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OncoMed Pharmaceuticals Inc – IPO: ‘S-1/A’ on 10/24/12 – EX-10.21

On:  Wednesday, 10/24/12, at 9:46pm ET   ·   As of:  10/25/12   ·   Accession #:  1193125-12-433969   ·   File #:  333-181331

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  As Of                Filer                Filing    For·On·As Docs:Size              Issuer               Agent

10/25/12  OncoMed Pharmaceuticals Inc       S-1/A                  6:3.0M                                   RR Donnelley/FA

Document/Exhibit                   Description                      Pages   Size 

 1: S-1/A       Amendment No. 4 to Registration Statement on Form   HTML   1.91M 
                          S-1                                                    
 2: EX-10.1(C)  Second Amendment Regarding Payment of Certain       HTML     16K 
                          Milestone Payments                                     
 3: EX-10.2(B)  Amendment 1 to the Collaboration and Option         HTML     31K 
                          Agreement                                              
 4: EX-10.20    Collaboration Agreement                             HTML     74K 
 5: EX-10.21    Multi-Product License Agreement                     HTML    131K 
 6: EX-23.1     Consent of Independent Registered Public            HTML      6K 
                          Accounting Firm                                        

Exhibit 10.21

MULTI-PRODUCT LICENSE AGREEMENT

between

LONZA SALES AG

and

ONCOMED PHARMACEUTICALS, INC.

INDEX

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THIS AGREEMENT is made the 22nd day of August 2012

BETWEEN

LONZA SALES AG, incorporated and registered in Switzerland whose registered office is at Muenchensteinerstrasse 38, CH-4002, Basel, Switzerland(hereinafter referred to as “Lonza”), and

ONCOMED PHARMACEUTICALS, INC., incorporated in Delaware whose office is at 800 Chesapeake Drive, Redwood City, CA 94063, USA (hereinafter referred to as “OncoMed”).

WHEREAS

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NOW, THEREFORE, in consideration of the mutual promises and covenants contained herein, and other good and valuable consideration the receipt of which is hereby acknowledged, the parties hereby agree as follows:

“Affiliate” means any company, partnership or other entity which directly or indirectly controls, is controlled by or is under common control with the relevant party to this Agreement. For the purposes of this paragraph, “control” means the ownership of more than fifty percent (50%) of the issued share capital or the legal power to direct or cause the direction of the general management and policies of the party in question.

“Approved Territories” means the [***], and all territories and possessions of each of the foregoing.

“Cell Lines” means the cell lines provided by Lonza [***] to OncoMed under this Agreement or the REA for use with the System.

“Collaboration Agreement” means the Collaboration Agreement, by and between the parties, dated as of the Effective Date.

“Clinical Trial Commencement” means the date of first administration of a Product to a human subject in a clinical trial.

“Competing Contract Manufacturer” means any entity that conducts [***] as a [***].

“Effective Date” means the date first above written.

“EMA” means the European Medicines Agency and any successor agency.

“FDA” means the United States Food & Drug Administration and any successor agency.

“First Commercial Sale” means the date of the first sale or other disposal of Product for money or money’s worth by OncoMed, its Affiliates, or its sublicensees to a third party after Regulatory Approval of such Product, excluding disposal of Product (A) as commercial or registration samples, (B) for educational purposes, (C) for use in

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clinical studies, (D) for compassionate use, or (E) to third parties for evaluation purposes, in each of [***]. OncoMed’s Affiliates in existence as of the Effective Date are listed on Schedule 4.

“Intellectual Property” means Materials Know-How and Patent Rights.

“Insolvency” means, for purposes of Clauses 5.3 and 5.4, that a party has been affected by circumstances described in Clause 9.6(b) of the MSA or Clause 11.1.3 of the Collaboration Agreement, as applicable.

“Know-How” means unpatented technical and other information, including but without prejudice to the generality of the foregoing ideas, concepts, inventions, discoveries, data, formulae, specifications, procedures for experiments and tests and other protocols, results of experimentation and testing, fermentation and purification techniques and assay protocols.

“Materials” means any materials that are provided by Lonza [***] to OncoMed under this Agreement or the REA for use with the System, including without limitation the [***]; but excluding any [***].

“Materials Know-How” means Know-How owned or controlled by Lonza [***] and provided to OncoMed under this Agreement.

“Media and Feed Packages” means the [***] and the related know-how used in [***] as fully set out in Schedule 3.

“Net Sales” means:

(i) with respect to sales of Product by OncoMed or its Affiliates, the net amounts received in respect of sales of Products by OncoMed or its Affiliates in the Territory, after Regulatory Approval of such Product in the country of sale, less the following items to the extent that they are paid or allowed and included in the invoice price:

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(ii) with respect to sales of Product by an OncoMed sublicensee [***]; provided that such [***]. Lonza agrees that the [***] for purposes of this subclause (ii), are [***].

Upon any sale or other disposal of Product by or on behalf of OncoMed or its Affiliates hereunder other than a bona fide arm’s length transaction exclusively for money, such sale, or other disposal, shall be deemed to constitute a sale at the then current [***] in the country in which such sale, other disposal or use of such Product occurs.

For the avoidance of doubt, the determination of Net Sales under subclause (i), above, shall exclude any Product supplied (A) as commercial or registration samples, (B) for educational purposes, (C) for use in clinical studies, (D) for compassionate use, or (E) to third parties for evaluation purposes.

“Patent Rights” means any and all patents and patent applications owned or otherwise controlled by Lonza that claim or cover [***] including but not limited to the patents and patent applications set forth in Schedule 1 to this Agreement, as may be modified by the written agreement of the parties from time to time in accordance with Clauses 9.1 and 15.2, and any and all foreign counterparts thereof throughout the world (whether national or regional), including but without prejudice to the generality of the foregoing, author certificates, inventor certificates, improvement patents, utility certificates and models and certificates of addition, and any and all divisions,

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renewals, continuations, continuations in part, reexaminations, reissues, any extensions of any of the foregoing, and any foreign counterparts thereof.

“Phase 3 Clinical Trials” means those human clinical studies regulated by the FDA or equivalent organisation conducted to gain evidence of efficacy on the target population, determine optimal dosage, and obtain expanded evidence of safety for the Product as set forth in 21 C.F.R. § 312.21(c) in the United States of America or the equivalent regulations or legislation in a different jurisdiction.

“Product(s)” means one or more products covered by intellectual property rights that are [***] particulars of which will be set out in Schedule 2 to this Agreement, as may be modified by the written agreement of the parties from time to time in accordance with Clause 4.2 or 4.4.

“Regulatory Approval” means, with respect to any Product in any jurisdiction, all approvals, including without limitation pricing approvals, granted by any regulatory authority, including the FDA, EMA or other equivalent organisation, that are necessary for the marketing and sale of a Product in such jurisdiction.

“Strategic Partner” means a third party with whom OncoMed has entered into a contractual relationship to [***]. In no event may any entity that is [***] be deemed a Strategic Partner for the purposes of this Agreement.

“System” means Lonza’s [***]. For the avoidance of doubt, [***] does not form part of the System.

“Territory” means world-wide.

“Transfected Cell Line” means a Cell Line containing [***].

“Valid Claim” means [***] that has not [***] by the decision of a court or other governmental agency of competent jurisdiction unappealable or unappealed within the time allowed for appeal and which has not been admitted to be [***] through re-issue or disclaimer or otherwise, and has not been abandoned or disclaimed.

“Vectors” means the vectors provided by Lonza [***] to OncoMed under this Agreement or the REA [***].

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(a) to use the Materials; and

(b) to use the Materials Know-How;

in each case solely for the purposes of exercising the rights granted under the license granted in Clause 4.1 or as otherwise permitted under the REA, and

(a) to use [***]; and

(b) to use [***];

in each case solely for the purposes of exercising the rights granted under the license granted in Clause 4.1. In the event OncoMed determines that [***] for such sublicensees or independent contractors to manufacture, use and/or sell Product, [***] such [***] by OncoMed’s sublicensees and independent contractors.

For purposes of clarity, OncoMed and its Affiliates may only use the Materials to make the Products by [***] and otherwise in accordance with the license granted in Clause 4.1.

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(b) Lonza’s prior written consent shall [***] pursuant to this Clause 4 to any third party (including without limitation any Strategic Partner and/or Competing Contract Manufacturer) [***], such consent not to be unreasonably withheld, delayed or conditioned. Lonza shall notify OncoMed whether it will not provide such [***] promptly after receiving OncoMed’s written request therefor. For purposes of the foregoing, it shall be deemed to be [***].

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Lonza and OncoMed shall amend this Agreement by updating Schedule 2 to delete such Product(s), which shall thereafter not be deemed a “Product” under this Agreement. Any such agreement between Lonza and such Strategic Partner shall include without limitation the pricing applicable in Schedule 1 of the Collaboration Agreement.

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(i) Lonza and OncoMed (or OncoMed’s Affiliate) have entered into a separate manufacturing agreement in respect of Lonza’s manufacture of a Product (including without limitation the MSA), but Lonza materially breaches such agreement;

(ii)during the term of the Collaboration Agreement, Lonza acknowledges that Lonza is [***] for a Product that is subject to Clause 3.3.1 of the Collaboration Agreement (Lonza having been provided with reasonable notice [***] of OncoMed’s [***] pursuant to the Collaboration Agreement so as to afford Lonza the opportunity to discuss, pursuant to Clause 3.3.1 of the Collaboration Agreement, with OncoMed whether Lonza will manufacture such Product;

(iii) during the term of the Collaboration Agreement, OncoMed, pursuant to Section 3.3.1 or 3.3.4 of the Collaboration Agreement, exercises its rights thereunder to engage a third party to manufacture a Product, and it is determined in accordance with such Sections and, if applicable, Clauses 12.3 and 12.4 of this Agreement that, for purposes of determining the royalty due to Lonza with respect to any such Product that is manufactured by a third party, Lonza was [***] as to (A) [***] (B) [***] or (C) [***] of expected [***] of such Products;

(iv) the Collaboration Agreement has terminated prior to its expiration because of Lonza’s breach or Lonza’s Insolvency under the Collaboration Agreement or because the MSA terminated due to breach of the MSA by Lonza or Lonza’s Insolvency under the MSA;

(v) OncoMed’s [***] of the Collaboration Agreement, that a Product should be [***]; or

(vi) OncoMed’s Strategic Partner and/or OncoMed, or an Affiliate of such Strategic Partner or OncoMed, [***];

then in each of the conditions set forth in subclauses (i) through (vi), should the relevant Product (in the case of subclause (iv), such relevant Product

12

means any Product that was subject to the Collaboration Agreement or would have been subject to the Collaboration Agreement had that agreement not terminated early) be manufactured by [***] of (A) such Products manufactured for [***] shall be [***] of Net Sales of each such Product, and (B) such Products manufactured for [***] of Net Sales of each such Product.

(i) a manufacturing agreement between Lonza and OncoMed for such Product expires or will expire according to its terms, and [***], within [***] following a request by [***], or

(ii) the Collaboration Agreement expires or will expire according to its terms, and [***] within [***] following a request by [***] (provided that the relevant Product would have [***])].

provided that if subclause (ii) applies, such payments shall [***].

13

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Such statement shall be submitted to Lonza (i) with respect to sales of Product by OncoMed or its Affiliates, within [***] days of the end of the calendar quarter to which it relates together with a remittance for the amount due to Lonza, or (ii) with respect to sales of Product by any OncoMed sublicensee under this Agreement, within [***] days following OncoMed’s receipt of the relevant payment from such sublicensee for each calendar quarter for which payments are due in accordance with Clause 5, together with a remittance for the amount due to Lonza.

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expense of and borne by Lonza. OncoMed and Lonza will cooperate with respect to all documentation required by any taxing authority or reasonably requested by the other to secure a reduction in the rate of applicable withholding taxes.

7.1.1 such party is duly organized and validly existing under the laws of the jurisdiction of its incorporation or formation and is authorized to do business to the extent necessary to fulfil its obligations hereunder;

7.1.2 such party is duly authorized to execute and deliver this Agreement and the person or persons executing this Agreement on its behalf have been duly authorized to do so by all requisite corporate or partnership action;

7.1.3 this Agreement is legally binding upon such party, enforceable in accordance with its terms, and does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such party; and

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In the event that Lonza elects not to take proceedings in respect of any infringement or threatened infringement or challenge to validity Lonza shall [***]. In such case OncoMed shall be entitled to retain any monies recovered from such alleged infringers or challengers of validity.

21

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to recover damages against the other and all provisions which are expressed to survive this Agreement shall remain if full force and effect.

In the event of any Change of Control of OncoMed, Clause 4.2 shall no longer apply following the closing of the relevant transaction. For purposes of this Clause 11.1, “Change of Control” means the occurrence of any of the following:

(a) OncoMed’s entering into a merger, consolidation or sale of a controlling interest in OncoMed or a sale of all or substantially all of its assets to which this Agreement relates with or to [***], unless, following such transaction , (i) the individuals and entities who were the beneficial owners of the outstanding voting securities of OncoMed immediately prior to such transaction beneficially own, directly or indirectly, at least [***] of the then outstanding voting securities entitled to vote generally in the election of directors or similar governing persons of the corporation or other entity resulting from such transaction (“Successor”), and (ii) at least [***] of the members of the Board of Directors or similar governing body of the Successor were members of the Board of Directors of OncoMed at the time of the execution of the initial agreement, or the action of the Board of Directors of OncoMed, governing such transaction; or

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(b) any transaction in which [***] acquires beneficial ownership of securities of OncoMed representing more than [***] of the then outstanding securities of OncoMed;

provided, however, that, notwithstanding subsections (a) or (b) above, neither the sale of OncoMed’s securities in an underwritten public offering of OncoMed’s securities to multiple non-affiliated investors, nor the grant of a license by OncoMed to [***], shall constitute a Change of Control.

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Neither party shall be in breach of this Agreement if there is any total or partial failure of performance by it of its duties and obligations under this Agreement occasioned by any act of God, fire, act of government or state, war, civil commotion, insurrection, embargo, prevention from or hindrance in obtaining any raw materials, energy or other supplies, labour disputes of whatever nature and any other reason beyond the control of either party. If either party is unable to perform its duties and obligations under this Agreement as a direct result of the effect of one of the reasons set out in this Clause 13 such party shall give written notice to the other of such inability stating the reason in question. The operation of this Agreement shall be suspended during the period (and only during the period) in which the reason continues. Forthwith upon the reason ceasing to exist the party relying upon it shall give written advice to the other of this fact. If the reason continues for a period of more than ninety (90) days and substantially affects the commercial basis of this Agreement the party not claiming under this Clause 13 shall have the right to terminate this Agreement by giving sixty (60) days written notice of such termination to the other party.

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If any provision or term of this Agreement or any part thereof shall become or be declared illegal, invalid or unenforceable for any reason whatsoever including but without limitation by reason of the provisions of any legislation or other provisions having the force of law or by reason of any decision of any court or other body or authority having jurisdiction over the parties hereto or this Agreement, such terms or provisions shall be divisible from this Agreement and shall be deemed to be deleted from this Agreement in the jurisdiction in question provided always that if any such deletion substantially affects or alters the commercial basis of this Agreement either party shall have the right to terminate this Agreement by giving sixty (60) days written notice of such termination to the other party.

15.1 This Agreement, together with the REA, the MSA, and the Collaboration Agreement (collectively, the “OMP/Lonza Agreements”), and all attachments hereto and thereto, embody and set forth the entire agreement and understanding of the parties and supersede all prior and contemporaneous oral and written agreements, understandings or arrangements relating to the subject matter of this Agreement. Neither party shall be entitled to rely on any agreement, understanding or arrangement which is not expressly set forth in this Agreement. For clarity, while the OMP/Lonza Agreements set forth the entire agreement and understanding of the parties, the parties recognize that each of such agreements has been individually negotiated and that where such agreements provide for specific remedies for a failure by Lonza to supply Product confirming to applicable specifications and other requirements under such agreements, such specific remedies shall be given effect.

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Address of Lonza

Lonza Sales AG, 228 Bath Road, Slough, Berkshire SL1 4DX

Facsimile: 01753 777001

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For the attention of the Head of Legal Services

Address of OncoMed

OncoMed Pharmaceuticals, Inc.

800 Chesapeake Drive

Redwood City, CA 94063

USA

Facsimile: 1-650-995-4570

For the attention of President and CEO

or to such other address as either party hereto may hereafter notify the other in accordance with the provisions of this Clause 16.

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(Signature page follows)

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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their respective representatives thereunto duly authorised as of the Effective Date.

[Signature page to Multi-Product License Agreement]

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SCHEDULE 1

PATENT RIGHTS

[***]

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SCHEDULE 2

PRODUCTS

32

SCHEDULE 3

Media and Feeds

[***]

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SCHEDULE 4

ONCOMED’S AFFILIATES AS OF THE EFFECTIVE DATE

None.

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Dates Referenced Herein

This ‘S-1/A’ Filing		Date		Other Filings
Filed as of:		10/25/12		None on these Dates
Filed on:		10/24/12
		12/5/08
		5/21/07
				List all Filings

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Filing Submission 0001193125-12-433969   –   Alternative Formats (Word / Rich Text, HTML, Plain Text, et al.)

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