiliates before the Effective Date or during the Term of this Agreement, whether alone or jointly with TSD and its Affiliates or a Third Party that (i) relates to the composition of matter, manufacture or use of a Compound, or (ii) is incorporated into any Product or its use, or (iii) is necessary for the discovery, identification, manufacture, development, or commercial use or sale of any Product.
1.29 “Joint Development Committee” or “JDC” means a committee composed as set forth in Section 4.5 and having the duties set forth in Section 4.6.
1.30 “MAA” means Marketing Authorization Application submitted to the EMEA.
1.31 “Marketing Authorization” means any Regulatory Approval required to market and sell a Product in any country.
1.32 “Marketing Plan” means an annual marketing plan prepared by TSD, its Affiliates or licensees or subcontractors, that includes, but is not limited to, a prospective description of TSD’s commercial objectives for the upcoming year with respect to a Product throughout the Territory and the strategy by which TSD intends to achieve such objectives.
1.33 “Material” means any tangible material that comprises, consists of, or incorporates a Collaboration Compound and any precursor, prodrug, metabolite, ionized form (e.g., salt), solvate (e.g., hydrate), stereoisomer (e.g., enantiomer, diastereomer, mixture of isomers), resonant form, or tautomer thereof.
1.34 “NDA” means a New Drug Application submitted and filed with the FDA necessary for approval of a Product in conformance with applicable laws and regulations.
1.35 “Net Sales” means the total gross amount billed or invoiced in United States dollars (or converted into US dollars in accordance with this Agreement) by TSD, its Affiliates, or licensees for sales of Products to a Third Party less, to the extent included within the amount invoiced to and paid by the customer, deductions for: (a) transportation charges, and other charges, such as insurance, relating thereto, (b) sales and excise taxes, customs and any other taxes, all to the extent imposed upon the sale of the Products and paid by the selling party and not refundable in accordance with applicable law (but not including taxes assessed against the income derived from such sale), (c) rebates or allowances actually granted or allowed to group purchasing organizations, managed health care organizations and to governments, including their agencies, or to trade customers, in each case that are not Affiliates or licensees of TSD, (d) quantity discounts, cash discounts or chargebacks actually granted, allowed or incurred in the ordinary course of business in connection with the sale of the Products, and (e) allowances or credits to customers, not in excess of the selling price of the Products, on account of governmental requirements, rejection, outdating recalls or return of the Products. Such amounts shall be determined from the books and records of TSD maintained in accordance with GAAP or another generally accepted accounting method agreed by the Parties, consistently applied. In the event a Product is sold as part of a Combination Product or a Takeda Combination Product, Net Sales for purposes of determining royalty and milestone payments hereunder, shall be as follows:
(i) Net Sales in United States of Combination Products and Takeda Combination Products [*]: As long as [*], Net Sales of a Combination Product or a Takeda Combination Product, as the case may be, for purposes of determining royalty and milestone payments hereunder, shall be [*]% of Net Sales of such Combination Product or Takeda Combination Product, as the case may be. For sake of clarity, [*] shall not, in and of themselves, cause a Combination Product or a Takeda Combination Product to be [*] pursuant to this Subsection 1.35(i).
(ii) Net Sales in United States of Takeda Combination Products Not Subject to Section 1.35(i) [*]: In regard to Takeda Combination Products that are not subject to Section 1.35(i), for the [*] period commencing on [*], Net
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
Sales of such Takeda Combination Product for purposes of determining royalty and milestone payments hereunder, shall be [*]% of Net Sales of such Takeda Combination Product. For sake of clarity, [*] shall not, in and of themselves, cause a Takeda Combination Product to be [*] pursuant to this Subsection 1.35(ii).
(iii) Net Sales in United States of Combination Products or Takeda Combination Products Not Subject to Sections 1.35(i-ii) [*]: In regard to Combination Products and Takeda Combination Products that are not subject to Sections 1.35(i-ii), for the [*] period commencing on [*], Net Sales of such Combination Product or Takeda Combination Product, as the case may be, for purposes of determining royalty and milestone payments hereunder, shall be [*]% of Net Sales of such Combination Product or Takeda Combination Product, as the case may be. For sake of clarity, [*] shall not, in and of themselves, cause a Combination Product or a Takeda Combination Product to be [*] pursuant to this Subsection 1.35(iii).
(iv) Net Sales in United States of Takeda Combination Products Not Subject to Sections 1.35(i-iii) [*]: In regard to Takeda Combination Products that are not subject to Sections 1.35(i-iii), for the period commencing on [*], Net Sales of a Takeda Combination Product for purposes of determining royalty and milestone payments hereunder, shall be [*]% of Net Sales of such Takeda Combination Product.
(v) Net Sales in United States of Combination Products Not Subject to Section 1.35(i) or Section 1.35(iii) [*]: In regard to Combination Products that are not subject to Section 1.35(i) or Section 1.35(iii), for the period commencing on [*], Net Sales of such Combination Product for purposes of determining royalty and milestone payments hereunder, shall be [*]% of Net Sales of such Combination Product.
(vi) Net Sales outside of United States of Takeda Combination Products and Combination Products: Net Sales outside of the United States for Takeda Combination Products and Combination Products, for the purpose of determining royalty and milestone payments hereunder, shall be determined on a country by country basis by multiplying the actual Net Sales of the Takeda Combination Product or Combination Product by the fraction [*], where A is [*] and B is [*]. Where available in a given country, the [*] or [*] for the other product(s) in the given country will be used as [*]. In the event that such [*] cannot be determined for either the Product or other product(s) in the Combination Product or the Takeda Combination Product, Net Sales for purposes of determining royalty payments hereunder shall be calculated by multiplying the Net Sales of the Combination Product or Takeda Combination Product by the fraction [*], where C is [*] and D is [*], determined in accordance with GAAP or another generally accepted accounting method agreed by the parties, consistently applied. PPD shall have the right to inspection to verify the accuracy of the calculation of the Net Sales in accordance with Section 6.5.
A sale of Product shall be deemed to have occurred upon the invoicing of such Product to a Third Party; or if not invoiced, then when delivered, shipped, or paid for, whichever
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
first occurs, provided that there shall be no double counting of sales if a sale is deemed to have occurred when Product is delivered to a Third Party. For purposes of clarification, a sale of a Product shall be deemed to be made in a particular country when the Product sold is intended for use by consumers in such country. In the case of a sale or other disposal of a Product for value other than in an arm’s-length transaction exclusively for money, such as barter or counter-trade, the amount of such sale shall be calculated using the fair market value of such Product (if higher than the stated sales price) in the country of disposition.
1.36 “Party” or “Parties” shall have the meaning set forth in the first paragraph of this Agreement.
1.37 “Patent” means (a) an unexpired letters patent (including inventor’s certificates) issued anywhere in the world which has not been held invalid or unenforceable by a court of competent jurisdiction from which no appeal can be taken or has been taken within the required time period, including without limitation any substitution, extension, registration, confirmation, reissue, re-examination, renewal or any like filing thereof, or (b) a pending application for a letters patent pending anywhere in the world, including without limitation any continuation, division or continuation-in-part thereof and any provisional applications.
1.38 “Permitted Seller” means TSD and any Affiliate, licensee or sublicensee having the right to sell Product, including without limitation, TPC and any permitted licensee of TPC.
1.39 “Phase II Trial” means a clinical trial of a Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Product is safe for its intended use and to obtain sufficient information about such Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b).
1.40 “Phase III Trial” means that portion of the clinical development program that provides for the pivotal human clinical trials of a Product, which trial(s) is/are designed to (a) establish that such Product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the Product in the dosage range to be prescribed; (c) be a pivotal study for submission of a NDA; and (d) be generally consistent with 21 CFR §312.21(c).
1.41 “Phase III Development Costs” means all development costs incurred by either Party with TSD’s prior approval under the Collaboration Agreement for (a) direct support of the performance of a Phase III Trial or (b) process development for a Product in a Phase III Trial. For clarity, Phase III Development Costs include costs to formulate and manufacture Phase III Trial CTM.
1.42 “PMDA” means the Pharmaceutical and Medical Devices Agency in Japan.
1.43 “PPD Product” means a human therapeutic product that comprises SYR110322, SYR110619, [*] that PPD develops under this Agreement by electing to exercise its option as to a PPD Product pursuant to Article 12.
1.44 “Product” means a human therapeutic product that comprises, consists of, or
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
incorporates a Compound that has less than [*], or has [*] and has not been shown to have [*] the Target, including a prodrug, metabolite, ionized form (e.g., salt), solvate (e.g., hydrate), stereoisomer (e.g., enantiomer, diastereomer, mixture of isomers), resonant form, or tautomer of such Compound together with any formulation ingredients, regardless of the formulation or mode of administration of such Product. For sake of clarity, Product includes Combination Products and Takeda Combination Products.
1.45 “Regulatory Approval” means any and all approvals (including supplements, amendments, pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations or authorizations of any national, supra-national (e.g., the European Commission or the Council of the EU), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, that are necessary for the manufacture, distribution, use or sale of a Product in a regulatory jurisdiction.
1.46 “Regulatory Documentation” means, with respect to a Product, all regulatory filings and supporting documents created, submitted to the FDA or any equivalent agency or government authority outside of the United States (including any supra-national agency such as in the EU) relating to such Product, and all data contained therein, including, without limitation, the contents of any IND(s), NDA(s), BLA(s), Drug Master File, correspondence to and from the FDA or any equivalent agency or governmental authority outside of the United States, minutes from meetings (whether in person or by audio conference or videoconference) with regulatory authorities, registrations and licenses, regulatory drug lists, advertising and promotion documents shared with regulatory authorities, adverse event files, complaint files and manufacturing records.
1.47 “Regulatory Filing” means the NDA or BLA or IND or any foreign counterparts thereof and any other filings required by any regulatory agency, department, bureau, commission, council or other governmental entity in a regulatory jurisdiction relating to the study, development, manufacture or commercialization of any Product.
1.48 “Serious Adverse Event” means any adverse event related to a Product that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a Serious Adverse Event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
1.49 “Takeda Combination Product” means a formulation including two or more active pharmaceutical ingredients, or a package including two or more different pharmaceutical products, which includes a Compound and at least one Takeda Proprietary Compound.
1.50 “Takeda Proprietary Compound” means an active pharmaceutical ingredient that (i) [*], (ii) is not a Compound, (iii) either (x) is Controlled exclusively or
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
semi-exclusively in a country or a region by TSD, TPC or Takeda or an Affiliate thereof, or (y) TSD, TPC or Takeda or an Affiliate thereof has or had exclusive or semi-exclusive rights to commercialize and market such active pharmaceutical ingredient in a country or a region, and (iv) has been incorporated into a pharmaceutical product (including a Product) that was introduced into the commercial market. ACTOS is one example of a Takeda Proprietary Compound.
1.51 “Target” means human serine protease dipeptidyl peptidase IV (DP4).
1.52 “Term” shall have the meaning assigned to it in Section 10.1.
1.53 “Territory” means throughout the world.
1.54 “Third Party” means any individual, corporation, partnership, limited liability company or other entity other than (i) TSD, (ii) PPD or (iii) an Affiliate of either of them.
ARTICLE 2
2.1 Termination of Collaboration Agreement.
(a) TSD and PPD agree that the Collaboration Agreement is hereby terminated in its entirety as of the Effective Date. As of the Effective Date, the Collaboration Agreement shall have no further force or effect (including, subject to Section 2.1(a)(iii), any provisions that would otherwise survive) and no Party thereto shall have any further right or obligation thereunder except that:
(i) PPD shall assign, and TSD shall assume, in an Assignment and Assumption Agreement substantially in the form of Schedule 2.1(a)(i)(1), all contracts with Third Parties under or in connection with the Collaboration Agreement, including investigator sites, that are in existence as of the Effective Date, to the extent assignable; provided, that PPD and TSD shall each use reasonable efforts to obtain any necessary consents from Third Parties promptly after the Effective Date. Schedule 2.1(a)(i)(2) lists all Third Party contracts in existence as of the Effective Date. PPD confirms that it has provided TSD with true and correct copies of all Third Party contracts in existence as of the Effective Date and as listed in Schedule 2.1(a)(i)(2).
(ii) TSD shall have the obligations of payment for services to be performed by PPD pursuant to the Collaboration Agreement as set forth in Section 5.4 of this Agreement; and
(iii) Articles 12, 14, 15, 16, and 17 and Sections 3.4(e)(ii) and 11.1 of the Collaboration Agreement shall survive termination.
(b) Without limiting the generality of the foregoing, following the Effective Date, and except as specifically set forth herein, PPD shall not, directly or indirectly, have any liability or obligation for any cost or expense related to any Compound or Product, including but not limited to costs or expenses for research, development, manufacturing, or commercialization of any Compound or any Product.
rights and licenses granted by TSD to PPD under the Collaboration Agreement shall terminate and revert to TSD, and (b) all rights and licenses granted by PPD to TSD under the Collaboration Agreement shall terminate and revert to PPD.
A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM MUST HAVE MATERIALLY AFFECTED HIS SETTLEMENT WITH THE DEBTOR.
ARTICLE 3
3.4 Notice of New Intellectual Property Developed by PPD After the Effective Date. PPD shall promptly provide TSD with notice of any Intellectual Property that PPD develops following the Effective Date. PPD will promptly provide to TSD information and access to personnel reasonably requested by TSD that is necessary for seeking protection of such Intellectual Property. All expenses incurred by TSD associated with seeking protection of Intellectual Property shall be paid by TSD.
ARTICLE 4
4.2 Design and Modifications to the Development Plan. Except as set forth in Section 4.3, TSD shall consult PPD with regard to the design and implementation of a Development Plan as well as modifications to a Development Plan and take PPD’s suggestions into consideration. Except as set forth in this Section 4.2 and Section 4.3, TSD shall have the right, in its sole reasonable discretion, to modify a Development Plan after TSD consults with PPD about any proposed material changes to a Development Plan and TSD shall give full consideration to any reasonable comments or suggestions by PPD. TSD shall at all times exercise Diligent Efforts in the design, development, implementation, and modification of a Development Plan.
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
4.8 Serious Adverse Event. TSD shall immediately inform PPD in writing of the occurrence of any Serious Adverse Event with regard to a Product.
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
of the Products and biostatistics and data management services related to Phase II-IV trials of the Products. CRO services performed by PPD pursuant to this Section 4.9 shall be governed by that certain Global Master Agreement, Clinical Research Management Services (Phase II-IV) dated July 1, 2004, that certain Global Master Agreement, Bioanalytical Laboratory Services dated September 1, 2004 and that certain Global Master Agreement, Biostatistics and Data Management Services (Phase II-IV) dated July 13, 2005, each of which is executed among TGRD, TeuR&D and PPD Development, LP (the “Takeda MSAs”). Schedule 4.9 includes a description of initial services that will be performed by PPD under the 322 Development Plan. Individual task orders, which more fully describe the specific types of services and activities to be undertaken by PPD for each study under the 322 Development Plan, will be executed under the appropriate Takeda MSA. Each task order will be signed by TSD, as an affiliate of TGRD and TeuR&D. If PPD is asked to perform CRO services for multiple Products at the same time, PPD shall conduct such CRO services for such multiple Products pursuant to the Development Plan for each such Product, and pursuant to guidance from TSD regarding the coordination between such Products as necessary. In case of conflict between this Agreement and the Takeda MSAs regarding the assignment or license of Intellectual Property to TSD, the terms of this Agreement shall prevail.
ARTICLE 5
(a) TSD shall make the milestone payments set forth below to PPD within thirty (30) days of the occurrence of the related milestone events with regard to a Product. Each such milestone payment shall not come due until the related milestone event occurs and shall only be payable upon the first occurrence of the related milestone event. Once TSD provides PPD with payment for the occurrence of a given milestone event, TSD shall have no further obligation to make any further milestone payments to PPD for any future occurrence of such milestone event whether with the same Product or a different Product. TSD shall give PPD notice of the occurrence of a milestone event within five (5) business days of the occurrence of such milestone event.
Milestone Event | Milestone Payment | |
First dosing of any Product to a subject in a Phase III Trial | Fifteen million dollars ($15,000,000) | |
[*] | [*] million dollars ($[*]) | |
[*] | [*] million dollars ($[*]) | |
[*] | [*] million dollars ($[*]) | |
[*] | [*] million dollars ($[*]) | |
[*] | [*] million dollars ($[*]) | |
[*] | [*] million [*] thousand dollars ($[*]) |
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
(b) TSD shall pay to PPD milestone payments in accordance with the schedule set forth below with regard to Products, based on total worldwide Net Sales of all Products for the first consecutive twelve month period during which such sales milestone event is achieved, such payment to be made within thirty (30) days after achievement of such milestone event. Each of the milestone payments listed in Section 5.2(b) shall be payable only once under this Agreement regardless of the number of Products that individually achieve the sales milestone event in a given twelve month period or the number of times a given Product achieves such sales milestone event in a given twelve month period.
Sales Milestone Event | Milestone Payment | |
First time that aggregate worldwide Net Sales of all Products in a twelve consecutive month period exceed [*] dollars ($[*]) | [*] dollars ($[*]) | |
First time that aggregate worldwide Net Sales of all Products in a twelve consecutive month period exceed [*] dollars ($[*]) | [*] dollars ($[*]) |
Such royalties shall be payable on cumulative Net Sales on a Compound by Compound basis and on a country-by-country basis beginning upon the First Commercial Sale of a Product in the country until the later of (a) the [*] year anniversary of the First Commercial Sale of that Product in that country or (b) [*] following [*]. For the avoidance of doubt and except as provided in (a) of the preceding sentence, no royalties shall be payable by TSD with respect to Net Sales of Product after the date that is [*]. Royalties under this Section 5.3 shall be based on cumulative Net Sales of Products containing the same Compound, as calculated in accordance with Section 1.35.
During the [*] period following expiration of all Patents in the Collaboration Patent Estate which [*], the specified royalty rate shall be reduced [*]. For example, if there is at least one Patent in the Collaboration Patent Estate issued in a country that [*] and the applicable royalty rate is [*]%, then for a period of [*] following [*], the royalty rate will be [*]%.
Independent but including the preceding paragraph, the royalty rates set forth in this Section 5.3 shall be reduced by [*] percent ([*]%) if [*]. For example, if the stated royalty rate is [*]%, then the royalty rate is [*]% if [*] and [*]% if the Product [*].
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
(a) | U.S. Net Sales. |
Annual Net Sales in the United States | Royalty rate(s) per annual U.S. Net Sales | |
On the portion of annual Net Sales less than [*] US dollars ($[*]) | [*] percent ([*]%) of Net Sales | |
On the portion of annual Net Sales equal to or greater than [*] US dollars ($[*]) but not greater than [*] US dollars ($[*]) | [*] percent ([*]%) of Net Sales | |
On the portion of annual Net Sales greater than [*] US dollars ($[*]) | [*] percent ([*]%) of Net Sales |
(b) | EU Net Sales. |
Annual Net Sales in the EU | Royalty rate(s) per annual EU Net Sales | |
On the portion of annual Net Sales less than [*] US dollars ($[*]) | [*] percent ([*]%) of Net Sales | |
On the portion of annual Net Sales equal to or greater than [*] US dollars ($[*]) but not greater than [*] US dollars ($[*]) | [*] percent ([*]%) of Net Sales | |
On the portion of annual Net Sales greater than [*] US dollars ($[*]) | [*] percent ([*]%) of Net Sales |
(c) | Japan Net Sales. |
Annual Net Sales in Japan | Royalty rate(s) per annual Japanese Net Sales | |
On the portion of annual Net Sales less than [*] US dollars ($[*]) | [*] percent ([*]%) of Net Sales | |
On the portion of annual Net Sales equal to or greater than [*] US dollars ($[*]) but not greater than [*] US dollars ($[*]) | [*] percent ([*]%) of Net Sales | |
On the portion of annual Net Sales greater than [*] US dollars ($[*]) | [*] percent ([*]%) of Net Sales |
(d) | Rest of World Net Sales. |
Annual Net Sales in all countries (in the aggregate) other than the United States, EU and Japan | Royalty rate(s) per annual Net Sales in all countries (in the aggregate) other than the United States, EU and Japan | |
On the portion of annual Net Sales less than [*] US dollars ($[*]) | [*] percent ([*]%) of Net Sales | |
On the portion of annual Net Sales equal to or greater than [*] US dollars ($[*]) but not greater than [*] US dollars ($[*]) | [*] percent ([*]%) of Net Sales | |
On the portion of annual Net Sales greater than [*] US dollars ($[*]) | [*] percent ([*]%) of Net Sales |
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
5.4 Costs and Expenses. The Parties shall apportion costs and expenses as follows:
(a) PPD shall be solely responsible for all direct and indirect costs and expenses (including internal personnel and other internal costs and expenses) related to Phase II Trials pursuant to the Collaboration Agreement accrued prior to [*]; and
(b) TSD shall reimburse PPD for [*]% of all Phase III Development Costs accrued before [*] and PPD shall be responsible for the remaining [*]% of such costs.
(c) Within six (6) months of the Effective Date, PPD shall submit a final request for reimbursement for any and all monies PPD seeks reimbursement for from TSD under Section 5.4(b) hereof. Schedule 5.4 lists all expenses that are outstanding under Section 5.4(b) as of the Effective Date. TSD shall pay to PPD such amounts owed no later than thirty (30) days after receipt of such final request from PPD.
ARTICLE 6
(a) All payments to PPD pursuant to Article 5 shall be made by Federal Reserve electronic wire transfer in immediately available funds to an account designated by PPD. All payments pursuant to Article 5 and this Section 6.1(a) shall be made in U.S. dollars.
(b) Within forty five (45) days after the close of each calendar quarter in which there are any Net Sales during the Term, TSD shall furnish to PPD a statement of
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
Net Sales of each Product for such calendar quarter setting forth the Net Sales for each country in which Products were sold during such calendar quarter, and a calculation of royalties due pursuant to Section 5.3, together with a payment for royalties due for such quarter. TSD will mail such report to the attention of: Pharmaceutical Product Development, Inc., 0000 Xxxxx 00xx Xxxxxx, Xxxxxxxxxx, Xxxxx Xxxxxxxx, 00000, Attn: Corporate Controller. The amount of royalty payment due to PPD shall be paid by TSD concurrently with the remittance of each royalty report. Interest shall accrue on any payments due under this Agreement (including royalties) not paid when due through and including the date upon which PPD has collected the funds in accordance herewith at a rate equal to the lesser of (i) the sum of [*] percent ([*]%) plus the prime rate of interest quoted in the Money Rates (or equivalent) section of The Wall Street Journal (or any substitute source mutually agreed to by the Parties), calculated daily on the basis of a three hundred sixty (360) day year, or (ii) the maximum interest rate allowed by applicable law. Except as set forth in Section 6.3, payments pursuant to this Section 6.1(b) shall be made in U.S. dollars.
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
have received in the absence of such errors, plus interest pursuant to and in accordance with Section 6.1(b). Inspections conducted under this Section 6.5 shall be at the expense of PPD, unless a variation or error in favor of TSD exceeding [*] percent ([*]%) of the amount stated for the period covered by the inspection is established in the course of such inspection, whereupon all costs relating to the inspection for such period will be paid promptly by TSD.
ARTICLE 7
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
connection with the performance of its respective obligations or the exercise or its respective rights under this Agreement; and/or (iv) the negligence or willful misconduct of PPD or its Affiliates in the performance of this Agreement; except to the extent such Losses result from (1) breach by TSD or its Affiliates of a representation or warranty contained in this Agreement; (2) breach of this Agreement or applicable law by the TSD Indemnitee; and/or (3) the negligence or willful misconduct of the TSD Indemnitee in the performance of this Agreement.
7.6 Clinical Trial Insurance. Prior to TSD initiating any clinical trial with respect to a Compound or Product, TSD shall have and maintain such type and amounts of liability insurance covering the development activities contemplated hereunder and that are normal and customary in the pharmaceutical industry generally for parties similarly situated, and shall name PPD as an additional insured thereunder. TSD shall furnish to PPD certificates evidencing the insurance coverage, including amendments and revisions thereto, within five (5) business days of PPD’s written request.
ARTICLE 8
minimum each Party shall use commercially reasonable efforts), (b) not disclose such Confidential Information to any Third Party without prior written consent of the other Party, and (c) not use such Confidential Information for any purpose except those permitted by this Agreement.
(a) Is publicly disclosed by the disclosing Party, either before or after it is disclosed to the receiving Party hereunder; or
(b) Was known to the receiving Party, without obligation to keep it confidential, prior to disclosure by the disclosing Party; or
(c) Is subsequently disclosed to the receiving Party by a Third Party lawfully in possession thereof and without obligation to keep it confidential; or
(d) Has been published by a Third Party; or
(e) Has been independently developed by the receiving Party without the aid, application or use of all or any part of Confidential Information.
For purposes of clarification, all Information and Intellectual Property, including without limitation all Regulatory Filings, all Regulatory Documentation and all Regulatory Approvals assigned by PPD to TSD pursuant to Section 3.1, shall be deemed Confidential Information of TSD and shall not be subject to the exceptions set forth in (b) and/or (e) in this Section 8.2.
(a) Prosecuting or defending litigation;
(b) Complying with applicable court order, law, governmental regulations or the rules of any national securities exchange or association; and
(c) Disclosure, in connection with the performance of this Agreement, to licensees, research collaborators, employees, consultants, or agents, each of whom prior to disclosure must be bound by similar obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Article 8.
The Parties acknowledge that the terms of this Agreement shall be treated as Confidential Information of both Parties. Such terms may be disclosed by a Party to investment bankers, investors, potential investors, lenders and other financing parties, provided that they are bound by similar obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Article 8. In addition, a copy of this Agreement may be filed by either Party with the Securities and Exchange Commission if such filing is required by law or regulation. In connection with any such filing, such Party shall endeavour to obtain confidential treatment of such terms and other trade secret information to the extent permitted by the Securities and Exchange Commission. Notwithstanding the foregoing, the Parties shall have the right to publicly disclose the financial information regarding this Agreement as set forth in Schedule 8.3.
ARTICLE 9
REPRESENTATIONS AND WARRANTIES AND COVENANTS
(a) Such Party is duly organized and validly existing and in good standing under the laws of the jurisdiction of its organization;
(b) Such Party has the full power and is duly authorized to enter into, execute and deliver this Agreement, and to carry out and otherwise perform its obligations hereunder;
(c) This Agreement has been duly executed and delivered by, and is the legal and valid obligation binding upon such Party and the entry into, the execution and delivery of, and the carrying out and other performance of its obligations under this Agreement by such Party (i) does not conflict with, or contravene or constitute any default under, any agreement, instrument or understanding, oral or written, to which it is a party, and (ii) does not violate applicable law or any judgment, injunction, order or decree of any government authority having jurisdiction over it; and
(d) Such Party does not, to its knowledge, employ and will not, to its knowledge, employ, or use, a person or entity debarred under Section 306(a) or (b) of the Federal Food, Drug, and Cosmetic Act. Further, such Party, to its knowledge, does not employ and, to its knowledge, has not used a contractor or consultant that has employed, any individual or entity debarred by the FDA, or, to the knowledge of such Party, any individual who or entity which is the subject of an FDA debarment investigation or proceeding.
(a) To PPD’s knowledge PPD has the right and authority to make the assignments and to grant the rights and licenses specified in Article 3 to TSD in all material respects;
(b) PPD’s interest in Intellectual Property arising under the Collaboration Agreement are free and clear of any lien, encumbrance, security interest or restriction;
(c) PPD has not granted any right, license or interest in, to or under the Intellectual Property inconsistent with the assignment and license rights granted to TSD under Article 3;
(d) PPD has no knowledge of any actions, suits, investigations, claims or proceedings pending or threatened relating to the Intellectual Property;
(e) To PPD’s knowledge, PPD has conducted research, development and other activities under the Collaboration Agreement in compliance with all applicable laws, regulations, standards, and guidelines in force in the United States, including, but not limited to, the GCP, GLP, and GMP;
(f) PPD has disclosed to TSD all material Information regarding the Products in PPD’s possession, including, but not limited to, all safety data and information;
(g) DISCLAIMER OF PPD IMPLIED WARRANTIES. EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE, PPD MAKES NO REPRESENTATION OR WARRANTY THAT THE USE OF INTELLECTUAL PROPERTY WILL NOT VIOLATE ANY INTELLECTUAL PROPERTY RIGHTS OF ANY PERSON. PPD SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED OR STATUTORY WARRANTIES INCLUDING WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE WITH REGARD TO THE LIKELIHOOD OF SUCCESS OF PRODUCT AFTER THE EFFECTIVE DATE, PROVIDED HOWEVER, THAT NOTHING IN THIS SECTION 9.2(g) SHALL BE CONSTRUED AS LIMITING PPD’S OBLIGATION TO DISCLOSE INFORMATION PURSUANT TO SECTION 2.3 AND 3.3 HEREUNDER TO TSD.
(a) PPD covenants that it will not discover, develop, or commercialize any product directed to the Target;
(b) PPD covenants that it will not acquire from any Third Party the right to discover, develop, or commercialize any product directed to the Target;
(c) PPD covenants that it will not enter into any agreement in which any Third Party pursuant to such agreement discovers, develops, or commercializes any product directed to the Target; and
(d) PPD covenants that it will not invest in any Third Party that, to PPD’s knowledge at the time such investment is made, is engaged or intends to engage in the discovery, development or commercialization of any product directed to the Target.
Notwithstanding the foregoing covenants, PPD may provide services to Third Parties in connection with the preclinical and clinical development of one or more inhibitors of the Target and products containing or comprising such inhibitors, provided that (a) such services are limited to those that are usual and customary for clinical research organizations in general and PPD in particular; and (b) PPD shall not retain (1) any right, title, interest or license in any such inhibitor; or (2) any right to receive (directly or indirectly) any consideration in connection with the subsequent development, regulatory filings, regulatory approval, promotion or sales of such inhibitors or products (other than normal and customary fees and expenses charged by PPD for any such services).
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
ARTICLE 10
ARTICLE 11
11.3 Enforcement of Intellectual Property Rights
(a) If PPD believes that a Third Party is or may be infringing a Patent in the Collaboration Patent Estate with respect to such Third Party’s serine protease dipeptidyl peptidase IV inhibitor, PPD shall immediately provide TSD notice of such belief and the related facts in reasonable detail to allow TSD to assess the potential infringement.
(b) If a Third Party infringes a Patent in the Collaboration Patent Estate with respect to such Third Party’s serine protease dipeptidyl peptidase IV inhibitor, TSD or its Affiliate shall have the sole right (but not the obligation) to pursue any and all injunctive relief, and any or all compensatory and other remedies and relief (collectively, “Remedies”), against such Third Party.
ARTICLE 12
12.1 PPD Option #1 to Develop PPD Products. PPD may elect to pursue the development and commercialization of one or more of SYR110322, SYR110619, [*] as a PPD Product at such time that TSD is not actively developing or commercializing at least one of SYR110322, SYR110619, [*] (“PPD Option #1”).
12.2 PPD Option #2 to Develop PPD Products. In the event that (a) PPD provides TSD with notice that a material breach has occurred under the Agreement with regard to TSD’s failure to use Diligent Efforts to develop SYR110322, SYR110619, [*]; (b) TSD does not make substantial sustained efforts to effect a cure of such material breach within ninety (90) days of receipt of such written notice by PPD where such substantial sustained efforts are reasonably likely to cure such breach; and (c) PPD provides notice that that such material breach has not been cured, then PPD may pursue the development and commercialization of the Compound that was the subject of the material breach as a PPD Product if PPD provides notice to TSD within one (1) year from the date of written notice of such material breach (“PPD Option #2”).
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
effective on a Compound by Compound basis following the exercise of PPD Option #1 or PPD Option #2 pursuant to Sections 12.1-12.3, subject to the expiration or earlier termination of any notice and waiting period under the HSR Act, if necessary. Any costs not otherwise reimbursed by PPD for licenses to Third Party intellectual property rights acquired pursuant to Section 5.5, to the extent transferred (TSD does not assure their transferability) from TSD to PPD at PPD’s request, shall be immediately reimbursed by PPD.
12.5 TSD Obligations Following PPD’s Exercise of Option #1 or Option #2. At such time that PPD exercises PPD Option #1 or PPD Option #2 pursuant to Section 12.3, the PPD License shall become effective. Promptly following effectiveness of the PPD License, TSD shall deliver to PPD any and all data and documentation in TSD’s Control relating to the development of such elected Compound. TSD shall also promptly notify PPD if it later discovers any data or documentation in TSD’s Control related to the development of such elected Compound that was not previously delivered to PPD and shall promptly deliver such to PPD. TSD shall also transfer to PPD the legal title to the associated INDs presently on file and any comparable filings in other countries of the Territory for such elected Compound. TSD shall also transfer to PPD ownership of all Drug Substance, CTM and Finished Product of such elected Compound and any other Material in TSD’s possession as of the time such option is exercised.
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
12.10 Specific Performance as Remedy for Breach of Section 12.5. The Parties agree that following PPD’s proper exercise of PPD Option #1 or PPD Option #2 pursuant to Sections 12.1-12.3, should TSD fail to reasonably comply with its obligations under Section 12.5, then, following such breach, PPD shall have the right to seek specific performance by TSD of its obligations under Section 12.5.
ARTICLE 13
13.2 Governing Law. Resolution of all disputes arising out of or related to this Agreement or the performance, enforcement, breach or termination of this Agreement and any remedies relating thereto, shall be governed by and construed under the substantive laws of the State of New York, without regard to conflicts of law rules that would provide for application of the law of a jurisdiction outside New York.
For TSD: | Takeda San Diego, Inc. | |
00000 Xxxxxxx Xxxxxx Xxxxx | ||
Xxx Xxxxx, XX 00000 | ||
Fax: (000) 000-0000 | ||
Attention: General Counsel | ||
With a copy to: | Takeda Pharmaceutical Company Limited | |
0-0 Xxxxxxxxxx 0-xxxxx, Xxxx-xx, Xxxxx, Xxxxx | ||
Fax: 00-0-0000-0000 | ||
Attention: General Manager, Legal Department | ||
For PPD: | Development Partners, LLC | |
0000 Xxxxx 00xx Xxxxxx | ||
Xxxxxxxxxx, XX 00000 | ||
Fax: (000) 000-0000 | ||
Attention: President |
With a copy to: | Pharmaceutical Product Development, Inc. | |
0000 Xxxxx 00xx Xxxxxx | ||
Xxxxxxxxxx, XX 00000 | ||
Fax: (000) 000-0000 | ||
Attention: General Counsel |
(b) All disputes arising out of or in connection with the Agreement shall be settled by final and binding arbitration by the American Arbitration Association (“AAA”), under its commercial rules then in effect except as provided herein. The arbitration will be conducted in New York, NY or such other geographically neutral site within the United States that is mutually agreed by the Parties. All proceedings shall be held in English and a transcribed record prepared in English. The parties shall choose, by mutual agreement, one arbitrator within twenty (20) days of the filing of an arbitration demand with the AAA. If the parties are unable to appoint an arbitrator within the time herein provided or any extension of time that is mutually agreed on, one arbitrator will be appointed by PPD, one arbitrator will be appointed by TSD, and the third arbitrator will be appointed by the two arbitrators within thirty (30) days of the date on which the initial period for appointment of a sole arbitrator by mutual agreement lapsed. The award rendered by the arbitrator shall include all costs of arbitration, reasonable attorneys’ fees and reasonable costs for expert and other witnesses, and judgment on such award may be entered in any court having jurisdiction thereof. Nothing in this Agreement shall be deemed as preventing either party from seeking injunctive relief (or any other provisional remedy) from any court having jurisdiction over the Parties and the subject matter of the dispute as necessary to protect either Party’s name, proprietary information, trade secrets, know-how or any other proprietary right. If the issues in dispute involve scientific or technical matters, any arbitrator chosen hereunder shall have educational training and/or experience sufficient to demonstrate a reasonable level of knowledge in the field of biotechnology.
(b) TSD and TPC shall be jointly and severally liable for any and all obligations of either of them hereunder. TPC hereby unconditionally and irrevocably guarantees to PPD the performance of all of the obligations of TSD under this Agreement, including the due and prompt payment by TSD of any amounts payable under Articles 5, 6 and 7 of this Agreement and the satisfaction of each of the representations, warranties and indemnities of TSD set forth therein. In case of the failure of TSD to promptly pay any amounts due to PPD pursuant Articles 5 or 6 of this Agreement, or to satisfy any of its obligations under Article 7 of this Agreement, TPC hereby agrees to cause the payment of such amounts to be made promptly when and as such amounts become due and payable and as if such amounts were paid by TSD. TPC’s obligations under this Section 13.15 shall survive any transfer of ownership of TPC or any of its assets or the assignment by TPC of any of its obligations under this Agreement.
[Signature page follows]
IN WITNESS WHEREOF, the Parties have signed this Agreement as of the date(s) set forth below.
Takeda San Diego, Inc. | ||
By: |
| |
Name: | Xxxxx Xxxxxx | |
Title: | President and Chief Scientific Officer | |
Date: |
| |
Takeda Pharmaceutical Company Limited | ||
By: |
| |
Name: | Xxxxxxxxx Xxxxxxxx | |
Title: | President and Chief Operating Officer | |
Date: |
| |
Development Partners, LLC | ||
By: |
| |
Name: |
| |
Title: |
| |
Date: |
| |
Pharmaceutical Product Development, Inc. | ||
By: |
| |
Name: |
| |
Title: |
| |
Date: |
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Schedule 1.5
COLLABORATION PATENT ESTATE
[*]
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
Schedule 1.12
322 DEVELOPMENT PLAN
[*]
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
Schedule 2.1(a)(i)(1)
ASSIGNMENT AND ASSUMPTION AGREEMENT
THIS ASSIGNMENT AND ASSUMPTION AGREEMENT is made and entered into this [ ] day of July, 2005 by and among Pharmaceutical Product Development, Inc., a North Carolina corporation, PPD Development, LP, a Texas limited partnership, and Development Partners, LLC, a Delaware limited liability company (hereinafter collectively referred to as the “Assignor”) and Takeda San Diego, Inc., a Delaware corporation (hereinafter “Assignee”). Unless otherwise defined herein, capitalized terms used in this Assignment and Assumption Agreement shall have the meanings assigned to them in the Agreement among the Assignor, the Assignee and Takeda Pharmaceutical Company Limited, dated as of July [ ], 2005 (the “Agreement”).
1. Assignor hereby grants, conveys, sells, assigns and transfers to Assignee, its successors and assigns, forever, without reservation, all of Assignor’s right, title and interest as of the date hereof in the Assigned Contracts.
2. Assignee hereby assumes and agrees that it will perform and discharge all liabilities and obligations of Assignor under the Assigned Contracts that arise or are to be performed from and after the date hereof.
3. This Assignment and Assumption Agreement has been executed and delivered pursuant to the Agreement, the terms, conditions, representations and warranties of which are incorporated by reference herein. This Assignment and Assumption Agreement shall not be deemed to modify or supersede the Agreement in any manner whatsoever.
4, This Assignment and Assumption Agreement shall be binding upon and inure to the benefit of Assignor and Assignee and their respective successors and assigns, and shall be construed under and governed by the laws of the State of New York. This Assignment and Assumption Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
Pharmaceutical Product Development, Inc. | ||
By: | ||
Name: | ||
Title: | ||
PPD Development, LP By: PPD GP, LLC Its: Sole General Partner | ||
By: | ||
Name: | ||
Title: | ||
Development Partners, LLC By: Applied Bioscience International Inc. Its: Sole Manager | ||
By: | ||
Name: | ||
Title: | ||
Takeda San Diego, Inc. | ||
By: | ||
Name: | ||
Title: |
Schedule 2.1(a)(i)(2)
THIRD PARTY CONTRACTS ASSUMED BY TSD
[*]
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
Schedule 3.3
322 AND 619 MATERIAL
[*]
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
Schedule 4.9
ADDENDUM FOR 322 DEVELOPMENT SERVICES
[*]
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
Schedule 5.3
EXAMPLES OF ROYALTY CALCULATIONS
[*]
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
Schedule 5.4
OUTSTANDING DEVELOPMENT EXPENSES
[*]
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
Confidential
Schedule 8.3
AUTHORIZED PUBLIC DISCLOSURE
The parties shall have the right to disclose the following information:
• | Takeda will pay PPD an upfront payment of $15 million, |
• | Takeda will pay PPD a development milestone of $15 million if and when the first dosing of a subject in a Phase III trial occurs, |
• | Takeda will pay PPD additional milestone payments of up to $70.5 million upon the occurrence of certain milestone events. The parties may disclose the milestone events, if SEC requires so. |
• | Commercial milestone payments of up to $33 million based on the achievement of specified worldwide sales targets for the DPP-IV compounds, and |
• | Tiered Royalties, based on sales of the DPP-IV compounds. In the US, royalties range from middle single digit royalties to low double digit royalties. For EU and Japan, royalties range from mid to upper single digit royalties, with similar royalties for ROW. |
Schedule 13.17
PRESS RELEASE
Takeda Pharmaceutical Company Limited
PPD, Inc.
Contact for Takeda:
Xxxxx Xxxxxx
x00-0-0000-0000
Xxxxxx_Xxxxx@xxxxxx.xx.xx
Contact for PPD:
Xxxxx Xxxxx
x000 000 0000
xxxxxxx.xxxxx@xxxx.xxxx.xxx
July xx, 2005
Takeda Acquires the Rights to DPP4 Inhibitors Granted to PPDI
Osaka, Japan/Wilmington, N.C., July xx, 2005 — Takeda Pharmaceutical Company Limited (“Takeda”) and PPD, Inc. (Nasdaq: PPDI) today announced an agreement in which Takeda acquired the development and marketing rights to all dipeptidyl peptidase IV (DPP4) inhibitors previously granted to PPD under an agreement between PPD and Syrrx, Inc. Takeda acquired Syrrx, Inc., now known as Takeda San Diego, Inc., in March 2005.
Under the new agreement, Takeda, through Takeda San Diego, acquired all the remaining rights to develop and commercialize the DPP4 inhibitors, which rights had been shared by PPD and Takeda San Diego under the collaboration agreement dated November 19, 2003. In exchange for terminating the collaboration agreement and transferring its rights to Takeda, PPD will receive an upfront payment of US$15.0 million, plus development and sales milestones, and royalties on sales of DPP4 inhibitors if approved for marketing.
The agreement further provides that PPD will serve as the sole provider to Takeda of Phase II and Phase III clinical development services in the US and the EU for the DPP4 inhibitors. This will enable the DPP4 development program to continue without interruption. Further details of the financial terms of the agreement were not disclosed.
A variety of pre-clinical and clinical findings to date indicate DPP4 inhibitors have the potential to treat type 2 diabetes. DPP4 degrades GLP-1 (Glucagon-like peptide-1), an important hormone that is released in response to the intake of food and that stimulates pancreatic beta cells to increase the secretion of insulin and that has potential to improve beta cell function itself. DPP4 inhibitors, taken orally, work by blocking GLP-1 degradation to keep its concentration for a longer period of time. Therefore, DPP4 inhibitors are expected to be one of the new generation agents for diabetes treatment.
“We are pleased to reach this agreement with PPD, allowing us full rights to DPP4 inhibitors created by our new colleagues at Takeda San Diego,” said Xxxxxxxxx Xxxxxxxx, President & Chief Operating Officer of Takeda. “We believe that these DPP4 inhibitors will enhance Takeda’s diabetes franchise in the future”.
“We too are excited with the new arrangement with Takeda for the continued development and commercialization of the DPP4 assets,” said Xxxx Xxxxxxxx, Chief Executive Officer of PPD. “With the signing of this agreement, this becomes the second program under which we have advanced the clinical development of a compound and then transferred it to a third party for continued development and commercialization, thereby further validating our compound partnering strategy. As a worldwide leader in diabetes medicines, we believe that Takeda is an outstanding partner for this program.”
###
<About Takeda>
Takeda, located in Osaka, Japan, is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.
For more information on Takeda, visit our website, xxxx://xxx.xxxxxx.xxx
<About PPD>
As a leading global provider of discovery and development services and products for pharmaceutical, biotechnology and medical device companies, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients maximize the return on their R&D investments. With proven early discovery through post-market resources, the company also offers compound partnering opportunities. PPD has more than 7,100 professionals worldwide with offices in 28 countries. For more information on PPD, visit our Web site at xxxx://xxx.xxxx.xxx.
Except for historical information, all of the statements, expectations and assumptions contained in this news release, including the expectations and assumptions about the future development and commercialization of DPP4 inhibitors, are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause results to differ materially include the following: risks associated with the development and commercialization of drugs; risks associated with and dependence on collaborative relationships; rapid technological advances that make products less competitive; economic conditions and competition in the pharmaceutical industry; and the other risk factors set forth from time to time in the SEC filings for PPD, copies of which are available free of charge upon request from the PPD investor relations department.
###
Portions of this exhibit marked [*] are omitted and are requested to be treated confidentially.
AMENDMENT NO. 1 TO THE AGREEMENT
This Amendment No. 1 (the “Amendment”), is effective as of the 10th day of October, 2005, by and among Takeda San Diego, Inc., a Delaware corporation having a place of business at 00000 Xxxxxxx Xxxxxx Xxxxx, Xxx Xxxxx, XX 00000 (“TSD”), Takeda Pharmaceutical Company Limited, a corporation organized under the laws of Japan, having its principal place of business at 0-0 Xxxxxxxxxx 0-xxxxx, Xxxx-xx, Xxxxx, Xxxxx ( “TPC”), Development Partners, LLC, a Delaware limited liability company having its principal place of business at 0000 Xxxxx 00xx Xxxxxx, Xxxxxxxxxx, XX 00000 (“PPD”), and Pharmaceutical Product Development, Inc., a North Carolina corporation having its principal place of business at 0000 Xxxxx 00xx Xxxxxx, Xxxxxxxxxx, XX 00000 (“PPD, Inc.”).
1. All capitalized terms used but not otherwise defined herein will have the meanings ascribed to them in the Agreement.
2. Schedule 2.1(a)(i)(2) (Third Party Contracts Assumed by TSD) is replaced in its entirety with the attached new Schedule 2.1(a)(i)(2) in which subsection I (Renal Impairment Site Agreements) has been deleted.
3. Section 3.3 is replaced in its entirety with the following new Section 3.3:
4. The table in Section 5.2(a) is replaced in its entirety with the following new table for Section 5.2(a):
Milestone Event | Milestone Payment | |
Dosing of any Product to the twentieth (20th) subject in a Phase III Trial | Fifteen million dollars ($15,000,000) | |
[*] | [*] million dollars ($[*]) | |
[*] | [*] million dollars ($[*]) | |
[*] | [*] million dollars ($[*]) | |
[*] | [*] million dollars ($[*]) | |
[*] | [*] million dollars ($[*]) | |
[*] | [*] million [*] hundred thousand dollars ($[*]) |
5. Section 7.1 is deleted in its entirety and replaced with the following:
7.1 TSD Indemnification of PPD. TSD hereby agrees to indemnify, defend and hold harmless PPD and its Affiliates and their directors, officers, agents and employees (the “PPD Indemnitees”) from and against any and all damages,
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
liabilities, expenses and/or loss, including reasonable legal expenses and reasonable attorneys’ fees (“Losses”) resulting from suits, claims, proceedings, or causes of action (“Claims”) brought by a Third Party against such PPD Indemnitee arising from: (i) any allegation of infringement or misappropriation of a Third Party’s intellectual property relating to the subject matter of this Agreement; (ii) any breach by TSD or its Affiliates of a representation or warranty contained in this Agreement; (iii) any breach of this Agreement or applicable law by TSD or its Affiliates; (iv) the handling, possession, development, manufacturing, marketing, distribution, promotion, sale or use of Product; (v) any allegation of injury or death caused by any person’s use of Product; (vi) any liability or other claim (including without limitation, injury or death) for the use of any Drug Substance, CTM, or Product; (vii) the breach or other violation of any underlying license to the Intellectual Property licensed to TSD by PPD in Section 3.2, by TSD and its Permitted Sellers and other licensees or subcontractors; (viii) the exercise of any right(s) under the Intellectual Property, by TSD and its Permitted Sellers and other licensees or subcontractors; (ix) any failure by TSD or its Affiliates to comply in all material respects with applicable laws in connection with the performance of their respective obligations or the exercise of their respective rights under this Agreement; (x) the negligence or willful misconduct of TSD or its Affiliates in the performance of this Agreement; (xi) the contracts listed in Schedule 2.1(a)(i)(l) that are assigned to TSD pursuant to Section 2.1(a)(i), but only to the extent such Claim arises from activities under such contracts that occur after the Effective Date; and/or (xii) the Letters of Indemnification, Phase II Clinical Research Agreements and Renal Impairment Site Agreements identified on Schedule 7.1 attached hereto, but only to the extent a Claim arises from activities under such agreements that occur after the Effective Date.
The foregoing indemnification obligations shall not apply to the extent such PPD Losses result from (1) breach by PPD or its Affiliates of a representation or warranty contained in this Agreement or, with respect to Section 7.1(xii) only, the Global Master Agreement, Clinical Research Management Services (Phases II-IV) dated July 13, 2005 executed by PPD, Takeda Global Research & Development Center, Inc. and Takeda Europe Research & Development Centre Ltd. (“Clinical Agreement”); and/or (2) breach of this Agreement, applicable law or, with respect to Section 7.1(xii) only, the Clinical Agreement by the PPD Indemnitee; and/or (3) the negligence or willful misconduct of the PPD Indemnitee in the performance of this Agreement or, with respect to Section 7.1(xii) only, the Clinical Agreement. TSD and TPC agree to indemnify, defend and hold the PPD Indemnitees harmless from any Claim against the PPD Indemnitees as a result of [*].
6. Attached hereto is a new Schedule 7.1 to the Agreement containing a list of Phase II Clinical Research Agreements and Letters of Indemnification and a list of Renal Impairment Site Agreements for which TSD or an Affiliate of TSD will assume the role of sponsor as defined in 21 CFR §312.3(b) after the Effective Date.
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
7. Section 7.3 is deleted in its entirety and replaced with the following:
7.3 Indemnification Procedure.
(a) | If any action is brought against a party entitled to indemnification under Section 7.1 or 7.2, as applicable, (each, an “Indemnified Party”), such Indemnified Party or Parties shall promptly notify the party obligated to provide indemnification (an “Indemnifying Party”) in writing of the institution of such action. |
(b) | Promptly upon receipt of notice pursuant to subparagraph (a) above, the Indemnifying Party shall promptly assume the defense of such action, including, without limitation, the employment of counsel reasonably satisfactory to such Indemnified Party or Parties, and payment of expenses. An Indemnified Party or Parties shall have the right to employ its or their own counsel in any such case, but the fees and expenses of such counsel shall be at the expense of such Indemnified Party or Parties, unless: |
(i) | the employment of such counsel shall have been authorized in writing by the Indemnifying Party in connection with the defense of such action; or |
(ii) | the named parties to such action include both the Indemnified Party or Parties and the Indemnifying Party and such Indemnified Party or Parties shall have reasonably concluded that there may be one or more legal defenses available to it or them or to other Indemnified Parties which are different from, or in addition to, those available to the Indemnifying Party. |
In either of the foregoing events, such fees and expenses shall be borne by the Indemnifying Party and the Indemnifying Party shall not have the right to direct the defense of such action on behalf of the Indemnified Party or Parties. Notwithstanding anything to the contrary set forth herein, under no circumstances shall the Indemnifying Party be obligated to assume responsibility for the expenses for more than one counsel for all the Indemnified Parties.
(c) Notwithstanding anything contained in this Section 7.3 to the contrary, the Indemnifying Party shall not be liable for any settlement of any such claim or action effected without its written consent, which consent shall not be unreasonably withheld. The Indemnifying Party shall have the right to settle or compromise any action, or permit a default or consent to the entry of judgment in, or otherwise seek to terminate, any pending or threatened action, in respect of which indemnity may be sought hereunder (whether or not any Indemnified Party is a party thereto), provided such settlement, compromise, consent, or termination includes an unconditional release of each Indemnified Party from all liability in respect of such action. In the event such an unconditional release is not obtainable for each Indemnified Party, then the Indemnifying Party must obtain the prior written consent of any Indemnified Party not so released before the Indemnifying Party may enter into such settlement, compromise, consent or termination.
8. PPD represents and warrants that the Sites listed under “Phase II Clinical Research Agreements and Letters of Indemnification” on Schedule 7.1 have not executed contracts with third party providers for services performed under the respective Clinical Research Agreements for Protocol [*] entitled, “[*]”.
9. Except as expressly provided herein, in the event of a conflict between the terms of this Amendment and the Agreement, the terms of this Amendment shall control.
10. Except as otherwise amended herein, the Agreement shall remain in full force and effect.
Takeda San Diego, Inc. | Takeda Pharmaceutical Company Limited | |||||
By: | /s/ Xxxxxxx X. Xxxxxx | By: | /s/ Xxxxxxxx Xxxxxxxx | |||
Name: | Xxxxxxx X. Xxxxxx | Name: | Xxxxxxxx Xxxxxxxx | |||
Title: | President and Chief Scientific Officer | Title: | General Manager, Corporate Strategy and Planning | |||
Development Partners, LLC | Pharmaceutical Product Development, Inc. | |||||
By: | /s/ Xxxx X. Xxxxxxxx | By: | /s/ Xxxx X. Xxxxxxxx | |||
Name: | Xxxx X. Xxxxxxxx | Name: | Xxxx X. Xxxxxxxx | |||
Title: | President | Title: | Chief Executive Officer |
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
Schedule 2.1(a)(i)(2)
THIRD PARTY CONTRACT TO BE ASSUMED BY TSD
[*]
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
Schedule 7.1
CLINICAL RESEARCH AGREEMENTS AND
LETTERS OF INDEMNIFICATION
[*]
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |