EXECUTION COPY
3-HYBRID COLLABORATION AND LICENSE AGREEMENT
THIS 3-HYBRID-COLLABORATION AND LICENSE AGREEMENT (the Agreement) is entered into as of the Effective Date (as hereinafter defined) by and between ALTANA PHARMA AG, with offices at Byk-Gulden-Strasse 2, D-78467 Konstanz, Germany (ALTANA Pharma) and the ALTANA RESEARCH INSTITUTE, a wholly-owned subsidiary of ALTANA PHARMA AG, with offices at 610 Lincoln Street, Waltham, MA 02451 (ARI)(ALTANA Pharma and ARI collectively referred to as ALTANA) and GPC BIOTECH AG, with offices at Fraunhoferstrasse 20, D-82152 Martinsried/Munich, Germany (GPC AG) and GPC BIOTECH INC; with offices at 610 Lincoln Ave., Waltham, MA 02451 (GPC INC) (GPC AG and GPC INC collectively referred to as GPC). Each of ALTANA and GPC may be referred to herein as a Party, or, collectively, as the Parties.
RECITALS
WHEREAS, GPC owns or has licensed rights to certain know how, trade secrets, patents and patent applications relating to GPC Yeast 3-Hybrid Technology and Third Party 3-Hybrid Technology (as defined herein) as a tool for drug discovery and research;
WHEREAS, ALTANA is interested in obtaining rights to the GPC Yeast 3-Hybrid Technology;
WHEREAS, GPC is willing to grant certain rights, and provide certain services, with respect to the GPC Yeast 3-Hybrid Technology and certain other technologies (defined herein as Third Party 3-Hybrid Technology), together with certain improvements thereof (collectively defined herein as 3-Hybrid Intellectual Property Rights) by the transfer and/or practice of said technologies to or for the benefit of ALTANA during the Establishment Term (as defined herein) on the terms set forth herein; and
WHEREAS, GPC and ALTANA desire to enter into a target discovery collaboration (the Collaboration) at ARI using the GPC Yeast 3-Hybrid Technology and Third Party 3-Hybrid Technology in connection therewith, under which GPC and ALTANA will identify and validate targets and ALTANA will obtain rights to commercialize Products (as defined herein) directed to or based on such targets.
NOW, THEREFORE, in consideration of the foregoing and the covenants and promises contained in this Agreement, the Parties agree as follows:
ARTICLE 1
Definitions
As used throughout this Agreement, the following capitalized terms shall have the meanings ascribed to them below:
1.1. Accepted Y3H Target shall mean a Catalogue Y3H Target that has been selected by ALTANA pursuant to Section 2.6.6 and to which Section 2.6.7 shall not apply.
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1.2. Affiliate shall mean any company or entity controlled by, controlling or under common control with a Party hereto, whereby the term control shall include without limitation the owning of fifty percent (50%) or more of any companys voting stock or participating profit interest or having the power to directly or indirectly direct the management or determine the policies of an entity.
1.3. ALTANA Compound shall mean a compound that, at the time of determination of whether such compound is an ALTANA compound, meets any one of the following criteria:*** For the avoidance of doubt, the phrase at the time of determination shall mean at the time of the achievement of a relevant milestone, for purposes of Section 6.1.6, and at the time ownership is being determined, for purposes of Section 11.1.
1.4. ALTANA Intellectual Property shall mean the patent rights, know-how, trade secret rights, proprietary materials and other intellectual property rights, exclusive of Joint Inventions and Collaboration Patents, Controlled by ALTANA and relating to any Y3H Target, Catalogue Y3H Target, Accepted Y3H Target, Viable Y3H Target, Project Candidate and/or Product. ALTANA Intellectual Property shall not include ALTANA Third Party Compound Manufacturing Improvements, ALTANA Third Party 3-Hybrid Technology Improvements or ALTANA Yeast 3-Hybrid Technology Improvements.
1.5. ALTANA Invention shall mean any invention, development, discovery, method, process, Information or other know-how that is conceived, discovered, identified or first reduced to practice by ALTANA in the conduct of research as part of the Collaboration under the Agreement (other than an ALTANA Third Party 3-Hybrid Technology Improvement, an ALTANA Yeast 3-Hybrid Technology Improvement, or an ALTANA Third Party Compound Manufacturing Improvement).
1.6. ALTANA Non-Program Invention shall mean any invention, development, discovery, method, process, Information or other know-how that is conceived, discovered, identified or first reduced to practice by ALTANA in the conduct of research other than as part of the Collaboration (other than an ALTANA Yeast 3-Hybrid Technology Improvement, an ALTANA Third Party Compound Manufacturing Improvement or an ALTANA Third Party 3-Hybrid Technology Improvement).
1.7. ALTANA R&D Compound shall mean a compound that ALTANA has in lead generation (after hit evaluation) or lead optimization programs or that ALTANA has nominated as a clinical development candidate prior to the use by ALTANA of any Licensed Patents or Collaboration Technology with respect to such compound.
1.8. ALTANA Third Party Compound Manufacturing Improvements shall mean any enhancement, invention, discovery, or modification comprising methods or processes of manufacture of the Third Party Compounds, conceived, discovered, identified or first reduced to practice by ALTANA alone, by or with a Third Party or jointly by ALTANA and GPC and, in each case, is Controlled by ALTANA.
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1.9. ALTANA Third Party 3-Hybrid Technology Improvement shall mean any enhancement, invention, discovery, or modification to the Third Party 3-Hybrid Technology or Third Party Compound which is conceived, discovered, identified or first reduced to practice by ALTANA alone, by or with a Third Party or jointly by ALTANA and GPC and, in either case, is Controlled by ALTANA.
1.10. ALTANA Validated Y3H Target shall mean a target that ALTANA has in an internal research and development program and that ALTANA has validated or that is under validation in an in-vitro or in-vivo model systems prior to the use by ALTANA of any Licensed Patents or Collaboration Technology with respect to such target.
1.11. ALTANA Y3H Target shall mean a target that, at the time of determination of whether such target is an ALTANA Y3H Target, meets any one of the following criteria***: For the avoidance of doubt, the phrase at the time of determination shall mean at the time of an achievement of a relevant milestone, for purposes of Section 6.1.6, and at the time of ownership is being determined, for purposes of Section 11.1.
1.12. ALTANA Yeast 3-Hybrid Technology Improvement shall mean any enhancement, invention, discovery, or modification to (i) the GPC Yeast 3-Hybrid Technology, (ii) the 3-Hybrid Technology utilizing the split ubiquitin technology in yeast as encompassed by certain licenses in Exhibit F, or (iii) any equivalent or alternative of the foregoing 3-Hybrid Technologies established for relevant cell systems (e.g. yeast, bacterial and mammalian cell systems), which is conceived, discovered, identified or first reduced to practice by ALTANA alone, by or with a Third Party or jointly by ALTANA and GPC and, in either case, is Controlled by ALTANA.
1.13. Cancer shall mean the process of invasive tumor cell growth that occurs as a result of genetic mutations that initiate and promote irreversible cellular events.
1.14. Catalogue Y3H Target shall mean a Y3H Target that meets the Designation Criteria as determined pursuant to Section 1.25 and 2.6.4 hereof.
1.15. Claim shall mean any and all liabilities, damages, losses, settlements, claims, actions, suits, penalties, fines, costs or expenses (including, without limitation, reasonable attorneys fees).
1.16. Collaboration shall mean the program of research and testing consisting of the Reverse Genomics Research Program.
1.17. Collaboration Patents shall mean and collectively includes United States and foreign patent applications, provisional patent applications, patents, certificates of invention and applications for certificates of invention, reissues, extensions, renewals, substitutions, supplementary protection certificates, additions, continuations, divisions and continuations-in-part that claim Joint Inventions.
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1.18. Collaboration Technology shall mean all GPC Inventions related to Catalogue Y3H Targets and Accepted Y3H Targets and uses thereof and Joint Inventions related to Catalogue Y3H Targets and Accepted Y3H Targets and uses thereof.
1.19. Collaboration Term shall have the meaning set forth in Section 2.5.1 hereof.
1.20. Commercially Reasonable Efforts shall mean efforts and resources commensurate with the efforts and resources in research and development used by a reasonable party for projects of commensurate economic value in consideration of the continuing progress and state of scientific knowledge and in consideration of reasonably available resources, at the time.
1.21. Contract Year shall mean each 12-month period ending on the first anniversary of the Effective Date and each anniversary thereafter.
1.22. Confidential Information shall have the meaning set forth in Section 10.1 hereof.
1.23. Control shall mean, with respect to a material, Information or intellectual property right, possession (by ownership or exclusive license) by a Party of the ability to grant the other Party access to or a license or sublicense as provided for herein under such material, Information or intellectual property right without violating the terms of any bona fide agreement or other arrangements with any Third Party existing at the time such Party would be first required hereunder to grant the other Party such access or license or sublicense.
1.24. Derivative shall mean, as appropriate, (i) a homolog, isoform, isomer or racemate of the parent Third Party Compounds; (ii) an analog, fragment of the parent Third Party Compounds; or (iii) a composition containing any of the foregoing described in clauses (i) and (ii) of this sentence.
1.25. Designation Criteria shall mean the in-vitro and/or in-vivo validation of a Y3H Target in a in vitro and/or in an in-vivo model system agreed on by the Collaboration Committee on a case by case basis.
1.26. Dollar and $ shall mean United States dollars.
1.27. EMEA shall mean the European Medicines Evaluation Agency and any successor thereto.
1.28. Effective Date shall mean January 31, 2003.
1.29. Establishment Term shall mean the fifty three (53) month period beginning on the Effective Date.
1.30. Evaluation Period shall have the meaning set forth in Section 2.6.6 hereof.
1.31. FDA shall mean the United States Food and Drug Administration and any successor thereto.
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1.32. Field shall mean, except as set forth in Exhibit D and subject to the Third Party Agreements in Exhibit E, those therapeutic areas that are the subject of all current and future internal ALTANA pharmaceutical research and development programs.
1.33. First Commercial Sale shall mean the first sale or other disposition for value of a Product, in a final dosage form packaged for the ultimate consumer, to an independent Third Party following Regulatory Approval, by ALTANA, its Affiliates or a sublicensee of ALTANA.
1.34. Force Majeure shall mean any act of God, any accident, explosion, fire, storm, earthquake, flood, drought, peril of the sea, riot, embargo, war or foreign, federal, state or municipal order of general application, seizure, requisition or allocation, any failure or delay of transportation, shortage of or inability to obtain supplies, equipment, fuel or labor or any other circumstances or event beyond the reasonable control of the Party relying upon such circumstance or event to excuse its non-performance.
1.35. FTE shall mean the equivalent of a full-time employee or consultant based on at least forty-six (46) weeks per year of work less public holidays carried out by one or more employees or consultants of GPC, each of whom devotes a portion of his or her time to scientific work on or directly related to the Collaboration and having a qualification which is reasonably sufficient and adequate in view of the tasks to be performed; provided, however, that ALTANA understands and agrees that GPC retains complete discretion to change the identity, the frequency and time which any individual employee devotes to the Collaboration. Work on or directly related to the Collaboration to be performed by GPC employees or consultants can include, but is not limited to, experimental laboratory work, recording and writing up results, reviewing literature and references, attending selected and appropriate seminars and symposiums, managing and leading scientific staff, and carrying out Collaboration management duties (including service on a Steering Committee).
1.36. Genomics Center shall mean the Altana Research Institute currently located in Waltham, Massachusetts.
1.37. GPC Elected Y3H Target shall have the meaning set forth in Section 2.6.7 hereof.
1.38. GPC Invention shall mean any invention, development, discovery, method, process, Information or other know-how that is conceived, discovered, identified or first reduced to practice by GPC in the conduct of research as part of the Collaboration under the Agreement (other than a GPC Yeast 3-Hybrid Technology Improvement, a GPC Third Party 3-Hybrid Technology Improvement, or a GPC Third Party Compound Manufacturing Improvement).
1.39. GPC Patents shall mean and collectively includes all United States and foreign patent applications, provisional patent applications, patents, certificates of invention and applications for certificates of invention, reissues, extensions, renewals, substitutions, supplementary protection certificates, additions, continuations, divisions and continuations-in-part (but only to the extent that claims in such continuations-in-part are entitled to the priority date of the parent patent application and cover the same subject matter as claimed in the parent patent application) that claim GPC Inventions.
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1.40. GPC Third Party Compound Manufacturing Improvements shall mean any enhancement, invention, discovery, or modification to the methods or processes of manufacture of the Third Party Compound, conceived, discovered, identified or first reduced to practice during the Establishment Term by GPC alone or with a Third Party and is Controlled by GPC.
1.41. GPC Third Party 3-Hybrid Technology Improvement shall mean the use of any enhancement, invention, discovery, or modification to the Third Party 3-Hybrid Technology which is conceived, discovered, identified or first reduced to practice during the Establishment Term by GPC alone or with a Third Party and is Controlled by GPC.
1.42. GPC Yeast 3-Hybrid Technology shall mean the use of the 3-Hybrid Technology owned by GPC as of the Effective Date for monitoring interactions of small molecules with target proteins or polypeptides in yeast cells by making use of two or more chimeric protein(s) and one chimeric small molecule(s) synthesized using GPC and/or other linker technology where the readout is growth selection based on reconstitution of a transcriptional activation protein that controls a reporter, for the identification, discovery, optimization or selection of drug targets and/or drug candidates including all Information and protocols owned by GPC and required to practice such technology, including but not limited to technology covered by Valid Claims of patent applications and patents deriving thereof as listed in Exhibit H to this Agreement and only to the extent such Valid Claims cover any such use. For the avoidance of doubt, any technology in-licensed or acquired by GPC from any Third Party is specifically excluded.
1.43. GPC Yeast 3-Hybrid Technology Improvement shall mean the use of any enhancement, invention, discovery, or modification to (i) the GPC Yeast 3-Hybrid Technology, (ii) the 3-Hybrid Technology utilizing the split ubiquitin technology in yeast as encompassed by certain licenses listed in Exhibit F, or (iii) any equivalent or alternative of the foregoing 3-Hybrid Technologies established for relevant cell systems (e.g. yeast, bacterial and mammalian cell systems), which is conceived, discovered, identified or first reduced to practice during the Establishment Term by GPC alone or with a Third Party and is Controlled by GPC, wherein such use is for the identification, discovery, optimization or selection of drug targets and/or drug candidates. For the avoidance of doubt, any technology in-licensed or acquired by GPC from any Third Party is specifically excluded.
1.44. Gross Sales means the gross amount invoiced on sales to independent Third Parties of a Product by ALTANA, its Affiliates and/or sublicensees.
1.45. Information shall mean information and data of any type and in any tangible or intangible form, including without limitation 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, results of studies and patent and other legal information or descriptions.
1.46. Joint Invention shall mean any invention, development, discovery, method, process, Information or other know-how that is conceived, discovered, identified or first reduced to practice by the Parties jointly in the conduct of research as part of the Collaboration under the
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Agreement (other than a Yeast 3-Hybrid Technology Improvement, Third Party Compound Manufacturing Improvement or Third Party 3-Hybrid Technology Improvement).
1.47. Licensed Patents shall mean any (i) GPC Patents that claim any Catalogue Y3H Target or Accepted Y3H Target or any use thereof and (ii) Collaboration Patents that claim any Catalogue Y3H Target or Accepted Y3H Target or any use thereof.
1.48. MAA shall mean a Marketing Authorization Application or similar application filed with the EMEA after completion of human clinical trials to obtain marketing approval for a Product in the European Union.
1.49. MHW shall mean the Ministry of Health and Welfare in Japan and any successor agency.
1.50. NDA shall mean a New Drug Application, or other application for the approval to market a Product, which is submitted to the FDA.
1.51. Net Sales shall mean the total amount received by ALTANA or its sublicensees on account of the sale of a Product to a non-Affiliate whether invoiced or not, less the following deductions incurred based upon the sale of such Product: (a) value added tax, sales and other excise taxes, cost of nationalization (custom duties related to importation including handling fees) and (b) a lump sum deduction of *** of Gross Sales to cover all other deductions, including, without limitation, customary cash discounts, trade discounts, quantity discounts, allowances or credits to Third Party customers on account of settlement of complaints, rejections, recalls, allowances or returns. Should ALTANA demonstrate to GPCs reasonable satisfaction that the actual amounts referred to under (a) and (b) above exceed in a country *** of ALTANAs Gross Sales of Product in such country, then ALTANA shall be entitled to deduct from ALTANAs Gross Sales such actual amounts in determining its Net Sales with respect to such country.
No deductions shall be made for commissions paid to individuals whether they be with independent sales agencies or regularly employed by such seller and on its payroll, or for the cost of collections.
Transfer between ALTANA and any of its Affiliates for resale shall not be considered a sale, and in such case, Net Sales shall be based on the Gross Sales for the Products received by the Affiliate who sells to a Third Party, less those deductions set forth above.
In the event that a Product is sold as part of a Combination Product as defined below, the Net Sales from the Combination Product, for the purpose of determining the royalty amount payable by ALTANA to GPC, shall be determined by multiplying the Net Sales of the Combination Product during the Accounting Period applicable under Section 6.2.1 by the fraction, A/A+B where A is the average sales price of the Product when sold separately in finished form and B is the average sales price of the other Product(s) included in the Combination Product, when sold separately in finished form, in each case during the applicable reporting period or, if sales of both the Product and the other Product(s) did not occur in such period, then in the most recent royalty reporting period in which sales of both occurred. In the event that such average sales price cannot be determined for both the Product and all other Product(s) included in the Combination Product, Net Sales for the purposes of determining
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Royalty payments shall be calculated by multiplying the Net Sales of the Product by the fraction C/C+D where C is the fair market value of the Product and D is the fair market value of all other Product(s) included in the Combination Product. As used above, the term Combination Product means any therapeutic product which comprises a Product and other active compounds and/or ingredients. Notwithstanding the foregoing, Net Sales from a Combination Product shall not be reduced below a level that results in an effective royalty rate pursuant to Section 6.2 hereof of less than *** of sales of such Combination Product, as determined pursuant to the first paragraph of this Section.
1.52. Phase I Clinical Trial shall mean a clinical trial which is defined as Phase I in FDA regulations as amended from time to time, or any foreign equivalent thereof.
1.53. Phase II Clinical Trial shall mean a clinical trial which is defined as Phase II in FDA regulations as amended from time to time, or any foreign equivalent thereof.
1.54. Phase III Clinical Trial shall mean a clinical trial which is defined as Phase III in FDA regulations as amended from time to time, or any foreign equivalent thereof.
1.55. Product shall mean any biotherapeutic, gene therapy or small molecule product (a) that is developed for commercial purposes by ALTANA or its sublicensees as a result of using Collaboration Technology, an ALTANA Invention or Licensed Patents or (b) that is covered by a Valid Claim of any Licensed Patents, or the manufacture, use or sale of which is covered by a Valid Claim of any Licensed Patents. Notwithstanding the foregoing, Products shall not include products which consist solely of ALTANA R&D Compounds or are based solely on the use of ALTANA Validated Y3H Targets.
1.56. Primary Contact Person shall have the meaning set forth in Section 2.4 hereof.
1.57. Project Candidate shall mean any substance or compound that is based on or directed to a Viable Y3H Target or Accepted Y3H Target or which results from the Reverse Genomics Research Program and which is selected by the ALTANA preclinical research steering committee for development as a drug project or for which ALTANA or Third Parties on ALTANAs behalf commence drug project development activities.
1.58. Regulatory Approval shall mean, with respect to a country, all approvals (including price and reimbursement approvals), licenses, registrations or authorizations based on determinations of quality, safety and efficacy of any federal, state or local regulatory agency, department, bureau or other government entity, necessary for the use, storage, import, transport and sale of a Product in such country.
1.59. Research Milestones shall have the meaning set forth in Section 6.1.4.
1.60. Research Plan shall mean the work plan for the research to be conducted by GPC under this Agreement, as amended from time to time as provided in Section 2.3. The initial Research Plan is as set forth in Exhibit B attached hereto, and any amendments thereto will be attached to Exhibit B.
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1.61. Research Year shall mean each twelve (12) month period during the term of the Collaboration beginning on the Effective Date.
1.62. Resource Plan shall mean the schedule of FTEs as described in Section 5.2
1.63. Reverse Genomics Research Program shall mean a research program in which target interaction landscapes shall be determined for publicly available inhibitors/small molecules with relevance for ALTANA research (to be defined and agreed upon by the Collaboration Committee) and internal ALTANA Compounds, which research program includes identification and validation of target genes/gene products.
1.64. Reverted Y3H Target shall have the meaning set forth in Section 2.6.5 hereof.
1.65. RGRP ALTANA Data shall mean data derived from the use of ALTANA Compounds or ALTANA Y3H Targets in the Reverse Genomics Research Program.
1.66. RGRP Public Data shall mean data derived from the use of publicly available compounds in the Reverse Genomics Research Program.
1.67. Third Party shall mean any individual or entity other than ALTANA or GPC.
1.68. Third Party Compounds shall mean any of the following compounds used in the GPC Yeast 3-Hybrid Technology: (i) AP1867, (ii) AP14270, (iii) AP1768, (iv) such other Third Party Compounds that GPC obtains rights to pursuant to the Third Party Agreements in Exhibit E, and (v) Derivatives of the compounds listed in clauses (i) through (iv).
1.69. Third Party Compound Manufacturing Improvements shall mean the GPC Third Party Compound Manufacturing Improvements and the ALTANA Third Party Compound Manufacturing Improvements.
1.70. Third Party 3-Hybrid Technology shall mean those technologies Controlled by GPC as of the Effective Date and described in the Third Party Agreements identified in Exhibit E.
1.71. Third Party 3-Hybrid Technology Improvements shall mean ALTANA Third Party 3-Hybrid Technology Improvements and GPC Third Party 3-Hybrid Technology Improvements.
1.72. 3-Hybrid Intellectual Property Rights shall mean together the GPC Yeast 3-Hybrid Technology, Yeast 3-Hybrid Technology Improvements, the Third Party 3-Hybrid Technology and the Third Party 3-Hybrid Technology Improvements.
1.73. 3-Hybrid Technology(ies) shall mean any technology or technologies for monitoring the interaction(s) of small molecules with target proteins or (poly)peptides by screening chimeric compounds with cells expressing two or more chimeric proteins and detecting the cross linking of chimeric proteins by a chimeric compound, either directly or through the detection of the activation of a target gene or signaling protein, wherein the target gene or protein is a reporter whose activation is detected in an assay, but which itself is not being evaluated for its intrinsic biological activity or as a drug target. For the avoidance of doubt, 3-Hybrid Technology does not include the use of a chimeric compound to induce a
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protein-protein association, cellular signaling, gene transcription, or any other cellular event which occurs as a result of the cross-linking of chimeric proteins by the chimeric compound, for the purposes of studying the biological role of that event or of any specific gene, protein or signaling pathway, or for detection or evaluation of compounds that affect an induced cellular event or its consequences (other than the interaction of the chimeric compound with a chimeric protein), or for therapeutic use.
1.74. Viable Y3H Target shall mean an Accepted Y3H Target with respect to which ALTANA determines there is a good scientific and economic rationale and a reasonable practical basis to pursue efforts which finally might result in the development of a Product pursuant to this Agreement.
1.75. Valid Claim shall mean an issued claim of an unexpired patent, or a claim of a pending patent application, owned or Controlled by a Party or its Affiliates which shall not have been withdrawn, canceled or disclaimed, or held invalid or unenforceable by a court of competent jurisdiction in an unappealed or unappealable decision.
1.76. Y3H Target shall mean a gene and/or gene product that is identified prior to the second (2nd) anniversary of the expiration of the Collaboration Term by GPC or by ALTANA or its Affiliates in research that makes any direct or indirect use of any know-how, data, information, patent rights, results or other Information resulting from the Collaboration.
1.77. Yeast 3-Hybrid Technology Improvements shall mean the GPC Yeast 3-Hybrid Technology Improvements and the ALTANA Yeast 3-Hybrid Technology Improvements.
ARTICLE 2
Conduct of Collaboration
2.1. Overview of Collaboration. Under the Collaboration, GPC shall conduct the Reverse Genomics Research Program. The goal of this program is the identification and validation of Y3H Targets which may be useful in developing Products. The program shall reflect the focus of and prioritization within ALTANAs research programs. Such research will be conducted by GPC and ALTANA using the 3-Hybrid Intellectual Property Rights under the Research Plan attached hereto as Exhibit B, which describes possible projects within the programs. The Research Plan may be amended by the Joint Steering Committee as allowed in Section 2.2(ii). ALTANA is entitled to request reasonable adaptations or modifications of the Research Plan to meet changes and developments that will occur in research and changed requirements of ALTANA deriving thereof. GPC shall not be obligated to use any other technology in the conduct of the Collaboration other than the 3-Hybrid Intellectual Property Rights licensed pursuant to Section 3.2.1 and 3.2.3. GPC acknowledges that ALTANA is and may continue to be involved in genomics and proteomic research outside of the Collaboration and may develop products as a result of such research which shall not be subject to the terms of this Agreement. GPC also acknowledges that ALTANA may use additional technology platforms established in its own research facilities and/or technologies provided by Third Parties and to be transferred to ARI and/or outsourcing of working programs to Third Parties for the validation of targets.
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2.2. Transfer of the 3-Hybrid Intellectual Property Rights. Immediately upon execution of the Agreement and other necessary licenses to Third Party Technology relating to certain Stanford patents and patent applications controlled by ARIAD Pharmaceuticals as referred to in Exhibit F, GPC shall, together with ALTANA scientists, begin transfer and/or practice of the 3-Hybrid Intellectual Property Rights to or for the benefit of ALTANA as outlined on Exhibit A as attached and as amended by the Transfer Committee during the Establishment Term.
ALTANA shall, upon six months written notice to GPC with effect as of (i) the termination of the Collaboration Term, or (ii) the first anniversary following such termination (the Transfer Notice), as specified by ALTANA in the Transfer Notice, be entitled to transfer ARI to another location not more than thirty (30) miles from Waltham, Massachusetts (the Transfer) in which case GPC agrees to reasonably assist ALTANA to transfer the GPC Yeast 3-Hybrid Technology, GPC Yeast 3-Hybrid Technology Improvements, Third Party 3-Hybrid Technology and Third Party 3-Hybrid Technology Improvements, ALTANA Yeast 3-Hybrid Technology Improvements, ALTANA Third Party Compound Manufacturing Improvements, including GPC FTEs working under this Agreement, to such new location, and will complete the transfer of the GPC Yeast 3-Hybrid Technology, GPC Yeast 3-Hybrid Technology Improvements, Third Party 3-Hybrid Technology and Third Party 3-Hybrid Technology Improvements, ALTANA Yeast 3-Hybrid Technology Improvements, ALTANA Third Party Compound Manufacturing Improvements as set forth in the Transfer Plan and this Agreement at such new location; provided, however, that ALTANA will reimburse GPC for all costs, expenses and losses incurred by GPC in connection with the Transfer. Promptly after receipt by GPC of such Transfer Notice, the Parties shall confer to determine the process to accomplish the Transfer and shall initiate the activities necessary for such Transfer; provided, however, that ALTANA shall be entitled to withdraw such Transfer Notice by written notice to GPC at least one (1) month prior to the projected effective date of such Transfer if ALTANA determines that such Transfer is not feasible based on the required deadlines and costs of such Transfer; provided further, however, that such withdrawal will not relieve ALTANA of its obligations to reimburse GPC for any costs, expenses or losses incurred by GPC after receipt of the Transfer Notice in connection with the withdrawn Transfer.
2.3. Steering Committees.
2.3.1 Formation, Composition and Term. ALTANA and GPC shall establish a Joint Steering Committee which shall be responsible for the overall supervision and management of the Collaboration and the transfer of the 3-Hybrid Intellectual Property Rights (the Joint Steering Committee). The Joint Steering Committee shall establish sub-committees: a Transfer Committee and a Collaboration Committee for the purpose of directing the transfer and Collaboration, respectively. The Joint Steering Committee and the Transfer Committee shall be active during the Establishment Term, the Collaboration Committee shall be active during the Collaboration Term and the two (2) year period immediately thereafter. The three (3) joint committees shall be comprised of three (3) named representatives of each of ALTANA and GPC. The representatives to the Committees shall be as designated in the table below:
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Committee |
ALTANA Representatives |
GPC Representatives | ||
| Joint Steering Committee | Oliver Steinbach, Klaus Melchers, Uli Thibaut | Nikolai Kley, David Bancroft, Dana Torrey | ||
| Transfer Committee | Thomas Wagner, Deepika Madan, Ge Zhang | David Bancroft, Gabriele Zybarth, Shah Imran | ||
| Collaboration Committee | Thomas Wagner, Klaus Melchers, Christian Prothmann | Nikolai Kley, Franz Obermayr, Gabriele Zybarth | ||
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The Collaboration Committee may establish additional Subcommittees (the Sub-Committees) to execute individual duties of the Collaboration Committee to the extent they relate to a particular therapeutic indication. Each of the Steering Committees shall meet as needed, but not less than once each quarter during the Establishment Term. Subject to the foregoing, such meetings shall be at such times agreed to by ALTANA and GPC and shall be held, to the extent practicable, at GPCs or the Genomics Centers offices in Waltham, Massachusetts unless the Parties otherwise agree or shall be in such other form (e.g., telephone or video conference) as the members of the relevant Steering Committee shall agree.
2.3.2 Steering Committees: Functions and Powers.
(a) The Joint Steering Committee shall be responsible for the overall supervision and management of the Collaboration and the transfer of the 3-Hybrid Intellectual Property Rights to ARI. The principal functions of the Joint Steering Committee shall include, without limitation:
(i) receiving reports from GPC on a regular basis which specify the ongoing developments regarding the GPC Yeast 3-Hybrid Technology and Third Party 3-Hybrid Technology and outline the GPC Yeast 3-Hybrid Technology Improvements and Third Party 3-Hybrid Technology Improvements which will be transferred and implemented under this Agreement;
(ii) considering and approving reasonable adaptations or modifications to the Research Plan as a result of changes and developments that occur in the research performed in the Collaboration and the changing requirements of ALTANA arising therefrom;
(iii) evaluating, monitoring and recommending on a periodic basis the in-licensing of any Third Party intellectual property for ARI or for the Collaboration; and
(iv) recommending to ALTANA whether a Target should be designated as a Catalogue Y3H Target by ALTANA in accordance with Section 2.6.2. Recommendation shall be made based on the discussions and mutual understandings in the Collaboration Committee.
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(b) The Transfer Committee shall be responsible for the overall supervision of the transfer of the 3-Hybrid Intellectual Property Rights. The principal functions of the Transfer Committee shall include, without limitation, monitoring the progress and results under the transfer of the 3-Hybrid Intellectual Property Rights and revising, as necessary, the Transfer Plan.
(c) The Collaboration Committee or the Sub-Committees established by it, shall be responsible for the overall supervision and management of the Collaboration. The Collaboration Committee shall report to the Joint Steering Committee, the Sub-Committees to the Collaboration Committee. The principal functions of the Collaboration Committee shall include, without limitation:
(i) monitoring the progress and results achieved under the Collaboration and revising, as necessary, the Research Plan;
(ii) determining the Designation Criteria to be fulfilled for target validation on a case by case basis in accordance with Section 2.6.1;
(iii) recommending to the Joint Steering Committee, whether a Y3H Target resulting from the Collaboration should be designated as a Catalogue Y3H Target by ALTANA in accordance with Section 2.6.2;
(iv) determining and agreeing whether a compound to be assayed by use of the GPC Yeast 3-Hybrid Technology, GPC Yeast 3-Hybrid Technology Improvements, and Third Party 3-Hybrid Technology, and Third Party 3-Hybrid Technology Improvements during the Collaboration Term is an ALTANA Compound; and
(v) determining and agreeing whether a target to be assayed by use of the GPC Yeast 3-Hybrid Technology, GPC Yeast 3-Hybrid Technology Improvements, or Third Party 3-Hybrid Technology, and Third Party 3-Hybrid Technology Improvements during the Collaboration Term is an ALTANA Target.
A Party may change one or more of its representatives to a Steering Committee at any time upon written notice to the other Party. Members of a Steering Committee may be represented at any meeting by another member of the Steering Committee, or by a deputy. Either Party may permit additional employees and consultants to attend and participate (on a non-voting basis) in Steering Committee meetings, subject to the confidentiality provisions of Article 10.
2.3.3 Decisions of the Steering Committees. A quorum for a given Steering Committee shall be present at any meeting of the respective Steering Committee if at least one (1) representative of each Party is present at such meeting in person or by telephone or video conference. If a quorum exists at any meeting, the unanimous consent of all members of the respective Steering Committee present at such meeting is required to take any action on behalf of such Steering Committee. In the event that a Steering Committee cannot reach agreement within thirty (30) days as to any matter that is subject to its decision-making authority, the matter shall, in case of decisions of the Transfer Committee or the Collaboration Committee, be referred to
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the Joint Steering Committee, in case of the Joint Steering Committee be referred to dispute resolution in accordance with Article 16. |
2.3.4 Co-Chairs. Each Steering Committee shall be co-chaired by one ALTANA representative appointed by ALTANA and one GPC representative appointed by GPC from the membership of the respective Steering Committee.
2.3.5 Minutes and Reports. Each Steering Committee shall be responsible for keeping accurate minutes of its deliberations which record all proposed decisions and all actions recommended or taken. Within ten (10) business days of each meeting, the co-chairs shall provide the Parties with draft minutes of such meeting and a draft of a written accompanying report describing, in reasonable detail, the status of the Research Program or such other program as it falls under the responsibility of the respective Steering Committee, a summary of the work and progress to date, any issues requiring resolution and any proposed decisions and the action taken to all members of the respective Steering Committee. Within thirty (30) days of each meeting, the co-chairs will sign final versions of the meeting minutes and the accompanying report and such minutes and such report shall thereafter be recognized as duly accepted by the Parties. All records of the Steering Committees shall be available to both Parties.
2.3.6 Information and Results. Except as otherwise provided, the Parties will make available and disclose to one another all results of the work conducted pursuant to the Collaboration prior to and in preparation for the Steering Committee meetings, by the deadline and in the form and format to be designated by the Steering Committee.
2.4. Primary Contact Persons. The initial primary contact person of GPC shall be Dana Torrey and the primary contact person for ALTANA shall be Klaus Melchers (each a Primary Contract Person) who shall be responsible for the day-to-day interactions between the Parties related to the Collaboration and the management of the day-to-day operation of the Collaboration. Each Party may change its Primary Contact Person upon written notice to the other Party.
2.5. Collaboration Term; Extension of Establishment Term.
2.5.1 Unless this Agreement is terminated sooner in accordance with Section 15.2, the research term of the Collaboration (the Collaboration Term) shall commence on the Effective Date and shall continue for twenty-seven (27) months thereafter.
2.5.2 Upon ALTANAs written request made at least six (6) months prior to the then-current end of the Establishment Term, GPC consents to annual extensions of the Establishment Term as requested by ALTANA for the purposes described in this Section, provided that ALTANA continues to make payments under Article 5 of this Agreement for FTE support to the extent such support is still required by ALTANA, and Article 6 of this Agreement to the extent ALTANA elects to have the Establishment Term extended for the purposes described in the next two sentences. Pursuant to any extension of the Establishment Term under this Section, the Parties agree that no payments shall be due under Sections 6.1.1 and 6.1.3 unless ALTANA elects to have the license set forth in Section 3.2.1 include Third Party 3-Hybrid Technology Improvements and/or Yeast 3-Hybrid Technology Improvements each conceived, discovered, identified or first reduced to practice during the extended Establishment Term, in which case the Parties shall adapt, if possible, the payments due under 6.1.1 and 6.1.3
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based on the extent of ALTANAs election of the Third Party 3-Hybrid Technology Improvements and/or Yeast 3-Hybrid Technology Improvements during the extended Establishment Term. The Parties shall adapt, if possible, the payments under Section 6.1.2, and ALTANA shall make sublicense payments under Section 6.1.2 if ALTANA elects to extend the rights and license set forth in Section 3.2.3 during the extended Establishment Term. ALTANA hereby agrees to promptly inform GPC about any such election by ALTANA.
2.6. Y3H Target Identification and Disposition.
2.6.1 Y3H Target Identification. GPC and ALTANA shall use Commercially Reasonable Efforts in the Field to identify and validate Y3H Targets in the performance of the Collaboration, managed by the Collaboration Committee, according to the Research Plan in Exhibit B. The Collaboration Committee shall promptly notify the Joint Steering Committee of any such Y3H Target identified and submit the Designation Criteria of such Y3H Target and information regarding such place at which the agreed validation experiments have to be carried out as agreed by the Collaboration Committee. The Joint Steering Committee shall prioritize, coordinate and determine the extent of the further work to be performed as agreed by the Collaboration Committee for such Y3H Targets identified. Upon completion of such validation by ALTANA or GPC (as determined by the Collaboration Committee), the Collaboration Committee shall promptly notify the Joint Steering Committee of the results of such experiments pursuant to Section 2.6.2.
2.6.2 Recommendation by Collaboration Committee and Joint Steering Committee. The Collaboration Committee shall, further to Section 2.6.1, without undue delay following disclosure of the validation results of any Y3H Target pursuant to Section 2.6.1, convene in person, by telephone or by video conference in order to evaluate each Y3H Target so validated and shall, if it considers the Designation Criteria to be met, recommend to the Joint Steering Committee that such Y3H Target be designated as a Catalogue Y3H Target. Upon receipt of such recommendation from the Collaboration Committee, the Joint Steering Committee itself shall review the results and, if it also considers the Designation Criteria to be met, recommend to ALTANA to designate such Y3H Target as a Catalogue Y3H Target, all without undue delay. Following such recommendation, ALTANA shall determine pursuant to Section 2.6.4 and 2.6.5 hereof, whether such Y3H Target shall be designated a Catalogue Y3H Target or a Reverted Y3H Target.
2.6.3 Determination by ALTANA. Following the recommendation by the Joint Steering Committee pursuant to Section 2.6.2, ALTANA shall, through its internal committee, further evaluate each Y3H Target to determine if such Y3H Target meets the Designation Criteria.
2.6.4 Catalogue Y3H Target. If ALTANA determines, within ninety (90) days of the date of the Joint Steering Committee meeting at which the recommendation to ALTANA with respect to a Y3H Target pursuant to Section 2.6.2 was made, that such Y3H Target meets the Designation Criteria, then ALTANA shall notify GPC in writing (the Catalogue Y3H Target Notice) and such Y3H Target shall constitute a Catalogue Y3H Target. ALTANA shall make the Research Milestone payment as specified in Section 6.1.4(c) within thirty (30) days from the Catalogue Y3H Target Notice. ALTANA shall have exclusive rights to any Licensed Patents claiming such Catalogue Y3H Target pursuant to Section 3.1.1. Within thirty (30) days after any
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Y3H Target becomes a Catalogue Y3H Target, GPC shall provide ALTANA with access to all Information under GPC Control for such Catalogue Y3H Target.
2.6.5 Reverted Y3H Target. If ALTANA determines that a Y3H Target does not meet the Designation Criteria and so notifies GPC in writing, or if ALTANA fails to notify GPC in writing with a Catalogue Y3H Target Notice of its determination within ninety (90) days of the Joint Steering Committees recommendation to ALTANA with respect to a Y3H Target pursuant to Section 2.6.2, or fails to make the payment required in Section 6.1.4(c) hereof and such failure has not been cured within twenty (20) days after receipt of notice thereof from GPC, then such Y3H Target shall be designated a Reverted Y3H Target, and GPC shall have exclusive rights to Collaboration Patents claiming such Reverted Y3H Target pursuant to Section 3.3.2.
2.6.6 ALTANA Accepted Y3H Target. In the event a Y3H Target is designated by ALTANA as a Catalogue Y3H Target pursuant to Section 2.6.4 hereof, ALTANA shall diligently undertake to additionally validate a Catalogue Y3H Target as soon as reasonably possible (taking into account ALTANAs resources) and shall have the right to elect a Catalogue Y3H Target to become an Accepted Y3H Target. Such election must be made within the twenty-one (21) month period beginning on the date ALTANA designates a Y3H Target as a Catalogue Y3H Target (the Evaluation Period). In the event that, despite ALTANAs Commercially Reasonable Efforts, ALTANA is unable to sufficiently validate a Catalogue Y3H Target within the Evaluation Period, the Parties shall negotiate in good faith an extension of the Evaluation Period, if any. In the event ALTANA desires to elect to have a Catalogue Y3H Target designated as an Accepted Y3H Target pursuant to this Section, ALTANA shall notify GPC within the Evaluation Period (as it may be extended pursuant to the preceding sentence) in writing of such election (the Accepted Y3H Target Notice) and such Y3H Target shall constitute an Accepted Y3H Target. ALTANA shall effect the payment required in Section 6.1.4(d) hereof within thirty (30) days from the Accepted Y3H Target Notice.
2.6.7 GPC Elected Y3H Target. In the event ALTANA does not elect a Catalogue Y3H Target to become a ALTANA Accepted Y3H Target and make the payment required by Section 6.1.4(c) pursuant to Section 2.6.6 hereof, or fails to notify GPC in writing with an Accepted Y3H Target Notice of the election of an Accepted Y3H Target with respect to a Catalogue Y3H Target pursuant to Section 2.6.6, then such Catalogue Y3H Target shall automatically be designated a GPC Elected Y3H Target, and ALTANAs license to such Catalogue Y3H Target under Sections 3.1.1 and 3.1.2 shall automatically terminate, and GPC shall have exclusive rights to ALTANA Intellectual Property and Collaboration Patents claiming such GPC Elected Y3H Target pursuant to Section 3.3.3. Within thirty (30) days after any Catalogue Y3H Target becomes a GPC Elected Y3H Target, ALTANA shall provide GPC with access to Information under ALTANA Control for such GPC Elected Y3H Target.
2.7. Option on Third Party Technologies. At any time, and from time to time, during the Establishment Term, ALTANA may exercise an option (the Option) to enter into negotiations to obtain a non-exclusive license as an amendment under this Agreement only for use with or in 3-Hybrid Technology, to any technology in-licensed or acquired by GPC from any Third Party, wherein such technology is used by GPC in 3-Hybrid Technology(the In-Licensed 3-Hybrid Technology). GPC shall, upon execution of such in-licensing or acquisition agreement with a Third Party, inform the Joint Steering Committee accordingly and ALTANA may exercise the Option by providing written notice (the Option Notice) to GPC. If GPC is
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not, at the time of receipt of the Option Notice, restricted from granting a non-exclusive license to such In-Licensed 3-Hybrid Technology, GPC shall negotiate in good faith with ALTANA, for a period of not less than 90 days, the terms of a non-exclusive license to the In-Licensed 3-Hybrid Technology. If, at the end of such 90-day period, ALTANA and GPC are, despite good faith efforts, unable to agree on the terms of such a non-exclusive license, then GPC shall be under no further obligation to grant to ALTANA a license to the In-Licensed 3-Hybrid Technology. Notwithstanding this and for the avoidance of doubt, an In-Licensed 3-Hybrid Technology being an improvement (i.e. vector systems, new readout systems) that replaces or modifies a part of or is an incorporation within an existing 3-Hybrid Technology used by the Parties shall be available for non-exclusive license (where GPC is not restricted in such license grant as above) as an Option to ALTANA against reasonable participation by ALTANA in the costs incurred with GPC regarding such In-Licensed 3-Hybrid Technology. In case such In-Licensed 3-Hybrid technology is a minor improvement, such non-exclusive license shall be as an Option to Altana on terms equivalent to the cost incurred by GPC to grant such license.
ARTICLE 3
License Grants
3.1. Collaboration Licenses.
3.1.1 Exclusive Commercialization License. Subject to the terms and conditions of this Agreement and the Third Party Agreements identified in Exhibit E, including, without limitation, the rights of GPC with respect to Reverted Y3H Targets and GPC Elected Y3H Targets under Sections 3.3.2 and 3.3.3, GPC hereby grants to ALTANA a worldwide, royalty-bearing exclusive license, with the right to sublicense, under GPCs interest in the Licensed Patents and the Collaboration Technology to develop, register, make, have made, use, offer for sale, sell and import Products in the Field. Such license shall be perpetual for Project Candidates and Products for which ALTANA complies with its payment obligations under Section 6.1, to the extent applicable, and under Section 6.2.
3.1.2 Exclusive Research License. Subject to the terms and conditions of this Agreement, GPC hereby grants to ALTANA a worldwide, royalty-free exclusive license, without the right to sublicense, under GPCs interest in the Licensed Patents and the Collaboration Technology to conduct research solely within the Field, (i) on a Catalogue Y3H Target-by-Catalogue Y3H Target basis during the Evaluation Period for each Catalogue Y3H Target, and (ii) perpetually for each Accepted Y3H Target for which ALTANA complies with its payment obligations under Section 6.1, to the extent applicable.
3.1.3 ALTANA License Limitations.
(a) The licenses granted to ALTANA under Sections 3.1.1 and 3.1.2 are subject to the retention by GPC of a non-exclusive research license with the right to sublicense or subcontract solely for purposes of conducting GPCs obligations in the Collaboration under the Research Plan.
(b) Any sublicense by ALTANA of the rights granted to ALTANA in Section 3.1.1 shall be consistent with the terms of this Agreement and shall include an obligation for the sublicensee to comply with the applicable obligations of this Agreement including, without limitation, Article 6 pertaining to payments, Article 7 pertaining to reports and audits,
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Article 8 pertaining to books and records and Article 10 pertaining to confidentiality. ALTANA shall notify GPC of the existence of any sublicense of the rights granted herein to a Third Party within ten (10) days of entering into such sublicense.
(c) ALTANA shall not sell or otherwise transfer to a Third Party all or a portion of its rights to an Accepted Y3H Target, Viable Y3H Target, Project Candidate or Product (a Transfer) without first complying with the terms of this Section 3.1.3(c). In the event that ALTANA desires to effect a Transfer, then, prior to any such Transfer, ALTANA shall so notify GPC, specifying the Y3H Target, Project Candidate or Product that ALTANA desires to so transfer and the terms upon which such Transfer is proposed (the Transfer Notice). ALTANA and GPC shall negotiate in good faith, for a period of not less than sixty (60) days from GPCs receipt of the Transfer Notice, the terms under which ALTANA may effect such Transfer. In the event that ALTANA and GPC are unable to agree on such terms within such 60-day period, then the matter shall be submitted to dispute resolution in accordance with the terms of Article 16 hereof. Upon final resolution of such terms pursuant to agreement of the parties or the dispute resolution provisions of Section 16, ALTANA may effect the Transfer on the terms specified in the Transfer Notice. In the event that ALTANA subsequently desires to effect a Transfer with respect to any other Y3H Target resulting from the Collaboration, Project Candidate or Product, the terms of this Section 3.1.3(c) continue to apply.
3.2. 3-Hybrid Licenses to Altana.
3.2.1 GPC Yeast 3-Hybrid Technology and Improvements Licenses. Subject to the terms and conditions of this Agreement, GPC hereby grants to ALTANA a worldwide, non-exclusive, perpetual, fully paid up (after payments relating thereto having been made as provided for herein) license without the right to sub-license (except as expressly set forth in this Section 3.2.1) under (i) the GPC Yeast 3-Hybrid Technology, GPC Yeast 3-Hybrid Technology Improvements, GPC Third Party 3-Hybrid Technology Improvements, ALTANA Yeast 3-Hybrid Technology Improvements, ALTANA Third Party Yeast 3-Hybrid Technology Improvements, and ALTANA Third Party Compound Manufacturing Improvements, and (ii) any Valid Claims of patent applications and patents deriving thereof as listed in Exhibit H to the extent such Valid Claims cover the practice of the foregoing technologies, and in each case for use by ALTANA only in the Field. GPC agrees that ALTANA may sublicense a Third Party under the rights granted to ALTANA in this Section 3.2.1 solely to perform research on behalf of ALTANA and for the sole benefit of ALTANA; provided, however, that ALTANA will provide to GPC a copy of each such sublicense agreement promptly after execution thereof; provided further, that ALTANA may redact any Confidential Information contained in such copies provided to GPC. Any such sublicense will be granted pursuant to an agreement between ALTANA and such Third Party which contains restrictions on the use and disclosure of the GPC Yeast 3-Hybrid Technology, GPC Yeast 3-Hybrid Technology Improvements and GPC Third Party 3-Hybrid Technology Improvements which are no less onerous than the restrictions on ALTANA contained in this Agreement and shall prohibit such Third Party from sublicensing the rights sublicensed to it by ALTANA under this Section 3.2.1. ALTANA acknowledges that it or its sublicensees as above may be obligated to enter into, at its own expense, other necessary licenses covering Third Party intellectual property as listed in Exhibit E and Exhibit F in order to fully practice the GPC Yeast 3-Hybrid Technology or GPC Yeast 3-Hybrid Technology Improvement. GPC will reasonably assist ALTANA in obtaining such licenses.
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3.2.2 Source Code to Software Included in GPC Yeast 3-Hybrid Technology. GPC agrees to provide ALTANA with one (1) copy of the source code to each software program transferred to ALTANA pursuant to Section 2.1 hereof, in each case solely for use as permitted in Section 3.2.1. GPC will transfer the source code only after installation of such software at one ALTANA site and acceptance by ALTANA of such software as fully functioning.
3.2.3 Sublicense of Third Party 3-Hybrid Technology. Subject to the terms and conditions of this Agreement and the Third Party Agreements identified in Exhibit E, GPC hereby grants to ALTANA a worldwide, non-exclusive, non-transferable sublicense, without the right to sublicense, under GPCs rights to sublicense the Third Party 3-Hybrid Technology for use by ALTANA in combination with the GPC Yeast 3-Hybrid Technology and GPC Yeast 3-Hybrid Technology Improvements, ALTANA Yeast 3-Hybrid Technology Improvements and Third Party 3-Hybrid Technology Improvements, only in the Field and only during the Establishment Term. During the Establishment Term or any extension thereof pursuant to Section 2.5.2, GPC agrees not to exercise its rights to terminate the MIT Agreement as identified in Exhibit E without prior written consent of ALTANA, such consent not to be unreasonably refused. GPC undertakes to perform any and all obligations during the Establishment Term (excluding any extensions thereof as allowed for in Section 2.5.2) relating to GPC specified in the License Agreement between ALTANA and ARIAD regarding the Stanford IP (ALTANA/ARIAD Agreement) and the License Agreement between ARIAD and GPC (ARIAD Regulation Technology for GPC 3-Hybrid System dated January 31, 2003) to secure the sublicense granted by ARIAD to ALTANA so long as ALTANA fulfills all of its obligations under this Agreement and the ALTANA/ARIAD Agreement. For the avoidance of doubt, GPC will not be obligated to extend the term of the License Agreement between ARIAD and GPC (ARIAD Regulation Technology for GPC 3-Hybrid System) during any extensions of the Establishment Term as provided for in Section 2.5.2, however GPC will use reasonable efforts to assist ALTANA in obtaining a license to the ARIAD Regulation Technology for GPC 3-Hybrid System directly from ARIAD as provided for in the License Agreement between ARIAD and GPC (ARIAD Regulation Technology for GPC 3-Hybrid System) and the ALTANA/ARIAD Agreement so long as ALTANA (i) fulfills all of its obligations under this Agreement and the ALTANA/ARIAD Agreement, and (ii) continues to extend the Establishment Term and the relating collaboration efforts with GPC under this Agreement. GPC further agrees to guarantee in writing the payments to ARIAD from ALTANA to the extent required under the License Agreement between ARIAD and GPC and the ALTANA/ARIAD Agreement, and, upon GPCs making of such guarantee, ALTANA hereby guarantees any obligation GPC may have under GPCs guarantee, and shall make GPC whole in the event GPC is required to make payments to ARIAD under GPCs guarantee. Notwithstanding the foregoing guarantees, GPC hereby agrees that if payment to ARIAD is required under Section 4.3.1(ii) of the ALTANA/ARIAD Agreement, ALTANA shall only be required to make GPC whole for the first *** of any applicable fees due under said Section 4.3.1(ii), and that GPC shall make ALTANA whole for any payment made directly by ALTANA to ARIAD under Section 4.3.1(ii)in excess of *** of any applicable fees due under the GPC/ARIAD Agreement. The Parties are further in agreement that any payments to be made by ALTANA directly to ARIAD according to Sections 4.2.1 and 4.3.1 of the ALTANA/ARIAD Agreement that are triggered by and are based on payments to GPC by ALTANA under Sections 6.1.1, 6.1.3, 6.1.4, 6.1.6, and 6.2 of this Collaboration and License Agreement shall entitle ALTANA to deduct such amounts from payments due to GPC.
| *** | Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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3.2.4 Sublicense of Third Party Compounds and Third Party Compound Manufacturing. Subject to the terms and conditions of this Agreement and the agreement between GPC and Ariad identified in Exhibit E, GPC hereby grants to ALTANA a worldwide, non-exclusive, non-transferable sublicense, without the right to sublicense, under GPCs right to sublicense the right to make and use the Third Party Compounds in combination with the GPC Yeast 3-Hybrid Technology, GPC Yeast 3-Hybrid Technology Improvements, ALTANA Yeast 3-Hybrid Technology Improvements and Third Party 3-Hybrid Technology Improvements, and, subject to the transfer of manufacturing information about the Third Party Compounds pursuant to Section 3.2.5, GPC Third Party Compound Manufacturing Improvements, in each case only in the Field and only during the Establishment Term.
3.2.5 Transfer of Manufacturing Information Regarding Third Party Compounds. Subject to receipt of consent from Ariad pursuant to the agreement between GPC and Ariad identified in Exhibit E, which consent GPC shall seek promptly following the execution of this Agreement, GPC shall transfer to ALTANA all manufacturing information in its possession for the Third Party Compounds promptly after receipt of such consent.
3.2.6 New Technology other than Yeast 3-Hybrid Improvements. GPC hereby grants to ALTANA a perpetual, worldwide, co-exclusive license, with the right to grant sublicenses, to GPCs interest in any intellectual property jointly conceived, discovered, identified or first reduced to practice during the Establishment Term by employees of GPC working on the Collaboration and employees of ALTANA that is not a Collaboration Technology, Yeast 3-Hybrid Technology Improvement, a Third Party 3-Hybrid Technology Improvement, or a Third Party Compound Manufacturing Improvement.
3.3. Licenses to GPC.
3.3.1 Research License. Subject to the terms and conditions of this Agreement, ALTANA hereby grants GPC a non-exclusive research license in the Field, during the Collaboration Term, under the ALTANA Intellectual Property rights solely to use the proprietary materials and information that ALTANA provides to GPC under the Collaboration for conducting GPCs obligations in the Collaboration under the Research Plan.
3.3.2 Exclusive License for Reverted Y3H Targets. Subject to the terms and conditions of this Agreement, ALTANA hereby grants GPC a worldwide, fully paid, exclusive license, with the right to sublicense, under ALTANAs interest in the Joint Inventions, Collaboration Patents, ALTANA Intellectual Property and, to the extent assigned to ALTANA under Section 11.2, GPC Patents claiming any Reverted Y3H Target to conduct research and to develop, make, use, offer for sale, sell and import products, which products are based on such Reverted Y3H Target.
3.3.3 Exclusive License for GPC Elected Y3H Targets. Subject to the terms and conditions of this Agreement, ALTANA hereby grants GPC a worldwide, fully paid, exclusive license or sublicense, with the right to sublicense, under ALTANAs interest in the ALTANA Intellectual Property, Joint Inventions, and Collaboration Patents claiming any GPC Elected Y3H Target to conduct research and to develop, make, use, offer for sale, sell and import products, which products are based on such GPC Elected Y3H Target.
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3.3.4 New Technology other than Yeast 3-Hybrid Improvements. ALTANA hereby grants to GPC a perpetual, worldwide, co-exclusive license, with the right to grant sublicenses, to ALTANAs interest in any intellectual property jointly conceived, discovered, identified or first reduced to practice during the Establishment Term by employees of GPC and employees of ALTANA working on the Collaboration that is not a Collaboration Technology, Yeast 3-Hybrid Technology Improvement, a Third Party 3-Hybrid Technology Improvement or a Third Party Compound Manufacturing Improvement.
3.3.5 Non-Exclusive License to ALTANA Blocking Inventions. ALTANA acknowledges that ALTANA may make, create or identify through the use of the 3-Hybrid Intellectual Property Rights make discoveries or inventions that block GPC, its Affiliates, its Licensors listed in Exhibit E or sublicensees or other customers of GPC from using the 3-Hybrid Intellectual Property Rights or Third Party Compound Manufacturing Improvements to the extent of the rights granted to ALTANA hereunder (Blocking Inventions). To prevent this occurrence, ALTANA hereby grants GPC a fully paid-up, irrevocable, non-exclusive, royalty-free right and license, with the right to grant sublicenses, under ALTANAs rights to Blocking Inventions and any patents arising from patent inventions filed on Blocking Inventions which are required, and only to the extent required, to enable GPC, its Affiliates, its Licensors listed in Exhibit E, sublicensees and other customers to use the 3-Hybrid Intellectual Property Rights and Third Party Compound Manufacturing Improvements.
3.4. No Other Rights. Except as otherwise expressly provided in this Agreement, under no circumstances shall a Party hereto, as a result of this Agreement, obtain any ownership interest in or other right to any technology, know-how, patents, patent applications, products or materials of the other Party.
ARTICLE 4
Diligence
4.1. Diligence. Only as a condition for ALTANA maintaining its exclusive license granted to ALTANA pursuant to Sections 3.1.1 and 3.1.2, but not as a legal obligation, ALTANA shall itself or through its corporate partners or sublicensees use Commercially Reasonable Efforts to start and continue development activities of a Project Candidate based on each Catalogue Y3H Target during the Evaluation Period (until such time as a Catalogue Y3H Target is determined not to be an Accepted Y3H Target pursuant to Section 2.5.6) and each Accepted Y3H Target for which ALTANA has paid the Research Milestone under Section 6.1.4(d) (until such time as an Accepted Y3H Target is determined not to be a Viable Y3H Target) consisting of the initiation of clinical trials of Project Candidate, submission of regulatory filings and commercial launch of a Product.
With respect to each Y3H Target, beginning with the designation of each Catalogue Y3H Target by ALTANA pursuant to Section 2.5.4 and quarterly thereafter, ALTANA shall submit to GPC a summary progress report covering its activities related to developing Project Candidates and commercializing Products and preparing and filing all necessary regulatory approvals. Such progress reports shall be treated as Confidential Information. These progress reports shall be made for each Product until the First Commercial Sale of that Product.
4.2. Return of an Accepted Y3H Target, Project Candidate or a Product to GPC.
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4.2.1 If any one of the following events (a Return Event) occurs, then, except as set forth in Section 4.2.3 below, the Accepted Y3H Target, Project Candidate or Product, as the case may be, shall be returned to GPC, as described in Section 4.2.2 below:
(a) ALTANA at any time determines that an Accepted Y3H Target is not a Viable Y3H Target;
(b) ALTANA or its sublicensee fails to use Commercially Reasonable Efforts to develop a Project Candidate for a Viable Y3H Target in accordance with Section 4.1 and GPC notifies ALTANA of such failure, which notification is either accepted by ALTANA or there is a final determination pursuant to Article 16 that such failure has occurred, and neither ALTANA or a sublicensee is using Commercially Reasonable Efforts in accordance with Section 4.1 to develop at least one Project Candidate for the same Viable Y3H Target, and ALTANA or its sublicensee fails to remedy or take reasonable action to remedy such event within ninety (90) days after notice thereof by GPC; or
(c) following receipt by ALTANA or its sublicensee of all necessary regulatory approvals to market a Product in a major market country as listed in Exhibit C (a Major Market Country), there is a continuous one (1) year period during which no such Product is sold in such Major Market Country (provided that such sale is not prevented by Force Majeure, government regulation or intervention or institution of a law suit by a Third Party), and ALTANA or its sublicensee fails to take reasonable action to initiate the sales of such Product in the respective Major Market Country during such one (1) year period within one hundred and twenty (120) days after notice thereof by GPC.
4.2.2 Upon the occurrence of a Return Event and except as described in Section 4.2.3, (A) GPC shall have the right to terminate the licenses and rights granted to ALTANA pursuant to Section 3.1 with respect to such Accepted Y3H Target and/or such Product (but, as to Section 4.2.1(c) above, only in such country), and, following such termination, (B) ALTANA will immediately cease to develop or manufacture and sell, as applicable, such Accepted Y3H Target, Project Candidate or Product (but, as to Section 4.2.1(c) above, only in such country), and (C) GPC shall have a worldwide, perpetual right and license under ALTANA Intellectual Property (however, with respect to trademarks Controlled by ALTANA or its Affiliates such license shall be limited to the country referred to in Section 4.2.1(c) above and subject to the restrictions referred to in Section 15.3.5 second sub-paragraph) to conduct research and development using Commercially Reasonable Efforts within the Field with respect to such Accepted Y3H Target, Project Candidate or Product (but, as to Section 4.2.1(c) above, only in such country) and to sell such Product or any Product resulting from such research and development using Commercially Reasonable Efforts which license shall be royalty bearing on the same terms as Products sold by ALTANA bear royalties hereunder; provided, however, that GPC shall not have the right to terminate this Agreement in its entirety based on any failure to diligently develop Product so long as ALTANA at least diligently pursues a Y3H Target according to the Y3H Target election procedure or one Project Candidate and/or Product is being pursued diligently by ALTANA in accordance with Section 4.1, and further provided that the rights of GPC described in this Section 4.2.2 shall be in lieu of any right to terminate this Agreement in its entirety in the event of failure by ALTANA to commercialize a Product pursuant to Section 4.2.1(c) in any particular Major Market Country (provided that ALTANA is commercializing a Product in no less than three (3) other Major Market Countries).
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4.2.3 Upon the occurrence of an event described in Section 4.2.1(b) above, ALTANA may elect, in lieu of GPCs exercise of the rights described in Section 4.2.2, to (a) suspend research and development of such Accepted Y3H Target, Project Candidate or Product, (b) retain all rights hereunder with respect to such Accepted Y3H Target, Project Candidate or Product and (c) pay to GPC an amount equal to One Hundred Thousand Dollars ($100,000) per calendar year with respect to each Accepted Y3H Target, Project Candidate or Product, payable quarterly in advance and pro rated for any partial calendar quarters, with the first payment due within ninety (90) days of the occurrence of the event described in Section 4.2.1(b) for the quarter or partial quarter in which such period ends. If at any time ALTANA fails to make a payment within thirty (30) business days of the date that such payment is due in accordance with this Section, GPC shall have the rights described in Section 4.2.2 with respect to such Accepted Y3H Target or Product.
ARTICLE 5
FTE and Research Funding
5.1. FTE Rates and Adjustments. The annual FTE rate for FTEs working on the Collaboration shall be based on a rate of Two Hundred Sixty-Five Thousand two hundred twenty five Dollars ($265,225) per FTE for 2003, with such rate to be increased by three percent (3%) per year for each year after 2003. Beginning on January 1, 2004, the annual FTE rate shall, therefore, be an adjusted rate.
5.2. FTE Support. GPC shall provide the following FTEs for transfer of the GPC Yeast 3-Hybrid Technology and the Collaboration. Until December 31, 2004: *** FTEs; during 2005, *** FTEs; during 2006 , *** FTE, and from January 1, 2007 through June 30, 2007, *** FTE. The Joint Steering Committee shall allocate the FTEs depending on the progress and needs of the Collaboration.
5.3. Payment of Research Funding. The funding of GPC FTEs set forth in the Resource Plan shall be paid by ALTANA quarterly in advance, on a calendar quarter basis, during the Establishment Term with the first payment to be paid within ninety (90) days after the Effective Date.
ARTICLE 6
Payments
6.1. Payments to GPC.
6.1.1 Annual License Fee. In consideration of ALTANAs continued access to the GPC Yeast 3-Hybrid Technology and Yeast 3-Hybrid Technology Improvements, ALTANA shall pay to GPC a total annual license fee (the Annual License Fee) of Two Hundred Thousand Dollars ($200,000) as of the Effective Date and the following four anniversaries of the Effective Date. The Annual License Fee shall be payable effective as of the respective anniversary of the Effective Date, with the first payment of $200,000 due one hundred and twenty (120) days after the Effective Date. For the avoidance of doubt, the Annual License Fees shall amount to a total sum of One Million Dollars ($1,000,000).
6.1.2 Annual Sublicense Fee. In consideration of ALTANAs continued access to the Third Party 3-Hybrid Technology, ALTANA shall pay to GPC a total annual
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license (the Annual Sublicense Fee) fee of *** for the first year, *** per each whole or partial year for the remainder of the Establishment Term. The Annual Sublicense Fee shall be payable annually in advance, with the first payment of *** due one hundred and twenty (120) days after the Effective Date.
6.1.3 Annual Technology Transfer Fee. In consideration of the transfer to ALTANA of the GPC Yeast 3-Hybrid Technology and GPC Yeast 3-Hybrid Technology Improvements, ALTANA shall pay to GPC a technology transfer fee (the Annual Technology Transfer Fee) of Two Hundred Thousand Dollars ($200,000), per Research Year for the first three Contract Years, payable pro rata based upon the achievement of the implementation milestone (the Implementation Milestone) for the given Contract Year, the first of which is set forth in Exhibit G attached hereto. Such payment is due within thirty (30) days of achievement of the Implementation Milestone, as determined by the Joint Steering Committee. Payments for milestones not achieved in a particular year shall be paid in a succeeding year if the milestone is achieved in such succeeding year.
6.1.4 Research Milestones. ALTANA shall make the following research-based milestone payments to GPC upon the achievement of each of the applicable milestones with respect to Y3H Targets and Products (the Research Milestones):
(a) upon completion of the determination of target interaction landscapes for the agreed upon publicly available *** or other publicly available small molecules on the Reverse Genomics Research Program, *** for each publicly available inhibitor/small molecule with a maximum of five (5) inhibitors/small molecules.
(b) upon the completion of the determination of target interaction landscapes for the agreed upon *** or other small molecules with relevance to ALTANAs research in the Reverse Genomics Research Program, *** for each inhibitor/small molecule with relevance to ALTANAs research with a maximum funding of five (5) inhibitors/small molecules.
(c) upon the designation by ALTANA of a Catalogue Y3H Target pursuant to Section 2.6.4, *** for each Catalogue Y3H Target;
(d) upon the designation by ALTANA of an Accepted Y3H Target pursuant to Section 2.6.6, *** for each Accepted Y3H Target; and
(e) upon the selection by ALTANA of a Project Candidate, *** for each Project Candidate. Notwithstanding the foregoing, in a case where a Project Candidate directed against an Accepted or Viable Y3H Target fails in research and clinical development, and ALTANA moves another Project Candidate against the same Accepted or Viable Y3H Target into research and clinical development (a Substituted Project Candidate) as a backup to the failed Project Candidate, then the Research Milestone previously paid in connection with the failed Project Candidate shall not be due on the Substituted Project Candidate.
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6.1.5 All payments to be made to GPC by ALTANA pursuant to Section 6.1.4 shall be made within thirty (30) days of receipt of the corresponding invoice by GPC following the achievement of each applicable Research Milestone. The Party initiating any event triggering a Research Milestone payment hereunder shall promptly report the achievement of such milestone to the other Party.
6.1.6 Clinical Milestones. In consideration of the grant of license rights to ALTANA hereunder, ALTANA shall make the payments set forth below for each Product per Accepted or Viable Y3H Target to achieve the corresponding clinical milestone event with respect to Products as set forth below. ALTANA shall promptly notify GPC of the occurrence of any milestone event. Notwithstanding the foregoing, in a case where a Product directed against an Accepted or Viable Y3H Target fails in clinical development, and ALTANA moves another Product against the same Accepted or Viable Y3H Target into clinical development (a Substituted Product) as a backup to the failed Product, then clinical milestone payments previously paid in connection with the failed Product shall not be due on a Substituted Product. Fifty percent (50%) of payments made pursuant to this Section with respect to each subsequent Product directed against the same Accepted or Viable Y3H Target after the first such Product (and where such subsequent Product is not a Substituted Product) shall be credited against payments due to GPC pursuant to Section 6.2.
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Milestone Event |
Payment | |
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(i) Filing of IND with the FDA (if not rejected) | *** | |
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(ii) Initiation of Phase II or Phase I/II Clinical Trial | *** | |
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(iii) Initiation of Phase III Clinical Trial | *** | |
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(iv) Filing of an NDA with the FDA | *** | |
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(v) Filing of MAA with the EMEA | *** | |
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(vi) Filing of drug approval application with MHW | *** | |
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(vii) Regulatory Approval of Product in U.S. | *** | |
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(viii) Regulatory Approval of Product in Europe | *** | |
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(ix) Regulatory Approval of Product in Japan | *** | |
For the avoidance of doubt, with respect to the clinical milestones set forth in (ii) and (iii) above, in the event a clinical trial is initiated which is a combination of Phase I Clinical Trial and Phase II Clinical Trial or a Phase II Clinical Trial and a Phase III Clinical Trial, then ALTANA shall pay both applicable milestone payments to GPC. All payments to be made to GPC by ALTANA pursuant to this Section 6.1.6 shall be made within thirty (30) days of receipt of the corresponding invoice by GPC following the achievement of each applicable milestone.
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6.1.7 Limitations on Milestone Payments. Notwithstanding anything contained herein, no Research Milestones or Clinical Milestones shall be payable with respect to ALTANA R&D Compounds or ALTANA Validated Y3H Targets.
6.2. Royalties.
6.2.1 Products. In further consideration of the licenses granted herein, ALTANA shall pay to GPC the following royalties on worldwide cumulative annual Net Sales of Products in any calendar year:
|
Royalty Rate | ||||
|
Net Sales |
Products Marketed for *** |
Products Marketed for Indications *** | ||
|
Less than or equal to $100 million | *** | *** | ||
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Greater than $100 million but less than or equal to $250 million | *** | *** | ||
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Greater than $250 million but less than or equal to $500 million | *** | *** | ||
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Greater than $500 million but less than or equal to $1,000 million | *** | *** | ||
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Greater than $1,000 million | *** | *** | ||
Royalties with respect to each Product shall be paid to GPC on a country-by-country basis for the longer of (a) 10 years from First Commercial Sale of such Product in such country; (b) until there no longer exists a Valid Claim covering the therapeutic agent or active ingredient within such Product (without regard to other Valid Claims covering other aspects of such Product, including, for example, claims covering the formulation, application or synthesis of such Product); or (c) until there no longer exists a Valid Claim of Licensed Patents whose use resulted in the Product. Payments shall be made concurrently with delivery of the quarterly payment report pursuant to Section 7.4. Royalties shall be paid at the applicable marginal rate set forth above with respect to Net Sales in a particular year. Therefore, for example, if cumulative annual Net Sales of a Product marketed for *** were ***, ALTANA would pay to GPC royalties at the rate of *** of Net Sales up to $100 million ***, ***% of Net Sales above $100 million up to $250 million ***, and *** of Net Sales above $250 million up to $400 million *** for total royalties due in that year of ***.
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6.2.2 Reductions to Royalties. The royalties set forth in Section 6.2.1 shall be reduced as follows:
(i) If ALTANA is required to pay royalties to Third Parties for rights under patents necessary to develop, make or sell Products, it may deduct an amount equal to up to *** of such royalties from the royalties due to GPC under Section 6.2.
(ii) In the event that there exists Significant Generic Competition (as defined below) in a country, the royalty rate that would otherwise be applicable to sales in such country shall be reduced by ***. Significant Generic Competition shall occur in a country where (i) there is no Valid Claim covering a Product in such country, (ii) another entity is selling the same product as the Product for the same indication in such country, and (iii) sales by ALTANA of the Product in such country have been negatively impacted in such country by more than *** over a one (1) year period by the entry of the generic competitor selling the same Product.
Notwithstanding the foregoing, in no event shall the applicable royalty in any country be reduced below the greater of (i) *** of the royalty otherwise applicable or (ii) *** of Net Sales. Notwithstanding the foregoing, the minimum royalty rate for Combination Products marketed shall be***.
6.3. Non-Duplication of Payments. Any payment specifically due under this Agreement shall be paid only once under this Agreement and shall be in lieu of any payment obligations under any other agreements between the Parties.
ARTICLE 7
General Payment Provisions and Royalty Reports
7.1. Currency. All monies due to GPC hereunder are payable in United States dollars. When Products are sold for monies other than United States dollars, the earned royalties will first be determined in the foreign currency of the country in which such Products were sold and then converted into equivalent United States funds. The exchange rate will be the average rate between the buying and selling rate as quoted in the Wall Street Journal on the last business day of the reporting period.
7.2. Foreign Legal Restrictions on Payment. If at any time legal restrictions prevent the prompt remittance of part or all payments by ALTANA with respect to any country where a Product is sold, unless prohibited from lawfully doing so, ALTANA shall pay GPC directly from another source of funds for the amount impounded. ALTANA will then pay all future royalties due to the other from another source of funds so long as the legal restrictions of this section still apply.
7.3. First Commercial Sale. ALTANA also agrees to report to GPC in its immediately subsequent progress and royalty report the date of First Commercial Sale of a Product in each country.
7.4. Quarterly Payment Reports. After the First Commercial Sale of a Product anywhere in the world, ALTANA shall make quarterly payment reports to GPC on or before the first day of March, June, September and December of each year for the preceding calendar quarter. Each report shall cover the most recently completed calendar quarter and shall show (a) the gross sales and Net Sales of Products sold during the most recently completed calendar quarter; (b) the number of each type of Products sold; (c) the royalties, in U.S. dollars, payable